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Article 44 imposes no duty on the provider himself; this is the practical working out we read into it, see the note on the provision."}],"exceptions":[],"statements":[],"legal_status":null,"deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"The Regulation on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:action:map-system-to-annex-iii-area","legacy_id":"raip:action:map-system-to-annex-iii-area","type":"action","slug":"map-system-to-annex-iii-area","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"0ec43a226df935b1465f0ea61fd40197b8d386269327ef2574d0a84bb81c6835","label":"Map every system to a point of Annex III","summary":"Determine per AI system which of the eight areas and which lettered subpoint the intended purpose touches, or establish with reasons that no point applies. Then run the Article 6(3) test and record the outcome as Article 6(4) requires. Do so at the level of the intended purpose and not at the level of the department or the sector.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-eight-areas"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"map-system-to-annex-iii-area-scope","operator":"all","description":"To be carried out before a system is placed on the market or put into service, and again on every change to the intended purpose. Well before 2 December 2027, because the answer determines how much work follows."}],"exceptions":[],"statements":[],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Annex III on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:action:mark-confidential-material-on-submission","legacy_id":"raip:action:mark-confidential-material-on-submission","type":"action","slug":"mark-confidential-material-on-submission","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"1a1c83bf26c7b8cc95f52cc0350a637355d9b59e0da7bf6f9156788e1ccd37f8","label":"Mark and register what you submit to an authority or body","summary":"State on every submission which part is confidential business information, trade secret or source code, keep track of what was handed to whom on what date, and on a further request ask about the necessity and the purpose within the meaning of Article 78(2).","topics":["enforcement","governance"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-78-confidentiality"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"mark-confidential-material-on-submission-scope","operator":"all","description":"Arises on every submission to a market surveillance authority, a notified body, the Commission or the AI Office, and on every registration part of which lands in the secure non-public section of the EU database."}],"exceptions":[],"statements":[],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 78 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/78","label":"Read Article 78 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:action:notify-systemic-risk-threshold","legacy_id":"raip:action:notify-systemic-risk-threshold","type":"action","slug":"notify-systemic-risk-threshold","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"65a8b063463c2dc75b5dc4818d987c332a94fbaca9284ee52d4ac412ac01f266","label":"Notify the Commission within two weeks","summary":"Notify the model as soon as it meets the condition in Article 51(1), point (a), or as soon as it becomes known that it will, with the information necessary to demonstrate that the requirement has been met, and with any substantiation that the model does not present systemic risks after all.","topics":["gpai-systemic-risk"],"actor_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-52-systemic-risk-classification"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"notify-systemic-risk-threshold-scope","operator":"all","description":"To be carried out within two weeks after the requirement in Article 51(1), point (a), is met or after it becomes known that it will be met, and to be revisited for every new model version that touches the threshold. For models placed on the market before 2 August 2025 the date in Article 111(3) applies."}],"exceptions":[],"statements":[],"legal_status":"applicable","deadline_at":"2025-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 52 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:action:open-a-protected-reporting-route","legacy_id":"raip:action:open-a-protected-reporting-route","type":"action","slug":"open-a-protected-reporting-route","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"c5c2f21f3f2103b26d48c110857c7bc3ce689178cc441e6d18d32749b39635df","label":"Make sure a report about an AI system reaches your reporting channel","summary":"Only for organisations that must already have a reporting arrangement. Make visible in it that an infringement of the AI Regulation is a reportable infringement, designate who receives such a report, agree how the identity of the person reporting stays out of the rest of the process, and record whether you handle anonymous reports.","topics":["fundamental-rights","governance"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"This action does not follow from Article 87 but from Directive (EU) 2019/1937 and its national transposition, and it applies only to those already covered by it. Article 87 adds subject matter to that arrangement, not a duty to set one up: it brings infringements of the AI Regulation within reach of a report. A defensible alternative reading is that there is nothing for you to do because your reporting arrangement already accepts any breach of Union law and the AI Regulation falls under it without change. Below the threshold of fifty workers there is nothing to set up at all. The date on which an existing channel requirement started is 17 December 2021, or 17 December 2023 for entities with fifty to two hundred and forty-nine workers, and not 2 August 2026; that last date is only when Article 87 brings the extension of subject matter. That is why no deadline_at is set here.","obligation_ids":["praxikon:eu:ai-act:obligation:article-87-reporting-infringements"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"open-a-protected-reporting-route-scope","operator":"all","description":"Applies where an internal reporting requirement already rests on you under the national transposition of Directive (EU) 2019/1937, in principle at fifty or more workers, and you develop or use AI systems covered by the Regulation. To be revisited whenever your reporting arrangement or that national law changes."}],"exceptions":[{"id":"open-a-protected-reporting-route-below-threshold","operator":"any","description":"Does not apply to organisations falling outside the channel requirement under Article 8(3) or Article 8(9) of Directive (EU) 2019/1937. For them there is nothing to set up; the person reporting retains the external route of Article 10 of that Directive."}],"statements":[{"kind":"editorial_interpretation","text":"What is asked of you here is not stated in Article 87. It sits in Directive (EU) 2019/1937 and in national transposition law, and it applies only if you are already covered by it. Article 87 does one thing: it makes an infringement of the AI Regulation something that can be reported through that channel. The set-up question is therefore narrow. Does the person receiving the report recognise that the AI Regulation may be engaged, does the identity of the person reporting stay out of the substantive follow-up, and have you recorded whether you handle anonymous reports, which Article 6(2) of that Directive leaves to the Member State.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 87","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 87 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:action:plan-legacy-public-system-compliance","legacy_id":"raip:action:plan-legacy-public-system-compliance","type":"action","slug":"plan-legacy-public-system-compliance","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"1664bab006c5a034f299bad5cdd9f511aef0b1803a44e0b72fd9e299d964b701","label":"Plan compliance for legacy public sector systems by 2 August 2030","summary":"Determine which high-risk systems are intended to be used by public authorities and were already running before the cut off date for their route, and count back from the conformity assessment and the registration to a plan that finishes before 2 August 2030.","topics":["high-risk","timeline"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-111-legacy-public-systems"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"plan-legacy-public-system-compliance-scope","operator":"all","description":"Applies once it is established that a high-risk system is intended to be used by public authorities. The 2 August 2030 deadline applies to that group regardless of when the system reached the market and regardless of whether the design changes. To be revisited when the system is replaced, phased out or supplied to a different customer group."}],"exceptions":[],"statements":[],"legal_status":"applicable","deadline_at":"2030-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Regulation (EU) 2024/1689 on EUR-Lex"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Regulation (EU) 2026/1744 on EUR-Lex, which amends Article 111"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:action:prepare-article-46-derogation-request","legacy_id":"raip:action:prepare-article-46-derogation-request","type":"action","slug":"prepare-article-46-derogation-request","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"4a0a2703e7c513ee90b17ea72c10dd64c87785258a9fdda798b971ec3eac66f6","label":"Prepare a derogation request and the exit plan that goes with it","summary":"Write in advance the reasoning paragraph 1 calls for, with the exceptional reason invoked, the evidence that the system complies with the requirements of Section 2, the status of the ongoing conformity assessment, and an exit plan in case the authorisation is refused or withdrawn.","topics":["conformity","enforcement"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-46-derogation-from-conformity-assessment"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"prepare-article-46-derogation-request-scope","operator":"all","description":"Arises as soon as a high-risk system is needed for one of the four exceptional reasons sooner than the conformity assessment allows, and on every deployment by a law-enforcement or civil protection authority that may start without prior authorisation under paragraph 2. Does not arise for systems in products under Section A of Annex I: paragraph 7 excludes them."}],"exceptions":[],"statements":[],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 46 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/46","label":"Read Article 46 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:action:prepare-for-a-complaint","legacy_id":"raip:action:prepare-for-a-complaint","type":"action","slug":"prepare-for-a-complaint","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"e2bb240a6b4679450ecfb8da63f94ca2640a3be05ce90eafee89a446a4700747","label":"Make sure you can answer a complaint with documents","summary":"Record per AI system which assessment was carried out, by whom, on what date and against which system version, and agree who receives a question from the authority and within what period.","topics":["fundamental-rights"],"actor_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-85-right-to-complain"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 85 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:action:record-bias-testing-legal-basis","legacy_id":"raip:action:record-bias-testing-legal-basis","type":"action","slug":"record-bias-testing-legal-basis","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"b55a1476df5655c40a73f8fa334e80c3ed68ee44e4e178678829be3142ba58fc","label":"Justify and record your reliance on Article 4a","summary":"Only for those who themselves decide to process special categories of personal data for bias testing. 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Without this control the channel exists but goes unused, and the first person who noticed something never reaches you.","topics":["control","fundamental-rights"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-87-reporting-infringements"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 87 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:control:safety-component-reassessment-trigger","legacy_id":"raip:control:safety-component-reassessment-trigger","type":"control","slug":"safety-component-reassessment-trigger","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"2b7a06f34c9bf60a67bc1c01bc2cc893fae70b7505eb55a44f53ab7f338be88f","label":"Reassessment on a change of function or purpose","summary":"The control that ensures the assessment is redone as soon as the intended purpose, the function of the component or the applicable harmonisation legislation changes, so that a system does not stay outside the route on the basis of an outdated description. A recommended practice, not a legal duty.","topics":["conformity","high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-6-1bis-1quater-route"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"related","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Inserted paragraphs on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:control:systemic-risk-notification-deadline","legacy_id":"raip:control:systemic-risk-notification-deadline","type":"control","slug":"systemic-risk-notification-deadline","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"a1360f831fc363afa31b7d27ce19e2052508240de43a2a817385d5e384640dea","label":"Deadline tracking of the notification","summary":"The control that ensures the signal from the training pipeline reaches an identifiable owner and that the notification goes out within two weeks. Its trigger point is the allocation of compute and not the end of the run, because recital 111 also counts pre-training, synthetic data and fine-tuning and recital 112 assumes the provider knows the outcome before then. It sits alongside the monitoring of compute itself: that measures the threshold, this guards the clock that starts afterwards.","topics":["gpai-systemic-risk"],"actor_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-52-systemic-risk-classification"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":"applicable","deadline_at":"2025-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 52 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:control:value-chain-representative-control","legacy_id":"raip:control:value-chain-representative-control","type":"control","slug":"value-chain-representative-control","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"092d622c30e9a7df25f8f59e6f5734fb380006a1e183c6f0e3009f8fe684988a","label":"Role reassessment on every change","summary":"Repeat the role assessment on every rebranding, modification or new use of an existing system.","topics":["control","value-chain"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:value-chain-representative"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":null,"deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:definition:annex-iii-area-1-biometrics","legacy_id":"raip:definition:annex-iii-area-1-biometrics","type":"definition","slug":"annex-iii-area-1-biometrics","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"06d2c055970a09dc388a0c89907336f3aeb31ab93d97a70346acf440d068bc97","label":"Annex III, point 1: biometrics","summary":"Annex III, point 1, as that point stands in the Regulation, with its lettered subpoints and the exceptions named in them.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"Two things are unsettled here. First, the boundary of this area. The text above is literally in the Regulation, but whether a concrete application falls inside a lettered subpoint depends on the intended purpose, and the Commission guidelines working that out point by point are still in draft at our knowledge date. Where the text leaves room we name that room instead of closing it. Second, the weight of this split. The Regulation gives a list and not eight self-standing norms; publishing each point as its own object is our choice, because the practical question arrives per area. A defensible alternative reading is that only the Article 6(2) route deserves an object of its own and that the points inside it are no more than parts of one norm. The summary and the commentary on this object are ours; only the text marked as official fact is the Regulation.","obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-eight-areas"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Biometrics, in so far as their use is permitted under relevant Union or national law: (a) remote biometric identification systems. This shall not include AI systems intended to be used for biometric verification the sole purpose of which is to confirm that a specific natural person is the person he or she claims to be; (b) AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or characteristics based on the inference of those attributes or characteristics; (c) AI systems intended to be used for emotion recognition.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 1","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The core rules of Chapter III, Sections 1 to 3, apply from 2 December 2027 to systems classified as high-risk pursuant to Article 6(2) and Annex III. That date follows from Article 113 as amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The area where order matters most: many biometric applications first engage a prohibition under Article 5 and only then the question whether they are high-risk. Note subpoint (b) too: the text covers not only categorisation on sensitive characteristics themselves but also categorisation based on the inference of those characteristics, and that inference element is exactly where this subpoint bites.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 1","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"official_fact","text":"Rules that were not postponed already apply in this area. Article 5(1)(f) has prohibited, since 2 February 2025, AI systems inferring emotions of a natural person in the workplace and in education, except where the system is put into service or placed on the market for medical or safety reasons, and Article 5(1)(g) prohibits biometric categorisation systems that categorise individually natural persons based on their biometric data to deduce or infer their race, political opinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation, with the carve-out attached to it that the prohibition does not cover any labelling or filtering of lawfully acquired biometric datasets, such as images, based on biometric data, or categorising of biometric data in the area of law enforcement. Article 50(3) has required deployers of emotion recognition and biometric categorisation systems, since 2 August 2026, to inform the persons exposed. The date of 2 December 2027 applies to the high-risk rules, not to those prohibitions and that transparency duty.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 5(1)(f) and (g), Article 50(3), Article 113","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Annex III on EUR-Lex"},{"relation":"public_page","href":"https://www.praxikon.com/nl/annex-iii/biometrie","label":"This area on praxikon.com"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:definition:annex-iii-area-2-critical-infrastructure","legacy_id":"raip:definition:annex-iii-area-2-critical-infrastructure","type":"definition","slug":"annex-iii-area-2-critical-infrastructure","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"66333c35ee0160d73cb5ce61d1610c52db447d25b29983457b79cc555e23b11f","label":"Annex III, point 2: critical infrastructure","summary":"Annex III, point 2, as that point stands in the Regulation, with its lettered subpoints and the exceptions named in them.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"Two things are unsettled here. First, the boundary of this area. The text above is literally in the Regulation, but whether a concrete application falls inside a lettered subpoint depends on the intended purpose, and the Commission guidelines working that out point by point are still in draft at our knowledge date. Where the text leaves room we name that room instead of closing it. Second, the weight of this split. The Regulation gives a list and not eight self-standing norms; publishing each point as its own object is our choice, because the practical question arrives per area. A defensible alternative reading is that only the Article 6(2) route deserves an object of its own and that the points inside it are no more than parts of one norm. The summary and the commentary on this object are ours; only the text marked as official fact is the Regulation.","obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-eight-areas"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Critical infrastructure: AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 2","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The core rules of Chapter III, Sections 1 to 3, apply from 2 December 2027 to systems classified as high-risk pursuant to Article 6(2) and Annex III. That date follows from Article 113 as amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The only area without lettered subpoints, and the only one excluded by Article 86 and Article 27: point 2 carries no right to an explanation and no fundamental rights impact assessment. The test sits in the words safety component and management and operation.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 2","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Annex III on EUR-Lex"},{"relation":"public_page","href":"https://www.praxikon.com/nl/annex-iii/kritieke-infrastructuur","label":"This area on praxikon.com"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:definition:annex-iii-area-3-education-and-vocational-training","legacy_id":"raip:definition:annex-iii-area-3-education-and-vocational-training","type":"definition","slug":"annex-iii-area-3-education-and-vocational-training","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"57245084664bd933a726eef3777437e56c1ef5f6c96e9b9429cb5fd24568f428","label":"Annex III, point 3: education and vocational training","summary":"Annex III, point 3, as that point stands in the Regulation, with its lettered subpoints and the exceptions named in them.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"Two things are unsettled here. First, the boundary of this area. The text above is literally in the Regulation, but whether a concrete application falls inside a lettered subpoint depends on the intended purpose, and the Commission guidelines working that out point by point are still in draft at our knowledge date. Where the text leaves room we name that room instead of closing it. Second, the weight of this split. The Regulation gives a list and not eight self-standing norms; publishing each point as its own object is our choice, because the practical question arrives per area. A defensible alternative reading is that only the Article 6(2) route deserves an object of its own and that the points inside it are no more than parts of one norm. The summary and the commentary on this object are ours; only the text marked as official fact is the Regulation.","obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-eight-areas"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Education and vocational training: (a) AI systems intended to be used to determine access or admission or to assign natural persons to educational and vocational training institutions at all levels; (b) AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer the learning process of natural persons in educational and vocational training institutions at all levels; (c) AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual will receive or will be able to access, in the context of or within educational and vocational training institutions at all levels; (d) AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of or within educational and vocational training institutions at all levels.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 3","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The core rules of Chapter III, Sections 1 to 3, apply from 2 December 2027 to systems classified as high-risk pursuant to Article 6(2) and Annex III. That date follows from Article 113 as amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Not limited to schools: every vendor of assessment, placement or proctoring software sits here. Note the context clause in subpoints (c) and (d), which ties them to the context of or within an educational or vocational training institution; proctoring outside that context does not fall under subpoint (d) on the text.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 3","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Annex III on EUR-Lex"},{"relation":"public_page","href":"https://www.praxikon.com/nl/annex-iii/onderwijs-beroepsopleiding","label":"This area on praxikon.com"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:definition:annex-iii-area-4-employment-and-workers-management","legacy_id":"raip:definition:annex-iii-area-4-employment-and-workers-management","type":"definition","slug":"annex-iii-area-4-employment-and-workers-management","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"0ac2c2682bf8940bebd5ad702b407ec6516a260eade226c66defed523d4ac055","label":"Annex III, point 4: employment and workers management","summary":"Annex III, point 4, as that point stands in the Regulation, with its lettered subpoints and the exceptions named in them.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"Two things are unsettled here. First, the boundary of this area. The text above is literally in the Regulation, but whether a concrete application falls inside a lettered subpoint depends on the intended purpose, and the Commission guidelines working that out point by point are still in draft at our knowledge date. Where the text leaves room we name that room instead of closing it. Second, the weight of this split. The Regulation gives a list and not eight self-standing norms; publishing each point as its own object is our choice, because the practical question arrives per area. A defensible alternative reading is that only the Article 6(2) route deserves an object of its own and that the points inside it are no more than parts of one norm. The summary and the commentary on this object are ours; only the text marked as official fact is the Regulation.","obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-eight-areas"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Employment, workers’ management and access to self-employment: (a) AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates; (b) AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal traits or characteristics or to monitor and evaluate the performance and behaviour of persons in such relationships.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 4","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The core rules of Chapter III, Sections 1 to 3, apply from 2 December 2027 to systems classified as high-risk pursuant to Article 6(2) and Annex III. That date follows from Article 113 as amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The area touching almost every employer, and where the line between administrative help and evaluating people is crossed fastest without anyone noticing. An employer that is a body governed by public law or provides public services also reaches Article 27 here.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 4","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Annex III on EUR-Lex"},{"relation":"public_page","href":"https://www.praxikon.com/nl/annex-iii/werkgelegenheid-personeelsbeheer","label":"This area on praxikon.com"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:definition:annex-iii-area-5-essential-private-and-public-services","legacy_id":"raip:definition:annex-iii-area-5-essential-private-and-public-services","type":"definition","slug":"annex-iii-area-5-essential-private-and-public-services","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"f02c2c4969764ca9c0b91e14aa9e8d6ab2f968214fc51fc44be7171318ba6e17","label":"Annex III, point 5: essential private and public services","summary":"Annex III, point 5, as that point stands in the Regulation, with its lettered subpoints and the exceptions named in them.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"Two things are unsettled here. First, the boundary of this area. The text above is literally in the Regulation, but whether a concrete application falls inside a lettered subpoint depends on the intended purpose, and the Commission guidelines working that out point by point are still in draft at our knowledge date. Where the text leaves room we name that room instead of closing it. Second, the weight of this split. The Regulation gives a list and not eight self-standing norms; publishing each point as its own object is our choice, because the practical question arrives per area. A defensible alternative reading is that only the Article 6(2) route deserves an object of its own and that the points inside it are no more than parts of one norm. The summary and the commentary on this object are ours; only the text marked as official fact is the Regulation.","obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-eight-areas"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Access to and enjoyment of essential private services and essential public services and benefits: (a) AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for essential public assistance benefits and services, including healthcare services, as well as to grant, reduce, revoke, or reclaim such benefits and services; (b) AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score, with the exception of AI systems used for the purpose of detecting financial fraud; (c) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance; (d) AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to establish priority in the dispatching of, emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 5","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The core rules of Chapter III, Sections 1 to 3, apply from 2 December 2027 to systems classified as high-risk pursuant to Article 6(2) and Annex III. That date follows from Article 113 as amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The broadest area: benefits, healthcare, credit, insurance and emergency services in one point. Subpoint (a) is tied to use by or on behalf of public authorities; subpoints (b) and (c) are not, and they are the only subpoints of Annex III that extend the Article 27 fundamental rights impact assessment to private deployers as well.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 5","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Annex III on EUR-Lex"},{"relation":"public_page","href":"https://www.praxikon.com/nl/annex-iii/essentiele-diensten-voordelen","label":"This area on praxikon.com"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:definition:annex-iii-area-6-law-enforcement","legacy_id":"raip:definition:annex-iii-area-6-law-enforcement","type":"definition","slug":"annex-iii-area-6-law-enforcement","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"baf7a4d2ca4edaa3e113103e3f8dbe2014f50da7f8d4d032da2b27d568c08491","label":"Annex III, point 6: law enforcement","summary":"Annex III, point 6, as that point stands in the Regulation, with its lettered subpoints and the exceptions named in them.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"Two things are unsettled here. First, the boundary of this area. The text above is literally in the Regulation, but whether a concrete application falls inside a lettered subpoint depends on the intended purpose, and the Commission guidelines working that out point by point are still in draft at our knowledge date. Where the text leaves room we name that room instead of closing it. Second, the weight of this split. The Regulation gives a list and not eight self-standing norms; publishing each point as its own object is our choice, because the practical question arrives per area. A defensible alternative reading is that only the Article 6(2) route deserves an object of its own and that the points inside it are no more than parts of one norm. The summary and the commentary on this object are ours; only the text marked as official fact is the Regulation.","obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-eight-areas"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Law enforcement, in so far as their use is permitted under relevant Union or national law: (a) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies in support of law enforcement authorities or on their behalf to assess the risk of a natural person becoming the victim of criminal offences; (b) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities as polygraphs or similar tools; (c) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies, in support of law enforcement authorities to evaluate the reliability of evidence in the course of the investigation or prosecution of criminal offences; (d) AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of natural persons or groups; (e) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal offences.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 6","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The core rules of Chapter III, Sections 1 to 3, apply from 2 December 2027 to systems classified as high-risk pursuant to Article 6(2) and Annex III. That date follows from Article 113 as amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Each of the five subpoints is tied to use by or on behalf of law enforcement authorities or by Union institutions in support of them. A recidivism risk model or profiling system outside that circle therefore does not enter through point 6, however closely it resembles the description; you then have to look at another point or at Article 5.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 6","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Annex III on EUR-Lex"},{"relation":"public_page","href":"https://www.praxikon.com/nl/annex-iii/rechtshandhaving","label":"This area on praxikon.com"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:definition:annex-iii-area-7-migration-asylum-and-border-control","legacy_id":"raip:definition:annex-iii-area-7-migration-asylum-and-border-control","type":"definition","slug":"annex-iii-area-7-migration-asylum-and-border-control","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"3356e73db9f1924b55062ac32d12d5de26108cbb13ed199789d0628abc4eac4c","label":"Annex III, point 7: migration, asylum and border control","summary":"Annex III, point 7, as that point stands in the Regulation, with its lettered subpoints and the exceptions named in them.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"Two things are unsettled here. First, the boundary of this area. The text above is literally in the Regulation, but whether a concrete application falls inside a lettered subpoint depends on the intended purpose, and the Commission guidelines working that out point by point are still in draft at our knowledge date. Where the text leaves room we name that room instead of closing it. Second, the weight of this split. The Regulation gives a list and not eight self-standing norms; publishing each point as its own object is our choice, because the practical question arrives per area. A defensible alternative reading is that only the Article 6(2) route deserves an object of its own and that the points inside it are no more than parts of one norm. The summary and the commentary on this object are ours; only the text marked as official fact is the Regulation.","obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-eight-areas"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Migration, asylum and border control management, in so far as their use is permitted under relevant Union or national law: (a) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies as polygraphs or similar tools; (b) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed by a natural person who intends to enter or who has entered into the territory of a Member State; (c) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assist competent public authorities for the examination of applications for asylum, visa or residence permits and for associated complaints with regard to the eligibility of the natural persons applying for a status, including related assessments of the reliability of evidence; (d) AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies, offices or agencies, in the context of migration, asylum or border control management, for the purpose of detecting, recognising or identifying natural persons, with the exception of the verification of travel documents.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 7","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The core rules of Chapter III, Sections 1 to 3, apply from 2 December 2027 to systems classified as high-risk pursuant to Article 6(2) and Annex III. That date follows from Article 113 as amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"All four subpoints are tied to use by or on behalf of competent public authorities or Union bodies; a vendor builds the system, but the point is engaged by the intended use inside that circle. The exception for verification of travel documents in subpoint (d) is narrow and covers only that verification.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 7","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Annex III on EUR-Lex"},{"relation":"public_page","href":"https://www.praxikon.com/nl/annex-iii/migratie-asiel-grenscontrole","label":"This area on praxikon.com"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:definition:annex-iii-area-8-justice-and-democratic-processes","legacy_id":"raip:definition:annex-iii-area-8-justice-and-democratic-processes","type":"definition","slug":"annex-iii-area-8-justice-and-democratic-processes","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"3f8c0153462a12cf70cb67280d79ac23299f6a968dc86474650f7fe27ec697bb","label":"Annex III, point 8: administration of justice and democratic processes","summary":"Annex III, point 8, as that point stands in the Regulation, with its lettered subpoints and the exceptions named in them.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"Two things are unsettled here. First, the boundary of this area. The text above is literally in the Regulation, but whether a concrete application falls inside a lettered subpoint depends on the intended purpose, and the Commission guidelines working that out point by point are still in draft at our knowledge date. Where the text leaves room we name that room instead of closing it. Second, the weight of this split. The Regulation gives a list and not eight self-standing norms; publishing each point as its own object is our choice, because the practical question arrives per area. A defensible alternative reading is that only the Article 6(2) route deserves an object of its own and that the points inside it are no more than parts of one norm. The summary and the commentary on this object are ours; only the text marked as official fact is the Regulation.","obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-eight-areas"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Administration of justice and democratic processes: (a) AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in researching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in a similar way in alternative dispute resolution; (b) AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise or structure political campaigns from an administrative or logistical point of view.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 8","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The core rules of Chapter III, Sections 1 to 3, apply from 2 December 2027 to systems classified as high-risk pursuant to Article 6(2) and Annex III. That date follows from Article 113 as amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The area reaching beyond the courts themselves: alternative dispute resolution and campaign tools that reach voters directly fall under it too. Subpoint (a) is tied to use by or on behalf of a judicial authority; a legal research tool at a law firm does not fall under it on the text.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, point 8","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"official_fact","text":"Duties that were not postponed already apply here as well. The transparency obligations of Article 50 apply since 2 August 2026: a provider of a system generating or manipulating synthetic content must mark that output in a machine readable format, and whoever publishes deepfake content must disclose that the content has been artificially generated or manipulated. 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The deadlines against which that is measured sit in Article 9(1) of Directive (EU) 2019/1937: acknowledgement of receipt within seven days (point (b)) and feedback within three months (point (f)). This file has limits that are as hard as the record keeping itself: the identity of the person reporting stays shielded and does not travel with the substantive follow-up (Article 16), nothing is retained longer than necessary and proportionate (Article 18(1)), and an oral report is recorded only with the consent of the person reporting (Article 18(2) to (4)). Without those limits the file is itself a risk, including under the GDPR.","topics":["evidence","fundamental-rights"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-87-reporting-infringements"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 87 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:evidence:legacy-system-transition-register","legacy_id":"raip:evidence:legacy-system-transition-register","type":"evidence","slug":"legacy-system-transition-register","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"a0d73b1e9e6d0a528df9b419472895124c96876c96c0da71e972719d4fa96471","label":"Transition register of legacy high-risk systems","summary":"Per type and model: the date the first unit was placed on the market or put into service, the route and therefore the cut off date, whether it is intended to be used by public authorities, which design changes have been made since that cut off, and per change the judgement whether it was significant with the reasoning and the date. This is the file that shows which track a system was on and why.","topics":["high-risk","timeline"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-111-legacy-public-systems"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Regulation (EU) 2024/1689 on EUR-Lex"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Regulation (EU) 2026/1744 on EUR-Lex, which amends Article 111"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:evidence:notified-body-certificate-record","legacy_id":"raip:evidence:notified-body-certificate-record","type":"evidence","slug":"notified-body-certificate-record","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"c345a9067412665954302500530413f4800d28e05a2d8ca20ef76fdf68d7c8c3","label":"Certificate file per system","summary":"Per high-risk system: the certificate itself and the route along which it was issued, the notified body that issued it, its validity period and expiry date, its supplements, the extension requests with the re-assessment underlying them, the assessment per change of whether it was substantial within the meaning of Article 43(4), every decision to suspend, withdraw or restrict together with the reasons the body gave for it, and the notices from the body on cessation or change of its designation with the confirmation that followed.","topics":["conformity","evidence"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-44-notified-body-certificates"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":null,"deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"The Regulation on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:evidence:notified-body-standing-record","legacy_id":"raip:evidence:notified-body-standing-record","type":"evidence","slug":"notified-body-standing-record","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"56f9eda5647bd23dbf43d538f9e3e670bb286785ece80df1ce6d64f4aa52eabe","label":"File on the chosen notified body","summary":"Per body: identification number, Member State of establishment, the conformity assessment activities and system types for which it is notified, the date of each check against the public list, the outcome of the independence test, the subcontracted tasks with your written agreement, and every notice of a change to its designation.","topics":["conformity","evidence","governance"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-28-39-notified-bodies"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Chapter III, Section 4, on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/31","label":"Read Article 31 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:evidence:safety-component-assessment-record","legacy_id":"raip:evidence:safety-component-assessment-record","type":"evidence","slug":"safety-component-assessment-record","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"7eb7584bed3094c35599cf257fb614f7c4d6e40f3d5de6380792ceca8654f80d","label":"Record of the safety component assessment","summary":"Per AI component: the intended purpose, the function inside the product, the failure analysis with its consequence for health and safety, the basis of the third-party conformity assessment, and which of paragraphs 1a, 1b and 1c was applied and why. This is a self-maintained file; the Regulation does not prescribe it, and for products under Annex I, Section B, the technical documentation of Article 11 and Annex IV does not apply at all.","topics":["conformity","high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-6-1bis-1quater-route"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"related","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Inserted paragraphs on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:evidence:standards-conformity-justification-file","legacy_id":"raip:evidence:standards-conformity-justification-file","type":"evidence","slug":"standards-conformity-justification-file","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"509b7a86a787c973d0cc794e078db8ee608a13d2331d6927de09686dafe11e0d","label":"Coverage matrix and justification for standards and specifications","summary":"Per requirement of Section 2: the harmonised standard or common specification applied with its version, the publication status of the reference in the Official Journal, what the standard or specification does and does not cover, and on departure the Article 41(5) justification with the technical solution chosen and the test showing equivalence.","topics":["conformity","evidence","standards"],"actor_ids":["praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-40-42-standards-and-specifications"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Articles 40 to 42 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/40","label":"Read Article 40 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:evidence:systemic-risk-notification-file","legacy_id":"raip:evidence:systemic-risk-notification-file","type":"evidence","slug":"systemic-risk-notification-file","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"905f723bedbd08a93711a9b87bff0a323bc966b6062131c4f19119025d149bc0","label":"Systemic-risk notification file","summary":"Per model version: the measured and planned training compute with the scope of recital 111, so including pre-training, synthetic data generation and fine-tuning, the moment the threshold was reached or foreseen, the notification sent with its supporting information, any arguments under paragraph 2, any reassessment request under paragraph 5, and the response or designation decision of the Commission.","topics":["gpai-systemic-risk"],"actor_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-52-systemic-risk-classification"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":"applicable","deadline_at":"2025-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 52 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:evidence:value-chain-representative-record","legacy_id":"raip:evidence:value-chain-representative-record","type":"evidence","slug":"value-chain-representative-record","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"8a1a79ce12646a7074a1a5732b7048064013029c563b9f5c1601a324b774ad09","label":"Value-chain file","summary":"Record per system of role, contractual arrangements on information and cooperation, and the appointment of a representative where required.","topics":["evidence","value-chain"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:value-chain-representative"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[],"legal_status":null,"deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"editorially_reviewed","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-4-gezichtsherkenning-toegangscontrole","legacy_id":"raip:example:example-artikel-4-gezichtsherkenning-toegangscontrole","type":"example","slug":"example-artikel-4-gezichtsherkenning-toegangscontrole","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"595c5cc236618a40fa4882c79603f0febc9762b4165cdf0ac60b70bdbbe5c457","label":"Facial recognition at access control: the guard behind the camera counts too","summary":"An organisation secures the entrances to its buildings with facial recognition and uses that biometric access control to register visitors as well. When the system returns no match, a security officer reviews the camera images and decides personally whether someone may enter. The question is whose measures have to reach that officer: those of the supplier of the model, those of the department that deploys the system, or both.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-4-ai-literacy"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 4(1) provides that providers and deployers of AI systems shall take measures to support the development of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf. In doing so they must take into account technical knowledge, experience, education and training and the context the AI systems are to be used in, and consider the persons or groups of persons on whom the AI systems are to be used. The same provision states that this obligation does not require providers or deployers to guarantee any specific level of AI literacy of any individual.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 4(1)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read the phrase about the persons on whom the system is used as the centre of gravity for biometrics: whoever stands in front of the camera is subject to the outcome and has little to set against it. That argues for equipping the officer who decides for himself when no match comes back more substantively than the colleague who merely switches the system on and off. The article itself names no sufficient level and expressly states that you need not guarantee one, so where the floor lies for each role stays open. In our assessment a record kept per role, stating the choice made and the reason for it, is easier to defend than one organisation-wide session backed only by an attendance list.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 4(1)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-4-politie-opsporingsanalyse","legacy_id":"raip:example:example-artikel-4-politie-opsporingsanalyse","type":"example","slug":"example-artikel-4-politie-opsporingsanalyse","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"60ac6751cd1959be17d92f129f223cca3fae064e4dfa4eed6759a8d2f88b5297","label":"Police using AI in investigations: context sets how deep the training goes","summary":"A police force uses AI to search large volumes of investigation files and surface connections a detective would otherwise miss. The outputs feed into the choice of which suspect is pursued further and end up in documents that enter the criminal process. The question is whether one and the same basic instruction is enough for the analyst operating the model and for the detective who acts on its output.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-4-ai-literacy"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 4(1) requires providers and deployers of AI systems to take measures supporting the development of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf. The provision prescribes that they take into account technical knowledge, experience, education and training and the context the AI systems are to be used in, as well as the persons or groups of persons on whom the AI systems are to be used. It also states that this obligation does not require any specific level of AI literacy of any individual to be guaranteed.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 4(1)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Article 4 requires you to weigh the context of use and the people the system is applied to, and in law enforcement both factors run high on our reading. Whether a general introduction to what AI can do is then enough for someone carrying an output into a file that affects a person's position as a suspect, we doubt, but the provision expressly names no level you must guarantee, so that floor is yours to justify. We would record for each role what someone must be able to recognise, for instance that a discovered connection is not yet evidence, and revisit that choice periodically.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 4(1)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-4-redactie-generatieve-content","legacy_id":"raip:example:example-artikel-4-redactie-generatieve-content","type":"example","slug":"example-artikel-4-redactie-generatieve-content","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"c17ece0eea8b5b5b7f25d80eb389c31dbc5e18c57449d3e19d41d7ba2b0a8658","label":"Newsroom with generative AI: do freelancers count within your measures?","summary":"A newsroom uses generative AI to prepare summaries, headlines and imagery, after which an editor finishes the piece and the desk decides to publish. Part of that work sits with freelancers, and an outside agency produces marketing content with the same tools. The question is whether your AI literacy measures must reach those freelancers and that agency, or only the people on the payroll.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-4-ai-literacy"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 4(1) is addressed to providers and deployers of AI systems and requires them to take measures supporting the development of AI literacy of their staff and of other persons dealing with the operation and use of AI systems on their behalf. The provision requires them to take into account technical knowledge, experience, education and training and the context the AI systems are to be used in, as well as the persons or groups of persons on whom the AI systems are to be used. It does not require any specific level of AI literacy of any individual to be guaranteed.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 4(1)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Alongside staff, the text expressly names other persons dealing with the operation and use of AI systems on your behalf, and we read that as a functional boundary rather than a contractual one. On that reading a freelance editor using your tool inside your workflow and on your instruction sits within your measures, employment contract or not. The outside agency is a harder case: if it works in your environment and on your instruction, the argument that it acts on your behalf holds up, but if it runs its own tools on its own account it is a deployer in its own right, and Article 4 does not say your measures must cover that work. In practice, in our assessment, that means recording in your agreements who works in which role and what instruction you give, rather than trusting the other side to arrange it.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 4(1)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-50-ai-chat-sollicitanten","legacy_id":"raip:example:example-artikel-50-ai-chat-sollicitanten","type":"example","slug":"example-artikel-50-ai-chat-sollicitanten","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"bbf1f3c5c8847982509ad7a4d086b513a5e0742db0e4415b178f1cdd5cfe1bc2","label":"AI chat in recruitment and selection: what the applicant must be told","summary":"A recruiter deploys an AI chat that puts candidates through a first screening conversation after they respond to a job posting, and adds their answers to their CV. The chat introduces itself with a first name and writes in a casual conversational tone. The question is whether these applicants reasonably realise that they are talking to an AI system.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-50-transparency"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 50(1) requires providers to ensure that AI systems intended to interact directly with natural persons are designed and developed in such a way that the natural persons concerned are informed that they are interacting with an AI system, unless this is obvious from the point of view of a natural person who is reasonably well-informed, observant and circumspect, taking into account the circumstances and the context of use. Article 50(5) provides that this information must be given to the natural persons concerned in a clear and distinguishable manner at the latest at the time of the first interaction, and must conform to the applicable accessibility requirements.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 50(1) and (5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read the obviousness test as a question about the audience the system actually meets, and in recruitment and selection that audience is not a trained professional group but a broad set of applicants under pressure who do not yet know the organisation. A human first name and a casual tone push that assessment the wrong way in our view, however well they convert. If you buy the chat rather than build it, Article 50(1) is by its wording addressed to the provider, while you are the one choosing the persona and the entry point; whether putting your own name on such a chat moves you into the provider role is a question Article 50 does not answer. So make the disclosure in the first message a procurement requirement and verify at delivery that it is genuinely there.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 50(1) and (5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-50-camera-toegangscontrole-categorisatie","legacy_id":"raip:example:example-artikel-50-camera-toegangscontrole-categorisatie","type":"example","slug":"example-artikel-50-camera-toegangscontrole-categorisatie","version":"1.0.0","effective_at":"2026-07-20T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"160b7164fde8818b8b2563f5a2e755e5669228072717a49f653bf2ca4c75bee6","label":"Camera at the entrance: access control versus biometric categorisation","summary":"An organisation admits staff through facial recognition at its access control gate and additionally runs a camera in the visitor area that sorts faces into age groups. Both applications run on the same biometric infrastructure and the same images. The question is which of the two requires the people involved to be actively informed.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-50-transparency"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The Commission guidelines of 20 July 2026 count automated facial-recognition access controls among the systems that merely collect data passively and are not capable of an exchange with natural persons, and therefore do not interact within the meaning of Article 50(1). For Article 50(3) they state that, unless the use is prohibited under Article 5(1)(g), the information duty applies to any biometric categorisation system, including outside the high-risk scope, and they give classification by age or gender on the basis of biometric data as an example. Article 50(3) itself carries a further exception for systems permitted by law to detect, prevent or investigate criminal offences. As a way of informing people the guidelines describe a visible notice at each possible entrance to an exhibition room stating that facial images are captured to assign visitors to an age group, provided at the latest at the moment of first exposure.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, point (30) and points (104) to (108)","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Our reading is that you should map this per processing purpose rather than per camera: the same lens that stays outside Article 50(1) at the access control gate moves inside Article 50(3) as soon as those images place people in a category. Record for each setup what happens to the capture and who the deployer is, because that decides whether a notice belongs at the entrance. The guidelines prescribe no fixed form, but they do fix the moment: the notice has to be there before someone walks into frame, and a line in the privacy statement rarely makes that moment, in our reading.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, point (30) and points (104) to (108)","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-50-code-assistent","legacy_id":"raip:example:example-artikel-50-code-assistent","type":"example","slug":"example-artikel-50-code-assistent","version":"1.0.0","effective_at":"2026-07-20T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"fe318cc5831d962473121e1af68d1c399dd3a01e1b3bd89e04d554385ee6a460","label":"Code assistant for developers: an exception, until it faces outward","summary":"A software company uses an AI assistant for code suggestions and code review, available only to professional developers. The same company also runs a helpdesk chatbot for customers.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-50-transparency"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The Commission guidelines of 20 July 2026 list code assistance and code review chatbots available only to professional developers as an example where the obviousness exception applies. Chatbots embedded in online platforms or helpdesks, where users may perceive outputs as human-generated, they list as an example where the disclosure duty does apply.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (45), lists with and without the obviousness exception","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Two AI assistants at the same company, two outcomes. Assess per application who the user is and what they reasonably expect, rather than taking one organisation-wide position on chatbots.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (45), lists with and without the obviousness exception","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-50-fraudemeldportaal-bank","legacy_id":"raip:example:example-artikel-50-fraudemeldportaal-bank","type":"example","slug":"example-artikel-50-fraudemeldportaal-bank","version":"1.0.0","effective_at":"2026-07-20T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"582aea2e3144049ca4f842c782162a26e0e60300ad221f75347d55f99d05a125","label":"Fraud reporting portal at a bank: why the law enforcement exception drops out","summary":"A bank opens an AI-driven reporting portal where customers can flag suspected fraud around their payment account or loan. The system asks follow-up questions, categorises the report and routes it to fraud detection and, where money laundering signals appear, to the internal reporting team. Because the portal concerns criminal offences, the bank assumes the disclosure duty for direct AI interaction does not apply.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-50-transparency"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The Commission guidelines of 20 July 2026 expressly list AI-assisted fraud reporting hotlines and digital portals operated by financial institutions or public authorities, where users can report suspected financial crimes, as an example that is not exempted and falls within the scope of Article 50(1). They explain that the exception does not apply where the system is available to the public and offers individuals the functionality to report a criminal offence. The fact that the system only gathers details, categorises and prioritises the report while human investigators validate the information before any action is taken does not change that in the guidelines.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, points (48) and (49), list of examples under the law enforcement exception","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"In our reading this is where banks most often take the wrong turn: the reporting portal sits organisationally under fraud and compliance, which makes the law enforcement exception feel natural, while it is precisely the public reporting channel that is carved out of that exception. On top of that, the exception is written for use authorised by law for law enforcement purposes, and the guidelines stretch it no further than to other public authorities holding such a legal basis, so in our reading a private bank rarely stands in it at all, before the public reporting channel even comes up. Treat the portal as an ordinary public-facing chat and put the disclosure in the first screen of the conversation. A line in the terms and conditions or a product leaflet is a weak choice for this channel, because by then the person is already telling their story.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, points (48) and (49), list of examples under the law enforcement exception","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-50-gemeentelijke-ai-tekst","legacy_id":"raip:example:example-artikel-50-gemeentelijke-ai-tekst","type":"example","slug":"example-artikel-50-gemeentelijke-ai-tekst","version":"1.0.0","effective_at":"2026-07-20T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"607ccc8ecea80ab82aa178e5832f9ad99914406b4a757935b3aabb504f27a676","label":"AI text from a municipality: when a final check counts as editorial control","summary":"A municipality has an AI system write the web pages about a changed scheme for social assistance and allowances, meant to explain to citizens what they are entitled to. A communications officer reads the text for style and spelling and publishes it. The question is whether this public service thereby falls under the exception to the labelling duty.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-50-transparency"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The Commission guidelines of 20 July 2026 count public administration and public services among the matters of public interest covered by the disclosure duty for published AI text in Article 50(4). For the exception, the guidelines require two cumulative conditions: the AI-generated or manipulated text has undergone human review or editorial control, and a natural or legal person holds editorial responsibility for the publication. They add that human review means a deliberate examination of the substance with fact-checking as a minimum requirement, and that superficial, purely formal or procedural checks such as spell-checking or grammatical correction do not meet it. For the second condition they expect the identity or the function carrying editorial responsibility to be publicly available in an easily findable place.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, point (131), points (133) to (136) and point (138)","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Our reading is that many municipalities do have a publication process but no identifiable person carrying substantive final responsibility, and that is exactly the hinge of this exception. Assign that role explicitly, make it findable who holds it, and record per page who checked the facts, or otherwise take the simpler route and label the text. Watch the order of steps in your workflow, because an AI tool that substantively rewrites the text after human sign-off removes the ground from under that sign-off.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, point (131), points (133) to (136) and point (138)","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-50-interne-medewerkersassistent","legacy_id":"raip:example:example-artikel-50-interne-medewerkersassistent","type":"example","slug":"example-artikel-50-interne-medewerkersassistent","version":"1.0.0","effective_at":"2026-07-20T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"fa7779195063a2d6c102ecd9efa1d0962397eab18f9e9a1016737e97d85efc17","label":"Internal assistant for HR and compliance: an exception with a condition","summary":"An organisation gives staff an internal AI assistant for HR, legal, procurement, compliance and IT questions. Must that assistant disclose at every turn that it is AI?","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-50-transparency"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The Commission guidelines of 20 July 2026 list an internal employee-facing assistant for properly trained, AI-literate staff who are aware they are using AI systems for internal organisational purposes as an example where the obviousness exception in Article 50(1) applies.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (45), lists with and without the obviousness exception","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The guidelines tie this exception explicitly to properly trained, AI-literate staff. Relying on it therefore stands or falls with what you have arranged and can demonstrate on literacy under Article 4: without that record you are leaning on an assumption about your own people.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (45), lists with and without the obviousness exception","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-50-klinisch-beslissysteem","legacy_id":"raip:example:example-artikel-50-klinisch-beslissysteem","type":"example","slug":"example-artikel-50-klinisch-beslissysteem","version":"1.0.0","effective_at":"2026-07-20T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"373ac7240ce91407219c0e1aa4125e839d59caee1738579bab6fc375dfa28564","label":"Diagnostic support for clinicians: no disclosure duty, still due care","summary":"A hospital deploys an interactive AI system used exclusively by properly trained health professionals to support medical diagnosis and suggest treatments. The question is whether the patient or the clinician must be told it is AI.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-50-transparency"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The Commission guidelines of 20 July 2026 list interactive AI systems intended only for properly trained health professionals to support medical diagnosis and suggest treatments as an example where the obviousness exception in Article 50(1) applies: for that user the AI nature is clear.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (45), lists with and without the obviousness exception","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The exception attaches to the user, not to the system. The moment the same model also speaks to patients, that ground falls away and the disclosure duty applies as normal. And an exception to Article 50 says nothing about the rest: where it is a medical device or a high-risk application, those regimes continue to apply in full.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (45), lists with and without the obviousness exception","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-artikel-50-opsporing-uitzondering","legacy_id":"raip:example:example-artikel-50-opsporing-uitzondering","type":"example","slug":"example-artikel-50-opsporing-uitzondering","version":"1.0.0","effective_at":"2026-07-20T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"f22913de6679b4a1f4549e5f0135681758c39a74b7ce0d57e99aab9ee6bb2603","label":"Law enforcement: exempt from the disclosure duty, with safeguards","summary":"An authority empowered by law to detect criminal offences wants to deploy an interactive AI system without telling those involved that they are communicating with AI.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-50-transparency"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 50(1) exempts providers of interactive AI systems from the disclosure duty where they are authorised by law to detect, prevent, investigate or prosecute criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties. The Commission guidelines of 20 July 2026 elaborate that exception.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (46), law-enforcement exception","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The exception is narrow and conditional: it requires a legal basis for the law-enforcement task and appropriate safeguards for third parties. A public task by itself is not enough, and the safeguards are not a footnote but part of the ground you are relying on.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (46), law-enforcement exception","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-beoordelingssysteem-personeel-incidentmelding","legacy_id":"raip:example:example-beoordelingssysteem-personeel-incidentmelding","type":"example","slug":"example-beoordelingssysteem-personeel-incidentmelding","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"10323fa9be53a342a148727da06c2c2e2326f11f0d1102e4586b4686a08f6df9","label":"Performance scoring for staff goes wrong: report or not","summary":"An employer uses an AI system that scores employee performance and lets that score weigh in promotion and dismissal. After a change to the model it turns out that a group of staff was scored too low for months, and decisions have already been taken on those scores. HR wonders whether this is a serious incident and who would have to report it.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-73-incident-reporting"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 3, point (49) defines a serious incident as an incident or malfunctioning of an AI system that directly or indirectly leads to, among other things, the infringement of obligations under Union law intended to protect fundamental rights. Article 73(1) places the duty to report serious incidents on the provider of the high-risk AI system placed on the Union market, towards the market surveillance authorities of the Member State where the incident occurred. Article 73(2) requires the report to be made immediately after the provider has established a causal link between the AI system and the serious incident, or the reasonable likelihood of such a link, and in any event no later than 15 days after the provider or, where applicable, the deployer becomes aware of the serious incident, with the period taking account of the severity of the incident. Article 73(6) obliges the provider, after reporting, to perform the necessary investigations without delay in relation to the serious incident and the AI system concerned, including a risk assessment and corrective action, cooperating with the competent authorities and, where relevant, with the notified body concerned. Article 26(5) requires a deployer that has identified a serious incident to inform, immediately, first the provider and then the importer or distributor and the relevant market surveillance authorities.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 3(49), Article 26(5) and Article 73(1), (2) and (6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"In the workplace the hard part is the awareness trigger in Article 73(2): harm spread thinly across many employees does not arrive as an alarm but trickles in through complaints, a performance review or the works council. Whether systematically low scores that feed into promotion and dismissal amount to a serious incident depends, on our reading, on whether obligations protecting fundamental rights have thereby been infringed within the meaning of Article 3, point (49)(c); Article 73 does not make that assessment for you. Decide in advance which HR signal counts as an incident signal and who puts it in front of the provider that same week, rather than reconstructing that afterwards; Article 26(5) also requires you as deployer, once you have identified a serious incident, to inform the provider immediately and then the importer or distributor and the market surveillance authority. Note finally that the corrective action in Article 73(6) concerns the system; what should happen to promotion or dismissal decisions already taken is, on our reading, not answered by this article and runs through other rules, employment law among them.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 3(49), Article 26(5) and Article 73(1), (2) and (6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-biometrische-verificatie-grenspoort","legacy_id":"raip:example:example-biometrische-verificatie-grenspoort","type":"example","slug":"example-biometrische-verificatie-grenspoort","version":"1.0.0","effective_at":"2026-05-19T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"e2f0da23dce88ea57a597d35e2ab6c9bbf07dbbf6bbc17182bbb2203a51e218c","label":"Face comparison at the border gate: verification or identification","summary":"An automated border gate uses biometric facial recognition to compare a traveller’s face with the photo in the passport chip. The same camera could technically also compare against a law-enforcement database, and exactly that difference decides whether this biometrics is high-risk.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-high-risk"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The Commission draft guidelines of 19 May 2026 state that biometric verification falls outside the high-risk classification: one-to-one comparison of presented biometrics with previously stored biometrics, for the sole purpose of confirming that a person is who they claim to be. Where the same capture is additionally compared against a law-enforcement database, it does become remote biometric identification. The document is a consultation version: non-binding and not yet final.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III, paragraph (136)","source_url":"https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Test your biometric application on purpose rather than technology: the same camera and the same model stay outside the high-risk route as long as the comparison is one-to-one and only confirms identity, and fall inside it as soon as that same capture is also held against a database. Record per application what the comparison runs against, because that single design choice moves the entire regime.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III, paragraph (136)","source_url":"https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-ernstig-incident-productielijn-meldtermijn","legacy_id":"raip:example:example-ernstig-incident-productielijn-meldtermijn","type":"example","slug":"example-ernstig-incident-productielijn-meldtermijn","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"ebe7b7020fc00e471f22844f0b97ed3e30f6702e78b04c376cd86720ec3d51bd","label":"Serious incident on the production line: who reports and within what deadline","summary":"A manufacturer supplies an AI system that runs as a safety component in a machine on the production line and at the same time drives quality control. At a customer's factory an operator is seriously injured after the machine failed to stop on an anomaly. The question is who reports, to whom, and which clock is already running at that moment.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-73-incident-reporting"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 73(1) places the reporting of serious incidents on the provider of the high-risk AI system placed on the Union market, addressed to the market surveillance authorities of the Member State where the incident occurred. Article 73(2) requires that report to be made immediately after the provider has established a causal link between the AI system and the serious incident, or the reasonable likelihood of such a link, and in any event no later than 15 days after the provider or, where applicable, the deployer becomes aware of the incident, with the reporting period taking account of the severity of the incident. Article 73(4) shortens that to no later than 10 days in the event of the death of a person. Article 73(6) obliges the provider, following the report, to perform the necessary investigations without delay, including a risk assessment and corrective action, and not to perform any investigation involving alteration of the AI system in a way that may affect the subsequent evaluation of the causes of the incident without first informing the competent authorities. Article 26(5) requires a deployer that has identified a serious incident to inform, immediately, first the provider and then the importer or distributor and the relevant market surveillance authorities, and makes Article 73 apply mutatis mutandis where the deployer cannot reach the provider.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 73(1), (2), (4) and (6), and Article 26(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read Article 73(2) as meaning that the clock can already start at the deployer on the factory floor, while the report under Article 73(1) sits with you as the provider of the AI system. That does not leave your customer free to sit still: Article 26(5) gives the deployer a notification route of its own, running past you, the importer or distributor and the market surveillance authority, and makes Article 73 apply mutatis mutandis if you cannot be reached. Fix that route in the contract and in the service line before anything happens. Where an operator is seriously injured but does not die, we read the outer limit of Article 73(2) as the one in play rather than the 10 days of Article 73(4); how much sooner than that outer limit you must report is left open by the text and turns on severity. Bear in mind as well that the reflex to repair the machine immediately and resume production can collide with Article 73(6), because an investigation that alters the system first requires notice to the competent authority. Working that out only during the incident costs days that these deadlines do not allow.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 73(1), (2), (4) and (6), and Article 26(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-fria-bijstandsuitkering-gemeente","legacy_id":"raip:example:example-fria-bijstandsuitkering-gemeente","type":"example","slug":"example-fria-bijstandsuitkering-gemeente","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"563700f6a56bbda6f2fd701e38b2eeb9df22a2523f7612fe1109c68a791ffe42","label":"Awarding social assistance in a municipality: the FRIA and the notification","summary":"A municipality wants to deploy an AI system that sorts applications for social assistance benefits and indicates which files merit extra scrutiny before a case worker decides. The application is already listed in the public algorithm register. The question is what has to be in place before the first citizen passes through this system.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-27-fria"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 27(1) requires deployers which are bodies governed by public law, or private entities providing public services, to perform an assessment of the impact on fundamental rights that the use of a high-risk AI system referred to in Article 6(2) may produce, prior to deploying it, with the exception of systems intended to be used in the area listed in point 2 of Annex III. That assessment covers, among other elements, the categories of natural persons and groups likely to be affected, the specific risks of harm to those categories, the implementation of human oversight measures, and the measures to be taken if those risks materialise, including the arrangements for internal governance and complaint mechanisms. Article 27(3) provides that once the assessment has been performed, the deployer shall notify the market surveillance authority of its results and submit the filled-out template referred to in paragraph 5 as part of that notification, and that in the case referred to in Article 46(1) deployers may be exempt from that obligation to notify. Article 27(5) provides that the AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers in complying with their obligations under this Article in a simplified manner.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 27(1), (3) and (5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read Article 27 as making the municipality the most obvious deployer here, and as requiring the assessment to be complete before the first application runs through the system, not as an account rendered afterwards. That duty does depend first on whether this system is high-risk at all: does it help decide entitlement to social assistance, or does it stay within a preparatory or narrowly procedural task under Article 6(3), which closes its own exception again once the system profiles citizens? Answer that question before you start on paragraph 1. An entry in the public algorithm register is on our reading something different from the assessment under paragraph 1, and it does not replace notifying the market surveillance authority of the results. In practice it pays to record the citizen's complaint route and the case worker's room to depart from the signal in the same file, because paragraph 1 asks for precisely those two elements.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 27(1), (3) and (5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-fria-recidiverisico-politie","legacy_id":"raip:example:example-fria-recidiverisico-politie","type":"example","slug":"example-fria-recidiverisico-politie","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"3136fdfa784bcee684810eafa3fc784e9ff1905adf38d86767b1e6daed7c37da","label":"Recidivism scoring in police work: when the assessment must be redone","summary":"A police service deploys an AI system that estimates the recidivism risk of a suspect, as an aid to the judgements later made by the prosecution service and the court. The model is subsequently retrained on newer investigative data and use is extended to a second region. The question is whether the assessment made for first use remains adequate.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-27-fria"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 27(1) requires deployers which are bodies governed by public law to perform, prior to deploying a high-risk AI system referred to in Article 6(2), an assessment of the impact on fundamental rights that its use may produce, with the exception of systems intended to be used in the area listed in point 2 of Annex III. That assessment consists of a description of the processes in which the system will be used, of the period and frequency of use, of the categories of natural persons and groups likely to be affected, of the specific risks of harm taking into account the information given by the provider pursuant to Article 13, of the implementation of human oversight measures according to the instructions for use, and of the measures to be taken if those risks materialise. Article 27(2) provides that the obligation applies to the first use, that previously conducted impact assessments or existing assessments carried out by the provider may be relied on in similar cases, and that a deployer who considers during use that any element listed in paragraph 1 has changed or is no longer up to date shall take the necessary steps to update the information. Article 27(3) provides that the results are notified to the market surveillance authority together with the filled-out template, and that in the case referred to in Article 46(1) an exemption from that notification duty may apply.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 27(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read Article 27 as covering a police service as a body governed by public law under paragraph 1, and as an assessment that does not stop at first use: retraining on newer investigative data or extending use to a second region touches the elements of paragraph 1 and, on our reading, calls for updating the record. That retraining also raises a question Article 27 itself does not answer, namely whether the change goes far enough to count as a substantial modification, which would make you a provider in your own right under Article 25. Bear in mind as well that the exception in paragraph 3 concerns, on our reading, the notification and not the assessment itself. Finally, start that assessment only after establishing that the deployment as such is permitted, because Article 5 rules out certain predictive applications in criminal investigation.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 27(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-fria-selectie-inschrijving-hogeschool","legacy_id":"raip:example:example-fria-selectie-inschrijving-hogeschool","type":"example","slug":"example-fria-selectie-inschrijving-hogeschool","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"81f378ec11bfd5271d13fa170d8d63f220e78317143a657af062421c1512c069","label":"Selection at student admission: a DPIA is not yet a FRIA","summary":"A university of applied sciences has an AI system rank applications for a vocational programme, using the exam results of earlier students to calibrate that ranking. A data protection impact assessment already exists for this processing. The question the school asks is whether that also covers the fundamental rights side of admission.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:public-service-provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-27-fria"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 27(1) provides that deployers which are bodies governed by public law, or private entities providing public services, and deployers of high-risk AI systems referred to in points 5(b) and (c) of Annex III, shall perform an assessment of the impact on fundamental rights prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of systems intended to be used in the area listed in point 2 of Annex III. That assessment consists of a description of the deployer's processes in which the system will be used in line with its intended purpose, of the period and frequency of use, of the categories of natural persons and groups likely to be affected, of the specific risks of harm to those categories, of the implementation of human oversight measures, and of the measures to be taken if those risks materialise, including the arrangements for internal governance and complaint mechanisms. Article 27(2) provides that the obligation applies to the first use, that the deployer may in similar cases rely on previously conducted impact assessments or existing assessments carried out by the provider, and that a deployer who considers during use that any element listed in paragraph 1 has changed or is no longer up to date shall take the necessary steps to update the information. Article 27(4) provides that where an obligation under this Article is already met through the data protection impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the assessment under paragraph 1 complements that data protection impact assessment.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 27(1), (2) and (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read Article 27 as placing the education institution that runs this selection itself in the deployer role, but that alone does not settle the duty. Paragraph 1 names bodies governed by public law and private entities providing public services, and whether a state-funded or a private university of applied sciences answers to either description is the question you have to settle first. If it does, an existing data protection impact assessment is on our reading the starting point rather than the last word: paragraph 4 has the fundamental rights assessment sit alongside it, and since Regulation (EU) 2026/1744 that assessment may incorporate or cross-refer to relevant parts of it, so the real question is which elements of paragraph 1 are still missing. For you that means recording which groups of students may be affected, how the admissions committee or the teacher can correct an outcome, and where a rejected applicant can lodge a complaint. If the selection rule or the assessment component underpinning the ranking changes, that is on our reading the moment to update the record, rather than the start of the next academic year.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 27(1), (2) and (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-fria-zorgverzekeraar-risicobeoordeling","legacy_id":"raip:example:example-fria-zorgverzekeraar-risicobeoordeling","type":"example","slug":"example-fria-zorgverzekeraar-risicobeoordeling","version":"1.0.0","effective_at":"2026-05-19T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"da4c33f856bb8621e0a1ecad5647b97f9511b86d1c9cc729d555166238398e7e","label":"Health insurer using AI for risk assessment: public or private makes no difference","summary":"A health insurer uses AI for risk assessment and pricing of health and life insurance. The question is whether this falls under point 5(c) of Annex III, and with that whether the Article 27 FRIA duty comes into play.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-27-fria"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The Commission draft guidelines of 19 May 2026 state that the health and life insurance in point 5(c) may be offered on a private or a public basis: a health insurer governed by public law also falls within it, so long as the system is intended for risk assessment or pricing with regard to natural persons. Privately serviced health insurance counts as an essential private service, even in a Member State with a public healthcare system. Unlike point 5(b), point 5(c) provides no exception for fraud detection. The document is a consultation version: non-binding and not yet final.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III, paragraphs (319) to (321)","source_url":"https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"For the FRIA question point 5(c) counts twice: it makes the system high-risk and it makes you, as deployer, one of the parties Article 27 names. A public-law form or a public healthcare system in your Member State changes nothing there. Do not count on the fraud-detection exception from point 5(b) either: it does not apply here, and a fraud feature alongside risk assessment does not take the system out.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III, paragraphs (319) to (321)","source_url":"https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-logging-hogeschool-aanmelding-toetsing","legacy_id":"raip:example:example-logging-hogeschool-aanmelding-toetsing","type":"example","slug":"example-logging-hogeschool-aanmelding-toetsing","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"87cc04e5994d67a08654e7bda8c7ea6eb508508cf029630e0faf71818cbd70bb","label":"Logging in admission and assessment: what the institution keeps in its own hands","summary":"A university of applied sciences uses a purchased AI system that ranks student admissions and also raises flags during digital assessment. The logs sit in the supplier environment, which hands them over on request. The teaching organisation wonders whether that settles the matter or whether the school retains a duty of its own.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-12-logging"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 12(1) requires a high-risk AI system to technically allow for the automatic recording of events (logs) over the lifetime of the system, and Article 12(2) ties that recording to a level of traceability appropriate to the intended purpose of the system. Article 26(6) provides that deployers keep the automatically generated logs to the extent those logs are under their control, for a period appropriate to the intended purpose, of at least six months, unless applicable Union or national law provides otherwise, in particular Union law on the protection of personal data. Article 19(1) places a corresponding retention duty on providers for the logs generated by their systems that are under their control, likewise for at least six months.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12(1) and (2), Article 19(1) and Article 26(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"On our reading, the fact that the supplier hosts the logs does not by itself place the school outside Article 26(6): what matters is whether the logs are under its control. The Regulation does not define that notion, and on our reading server location is not decisive in itself; the question is whether you can actually and contractually dispose of those logs, and it has to be answered for each procurement. So agree at procurement that the institution can request, export and itself retain the logs for the chosen period, and record which admission and assessment events that covers. Take data protection into account at the same time, because the same provision allows other Union or national law to cap the retention period.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12(1) and (2), Article 19(1) and Article 26(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-logging-productielijn-veiligheidscomponent","legacy_id":"raip:example:example-logging-productielijn-veiligheidscomponent","type":"example","slug":"example-logging-productielijn-veiligheidscomponent","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"624d417df4b70bdd1072de6b663f188dd48de9556bd5866eabfc9f1da5fe3d3a","label":"Logging on the production line: which logs the manufacturer keeps and which the factory keeps","summary":"A manufacturer supplies an AI system that runs as a safety component inside the machinery of a production line and also drives quality control. The factory operating the line keeps only the alerts visible in the local controller; the rest of the recording flows to the supplier environment. The question is who has to keep which logs when it later has to be reconstructed why the line was halted.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-12-logging"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 12(1) requires high-risk AI systems to technically allow for the automatic recording of events (logs) over the lifetime of the system. Under Article 12(2), those logging capabilities must enable the recording of events relevant for identifying situations that may result in the system presenting a risk within the meaning of Article 79(1) or in a substantial modification, for facilitating the post-market monitoring referred to in Article 72, and for monitoring the operation of the high-risk AI systems referred to in Article 26(5). Article 19(1) obliges providers to keep those automatically generated logs to the extent they are under their control, for a period appropriate to the intended purpose of the system, of at least six months, unless applicable Union or national law provides otherwise. Article 26(6) places a corresponding retention duty on deployers for the logs under their control, with the same six-month floor.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12(1) and (2), Article 19(1) and Article 26(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read Article 19 together with Article 26(6) as leaving the manufacturer, acting here as the provider, and the factory, acting as the deployer, each with a retention duty of its own for the logs under its control. The Regulation does not say when logs count as being under your control, and on our reading the place where the recording physically lands does not settle that by itself; the question has to be answered system by system. For a production line that means recording which events stay in the machinery controller and which travel to the supplier, and securing access to that second set contractually before you need it. Leave that unarranged and you risk being unable to trace a line stoppage or a quality control rejection back to the behaviour of the system.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12(1) and (2), Article 19(1) and Article 26(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-logging-taakverdeling-werkvloer","legacy_id":"raip:example:example-logging-taakverdeling-werkvloer","type":"example","slug":"example-logging-taakverdeling-werkvloer","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"be80038e3b50070a20f07e501c8a3a9c35fff975654135c454e9a4c5a9b96545","label":"Logging in task allocation at work: evidence about the system or a file on the employee","summary":"An employer deploys an AI system that handles task allocation among staff and summarises their performance for the performance review. HR wants to know what record of those outcomes has to be retained when an employee objects months later to a promotion decision.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-12-logging"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 12(1) requires high-risk AI systems to technically allow for the automatic recording of events (logs) over the lifetime of the system. Article 12(2)(c) names, as one of the purposes of those logging capabilities, monitoring the operation of the systems referred to in Article 26(5), and that paragraph obliges deployers to monitor operation on the basis of the instructions for use and, where relevant, to inform the provider in accordance with Article 72. Article 26(6) obliges deployers to keep the automatically generated logs to the extent they are under their control, for a period appropriate to the intended purpose, of at least six months, unless applicable Union or national law provides otherwise. Article 19(1) sets out a corresponding retention duty for providers, with the same six-month floor.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12(1) and (2)(c), Article 19(1) and Article 26(5) and (6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read Article 12(2) as putting the logging capabilities there first of all to follow risks, substantial modifications and the operation of the system, not to sharpen judgements about individual staff. Whether that statement of purpose also limits what the retained logs may later be used for is something Article 12 does not say: on our reading that limit has to come from data protection law, to which Article 26(6) itself refers. For HR a practical line follows: keep what is needed to trace an outcome and to carry out the monitoring under Article 26(5), and settle in writing beforehand whether those same files may double as a performance record. Bear in mind that the six-month floor can be shorter than the period within which an employee challenges a promotion decision; the Regulation does not govern that evidential position.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12(1) and (2)(c), Article 19(1) and Article 26(5) and (6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-politie-model-bijtrainen-opsporing","legacy_id":"raip:example:example-politie-model-bijtrainen-opsporing","type":"example","slug":"example-politie-model-bijtrainen-opsporing","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"f76e99119daefd7c5cfc07f8db92500ea93ce6a13b3e86aff47818a0a15cb89a","label":"Police fine-tuning a model for investigations: settle the role question first","summary":"A police service fine-tunes an open general-purpose model on its own files from ongoing criminal investigations, so that detectives can see links between suspects and cases sooner. The fine-tuned model stays inside the service and is not made available to anyone else. The question is whether the service thereby becomes a provider of a general-purpose AI model itself, and so falls under Article 53.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-53-gpai"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 53(1) requires providers of general-purpose AI models to do four things: draw up and keep up-to-date the technical documentation of the model, including its training and testing process and the results of its evaluation, containing at a minimum the information set out in Annex XI so that it can be provided on request to the AI Office and the national competent authorities; draw up, keep up-to-date and make available information and documentation to providers of AI systems who intend to integrate the model, containing at a minimum the elements set out in Annex XII; put in place a policy to comply with Union law on copyright and related rights; and draw up and make publicly available a sufficiently detailed summary about the content used for training, according to a template provided by the AI Office. Article 53(2) provides that the obligations under points (a) and (b) do not apply to providers of models released under a free and open-source licence that allows for the access, usage, modification and distribution of the model, and whose parameters, including the weights, the information on the model architecture and the information on model usage, are made publicly available, and that this exception does not apply to general-purpose AI models with systemic risks.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 53(1) and (2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Start with your role, because merely using someone else's model does not by itself make you a model provider; Article 53 does not say at what point a service that fine-tunes crosses that line, and the point deserves an explicit answer rather than an assumption. A further question comes before Article 53: whether your fine-tuned investigation model has been placed on the market within the meaning of the Regulation. That it never leaves the service does not settle this on its own, since the Commission's guidelines on the scope of the obligations for providers of general-purpose AI models also treat internal use affecting the rights of natural persons as placing on the market. We read paragraph 2 as attaching the open-source exception to your own model rather than carrying it over automatically from the model you started out with: if you do not publish the weights and architecture of the fine-tuned model, which is the obvious course in criminal matters, then on that reading the exception is not open to you, and the duties under points (c) and (d) remain in place in any event, since paragraph 2 lifts only points (a) and (b). So record, version by version, exactly what you changed, on which data and to what end, because that record is what decides whether you stand here as a user or as a provider.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 53(1) and (2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-post-market-monitoring-hr-beoordelingssysteem","legacy_id":"raip:example:example-post-market-monitoring-hr-beoordelingssysteem","type":"example","slug":"example-post-market-monitoring-hr-beoordelingssysteem","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"834c3d7f217e8710ac5698e4b555f10d6b66e59eddbb6facca765496ad4b791d","label":"Assessing staff: signals from the workplace flowing back to the provider","summary":"A provider supplies a system that summarises employee performance data and supports HR in promotion decisions. After a year in use, departments turn out to apply it differently than intended, and managers factor the outputs into the performance review. The question is what the provider is supposed to know about that.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-72-post-market-monitoring"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 72(1) requires providers to establish and document a post-market monitoring system in a manner proportionate to the nature of the AI technologies and the risks of the high-risk AI system. Article 72(2) requires that system to actively and systematically collect, document and analyse relevant data, which may be provided by deployers or collected through other sources, on performance throughout the system's lifetime, allowing the provider to evaluate continuous compliance with the requirements set out in Chapter III, Section 2. Article 72(3) provides that the system is based on a plan forming part of the technical documentation referred to in Annex IV, and instructs the Commission to adopt an implementing act laying down detailed provisions establishing a template for that plan and the list of elements to be included in it; the Regulation sets 2 February 2026 as the date for that act.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 72(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Our reading is that use which departs from what was intended is exactly the kind of real-world data paragraph 2 has in mind, because it bears on the human oversight and the intended purpose laid down in Section 2. Paragraph 3 points to a Commission template for which the Regulation sets 2 February 2026 as the date; check whether that template has since been adopted and align with it if so, since paragraph 4 refers to it as well. In the meantime we would not put the design of your monitoring on hold for it: which data you need already follows from the requirements the system must continue to meet. Agree with the organisations using the system on the route by which employee complaints and deviations in assessments reach you.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 72(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-post-market-monitoring-proctoring-tentamens","legacy_id":"raip:example:example-post-market-monitoring-proctoring-tentamens","type":"example","slug":"example-post-market-monitoring-proctoring-tentamens","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"683c18d4fac97ff4db4363416589f34e9615625ed4323784e0b292b8d25ad231","label":"Proctoring during exams: which real-world data the institution reports back","summary":"A vendor offers proctoring software that flags possible cheating during exams. Several universities of applied sciences use the system, each with its own assessment formats and its own student populations. The vendor wants to know which real-world data it must keep collecting after roll-out, and from whom.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-72-post-market-monitoring"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 72(1) requires providers to establish and document a post-market monitoring system, proportionate to the nature of the AI technologies and the risks of the system. Article 72(2) provides that this system actively and systematically collects, documents and analyses relevant data which may be provided by deployers or collected through other sources on the performance of high-risk AI systems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of those systems with the requirements set out in Chapter III, Section 2. Where relevant, monitoring includes an analysis of the interaction with other AI systems. Article 72(3) provides that the system is based on a plan forming part of the technical documentation referred to in Annex IV.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 72(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The duty sits with the provider, but the useful signals arise in education itself: unfounded suspicions, student complaints, differences between programmes and assessment formats. Our reading is that paragraph 2 allows deployers to supply that data while leaving the duty to collect and analyse it with the provider. What the article does not settle is the route by which the data reaches you, or whether the institutions are bound to supply it; that is something you have to arrange with them and cannot read out of Article 72. We would therefore fix that route before the system goes live, and would also set out in the plan how you break performance down by assessment format and by group, since an average across all schools hides precisely the pattern you are looking for.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 72(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-post-market-monitoring-veiligheidscomponent-productielijn","legacy_id":"raip:example:example-post-market-monitoring-veiligheidscomponent-productielijn","type":"example","slug":"example-post-market-monitoring-veiligheidscomponent-productielijn","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"b1ed8bb9e9486b8528de2cce401e4f0ce0bed59bd284ede4a90ac5703f85dc09","label":"Safety component on the production line: the manufacturer keeps watching after delivery","summary":"A manufacturer supplies an AI safety component that halts machinery on a production line as soon as someone comes too close to the robot. The component already falls under product legislation for machinery, and the manufacturer runs quality control and incident follow-up for it. The question is what Article 72 adds on top of that.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-72-post-market-monitoring"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 72(1) requires providers to establish and document a post-market monitoring system in a manner proportionate to the nature of the AI technologies and the risks of the high-risk AI system. Article 72(3) provides that this system is based on a post-market monitoring plan, and that the plan forms part of the technical documentation referred to in Annex IV. Article 72(4) gives providers of high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where a post-market monitoring system and plan are already established under that legislation, the choice of integrating the necessary elements described in paragraphs 1, 2 and 3 into those systems and plans, using the template referred to in paragraph 3, provided this achieves an equivalent level of protection.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 72(1), (3) and (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Our reading is that Article 72 does not force a second, separate monitoring structure here: paragraph 4 gives you the choice of housing the elements in the system and plan you already run under product legislation, using the template from paragraph 3 and as long as the level of protection remains equivalent. That route stands or falls on a question the article does not answer for you: does the applicable product legislation genuinely have an established post-market monitoring system and plan, or do you run quality control and incident follow-up that were never established as such. Beyond that, you need to be able to show that the signals coming off the factory floor genuinely speak to continued compliance with the high-risk AI requirements, and not only to the mechanical safety of the machine. We would therefore record, for each production signal, which requirement it touches, so that integration does not become dilution.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 72(1), (3) and (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-proctoring-tentamen-incidentmelding","legacy_id":"raip:example:example-proctoring-tentamen-incidentmelding","type":"example","slug":"example-proctoring-tentamen-incidentmelding","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"9acab6c994b68ac7110c3307f8907ee18580a895ef51f8ed17588a3e03b73504","label":"Proctoring during an exam overshoots: from signal to reporting duty","summary":"A university of applied sciences uses proctoring software during an online exam and finds that a group of students is systematically and wrongly flagged as suspicious, after which grades were withdrawn. Teaching staff and the examination board want to know whether this pattern is a serious incident and, if so, who has to report it and within what time.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-73-incident-reporting"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 3, point (49) defines a serious incident as an incident or malfunctioning of an AI system that directly or indirectly leads to, among other things, the infringement of obligations under Union law intended to protect fundamental rights. Article 73(1) obliges the provider of a high-risk AI system placed on the Union market to report serious incidents to the market surveillance authorities of the Member State where the incident occurred. Article 73(2) requires the report to be made immediately after the provider has established the causal link or the reasonable likelihood of such a link, and in any event no later than 15 days after the provider or, where applicable, the deployer becomes aware of the serious incident. Article 73(5) allows an initial, incomplete report followed by a complete report where this is necessary to ensure timely reporting. Article 73(7) provides that upon receiving a report concerning a serious incident as referred to in Article 3, point (49)(c), the market surveillance authority informs the national public authorities or bodies referred to in Article 77(1). Article 26(5) requires a deployer that has identified a serious incident to inform, immediately, first the provider and then the importer or distributor and the relevant market surveillance authorities.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 3(49), Article 26(5) and Article 73(1), (2), (5) and (7)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read Article 73 as meaning that an incident in education is rarely a single dramatic moment: the signal sits in the pattern in exam results, and the institution sees that pattern before the software supplier does. Whether that pattern amounts to a serious incident is a separate question: it turns on whether the wrongful flagging and the withdrawal of grades count as an infringement of obligations protecting fundamental rights within the meaning of Article 3, point (49)(c), and Article 73 does not make that assessment for you. Leaving the question open until your own investigation is finished carries a risk, because the Article 73(2) period runs from awareness. Set up your examination and complaints process so that such a pattern reaches the provider within days; Article 26(5) also puts a notification duty on the institution itself as deployer, towards the provider, the importer or distributor and the market surveillance authority. The initial, incomplete report of Article 73(5) is the pressure valve here; waiting for a finished investigation report is not.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 3(49), Article 26(5) and Article 73(1), (2), (5) and (7)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-securitymonitoring-kritieke-digitale-infrastructuur","legacy_id":"raip:example:example-securitymonitoring-kritieke-digitale-infrastructuur","type":"example","slug":"example-securitymonitoring-kritieke-digitale-infrastructuur","version":"1.0.0","effective_at":"2026-05-19T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"8dd8de28fda79bd209141410f49769cdb9af6a28ce4f10a431b5106d06367115","label":"Security monitoring by a SaaS company: cybersecurity alone is not a safety component","summary":"A software company supplies a SaaS platform that monitors network traffic at an operator of critical digital infrastructure and reports anomalous patterns to that customer's security team. Its developers see that use at such an operator may fall under point 2 of Annex III and wonder whether their own product therefore becomes a high-risk AI system.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-high-risk"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The Commission draft guidelines of 19 May 2026 state that point 2 of Annex III lists AI systems intended to be used as safety components in the management and operation of, among other things, critical digital infrastructure, and that Recital 55 draws a clear distinction between a safety component and a cybersecurity component. To fall within point 2, an AI system must not be used solely for cybersecurity purposes; without a direct safety role it cannot be a safety component in critical infrastructure and therefore cannot be classified as high-risk under Article 6(2). As examples of systems used solely for cybersecurity and thus falling outside point 2, they list an AI honeypot that identifies and neutralises cyber threats in real time, technology that actively engages with potential attackers to learn new attack patterns, a system supporting the detection of unauthorised access, and a system that detects suspicious email addresses and identifies stolen data. They add that an AI system is classified as a safety component in critical infrastructure only where it is used by an entity identified as a critical entity by a Member State under the CER Directive, and that this interpretation does not require that status to be disclosed to a third-party provider. The document is a consultation version: non-binding and not yet final.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines","source_locator":"Draft guidelines on the classification of high-risk AI systems, 19 May 2026, annex on Annex III, paragraphs (187), (188), (190) and (191)","source_url":"https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read this passage as a line drawn function by function rather than customer by customer: the fact that your client operates critical digital infrastructure does not by itself turn your monitoring product into a safety component. What we cannot settle from the text is where mere flagging ends and a safety function begins, because the same guidelines also count monitoring and detecting situations that may directly lead to physical harm among the safety functions. The open question is therefore whether your SaaS platform stands apart from the systems that drive physical control, or in practice becomes part of them. So record, per product function, what the system performs and what it expressly leaves to the operator, because that distinction carries your entire classification and is hard to reconstruct after the fact.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines","source_locator":"Draft guidelines on the classification of high-risk AI systems, 19 May 2026, annex on Annex III, paragraphs (187), (188), (190) and (191)","source_url":"https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-toelating-hogeschool-registratie-eu-databank","legacy_id":"raip:example:example-toelating-hogeschool-registratie-eu-databank","type":"example","slug":"example-toelating-hogeschool-registratie-eu-databank","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"3d53527e1fe64875c7712e50282816d365b64c9b924e3a6965b22cf6c50a7dff","label":"Admission system at a higher education institution: who registers in the EU database","summary":"A higher education institution procures an AI system that organises student applications and enrolment and produces an admission recommendation for each candidate in its vocational programmes. The supplier says it handles the conformity assessment itself and affixes the CE marking. What is left unresolved is whether the institution still has a step of its own to take before the system goes into use in its teaching.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:conformity-ce-registration"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 43(2) provides that for high-risk AI systems referred to in points 2 to 8 of Annex III, providers follow the conformity assessment procedure based on internal control set out in Annex VI, which does not provide for the involvement of a notified body. Article 47(1) requires the provider to draw up, for each high-risk AI system, a written machine-readable, physical or electronically signed EU declaration of conformity and to keep it at the disposal of the national competent authorities for ten years after the system has been placed on the market or put into service. Article 49(1) requires the provider or, where applicable, the authorised representative to register themselves and their system in the EU database referred to in Article 71 before an Annex III high-risk system is placed on the market or put into service, with the exception of the systems listed in point 2 of Annex III. Article 49(3) provides that deployers that are public authorities or Union institutions, bodies, offices or agencies, or persons acting on their behalf, register themselves, select the system and register its use in that same database before putting such a system into service or using it, again with the exception of the systems listed in point 2 of Annex III.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43(2), Article 47(1) and Article 49(1) and (3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"We read Article 49 as two separate registrations: paragraph 1 covers the provider and its system, paragraph 3 covers your own use, and on that reading the first does not relieve you of the second. The hinge question for the institution is therefore not whether the supplier does its job, but whether it is a public authority within the meaning of paragraph 3. The Regulation does not define that term, and until that is settled it remains open whether the institution must itself appear in the EU database. In practice we would move the request for the EU declaration of conformity and the registration number into the procurement stage, so that the question does not turn into a blocker just before an application period opens.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43(2), Article 47(1) and Article 49(1) and (3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-triage-spoedeisende-hulp","legacy_id":"raip:example:example-triage-spoedeisende-hulp","type":"example","slug":"example-triage-spoedeisende-hulp","version":"1.0.0","effective_at":"2026-05-19T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"62d16510c753780018aa9840884d802dfdc1b68e969a525fc0d205fdd486c3f3","label":"Emergency triage system: two routes to high risk","summary":"A hospital uses AI to prioritise incoming patients at the emergency department. The question is not whether the system is high-risk but by which route: as a medical device under product legislation, or directly under Annex III.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:annex-iii-high-risk"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The Commission draft guidelines of 19 May 2026 state that an emergency healthcare patient triage system may qualify as a medical device; where it then meets Article 6(1), it is high-risk via Annex I and sectoral rules apply. A triage system that is not a medical device is high-risk via Article 6(2) and point 5(d) of Annex III. The document is a consultation version: non-binding and not yet final.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III, paragraphs (334) and (335)","source_url":"https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"First establish whether your triage system is a medical device, because that question decides the whole route: via Annex I the assessment travels with the medical conformity assessment and its date, via Annex III the separate timeline of Article 6(2) applies. Either way the outcome is high-risk, so postponing that determination only creates uncertainty about which regime to set up.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III, paragraphs (334) and (335)","source_url":"https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:example:example-webshop-kredietcheck-technisch-dossier","legacy_id":"raip:example:example-webshop-kredietcheck-technisch-dossier","type":"example","slug":"example-webshop-kredietcheck-technisch-dossier","version":"1.0.0","effective_at":"2024-08-01T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"d78a5fb746a80b877e3392af6e2f5baa03e844e1777db2c3b305ccb327eb0704","label":"Webshop builds its own consumer credit check: what belongs in the file","summary":"A non-food retail chain lets customers pay later in its webshop and decides at checkout whether a consumer qualifies. The team builds that assessment system in house, on top of a pre-trained model supplied by a vendor. The question is what has to be on record before the feature goes live, and who has to put it there.","topics":["examples"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-11-technical-documentation"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"Article 11(1) requires the technical documentation of a high-risk AI system to be drawn up before that system is placed on the market or put into service, and to be kept up to date. It must be drawn up so as to demonstrate compliance with the requirements of that Section and to give national competent authorities and notified bodies the necessary information, in a clear and comprehensive form, to assess that compliance; it contains at a minimum the elements set out in Annex IV. Annex IV lists those elements as applicable to the AI system concerned, and asks among other things for the methods and steps performed for development, including, where relevant, recourse to pre-trained systems or tools provided by third parties and how those were used, integrated or modified by the provider, for the validation and testing procedures used, and for a description of relevant changes made by the provider to the system through its lifecycle. SMEs, including start-ups, may supply those elements in a simplified manner; where they take that route, they must use the simplified form the Commission is to establish for that purpose.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 11(1) and Annex IV","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Article 11 puts the documentation duty on the provider, so the first open question here is who that provider is. If the creditworthiness assessment of consumers counts as high-risk in your situation, then in our reading there is a strong case that a webshop assembling the system itself and putting it into service under its own name is no longer merely a deployer but ends up on the provider side, carrying the documentation duty that comes with it. Article 11 does not settle that allocation of roles, so test it against the definitions and against Article 25 before assuming the file is your vendor's problem. In our reading the hard part in retail is not the first version of the file but the pace afterwards, because a webshop often ships changes per release while the file stays frozen at the state it had when the feature went into service. So contract for the provenance, training and testing information that Annex IV expects from you when you buy the pre-trained model, and assign per release who updates the file.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 11(1) and Annex IV","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"editorial","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:annex-iii-eight-areas","legacy_id":"raip:obligation:annex-iii-eight-areas","type":"obligation","slug":"annex-iii-eight-areas","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"fefd34d9142cbbda7f5ba59c3a3ec858bd9f1101363c0e874cf8b071780790e6","label":"Annex III: the eight areas separately","summary":"Annex III names eight areas in which an AI system can be high-risk under Article 6(2). This object publishes those eight areas as separate objects, so that a question about recruitment, assessment, creditworthiness or border control lands on the point that names it rather than on the list as a whole.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"What is open here is not the text but the boundary and the form. The eight points are reproduced verbatim, but whether a concrete application falls inside a lettered subpoint depends on the intended purpose, and the Commission guidelines working that out point by point are still in draft at our knowledge date. Publishing the points as separate objects is also our choice; the Regulation gives a list and not eight self-standing norms. A defensible alternative reading is that only the Article 6(2) route deserves an object of its own. It also remains unclear how Article 6(3) works out per area: the exception is drafted in general terms, but the profiling proviso bites in almost every case in one area and rarely in another. Finally, we have checked that Regulation (EU) 2026/1744 inserts Article 6(1a) to (1c) without renumbering or amending paragraphs 2 and 3; if that changes, the route in this object changes with it.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:map-system-to-annex-iii-area"],"evidence_ids":["praxikon:eu:ai-act:evidence:annex-iii-area-mapping-record"],"control_ids":["praxikon:eu:ai-act:control:annex-iii-area-rescan-trigger"],"template_ids":["praxikon:eu:ai-act:template:annex-iii-eight-areas-legal-text"],"conditions":[{"id":"annex-iii-eight-areas-intended-purpose","operator":"any","description":"Applies where the intended purpose of the AI system falls within one of the eight areas listed in Annex III: biometrics, critical infrastructure, education and vocational training, employment and workers management, access to essential private and public services, law enforcement, migration and border control management, or administration of justice and democratic processes."},{"id":"annex-iii-eight-areas-route","operator":"all","description":"Classification follows Article 6(2). For points 1, 6 and 7 the text adds the condition that the use is permitted under relevant Union or national law. We read that condition as meaning that a prohibition under Article 5 comes before the question whether the system is high-risk; that is our reading and not the literal text, which states the condition without naming the order."},{"id":"annex-iii-eight-areas-article-25-role-shift","operator":"any","description":"The duty rests on the provider, but the role can shift. Under Article 25(1) a distributor, importer, deployer or third party becomes a provider itself where it puts its name or trademark on the system, makes a substantial modification, or changes the intended purpose such that the system becomes high-risk under Article 6. From that moment it carries the mapping to a point of Annex III itself."}],"exceptions":[{"id":"annex-iii-eight-areas-article-6-3-derogation","operator":"not","description":"Article 6(3) takes a system listed in Annex III back outside high-risk where it does not pose a significant risk of harm to health, safety or fundamental rights, including by not materially influencing the outcome of decision making, and one of four conditions is met: the system performs a narrow procedural task, it improves the result of a previously completed human activity, it detects decision making patterns or deviations from prior patterns without replacing or influencing the previously completed human assessment without proper human review, or it performs a preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III. A system that performs profiling of natural persons is always high-risk."},{"id":"annex-iii-eight-areas-article-6-4-documentation","operator":"all","description":"The derogation is not free. Article 6(4) requires a provider who considers that a system referred to in Annex III is not high-risk to document its assessment before the system is placed on the market or put into service, subjects that provider to the registration obligation in Article 49(2), and requires it to provide the documentation to national competent authorities on request."}],"statements":[{"kind":"official_fact","text":"The introductory sentence of Annex III reads: High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas. Eight numbered areas follow. 1. Biometrics, in so far as their use is permitted under relevant Union or national law. 2. Critical infrastructure. 3. Education and vocational training. 4. Employment, workers’ management and access to self-employment. 5. Access to and enjoyment of essential private services and essential public services and benefits. 6. Law enforcement, in so far as their use is permitted under relevant Union or national law. 7. Migration, asylum and border control management, in so far as their use is permitted under relevant Union or national law. 8. Administration of justice and democratic processes. The full text of each point, with its lettered subpoints, sits on the object for that area.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, points 1 to 8","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Annex III is not fixed. Article 7(1) empowers the Commission to add or amend use cases in Annex III by delegated act, and Article 7(3) to remove them. Article 7(1)(a) requires the system to be intended for use in one of the areas listed in Annex III. The eight areas are therefore the stable layer; the lettered subpoints inside them can change without the Regulation itself being revised.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 7(1) and (3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Seven of the eight areas are subdivided into lettered subpoints in the text: point 1 into (a) to (c), point 3 into (a) to (d), point 4 into (a) and (b), point 5 into (a) to (d), point 6 into (a) to (e), point 7 into (a) to (d) and point 8 into (a) and (b). Point 2 has no lettered subpoints. We therefore count twenty-four lettered subpoints across seven areas. That number appears nowhere in the Regulation: it is our count of the text as it stands at our knowledge date, and a delegated act under Article 7 can silently make it stale.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex III, points 1 to 8","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Reading Annex III as one block leads to the wrong question. The question is not whether your organisation works in one of the eight areas, because nearly everyone does: a hospital touches point 5, a school point 3, and every employer point 4. The question is whether the intended purpose of this one system coincides with the description of a lettered subpoint. A CV parser that only deduplicates repeat applications does something other than a system that evaluates candidates, and yet both get filed under recruitment in practice. Note the order too. Points 1, 6 and 7 carry the condition that the use must be permitted, and that is where Article 5 comes first. Emotion recognition in the workplace and in education is prohibited under Article 5(1)(f), except where the system is placed on the market or put into service for medical or safety reasons; whoever reverses that builds a conformity file for something that is not allowed. Finally, the area also determines which duties then weigh heavily. Article 86 gives a right to an explanation for decisions based on any system listed in Annex III other than point 2, and Article 27 requires bodies governed by public law and private providers of public services to carry out a fundamental rights impact assessment on every Annex III route other than point 2, with point 5(b) and (c) extending that duty to any deployer. For systems already on the market before the application date, the separate transitional rule of Article 111(2) applies as well.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 5(1)(f), Article 27(1), Article 86(1), Article 111(2) and Annex III","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"For every AI system, record in your register not that it falls under Annex III but which point and which lettered subpoint it touches, with the intended purpose in your own words alongside. The eight area objects sit in the graph under the slugs annex-iii-area-1-biometrics through annex-iii-area-8-justice-and-democratic-processes; refer to those rather than to Annex III as a whole. Add four fields: is the use permitted, and if not, why is Article 5 not engaged; has the Article 6(3) test been carried out, which of the four conditions was met, and has the assessment been documented and the system registered under Article 6(4) and Article 49(2); does the system perform profiling, because the exception then falls away; and who carries the provider role after Article 25. Repeat that record on every change to the intended purpose.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(2)-(4), Article 25(1), Article 49(2) and Annex III","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/annex-iii-eight-areas","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Annex III on EUR-Lex"},{"relation":"public_page","href":"https://www.praxikon.com/nl/ai-act/bijlage/3","label":"Annex III in the AI Act Explorer"},{"relation":"related","href":"https://www.praxikon.com/nl/annex-iii","label":"The eight areas on praxikon.com"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:annex-iii-high-risk","legacy_id":"raip:obligation:annex-iii-high-risk","type":"obligation","slug":"annex-iii-high-risk","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"c0afd1789ed393ba3f9ce04205bd74b4831ff0fd58146108fdd8dd08d2f4f6c9","label":"Annex III: high-risk AI","summary":"Classification route for standalone high-risk AI systems under Article 6(2) and Annex III.","topics":["high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:annex-iii-classify"],"evidence_ids":["praxikon:eu:ai-act:evidence:annex-iii-classification-record"],"control_ids":["praxikon:eu:ai-act:control:annex-iii-change-trigger"],"template_ids":["praxikon:eu:ai-act:template:annex-iii-classifier"],"conditions":[{"id":"annex-iii-listed-purpose","operator":"all","description":"The intended purpose falls within a use case listed in Annex III."},{"id":"article-6-2-route","operator":"all","description":"Classification follows Article 6(2)."}],"exceptions":[{"id":"article-6-3-exception","operator":"not","description":"A listed Annex III system may fall outside high-risk under the strict conditions in Article 6(3), except where it profiles. The assessment and registration must be documented."}],"statements":[{"kind":"official_fact","text":"The core rules in Chapter III, Sections 1 to 3, for systems under Article 6(2) and Annex III become applicable on 2 December 2027.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, Article 6(2) and Annex III application date","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The later application date does not remove the classification question. An early classification record avoids design and procurement decisions without evidence.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6 and Annex III","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Document now the intended purpose, Annex III point, Article 6(3) assessment, profiling and selected registration path.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(2)-(4), Article 49 and Annex III","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/annex-iii-high-risk","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Binding amended application calendar"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-10-data-governance","legacy_id":"raip:obligation:article-10-data-governance","type":"obligation","slug":"article-10-data-governance","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"1b6992c5a6d684dd828c8b00a7239e768eee9d4a5cb4fdbc4fbaee3dbf561d91","label":"Article 10: data and data governance","summary":"Quality and governance requirements for training, validation and test data of high-risk AI.","topics":["high-risk-requirements"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-10-data-governance-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-10-data-governance-record"],"control_ids":["praxikon:eu:ai-act:control:article-10-data-governance-control"],"template_ids":["praxikon:eu:ai-act:template:article-10-data-governance-legal-text"],"conditions":[{"id":"article-10-data-governance-scope","operator":"all","description":"The high-risk system is trained with data; the provider composes the datasets, the deployer controls relevant input data."}],"exceptions":[{"id":"article-10-data-governance-exception","operator":"not","description":"For special categories of personal data the strict exception of Article 10(5) applies (bias detection and correction under conditions)."}],"statements":[{"kind":"official_fact","text":"Article 10 requires datasets appropriate to the intended purpose, with governance over origin and composition, attention to representativeness, errors and completeness, and examination of possible bias with appropriate measures.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 10(1)-(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Today’s dataset choices determine whether compliance is feasible later: data bought or collected today without provenance records cannot be repaired in 2027.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 10(1)-(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Record origin and assumptions per dataset and include data quality as a requirement in every AI or data procurement contract.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 10(1)-(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-10-data-governance","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 10 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-11-technical-documentation","legacy_id":"raip:obligation:article-11-technical-documentation","type":"obligation","slug":"article-11-technical-documentation","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"15571dc37c23ef11a79a3b7b9b7d5674ee4fc7161cc4a9bb8f62321f66294a2c","label":"Article 11: technical documentation","summary":"The technical file demonstrating before market placement that a high-risk system meets the requirements.","topics":["high-risk-requirements"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-11-technical-documentation-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-11-technical-documentation-record"],"control_ids":["praxikon:eu:ai-act:control:article-11-technical-documentation-control"],"template_ids":["praxikon:eu:ai-act:template:article-11-technical-documentation-legal-text"],"conditions":[{"id":"article-11-technical-documentation-scope","operator":"all","description":"The provider places a high-risk AI system on the market or puts it into service."}],"exceptions":[{"id":"article-11-technical-documentation-exception","operator":"not","description":"Small providers (SMEs) may provide the documentation in the simplified form established by the Commission."}],"statements":[{"kind":"official_fact","text":"Article 11 requires technical documentation drawn up before market placement, kept up to date and containing the Annex IV elements, so that compliance with Section 2 is demonstrable to supervisors.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 11(1)-(3) and Annex IV","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"For buying organisations, Annex IV is the checklist of what you must be able to request contractually from your supplier; without that file you cannot meet your own Article 26 duties.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 11(1)-(3) and Annex IV","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Include the right to access the technical documentation in AI procurement and supplier contracts now.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 11(1)-(3) and Annex IV","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-11-technical-documentation","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 11 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-111-legacy-public-systems","legacy_id":"raip:obligation:article-111-legacy-public-systems","type":"obligation","slug":"article-111-legacy-public-systems","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"f6d9b4b81b0a9ef37eec8fdd812d98a712cc1688491f8db5c61b8a857ee419e4","label":"Article 111(2): legacy high-risk systems and the 2 August 2030 date","summary":"High-risk AI systems placed on the market or put into service before the date of application of Chapter III, since the Digital Omnibus 2 December 2027 for Annex III systems and 2 August 2028 for Annex I systems, come under the high-risk requirements of that Chapter only once their design is significantly changed as from that date. This is not an exemption from the whole Regulation: Article 4 and Article 50 keep running. For systems intended to be used by public authorities the carve out falls away entirely: their providers and deployers must in any case comply with the requirements and obligations by 2 August 2030.","topics":["high-risk","timeline"],"actor_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:distributor","praxikon:eu:ai-act:actor:importer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:distributor","praxikon:eu:ai-act:actor:importer"],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"The text above is the consolidated text and has been checked against the Official Journal; what is preliminary is our reading of it. 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That is not the same wording as the defined substantial modification used elsewhere in the Regulation, and there is no guidance or case law saying whether a model update, a retraining run or a new data source counts. We read it as a change that touches the intended purpose, the functioning or the risk profile, and not as every release. Third, the reach of intended to be used by public authorities. It is unclear whether a system supplied to both public and private customers falls under it in full, and whether a private party carrying out a public task is a public authority. We read the intention as following from the market the system is offered for and not from the legal form of the individual customer.","obligation_ids":[],"change_ids":["praxikon:eu:ai-act:change:2026-07-27-annex-iii-date","praxikon:eu:ai-act:change:2026-12-02-article-50-marking-grace-ends","praxikon:eu:ai-act:change:2028-08-02-annex-i-high-risk-applicable"],"action_ids":["praxikon:eu:ai-act:action:assess-significant-design-change","praxikon:eu:ai-act:action:plan-legacy-public-system-compliance"],"evidence_ids":["praxikon:eu:ai-act:evidence:legacy-system-transition-register"],"control_ids":["praxikon:eu:ai-act:control:design-change-review-gate"],"template_ids":["praxikon:eu:ai-act:template:article-111-legal-text"],"conditions":[{"id":"article-111-2-scope-article-5-unaffected","operator":"all","description":"The transitional rule is without prejudice to the application of Article 5, as referred to in Article 113, third paragraph, point (a). A prohibited practice remains prohibited, regardless of when the system was placed on the market or put into service and regardless of whether the design has changed."},{"id":"article-111-2-scope-limited-to-chapter-iii","operator":"all","description":"The transitional rule concerns the high-risk requirements of Chapter III and is not an exemption from the whole Regulation. Article 4 has applied since 2 February 2025 irrespective of when a system reached the market, and Article 50 has applied to all systems in scope since 2 August 2026. The paragraph 4 added by the Digital Omnibus confirms this: it gives legacy generative systems a short extra period for Article 50(2), which would make no sense if Article 50 did not reach them."},{"id":"article-111-2-legacy-scope","operator":"all","description":"Applies to operators of high-risk AI systems placed on the market or put into service before the date of application of Chapter III referred to in Article 113, other than the systems referred to in paragraph 1 that are components of the large-scale IT systems listed in Annex X. That date is 2 December 2027 for systems that are high-risk under Article 6(2) and Annex III, and 2 August 2028 for systems that are high-risk under Article 6(1) and Annex I. For that group the high-risk requirements bite only once the systems are subject to significant changes in their designs as from that date."},{"id":"article-111-2-type-and-model","operator":"all","description":"The grace period runs per type and model, not per unit. If at least one individual unit of the type and model was lawfully placed on the market or put into service before the cut off date, other units of the same type and model are covered too and may be offered without additional obligations, requirements or additional certification, as long as the design remains unchanged. The decisive date is the one on which the first unit of that type and model was placed on the market or put into service in the Union."},{"id":"article-111-2-public-authority-deadline","operator":"all","description":"Applies independently to providers and deployers of high-risk AI systems intended to be used by public authorities. They must in any case take the necessary steps to comply with the requirements and obligations of the Regulation by 2 August 2030, even where the design remains unchanged."}],"exceptions":[{"id":"article-111-2-exception-annex-x-systems","operator":"not","description":"Systems that are components of the large-scale IT systems established by the legal acts listed in Annex X fall not under paragraph 2 but under paragraph 1. Paragraph 1 was not amended by the Digital Omnibus and keeps its own cut off: placed on the market or put into service before 2 August 2027, with compliance by 31 December 2030."}],"statements":[{"kind":"official_fact","text":"Without prejudice to the application of Article 5 as referred to in Article 113, third paragraph, point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed on the market or put into service before the date of application of Chapter III referred to in Article 113, only if, as from that date, those systems are subject to significant changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations laid down in this Regulation by 2 August 2030.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 111(2)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5), applies from 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III, and from 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text content, that have been placed on the market before 2 August 2026 shall take the necessary steps in order to comply with Article 50(2) by 2 December 2026.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"New Article 111(4)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The grace period in paragraph 2 applies where the type and model of an AI system has already been placed on the market. If at least one individual unit was lawfully placed on the market or put into service before the cut off date, the grace period also covers other units of the same type and model, which may be offered without additional obligations, requirements or mandatory additional certification, as long as the design remains unchanged. On a significant change to the design after the cut off date the provider must fully comply with all relevant provisions applicable to high-risk AI systems, including the conformity assessment requirements.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Recital 39 of Regulation (EU) 2026/1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"In practice this provision is read exactly the wrong way round. Executives hear that existing systems are left alone and conclude that nothing is needed until well into the 2030s. That is wrong in two ways. For a public sector organisation the second sentence gives no escape but a deadline, and it applies whether or not you change anything about the system. And for everyone the transitional rule concerns only the high-risk requirements: Article 4 has been running since February 2025 and Article 50 since August 2026, with legacy generative systems having only until 2 December 2026 to get the machine-readable marking of Article 50(2) in order. The first sentence, moreover, is not a resting place but a switch. As soon as the design is significantly changed you must comply fully with what applies to high-risk systems, the conformity assessment first of all; those duties do follow the shifted calendar of 2 December 2027 and 2 August 2028. That switching moment rarely arises at a time you choose: it arises on a supplier update, a migration or a new data source. Two things therefore matter more than the date itself. You need to know when the first unit of each type and model reached the market, because that is the decisive date and without it you cannot later show which track a system was on. And you need a moment in your change process at which someone assesses whether a change is significant, before it goes live.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 111(2)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Recital 39 of Regulation (EU) 2026/1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"New Article 111(4)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Determine per type and model of your high-risk AI systems when the first unit was placed on the market or put into service, and whether the system is intended to be used by public authorities. Record that determination with a date and a reasoning, and note which route applies, because that decides whether your cut off is 2 December 2027 or 2 August 2028. For the systems intended for public authority use, set a plan towards 2 August 2030 that counts back from the conformity assessment and the registration, not from the end date. Also build into your change and release process a review moment at which someone records whether an intended design change is significant, before the change goes into production. Separately, check whether Article 111(4) catches you: if so you have until 2 December 2026 for the marking under Article 50(2).","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 111(2)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"New Article 111(4)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2030-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-111-legacy-public-systems","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Regulation (EU) 2024/1689 on EUR-Lex"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Regulation (EU) 2026/1744 on EUR-Lex, which amends Article 111"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-12-logging","legacy_id":"raip:obligation:article-12-logging","type":"obligation","slug":"article-12-logging","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"92daf8448d3471e5014ea66a2dc2731909f2689e5e3bdb243f49a75572002f20","label":"Article 12: logging and traceability","summary":"Automatic recording of events over the lifetime of a high-risk AI system.","topics":["high-risk-requirements"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-12-logging-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-12-logging-record"],"control_ids":["praxikon:eu:ai-act:control:article-12-logging-control"],"template_ids":["praxikon:eu:ai-act:template:article-12-logging-legal-text"],"conditions":[{"id":"article-12-logging-scope","operator":"all","description":"The system is high-risk; the provider designs the logging, provider and deployer retain the logs under their control."}],"exceptions":[{"id":"article-12-logging-exception","operator":"not","description":"The retention period may be limited by Union or national law, including data protection."}],"statements":[{"kind":"official_fact","text":"Article 12 requires high-risk AI systems to be technically capable of automatically recording events over their lifetime, for traceability, risk signalling and post-market monitoring; Article 19 and Article 26(6) govern log retention.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12, Article 19 and Article 26(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Logging is the backbone of all other evidence: without logs an incident cannot be reconstructed and a monitoring duty cannot be fulfilled. Buyers should already test whether a system is technically capable of this.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12, Article 19 and Article 26(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Include logging capability and log access as a requirement in every AI purchase and assign the retention regime (who, where, how long) per system.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12, Article 19 and Article 26(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-12-logging","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 12 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-13-instructions","legacy_id":"raip:obligation:article-13-instructions","type":"obligation","slug":"article-13-instructions","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"818266e8912de0d2c95a38a4a16c67b1aad02d10359b3571710fd757c678819b","label":"Article 13: transparency towards deployers","summary":"Comprehensible instructions for use and system information so deployers can operate the system correctly.","topics":["high-risk-requirements"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-13-instructions-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-13-instructions-record"],"control_ids":["praxikon:eu:ai-act:control:article-13-instructions-control"],"template_ids":["praxikon:eu:ai-act:template:article-13-instructions-legal-text"],"conditions":[{"id":"article-13-instructions-scope","operator":"all","description":"The provider supplies a high-risk system; the deployer uses it according to the instructions."}],"exceptions":[{"id":"article-13-instructions-exception","operator":"not","description":"The level of detail may match the intended deployer’s knowledge; trade secrets need not be disclosed."}],"statements":[{"kind":"official_fact","text":"Article 13 requires high-risk systems to be designed transparently enough for deployers to interpret and use the output, with instructions covering purpose, accuracy, limitations, human oversight and maintenance.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 13(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The instructions are the hinge between provider and deployer duties: what the provider fails to supply here, the deployer cannot deliver under Article 26. Ask for it explicitly at procurement.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 13(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Translate received instructions per system into internal work instructions per role and record who received them.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 13(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-13-instructions","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 13 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-14-human-oversight","legacy_id":"raip:obligation:article-14-human-oversight","type":"obligation","slug":"article-14-human-oversight","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"02da6ce26c5036d2cdea0842564e14a1227cd8f8e5fe5e67e15b52cd5332f98b","label":"Article 14: human oversight","summary":"High-risk AI must be designed so that humans can effectively oversee it and intervene.","topics":["high-risk-requirements"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-14-human-oversight-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-14-human-oversight-record"],"control_ids":["praxikon:eu:ai-act:control:article-14-human-oversight-control"],"template_ids":["praxikon:eu:ai-act:template:article-14-human-oversight-legal-text"],"conditions":[{"id":"article-14-human-oversight-scope","operator":"all","description":"The system is high-risk; the provider builds in oversight measures, the deployer assigns oversight to competent persons."}],"exceptions":[{"id":"article-14-human-oversight-exception","operator":"not","description":"For remote biometric identification the reinforced requirement of verification by at least two authorised persons applies (Article 14(5)), with the exceptions listed there."}],"statements":[{"kind":"official_fact","text":"Article 14 requires high-risk systems to be effectively overseeable by natural persons, with measures enabling them to understand the system, correctly interpret output, remain aware of automation bias, and decide not to use, to disregard or to stop the system.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 14(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Oversight on paper is not oversight: the law names automation bias explicitly, so a human who may only click through does not count. Effective oversight requires understanding, time and mandate, which ties directly into the Article 4 literacy measures.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 14(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Appoint the overseeing persons per (upcoming) high-risk system now, train them specifically and record their mandate to intervene in writing.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 14(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release 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that continue learning after deployment carry additional requirements to control feedback loops and drift."}],"statements":[{"kind":"official_fact","text":"Article 15 requires high-risk systems to achieve and maintain appropriate levels of accuracy, robustness and cybersecurity throughout the lifecycle, including resilience against errors and AI-specific attacks such as data poisoning and adversarial examples.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 15(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Accuracy here is not a marketing number but a declared, testable value stated in the instructions for use and held against you in production.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 15(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Ask suppliers now for declared accuracy levels and test reports, and set up production monitoring against those levels.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 15(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-15-accuracy-robustness","label":"Open the human 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service."}],"exceptions":[{"id":"article-17-quality-management-exception","operator":"not","description":"Providers already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form."}],"statements":[{"kind":"official_fact","text":"Article 17 requires a documented quality management system covering a compliance strategy, design and development procedures, data management, risk management, post-market monitoring, incident reporting and an accountability structure.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The QMS is the umbrella over all other provider duties: those with the separate files but no system connecting them fail exactly this article in an audit.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Build the QMS not as a separate document but as an index on top of the existing files (risk, data, documentation, monitoring) with owners per procedure.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release 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period ending ten years after the system has been placed on the market or put into service.","topics":["high-risk-requirements"],"actor_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:keep-high-risk-documentation-available"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-18-retention-dossier"],"control_ids":["praxikon:eu:ai-act:control:article-18-retention-review"],"template_ids":["praxikon:eu:ai-act:template:article-18-legal-text"],"conditions":[{"id":"article-18-scope","operator":"all","description":"Applies to the provider of a high-risk AI system. The period ends ten years after the system has been placed on the market or put into service."},{"id":"article-18-financial-institutions-regime","operator":"all","description":"Where the provider is a financial institution subject to requirements regarding internal governance, arrangements or processes under Union financial services law, it maintains the technical documentation of point (a) as part of the documentation it already keeps under that law. That is not an exemption from the retention duty but an indication of the regime in which it is carried out for that one component. Paragraph 3 does not mention points (b) to (e)."}],"exceptions":[],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides that the provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities: (a) the technical documentation referred to in Article 11; (b) the documentation concerning the quality management system referred to in Article 17; (c) the documentation concerning the changes approved by notified bodies, where applicable; (d) the decisions and other documents issued by the notified bodies, where applicable; (e) the EU declaration of conformity referred to in Article 47. Paragraph 2 provides that each Member State shall determine conditions under which that documentation remains at the disposal of the national competent authorities for the period indicated for the cases when a provider or its authorised representative established on its territory goes bankrupt or ceases its activity prior to the end of that period. Paragraph 3 provides that providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services law.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 18(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The amended application dates for Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5), are 2 December 2027 for the standalone Annex III route and 2 August 2028 for high-risk AI in products covered by the Annex I harmonisation legislation.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Four things here are our reading and not the text. First the application date: Regulation (EU) 2026/1744 does not name Article 18 separately, so the fact that this duty moves with 2 December 2027 and 2 August 2028 follows from its placement in Chapter III, Section 3, and not from an explicit provision. Second the starting moment. Paragraph 1 names the placing on the market and the putting into service side by side without choosing, and for a system where both moments occur that is years of difference at the end of the period. Counting from the later moment is the only count that falls short under neither reading, and that is what we would advise a provider. The other reading is defensible: in Union product law the placing on the market is usually the moment that counts, and then the period ends earlier. Third a substantially modified version: the text is silent, and it is equally defensible that every version gets its own period as that the original one continues. Fourth the reach of paragraph 3: it names only the technical documentation, so we keep points (b) to (e) under the general regime until the contrary is settled. Paragraph 2, finally, is addressed to the Member State and not to you. The Netherlands has not yet determined those conditions, so what happens to your file on insolvency or cessation of activity currently follows from contract and not from law.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 18(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Watch the boundaries of this duty, because they get crossed in both directions. The automatically generated logs are not among the five components: they fall under Article 19, with its own and much shorter period of at least six months, appropriate to the intended purpose, and with a clause for financial institutions that parallels paragraph 3. So do not stretch the ten years to your logs, and conversely do not settle for six months for your documentation. For a provider established in a third country the actual availability moreover sits with two parties at once: Article 22(3)(b) requires the authorised representative to keep, for ten years, the contact details of the provider, a copy of the EU declaration of conformity, the technical documentation and, if applicable, the certificate issued by the notified body at the disposal of the competent authorities and of the bodies referred to in Article 74(10). Two files that drift apart are worse than one. Point (e) overlaps with Article 47(1), which gives the declaration of conformity its own ten year period, and under Article 23(5) the importer carries ten years again for the certificate, the instructions for use and the declaration of conformity. That overlap is no reason to drop one of the periods: they are independent duties of different parties. It is a reason to choose a place of retention where they coincide. On the GDPR, finally: a retention duty under Union law is itself a ground under Article 6(1)(c) GDPR, and the storage limitation of Article 5(1)(e) permits retention that the law requires. The question is therefore not whether it is allowed but how far it reaches. Ten years applies to what Article 18(1) names, and not to everything created along the way: separate test sets, log samples and raw data dumps from the documentation you must be able to produce.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 18(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"This is the duty that asks nothing at the moment you take it on and everything at the moment you have forgotten it. Ten years is longer than the average life of a supplier contract, a document management system and a product team. In the organisations where we encounter this, the five components rarely sit in one archive: the quality system sits with compliance, the notified body decisions with certification, the declaration of conformity with legal. That is not law, but it is common enough that it is worth checking before you assume your situation is different. Whoever first assembles the documents when an authority asks discovers that retention in fact depended on a person and not on a process. Note also the side that is not about you: paragraph 2 concerns the situation where the provider or its representative goes bankrupt, and that is exactly the risk you run as a customer of a small supplier. It is a contracting question before it becomes a compliance question.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 18(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Designate per high-risk system one place of retention where the five components of paragraph 1 come together. Record side by side when the system was placed on the market and when it was put into service, and calculate the end date from the later of those two moments, so that you do not fall short under either reading. Set that end date as a commitment in a system that survives a change of staff, and keep the Article 19 logs separately with their own period. If you work with an authorised representative, record who holds which copy, because Article 22(3)(b) places the same availability on them as well. When procuring a high-risk system, put in the contract what happens to the documentation if the supplier stops or goes bankrupt, because paragraph 2 leaves that arrangement to national law that does not yet exist in the Netherlands.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 18(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-18-document-retention","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 18 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/18","label":"Read Article 18 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-27-fria","legacy_id":"raip:obligation:article-27-fria","type":"obligation","slug":"article-27-fria","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"498c93501f9972d34831aea9c643908d910568bd188c1f76ddb2786c3836b98e","label":"Article 27: FRIA","summary":"Fundamental rights impact assessment before deploying certain high-risk AI systems.","topics":["fundamental-rights","high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:credit-or-insurance-deployer","praxikon:eu:ai-act:actor:public-law-body","praxikon:eu:ai-act:actor:public-service-provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:credit-or-insurance-deployer","praxikon:eu:ai-act:actor:public-law-body","praxikon:eu:ai-act:actor:public-service-provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:credit-or-insurance-deployer","praxikon:eu:ai-act:actor:public-law-body","praxikon:eu:ai-act:actor:public-service-provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:fria-assess"],"evidence_ids":["praxikon:eu:ai-act:evidence:fria-report"],"control_ids":["praxikon:eu:ai-act:control:fria-pre-deployment-gate"],"template_ids":["praxikon:eu:ai-act:template:fria-questionnaire"],"conditions":[{"id":"fria-annex-iii-high-risk","operator":"all","description":"The system is high-risk under Article 6(2) and Annex III, excluding Annex III point 2."},{"id":"fria-covered-deployer","operator":"any","description":"The deployer is a body governed by public law, a private provider of public services or uses a relevant system in Annex III point 5(b) or 5(c)."}],"exceptions":[{"id":"fria-emergency-notification","operator":"not","description":"In the situation covered by Article 46(1), an exemption from notification may apply. This does not generally remove the assessment itself."}],"statements":[{"kind":"official_fact","text":"The listed deployers must perform a FRIA before deployment. For this Annex III route, the obligation follows the application date of 2 December 2027.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 27(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended application schedule and Article 27 DPIA cross-reference","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"A FRIA is not a generic risk assessment for every AI system. First establish the system route, Annex III category and type of deployer.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 27(1)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Link the FRIA to the AI inventory and, where relevant, the DPIA. Keep scope, affected groups, mitigations, residual risks and notification in one versioned record.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 27 amendment on DPIA inclusion or cross-reference","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-27-fria","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 27 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-28-39-notified-bodies","legacy_id":"raip:obligation:article-28-39-notified-bodies","type":"obligation","slug":"article-28-39-notified-bodies","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"244200659e300ee841c99c7ece25bf19795a8036b16b7faca26e35a05ecae3b1","label":"Articles 28 to 39: notifying authorities and notified bodies","summary":"Section 4 of Chapter III governs who may carry out your conformity assessment and on what conditions that power continues to exist. Each Member State designates a notifying authority that assesses, designates, notifies and monitors conformity assessment bodies. A notified body is established under the national law of a Member State, has legal personality, and is independent of the provider, of any other operator with an economic interest and of the provider competitors; consultancy services in particular are ruled out. Subcontracting to a subcontractor or a subsidiary is allowed only with the agreement of the provider, and the body then retains full responsibility. In its work it avoids unnecessary burdens for providers and minimises administrative burdens and compliance costs for micro- and small enterprises, without giving up the required degree of rigour. Article 36 distinguishes the cases. Where it ceases its activities, the certificates remain valid under paragraph 3 for at most nine months, provided another notified body assumes responsibility in writing. Where its designation is suspended, restricted or withdrawn, it informs the providers concerned within ten days under paragraph 5; paragraph 8 sets continuity conditions there without that general nine-month limit, and paragraph 9 gives certificates a nine-month validity on withdrawal, with a conditional extension in periods of three months up to twelve months at most. A body from a third country can carry out these activities only where the Union has concluded an agreement with that country.","topics":["conformity","governance"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":["praxikon:eu:ai-act:actor:provider"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:market-surveillance-authority"],"evidence_owner_ids":[],"duty_holder_uncertainty_status":"out_of_scope","interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:verify-notified-body-standing"],"evidence_ids":["praxikon:eu:ai-act:evidence:notified-body-standing-record"],"control_ids":["praxikon:eu:ai-act:control:notified-body-continuity-review"],"template_ids":["praxikon:eu:ai-act:template:article-28-39-legal-text"],"conditions":[{"id":"article-28-39-scope","operator":"all","description":"Practically engaged as soon as a notified body comes into the picture for your system. Within Annex III that is, under Article 43(1), only for the biometrics of point 1, and then only along the Annex VII procedure. Within Annex I, Section A, it happens through the sectoral conformity assessment of Article 43(3). For the systems of points 2 to 8 of Annex III, which follow the internal control of Annex VI, no notified body is involved and this Section has no direct bearing on you. The Section itself has applied since 2 August 2025 and therefore well before the underlying high-risk obligations bite: the notification chain has to exist before there is anything to assess."},{"id":"article-28-39-subcontracting-consent","operator":"all","description":"Article 33(3) makes the agreement of the provider a condition for subcontracting: activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. That is a right you can exercise only if you ask about it, because the provision does not prescribe any active notice to you."}],"exceptions":[{"id":"article-28-39-third-country-bodies","operator":"not","description":"Article 39 rules out a free choice of a foreign body. Only conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified bodies, and then only where they meet the requirements laid down in Article 31 or ensure an equivalent level of compliance."},{"id":"article-28-39-presumption-limited","operator":"not","description":"The presumption in Article 32 is narrow. A conformity assessment body is presumed to comply with the requirements of Article 31 in so far as the applicable harmonised standards cover those requirements and their references have been published in the Official Journal of the European Union. Without that publication the presumption does not operate, and it never reaches further than what the standard covers."}],"statements":[{"kind":"official_fact","text":"Article 28(1) provides: Each Member State shall designate or establish at least one notifying authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring. Those procedures shall be developed in cooperation between the notifying authorities of all Member States. Paragraph 3 provides: Notifying authorities shall be established, organised and operated in such a way that no conflict of interest arises with conformity assessment bodies, and that the objectivity and impartiality of their activities are safeguarded. Paragraph 5 provides: Notifying authorities shall offer or provide neither any activities that conformity assessment bodies perform, nor any consultancy services on a commercial or competitive basis. Article 29(1) provides: Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established. Paragraph 2 provides: The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the types of AI systems for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 31. Article 30(1) provides: Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31. Paragraph 2, as replaced by Article 1, point (16), of Regulation (EU) 2026/1744, provides: Notifying authorities shall notify the Commission and the other Member States, based on the list of codes, categories, and corresponding types of AI systems referred to in Annex XIV, and using the electronic notification tool developed and managed by the Commission, of each conformity assessment body referred to in paragraph 1. The second subparagraph of that paragraph empowers the Commission to amend Annex XIV by delegated act. Until 27 July 2026 paragraph 2 carried no such list of codes; since then it sets the scope of the designation. Paragraph 4 provides: The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification by a notifying authority where it includes an accreditation certificate referred to in Article 29(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 29(3).","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 28(1), (3) and (5); Article 29(1) and (2); Article 30(1), (2) and (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 28(8), as added by Article 1, point (14), of Regulation (EU) 2026/1744, provides: notifying authorities designated pursuant to this Regulation that are responsible for AI systems covered by the Union harmonisation legislation listed in Section A of Annex I shall ensure that the conformity assessment body that applies for designation both pursuant to this Regulation and that legislation is provided with the possibility to submit a single application and undergoes a unified assessment procedure, where the relevant Union harmonisation legislation provides for such a procedure. A conformity assessment body designated pursuant to more than one piece of that legislation shall have to apply only once to be designated pursuant to this Regulation, and a designation pursuant to this Regulation shall be applicable for all Union harmonisation legislation listed in Section A of Annex I for which it is designated. Paragraph 9 provides that a notifying authority designated pursuant to that legislation is also the notifying authority for the application of that procedure, unless the Member State designates another notifying authority for this Regulation. Article 29(4), as replaced by Article 1, point (15), provides that notified bodies undergoing the unified assessment procedure shall submit the single application to the notifying authority designated pursuant to that Union harmonisation legislation.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, points (14) to (16), amending Articles 28, 29 and 30","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 31(1) provides: A notified body shall be established under the national law of a Member State and shall have legal personality. Paragraph 4 provides: Notified bodies shall be independent of the provider of a high-risk AI system in relation to which they perform conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic interest in high-risk AI systems assessed, as well as of any competitors of the provider. This shall not preclude the use of assessed high-risk AI systems that are necessary for the operations of the conformity assessment body, or the use of such high-risk AI systems for personal purposes. Paragraph 5 provides: Neither a conformity assessment body, its top-level management nor the personnel responsible for carrying out its conformity assessment tasks shall be directly involved in the design, development, marketing or use of high-risk AI systems, nor shall they represent the parties engaged in those activities. They shall not engage in any activity that might conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall, in particular, apply to consultancy services. Paragraph 6 provides: Notified bodies shall be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities. Paragraph 8 provides: Notified bodies shall have procedures for the performance of activities which take due account of the size of a provider, the sector in which it operates, its structure, and the degree of complexity of the AI system concerned. Paragraph 11 provides: The notified body shall have permanent availability of sufficient administrative, technical, legal and scientific personnel who possess experience and knowledge relating to the relevant types of AI systems, data and data computing, and relating to the requirements set out in Section 2.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 31(1), (4), (5), (6), (8) and (11)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 32 provides: Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 31 in so far as the applicable harmonised standards cover those requirements. Article 33(1) provides: Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 31, and shall inform the notifying authority accordingly. Paragraph 2 provides: Notified bodies shall take full responsibility for the tasks performed by any subcontractors or subsidiaries. Paragraph 3 provides: Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. Notified bodies shall make a list of their subsidiaries publicly available. Paragraph 4 provides: The relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation shall be kept at the disposal of the notifying authority for a period of five years from the termination date of the subcontracting.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 32; Article 33(1) to (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 34(1) provides: Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43. Paragraph 2 provides: Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account of the size of the provider, the sector in which it operates, its structure and the degree of complexity of the high-risk AI system concerned, in particular in view of minimising administrative burdens and compliance costs for micro- and small enterprises within the meaning of Recommendation 2003/361/EC. The notified body shall, nevertheless, respect the degree of rigour and the level of protection required for the compliance of the high-risk AI system with the requirements of this Regulation. Paragraph 3 provides: Notified bodies shall make available and submit upon request all relevant documentation, including the providers documentation, to the notifying authority referred to in Article 28 to allow that authority to conduct its assessment, designation, notification and monitoring activities, and to facilitate the assessment outlined in this Section. Article 35(1) provides: The Commission shall assign a single identification number to each notified body, even where a body is notified under more than one Union act. Paragraph 2 provides: The Commission shall make publicly available the list of the bodies notified under this Regulation, including their identification numbers and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 34(1) to (3); Article 35(1) and (2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 36(3) provides: Where a notified body decides to cease its conformity assessment activities, it shall inform the notifying authority and the providers concerned as soon as possible and, in the case of a planned cessation, at least one year before ceasing its activities. The certificates of the notified body may remain valid for a period of nine months after cessation of the notified body activities, on condition that another notified body has confirmed in writing that it will assume responsibilities for the high-risk AI systems covered by those certificates. The latter notified body shall complete a full assessment of the high-risk AI systems affected by the end of that nine-month-period before issuing new certificates for those systems. Where the notified body has ceased its activity, the notifying authority shall withdraw the designation. Paragraph 5 provides: Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the providers concerned within 10 days. Paragraph 6 provides: In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall take appropriate steps to ensure that the files of the notified body concerned are kept, and to make them available to notifying authorities in other Member States and to market surveillance authorities at their request. Paragraph 9 provides: With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months under the following circumstances: (a) the national competent authority of the Member State in which the provider of the high-risk AI system covered by the certificate has its registered place of business has confirmed that there is no risk to health, safety or fundamental rights associated with the high-risk AI systems concerned; and (b) another notified body has confirmed in writing that it will assume immediate responsibility for those AI systems and completes its assessment within 12 months of the withdrawal of the designation.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 36(3), (5), (6) and (9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 37(1) provides: The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its applicable responsibilities. Paragraph 2 provides: The notifying authority shall provide the Commission, on request, with all relevant information relating to the notification or the maintenance of the competence of the notified body concerned. Paragraph 4 provides: Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation. Article 38(1) provides: The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies. Paragraph 2 provides: Each notifying authority shall ensure that the bodies notified by it participate in the work of a group referred to in paragraph 1, directly or through designated representatives. Paragraph 3 provides: The Commission shall provide for the exchange of knowledge and best practices between notifying authorities. Article 39 provides: Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified bodies under this Regulation, provided that they meet the requirements laid down in Article 31 or they ensure an equivalent level of compliance.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 37(1), (2) and (4); Article 38(1) to (3); Article 39","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Read this Section as the supplier terms of your conformity assessor, because that is exactly what it is. Three points in it go wrong in practice. The first is the independence requirement of Article 31(4) and (5). It prohibits not only the obvious double role but rules out consultancy services in particular. Anyone who has his high-risk file built by the advisory firm that later performs the assessment buys a certificate that can be challenged on that ground. Separate those two purchases at the outset, not halfway through. The second is Article 31(1) read alongside Article 39. The body must be established under the national law of a Member State and have legal personality; a body from a third country comes into the picture only where the Union has concluded an agreement with that country. For a group that places its worldwide certification with a single house, that is a hard limit: the European assessment must sit with a European notified legal person, and the group brand name says nothing about that. The third is Article 33. Subcontracting is allowed, but only with your agreement, and the body retains full responsibility for what the subcontractor does. The provision does not oblige it to tell you of its own motion; it only makes its subsidiaries publicly available. So ask, and record the answer, because without the question the agreement never comes up.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 31(1), (4), (5), (6), (8) and (11)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 32; Article 33(1) to (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Two provisions in this Section work in your favour and are rarely used. Article 34(2) is the first. It requires the body to avoid unnecessary burdens for providers and to take due account of your size, your sector, your structure and the complexity of the system, in particular in view of minimising administrative burdens and compliance costs for micro- and small enterprises. That is not a policy aspiration but an operational obligation of the body, and it sits alongside Article 31(8), which demands the same proportionality in its procedures. The second sentence of paragraph 2 immediately bounds it: the degree of rigour and the level of protection stand. The practical reading is therefore not that a small provider has to demonstrate less, but that the road there must be proportionate. If you are handed a standard package plainly designed for a different kind of organisation, this is the provision on which you raise it. Article 36 is the second. It holds the scenario that hits a provider hardest and appears in no project plan: your body ceases or loses its designation. Your certificates then remain valid for at most nine months, and only where another notified body has confirmed in writing that it will assume responsibility. You hear about it within ten days, and that is the only deadline in this Section that runs directly to you. The follow-on steps for the certificate itself sit in the object on Article 44; what matters here is that the continuity of your market access depends on a party over which you have no control. So treat the notified body as a supplier with concentration risk, and not as a quality mark.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 34(1) to (3); Article 35(1) and (2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 36(3), (5), (6) and (9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43(1) and (3); Article 44(2); Article 113, third paragraph, point (b)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"First establish whether this Section touches you at all: only where your system goes through a notified body via Annex VII or via the sectoral route of Article 43(3). If it does, check four things in the Commission public list at the moment of choice and annually thereafter: is the body still listed, what identification number does it carry, for which conformity assessment activities and which types of AI systems is it notified, and has its designation been restricted or suspended. Record for each choice that you tested the independence of Article 31(4) and (5), in particular whether the same group previously advised you on the same system. When placing the assignment, ask explicitly which tasks are subcontracted to a subcontractor or a subsidiary, give or withhold your agreement under Article 33(3) in writing, and provide in the contract that any change to it requires your agreement again. Add two clauses: a duty on the body to report any change to its designation, mirroring the ten days of Article 36(5), and a handover clause describing which files you get back within what period if it ceases. Finally, keep a second notified body in view that is notified for your type of system, so that the nine months of Article 36(3) and (9) become a handover rather than a search.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43(1) and (3); Article 44(2); Article 113, third paragraph, point (b)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 36(3), (5), (6) and (9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-28-39-notified-bodies","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Chapter III, Section 4, on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/31","label":"Read Article 31 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-4-ai-literacy","legacy_id":"raip:obligation:article-4-ai-literacy","type":"obligation","slug":"article-4-ai-literacy","version":"2.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"7a9516670dfca5dd7dcc96ae019e5714f843e20235abd3e9d92b71eb42445ff1","label":"Article 4: AI literacy","summary":"Providers and deployers take measures that support the development of AI literacy.","topics":["ai-literacy"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-4-measures"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-4-measures-record"],"control_ids":["praxikon:eu:ai-act:control:article-4-periodic-review"],"template_ids":["praxikon:eu:ai-act:template:article-4-measures-plan"],"conditions":[{"id":"article-4-in-scope-ai","operator":"all","description":"The organisation is a provider or deployer of an AI system within scope."}],"exceptions":[{"id":"article-4-no-specific-level","operator":"not","description":"The provision does not require a specific individual level to be guaranteed."}],"statements":[{"kind":"official_fact","text":"Since 27 July 2026, providers and deployers must take measures supporting the development of AI literacy. The provision does not require a guaranteed individual level.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amendment of Article 4; entry into force 27 July 2026","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Evidence is primarily a proportionate record of measures by role and context, not one prescribed course or certificate.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-ai-literacy-qa","source_locator":"Questions on measures, formats, certificates and records","source_url":"https://digital-strategy.ec.europa.eu/en/faqs/ai-literacy-questions-answers","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Inventory roles and AI systems, select appropriate measures and record the choice, implementation and periodic review.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-ai-literacy-qa","source_locator":"Implementation examples and evidence guidance","source_url":"https://digital-strategy.ec.europa.eu/en/faqs/ai-literacy-questions-answers","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2025-02-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-4-ai-literacy","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Official amending regulation"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-40-42-standards-and-specifications","legacy_id":"raip:obligation:article-40-42-standards-and-specifications","type":"obligation","slug":"article-40-42-standards-and-specifications","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"5ed867d4d391f1d4f1bd452fb12e1a85d2b504978e3ac431460b7871eb18c51c","label":"Articles 40 to 42: standards, common specifications and presumption of conformity","summary":"A party applying a harmonised standard whose reference has been published in the Official Journal of the European Union is presumed to be in conformity with the requirements of Section 2 or with the obligations of Chapter V, Sections 2 and 3, to the extent that the standard covers them. As long as no such standard exists, the Commission may adopt common specifications by implementing act, and those carry the same presumption. If you do not apply such a common specification, you must duly justify that you have adopted technical solutions that are at least equivalent. Article 42 adds three narrow presumptions, and they do not all arise in the same way. Paragraph 1 gives the presumption of conformity with Article 10(4) to systems trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be used; no publication in the Official Journal is attached to it. Paragraph 2 does carry that condition: the presumption of conformity with the cybersecurity requirements of Article 15 applies to systems certified under a scheme pursuant to Regulation (EU) 2019/881 the references of which have been published in the Official Journal. The paragraph 3 added by Article 1, point (18), of Regulation (EU) 2026/1744 gives that same presumption to systems falling within the scope of Regulation (EU) 2024/2847 that meet the conditions in Article 12(1) thereof. Each of these presumptions is rebuttable and reaches no further than what the standard, the specification or the certification covers.","topics":["conformity","standards"],"actor_ids":["praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"What is open is the anchoring of the duty holder. Of the three Articles only Article 41(5) contains a rule of conduct addressed to a role this graph knows: providers of high-risk AI systems or general-purpose AI models must duly justify that they have adopted at least equivalent technical solutions where they do not apply a common specification. The object is anchored on that paragraph. A defensible alternative reading treats Articles 40 to 42 as entirely institutional, with an empty duty holder and `out_of_scope`, and hangs the justification on Article 11 and Annex IV, where the technical documentation is described. On that reading the recommended action and the file below move to the object on Article 11; the substance does not change, the basis does. Also open is where the justification must be recorded. Article 41(5) prescribes no form, no place and no recipient. We read it as belonging in the technical documentation, because that is the only file a market surveillance authority can request under Article 21; that is an inference and not text. Not open is the dating: Articles 40, 41 and 42 sit in Chapter III, Section 5, and that Section is not excepted in the third paragraph of Article 113, so the general application date of the second paragraph governs, 2 August 2026.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:justify-standards-and-specification-choices"],"evidence_ids":["praxikon:eu:ai-act:evidence:standards-conformity-justification-file"],"control_ids":["praxikon:eu:ai-act:control:official-journal-citation-watch"],"template_ids":["praxikon:eu:ai-act:template:article-40-42-legal-text"],"conditions":[{"id":"article-40-42-publication-condition","operator":"all","description":"The presumption in Article 40(1) arises only where the references of the harmonised standard have been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, and it reaches only to the extent that those standards cover those requirements or obligations. The same holds for the cybersecurity certification of Article 42(2), the references of which must likewise have been published in the Official Journal."},{"id":"article-40-42-justification-condition","operator":"all","description":"The justification duty of Article 41(5) arises only where a common specification has actually been established by implementing act for the requirement concerned and the provider does not apply it. Where no such specification exists, there is nothing to depart from and you demonstrate conformity by the ordinary route."}],"exceptions":[{"id":"article-40-42-presumption-is-rebuttable","operator":"not","description":"A presumption of conformity is not a finding of compliance. The text says the system shall be presumed to be in conformity, and only in so far as the standard or the specification covers the requirements or obligations concerned. Outside that coverage the burden of proof rests fully on the provider, and a market surveillance authority can rebut the presumption where the system in fact does not meet the requirements."},{"id":"article-40-42-specification-withdrawn","operator":"not","description":"Article 41(4) makes a common specification lapse as soon as the standard exists: when reference to a harmonised standard is published in the Official Journal of the European Union, the Commission repeals the implementing acts, or parts thereof, which cover the same requirements or obligations. A file leaning on a repealed specification thereby loses its basis."}],"statements":[{"kind":"official_fact","text":"The final subparagraph of Article 40(2), as added by Article 1, point (17), of Regulation (EU) 2026/1744, provides: the Commission shall request, in accordance with Regulation (EU) No 1025/2012 and without undue delay, the European standardisation organisations to develop standardisation deliverables, including, as appropriate, harmonised standards, to facilitate the joint compliance and presumption of conformity with the requirements or obligations set out in Chapter III, Sections 2 and 3 of this Regulation, and the relevant requirements and obligations laid down in the Union harmonisation legislation listed in Annex I to this Regulation. Article 42(3), added by Article 1, point (18), provides: where high-risk AI systems fall within the scope of Regulation (EU) 2024/2847 and the conditions laid down in Article 12(1) of that Regulation are fulfilled, such systems shall be deemed to comply with the cybersecurity requirements set out in Article 15 of this Regulation.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, points (17) and (18), amending Article 40(2) and Article 42","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 40(1) provides: High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of this Regulation, to the extent that those standards cover those requirements or obligations. Paragraph 2 provides: In accordance with Article 10 of Regulation (EU) No 1025/2012, the Commission shall issue, without undue delay, standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation requests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shall also ask for deliverables on reporting and documentation processes to improve AI systems’ resource performance, such as reducing the high-risk AI system’s consumption of energy and of other resources during its lifecycle, and on the energy-efficient development of general-purpose AI models. When preparing a standardisation request, the Commission shall consult the Board and relevant stakeholders, including the advisory forum. When issuing a standardisation request to European standardisation organisations, the Commission shall specify that standards have to be clear, consistent, including with the standards developed in the various sectors for products covered by the existing Union harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems or general-purpose AI models placed on the market or put into service in the Union meet the relevant requirements or obligations laid down in this Regulation. Paragraph 3 provides: The participants in the standardisation process shall seek to promote investment and innovation in AI, including through increasing legal certainty, as well as the competitiveness and growth of the Union market, to contribute to strengthening global cooperation on standardisation and taking into account existing international standards in the field of AI that are consistent with Union values, fundamental rights and interests, and to enhance multi-stakeholder governance ensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 40(1) to (3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 41(1) provides: The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following conditions have been fulfilled: (a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter, or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and: (i) the request has not been accepted by any of the European standardisation organisations; or (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or (iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or (iv) the harmonised standards do not comply with the request; and (b) no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period. When drafting the common specifications, the Commission shall consult the advisory forum referred to in Article 67. Paragraph 2 provides: Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers the conditions laid down in paragraph 1 of this Article to be fulfilled. Paragraph 3 provides: High-risk AI systems or general-purpose AI models which are in conformity with the common specifications referred to in paragraph 1, or parts of those specifications, shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, to comply with the obligations referred to in Sections 2 and 3 of Chapter V, to the extent those common specifications cover those requirements or those obligations.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 41(1) to (3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 41(4) provides: Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the publication of its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter or, as applicable, the same obligations set out in Sections 2 and 3 of Chapter V. Paragraph 5 provides: Where providers of high-risk AI systems or general-purpose AI models do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the requirements referred to in Section 2 of this Chapter or, as applicable, comply with the obligations set out in Sections 2 and 3 of Chapter V to a level at least equivalent thereto. Paragraph 6 provides: Where a Member State considers that a common specification does not entirely meet the requirements set out in Section 2 or, as applicable, comply with obligations set out in Sections 2 and 3 of Chapter V, it shall inform the Commission thereof with a detailed explanation. The Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification concerned.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 41(4), (5) and (6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 42(1) provides: High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be used shall be presumed to comply with the relevant requirements laid down in Article 10(4). Paragraph 2 provides: High-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 and the references of which have been published in the Official Journal of the European Union shall be presumed to comply with the cybersecurity requirements set out in Article 15 of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those requirements.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 42(1) and (2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The word everything turns on is presumed. A presumption of conformity is not proof of compliance and it is rebuttable: it shifts who has to demonstrate what, and nothing more. If a market surveillance authority shows that your system in fact does not meet a requirement of Section 2, the standard you applied does not stop that. Two limits set out in the text itself come on top. The first is the coverage limit: the presumption operates only in so far as the standard or the specification covers the requirements or obligations concerned. EN 18286 shows exactly what that means, because the coverage statement accompanying that standard expressly excludes Article 17(2) to (4) and Article 72; whatever falls outside the coverage you substantiate yourself. The second is the publication limit: without a reference in the Official Journal of the European Union no presumption arises, however complete the standard may be. That is why all twelve standard objects in data/ai-act/graph/standards.ts carry guidance and not applicable. So anyone hearing a supplier say that his product meets the European standard and is therefore AI Act compliant is hearing two leaps at once: from coverage to completeness, and from standard to legal effect.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 40(1) to (3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN 18286:2026, CEN/CLC/JTC 21 under standardisation request M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Article 41 is often dismissed as an emergency valve that will never be used, and that is the wrong call. The European standards under standardisation request M/613 are not all available yet: the standards layer in data/ai-act/graph/standards.ts shows one completed EN and six deliverables still at drafting or enquiry stage. That is precisely the state described by the conditions of Article 41(1), point (a)(ii), and point (b), and so the common specification route remains practically relevant. For you that means two things. First, an implementing act may appear for a requirement of Section 2 that you did not see coming and that touches your design choices; those acts are adopted under the examination procedure of Article 98(2) and not in consultation with individual providers. Second, there is then a paragraph that asks something of you directly: paragraph 5. If you do not apply the common specification, you must duly justify that your technical solution is at least equivalent. That is the only place in these three Articles where you have to write something yourself, and the text does not say where. In practice that justification belongs in the technical documentation, because that is the file that has to be handed over upon a reasoned request. Article 42 is narrower than it looks and is overrated for that reason. Paragraph 1 touches only Article 10(4) and not the rest of the data governance of Article 10; paragraph 2 touches only the cybersecurity requirements of Article 15 and only where the references of the scheme under Regulation (EU) 2019/881 have been published in the Official Journal. A certificate under a scheme not yet published yields no presumption, and a presumption on Article 15 says nothing about your Article 9, 11, 12, 13 or 14.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 41(4), (5) and (6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 42(1) and (2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN 18286:2026, CEN/CLC/JTC 21 under standardisation request M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18228 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Build a coverage matrix per high-risk system and per general-purpose AI model: put every requirement of Section 2 that applies to you in the left column, and next to it which harmonised standard, which common specification or which document of your own covers that requirement. Note per row whether the reference of that standard has been published in the Official Journal of the European Union, because only those rows carry a presumption; the remaining rows call for evidence of your own. For every requirement where a common specification exists that you do not apply, write a justification under Article 41(5): which technical solution you adopted, why it is at least equivalent to what the specification demands, and which test shows it. Include that justification in the technical documentation so that it can travel immediately upon a reasoned request. Set up a standing check on publications in the Official Journal as well: a new reference switches a presumption on, and under Article 41(4) repeals an existing common specification, which can remove the basis under a row of your matrix. If you want to rely on Article 42, record why your training and testing data reflect the geographical, behavioural, contextual or functional setting within which the system is intended to be used, and confine the conclusion to Article 10(4). For the cybersecurity route, first check whether the references of the scheme under Regulation (EU) 2019/881 appear in the Official Journal; without that publication the certificate is a good document with no legal effect under Article 15.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 41(4), (5) and (6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 10(4); Article 15; Article 43(1); Chapter III, Section 5, and Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-40-42-standards-and-specifications","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Articles 40 to 42 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/40","label":"Read Article 40 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-44-notified-body-certificates","legacy_id":"raip:obligation:article-44-notified-body-certificates","type":"obligation","slug":"article-44-notified-body-certificates","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"458f4f14180a115bbccca9bac5e76eae0e9642c92bc0831b57b8e803ebb447b9","label":"Article 44: certificates of notified bodies","summary":"A certificate issued by a notified body is valid for at most five years for AI systems covered by Annex I and at most four years for AI systems covered by Annex III, and may be extended at the request of the provider after a re-assessment. Where the system no longer meets the requirements of Section 2, the body shall, taking account of the principle of proportionality, suspend or withdraw the certificate or impose restrictions on it, unless the provider takes corrective action within an appropriate deadline it sets so as to ensure compliance with those requirements. An appeal procedure against that decision is available.","topics":["conformity"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":["praxikon:eu:ai-act:actor:provider"],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":"out_of_scope","interpretation_status":"preliminary","interpretation_note":"What this Article asks of a provider remains unsettled. The text addresses the notified body alone and imposes no duty at all on the provider. We read a practical consequence into it, namely that whoever holds a certificate watches its expiry date, asks for a re-assessment in time and is able to correct within the deadline set by the body. A defensible alternative reading is that for the provider Article 44 merely describes what the body does and that his duties follow entirely from Articles 16, 17 and 43. On that reading the recommended action and the file below hang on Article 43 rather than Article 44; the substance does not change, the basis does. On the dating that doubt no longer exists: Article 44 sits in Section 5 of Chapter III, the third paragraph of Article 113 excepts only Sections 1, 2 and 3 of that Chapter, and so the general application date of the second paragraph of Article 113 governs, 2 August 2026. When the provision bites in practice does differ per route: for the systems of Annex III the underlying obligations run from 2 December 2027 and for the regulated products of Annex I from 2 August 2028, while the Section B products of Annex I fall outside this Article altogether since 27 July 2026. Those two dates do not fit in a field that carries one, which is why the field carries the application date of the Article itself. It also remains unclear whom the last sentence of paragraph 3 addresses: an appeal procedure against decisions of the notified bodies shall be available, but the text does not say who provides it. That the route exists is stated.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:manage-notified-body-certificate"],"evidence_ids":["praxikon:eu:ai-act:evidence:notified-body-certificate-record"],"control_ids":["praxikon:eu:ai-act:control:certificate-expiry-monitoring"],"template_ids":["praxikon:eu:ai-act:template:article-44-legal-text"],"conditions":[{"id":"article-44-scope","operator":"all","description":"Applies as soon as a notified body has issued a certificate for a high-risk AI system. That happens along two routes. The certificate under Annex VII, which under Article 43(1) and (2) arises within Annex III only for the biometrics of point 1. There it can arise along two ways: a provider who has applied harmonised standards or common specifications may under the first subparagraph of paragraph 1 choose between the internal control of Annex VI and the procedure involving a notified body of Annex VII, and the second subparagraph makes Annex VII mandatory in the four cases it lists. And the certificate issued under Article 43(3) as replaced with effect from 27 July 2026, within the sectoral conformity assessment of the products of Annex I, Section A, where the body is notified under that sectoral legislation, where the quality management system of Article 17 is assessed as well, and where point 3, points 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. For the products of Annex I, Section B, which cover machinery since 27 July 2026, this Article has no bearing: the amended Article 2(2) makes only Article 6(1), Article 60a and Articles 102 to 112 applicable to those systems, and Article 44 is not in that list. Nor does it bear on the systems of points 2 to 8 of Annex III, which under Article 43(2) follow the internal control of Annex VI, where no notified body is involved."}],"exceptions":[{"id":"article-44-exception-corrective-action","operator":"not","description":"Paragraph 3 withholds suspension, withdrawal or restriction where compliance with the requirements of Section 2 is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The principle of proportionality also allows the body to confine itself to restrictions instead of withdrawal."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides that certificates issued by notified bodies in accordance with Annex VII shall be drawn up in a language which can be easily understood by the relevant authorities in the Member State in which the notified body is established. Paragraph 2 provides that certificates shall be valid for the period they indicate, which shall not exceed five years for AI systems covered by Annex I and four years for AI systems covered by Annex III, that at the request of the provider the validity may be extended for further periods, each not exceeding five years and four years respectively, based on a re-assessment in accordance with the applicable conformity assessment procedures, and that any supplement to a certificate shall remain valid provided that the certificate which it supplements is valid. Paragraph 3 provides that where a notified body finds that an AI system no longer meets the requirements set out in Section 2, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose restrictions on it, unless compliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body, that the notified body shall give reasons for its decision, and that an appeal procedure against decisions of the notified bodies, including on conformity certificates issued, shall be available.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 44(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 43 sets out along which route a certificate arises and when it must be earned again. Paragraph 1 lets the provider of the systems listed in point 1 of Annex III choose between the internal control of Annex VI and the procedure involving a notified body of Annex VII where he has applied harmonised standards or common specifications, and makes the Annex VII procedure mandatory in four cases: the harmonised standards referred to in Article 40 do not exist and the common specifications referred to in Article 41 are not available; the provider has not applied, or has applied only part of, the harmonised standard; the common specifications referred to in point (a) exist but the provider has not applied them; or one or more of the harmonised standards referred to in point (a) has been published with a restriction, and then only on the part of the standard that was restricted. Paragraph 2 provides that for the systems of points 2 to 8 of Annex III providers follow the internal control of Annex VI, for which the involvement of a notified body is not required. Paragraph 4 provides that high-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new procedure whenever they are substantially modified, regardless of whether the modified system is intended to be further distributed or continues to be used by the current deployer, and that for systems that continue to learn, changes predetermined by the provider at the moment of the initial conformity assessment and part of the technical documentation referred to in point 2(f) of Annex IV do not constitute a substantial modification.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43(1), (2) and (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 3 of Article 43 was replaced with effect from 27 July 2026. Under the text in force, the provider of a high-risk AI system covered by the Union harmonisation legislation listed in Section A of Annex I follows the relevant conformity assessment procedure as required in accordance with that harmonisation legislation, the requirements set out in Section 2 of this Chapter apply to those systems and form part of that assessment, an assessment of the quality management system set out in Article 17 is also undertaken, and points 3, 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. The second subparagraph gives notified bodies notified under that harmonisation legislation the power to assess the conformity of those systems with the requirements of Section 2, provided that their compliance with the requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure under that harmonisation legislation, which is evidenced through the assessment as part of the existing notification, and requires those same bodies, without prejudice to Article 28, to apply for designation in accordance with Section 4 of this Chapter by 28 January 2028. The third subparagraph provides that a manufacturer entitled under that harmonisation legislation to rely on a conformity assessment not involving a third party may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41 covering all requirements of Section 2, that the classification of a product as a high-risk AI system in accordance with Article 6(1) does not affect the choice of conformity assessment procedure provided to those manufacturers, and that those manufacturers are not required to choose a procedure involving third-party conformity assessment only because the product includes a high-risk AI system as a safety component, if that harmonisation legislation does not require it. The fourth subparagraph provides that the provider of a system both covered by that harmonisation legislation and falling within one of the categories listed in Annex III follows the relevant conformity assessment procedure as required pursuant to the relevant Union harmonisation legislation listed in Section A of Annex I.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Article 1, point (19), replacing Article 43(3)"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Annex I was amended with effect from 27 July 2026: in Section A, point 1 was deleted, and in Section B, point 21 was added, referring to Regulation (EU) 2023/1230 on machinery. Article 2(2), likewise replaced, provides that for AI systems classified as high-risk in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Article 60a and Articles 102 to 112 apply, and that Articles 57, 58 and 59 apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that harmonisation legislation.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 36 governs what happens to certificates already issued where the notified body itself is concerned. Paragraph 3 provides that a body deciding to cease its conformity assessment activities shall inform the notifying authority and the providers concerned as soon as possible, and in the case of a planned cessation at least one year beforehand, and that its certificates may remain valid for nine months after the cessation on condition that another notified body has confirmed in writing that it will assume responsibility, that other body carrying out a full assessment before the end of those nine months before issuing new certificates. Paragraph 5 provides that a notified body whose designation is suspended, restricted or withdrawn in whole or in part shall inform the providers concerned within ten days. Paragraph 7 provides that in that case the notifying authority shall assess the impact on the certificates issued, shall require the body to suspend or withdraw within a reasonable period any certificates unduly issued, and shall provide the national competent authorities of the Member State in which the provider has its registered place of business with all relevant information on the certificates whose suspension or withdrawal it has ordered. Paragraph 8, point (b), provides that where the notifying authority establishes that the body is not capable of supporting existing certificates issued, the provider of the system covered by the certificate shall confirm in writing to the national competent authorities of the Member State of its registered place of business, within three months of the suspension or restriction, that another qualified notified body will temporarily assume the monitoring of and responsibility for the certificates. Paragraph 9 provides that upon withdrawal of a designation certificates, with the exception of those unduly issued, remain valid for nine months where the national competent authority has confirmed that there is no risk and another notified body has confirmed in writing that it assumes immediate responsibility and will complete its assessment within twelve months of the withdrawal.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 36(3), (5), (7), (8) and (9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 45(2), point (b), provides that each notified body shall inform the other notified bodies of Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and supplements which it has issued.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 45(2), point (b)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Point (c) of the third paragraph of Article 113 was replaced with effect from 27 July 2026 and now provides that Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5), applies from 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III, and from 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. That deferral concerns those three Sections alone. Article 44 sits in Section 5 of Chapter III and therefore falls under the general application date given in the second paragraph of Article 113: 2 August 2026.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Chapter III, Section 5, and Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Start with the question whether this Article touches you at all, because for most high-risk systems the answer is no. Of Annex III only the biometrics of point 1 pass through a notified body, and there only where you choose that route yourself or where one of the four cases in the second subparagraph of Article 43(1) arises; points 2 to 8 follow the internal control of Annex VI and produce no certificate whatsoever. Whoever does hold a certificate usually holds it through the regulated products of Annex I, Section A, and that certificate comes out of the sectoral conformity assessment of Article 43(3) rather than out of Annex VII. Check first which Section carries your product, because that shifted on 27 July 2026: machinery was taken out of Section A and placed in Section B as Regulation (EU) 2023/1230, and for Section B products the amended Article 2(2) makes only Article 6(1), Article 60a and Articles 102 to 112 applicable. Article 44 is not among them, so for AI in machinery this Article no longer bears, while it applies in full to the remaining products of Section A. On that Section A route the assessment is moreover wider than it was: since 27 July 2026 the quality management system of Article 17 is assessed as well, and point 3, points 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. That difference is practical: the language requirement of paragraph 1 is tied to the Annex VII certificate and does not carry over unchanged to that sectoral route, whereas the five years of paragraph 2 simply apply. The mistake the Article exposes is the idea that conformity assessment is a project that ends. The certificate has an end date, at most four years for an Annex III system and at most five for an Annex I product, and the re-assessment that carries the extension itself takes time. Whoever knocks on the door only in the final month stands on the expiry date without valid paper while the system simply runs in production. The clock is moreover not the most frequent reason to go back. Article 43(4) sends a system through the assessment again whenever it is substantially modified, including where you only keep using it internally; only changes you predetermined and recorded in the technical documentation do not count. In practice that trigger arrives years before the expiry date. Where things do go wrong, the response of the body is not binary: the principle of proportionality in paragraph 3 allows it to confine itself to restrictions instead of withdrawal, correcting within the deadline it sets holds off the measure, and an appeal procedure against its decision is available. Count on none of the three as a matter of course, but know that they exist. Nor should you count on starting afresh elsewhere after a refusal: Article 45(2), point (b), obliges the body to inform its peer bodies of certificates refused, withdrawn, suspended or restricted. Also put 28 January 2028 in your diary, even though that date is not addressed to you. The second subparagraph of the new Article 43(3) lets bodies notified only under the sectoral legislation of Annex I, Section A, assess conformity with Section 2, but only where their compliance with Article 31(4), (5), (10) and (11) has already been assessed in their existing notification, and requires those same bodies to apply for designation under Section 4 by that date. The recital accompanying the amendment describes that power as an arrangement for eighteen months from 27 July 2026. So ask your body what its status is and whether it is applying, because who can carry out your assessment after that date depends on it. Finally, watch the side that has nothing to do with your system. A notified body can cease its activities or lose its designation. Article 36 then gives you nine months, but only where another body assumes responsibility in writing, and the body must inform you within ten days. In a suspension where the authority establishes that your body can no longer support the existing certificates, there is even a genuine duty on you: to confirm in writing to your national competent authority, within three months, which other qualified body will temporarily take over the monitoring. That is the only hard deadline in this whole block that lands on your desk.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 44(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43(1), (2) and (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Article 1, point (19), replacing Article 43(3)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 36(3), (5), (7), (8) and (9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 45(2), point (b)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"First establish per high-risk system whether there is a certificate at all, and along which route it was issued: Annex VII or the sectoral procedure of Article 43(3). Check while doing so whether your product still sits in Section A of Annex I since 27 July 2026, because for the Section B products, machinery among them, the amended Article 2(2) does not make this Article apply. Then record which certificate belongs to it, which notified body issued it, on what date it expires and which supplements are attached to it, and put that expiry date in the same watch list as your contracts. Plan the extension request well before the expiry date, because the extension rests on a re-assessment in accordance with the applicable conformity assessment procedures. Also tie your change management to Article 43(4): determine per change whether it is substantial, and record the predetermined changes of a learning system in the technical documentation of point 2(f) of Annex IV, because only those do not count as a substantial modification. Designate who receives a message from the notified body, so that a deadline set for corrective action does not expire in a general inbox, and keep the appeal procedure of paragraph 3 open as a route alongside correcting itself. Finally, bring the body itself into the same watch list: track whether it ceases its activities or loses its designation, ask whether it is filing the application for designation under Section 4 that the second subparagraph of Article 43(3) requires of it by 28 January 2028, and make sure you can file the confirmation of Article 36(8), point (b), in writing with your national competent authority within three months.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 44(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43(1), (2) and (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 36(3), (5), (7), (8) and (9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-44-notified-body-certificates","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"The Regulation on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-46-derogation-from-conformity-assessment","legacy_id":"raip:obligation:article-46-derogation-from-conformity-assessment","type":"obligation","slug":"article-46-derogation-from-conformity-assessment","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"1750dded1098676522ac2284e471cb504967e1c6055f5c0a19d556778c2e3792","label":"Article 46: derogation from conformity assessment procedure","summary":"By way of derogation from Article 43, a market surveillance authority may, upon a duly justified request, authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security, the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. The authorisation is for a limited period while the conformity assessment is carried out, and those procedures are completed without undue delay. Law-enforcement authorities and civil protection authorities may start without an authorisation in a situation of urgency, provided that it is requested without undue delay; if it is refused, use stops with immediate effect and all results and outputs are discarded. The authorisation is issued only if the system complies with the requirements of Section 2, goes to the Commission and the other Member States, and is deemed justified after fifteen calendar days without objection.","topics":["conformity","enforcement"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":[],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:market-surveillance-authority"],"evidence_owner_ids":[],"duty_holder_uncertainty_status":"out_of_scope","interpretation_status":"preliminary","interpretation_note":"What the provision says is settled; who the duty holder is in this model is not. Article 46 addresses the market surveillance authority (paragraphs 1, 3 and 6) and the Commission (paragraph 5). The provider and the deployer are the requesting party and the party that bears the consequences, and they therefore sit in `affected_actor_ids` with `duty_holder_uncertainty_status: out_of_scope`. A defensible alternative reading writes the market surveillance authority in as duty holder: it exists as an actor in this dataset, and paragraphs 3 and 6 impose a notification and a withdrawal on it that read as duties. On that reading it moves from `oversight_actor_ids` to `duty_holder_ids` and the provider and deployer stay as affected parties; the substance of this object does not change, the basis does. We keep it in the oversight role because no other obligation in this dataset names it as addressee and the meaning of the field would otherwise differ within the same dataset. What also remains uncertain is what the limited period of paragraph 1 is: the text names no maximum and ties the duration only to the exceptional reasons justifying the derogation and to the conformity assessment being carried out. Anyone building on this route cannot read from the text how long it may last. On the dating there is no such doubt: Article 46 sits in Section 5 of Chapter III, the third paragraph of Article 113 excepts only Sections 1, 2 and 3 and its point (b) concerns Section 4, so the general application date of the second paragraph governs, 2 August 2026. On Regulation (EU) 2026/1744. That text was retrieved after all on 6 September 2026 from the Publications Office Cellar service and is archived in data/ai-act/review/sources/reg-eu-2026-1744-nl.txt and -en.txt. The amending regulation carries forty-three amendment points in its Article 1; which of those are reflected in the local legal texts is recorded per point in data/ai-act/review/consolidation-manifest.json. Where a point touches this Article, that is stated below with the statement concerned.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:prepare-article-46-derogation-request"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-46-derogation-request-file"],"control_ids":["praxikon:eu:ai-act:control:article-46-derogation-exit-review"],"template_ids":["praxikon:eu:ai-act:template:article-46-legal-text"],"conditions":[{"id":"article-46-exceptional-grounds","operator":"any","description":"The authorisation may be granted only for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That list is the entire basis: a commercial interest, a delivery deadline or a tender date is not in it."},{"id":"article-46-justified-request-and-territory","operator":"all","description":"A duly justified request is required, the authorisation comes from a market surveillance authority, it concerns specific high-risk AI systems, and it operates solely within the territory of the Member State concerned. It is moreover for a limited period while the necessary conformity assessment procedures are being carried out, and the completion of those procedures shall be undertaken without undue delay."},{"id":"article-46-section-2-compliance","operator":"all","description":"The authorisation is issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The derogation therefore concerns the procedure of Article 43 and not the substantive requirements of Articles 8 to 15: those must be met before the authorisation exists."}],"exceptions":[{"id":"article-46-urgency-without-prior-authorisation","operator":"not","description":"Paragraph 2 removes the prior authorisation in a duly justified situation of urgency for exceptional reasons of public security or in the case of a specific, substantial and imminent threat to the life or physical safety of natural persons. Only law-enforcement authorities and civil protection authorities may rely on it, and only for putting into service, provided that such authorisation is requested during or after the use without undue delay."},{"id":"article-46-annex-i-section-a-carve-out","operator":"not","description":"Paragraph 7 excludes this Article for high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I. There, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply. For a regulated product, Article 46 is therefore not a route."},{"id":"article-46-sensitive-operational-data","operator":"not","description":"The notification duty in paragraph 3 towards the Commission and the other Member States shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. The authorisation itself stands; the flow of data around it is limited."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides the following. By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That authorisation shall be for a limited period while the necessary conformity assessment procedures are being carried out, taking into account the exceptional reasons justifying the derogation. The completion of those procedures shall be undertaken without undue delay. Paragraph 2 provides the following. In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial and imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1, provided that such authorisation is requested during or after the use without undue delay. If the authorisation referred to in paragraph 1 is refused, the use of the high-risk AI system shall be stopped with immediate effect and all the results and outputs of such use shall be immediately discarded.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 46(1)-(2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 3 provides the following. The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the Commission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2. This obligation shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. Paragraph 4 provides the following. Where, within 15 calendar days of receipt of the information referred to in paragraph 3, no objection has been raised by either a Member State or the Commission in respect of an authorisation issued by a market surveillance authority of a Member State in accordance with paragraph 1, that authorisation shall be deemed justified.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 46(3)-(4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 5 provides the following. Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by a Member State against an authorisation issued by a market surveillance authority of another Member State, or where the Commission considers the authorisation to be contrary to Union law, or the conclusion of the Member States regarding the compliance of the system as referred to in paragraph 3 to be unfounded, the Commission shall, without delay, enter into consultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to present their views. Having regard thereto, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant operators. Paragraph 6 provides the following. Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance authority of the Member State concerned. Paragraph 7 provides the following. For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 46(5)-(7)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This is the only route in the Regulation along which a high-risk AI system reaches the market or is put into service without a completed conformity assessment, and that is exactly why it is not a commercial route. Three things make that firm. The grounds are exhaustive and none of them is about the supplier: public security, the protection of life and health of persons, environmental protection, the protection of key industrial and infrastructural assets. A tight delivery deadline, a tender closing in, or a notified body with a waiting list are not among them. The derogation moreover concerns only the procedure of Article 43 and not the substance: paragraph 3 allows the authorisation only where the market surveillance authority concludes that the system complies with the requirements of Section 2. So it does not buy you time to do Articles 9 to 15 later; at most it buys time for the paperwork of the assessment. And it is closed off geographically: the authorisation operates within the territory of the Member State concerned, which means a system running on this basis in one Member State simply has no basis in the next. Note finally paragraph 7. For high-risk AI systems related to products under Section A of Annex I this Article is not a route: there, only the derogations of the sectoral harmonisation legislation apply. Anyone building a regulated product therefore looks for the exit in his own sectoral framework and not here.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43(1), (2) and (4); Article 47(1); Article 48(1); Article 49(1); Article 79(1); Chapter III, Section 5, and Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Paragraph 2 reverses the order and that is the heaviest part of this Article for whoever uses it. In a situation of urgency a law-enforcement authority or a civil protection authority may put the system into service first and request the authorisation afterwards, provided that happens without undue delay. The other side sits in the same sentence: if the authorisation is refused, use stops with immediate effect and all results and outputs of that use are immediately discarded. That is not a suspension but a rollback, and it reaches what was produced in the meantime. Anyone starting on this basis must therefore know in advance which decisions, files, alerts and derived datasets count as results and outputs and how they can be found; working out afterwards what the system touched is too late by then, and a decision that rested on such an output is left standing without support. There is also a European aftermath that lands on the requester without him being a party to it. The market surveillance authority informs the Commission and the other Member States, and after 15 calendar days without objection the authorisation is deemed justified. If an objection is raised, by a Member State or by the Commission, the Commission enters into consultations, the operators concerned are consulted and the Commission decides. If it considers the authorisation unjustified, the market surveillance authority withdraws it. For the organisation that means: an authorisation is not firm for the first fifteen days, and it stays withdrawable afterwards. Plan for those two moments, and make sure the conformity assessment genuinely continues in the meantime, because the text names no maximum duration and ties the limited period only to the completion of those procedures.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43(1), (2) and (4); Article 47(1); Article 48(1); Article 49(1); Article 79(1); Chapter III, Section 5, and Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Treat this route as a contingency plan and not as a planning option. Establish, before you need it, whether it is open to you at all: if your system sits in a product from Section A of Annex I, paragraph 7 closes it and you look for the derogation in your sectoral framework. If it is open, draft the reasoning document now: which of the four exceptional reasons you invoke, on which facts, why delay is not possible, and why this system in particular. Add to it the evidence that the system complies with the requirements of Section 2, because without that conclusion the market surveillance authority cannot issue the authorisation. Record where the conformity assessment stands and what still has to happen, with an end date, and name the person who carries that procedure through while the system runs. If you prepare for the reversed order of paragraph 2, that comes with an exit plan written in advance: which decisions, files, alerts and derived datasets count as results and outputs, how they can be traced per system version, who discards them, within what period, and what happens to decisions that rested on them. Put the fifteen calendar days after the notification of paragraph 3 in your calendar as the moment the authorisation first counts as justified, and reckon with withdrawal after that. Finally, set out in supplier contracts who submits the request, who supplies the reasoning and who bears the cost if the authorisation is refused or withdrawn.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43(1), (2) and (4); Article 47(1); Article 48(1); Article 49(1); Article 79(1); Chapter III, Section 5, and Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-46-derogation-from-conformity-assessment","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 46 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/46","label":"Read Article 46 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-49-registration","legacy_id":"raip:obligation:article-49-registration","type":"obligation","slug":"article-49-registration","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"95cd9f806f657817dbdc6e5aa1c1b74b37239b8513edc6ad054fd87eaf7b858f","label":"Article 49: registration in the EU database before the system reaches the market","summary":"The provider of a high-risk AI system listed in Annex III, or where applicable its authorised representative, registers itself and that system in the EU database before it is placed on the market or put into service. The same duty applies to the provider that concludes under Article 6(3) that its Annex III system is precisely not high-risk: that provider too registers itself and that system. The deployer that is a public authority or a Union body, or that acts on behalf of such an authority, registers itself, selects the system and registers its use. For the areas of law enforcement, migration, asylum and border control management the registration goes into a secure non-public section with fewer fields, to which only the Commission and the national authorities referred to in Article 74(8) have access. For the systems in point 2 of Annex III registration does not run through the EU database but at national level.","topics":["conformity","high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:distributor","praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:distributor"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:market-surveillance-authority"],"evidence_owner_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:register-in-eu-database-before-market-entry"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-49-registration-dossier"],"control_ids":["praxikon:eu:ai-act:control:article-49-pre-market-registration-gate"],"template_ids":["praxikon:eu:ai-act:template:article-49-legal-text"],"conditions":[{"id":"article-49-route-secure-section","operator":"any","description":"Paragraph 4 does not except the registration but relocates it: for the systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, the registration referred to in paragraphs 1, 2 and 3 goes into a secure non-public section of the EU database, with a limited list of fields from Annex VIII and Annex IX, and only the Commission and the national authorities referred to in Article 74(8) have access to it."},{"id":"article-49-scope-provider","operator":"any","description":"Applies where a provider or, where applicable, an authorised representative places on the market or puts into service a high-risk AI system listed in Annex III, and where that same party places on the market or puts into service an AI system for which it has concluded that it is not high-risk according to Article 6(3)."},{"id":"article-49-scope-public-deployer","operator":"any","description":"Applies where a deployer that is a public authority, Union institution, body, office or agency, or a person acting on their behalf, puts into service or uses a high-risk AI system listed in Annex III."},{"id":"article-49-timing","operator":"all","description":"Registration is a precondition and not a notification afterwards: paragraphs 1 and 2 attach to the moment before the system is placed on the market or put into service, paragraph 3 to the moment before it is put into service or used."}],"exceptions":[{"id":"article-49-exception-annex-iii-point-2","operator":"not","description":"This is an exception to the route and not to the duty. Paragraphs 1 and 3 except the high-risk AI systems referred to in point 2 of Annex III from registration in the EU database, and paragraph 5 provides that those systems are registered at national level. For critical infrastructure the registration therefore does not fall away: it runs through the national register rather than through the Article 71 EU database."}],"statements":[{"kind":"editorial_interpretation","text":"Two readings existed of the date on this object, and Chef chose between them on 6 September 2026. Article 49 sits in Section 5 of Chapter III, and the third paragraph of Article 113 names a Section of Chapter III twice: point (b) names Section 4 and sets it at 2 August 2025, and point (c) names Sections 1, 2 and 3, with the exception of Article 6(5). Section 5 appears in neither point, nor in point (a) or point (d). Article 49 therefore falls under the general date in the second paragraph, and that is the date this object carries: 2 August 2026. Whoever places an Annex III system on the market today without registering is late, not early. The practical reading is not written away but sits alongside it: the duty only acquires an object once a high-risk AI system exists, and that status arises through Article 6(2) and Annex III on 2 December 2027, the date named in point (c) of the third paragraph as replaced by Article 1, point (40)(b), of Regulation (EU) 2026/1744. That date sits in high_risk_regime_from and the ground of the chosen date in timing_basis. The decision is recorded in data/ai-act/review/decision-d1-application-dates.json.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 49(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"official_fact","text":"Paragraph 1 provides that, before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to in Article 71. Paragraph 2 provides that, before placing on the market or putting into service an AI system for which the provider has concluded that it is not high-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register themselves and that system in the EU database referred to in Article 71. Paragraph 3 provides that, before putting into service or using a high-risk AI system listed in Annex III, with the exception of high-risk AI systems listed in point 2 of Annex III, deployers that are public authorities, Union institutions, bodies, offices or agencies or persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to in Article 71.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 49(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 4 provides that, for high-risk AI systems referred to in points 1, 6 and 7 of Annex III, in the areas of law enforcement, migration, asylum and border control management, the registration referred to in paragraphs 1, 2 and 3 of this Article shall be in a secure non-public section of the EU database referred to in Article 71 and shall include only the following information, as applicable, referred to in: (a) Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9; (b) Section B, points 1 to 5, and points 8 and 9 of Annex VIII; (c) Section C, points 1 to 3, of Annex VIII; (d) points 1, 2, 3 and 5, of Annex IX. Only the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted sections of the EU database listed in the first subparagraph of this paragraph. Paragraph 5 provides that high-risk AI systems referred to in point 2 of Annex III shall be registered at national level.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 49(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Paragraph 2 is the most expensive sentence in this article and it is missed systematically. Anyone invoking the Article 6(3) exception for an Annex III system believes they have stepped out of the high-risk regime. That is true for the requirements on the system, but not for the registration: it is precisely that provider that registers itself and that system in the EU database, and does so before it is placed on the market or put into service. The exception is therefore not free. It is paid for in visibility: your name, your system and the Article 6(3) condition you rely on end up in a publicly searchable register, exactly where you thought you would stay out of sight. The mistake that follows is predictable and expensive. An organisation carries out the Article 6(3) assessment properly, documents it, and skips the registration because in its mind that belongs to the high-risk regime. The result is that the database holds no trace of a choice it did in fact make deliberately, and that a regulator meets it as a party that simply failed to register the system. The matching piece of evidence already exists in this knowledge base as the registration record for the Article 6(3) route and hangs off the Annex III obligation; the object below covers registration under paragraphs 1, 3, 4 and 5. Note the sequence, finally. Registration is a precondition, not a notification afterwards. Delivering first and registering later repairs nothing: the moment the duty is breached is the placing on the market itself.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 49(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(2)-(4), Article 49 and Annex III","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Read Article 49 together with Article 71 and with Article 26(8), because those three form a chain that in practice stalls at its weakest point. Article 71 describes the database and says who fills in which fields; Article 49 says when that must happen and by whom; Article 26(8) turns the result into a procurement condition. That last one is the sharpest: a deployer with the status of a public authority that establishes that the system it intends to use is not registered in the EU database shall not use that system and shall inform the provider or the distributor. For a supplier that means a missing registration is not an administrative backlog but a block on the public market, and the party raising it with you is your own customer. For a public sector organisation it means the check belongs in the procurement process and not at the moment of deployment. Two routes deviate and are forgotten for exactly that reason. The first is paragraph 4: for the areas of law enforcement, migration, asylum and border control management the registration moves into a secure non-public section with a shorter list of fields, and only the Commission and the national authorities referred to in Article 74(8) can look into it. That is not an exemption but a different counter, and whoever reads it as an exemption registers nothing. The second is paragraph 5: the systems in point 2 of Annex III, critical infrastructure, are registered at national level. The Regulation does not say which national register that is, so you answer that question in national law and not here. For a grid operator or a water utility that is the difference between an existing counter and a search that only starts once the system is already running.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 49(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 26(1)-(12)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Make registration a hard gate in the release process, before the moment of placing on the market or putting into service, not after. Work through three questions per system. First: does the intended purpose fall under a point of Annex III, and if so, under which point. Second: are you relying on Article 6(3). If you are, the registration in paragraph 2 is your duty and not your choice, and you register yourself and that system, together with the condition you rely on. Third: if it concerns point 2 of Annex III, the registration does not go to the EU database but to national level, and you locate that counter before you need the system. If you are a public sector organisation, do not only register yourself but also select the system and register its use, and build the Article 26(8) check into your procurement process: no deployment as long as the provider entry is not in the database, with a written notification to the provider or the distributor where it is missing. If you supply into the areas of law enforcement, migration, asylum or border control management, record that your registration runs through the secure non-public section and which limited fields go into it. Keep, per system, the registration number, the date of registration and the name of the person who submitted it, together with the system version the entry relates to, and update that entry as soon as the intended purpose, the status or the conformity documentation changes.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 49(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 26(1)-(12)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":"text_date","high_risk_regime_from":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-49-registration","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 49 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/49","label":"Read Article 49 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-4a-bias-testing-legal-basis","legacy_id":"raip:obligation:article-4a-bias-testing-legal-basis","type":"obligation","slug":"article-4a-bias-testing-legal-basis","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"ffee7eb28c48cc8a2586f097f3abec38cbe7590c73e15b9845f9295f8f095d4c","label":"Article 4a: legal basis for bias testing with special categories of personal data","summary":"Article 4a grants permission rather than instruction, and to two different sets of parties. Paragraph 1 allows only the provider of a high-risk AI system to process special categories of personal data by way of exception, to the extent strictly necessary for bias detection and correction within the meaning of Article 10(2), points (f) and (g), and only where all six conditions (a) to (f) are met. Paragraph 2 opens the same room to providers and deployers of other AI systems and models and to deployers of high-risk systems, but only for bias likely to affect the health and safety of persons, to have a negative impact on fundamental rights or to lead to discrimination prohibited under Union law, and subject to the same six conditions. Until 27 July 2026 this basis sat in Article 10(5).","topics":["fundamental-rights","high-risk-requirements"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"Two things are open here, and the risk runs the other way round than with a right such as Article 86: a broad reading here benefits the controller and not the data subject, because this concerns data on ethnicity, health, religion, trade union membership and sexual orientation. Where in doubt the narrow reading is therefore the safe one. First, the reach of \"other AI systems and models\" in paragraph 2, which on its face covers any AI system and any model and for which no delimitation exists. We read it on its face, but with the threshold in paragraph 2, point (a), as the real boundary: without a consequence for health and safety, fundamental rights or prohibited discrimination there is no basis. A defensible alternative reading is that paragraph 2 is confined to systems comparable to the examples in recital 9, such as scoring tools for permits and public services. Second, the relationship with Article 9 GDPR. Recital 9 states that the extension is subject to the same limitations, conditions and safeguards and thereby ensures compliance with Article 9(2), point (g), of Regulation (EU) 2016/679, so we read Article 4a as the Union law measure that point requires, with the safeguards carried by the six conditions themselves. The counterargument stands against that and has not gone away, but it has narrowed since 27 July 2026: the anchoring sits in a recital and not in the article, and the article itself designates no ground from Article 9(2). What no longer supports that counterargument is Article 2(7). Until 27 July 2026 that paragraph left the GDPR unaffected without reservation, but it was replaced by Article 1, point 2(b), of Regulation (EU) 2026/1744 and now reads: \"Union law on the protection of personal data, privacy and the confidentiality of communications applies to personal data processed in connection with the rights and obligations laid down in this Regulation. Without prejudice to Articles 4a and 59 of this Regulation, this Regulation shall not affect Regulation (EU) 2016/679 or (EU) 2018/1725, or Directive 2002/58/EC or (EU) 2016/680.\" The Union legislature therefore carved the reservation out for Article 4a precisely, which points towards reading Article 4a as the Union law measure itself rather than a mere cross-reference to the GDPR. Anyone citing this object while quoting the former wording of Article 2(7) is quoting a replaced provision. A defensible alternative reading remains that a national or Union measure with specific safeguards is still needed alongside it, but it now rests only on the absence of an express designation in the article itself. On the date from which the basis operates, part is settled and part is not. What is settled is what recital 9 says, namely that the basis should apply from the date of entry into application of Regulation (EU) 2024/1689; that has been read and is not a house reading. What remains open is which date this object therefore carries. We hold to 27 July 2026, the day Article 4a entered the text, because a basis that was not yet there was in fact not available. The alternative reading follows recital 9 literally and lets the basis reach back to the date of application of the base Regulation. That difference is not academic for anyone who has to justify processing from that period. The editorial statement below marks that choice as our inference.","obligation_ids":[],"change_ids":["praxikon:eu:ai-act:change:2026-07-27-article-4a-inserted"],"action_ids":["praxikon:eu:ai-act:action:record-bias-testing-legal-basis"],"evidence_ids":["praxikon:eu:ai-act:evidence:bias-testing-necessity-record"],"control_ids":["praxikon:eu:ai-act:control:bias-testing-data-deletion"],"template_ids":["praxikon:eu:ai-act:template:article-4a-legal-text"],"conditions":[{"id":"article-4a-paragraph-1-high-risk-provider-only","operator":"all","description":"Paragraph 1 is open only to the provider of a high-risk AI system, and only to the extent that the processing is strictly necessary to detect and correct bias in accordance with Article 10(2), points (f) and (g). The deployer cannot rely on this paragraph, not even for a high-risk system; for the deployer the route runs through paragraph 2."},{"id":"article-4a-paragraph-2-wider-circle-with-harm-threshold","operator":"all","description":"Paragraph 2 is open to providers and deployers of other AI systems and models and to deployers of high-risk AI systems, but carries its own substantive threshold: the processing must be strictly necessary in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations. Bias without one of those consequences falls outside it."},{"id":"article-4a-cumulative-conditions","operator":"all","description":"The six conditions in paragraph 1 are cumulative and, through paragraph 2, point (b), apply to the wider circle as well: (a) other data, including synthetic or anonymised data, demonstrably do not suffice; (b) technical limitations on re-use apply plus state of the art security and privacy preserving measures, including pseudonymisation; (c) there is strict access control with documentation and confidentiality; (d) the data are not transmitted, transferred or otherwise accessed by other parties; (e) they are deleted once the bias has been corrected or the retention period ends, whichever comes first; (f) the record of processing activities states why the processing was strictly necessary and why the objective could not be achieved with other data."}],"exceptions":[{"id":"article-4a-no-duty-to-test","operator":"not","description":"Paragraph 2 closes by providing that it creates no obligation to carry out bias detection and correction. Article 4a is therefore a basis and not an instruction: without carrying out such processing there is nothing to comply with under this article, there is no date by which anything must be done, and outside the purpose of bias detection and correction it grants no room at all."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides that, to the extent strictly necessary to ensure bias detection and correction in relation to high-risk AI systems in accordance with Article 10(2), points (f) and (g), of this Regulation, providers of such systems may exceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to the provisions set out in Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable, all the following conditions shall be met in order for such processing to occur: (a) the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data; (b) the special categories of personal data are subject to technical limitations on the re-use of personal data, and state-of-the-art security and privacy-preserving measures, including pseudonymisation; (c) the special categories of personal data are subject to measures to ensure that the personal data processed are secured and protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and to ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations; (d) the special categories of personal data are not transmitted, transferred or otherwise accessed by other parties; (e) the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whichever comes first; and (f) the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 include the reasons why the processing of special categories of personal data was strictly necessary to detect and correct biases, and why that objective could not be achieved by processing other data.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point 6, inserting Article 4a: Article 4a(1), points (a) to (f), and Article 4a(2), points (a) and (b)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 2 provides that providers and deployers of other AI systems and models and deployers of high-risk AI systems may exceptionally process special categories of personal data to the extent that: (a) such processing is strictly necessary to ensure bias detection and correction in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited pursuant to Union law, especially where data outputs influence inputs for future operations; and (b) all of the conditions and safeguards set out in paragraph 1 are applied. Paragraph 2 closes with a separate subparagraph: this paragraph does not create any obligation to conduct such bias detection and correction. Article 4a has no paragraph 3.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point 6, inserting Article 4a: Article 4a(1), points (a) to (f), and Article 4a(2), points (a) and (b)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Regulation (EU) 2026/1744 inserts Article 4a into Regulation (EU) 2024/1689 by Article 1, point 6, and deletes Article 10(5) by Article 1, point 9(b). The same point 9 replaces Article 10(1) and Article 10(6) so that they now refer to the quality criteria in Article 4a(1). The basis therefore no longer sits with the requirements for high-risk systems in Chapter III, but as a standalone article in Chapter I, immediately after Article 4, while Article 10 refers back to it from the outside. In the Dutch language version of the Official Journal the inserted article is numbered \"artikel 4 bis\"; \"Article 4a\" is the English numbering of the same provision.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point 6 (insertion) and point 9 (Article 10 amended, paragraph 5 deleted)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The same amending Regulation replaces Article 2(7) of Regulation (EU) 2024/1689 by Article 1, point 2(b). Since 27 July 2026 that paragraph reads: \"Union law on the protection of personal data, privacy and the confidentiality of communications applies to personal data processed in connection with the rights and obligations laid down in this Regulation. Without prejudice to Articles 4a and 59 of this Regulation, this Regulation shall not affect Regulation (EU) 2016/679 or (EU) 2018/1725, or Directive 2002/58/EC or (EU) 2016/680.\" The previous version of that paragraph carried no such reservation for Article 4a.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point 2(b), replacing Article 2(7)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Recital 9 of Regulation (EU) 2026/1744 states that bias detection and correction constitute a substantial public interest, that the extended legal basis is subject to the same limitations, conditions and safeguards as the existing Article 10(5), and that this thereby ensures compliance with Article 9(2), point (g), of Regulation (EU) 2016/679, Article 10(2), point (g), of Regulation (EU) 2018/1725 and Article 10, point (a), of Directive (EU) 2016/680. The same recital states that the legal basis established by Article 4a should apply from the date of entry into application of Regulation (EU) 2024/1689, so as to enable providers of high-risk AI systems lawfully to undertake bias detection and correction activities in preparation for compliance with the requirements for high-risk AI systems. Article 4 of the amending Regulation governs only entry into force on the third day following publication and provides for no deferred application; the amended Article 113, third paragraph, point (a), provides that Chapters I and II apply from 2 February 2025, with the exception of Article 5(1), first subparagraph, points (ba) and (bb), and Article 5(1a) and (1b), which apply from 2 December 2026. Article 4a sits in Chapter I and falls outside that exception.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Recital 9, Article 4 (entry into force) and Article 1, point 40(a), replacing Article 113, third paragraph, point (a)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Three things matter more in practice than the relocation itself. The first is that this article instructs you to do nothing. Paragraph 2 says so in as many words, and no date by which anything must be done belongs with it either. The second, and the more dangerous misreading, is that the move into Chapter I means you may now start collecting sensitive attributes because you want to run fairness measurements. What has widened is the set of parties, not the room inside the basis: recital 9 expressly states that the same limitations, conditions and safeguards apply as under the former Article 10(5). In practice it therefore starts with a written justification of why synthetic or anonymised data do not suffice, and not with assembling a dataset. The third is the condition that bites hardest and appears in no summary: point (d) provides that the data are not transmitted, transferred or otherwise accessed by other parties. That is in effect a ban on outsourcing. An external fairness vendor, a bias auditing firm, a research partner or a cloud party that can reach the data itself does not fit inside this basis, however good the contract. Anyone who intended to buy in their bias testing must run it in house here, or work with data that are not a special category. Finally, watch your own documentation: records of processing, data protection impact assessments and AI policy documents that refer to Article 10(5) have been referring to a deleted provision since 27 July 2026. The same holds for documents citing Article 2(7) to argue that the GDPR prevails without qualification: that paragraph too has been replaced and now expressly reserves Articles 4a and 59. Two dates to close on, and the second is our inference rather than source text. Article 4a sits in Chapter I, which under Article 113, third paragraph, point (a), has applied since 2 February 2025, but the provision only entered the text on 27 July 2026; we therefore treat 27 July 2026 as the day the basis actually became available, while recital 9 states that it should apply from the date of entry into application of Regulation (EU) 2024/1689. Finally, note that the requirements in Article 10(2), points (f) and (g), which paragraph 1 refers to, themselves only start to apply on 2 December 2027 for Annex III systems and on 2 August 2028 for Annex I systems. The basis therefore deliberately runs ahead of the duty you use it for, exactly as recital 9 intends.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point 6, inserting Article 4a: Article 4a(1), points (a) to (f), and Article 4a(2), points (a) and (b)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point 2(b), replacing Article 2(7)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Recital 9, Article 4 (entry into force) and Article 1, point 40(a), replacing Article 113, third paragraph, point (a)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Carry out the data protection impact assessment before you start. Processing special categories at scale for bias testing engages Article 35 GDPR in almost every case, and Article 4a does not remove that assessment: it supplies the legal basis, not the risk appraisal. Then record, per processing operation, which paragraph of Article 4a you rely on, for which system or model, why synthetic or anonymised data do not suffice, which technical and organisational safeguards apply, who has access and at what point the data are deleted. In the same pass, review your record of processing activities, your impact assessments and your AI policy documents for references to Article 10(5) and replace them with Article 4a. Set the deletion moment as a monitored deadline rather than an intention, verify that no external party can reach the data, and align the justification with your data protection officer.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point 6, inserting Article 4a: Article 4a(1), points (a) to (f), and Article 4a(2), points (a) and (b)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-4a-bias-testing-legal-basis","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Inserted Article 4a on EUR-Lex"},{"relation":"related","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Regulation (EU) 2024/1689 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-5-prohibited-practices","legacy_id":"raip:obligation:article-5-prohibited-practices","type":"obligation","slug":"article-5-prohibited-practices","version":"1.0.0","effective_at":"2025-02-02T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"674c4b85d1cf177b2ab9256989e18b2d685fdb69388f02f22bcc8cebd4f5faf8","label":"Article 5: prohibited practices","summary":"The prohibition of AI practices carrying unacceptable risk, such as manipulation, social scoring and certain biometric applications.","topics":["prohibited-practices"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-5-screen"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-5-screening-record"],"control_ids":["praxikon:eu:ai-act:control:article-5-intake-gate"],"template_ids":["praxikon:eu:ai-act:template:article-5-legal-text"],"conditions":[{"id":"article-5-listed-practice","operator":"any","description":"Placing on the market, putting into service or using AI falls under one of the practices in Article 5(1), including harmful manipulation or exploitation of vulnerabilities, social scoring, predicting criminal offences based on profiling, untargeted scraping of facial images, emotion recognition in the workplace or education, biometric categorisation by sensitive characteristics and real-time remote biometric identification in publicly accessible spaces for law enforcement."}],"exceptions":[{"id":"article-5-narrow-exceptions","operator":"not","description":"The exceptions are narrow: among others, emotion recognition for medical or safety reasons, and the exhaustively defined law-enforcement situations with authorisation for real-time remote biometric identification in Article 5(2) to (7). The exception must be established and documented in advance."}],"statements":[{"kind":"official_fact","text":"The prohibited practices of Article 5 apply since 2 February 2025 and are the only AI Act category enforceable for that entire period. Violations carry the highest fine ceiling in the regulation: up to 35 million euro or 7 percent of worldwide annual turnover.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 5, Article 99(3) and Article 113(a)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The Digital Omnibus adds a prohibition on AI for child sexual abuse material and non-consensual intimate synthetic content; the accompanying technical safeguards are required by 2 December 2026.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amendment to Article 5 and transition to 2 December 2026","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The line often sits in the definitional details: the same technique can be prohibited in the workplace and permitted in another context. Screen per concrete use and context, not per technology, and do so before procurement or go-live.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 5(1)(a)-(h)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Make the Article 5 screening the first step of every classification and record the outcome per system in the register, including the reasoning why a practice does not fall under the prohibition.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 5 read with Article 6 classification order","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2025-02-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-5-prohibited-practices","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 5 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-50-transparency","legacy_id":"raip:obligation:article-50-transparency","type":"obligation","slug":"article-50-transparency","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"239fbac0e4728dc239352b2f88b199c3cc098082ff72e2972b4b5e8a2b121406","label":"Article 50: transparency","summary":"Specific disclosure, marking and labelling duties for certain AI systems and synthetic content.","topics":["transparency"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-50-disclosure"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-50-implementation-record"],"control_ids":["praxikon:eu:ai-act:control:article-50-release-check"],"template_ids":["praxikon:eu:ai-act:template:article-50-checklist"],"conditions":[{"id":"article-50-direct-interaction","operator":"any","description":"An AI system is intended to interact directly with natural persons."},{"id":"article-50-synthetic-content","operator":"any","description":"The system generates or manipulates synthetic audio, image, video or text, or the use concerns a specifically listed deployer scenario."}],"exceptions":[{"id":"article-50-obvious-interaction","operator":"not","description":"The direct-interaction disclosure is not required where this is obvious to a reasonably well-informed, observant and circumspect person, considering circumstances and context."},{"id":"article-50-legacy-marking-grace","operator":"not","description":"Only Article 50(2) has a transition until 2 December 2026 for systems placed on the market before 2 August 2026."}],"statements":[{"kind":"official_fact","text":"Article 50 applies since 2 August 2026. The precise duty differs by scenario: direct AI interaction, machine-readable marking, emotion recognition or biometric categorisation, deepfakes and certain public-interest text.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 50(1)-(5) and Article 113","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"A generic rule that all AI content must always carry a visible label is too broad. First classify the specific Article 50 scenario.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Final guidelines, scope by Article 50 paragraph","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"For each system, record the applicable paragraph, responsible actor, implemented disclosure or marking and how it was tested.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-article-50-guidelines","source_locator":"Implementation guidance for providers and deployers","source_url":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-50-transparency","label":"Open the human explanation"},{"relation":"official_source","href":"https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems","label":"Final Commission guidelines"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-52-systemic-risk-classification","legacy_id":"raip:obligation:article-52-systemic-risk-classification","type":"obligation","slug":"article-52-systemic-risk-classification","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"fda72f0c021ed141ad0881c569a2e4d7e59aefdcec7c95a562b9f547352a974e","label":"Article 52: notification of a GPAI model with systemic risk","summary":"The provider of a general-purpose AI model that meets the condition in Article 51(1), point (a), notifies the Commission without delay and in any event within two weeks, with the information needed to demonstrate that the requirement has been met. With that notification the provider may present substantiated arguments that the model exceptionally does not present systemic risks after all.","topics":["gpai-systemic-risk"],"actor_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"affected_actor_ids":[],"oversight_actor_ids":["praxikon:eu:ai-act:actor:ai-office"],"evidence_owner_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_uncertainty_status":null,"interpretation_status":"settled","interpretation_note":null,"obligation_ids":[],"change_ids":["praxikon:eu:ai-act:change:2026-08-02-gpai-enforcement","praxikon:eu:ai-act:change:2027-08-02-legacy-gpai-models-comply"],"action_ids":["praxikon:eu:ai-act:action:notify-systemic-risk-threshold","praxikon:eu:ai-act:action:request-systemic-risk-reassessment"],"evidence_ids":["praxikon:eu:ai-act:evidence:systemic-risk-notification-file"],"control_ids":["praxikon:eu:ai-act:control:systemic-risk-notification-deadline"],"template_ids":["praxikon:eu:ai-act:template:article-52-legal-text"],"conditions":[{"id":"article-52-notification-trigger","operator":"all","description":"Applies to the provider of a general-purpose AI model as soon as that model meets the condition in Article 51(1), point (a): high impact capabilities, which under Article 51(2) are presumed where the cumulative amount of computation used for its training, measured in floating point operations, is greater than 10^25. The two-week period runs from the moment that requirement is met or it becomes known that it will be met. The second route to systemic risk, a Commission designation under Article 51(1), point (b), or Article 52(4), is not covered here: Article 52(1) refers only to point (a)."}],"exceptions":[{"id":"article-52-legacy-models-transitional","operator":"not","description":"For general-purpose AI models placed on the market before 2 August 2025, Article 111(3) provides that the provider shall take the necessary steps to comply with the obligations of this Regulation by 2 August 2027. For those models the governing date is therefore 2 August 2027 and not the two-week period."}],"statements":[{"kind":"official_fact","text":"Article 51(1), point (a), classifies a general-purpose AI model as a model with systemic risk where it has high impact capabilities evaluated on the basis of appropriate technical tools and methodologies, including indicators and benchmarks; Article 51(2) provides that a model is presumed to have such capabilities where the cumulative amount of computation used for its training, measured in floating point operations, is greater than 10^25. Article 51(1), point (b), reads in full: based on a decision of the Commission, ex officio or following a qualified alert from the scientific panel, it has capabilities or an impact equivalent to those set out in point (a) having regard to the criteria set out in Annex XIII. The requirement of equivalent capabilities or impact and the anchoring in Annex XIII are therefore part of the norm and not only of the procedure. Article 51(3) provides in addition: the Commission shall adopt delegated acts in accordance with Article 97 to amend the thresholds listed in paragraphs 1 and 2 of this Article, as well as to supplement benchmarks and indicators in light of evolving technological developments, such as algorithmic improvements or increased hardware efficiency, when necessary, for these thresholds to reflect the state of the art. The 10^25 threshold above is therefore movable; as long as that act does not exist, the threshold applies as it stands in paragraph 2. See data/ai-act/delegated-acts.json, key praxikon:eu:ai-act:delegated-act:article-51-3-thresholds. Article 52(1) refers only to point (a) and provides that the relevant provider shall notify the Commission without delay and in any event within two weeks after that requirement is met or it becomes known that it will be met, and that the notification shall include the information necessary to demonstrate that the relevant requirement has been met. If the Commission becomes aware of a general-purpose AI model presenting systemic risks of which it has not been notified, it may decide to designate it as a model with systemic risk. Paragraph 2 allows the provider to present, with its notification, sufficiently substantiated arguments to demonstrate that, exceptionally, although the model meets that requirement, it does not present systemic risks due to its specific characteristics and should therefore not be classified as a general-purpose AI model with systemic risk. Paragraph 3 provides that where the Commission concludes that those arguments are not sufficiently substantiated and the provider was not able to demonstrate that the model does not present systemic risks due to its specific characteristics, it shall reject those arguments and the model shall be considered to be a general-purpose AI model with systemic risk. Paragraph 4 empowers the Commission to designate a model as presenting systemic risks, ex officio or following a qualified alert from the scientific panel pursuant to Article 90(1), point (a), on the basis of the criteria set out in Annex XIII, and empowers it to adopt delegated acts in accordance with Article 97 to amend Annex XIII by specifying and updating the criteria set out in that Annex. Paragraph 5 provides that upon a reasoned request of a provider whose model has been designated pursuant to paragraph 4, the Commission shall take the request into account and may decide to reassess whether the model can still be considered to present systemic risks on the basis of the criteria set out in Annex XIII, that such a request shall contain objective, detailed and new reasons that have arisen since the designation decision, that providers may request reassessment at the earliest six months after the designation decision, and that where the Commission decides to maintain the designation a further six months must pass. Paragraph 6 provides that the Commission shall ensure that a list of general-purpose AI models with systemic risk is published and kept up to date, without prejudice to the need to observe and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 52(1)-(6) with Article 51(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Recital 111 states that the cumulative amount of computation used for training includes the computation used across the activities and methods that are intended to enhance the capabilities of the model prior to deployment, such as pre-training, synthetic data generation and fine-tuning. Recital 112 states that the provider should notify the AI Office at the latest two weeks after the requirements are met or it becomes known that a model will meet the requirements that lead to the presumption, and that this is especially relevant in relation to the threshold of floating point operations because training takes considerable planning which includes the upfront allocation of compute resources and, therefore, providers are able to know if their model would meet the threshold before the training is completed. The same recital states that in the context of that notification the provider should be able to demonstrate that the model exceptionally does not present systemic risks, that the information allows the AI Office to anticipate the placing on the market of models with systemic risks, and that it is especially important for models planned to be released as open-source. Recital 113 states that the Commission should be empowered to designate a model where it becomes aware that the model meets the requirements which previously had either not been known or of which the provider failed to notify it, and that a system of qualified alerts from the scientific panel should exist in addition to the monitoring activities of the AI Office.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Recitals 111 to 113","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 111(3) provides that providers of general-purpose AI models that have been placed on the market before 2 August 2025 shall take the necessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 111(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The Commission guidelines of 18 July 2025 (C(2025) 5045 final) state in point (63) that a downstream modifier is considered to be the provider of the modified model where the training compute used for the modification is greater than a third of the training compute of the original model, and in point (64) that where the downstream modifier cannot know and cannot estimate the original value, that threshold is replaced by a third of 10^25 FLOP where the original model is a model with systemic risk and otherwise by a third of 10^23 FLOP. Point (70) states that where a downstream actor modifies a model classified as having systemic risk in such a way that they become the provider of the modified model, the resulting model is presumed to have high-impact capabilities, and point (71) states that the modifier must then comply with the obligations for providers of models with systemic risk and notify the Commission in line with Article 52(1). The guidelines are not binding.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-gpai-guidelines","source_locator":"Commission Guidelines C(2025) 5045 final, 18.7.2025, Section 3.2 points (60) to (67) and Sections 3.2.1 and 3.2.2, points (68) to (71)","source_url":"https://digital-strategy.ec.europa.eu/en/policies/guidelines-gpai-providers","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The Commission enforcement powers for general-purpose AI models and the fine regime of Article 101 have been active since 2 August 2026. Article 101(1) provides that the Commission may impose on providers of general-purpose AI models fines not exceeding 3 percent of their annual total worldwide turnover in the preceding financial year or EUR 15 000 000, whichever is higher, where it finds that the provider intentionally or negligently infringed the relevant provisions of the Regulation.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 91-93, 101 and 113","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This is the only duty in this chapter with a numbered deadline, and two weeks is short. Other duties are also tied to a clock, only without a figure: Article 55(1), point (c), requires serious incidents to be reported to the AI Office without undue delay. The question here is therefore not whether you can notify, but whether you see the threshold being crossed in time. Recital 112 leaves little room to push that back: the legislator expressly assumes that the upfront allocation of compute lets you know before training ends that you will meet the threshold. The remaining edge question is how firm that knowledge is for a run not yet allocated, and it is small next to the duty itself. Four things are missed in practice. The first is the transitional rule: if your model was already on the market before 2 August 2025, Article 111(3) gives you until 2 August 2027, and that is the difference between two weeks and two years. The second is the reach of the trigger: only the threshold route of Article 51(1), point (a), starts this clock. If your model is designated by the Commission under Article 51(1), point (b), or Article 52(4), Article 55 begins without Article 52 asking anything of you. The third is the reversal in the last sentence of paragraph 1: if the Commission becomes aware of a model it was not notified about, it may designate it, and you then hold the conversation from a designation rather than from your own file. Since 2 August 2026 the Article 101 fine regime stands behind that. The fourth is the rebuttal route in paragraph 2: those arguments belong with the notification and not after it, so they must already be ready at the moment you notify. Once designated, only paragraph 5 remains, and that route is slow: six months after the decision at the earliest, and only with objective, detailed and new reasons that have arisen since it. The text names the Commission as addressee; recital 112 and Article 55(1), point (c), name the AI Office, which performs this task within the Commission. For an organisation that merely uses an external model this article does not bite: it addresses the provider of the model. That does not put further development out of reach: under point (71) of guidelines C(2025) 5045 final, a party that becomes the provider of a systemic-risk model through a modification must notify the Commission in line with Article 52(1).","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 52(1)-(6) with Article 51(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Recitals 111 to 113","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 111(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:commission-gpai-guidelines","source_locator":"Commission Guidelines C(2025) 5045 final, 18.7.2025, Section 3.2 points (60) to (67) and Sections 3.2.1 and 3.2.2, points (68) to (71)","source_url":"https://digital-strategy.ec.europa.eu/en/policies/guidelines-gpai-providers","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"First establish whether you are the provider of the model and not merely a user, and whether your model was already on the market before 2 August 2025, because the date in Article 111(3) then applies instead of the two-week period. If you are the provider of a new model, record the planned and the consumed training compute per training run, including pre-training, synthetic data generation and fine-tuning, because recital 111 counts all three. Agree who notifies once the threshold comes into view, so the two-week period is not spent finding an owner, and tie that to the moment compute is allocated rather than to the end of the run. Keep the reasoning with which you would argue that the model does not present systemic risks ready before you notify, because it belongs with the notification. If you have already been designated under paragraph 4, build deliberately towards objective, detailed and new reasons that have arisen since the designation decision, because only those get you to a reassessment after six months. Retain the notification, the substantiation sent with it, any reassessment request and the Commission response as a living file per model version.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 52(1)-(6) with Article 51(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Recitals 111 to 113","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 111(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2025-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-52-systemic-risk-classification","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 52 on EUR-Lex"},{"relation":"related","href":"https://digital-strategy.ec.europa.eu/en/policies/guidelines-gpai-providers","label":"Guidelines C(2025) 5045 final on the scope of the GPAI obligations"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-53-gpai","legacy_id":"raip:obligation:article-53-gpai","type":"obligation","slug":"article-53-gpai","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"55f22a1c21f936ec956fc61f7db4f29defb4524294046799c13af57745cd8b36","label":"Article 53: GPAI model providers","summary":"Documentation, information, copyright and transparency duties for providers of general-purpose AI models.","topics":["gpai"],"actor_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:gpai-document"],"evidence_ids":["praxikon:eu:ai-act:evidence:gpai-compliance-file"],"control_ids":["praxikon:eu:ai-act:control:gpai-documentation-change-control"],"template_ids":["praxikon:eu:ai-act:template:gpai-guide"],"conditions":[{"id":"gpai-union-market","operator":"all","description":"The party is a provider of a GPAI model placed on the Union market."},{"id":"gpai-market-date-transition","operator":"any","description":"For models placed on the market from 2 August 2025, the duties apply from that time. Models placed on the market before 2 August 2025 must comply by 2 August 2027."}],"exceptions":[{"id":"gpai-open-source-limited-exception","operator":"not","description":"The open-source exception is limited and retains, among other things, the copyright policy and public training-content summary. Additional duties apply to models with systemic risk."}],"statements":[{"kind":"official_fact","text":"Article 53 applies since 2 August 2025 to new GPAI models. Providers maintain technical documentation, provide information to downstream providers, operate a Union copyright policy and publish a sufficiently detailed summary of training content.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 53(1), Annex XI and Annex XII","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Providers of GPAI models placed on the market before 2 August 2025 must comply with the applicable obligations by 2 August 2027.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 113(3)(b)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"An organisation merely using an external GPAI model does not thereby automatically become a GPAI model provider. First determine its role in the value chain.","citations":[{"source_id":"praxikon:eu:ai-act:source:commission-gpai-guidelines","source_locator":"Scope and provider qualification guidance","source_url":"https://digital-strategy.ec.europa.eu/en/policies/guidelines-gpai-providers","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Record model versions, role qualification, documentation owners, downstream information, copyright policy and training summary in one change-controlled file.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 53 and Annexes XI-XII","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2025-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-53-gpai","label":"Open the human explanation"},{"relation":"official_source","href":"https://digital-strategy.ec.europa.eu/en/policies/guidelines-gpai-providers","label":"Guidelines for GPAI model providers"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-54-gpai-authorised-representative","legacy_id":"raip:obligation:article-54-gpai-authorised-representative","type":"obligation","slug":"article-54-gpai-authorised-representative","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"0c470c29e8f0c2ad222dc0517b6a9437615474bfc6429e9c37b90eb35572d5c5","label":"Article 54: authorised representative of a provider of a GPAI model","summary":"A provider established in a third country appoints, by written mandate, an authorised representative established in the Union before placing a general-purpose AI model on the Union market. The representative performs the tasks the mandate assigns to it and provides a copy of that mandate to the AI Office upon request. The mandate empowers it at least to verify the documentation, keep a copy available for ten years, provide information and cooperate, and appoints it as the point of contact in addition to or instead of the provider.","topics":["gpai","value-chain"],"actor_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:gpai-model-provider"],"affected_actor_ids":[],"oversight_actor_ids":["praxikon:eu:ai-act:actor:ai-office"],"evidence_owner_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-53-gpai","praxikon:eu:ai-act:obligation:article-55-gpai-systemic-risk"],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:appoint-gpai-authorised-representative"],"evidence_ids":["praxikon:eu:ai-act:evidence:gpai-representative-mandate-file"],"control_ids":["praxikon:eu:ai-act:control:gpai-mandate-review"],"template_ids":["praxikon:eu:ai-act:template:article-54-legal-text"],"conditions":[{"id":"article-54-scope","operator":"all","description":"Applies where the model qualifies as a general-purpose AI model within the meaning of Article 3(63), its provider is established in a third country, and that model is placed on the Union market. The appointment is made by written mandate within the meaning of Article 3(5), which is not only given but also accepted, and it is made before the model is placed on the market. The moment at which the latter occurs is fixed less sharply for a model than for a system; see the editorial interpretation."},{"id":"article-54-market-date-transition","operator":"any","description":"For models placed on the market from 2 August 2025, the appointment duty applies from that moment. Providers of models placed on the market before 2 August 2025 shall, under Article 111(3), take the necessary steps to comply with the obligations of the Regulation by 2 August 2027."}],"exceptions":[{"id":"article-54-open-source-exception","operator":"not","description":"Paragraph 6 excludes the obligation for providers of AI models released under a free and open-source licence that allows access, usage, modification and distribution, and whose parameters, including the weights, the information on the model architecture and the information on model usage, are made publicly available. That exception falls away as soon as the model presents a systemic risk. Whether a given release qualifies is a factual test that has not been settled anywhere; we read it narrowly, so a partially public release does not qualify."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides that, prior to placing a general-purpose AI model on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative which is established in the Union. Paragraph 2 provides that the provider shall enable its authorised representative to perform the tasks specified in the mandate received from the provider. Paragraph 3 provides that the authorised representative shall perform the tasks specified in the mandate received from the provider, that it shall provide a copy of the mandate to the AI Office upon request in one of the official languages of the institutions of the Union, and that for the purposes of the Regulation the mandate shall empower the authorised representative to carry out the following tasks: (a) verify that the technical documentation specified in Annex XI has been drawn up and all obligations referred to in Article 53 and, where applicable, Article 55 have been fulfilled by the provider; (b) keep a copy of the technical documentation specified in Annex XI at the disposal of the AI Office and national competent authorities, for a period of 10 years after the general-purpose AI model has been placed on the market, and the contact details of the provider that appointed the authorised representative; (c) provide the AI Office, upon a reasoned request, with all the information and documentation, including that referred to in point (b), necessary to demonstrate compliance with the obligations in that Chapter; (d) cooperate with the AI Office and competent authorities, upon a reasoned request, in any action they take in relation to the general-purpose AI model, including when the model is integrated into AI systems placed on the market or put into service in the Union. Paragraph 4 provides that the mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the AI Office or the competent authorities, on all issues related to ensuring compliance with the Regulation. Paragraph 5 provides that the authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be acting contrary to its obligations pursuant to the Regulation, and that in such a case it shall also immediately inform the AI Office about the termination of the mandate and the reasons therefor. Paragraph 6 provides that the obligation set out in that Article shall not apply to providers of general-purpose AI models that are released under a free and open-source licence that allows for the access, usage, modification, and distribution of the model, and whose parameters, including the weights, the information on the model architecture, and the information on model usage, are made publicly available, unless the general-purpose AI models present systemic risks.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 54(1)-(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 3(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 113(3)(b) provides that Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the exception of Article 101. Article 54 sits in Chapter V and therefore applies from 2 August 2025.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 113(3)(b)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 101(1) provides that the Commission may impose on providers of general-purpose AI models fines not exceeding 3 percent of their annual total worldwide turnover in the preceding financial year or EUR 15 000 000, whichever is higher. Article 101 is excluded by Article 113(3)(b) from the earlier application of Chapter XII and has therefore applied since 2 August 2026. The obligation in Article 54 has thus applied since 2 August 2025, while the Commission fining power behind it exists only since 2 August 2026.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 101(1)-(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 113(3)(b)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Providers of general-purpose AI models that have been placed on the market before 2 August 2025 shall take the necessary steps in order to comply with the obligations laid down in the Regulation by 2 August 2027.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 111(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This article touches two parties that rarely see themselves that way. The first is the model provider outside the Union that assumes nothing is required until a European customer asks: paragraph 1 places the appointment before the placing on the market, so the representative should exist before the first user in the Union can access the model. The second is the European party that accepts the mandate. It is not stepping into a mailbox role, but note how paragraph 3 is built: the first sentence obliges it to perform the tasks the mandate assigns to it, and only then does the article list what the mandate empowers it to do. Points (a) to (d) are therefore mandate content and empowerment, and its duty runs through them. That is where this article leaves its sharpest question open: is a representative that accepts a mandate omitting task (a) or (b) itself in breach, or does the failure rest entirely with the provider that drew up the mandate. We read paragraph 3 as making the list mandatory minimum content, so that a mandate lacking it does not satisfy the article, which leaves the provider answerable under paragraph 1 and the representative answerable for what it did accept. A defensible alternative reading is that a representative signing without those powers takes on a task it cannot discharge and thereby falls short itself. So do not assume the ten year retention in point (b) rests on you automatically, or automatically does not; write it out. Paragraph 5 closes this off in a way that is often missed: a representative that considers, or has reason to consider, that the provider is breaching its obligations terminates the mandate and immediately informs the AI Office. That is a duty rather than a power, and it calls for access to the documentation agreed in advance and for a moment at which that access is tested.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 54(1)-(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Three things about the timeline and the scope. First, the difference between duty and enforcement: the duty has applied since 2 August 2025, but Article 101 is excluded from the earlier application, so the Commission can only fine since 2 August 2026. For a provider outside the Union discovering today that it has no representative, that means: in breach for well over a year, and now also exposed to a fine. Second, the relationship with Article 22. That article carries the same figure for high-risk AI systems, starting on 2 December 2027 and 2 August 2028; Article 54 is the separate route for general-purpose AI models and has applied since 2 August 2025. Anyone looking up the role of authorised representative finds both and needs to know which route applies. Third, the trigger in paragraph 1. The Regulation fixes the moment of placing on the market less sharply for a model than for a system, and for a model made available only through an interface from a third country there is no case law. We read the duty as starting once the model is made available to users in the Union in the course of a commercial activity, because paragraph 1 attaches to placing on the market and not to establishment in the Union. A defensible alternative reading is that making a model available through an interface is not placing the model itself on the market, so that the duty only arises on an actual supply of the model.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 54(1)-(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 113(3)(b)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (40)(b) and (c), replacing Article 113, third paragraph, point (c) and adding point (d)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"First establish whether you are the provider of the model or only a user, because only the provider appoints. If you are established outside the Union, put the mandate in writing before the model becomes available here, and write the four tasks in paragraph 3 into it expressly, together with the access to the Annex XI documentation and the point of contact under paragraph 4. If your model was already on the market before 2 August 2025, work to 2 August 2027 rather than to today. If you are only now discovering that there is no representative, assume the duty has run since 2 August 2025 and that the Commission has been able to fine since 2 August 2026; remedy first and record when you did. If you accept a mandate, agree in advance how you carry out the verification in paragraph 3(a), who holds the copy for ten years, and at what moment you test whether termination under paragraph 5 is called for.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 54(1)-(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 101(1)-(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2025-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-54-gpai-authorised-representative","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 54 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/54","label":"Read Article 54 in the AI Act Explorer"},{"relation":"related","href":"/en/ai-act/artikel/53","label":"Article 53: the duties the representative verifies"},{"relation":"related","href":"https://digital-strategy.ec.europa.eu/en/policies/guidelines-gpai-providers","label":"Guidelines for GPAI model providers"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-55-gpai-systemic-risk","legacy_id":"raip:obligation:article-55-gpai-systemic-risk","type":"obligation","slug":"article-55-gpai-systemic-risk","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"112ee62609020ed4f49362f4910ee0bdb9155a472914dad7870a887141a5f589","label":"Article 55: GPAI models with systemic risk","summary":"Additional duties for the most capable general-purpose AI models, on top of Article 53.","topics":["gpai-systemic-risk"],"actor_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"affected_actor_ids":[],"oversight_actor_ids":["praxikon:eu:ai-act:actor:ai-office"],"evidence_owner_ids":["praxikon:eu:ai-act:actor:gpai-model-provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-55-gpai-systemic-risk-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-55-gpai-systemic-risk-record"],"control_ids":["praxikon:eu:ai-act:control:article-55-gpai-systemic-risk-control"],"template_ids":["praxikon:eu:ai-act:template:article-55-gpai-systemic-risk-legal-text"],"conditions":[{"id":"article-55-gpai-systemic-risk-scope","operator":"all","description":"The GPAI model has high-impact capabilities, presumed above 10^25 FLOPs of cumulative training compute, or is designated by the Commission."}],"exceptions":[{"id":"article-55-gpai-systemic-risk-exception","operator":"not","description":"The GPAI Code of Practice can, following the adequacy assessment, serve as a means to demonstrate compliance."}],"statements":[{"kind":"official_fact","text":"Article 55 obliges providers of GPAI models with systemic risk to perform model evaluations including adversarial testing, assess and mitigate systemic risks at Union level, track and report serious incidents, and ensure adequate cybersecurity of model and infrastructure. The duties apply since 2 August 2025; AI Office enforcement is active since 2 August 2026.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 55(1)-(2) with Article 51 and Article 52","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The 10^25 FLOPs threshold is a presumption, not a shield: the Commission can also designate models on capabilities, and fine-tuning on top of an existing model can in some circumstances trigger a qualification of its own.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 55(1)-(2) with Article 51 and Article 52","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Model providers near the threshold: set up compute monitoring now and join the Code of Practice to carry the burden of proof.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 55(1)-(2) with Article 51 and Article 52","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2025-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-55-gpai-systemic-risk","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 55 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-56-gpai-codes-of-practice","legacy_id":"raip:obligation:article-56-gpai-codes-of-practice","type":"obligation","slug":"article-56-gpai-codes-of-practice","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"f6e6afc9742736b52408f8c38c9435fc8be751641392f5d0b5d57a34afee4c1c","label":"Article 56: codes of practice for general-purpose AI models","summary":"The AI Office encourages and facilitates the drawing up of codes of practice at Union level, and the AI Office and the Board see to it that those codes cover at least the obligations in Articles 53 and 55. Providers of general-purpose AI models and national competent authorities may be invited to participate in the drawing up; civil society organisations, industry, academia and other stakeholders may support the process. Until 27 July 2026 the Commission could approve a code of practice by implementing act and give it general validity within the Union; Article 1, point (21), of Regulation (EU) 2026/1744 replaced paragraph 6 and removed that power. Since then the Commission assesses whether the codes cover the obligations of Articles 53 and 55 and publishes that assessment. The codes were to be ready by 2 May 2025 at the latest; if no code existed by 2 August 2025, or if the AI Office deems one inadequate, the Commission may lay down common rules by implementing acts for the implementation of Articles 53 and 55. For you this is therefore not a separate duty but a route: a code is a voluntary instrument with which you can demonstrate compliance.","topics":["governance","gpai","gpai-systemic-risk"],"actor_ids":["praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":["praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:ai-office"],"evidence_owner_ids":[],"duty_holder_uncertainty_status":"out_of_scope","interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:decide-and-record-gpai-code-adherence"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-56-code-adherence-decision-record"],"control_ids":["praxikon:eu:ai-act:control:article-56-code-commitment-review"],"template_ids":["praxikon:eu:ai-act:template:article-56-legal-text"],"conditions":[{"id":"article-56-scope-gpai-provider","operator":"any","description":"Arises for the provider of a general-purpose AI model: it may be invited under paragraph 3 to participate in the drawing up of a code of practice, and under paragraph 7 to adhere to a code of practice."},{"id":"article-56-scope-value-chain","operator":"any","description":"Arises for other stakeholders: paragraph 3 names civil society organisations, industry, academia and other relevant stakeholders, such as downstream providers and independent experts, that may support the process."}],"exceptions":[{"id":"article-56-limited-adherence-without-systemic-risk","operator":"not","description":"Paragraph 7 provides that for providers of general-purpose AI models not presenting systemic risks this adherence may be limited to the obligations provided for in Article 53, unless they declare explicitly their interest to join the full code. A provider without a systemic-risk model therefore does not have to sign up to the systemic-risk part in order to rely on the code."},{"id":"article-56-voluntary-instrument","operator":"not","description":"Article 56 does not impose a separate obligation on the provider. Paragraphs 3 and 7 speak of inviting, not of requiring, and the obligations themselves remain those of Articles 53 and 55. Not signing is therefore not an infringement of Article 56."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides that the AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in order to contribute to the proper application of this Regulation, taking into account international approaches. Paragraph 2 provides that the AI Office and the Board shall aim to ensure that the codes of practice cover at least the obligations provided for in Articles 53 and 55, including the following issues: (a) the means to ensure that the information referred to in Article 53(1), points (a) and (b), is kept up to date in light of market and technological developments; (b) the adequate level of detail for the summary about the content used for training; (c) the identification of the type and nature of the systemic risks at Union level, including their sources, where appropriate; (d) the measures, procedures and modalities for the assessment and management of the systemic risks at Union level, including the documentation thereof, which shall be proportionate to the risks, take into consideration their severity and probability and take into account the specific challenges of tackling those risks in light of the possible ways in which such risks may emerge and materialise along the AI value chain. Paragraph 3 provides that the AI Office may invite all providers of general-purpose AI models, as well as relevant national competent authorities, to participate in the drawing-up of codes of practice. Civil society organisations, industry, academia and other relevant stakeholders, such as downstream providers and independent experts, may support the process.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 56(1)-(9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 4 provides that the AI Office and the Board shall aim to ensure that the codes of practice clearly set out their specific objectives and contain commitments or measures, including key performance indicators as appropriate, to ensure the achievement of those objectives, and that they take due account of the needs and interests of all interested parties, including affected persons, at Union level. Paragraph 5 provides that the AI Office shall aim to ensure that participants to the codes of practice report regularly to the AI Office on the implementation of the commitments and the measures taken and their outcomes, including as measured against the key performance indicators as appropriate. Key performance indicators and reporting commitments shall reflect differences in size and capacity between various participants. Paragraph 6, as replaced by Article 1, point (21), of Regulation (EU) 2026/1744, provides that the Commission and the Board shall regularly monitor and evaluate the achievement of the objectives of the codes of practice by the participants and their contribution to the proper application of this Regulation. The Commission, taking utmost account of the opinion of the Board, shall assess whether the codes of practice cover the obligations provided for in Articles 53 and 55, and shall regularly monitor and evaluate the achievement of their objectives. The Commission shall publish its assessment of the adequacy of the codes of practice. The power to approve a code of practice by implementing act and give it general validity within the Union, which sat in the second subparagraph of paragraph 6 until 27 July 2026, lapsed with that replacement. Paragraph 7 provides that the AI Office may invite all providers of general-purpose AI models to adhere to the codes of practice. For providers of general-purpose AI models not presenting systemic risks this adherence may be limited to the obligations provided for in Article 53, unless they declare explicitly their interest to join the full code.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 56(1)-(9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (21), replacing Article 56(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 8 provides that the AI Office shall, as appropriate, also encourage and facilitate the review and adaptation of the codes of practice, in particular in light of emerging standards. The AI Office shall assist in the assessment of available standards. Paragraph 9 provides that codes of practice shall be ready at the latest by 2 May 2025. The AI Office shall take the necessary steps, including inviting providers pursuant to paragraph 7. The second subparagraph of paragraph 9 provides that if, by 2 August 2025, a code of practice cannot be finalised, or if the AI Office deems it is not adequate following its assessment under paragraph 6 of this Article, the Commission may provide, by means of implementing acts, common rules for the implementation of the obligations provided for in Articles 53 and 55, including the issues set out in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 56(1)-(9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"A code of practice is a voluntary instrument, and that word does all the work here. Signing creates no new obligation: your obligations remain those of Articles 53 and 55, and Article 56 changes nothing about them. Not signing is not an infringement either, because paragraphs 3 and 7 speak of inviting and not of requiring. What does shift is the burden of proof. A provider adhering to a code can point to a shared elaboration, assessed by the AI Office and the Board, when a regulator asks how it keeps its documentation up to date, how detailed its summary about the training content is, or how it assesses and manages systemic risk. A provider that does not sign has to write that elaboration itself and defend it itself, up to and including the question why its own approach is at least as good. That is not a legal difference in the norm, but it is a large difference in what is on the table when something is asked. Two things that are often conflated here. First: paragraph 7 allows a provider without a systemic-risk model to limit itself to the obligations in Article 53, unless it explicitly declares its interest in the full code. Partial participation is therefore an expressly foreseen choice and not half-heartedness. Second: paragraph 9 puts a stick behind the door that does not rest on you but does reach you. If no code comes about, or if the AI Office deems it inadequate, the Commission may lay down common rules by implementing acts for the implementation of Articles 53 and 55. Those rules, unlike a code, are not voluntary.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 56(1)-(9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Precision is in order about the state of play, because this is where the market overstates the most. It is established that the General-Purpose AI Code of Practice was published on 10 July 2025; that code is archived in this repository as three chapter PDF files, on transparency, copyright and safety and security, and it is present as a source record in this knowledge base. Whether an approving implementing act followed was not established for the period up to 27 July 2026, and after that date it is no longer the right question: paragraph 6 no longer carries that power. Since then the question is whether the Commission has published its assessment of adequacy. That too is not established here, and for as long as that is the case you must not read anywhere that the code has been approved or has general validity within the Union. That distinction is not a formality: a published code is a text you can voluntarily adhere to, a code approved by implementing act is on top of that an instrument with general validity in the Union. Anyone mistaking the first for the second overestimates what a signature buys and underestimates what they still have to record themselves. The content of the three chapters was also not read in this build, so nothing in this object says anything about what exactly is in them. In practice that means the following. Check the approval status yourself and by date before you rely on the code in a conversation with a regulator or a customer, and record which version of the code and which chapter your adherence relates to. A code may be reviewed and adapted under paragraph 8, in particular in light of emerging standards, so a reliance on the code without a version reference ages on its own.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 56(1)-(9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:gpai-code-of-practice","source_locator":"Code of Practice for General-Purpose AI, 10 July 2025","source_url":"https://digital-strategy.ec.europa.eu/en/policies/contents-code-gpai","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Treat the question whether you adhere to a code of practice as a decision that is taken and recorded, not as something that happens by itself. Record per model: do you adhere to a code, to which version and to which chapter, and if not, which elaboration of your own you apply instead for the issues named in paragraph 2, namely keeping the information in Article 53(1), points (a) and (b), up to date, the level of detail of the summary about the training content, and, where you offer a systemic-risk model, the identification and management of systemic risk. Decide explicitly whether under paragraph 7 the obligations in Article 53 are enough for you or whether you join the full code, and note that choice with a date and an authorised signatory. Before you rely on a code externally, check whether the Commission has published its assessment of adequacy under the amended paragraph 6, and claim no more than you can point at that moment. Do not ask for an approving implementing act: that power has not existed since 27 July 2026, and asking for it is asking for a decision nobody can take any more. Finally, put a review moment in your own calendar: paragraph 8 provides for review and adaptation of codes in light of emerging standards, and paragraph 9 allows the Commission to lay down common rules where a code fails to appear or is deemed inadequate, and both change what you are relying on without anyone calling you.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 56(1)-(9)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:gpai-code-of-practice","source_locator":"Code of Practice for General-Purpose AI, 10 July 2025","source_url":"https://digital-strategy.ec.europa.eu/en/policies/contents-code-gpai","eli":null}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-56-gpai-codes-of-practice","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 56 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/56","label":"Read Article 56 in the AI Act Explorer"},{"relation":"related","href":"https://digital-strategy.ec.europa.eu/en/policies/contents-code-gpai","label":"General-Purpose AI Code of Practice at the European Commission"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-6-1-annex-i-product-route","legacy_id":"raip:obligation:article-6-1-annex-i-product-route","type":"obligation","slug":"article-6-1-annex-i-product-route","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"69936813db0c35758e25c435a583907437346b30c52f1b9943517c31b41f9369","label":"Article 6(1): the product route to high risk","summary":"An AI system counts as high risk where it is intended to be used as a safety component of a product covered by the Union harmonisation legislation listed in Annex I, or is itself such a product, and that product is required to undergo a third-party conformity assessment. This route does not run through Annex III but through the product legislation that already applies to the product. For Section A products the requirements of Chapter III, Section 2, form part of the sectoral assessment under Article 43(3); for Section B products Article 2(2) limits the operation of this Regulation to a short list of provisions.","topics":["conformity","high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"What is mainly open is what condition (b) requires. The text of paragraph 1, point (b), asks whether the product must undergo a third-party conformity assessment, which reads as a reference to the procedure actually prescribed. Article 43(3), third subparagraph, as replaced by Regulation (EU) 2026/1744, points the other way: it subjects the opt-out from third-party assessment to an additional condition under this Regulation and expressly provides that classification as a high-risk AI system does not affect the choice of procedure. That presupposes such systems are high risk. The Commission draft guidelines of 19 May 2026 say the same: the fact that a manufacturer may rely on internal control based on harmonised standards does not affect classification under Article 6(1). We follow that reading and therefore assume a module A route does not take your system out of high risk where the legislature prescribed enhanced scrutiny for that product type. A defensible alternative reading holds to the letter of point (b): only those actually required to involve a third party fall under this route, and Article 43(3) concerns the procedure for an already classified system rather than classification itself. While the guidelines remain draft and the Court has not ruled, that difference in outcome is real. Second open point: the dates diverge within this route. Chapter III, Sections 1 to 3, applies from 2 August 2028, but Articles 102 to 110 apply from 27 July 2026. That range overlaps with what remains for products under Section B of Annex I but does not coincide with it: for Section B the amended Article 2(2) makes Article 6(1), Article 60a and Articles 102 to 112 applicable, so two articles more than the new point (d) brings forward. The date on this object is the Chapter III date, not that of the sectoral amendments. Third open point: machinery moved from Section A to Section B by the same amending Regulation. How the requirements land there depends on delegated acts under Regulation (EU) 2023/1230 that must apply by 2 August 2028 and have not yet been adopted.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:establish-annex-i-product-route"],"evidence_ids":["praxikon:eu:ai-act:evidence:annex-i-product-route-record"],"control_ids":["praxikon:eu:ai-act:control:annex-i-product-route-change-gate"],"template_ids":["praxikon:eu:ai-act:template:article-6-1-legal-text"],"conditions":[{"id":"article-6-1-covered-product","operator":"all","description":"The AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I. Whether the system is placed on the market independently of that product is irrelevant."},{"id":"article-6-1-third-party-assessment","operator":"all","description":"That product, or the AI system as a product itself, is required under that same harmonisation legislation to undergo a third-party conformity assessment with a view to its placing on the market or putting into service. Both conditions must be fulfilled together."}],"exceptions":[{"id":"article-6-1bis-non-safety-function","operator":"not","description":"Article 6(1a), inserted by Regulation (EU) 2026/1744, provides that AI systems solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control do not qualify as safety components. Paragraph 1b takes that exclusion back as soon as failure or malfunctioning would endanger health and safety."},{"id":"article-6-1quater-non-health-safety-assessment","operator":"not","description":"Article 6(1c), as inserted, provides that a product required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, is not considered to fulfil the condition in paragraph 1, point (b)."}],"statements":[{"kind":"official_fact","text":"Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled: (a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I; (b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(1) and Annex I","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 43(3) was replaced by Regulation (EU) 2026/1744. The third subparagraph of the new text reads: where Union harmonisation legislation listed in Section A of Annex I provides the product manufacturer with an option to rely on a conformity assessment that does not involve a third party, provided that that manufacturer has applied harmonised standards to ensure compliance with all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter. The classification of a product as a high-risk AI system in accordance with Article 6(1) does not affect the choice of the conformity assessment procedure provided to the manufacturers of products covered by Union harmonisation legislation listed in Section A of Annex I. The manufacturers of such products are not required to choose a conformity assessment procedure involving third-party conformity assessment only because the product includes a high-risk AI system as a safety component, if this is not required by that harmonisation legislation. The first subparagraph of the same paragraph provides that the requirements set out in Chapter III, Section 2, apply to those high-risk AI systems and form part of that assessment.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (19), replacing Article 43(3), third subparagraph","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 2(2) was replaced by Regulation (EU) 2026/1744 and reads: for AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Article 60a and Articles 102 to 112 shall apply. Articles 57, 58 and 59 shall apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation. The original text named only Article 6(1), Articles 102 to 109 and Article 112, and limited the effect of Article 57 in the same way.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (2)(a), replacing Article 2(2)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The same Regulation amends Annex I: in Section A point 1 is deleted and in Section B point 21 is added, Regulation (EU) 2023/1230 on machinery. Point 1 of Section A was Directive 2006/42/EC on machinery. Machinery therefore moves from Section A to Section B. Regulation (EU) 2023/1230 is amended at the same time so that the Commission adopts delegated acts supplementing Annex III to that Regulation with health and safety requirements for AI systems classified as high risk pursuant to Article 6(1) of Regulation (EU) 2024/1689, reflecting the requirements of Chapter III, Section 2, and Articles 17, 19, 72 and 73. Those delegated acts shall apply by 2 August 2028.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (41), and Article 3, point (1), amending Article 8 of Regulation (EU) 2023/1230","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 2(1), point (e), provides that this Regulation applies to product manufacturers placing on the market or putting into service an AI system together with their product and under their own name or trademark. Article 25(3) provides that in the case of high-risk AI systems that are safety components of products covered by the Union harmonisation legislation listed in Section A of Annex I, the product manufacturer shall be considered to be the provider of the high-risk AI system and shall be subject to the obligations under Article 16 under either of the following circumstances: (a) the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer; (b) the high-risk AI system is put into service under the name or trademark of the product manufacturer after the product has been placed on the market. Article 25(3) was not amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 2(1), point (e), and Article 25(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The text of Article 113, third paragraph, point (c), as published in the Official Journal provides that Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Regulation (EU) 2026/1744 replaces point (c) of the third paragraph of Article 113 with: Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply from (i) 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III, and (ii) 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. The same amendment adds a point (d) to that paragraph: Articles 102 to 110 shall apply from 27 July 2026.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (40)(b) and (c), replacing Article 113, third paragraph, point (c) and adding point (d)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 111(2) was replaced and reads: without prejudice to the application of Article 5 as referred to in Article 113, third paragraph, point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of that Article, that have been placed on the market or put into service before the date of application of Chapter III referred to in Article 113, only if, as from that date, those systems are subject to significant changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations laid down in this Regulation by 2 August 2030.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (39)(a), replacing Article 111(2)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The inserted Article 2(13) provides that for high-risk AI systems referred to in Article 6(1), the application of specific requirements or obligations laid down in Articles 9 to 15 and 17 to 25 may be limited, where and to the extent that Union harmonisation legislation listed in Section A of Annex I lays down requirements or obligations providing an equivalent or higher level of protection, and such limitation does not reduce the overall level of protection provided for by this Regulation. By 2 August 2027 the Commission shall adopt delegated acts specifying the systems concerned, the requirements that may be limited, the conditions and the scope.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (3), inserting Article 2(13)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"For most organisations the first question is not whether their system is AI, but what function their AI component performs and which section of Annex I their product falls under. What often goes wrong is the idea that the conformity route chosen determines the classification: we apply harmonised standards, therefore internal control, therefore no third party, therefore no high risk. That reasoning does not hold. The replaced Article 43(3) attaches an additional condition under this Regulation to the opt-out and states in the same subparagraph that classification as a high-risk AI system does not affect the choice of procedure, and the draft guidelines of 19 May 2026 read Article 6(1) the same way. Where you can genuinely fall outside this route is through the inserted paragraphs 1a and 1c: a model that solely supports throughput or quality control and whose failure does not endanger health and safety, and a product that needed a third party only because of radio spectrum or electromagnetic interference. Two further things go wrong in practice. The first is the date: whoever put 2 December 2027 in the plan because that was the date in the news is planning on the Annex III route and not their own, and whoever notes only 2 August 2028 misses that Articles 102 to 110 have applied since 27 July 2026. The second is the section: machinery has been in Section B since 27 July 2026, no longer in Section A. For a machine builder that means a different regime, with the requirements landing through delegated acts in Annex III to Regulation (EU) 2023/1230 rather than directly through Chapter III of this Regulation. What stands: if you do not build the AI system yourself but put it in your product under your own brand, Article 2(1), point (e), and Article 25(3) make you the provider, with the obligations of Article 16, and not merely a customer of your software supplier.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(1) and Annex I","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (19), replacing Article 43(3), third subparagraph","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 2(1), point (e), and Article 25(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (41), and Article 3, point (1), amending Article 8 of Regulation (EU) 2023/1230","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"List per product which Annex I legal act it falls under and whether that is Section A or Section B after the amendment of 27 July 2026, which conformity assessment procedure applies there, and which AI functions are safety components within the meaning of Article 3, point (14). Test classification not against the module you actually use but against whether the legislature prescribed enhanced scrutiny for that product type. For Section A products the provider follows the procedure required under that legal act and the requirements of Chapter III, Section 2, form part of that assessment; if you use the opt-out in Article 43(3), record which harmonised standards cover all requirements of Section 2. Determine whether Article 2(1), point (e), or Article 25(3) makes you the provider yourself. Plan on 2 August 2028 for Chapter III, and track separately that Articles 102 to 110 have applied since 27 July 2026. For existing products check whether Article 111(2) spares you as long as the design is not significantly changed, and whether 2 August 2030 applies for systems intended for use by public authorities.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (19), replacing Article 43(3), third subparagraph","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 2(1), point (e), and Article 25(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (40)(b) and (c), replacing Article 113, third paragraph, point (c) and adding point (d)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (39)(a), replacing Article 111(2)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2028-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-6-1-annex-i-product-route","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 6 on EUR-Lex"},{"relation":"related","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Regulation (EU) 2026/1744 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-6-1bis-1quater-route","legacy_id":"raip:obligation:article-6-1bis-1quater-route","type":"obligation","slug":"article-6-1bis-1quater-route","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"b1a3c8f90e9a6725cbe17956c5c8b7e1eef30c09b708afd4f0758b446f53b35f","label":"Article 6(1a) to (1c): the tightened classification route","summary":"The Digital Omnibus inserts three paragraphs into Article 6 that draw the notion of safety component more tightly: which AI systems do not qualify as safety components, which still do despite that exclusion because failure would endanger health and safety, and which mandatory third-party conformity assessment does not count. Paragraph 1a is written for the purposes of the Regulation as a whole and therefore bears on both the Annex I route and Annex III, point 2.","topics":["conformity","high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"The legal text below is settled; our reading of the route is not, which is why the whole object stands as preliminary. Three things. First, the sharpest textual tension, and it is not where you would look for it. In the adopted text of paragraph 1a the qualifier \"non-safety related aspects of\" governs the entire list, including user assistance and performance optimisation. In recital 7 that qualifier attaches to quality control alone: it says this does not in particular include AI systems intended to solely fulfil functions related to user assistance, performance optimisation, service efficiency, automation, convenience, or non-safety related aspects for quality control operations. We read the operative text, so with the qualifier across the whole list. A defensible alternative is the recital-conform, narrower reading in which only quality control is limited to non-safety related aspects and the rest is excluded unconditionally. Second, what paragraph 1a looks at. The text says \"are used\", while recital 7 is explicit: the safety function should be an intended purpose of the system, determined by the provider, and the mere fact that an AI system is integrated into or operates within a regulated product does not, in itself, mean that it fulfils a safety function. That second sentence and the amended definition in Article 3, point (14), make this question less open than it seems; we read it as the intended purpose. The alternative reading remains that actual use decides, so that a provider loses the exclusion as soon as a customer deploys the system differently. Third, from when. The amended definition sits in Chapter I and operates now, and the paragraphs have been binding law since 27 July 2026. They steer a live classification only once the route itself applies: 2 December 2027 for Annex III, point 2, and 2 August 2028 for the Annex I route. A defensible alternative reading is that the paragraphs, sitting in Chapter III, Section 1, do not operate at all before the later date. One point of candour: the published definition object on Article 3, point (14), still carries the unamended text and the reading that a component need not have an identifiable safety function. That is exactly what is qualified here, and while both objects stand side by side the text in this object governs.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:assess-safety-component-role"],"evidence_ids":["praxikon:eu:ai-act:evidence:safety-component-assessment-record"],"control_ids":["praxikon:eu:ai-act:control:safety-component-reassessment-trigger"],"template_ids":["praxikon:eu:ai-act:template:article-6-1bis-1quater-legal-text"],"conditions":[{"id":"article-6-1-annex-i-route","operator":"any","description":"Applies where it must be determined whether an AI system is intended to be used as a safety component of a product, or is itself a product, covered by the Union harmonisation legislation listed in Annex I, and whether that product is required to undergo a third-party conformity assessment. Because paragraph 1a writes itself for the purposes of this Regulation, the delimitation also bears on Annex III, point 2, where the notion of safety component is used for critical digital infrastructure, road traffic and the supply of water, gas, heating or electricity."},{"id":"article-6-1-section-a-only","operator":"all","description":"For the consequences under Chapter III only Annex I, Section A, counts. For products under Section B, including machinery since Regulation (EU) 2023/1230 was moved there, the amended Article 2(2) means that only Article 6(1), Article 60a and Articles 102 to 112 apply."}],"exceptions":[{"id":"article-6-1bis-non-safety-functions","operator":"not","description":"Paragraph 1a provides that AI systems solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control do not qualify as safety components. Paragraph 1b takes that exclusion back: AI systems the failure or malfunctioning of which would endanger health and safety do qualify as safety components."},{"id":"article-6-1quater-non-safety-conformity-assessment","operator":"not","description":"Paragraph 1c provides that a product required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, is not considered as fulfilling the condition in paragraph 1, point (b)."}],"statements":[{"kind":"official_fact","text":"Article 6(1) provides: irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled: (a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I; (b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(1)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Regulation (EU) 2026/1744 inserts three paragraphs into Article 6. Paragraph 1a: \"For the purposes of this Regulation, including paragraph 1 of this Article, AI systems that are solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control shall not qualify as safety components.\" Paragraph 1b: \"Notwithstanding paragraph 1a, AI systems the failure or malfunctioning of which would endanger health and safety shall qualify as safety components.\" Paragraph 1c: \"A product that is required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, shall not be considered as fulfilling the condition in paragraph 1, point (b).\"","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Inserted Article 6(1a)-(1c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The same Regulation amends the definition in Article 3, point (14). As amended it reads: \"safety component\" means a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property; for the purposes of this definition, a component fulfils a safety function where its intended purpose is to prevent or mitigate risks to the health and safety of persons or property. Article 3 sits in Chapter I, which under Article 113, third paragraph, point (a), has applied since 2 February 2025. This amended definition therefore operates from the entry into force of the amending Regulation on 27 July 2026 and not only from some later application date.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 3(14)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The amended Article 113, third paragraph, point (c), provides that Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5), shall apply from: (i) 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III; and (ii) 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. The added point (d) provides that Articles 102 to 110 shall apply from 27 July 2026. Annex III, point 2, uses the notion of safety component for critical digital infrastructure, road traffic and the supply of water, gas, heating or electricity; that route falls under the 2 December 2027 date.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The same Regulation moves machinery out of Chapter III. In Annex I, Section A, point 1 (the reference to Directive 2006/42/EC) is deleted and Section B gains point 21: Regulation (EU) 2023/1230 on machinery. The amended Article 2(2) reads that for AI systems classified as high-risk in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Article 60a and Articles 102 to 112 shall apply. The amended Article 43(3) adds that the classification of a product as a high-risk AI system in accordance with Article 6(1) does not affect the choice of the conformity assessment procedure provided to manufacturers of products covered by Annex I, Section A, and that those manufacturers are not required to choose a procedure involving third-party conformity assessment only because the product includes a high-risk AI system as a safety component, if the Section A legislation does not require it. The new Article 2(13) provides that specific requirements or obligations under Articles 9 to 15 and 17 to 25 may be limited where Section A legislation provides an equivalent or higher level of protection, and obliges the Commission to adopt delegated acts on this by 2 August 2027.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 2(2), Article 43(3) and Annex I","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"What changes in practice is what the discussion is about. Until now it was about whether your product falls under Annex I and whether a third party is involved. Those two questions remain, but a third one belongs in front of them: what function does your AI component actually perform. A recommendation model that optimises when a machine is serviced, or a model that improves throughput on a line, sits in the list in paragraph 1a, and such functions often ended up classified as safety components simply because they ran inside a regulated product. Be careful with quality control as an example: paragraph 1a names only the non-safety related aspects of it, and in many regulated products a vision model that flags deviations is safety QC. Paragraph 1b draws the line: as soon as failure or malfunctioning would endanger health and safety, the exclusion does not count. The question therefore moves from your product file to your failure analysis, and at most providers that analysis is recorded nowhere. Paragraph 1c is narrower: anyone who needed a third party only because of radio spectrum or electromagnetic interference does not meet paragraph 1, point (b), by that route. That paragraph too requires a weighing, because it works only if the third party is mandatory solely on account of those other risks; where your product falls under several Annex I acts, a second act may still satisfy the condition on health and safety grounds. Two things finally that move the stakes. Machinery no longer runs through this route: Regulation (EU) 2023/1230 now sits in Annex I, Section B, and for those products the amended Article 2(2) means Chapter III does not apply at all. And for Section A products the same Regulation pushes the other way: the amended Article 43(3) says expressly that classification under Article 6(1) does not affect the choice of conformity assessment procedure and pushes nobody towards a notified body who was not already headed there. So build your failure analysis as your own file, not as something you will have to put in front of a notified body anyway.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Inserted Article 6(1a)-(1c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 2(2), Article 43(3) and Annex I","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"This is our recommendation and not a legal duty: paragraphs 1a to 1c are delimiting rules and impose no obligation on anyone. First establish whether your product falls under Annex I, Section A or Section B; for Section B, which now includes machinery, Chapter III stops here. For Section A, record per AI component which function it performs, whether that is a safety function within the meaning of the amended Article 3, point (14), and what happens on failure or malfunctioning. Note which of the three paragraphs you apply and why. Use that file to support your own classification, not because a notified body asks for it: the amended Article 43(3) points the other way. Keep two dates apart: 2 December 2027 for the route via Annex III, point 2, and 2 August 2028 for the route via Annex I.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Inserted Article 6(1a)-(1c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 2(2), Article 43(3) and Annex I","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"in_force","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-6-1bis-1quater-route","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Inserted paragraphs on EUR-Lex"},{"relation":"related","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 6 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-61-informed-consent","legacy_id":"raip:obligation:article-61-informed-consent","type":"obligation","slug":"article-61-informed-consent","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"e7ff043231fa794c9c21494315ad879b5bac9ab1195f761cfec85493be5acd92","label":"Article 61: informed consent of test subjects for testing in real world conditions","summary":"If you test a high-risk AI system in real world conditions outside an AI regulatory sandbox, freely-given informed consent must be obtained from every test subject before they participate. Beforehand the subject receives concise, clear, relevant and understandable information on five prescribed topics: the nature and objectives of the testing and the possible inconvenience, the conditions under which the testing is to be conducted including the expected duration of participation, their rights and guarantees including the right to refuse and the right to withdraw at any time without detriment and without justification, the arrangements for requesting the reversal or the disregarding of the outputs of the system, and the Union-wide unique single identification number with the contact details from whom further information can be obtained. The consent is dated and documented and the subject is given a copy.","topics":["fundamental-rights","innovation"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:market-surveillance-authority"],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-61-inform-and-obtain-consent"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-61-subject-information-pack"],"control_ids":["praxikon:eu:ai-act:control:article-61-consent-and-withdrawal-review"],"template_ids":["praxikon:eu:ai-act:template:article-61-legal-text"],"conditions":[{"id":"article-61-scope","operator":"all","description":"Applies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026."},{"id":"article-61-joint-testing","operator":"any","description":"If under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file."}],"exceptions":[{"id":"article-61-law-enforcement-carve-out","operator":"not","description":"The only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides: for the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding: (a) the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation; (b) the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects participation; (c) their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification; (d) the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system; (e) the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained. Paragraph 2 provides: the informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 61(1) and (2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 60(4), point (i), sets as a condition: the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the testing itself and the outcome of the testing in the real world conditions shall not have any negative effect on the subjects, and their personal data shall be deleted after the test is performed. Article 60(5) provides: any subjects of the testing in real world conditions, or their legally designated representative, as appropriate, may, without any resulting detriment and without having to provide any justification, withdraw from the testing at any time by revoking their informed consent and may request the immediate and permanent deletion of their personal data. The withdrawal of the informed consent shall not affect the activities already carried out. Article 60(2), as replaced by Article 1, point (24), of Regulation (EU) 2026/1744, provides: providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III or covered by Union harmonisation legislation listed in Section A of Annex I in real world conditions at any time before the placing on the market or the putting into service of the high-risk AI system on their own or in partnership with one or more deployers or prospective deployers. Until 27 July 2026 that paragraph named only the Annex III route; the consent of Article 61 therefore now also applies when testing high-risk AI in a regulated product under Section A of Annex I.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This is the only place in this Regulation where the individual consent of a natural person is a condition. Nowhere else does the lawfulness of something you do turn on a signature from the person it affects. That makes it tempting to reuse the existing GDPR consent form, and that is exactly where it goes wrong. Consent under Article 61 is consent to take part in a test; it is one of the cumulative conditions in Article 60(4) under which you may test in real world conditions. Whether, and on what basis, personal data may be processed in that test is not governed by Article 61 and this Regulation does not say so here. That remains a question of data protection law, and you answer it separately. The two do not coincide and one does not replace the other. Look as well at the content of the five points, because two of them appear in no standard form. Point (e) requires the Union-wide unique single identification number of the testing from Article 60(4), point (c). That number arises on registration, so you can only approach the subject once that registration is done; anyone who recruits first and registers afterwards has inverted the order. Point (d) requires you to explain how someone can request the reversal or the disregarding of the predictions, recommendations or decisions of the system. That is not only information: Article 60(4), point (k), requires those outputs to be capable of being effectively reversed and disregarded. If you cannot describe that mechanism, it probably does not exist and your test design does not qualify.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Note the difference between paragraph 1 and paragraph 2, because organisations usually build only one of the two. Paragraph 1 is about informing beforehand: concise, clear, relevant and understandable, on five topics. Paragraph 2 is about the evidence afterwards: the consent is dated, is documented, and the subject is given a copy. A tick box in an app that leaves a line in a log file does not satisfy paragraph 2: no copy was given and usually there is no dating that can be shown independently of the logging system. So build two artefacts rather than one: the information pack you hand over, and the dated consent record you keep and of which the subject holds a copy. A second point missed in the design is withdrawal. Article 61(1), point (c), promises the subject a right to withdraw at any time without detriment and without justification, and Article 60(5) works that out: withdrawal is always possible, immediate and permanent deletion of the personal data may be requested, and the withdrawal does not affect the activities already carried out. Anyone who promises that right in the form but has no route to carry it out has not delivered on the promise. The practical question is therefore not how your form reads, but who receives the withdrawal on Monday morning, within what period the data disappear, and where that is recorded. Finally, do not leave the division of roles implicit. If you test together with a deployer, that party is often the one facing the subject, while the condition stays with you as the provider. Article 60(4), point (h), gives you the instrument to settle that, and that is the agreement specifying your tasks and responsibilities.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Draw up an information pack per test that names each of the five points of paragraph 1 separately, and check the pack line by line against those five points rather than against your existing privacy notice. Obtain the Union-wide unique single identification number from the registration under Article 60(4), point (c), and put it in the pack together with the contact details of the provider or the legal representative before you approach the first subject. Under point (d), describe the concrete mechanism through which someone can request the reversal or the disregarding of an output, with the place the request arrives and the period within which it is handled. Record a dated consent per subject and give a copy to the subject or the legal representative; keep that record separately from your application logs, so you can show it without consulting the system. Set up a withdrawal route with a named recipient, a period and a processing step for the request for immediate and permanent deletion of personal data, and rehearse that route once before the test starts. In the agreement with your deployer under Article 60(4), point (h), record who informs, who obtains consent, who keeps the record and who receives a withdrawal. If you test in the law enforcement domain and are considering the exception in Article 60(4), point (i), record in advance why seeking consent would prevent the testing, and how you ensure that the test has no negative effect and that the personal data are deleted after the test.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 60(2); Article 60(4), points (c), (h) and (i); Article 60(5); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-61-informed-consent","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 61 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/61","label":"Read Article 61 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-62-sme-support-measures","legacy_id":"raip:obligation:article-62-sme-support-measures","type":"obligation","slug":"article-62-sme-support-measures","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"89d0012409a5635c7734726e3fa30d2a1fa3427dc6277cfe8f675f151cd5d5dc","label":"Article 62: measures for providers and deployers that are SMEs or start-ups","summary":"Member States give SMEs, including start-ups, with a registered office or a branch in the Union priority access to the AI regulatory sandboxes, organise specific awareness raising and training activities, use or establish dedicated communication channels to provide advice and answer queries, and facilitate the participation of SMEs in the standardisation development process. When setting the fees for conformity assessment under Article 43, the specific interests and needs of SME providers are taken into account, those fees being reduced proportionately to their size, market size and other relevant indicators. The AI Office provides standardised templates, maintains a single information platform, organises communication campaigns and promotes the convergence of best practices in public procurement. This article lowers no requirement; it makes the road towards one cheaper and more accessible.","topics":["governance","innovation"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:ai-office"],"evidence_owner_ids":[],"duty_holder_uncertainty_status":"out_of_scope","interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-62-claim-sme-facilities"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-62-sme-status-record"],"control_ids":["praxikon:eu:ai-act:control:article-62-fee-and-access-review"],"template_ids":["praxikon:eu:ai-act:template:article-62-legal-text"],"conditions":[{"id":"article-62-scope","operator":"all","description":"The priority access in paragraph 1, point (a), applies to SMEs, including start-ups, having a registered office or a branch in the Union, and only to the extent that they fulfil the eligibility conditions and selection criteria. The reduction of fees in paragraph 2 attaches to conformity assessments under Article 43 and to the capacity of an SME provider, including start-ups. Article 62 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026."}],"exceptions":[{"id":"article-62-priority-access-not-exclusive","operator":"not","description":"Paragraph 1, point (a), expressly states that the priority access shall not preclude other SMEs, including start-ups, other than those referred to in that paragraph from access to the AI regulatory sandbox, provided that they also fulfil the eligibility conditions and selection criteria. Priority is therefore an order of precedence and not an exclusive right, and it releases nobody from the eligibility conditions and selection criteria."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides: Member States shall undertake the following actions: (a) provide SMEs, including start-ups, having a registered office or a branch in the Union, with priority access to the AI regulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria; the priority access shall not preclude other SMEs, including start-ups, other than those referred to in this paragraph from access to the AI regulatory sandbox, provided that they also fulfil the eligibility conditions and selection criteria; (b) organise specific awareness raising and training activities on the application of this Regulation tailored to the needs of SMEs including start-ups, deployers and, as appropriate, local public authorities; (c) utilise existing dedicated channels and where appropriate, establish new ones for communication with SMEs including start-ups, deployers, other innovators and, as appropriate, local public authorities to provide advice and respond to queries about the implementation of this Regulation, including as regards participation in AI regulatory sandboxes; (d) facilitate the participation of SMEs and other relevant stakeholders in the standardisation development process. Paragraph 2 provides: the specific interests and needs of the SME providers, including start-ups, shall be taken into account when setting the fees for conformity assessment under Article 43, reducing those fees proportionately to their size, market size and other relevant indicators.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 62(1) to (3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 3 provides: the AI Office shall undertake the following actions: (a) provide standardised templates for areas covered by this Regulation, as specified by the Board in its request; (b) develop and maintain a single information platform providing easy to use information in relation to this Regulation for all operators across the Union; (c) organise appropriate communication campaigns to raise awareness about the obligations arising from this Regulation; (d) evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 62(1) to (3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Article 62 is not an exemption but a facility, and that distinction is the whole article. Nowhere does it say that an SME or a start-up has to comply with less. What changes is the price and the access: priority access to the AI regulatory sandbox, tailored training and awareness raising, a channel to put questions, a seat at the standardisation table, and reduced fees for conformity assessment under Article 43. Anyone reading this article as an SME regime with lighter requirements is looking at the wrong provision; the only relief from a substantive requirement in this Regulation sits in Article 63 and touches only the quality management system of Article 17. Since 27 July 2026 that relief is available to SMEs, including start-ups, and no longer to microenterprises alone: Article 1, point (26), of Regulation (EU) 2026/1744 replaced Article 63(1) to that effect. A standalone small enterprise that is not a microenterprise therefore does fall within it, provided it has no partner enterprises or linked enterprises within the meaning of Recommendation 2003/361/EC. Read paragraph 2 carefully as well, because it says something stronger than is usually assumed. It is not a power but an instruction: the fees are reduced, proportionately to the size of the provider, the market size and other relevant indicators. If you receive a quotation for a conformity assessment without that proportionality being made visible, that is a question you can put and whose answer you can record. Do not confuse that reduction with free access to an AI regulatory sandbox: that sits in Article 58(2), point (d), applies to SMEs including start-ups, and expressly leaves standing the exceptional costs that national competent authorities may recover in a fair and proportionate manner. Two different provisions, two different flows of money.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43; Article 58(2), point (d); Article 63; Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"In practice the core of this article is that you have to ask for it yourself. The Member State grants priority access to those who come forward and meet the eligibility conditions and selection criteria; priority will not operate by itself for anyone who does not apply. That makes two things important. First, that you can show you are an SME in the sense in which the Regulation uses that word, and that you have a registered office or a branch in the Union; that is a matter of file, not of conversation. Second, that you know which national body in your Member State staffs the channel in paragraph 1, point (c), because that channel is meant to provide advice and answer queries about implementation, including on participation in a sandbox. Point (d) is almost always skipped and is the most valuable part for a technical company: the participation of SMEs in the standardisation development process is facilitated. The harmonised standards will settle what counts as sufficient in practice; having a say in that text is cheaper than having to build to it later. Finally, factor paragraph 3 into your own planning. The AI Office provides standardised templates and maintains a single information platform. As long as no template exists for your topic, you build your own document; once one arrives, it is a template and not a licence, and the substantive requirement stays the same.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43; Article 58(2), point (d); Article 63; Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Record once whether your organisation is an SME or a start-up in the sense in which this Regulation uses that word, with the reasoning and the date attached, and whether you have a registered office or a branch in the Union; refresh that file at every change in the corporate structure. Find out which national competent authority in your Member State runs the AI regulatory sandbox and which channel it offers for questions about implementation, and use that channel before you buy an expensive external route. If you apply for a conformity assessment under Article 43, ask explicitly with the quotation how the reduction proportionate to your size, the market size and other relevant indicators has been applied, and keep that answer with your procurement file. Sign up for the standardisation development process on the topics that touch your product, because that is the cheapest place to influence what later counts as sufficient. Before you build your own template, check whether the AI Office has already provided one, and use the single information platform as a first source rather than a secondary summary. Finally, do not assume that any of these facilities lightens a substantive requirement: in your planning, set out next to each facility which requirement continues to apply in full.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43; Article 58(2), point (d); Article 63; Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-62-sme-support-measures","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 62 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/62","label":"Read Article 62 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-63-sme-derogations","legacy_id":"raip:obligation:article-63-sme-derogations","type":"obligation","slug":"article-63-sme-derogations","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"249cec1c5363acf6ee7e50aca22d6a1f93b27a07655d9cb2d2ebd8494810bcde","label":"Article 63: derogations for SMEs in the quality management system","summary":"SMEs, including start-ups, may comply with certain elements of the quality management system required by Article 17 in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of Recommendation 2003/361/EC. Until 27 July 2026 this read microenterprises; Article 1, point (26), of Regulation (EU) 2026/1744 replaced paragraph 1 and widened the circle to SMEs. Which elements those are is for the Commission to set out in guidelines, considering the needs of SMEs and without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems. Paragraph 2 rules out any wider reading: the provision shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73.","topics":["high-risk-requirements","innovation"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":["praxikon:eu:ai-act:actor:provider"],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":"out_of_scope","interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-63-scope-simplified-quality-management"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-63-sme-eligibility-record"],"control_ids":["praxikon:eu:ai-act:control:article-63-simplification-boundary-review"],"template_ids":["praxikon:eu:ai-act:template:article-63-legal-text"],"conditions":[{"id":"article-63-scope","operator":"all","description":"Two cumulative conditions. The organisation is an SME, including a start-up, within the meaning of Recommendation 2003/361/EC, and it does not have partner enterprises or linked enterprises within the meaning of that Recommendation. A standalone small enterprise that is not a microenterprise is therefore covered since 27 July 2026. The thresholds and the notions of partner enterprise and linked enterprise sit in that Recommendation and not in this Regulation; anyone relying on this article tests against that text. The benefit touches only the quality management system required by Article 17, and only those elements of it that the Commission designates in its guidelines. Article 63 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026."}],"exceptions":[{"id":"article-63-no-exemption-from-other-requirements","operator":"not","description":"Paragraph 2 expressly provides that paragraph 1 shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73. The risk management system, data and data governance, technical documentation, record-keeping, transparency, human oversight, accuracy, robustness and cybersecurity, post-market monitoring and the reporting of serious incidents therefore continue to apply in full."}],"statements":[{"kind":"official_fact","text":"Paragraph 1, as replaced by Article 1, point (26), of Regulation (EU) 2026/1744, provides: SMEs, including start-ups, may comply with certain elements of the quality management system required by Article 17 in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of Recommendation 2003/361/EC. For that purpose, the Commission shall develop guidelines on the elements of the quality management system which may be complied with in a simplified manner considering the needs of SMEs, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems. Paragraph 2 provides: paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 63(1) and (2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 17(1) is the obligation to which the derogation in Article 63 relates and provides: providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects: (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system; (b) techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17(1); Article 62(2); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This article is called derogations and that word does more harm than good. Nothing is abolished. Paragraph 1 says that certain elements of a single obligation, the quality management system of Article 17, may be complied with in a simplified manner. Paragraph 2 then says in as many words that this shall not be interpreted as exempting those operators from other requirements or obligations under this Regulation, and names nine of them: Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73. That is the enumeration that heads off the misunderstanding, and it covers exactly the heaviest requirements: risk management, data and data governance, technical documentation, record-keeping, transparency, human oversight, accuracy and cybersecurity, post-market monitoring, and the reporting of serious incidents. A microenterprise providing a high-risk system therefore does very nearly everything a large company does; only the form in which the quality management system is written down may be lighter. Two things to settle now. First the entry test, because it is stricter than it looks: on top of the thresholds in Recommendation 2003/361/EC there is the additional condition that you have no partner enterprises or linked enterprises within the meaning of that Recommendation. A holding by a parent company or a shared shareholder can break that condition, and that is a structural question you do not want to raise in the last week before an assessment. Second the reach of the simplification: which elements exactly may be lighter is not in the Regulation but in guidelines the Commission develops under this article. We make no claim here about which elements those are or whether those guidelines already exist; until they do, you build the Article 17 system as it stands and keep a note of which parts you would later want to simplify.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17(1); Article 62(2); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Put Article 63 next to Article 62 and the picture sharpens. Article 62 lowers the price and the threshold, Article 63 simplifies the form of a document. Together they are the only two places in this Regulation where the size of an undertaking legally makes a difference, and neither touches the substantive requirements for high-risk AI systems. Anyone who hears in a sales conversation or a grant application that the AI Regulation is softer for small companies can test that against these two articles and will find the claim too broad. Think as well about the commercial side of paragraph 2. The nine articles it names are precisely the items a buyer asks for: the risk management system, the data governance, the technical documentation, the logs, the instructions for use, the human oversight, the performance and security figures, the post-market monitoring and the incident reporting. A microenterprise invoking Article 63 in order not to produce those items will be found out in the first serious procurement process, before a regulator comes into view at all. The sensible reading is therefore the reverse: use Article 63 to keep your quality management system small and workable, and invest the time you win in the nine topics of paragraph 2, because that is what both your customer and your market surveillance authority will judge you on.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17(1); Article 62(2); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"First test whether you fall within scope and record that test: are you a microenterprise within the meaning of Recommendation 2003/361/EC, and do you genuinely have no partner enterprises or linked enterprises within the meaning of that Recommendation? Put that second question to whoever knows the shareholding structure rather than to the product team, and repeat the test at every investment round or acquisition. Then build the Article 17 quality management system in full, and mark in your own documentation which elements you would want to simplify once the Commission guidelines on that exist; that way you do not start over when that text appears. Next, make an explicit list of the nine articles paragraph 2 names and set out per article who in your organisation produces the corresponding item and where it sits; that is the same list a buyer asks for and a market surveillance authority walks through. Put no sentence in quotations or contracts suggesting that your size releases you from a requirement. Finally, check whether Article 62 gives you something Article 63 does not, such as the reduced conformity assessment fee or priority access to a sandbox; those two tracks run separately and you can use both.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17(1); Article 62(2); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-63-sme-derogations","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 63 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/63","label":"Read Article 63 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-71-eu-database","legacy_id":"raip:obligation:article-71-eu-database","type":"obligation","slug":"article-71-eu-database","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"ceaa3da5b4cb893e068c9cbe5094b7934da65e8a20cc7cf57546945c0b877c06","label":"Article 71: EU database for high-risk AI systems listed in Annex III","summary":"The provider or, where applicable, the authorised representative enters the data listed in Sections A and B of Annex VIII into the EU database; the deployer who is, or who acts on behalf of, a public authority, agency or body enters the data listed in Section C. Information registered in accordance with Article 49 is publicly available in a user-friendly manner and machine-readable, except for the secure section covering law enforcement, migration, asylum and border control management and the registration of testing in real world conditions. Setting up and maintaining the database itself is a task of the Commission and not a duty of yours.","topics":["conformity","high-risk"],"actor_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"Two things about the law itself are unsettled here. First, the date. Article 71 falls under the general application date of 2 August 2026, while the entry duties in paragraphs 2 and 3 hang on the registration in Article 49, whose Annex III route was shifted to 2 December 2027 by Regulation (EU) 2026/1744. We therefore read the practical deadline as 2 December 2027. Two alternative readings are defensible, and they point in opposite directions: the mild one is that the database exists from 2 August 2026 and only the entering follows the later date, so whoever registers earlier is not being early but on time; the hard one is that the amended Article 113, third paragraph, point (c), names only Chapter III, Sections 1, 2 and 3, while Article 49 sits in Section 5 of that same Chapter, so the registration duty may not have moved with it and you may already be late rather than early. Anyone planning against this deadline is planning against our reading and not against a settled fact. Second, the Article 60 route. Article 60 sits in Chapter VI and the provider or prospective provider testing in real world conditions today must register under Article 60(4), point (c), in accordance with Article 71(4). Whether that route moved with the Annex III deferral or already runs under the general date of 2 August 2026 is unsettled. The fact that 2026/1744 widened the scope of Article 60 to Annex I Section A and placed an Article 60a alongside it for Annex I Section B makes that question larger rather than smaller. This object does not carry that duty and the status here says nothing about it. Settled, and therefore no longer a ground for the preliminary status: the content of Section B of Annex VIII. Article 1, point (42), of Regulation (EU) 2026/1744 deletes points 7 and 9, and the reading above follows that text rather than the base regulation. One cross-reference does follow from it that the legislator did not chase down: Article 49(4) is unamended and still lists point 9 of Section B for the secure section, a point that no longer exists. Whoever works through that list literally is looking for a field that is not there. In addition, and this expressly does not carry the status because it is not an unsettled reading but a coverage gap of this dataset: paragraphs 1 and 6 address the Commission, which is not an actor here, so this object carries only the entry duties of paragraphs 2 and 3; and paragraph 3 also names whoever acts on behalf of a public authority, a role that does not exist separately alongside the body governed by public law, so a private party registering on behalf of a public authority has to assess for itself whether paragraph 3 rests on it.","obligation_ids":[],"change_ids":["praxikon:eu:ai-act:change:2026-07-27-annex-iii-date"],"action_ids":["praxikon:eu:ai-act:action:enter-and-maintain-eu-database-data"],"evidence_ids":["praxikon:eu:ai-act:evidence:eu-database-entry-record"],"control_ids":["praxikon:eu:ai-act:control:eu-database-entry-currency"],"template_ids":["praxikon:eu:ai-act:template:article-71-legal-text"],"conditions":[{"id":"article-71-scope","operator":"any","description":"Applies where a provider or authorised representative places an Annex III high-risk AI system on the market or puts it into service and registers itself and that system in accordance with Article 49, where that same party registers a system considered not to be high-risk pursuant to Article 6(3), or where a deployer that is, or that acts on behalf of, a public authority, agency or body registers itself, selects the system and registers its use."}],"exceptions":[{"id":"article-71-exception-annex-iii-point-2","operator":"not","description":"Article 49(5) provides that high-risk AI systems referred to in point 2 of Annex III are registered at national level. For those systems the registration therefore does not run through the Article 71 EU database."},{"id":"article-71-exception-secure-section","operator":"not","description":"Paragraph 4 excludes the section referred to in Article 49(4) from public availability. For the systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, registration takes place in a secure non-public section of the database, with fewer fields than the full Sections: Section A, points 1 to 10 with the exception of points 6, 8 and 9; Section B, points 1 to 5 and points 8 and 9; Section C, points 1, 2 and 3; and points 1, 2, 3 and 5 of Annex IX. Only the Commission and the national authorities referred to in Article 74(8) have access to those sections. Mind the cross-reference: Article 49(4) was not amended by Regulation (EU) 2026/1744 and therefore still names point 9 of Section B, while Article 1, point (42), of that same Regulation deleted that point. There is nothing left to fill in there."},{"id":"article-71-exception-real-world-testing","operator":"not","description":"Paragraph 4 additionally excludes the section referred to in Article 60(4), point (c). The main rule there is not a secure section: the provider or prospective provider registers the testing in real world conditions in accordance with Article 71(4), with a Union wide unique single identification number and the information specified in Annex IX. Under the third sentence of paragraph 4 that information is accessible only to market surveillance authorities and the Commission, unless the provider or prospective provider has given consent for also making it accessible to the public. Only for points 1, 6 and 7 of Annex III does the testing registration go into the secure non-public section under Article 49(4), point (d), and for point 2 of Annex III to national level under Article 49(5)."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides that the Commission shall, in collaboration with the Member States, set up and maintain an EU database containing the information referred to in paragraphs 2 and 3 concerning high-risk AI systems referred to in Article 6(2) which are registered in accordance with Articles 49 and 60, and AI systems that are not considered as high-risk pursuant to Article 6(3) and which are registered in accordance with Article 6(4) and Article 49. When setting the functional specifications the Commission shall consult the relevant experts, and when updating them the Board. Paragraph 2 provides that the data listed in Sections A and B of Annex VIII shall be entered into the database by the provider or, where applicable, by the authorised representative. Paragraph 3 provides that the data listed in Section C of Annex VIII shall be entered by the deployer who is, or who acts on behalf of, a public authority, agency or body, in accordance with Article 49(3) and (4). Paragraph 4 provides that, with the exception of the section referred to in Article 49(4) and Article 60(4), point (c), the information registered in accordance with Article 49 shall be accessible and publicly available in a user-friendly manner, and that the information should be easily navigable and machine-readable. The same paragraph provides that the information registered in accordance with Article 60 shall be accessible only to market surveillance authorities and the Commission, unless the prospective provider or provider has given consent for also making the information accessible to the public. Paragraph 5 provides that the database shall contain personal data only in so far as necessary for collecting and processing information in accordance with this Regulation, and that such information shall include the names and contact details of natural persons who are responsible for registering the system and have the legal authority to represent the provider or the deployer. Paragraph 6 provides that the Commission shall be the controller of the database, shall make adequate technical and administrative support available to providers, prospective providers and deployers, and that the database shall comply with the applicable accessibility requirements.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 71(1)-(6)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Annex VIII sets out which information is submitted upon registration and kept up to date thereafter. Section A, for providers registering in accordance with Article 49(1), lists thirteen points, including the name, address and contact details of the provider and of the authorised representative, the trade name and any additional unambiguous reference allowing identification and traceability of the system, a description of the intended purpose and of the components and functions supported, a basic and concise description of the information used and of the operating logic, the status of the system, the details and a scanned copy of the notified body certificate where applicable, the Member States where the system is available, a copy of the EU declaration of conformity referred to in Article 47 and the electronic instructions for use, which are not provided for the law enforcement, migration, asylum and border control management areas of points 1, 6 and 7 of Annex III. Section C, for deployers registering under Article 49(3), lists five points: the name, address and contact details of the deployer, the same details of the person submitting information on its behalf, the URL of the entry of the system in the database by its provider, a summary of the findings of the fundamental rights impact assessment carried out in accordance with Article 27, and where applicable a summary of the data protection impact assessment. Neither Section was amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex VIII, Sections A and C","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Section B of Annex VIII, for registrations under Article 49(2), was amended. Article 1, point (42), of Regulation (EU) 2026/1744 reads: \"in Annex VIII, section B, points 7 and 9 are deleted\". Deleted are therefore point 7, the short summary of the grounds on which the AI system is considered not to be high-risk in application of the procedure under Article 6(3), and point 9, the statement of any Member States in which the system has been placed on the market, put into service or made available in the Union. The Regulation does not renumber the remaining points. Section B therefore now lists seven points, numbered 1 to 6 and 8: the name, address and contact details of the provider; the same details of another person submitting information on the provider behalf; the same details of the authorised representative where applicable; the trade name and any additional unambiguous reference allowing identification and traceability of the system; a description of the intended purpose; the condition or conditions under Article 6(3) on the basis of which the system is considered not to be high-risk; and the status of the system. Recital 22 of 2026/1744 explains that registration is thereby made simpler and more proportionate, while expressly maintaining that a provider applying Article 6(3) remains obliged to document its assessment before the system is placed on the market or put into service, and that national competent authorities may request that assessment.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex VIII, Section B","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (42), deleting Annex VIII, Section B, points 7 and 9","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Recital 22 of Regulation (EU) 2026/1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 49(4) lists exhaustively what goes into the secure non-public section, and that is less than the full Sections: Section A, points 1 to 10 with the exception of points 6, 8 and 9; Section B, points 1 to 5 and points 8 and 9; Section C, points 1, 2 and 3; and points 1, 2, 3 and 5 of Annex IX. The final subparagraph provides that only the Commission and the national authorities referred to in Article 74(8) have access to the respective restricted sections of the database. Annex IX carries the information provided upon registration of testing in real world conditions and kept up to date thereafter, and lists five points: a Union wide unique single identification number of the testing, the name and contact details of the provider or prospective provider and of the deployers involved, a short description of the AI system and its intended purpose together with the information needed to identify it, a summary of the main characteristics of the testing plan, and information on the suspension or termination of the testing.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 49(4) and Annex IX","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 60(4), point (c), provides that the provider or prospective provider has registered the testing in real world conditions in accordance with Article 71(4), with a Union wide unique single identification number and the information specified in Annex IX. For the systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management that registration takes place in the secure non-public section in accordance with Article 49(4), point (d), and for the systems referred to in point 2 of Annex III in accordance with Article 49(5). Article 60 sits in Chapter VI of the Regulation, on measures in support of innovation. That point (c) was not amended by Regulation (EU) 2026/1744.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 60(4), point (c), Article 49(4) and (5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"The scope of Article 60 itself was amended. Article 1, point (24), of Regulation (EU) 2026/1744 replaces the first subparagraph of Article 60(1) and Article 60(2): testing in real world conditions outside AI regulatory sandboxes is now also open to providers and prospective providers of high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, alongside the systems listed in Annex III. Article 1, point (25), inserts an Article 60a for high-risk AI systems covered by the harmonisation legislation listed in Section B of Annex I: Member States may adopt frameworks for real-world testing for those systems, must notify the Commission of any such framework before implementing it, and those frameworks must among other things ensure compliance with Article 60(2), (3), (4)(d)-(j) and (5)-(9). The registration duty in Article 60(4), point (c), which refers to Article 71(4), falls outside that enumeration.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, points (24) and (25), replacing Article 60(1), first subparagraph, and Article 60(2) and inserting Article 60a","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 1, point (40), of Regulation (EU) 2026/1744 amends the THIRD paragraph of Article 113, which is where points (a) to (d) sit. Point (40)(b) replaces point (c) with: Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), applies from 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III, and from 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. Two things belong with that and are often left out: the exception for Article 6(5) falls outside this deferral, and point (40)(c) adds a point (d) under which Articles 102 to 110 apply from 27 July 2026.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (40)(b) and (c), replacing Article 113, third paragraph, point (c) and adding point (d)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Recital 131 explains why the database exists and how far the public availability reaches. It names as the aim facilitating the work of the Commission and the Member States and increasing transparency towards the public, states that this part of the database should be publicly accessible and free of charge and that the information should be easily searchable, understandable and machine-readable, and that the database should be user-friendly, for example by offering search functionalities including through keywords, so that the general public can find the registration information. It adds that any substantial modification of high-risk AI systems should also be registered in the database, that access to the secure non-public section should be strictly limited to the Commission and, as regards their national section, to market surveillance authorities, and that the database should comply with the requirements of Directive (EU) 2019/882.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Recital 131","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This is one of the few obligations in the Regulation whose output is a public page about your organisation. Article 53(1), point (d), is the other one: the provider of a general-purpose AI model makes public a summary of the training content used. The difference is that the database is your own entry rather than a document on your own site. The rest of your file opens only when a supervisory authority asks; this opens to anyone who can search. On machine readability a caveat applies: the Dutch text of paragraph 4 says the information must be machine-readable, the English says should, and Recital 131 likewise speaks in recommending terms. So count on your text being read, but do not build an assumption of automated readability as a hard requirement. That changes who reads your text. The basic and concise description of the operating logic in Section A is read by competitors, journalists and municipal councils, and the summary of your fundamental rights impact assessment in Section C is read by exactly the people that assessment was about, with one important exception: for points 1, 6 and 7 of Annex III the secure section carries Section C only up to and including point 3, so that very summary is not entered there. Two things follow. First, the entry requires editing rather than form filling: whoever writes the summary as a formality publishes a formality. Second, keeping it current is not a side issue, because Annex VIII requires the information to be kept up to date thereafter and Recital 131 also names substantial modifications, and an entry that still shows a recalled system as in service is visibly wrong.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex VIII, Sections A and C","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 49(4) and Annex IX","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Recital 131","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Treat the entry as a publication and not as a form. Designate per system the natural person who has the legal authority to register, because paragraph 5 provides that their name and contact details go into the database. Write the description of the intended purpose, of the operating logic and, for a public deployer, the summary of the fundamental rights impact assessment so that you can let them be read without explanation. Settle the sequence in your procurement contract: point 3 of Section C asks for the URL of the entry of the system in the database by its provider, so a municipality can only complete its Section C after its supplier has entered Section A. Record within what period the supplier delivers that URL and what happens if it does not. Also record when the entry was last checked against reality and tie that to your change and decommissioning process, so that status, Member States and declaration of conformity move with it. On procurement, check that the system is listed in the database before you put it into use: if it is not listed, a deployer may not use it under Article 26(8) and has to inform the provider or the distributor.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Annex VIII, Sections A and C","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 26(1)-(12)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-71-eu-database","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 71 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-72-post-market-monitoring","legacy_id":"raip:obligation:article-72-post-market-monitoring","type":"obligation","slug":"article-72-post-market-monitoring","version":"2.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"6fe04840ffe25ded5e84488a9486d4fa3f46720b9c66ce47d2244110d9e33098","label":"Article 72: post-market monitoring","summary":"Systematic monitoring of high-risk AI in real use, after market placement.","topics":["post-market"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-72-post-market-monitoring-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-72-post-market-monitoring-record"],"control_ids":["praxikon:eu:ai-act:control:article-72-post-market-monitoring-control"],"template_ids":["praxikon:eu:ai-act:template:article-72-post-market-monitoring-legal-text"],"conditions":[{"id":"article-72-post-market-monitoring-scope","operator":"all","description":"The provider has a high-risk system on the market; deployers supply the real-world data via monitoring and signals."}],"exceptions":[{"id":"article-72-post-market-monitoring-exception","operator":"not","description":"The plan may be proportionate to the nature of the system and align with existing sectoral monitoring regimes."}],"statements":[{"kind":"official_fact","text":"Article 72 obliges providers to operate a post-market monitoring system with a plan forming part of the technical documentation, collecting relevant real-world data to evaluate continued compliance with Section 2.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 72(1)-(4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"This provision is named in none of the three points of Article 113, third paragraph, and therefore falls under the general application date in the second paragraph: 2 August 2026. The move to 2 December 2027 and 2 August 2028 in point (c) concerns only Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5). When a high-risk AI system that this provision addresses can practically exist is a second question: through Article 6(2) and Annex III that is 2 December 2027, and through Article 6(1) and Annex I 2 August 2028. That practical date sits in high_risk_regime_from and not in deadline_at. This is how decision D1 of 6 September 2026 is recorded; see data/ai-act/review/decision-d1-application-dates.json.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Compliance does not stop at go-live: this article turns compliance into a continuous state. For deployers it is also the basis to force suppliers to act on deviations.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 72(1)-(4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Design the monitoring together with the Article 12 logging: the same data flows feed both duties.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 72(1)-(4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":"text_date","high_risk_regime_from":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-72-post-market-monitoring","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 72 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-73-incident-reporting","legacy_id":"raip:obligation:article-73-incident-reporting","type":"obligation","slug":"article-73-incident-reporting","version":"2.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"5133c7de1c1f4ab76d5901cc7ac501afaca878740d840f576cbd3a528e3bd2df","label":"Article 73: serious incident reporting","summary":"The duty to report serious incidents with high-risk AI, under strict deadlines.","topics":["post-market"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:market-surveillance-authority"],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-73-incident-reporting-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-73-incident-reporting-record"],"control_ids":["praxikon:eu:ai-act:control:article-73-incident-reporting-control"],"template_ids":["praxikon:eu:ai-act:template:article-73-incident-reporting-legal-text"],"conditions":[{"id":"article-73-incident-reporting-scope","operator":"all","description":"A serious incident occurs with a high-risk system: death or serious harm to health, serious and irreversible disruption of critical infrastructure, infringement of fundamental-rights protections or serious damage to property or environment."}],"exceptions":[{"id":"article-73-incident-reporting-exception","operator":"not","description":"For systems under sectoral reporting regimes with equivalent duties, reporting may run through that regime to avoid duplication."}],"statements":[{"kind":"official_fact","text":"Article 73 obliges providers to report serious incidents to the market surveillance authority: immediately after establishing the causal link and at the latest within 15 days, shortened to 10 days in the event of death and to 2 days for widespread infringement or serious disruption of critical infrastructure. Deployers inform the provider without delay.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 73(1)-(11)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"This provision is named in none of the three points of Article 113, third paragraph, and therefore falls under the general application date in the second paragraph: 2 August 2026. The move to 2 December 2027 and 2 August 2028 in point (c) concerns only Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5). When a high-risk AI system that this provision addresses can practically exist is a second question: through Article 6(2) and Annex III that is 2 December 2027, and through Article 6(1) and Annex I 2 August 2028. That practical date sits in high_risk_regime_from and not in deadline_at. This is how decision D1 of 6 September 2026 is recorded; see data/ai-act/review/decision-d1-application-dates.json.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The deadlines are too short to design the process during the incident: those who decide who reports at the first incident will not make 15 days, let alone 2. This is the GDPR breach playbook, but for AI.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 73(1)-(11)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Connect the AI incident process to the existing breach and security process and add the AI-specific definitions and deadlines.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 73(1)-(11)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":"text_date","high_risk_regime_from":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-73-incident-reporting","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 73 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-78-confidentiality","legacy_id":"raip:obligation:article-78-confidentiality","type":"obligation","slug":"article-78-confidentiality","version":"1.0.0","effective_at":"2025-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"fe3d73fa9cc874bc4fc12b0f664ff4e60e68de553dfc7bf0c64c38bc1350c8e3","label":"Article 78: confidentiality of what you submit to an authority","summary":"The Commission, the market surveillance authorities, the notified bodies and everyone involved in the application of the Regulation respect the confidentiality of what they obtain in carrying out their tasks, and in doing so expressly protect the intellectual property rights, the confidential business information and the trade secrets of a natural or legal person, including source code. They may request only data that is strictly necessary, must secure it, and must delete it as soon as it is no longer needed. For you this is therefore not a duty but a protection, with a limit: the exception in Article 5 of Directive (EU) 2016/943 remains, and the provision leaves the exchange of information and the dissemination of warnings between authorities untouched.","topics":["enforcement","governance"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:provider"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:market-surveillance-authority"],"evidence_owner_ids":[],"duty_holder_uncertainty_status":"out_of_scope","interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:mark-confidential-material-on-submission"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-78-submission-register"],"control_ids":["praxikon:eu:ai-act:control:article-78-disclosure-review"],"template_ids":["praxikon:eu:ai-act:template:article-78-legal-text"],"conditions":[{"id":"article-78-scope","operator":"all","description":"Applies to all information and data obtained by the Commission, the market surveillance authorities, the notified bodies and any other natural or legal person involved in the application of this Regulation in carrying out their tasks and activities. The protection operates in accordance with Union or national law and not on its own."},{"id":"article-78-strict-necessity","operator":"all","description":"Paragraph 2 limits what an authority may request: only data that is strictly necessary for the assessment of the risk posed by AI systems and for the exercise of its powers in accordance with this Regulation and with Regulation (EU) 2019/1020. Two follow-on duties attach to that: adequate and effective cybersecurity measures, and deletion as soon as the data is no longer needed for the purpose for which it was obtained."}],"exceptions":[{"id":"article-78-trade-secrets-directive-carve-out","operator":"not","description":"The protection of intellectual property, confidential business information and trade secrets, including source code, applies except in the cases referred to in Article 5 of Directive (EU) 2016/943. Point (a) of paragraph 1 says so in as many words."},{"id":"article-78-information-exchange-unaffected","operator":"not","description":"Paragraph 4 provides that paragraphs 1, 2 and 3 do not affect the rights or obligations of the Commission, the Member States and their relevant authorities, or those of notified bodies, with regard to the exchange of information and the dissemination of warnings, including in the context of cross-border cooperation, nor the obligations of the parties concerned to provide information under criminal law of the Member States. Confidentiality under this article is therefore not a duty of silence between authorities."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides that the Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular: (a) the intellectual property rights and confidential business information or trade secrets of a natural or legal person, including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943; (b) the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits; (c) public and national security interests; (d) the conduct of criminal or administrative proceedings; (e) information classified pursuant to Union or national law. Paragraph 2 provides that the authorities involved in the application of this Regulation pursuant to paragraph 1 shall request only data that is strictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with this Regulation and with Regulation (EU) 2019/1020, that they shall put in place adequate and effective cybersecurity measures to protect the security and confidentiality of the information and data obtained, and that they shall delete the data collected as soon as it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 78(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 3 provides that, without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis between the national competent authorities or between national competent authorities and the Commission shall not be disclosed without prior consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in point 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities and when such disclosure would jeopardise public and national security interests. This exchange of information shall not cover sensitive operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities. The second subparagraph of paragraph 3 provides that when the law enforcement, immigration or asylum authorities are providers of high-risk AI systems referred to in point 1, 6 or 7 of Annex III, the technical documentation referred to in Annex IV shall remain within the premises of those authorities, that those authorities shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as applicable, can, upon request, immediately access the documentation or obtain a copy thereof, and that only staff of the market surveillance authority holding the appropriate level of security clearance shall be allowed to access that documentation or any copy thereof.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 78(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 4 provides that paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission, Member States and their relevant authorities, as well as those of notified bodies, with regard to the exchange of information and the dissemination of warnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned to provide information under criminal law of the Member States. Paragraph 5 provides that the Commission and Member States may exchange, where necessary and in accordance with relevant provisions of international and trade agreements, confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 78(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Read this article as the answer to the question your supplier asks and that you ask yourself as soon as you have to hand something over. The protection is real and it names source code expressly, which is unusually explicit in Union law. But it is a duty of the recipient and not a right of refusal for the party submitting. Article 21(1) requires the provider, upon a reasoned request, to give all the information and documentation necessary to demonstrate conformity; Article 78 does not say you may withhold anything, it says what the recipient must do afterwards. Anyone who inverts that and refuses on grounds of confidentiality is legally empty-handed. Two limits on top, because they get missed in practice. The first is Article 5 of Directive (EU) 2016/943: that exception sits verbatim in point (a) and it covers, among other things, exercising the right to freedom of expression and information and revealing misconduct in the general public interest. The second is paragraph 4: between authorities, and when disseminating warnings, confidentiality does not operate as a lock. Your file can therefore reach another Member State without that being a breach. What does work in your favour is paragraph 2. That is a strict necessity test on the request itself, with a retention limit attached: deletion as soon as the data is no longer needed for the purpose for which it was obtained. That is a question you can put to an authority and whose answer you can record.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 78(1)-(5)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"There is an asymmetry in this article that is rarely noticed. Paragraph 3 gives one set of parties a heavy extra protection: where a high-risk system from point 1, 6 or 7 of Annex III is used by a law enforcement, border control, immigration or asylum authority, information exchanged on a confidential basis may not be disclosed without prior consultation of the originating authority and the deployer, and the technical documentation stays physically within the premises of that authority where it is itself the provider. For a commercial provider in exactly the same Annex III areas that arrangement does not apply. The practical conclusion is not that one is better protected than the other, but that you need to know which side you are on: if you supply such an authority, your documentation travels a different path from your own archive, and you settle that path in the contract rather than after the fact. Note also what this article does not govern. It says nothing about the public availability of the EU database in Article 71, whose public part is meant to be found, and nothing about what a deployer must explain to an affected person under Article 86. Confidentiality towards a regulator and transparency towards a citizen are two separate tracks in this Regulation, and it is a mistake to try to close one with the other.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 21(1); Article 74(8) and (9); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Mark on every submission which part you regard as confidential business information, trade secret or source code, and why, and keep a register of what you handed to whom on what date. That register is your only starting point if you later want to know whether something left the circle. When asked for additional data, ask about the necessity within the meaning of paragraph 2 and about the purpose for which the data is obtained, and record the answer; that is not a refusal and it is the only way to be able to invoke the retention limit of paragraph 2 later. Put in supplier contracts who receives a request from an authority, who decides what is handed over, and that the other party is informed within an agreed period. If you supply a law enforcement, border control, immigration or asylum authority, record where the technical documentation stays physically and who has access to it. Finally, do not assume that confidentiality releases you from Article 21: the duty to deliver on request stands apart from the recipient’s duty to handle what is delivered with care.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 21(1); Article 74(8) and (9); Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-78-confidentiality","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 78 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/78","label":"Read Article 78 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-8-compliance-with-requirements","legacy_id":"raip:obligation:article-8-compliance-with-requirements","type":"obligation","slug":"article-8-compliance-with-requirements","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"4f3c944bd22b7f1e7152db7acbc5b5ff00963c180aee232371af34402e112e6f","label":"Article 8: compliance with the requirements for high-risk AI systems","summary":"High-risk AI systems comply with the requirements of Chapter III, Section 2, and that is assessed taking into account the intended purpose and the generally acknowledged state of the art on AI and AI-related technologies, with the risk management system of Article 9 as the instrument. Where the system sits in a product also covered by the Union harmonisation legislation of Section A of Annex I, the provider is responsible for full compliance with all applicable requirements of that legislation, and may integrate the testing and reporting processes and the information and documentation on the product into the documentation and procedures that already exist there.","topics":["conformity","high-risk-requirements"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"What the provision asks of a provider is settled; when it asks it has been derived here. Article 8 sits in Chapter III, Section 2, and names no date of its own. The timeline canon dates the high-risk requirements per route and not per chapter: 2 December 2027 for the systems that are high-risk through Annex III, and 2 August 2028 for those that are high-risk through Annex I. Those two dates do not fit in a field that carries one. `deadline_at` therefore carries 2 December 2027, the earlier of the two and the same date already carried by the objects for Articles 9 to 15. A defensible alternative reading is that a chapeau provision should carry no date of its own and that the dating belongs with the seven requirements it sits above; on that reading this field reads as the earliest of the two routes and not as the date of Article 8. On either reading: for a system inside a regulated product under Annex I, 2 December 2027 is too early and 2 August 2028 is the date that counts. What also remains open is the content of the second measure in paragraph 1. The generally acknowledged state of the art is not a term the Regulation defines and not a synonym for a harmonised standard; anyone who equates it with the standard of Article 40 closes an open measure. On Regulation (EU) 2026/1744. That text was retrieved after all on 6 September 2026 from the Publications Office Cellar service and is archived in data/ai-act/review/sources/reg-eu-2026-1744-nl.txt and -en.txt. The amending regulation carries forty-three amendment points in its Article 1; which of those are reflected in the local legal texts is recorded per point in data/ai-act/review/consolidation-manifest.json. Where a point touches this Article, that is stated below with the statement concerned.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-8-state-of-the-art-baseline"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-8-state-of-the-art-justification"],"control_ids":["praxikon:eu:ai-act:control:article-8-integrated-documentation-review"],"template_ids":["praxikon:eu:ai-act:template:article-8-legal-text"],"conditions":[{"id":"article-8-scope","operator":"all","description":"Applies to every AI system that qualifies as high-risk under Article 6, along both routes: the system that falls under the Union harmonisation legislation of Annex I as a safety component of a product or as a product in its own right, and the system that falls within one of the areas of Annex III. For the Annex I route there is a limit that this Article does not state itself: Article 2(2), as replaced by Article 1, point (2)(a), of Regulation (EU) 2026/1744, makes only Article 6(1), Article 60a and Articles 102 to 112 applicable to systems related to products covered by Section B of Annex I. Article 8 is not in that list, so for Section B products, machinery among them since 27 July 2026, this provision does not bear. In addition, Article 2(13), inserted by Article 1, point (3), can limit the application of the requirements in Articles 9 to 15 and 17 to 25 for Section A products, but only once the delegated act it prescribes exists. Article 8 sets no additional threshold of its own: what is high-risk is the subject of Article 6 and not of this provision."},{"id":"article-8-two-measures","operator":"all","description":"Compliance is not assessed in the abstract but against two measures at once: the intended purpose of the system, and the generally acknowledged state of the art on AI and AI-related technologies. The second measure lies outside the Regulation and has no fixed content, so what suffices changes without the text changing."},{"id":"article-8-annex-i-product","operator":"any","description":"Paragraph 2 only comes into play where a product contains an AI system to which both the requirements of this Regulation and those of the Union harmonisation legislation listed in Section A of Annex I apply. For a system that is high-risk through Annex III alone, paragraph 2 has no bearing."}],"exceptions":[{"id":"article-8-integration-is-a-choice","operator":"not","description":"The integration in paragraph 2 is a choice and not a duty: providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist. Anyone who does not integrate breaches nothing. What the provision does not permit is doing less: the responsibility for full compliance with all applicable requirements under the sectoral harmonisation legislation stands undiminished."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides that high-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements. Paragraph 2 provides that, where a product contains an AI system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their product is fully compliant with all applicable requirements under applicable Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order to ensure consistency, avoid duplication and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 8(1)-(2)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Read Article 8 not as an eighth requirement alongside the seven of Articles 9 to 15, but as the provision that says how those seven are to be read. It does two things none of the seven does itself. The first is that it brings in a measure from outside the Regulation. Article 8 is the only article in Section 2 that names the generally acknowledged state of the art, and that means the bar moves. A file that sufficed at the first conformity assessment does not necessarily still suffice some years later, without a single word of the Regulation changing: what was the state of the art then is no longer the state of the art later. The Regulation provides no re-certification rhythm for this beyond the substantial modification of Article 43(4), so anyone who does not set a rhythm of their own has none. Note also what the measure is not. The state of the art is not a synonym for a harmonised standard: Article 40 gives a presumption of conformity to whoever applies such a standard, but Article 8 sets an open measure alongside it that does not stop applying once the standard has been ticked off. The second is that paragraph 1 designates the risk management system of Article 9 as the instrument through which compliance with the other requirements is assessed. Article 9 is therefore not one requirement beside the other six but the file in which you show that you have met the other six at the right level. An organisation that keeps its risk analysis as a separate document beside the technical documentation misses exactly that connection.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(1); Article 9(1) and (2); Article 16, point (a); Article 40(1); Article 43(3) and (4); Annex I, Section A","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Paragraph 2 is the anti-duplication provision, and in practice it is rarely used. It concerns the product that contains an AI system and falls both under this Regulation and under the Union harmonisation legislation of Section A of Annex I: that is precisely the route of Article 6(1). Two different things are stated. The first is an allocation: the provider is responsible for his product being fully compliant with everything the sectoral legislation requires. It does not say that the AI Act replaces or lightens the sectoral requirements, nor that the sectoral assessment swallows the requirements of Section 2; it says that both stacks apply at once and that the provider of the product covers both. The second is a choice, not a duty: he may integrate the testing and reporting processes, the information and the documentation on the product into the documentation and procedures the sectoral legislation already prescribes. We see two mistakes there. The first is that the AI Act file is built beside the existing technical file, with two versions of the same risk analysis that drift apart after two releases; that is exactly the duplication paragraph 2 seeks to avoid. The second is that the integration happens but cannot be found. Whoever enters the sectoral conformity assessment of Article 43(3) must be able to point, per requirement of Articles 9 to 15, to where in the existing file the answer sits. Integrating is therefore not merging into invisibility; it is a cross-reference per requirement, and that is the form in which the choice of paragraph 2 actually saves work.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(1); Article 9(1) and (2); Article 16, point (a); Article 40(1); Article 43(3) and (4); Annex I, Section A","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Record once, per high-risk system, what you regard as the generally acknowledged state of the art, with the sources: which harmonised standards or common specifications you apply, which of them you do not apply and why, and which evaluation method, benchmark or test set you use for this application area. Attach a fixed re-assessment moment to it, for instance annually and at every release, and hang that record on the risk management file of Article 9 rather than on a separate document; paragraph 1 designates that file as the instrument through which compliance is assessed. Note against which intended purpose each requirement of Articles 9 to 15 has been met, so that a change of intended purpose visibly touches the whole series. If your system sits in a product also covered by Section A of Annex I, make the choice of paragraph 2 explicit before you start and record who made it: one combined file or two files. If you combine, build a cross-reference table that points, per requirement of Section 2, to where in the existing technical file the answer sits, and let that table travel through the sectoral assessment. If you keep two files, record who keeps them in step and on which change both are updated.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(1); Article 9(1) and (2); Article 16, point (a); Article 40(1); Article 43(3) and (4); Annex I, Section A","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-8-compliance-with-requirements","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 8 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/8","label":"Read Article 8 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-85-right-to-complain","legacy_id":"raip:obligation:article-85-right-to-complain","type":"obligation","slug":"article-85-right-to-complain","version":"2.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"c6e765304e4a6ec68888e1611d72b0dae35de32e420bd1f947eff02c902433f5","label":"Article 85: right to lodge a complaint with the market surveillance authority","summary":"Anyone with grounds to consider that the Regulation has been infringed may lodge a complaint with the relevant market surveillance authority. For an organisation that means your own staff, customers and candidates have a route to the regulator that does not run through you.","topics":["fundamental-rights"],"actor_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_ids":["praxikon:eu:ai-act:actor:deployer"],"affected_actor_ids":[],"oversight_actor_ids":["praxikon:eu:ai-act:actor:market-surveillance-authority"],"evidence_owner_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"The right itself is settled; what it asks of you is not. Article 85 addresses the market surveillance authority and imposes no literal duty on the organisation complained about: there is no deadline, no duty to inform and no requirement to set up an internal complaints channel. We nonetheless read a practical consequence into it, namely that you must be able to rebut a complaint with recorded evidence at the moment the authority asks, and that is not the same as a duty following from the text. A defensible alternative reading is that this article is purely procedural for you and that your preparation is governed entirely by Article 26 and Article 72. It is also unclear how this right to complain relates to the right to complain under the GDPR where the same conduct engages both.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:prepare-for-a-complaint"],"evidence_ids":["praxikon:eu:ai-act:evidence:explanation-request-record"],"control_ids":["praxikon:eu:ai-act:control:explanation-request-routing"],"template_ids":["praxikon:eu:ai-act:template:article-85-legal-text"],"conditions":[{"id":"article-85-scope","operator":"all","description":"Applies as soon as anyone has grounds to consider that the Regulation has been infringed. There is no standing threshold: the right belongs to any person, and the complaint goes to the market surveillance authority of the Member State concerned."}],"exceptions":[],"statements":[{"kind":"official_fact","text":"Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market surveillance authority. In accordance with Regulation (EU) 2019/1020, such complaints shall be taken into account for the purpose of conducting market surveillance activities, and shall be handled in line with the dedicated procedures established therefor by the market surveillance authorities.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 85","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The practical meaning of this article lies not in what it instructs you to do but in whom it gives a route. An employee who thinks the scheduling or appraisal system is wrong, a rejected candidate, a customer who feels mishandled: they do not have to convince you first and do not have to show standing. The complaint arrives at the authority, and the first question you then face is about record keeping: which system, which version, which assessment was carried out and when. That is the same record keeping Articles 26 and 72 already require of you, and that is exactly the point. Whoever has that file answers a complaint with documents; whoever does not answers it with a reconstruction after the fact, and a regulator reads that differently. Note too that this right does not depend on harm or on a decision, whereas the right to an explanation in Article 86 does.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 85","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Assume a complaint starts at the authority and not with you. Make sure that per AI system you can show which assessment was carried out, by whom, on what date and against which system version, and keep that as a living file rather than a one-off document. Also agree internally who receives a question from an authority and within what period.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 85","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":"text_date","high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-85-right-to-complain","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 85 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-86-right-to-explanation","legacy_id":"raip:obligation:article-86-right-to-explanation","type":"obligation","slug":"article-86-right-to-explanation","version":"2.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"62515aef8dd5cfe3e72e71bd0d1f12da34f9cbe0d884940264d26bce0c911b49","label":"Article 86: right to an explanation of a decision","summary":"A person affected by a decision that a deployer takes on the basis of the output of a high-risk AI system listed in Annex III may request an explanation of the role of that system in the decision-making procedure and of the main elements of the decision taken.","topics":["fundamental-rights"],"actor_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_ids":["praxikon:eu:ai-act:actor:deployer"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:deployer"],"duty_holder_uncertainty_status":null,"interpretation_status":"preliminary","interpretation_note":"One thing is unsettled here: how deep the explanation has to go. The Regulation asks for clear and meaningful explanations of the role of the system and the main elements of the decision taken, but there is no case law and no guidance saying whether a description of the factors used is enough or whether it concerns the weighting in the individual case. We read it as the latter, because the text speaks of the decision taken rather than of the system in general. The date question is no longer open: decision D1 of 6 September 2026 chooses the text reading, so Article 86 applies from 2 August 2026 to systems already in use at that point. The practical reading, that the right only acquires an object once the Annex III regime operates on 2 December 2027, is not written away but sits as an annotation in high_risk_regime_from.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:handle-explanation-requests"],"evidence_ids":["praxikon:eu:ai-act:evidence:explanation-request-record"],"control_ids":["praxikon:eu:ai-act:control:explanation-request-routing"],"template_ids":["praxikon:eu:ai-act:template:article-86-legal-text"],"conditions":[{"id":"article-86-scope","operator":"all","description":"Applies where a deployer takes a decision about a natural person on the basis of the output of a high-risk AI system listed in Annex III, with the exception of point 2 of that Annex, and that decision produces legal effects or similarly significantly affects that person in a way they consider to have an adverse impact on their health, safety or fundamental rights."}],"exceptions":[{"id":"article-86-exception-union-or-national-law","operator":"not","description":"Paragraph 2 excludes the right for AI systems where exceptions from, or restrictions to, that obligation follow from Union or national law in compliance with Union law. Paragraph 3 further limits the right to cases where it is not otherwise provided for under Union law, which makes the boundary with Article 22 GDPR a case-by-case question."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 gives any affected person subject to a decision taken by the deployer on the basis of the output of a high-risk AI system listed in Annex III, with the exception of point 2 of that Annex, and which produces legal effects or similarly significantly affects that person in a way that they consider to have an adverse impact on their health, safety or fundamental rights, the right to obtain from the deployer clear and meaningful explanations of the role of the AI system in the decision-making procedure and of the main elements of the decision taken. Paragraph 2 provides that paragraph 1 does not apply to the use of AI systems for which exceptions from, or restrictions to, that obligation follow from Union or national law in compliance with Union law. Paragraph 3 provides that this Article applies only to the extent that the right referred to in paragraph 1 is not otherwise provided for under Union law.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 86(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This right reaches you through a different channel than the rest of the Regulation. A regulator writes to you; a candidate or a citizen calls or emails, usually at your existing complaints or objections desk. That desk does not know today that an AI system was in the process, let alone what role it played, and that is where it goes wrong. Two things therefore matter more than the legal depth of the explanation itself: that your front line recognises such a request, and that it can be traced per decision which system in which version contributed to it. Without the second you can explain how your system works in general but not what happened in this case, and the latter is what is being asked. Note also the relationship with Article 22 GDPR: where that article already grants a right, Article 86 steps back, but the scope differs enough that you cannot settle the question in the abstract.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 86(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Record, per Annex III system that contributes to decisions about people, which decision was supported by which system version, and make sure your complaints or objections desk recognises a request for an explanation and routes it to someone who can answer it. Also determine per process whether Article 22 GDPR already grants a right, because Article 86 then steps back.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 86(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":"text_date","high_risk_regime_from":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-86-right-to-explanation","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 86 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-87-reporting-infringements","legacy_id":"raip:obligation:article-87-reporting-infringements","type":"obligation","slug":"article-87-reporting-infringements","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"57d296c3c6d5ddab8a529f000c40a1881459a3576d6c39ee4b5c031b9296adf6","label":"Article 87: reporting of infringements and protection of reporting persons","summary":"The whistleblower Directive applies to the reporting of infringements of the AI Regulation and to the protection of the persons who report them. For an organisation that falls under that Directive this means a report about an AI system runs through the same protected channel as any other report, and a person reporting who meets the conditions of that Directive may not be disadvantaged for it. Whether you fall under that Directive is not stated in Article 87 but in national transposition law.","topics":["fundamental-rights","governance"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":"requires_legal_judgment","interpretation_status":"preliminary","interpretation_note":"The reference is settled; what it asks of you is not. Article 87 consists of one sentence and makes Directive (EU) 2019/1937 applicable to reporting and to the protection of reporting persons. It imposes no channel requirement of its own, sets no deadline and names no threshold: those sit in Articles 8, 9 and 21 of that Directive and in national transposition law, a layer this dataset does not carry as a source. That is why no duty holder is assigned here and the status is requires_legal_judgment. The sharpest open point is the fit with national law: the material scope of the Directive is tied through Article 2(1)(a) to the Union acts in its Annex, and Regulation (EU) 2024/1689 is not in that Annex. One reading is that Article 87 operates directly and that national law tying its scope to that Annex simply lags behind; the other is that the protection only becomes practically available through the national channel, so that the extension requires national transposition. We have not settled that. What we do read into it is a practical consequence: an organisation that must already have a reporting channel must be able to receive a report about an AI system through it. Settled and not unclear is that the personal scope of the Directive is work-related; Article 4 is explicit about that. What is open is only what remains outside that context, and whether that amounts to the complaint route of Article 85 without the protection of Article 87.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:open-a-protected-reporting-route"],"evidence_ids":["praxikon:eu:ai-act:evidence:infringement-report-record"],"control_ids":["praxikon:eu:ai-act:control:reporting-person-protection"],"template_ids":["praxikon:eu:ai-act:template:article-87-legal-text"],"conditions":[{"id":"article-87-scope","operator":"all","description":"The trigger is a report of an infringement of this Regulation, whatever the risk class of the system: a report about an AI system outside the high-risk category is covered just as much. The protection itself is not unconditional. It comes from Directive (EU) 2019/1937, which in Article 4 requires the person reporting to have obtained the information in a work-related context, and in Article 6(1)(a) requires reasonable grounds to believe that what was reported was true and fell within the scope of that Directive."}],"exceptions":[{"id":"article-87-no-internal-channel-below-threshold","operator":"any","description":"Article 87 creates no channel requirement. That requirement comes from Article 8 of Directive (EU) 2019/1937. Paragraph 1 places it on legal entities in the private and the public sector; paragraph 3 limits paragraph 1 in the private sector to entities with 50 or more workers. That threshold is not general, however. Paragraph 4 provides that the threshold in paragraph 3 shall not apply to entities falling within the scope of the Union acts referred to in Parts I.B and II of the Annex to that Directive, which cover financial services, anti-money laundering and transport safety among others. Paragraph 7 allows a Member State, following a risk assessment, to require entities with fewer than 50 workers as well. Paragraph 9 applies paragraph 1 to all legal entities in the public sector, with the option for a Member State to exempt municipalities under 10 000 inhabitants and other small public entities. Below fifty workers there is therefore not simply no channel requirement: it depends on the sector you fall in and on what your Member State has decided. The right to report and the protection of the person reporting exist in any event, through the external route of Article 10 of that Directive."},{"id":"article-87-national-scope-not-settled","operator":"any","description":"The material scope of Directive (EU) 2019/1937 runs through Article 2(1)(a), which refers to the Union acts listed in the Annex to that Directive. Regulation (EU) 2024/1689 was not added to that Annex: it makes the Directive applicable directly, in Article 87. National transposition law that ties its own scope to that same Annex, such as the Dutch Wet bescherming klokkenluiders, may therefore lag behind the Regulation. Whether a report about an AI system falls under national law as a result is not settled."}],"statements":[{"kind":"official_fact","text":"Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 87","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This article is short because the work was done elsewhere, and that is exactly why it gets overlooked. Its practical meaning lies in the direction of travel: Articles 85 and 86 concern who knocks on your door from outside, Article 87 concerns who steps out from within. That is almost always the first person to notice something. The developer who knows the logging has not run for months, the recruiter who sees the selection model filtering out candidates on something that should never have been in it: they hold the facts a regulator only obtains after an investigation. Three things follow. If you must already have a reporting channel, that channel must be able to receive such a report and recognise it as touching the AI Regulation, because a report handled as a general complaint disappears into a different process. Whether you must have that channel is not a matter of a single number. Article 8(3) of Directive (EU) 2019/1937 imposes the channel requirement in the private sector at fifty or more workers, but paragraph 4 sets that threshold aside for entities falling within the scope of the Union acts referred to in Parts I.B and II of the Annex to that Directive, which cover financial services, anti-money laundering and transport safety among others. Paragraph 7 allows a Member State, after a risk assessment, to require smaller entities as well, and paragraph 9 imposes the requirement on all legal entities in the public sector, with an optional exemption a Member State may make for municipalities with fewer than ten thousand inhabitants or fewer than fifty workers, and for other public entities with fewer than fifty workers. Below fifty workers the question is therefore which sector you are in and what your Member State has decided, not whether you clear the threshold. If you are genuinely outside each of those cases the channel need not exist, and even then the person reporting has somewhere to go: Article 10 of that Directive gives them an external route to the competent authority without having to report internally first, and Article 15 permits public disclosure under conditions. And the protection is not a formality, but it is not enforced through this Regulation: Article 19 of the Directive prohibits retaliation and Article 21 sets out the protective measures, and enforcement runs through national whistleblower law, in the Netherlands through the Huis voor Klokkenluiders and the civil courts. Article 99 of this Regulation does not list Article 87 among the fineable infringements; there is therefore no AI Act fine for disadvantaging a person who reported. Note too that the report here does not depend on a decision or on harm, whereas the right to an explanation in Article 86 does.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 87","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:dir-eu-2019-1937","source_locator":"Directive (EU) 2019/1937, Article 8(1), (3), (4), (7) and (9)","source_url":"https://eur-lex.europa.eu/eli/dir/2019/1937/oj","eli":"http://data.europa.eu/eli/dir/2019/1937/oj"},{"source_id":"praxikon:eu:ai-act:source:dir-eu-2019-1937","source_locator":"Directive (EU) 2019/1937, Article 9(1), Article 16 and Article 18","source_url":"https://eur-lex.europa.eu/eli/dir/2019/1937/oj","eli":"http://data.europa.eu/eli/dir/2019/1937/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"First determine whether Directive (EU) 2019/1937 and national transposition law apply to you at all: below fifty workers there is in principle no channel requirement, in which case this object is not a set-up question for you. If you are covered, check whether your existing reporting channel recognises a report about an AI system and whether whoever receives it knows the AI Regulation may be engaged. Record per report what was reported, about which system, what was done with it and when feedback was given, and measure that against the deadlines in Article 9(1) of that Directive: acknowledgement of receipt within seven days under point (b), feedback within three months under point (f). Keep the identity of the person reporting out of what goes to line managers (Article 16), retain no longer than necessary and proportionate (Article 18(1)), and record an oral report only with consent (Article 18(2) to (4)). Also decide whether you will handle anonymous reports: Article 6(2) leaves that choice to the Member State, so check what your national law says. Finally, put to your lawyer the question whether your national whistleblower act already covers AI Act infringements, because such an act usually ties its scope to the Annex to the Directive and Regulation (EU) 2024/1689 is not listed there.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 87","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:dir-eu-2019-1937","source_locator":"Directive (EU) 2019/1937, Article 8(1), (3), (4), (7) and (9)","source_url":"https://eur-lex.europa.eu/eli/dir/2019/1937/oj","eli":"http://data.europa.eu/eli/dir/2019/1937/oj"},{"source_id":"praxikon:eu:ai-act:source:dir-eu-2019-1937","source_locator":"Directive (EU) 2019/1937, Article 9(1), Article 16 and Article 18","source_url":"https://eur-lex.europa.eu/eli/dir/2019/1937/oj","eli":"http://data.europa.eu/eli/dir/2019/1937/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-87-reporting-infringements","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 87 on EUR-Lex"},{"relation":"related","href":"/en/ai-act/artikel/85","label":"Article 85: right to lodge a complaint with the market surveillance authority"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-9-risk-management","legacy_id":"raip:obligation:article-9-risk-management","type":"obligation","slug":"article-9-risk-management","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"dba4fb36d8780aa218d15aae4742d2183cfcf1fd6f85a6d4db5901b93c9e6c53","label":"Article 9: risk management system","summary":"A continuous, documented risk management system across the entire lifecycle of a high-risk AI system.","topics":["high-risk-requirements"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-9-risk-management-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-9-risk-management-record"],"control_ids":["praxikon:eu:ai-act:control:article-9-risk-management-control"],"template_ids":["praxikon:eu:ai-act:template:article-9-risk-management-legal-text"],"conditions":[{"id":"article-9-risk-management-scope","operator":"all","description":"The system is high-risk under Article 6 and the provider places it on the market or puts it into service."}],"exceptions":[{"id":"article-9-risk-management-exception","operator":"not","description":"Risks arising only from misuse beyond any reasonably foreseeable use fall outside the mandatory scope."}],"statements":[{"kind":"official_fact","text":"Article 9 requires a risk management system as a continuous, iterative process across the entire lifecycle, with identification, analysis, evaluation and mitigation of risks to health, safety and fundamental rights, and testing to determine the most appropriate measures.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9(1)-(10)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This is not a one-off risk analysis but a living process: most organisations have an assessment, but no cycle that reruns on every change. The cycle is what a supervisor will request.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9(1)-(10)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Start the risk management file now for systems that will become high-risk towards 2 December 2027: today’s design and procurement choices determine tomorrow’s residual risks.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9(1)-(10)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-9-risk-management","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 9 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-95-voluntary-codes-of-conduct","legacy_id":"raip:obligation:article-95-voluntary-codes-of-conduct","type":"obligation","slug":"article-95-voluntary-codes-of-conduct","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"2b71546d72d3dbc5918daae97128ae05900c52ce93ba71de9866e90de4176e14","label":"Article 95: codes of conduct for voluntary application of specific requirements","summary":"The AI Office and the Member States encourage and facilitate the drawing up of codes of conduct, including related governance mechanisms, intended to foster the voluntary application to AI systems other than high-risk AI systems of some or all of the requirements set out in Chapter III, Section 2, taking into account the available technical solutions and industry best practices. They also facilitate codes on the voluntary application of specific requirements to all AI systems, on the basis of clear objectives and key performance indicators, with elements such as the Union ethical guidelines for trustworthy AI, assessing and minimising the impact on environmental sustainability, promoting AI literacy, facilitating an inclusive and diverse design, and assessing and preventing the negative impact on vulnerable persons. Codes may be drawn up by individual providers or deployers or by organisations representing them, and in encouraging and facilitating them the specific interests and needs of SMEs, including start-ups, and of small mid-cap enterprises are taken into account; that last group was added by Article 1, point (35), of Regulation (EU) 2026/1744. This article imposes no duty on the organisation and replaces no obligation.","topics":["governance","innovation"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:ai-office"],"evidence_owner_ids":[],"duty_holder_uncertainty_status":"out_of_scope","interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-95-scope-a-voluntary-code"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-95-voluntary-commitment-register"],"control_ids":["praxikon:eu:ai-act:control:article-95-voluntary-versus-mandatory-review"],"template_ids":["praxikon:eu:ai-act:template:article-95-legal-text"],"conditions":[{"id":"article-95-scope","operator":"all","description":"Paragraph 1 expressly concerns AI systems other than high-risk AI systems, and the voluntary application to them of some or all of the requirements set out in Chapter III, Section 2. Paragraph 2 is wider and concerns the voluntary application, including by deployers, of specific requirements to all AI systems, on the basis of clear objectives and key performance indicators to measure the achievement of those objectives. Article 95 sits in Chapter X, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026."},{"id":"article-95-who-may-draw-up","operator":"any","description":"Paragraph 3 sets out who may draw up a code of conduct: individual providers or deployers of AI systems, organisations representing them, or both, including with the involvement of any interested stakeholders and their representative organisations, including civil society organisations and academia. A code may cover one or more AI systems, taking into account the similarity of the intended purpose of the relevant systems."}],"exceptions":[{"id":"article-95-no-substitute-for-a-requirement","operator":"not","description":"Article 95 contains no provision that sets aside, suspends or replaces an obligation under this Regulation. The word voluntary refers to the application of requirements that precisely do not apply to the system concerned, and not to the requirements that do apply. A code of conduct on AI literacy leaves Article 4 untouched, and a code of conduct on transparency leaves Article 50 untouched."}],"statements":[{"kind":"official_fact","text":"Paragraph 1 provides: the AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct, including related governance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems, of some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical solutions and industry best practices allowing for the application of such requirements. Paragraph 2 provides: the AI Office and the Member States shall facilitate the drawing up of codes of conduct concerning the voluntary application, including by deployers, of specific requirements to all AI systems, on the basis of clear objectives and key performance indicators to measure the achievement of those objectives, including elements such as, but not limited to: (a) applicable elements provided for in Union ethical guidelines for trustworthy AI; (b) assessing and minimising the impact of AI systems on environmental sustainability, including as regards energy-efficient programming and techniques for the efficient design, training and use of AI; (c) promoting AI literacy, in particular that of persons dealing with the development, operation and use of AI; (d) facilitating an inclusive and diverse design of AI systems, including through the establishment of inclusive and diverse development teams and the promotion of stakeholders participation in that process; (e) assessing and preventing the negative impact of AI systems on vulnerable persons or groups of vulnerable persons, including as regards accessibility for persons with a disability, as well as on gender equality.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 95(1) to (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Paragraph 3 provides: codes of conduct may be drawn up by individual providers or deployers of AI systems or by organisations representing them or by both, including with the involvement of any interested stakeholders and their representative organisations, including civil society organisations and academia. Codes of conduct may cover one or more AI systems taking into account the similarity of the intended purpose of the relevant systems. Paragraph 4, as replaced by Article 1, point (35), of Regulation (EU) 2026/1744, provides: the AI Office and the Member States shall take into account the specific interests and needs of SMEs, including start-ups, and small mid-cap enterprises, when encouraging and facilitating the drawing up of codes of conduct.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 95(1) to (4)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Read this article first for what it is not. It imposes no duty on your organisation: paragraphs 1, 2 and 4 address the AI Office and the Member States, and paragraph 3 only says who may draw a code up. And paragraph 1 is expressly about AI systems other than high-risk AI systems. That is the core of the provision and at the same time the source of the biggest misunderstanding in practice. The common thought is that a code of conduct can replace a mandatory requirement, or that signing one produces a form of compliance a regulator can hold against you or count in your favour. Neither is in the text. The voluntariness in Article 95 concerns requirements that precisely do not apply to your system: Chapter III, Section 2, contains the requirements for high-risk AI systems, and Article 95 invites you to apply some or all of those requirements to a system that is not high-risk. The reverse, a lighter reading of a requirement that does apply, is not on offer in this article. Two limits go with that. Article 4 requires providers and deployers to take measures to ensure a sufficient level of AI literacy. Article 95(2), point (c), names promoting AI literacy as a possible element of a code of conduct. That is not a duplication: the first is the duty, the second is the superstructure. A code of conduct on AI literacy is therefore a fine addition and never a replacement of Article 4. The same holds for transparency: Article 50 imposes a number of transparency duties, and a code that says something about them leaves Article 50 untouched. Anyone suggesting in a tender document or annual report that a code covers one of those duties is making a claim the text does not support.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 4; Article 50; Chapter III, Section 2; Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"editorial_interpretation","text":"Then read the article for what it does offer, because that is underestimated. This is the only place in the Regulation that says what an organisation can do of its own accord, and the enumeration in paragraph 2 is strikingly concrete. It names assessing and minimising the impact of AI systems on environmental sustainability, including as regards energy-efficient programming and techniques for the efficient design, training and use of AI. That topic appears nowhere else in the Regulation as something you can do, and for many organisations it is the topic a board is already asking about. It further names facilitating an inclusive and diverse design, including through inclusive and diverse development teams and the involvement of stakeholders in that process, and assessing and preventing the negative impact on vulnerable persons or groups, including as regards accessibility for persons with a disability and gender equality. Note the form paragraph 2 prescribes alongside, because it separates a serious code from a statement of intent: clear objectives and key performance indicators to measure the achievement of those objectives. A code without measurable indicators does not meet the form the provision itself describes. In practice this is where you can hook your own AI policy onto the Regulation without promising anything you cannot deliver. The most useful use is the inverse application of paragraph 1: for a system that is not high-risk, deliberately adopt part of Chapter III, Section 2, for example the keeping of logs or the documentation of data quality, and say which part you are not adopting and why. That is defensible and it is preparation as well, because a system sometimes changes classification.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 4; Article 50; Chapter III, Section 2; Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"First make the separation visible in your own documentation: set out in two columns what you must do and what you do voluntarily, and make sure no line from the second column is used as cover for a line from the first. Then test every existing ethical code, AI policy document or supplier promise against that separation, because that is usually where the blending sits. If you are considering a code under Article 95, choose deliberately between the two routes: the paragraph 1 route for a system that is not high-risk, where you name which requirements of Chapter III, Section 2, you adopt and which you do not, or the paragraph 2 route for specific requirements across all your AI systems. In both cases give the code the form paragraph 2 describes: clear objectives and key performance indicators with which you measure the achievement, with a named owner and a moment of measurement. Then pick the elements that genuinely mean something to you rather than all five; environmental sustainability, AI literacy, inclusive and diverse design and the impact on vulnerable persons are separate topics with separate data. If you are an SME or a start-up, ask your national competent authority or the AI Office what support for drawing one up is available, because paragraph 4 requires your interests and needs to be taken into account. Finally, put no wording in quotations, tender responses or annual reports from which a reader could infer that participation in a code of conduct covers an obligation under the Regulation.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 4; Article 50; Chapter III, Section 2; Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-95-voluntary-codes-of-conduct","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 95 on EUR-Lex"},{"relation":"public_page","href":"/en/ai-act/artikel/95","label":"Read Article 95 in the AI Act Explorer"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:article-99-101-penalties","legacy_id":"raip:obligation:article-99-101-penalties","type":"obligation","slug":"article-99-101-penalties","version":"1.0.0","effective_at":"2026-08-02T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"eebb183c9d9b58597388256d80ac73dc95eca9b9c98dd975ed907b55791e6905","label":"Article 99, 100 and 101: the penalty structure per obligation","summary":"The Regulation carries no single fine amount. For operators, three ceilings attach to different paragraphs of Article 99; in addition the Commission itself fines providers of general-purpose AI models under Article 101, the AI Office can fine in its own right since the 2026 amendment, and Union institutions and bodies face the separate amounts of Article 100. Which ceiling applies depends on which provision was infringed and on who enforces, and not on how serious the consequences are.","topics":["enforcement","prohibited-practices"],"actor_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:distributor","praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:importer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:distributor","praxikon:eu:ai-act:actor:gpai-model-provider","praxikon:eu:ai-act:actor:importer","praxikon:eu:ai-act:actor:provider"],"oversight_actor_ids":["praxikon:eu:ai-act:actor:ai-office","praxikon:eu:ai-act:actor:market-surveillance-authority"],"evidence_owner_ids":[],"duty_holder_uncertainty_status":"out_of_scope","interpretation_status":"preliminary","interpretation_note":"Three things are unsettled here. First, whether an obligation not named in Article 99(3) to (5) carries a ceiling from the Regulation itself. We read Article 16, point (a), which obliges the provider to ensure that its high-risk systems comply with the requirements of Chapter III, Section 2, as meaning that non-compliance with Articles 9 to 15 by a provider is at the same time non-compliance with Article 16 and therefore sits inside the 3 percent ceiling, and Article 26 the same way for the deployer, including the duties that Article 26(5) draws in through Article 72 and Article 73. A defensible alternative reading is that the enumeration in paragraph 4 is meant strictly and covers only the duties written in Article 16 and Article 26 themselves, leaving the level for Articles 9 to 15 entirely to the national rules that paragraph 1 requires Member States to lay down. Second, what undertaking and total worldwide annual turnover in paragraphs 3 to 5 cover: the Regulation does not define this, and the difference between the turnover of the legal person fined and that of the group it belongs to is an order of magnitude in practice. We hold to the group reading because undertaking is construed that way in Union competition law, but that provenance is exactly the weak point: the Regulation nowhere refers to it, and the reading that the fined legal person is meant is equally defensible as long as there is no case law under this Regulation. Third, how far Article 75c(4) displaces the enumeration in paragraph 4: on its terms that provision governs enforcement by the AI Office over the operators of Article 75(1), and whether anything follows from it for the national route is unsettled. We read it narrowly, that is for the Office alone, and that is a reading and not settled law.","obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:article-99-101-map-penalty-tiers"],"evidence_ids":["praxikon:eu:ai-act:evidence:article-99-101-penalty-exposure-register"],"control_ids":["praxikon:eu:ai-act:control:article-99-101-mitigating-factor-record"],"template_ids":["praxikon:eu:ai-act:template:article-99-101-legal-text"],"conditions":[{"id":"article-99-101-penalties-scope","operator":"all","description":"Relevant as soon as you are an operator within the meaning of the Regulation, that is a provider, product manufacturer, deployer, authorised representative, importer or distributor, and one of the provisions named in Article 99(3), (4) or (5) is engaged. The Article 101 regime is additionally relevant where you are a provider of a general-purpose AI model, because there the Commission fines you itself. If you fall within the competence of the AI Office under Article 75(1), Article 75c is added on top."}],"exceptions":[{"id":"article-99-101-penalties-exception","operator":"not","description":"Paragraph 6 reverses the calculation for SMEs, including start-ups: for them the lower of the percentage and the amount applies, where for other undertakings it is the higher of the two, and it does so for every fine referred to in Article 99. The inserted paragraph 6a does the same for small mid-cap enterprises, but expressly only for paragraphs 4 and 5, so the Article 5 band is not reversed for them. Paragraph 8 leaves it to each Member State to determine to what extent administrative fines may be imposed on public authorities and bodies established in that Member State, so the ceiling for a public organisation does not follow from the Regulation. Paragraph 9 allows the fine to be imposed by the competent national courts or by other bodies rather than by the authority in some Member States."}],"statements":[{"kind":"official_fact","text":"Paragraph 1, as replaced by Regulation (EU) 2026/1744, requires Member States to lay down the rules on penalties and other enforcement measures, which may also include administrative fines, warnings and non-monetary measures, applicable to any infringement of this Regulation by operators, provides that those penalties shall be effective, proportionate and dissuasive, and requires Member States to take into account the interests of SMEs, including start-ups, and SMCs, and their economic viability when imposing penalties. Paragraph 2 requires Member States to notify those rules to the Commission without delay and at the latest by the date of entry into application, and to notify any subsequent amendment without delay. Paragraph 3 sets, for non-compliance with the prohibition of the AI practices referred to in Article 5, administrative fines of up to EUR 35 000 000 or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher. Paragraph 4 sets, for non-compliance with provisions related to operators or notified bodies other than those laid down in Article 5, fines of up to EUR 15 000 000 or, if the offender is an undertaking, up to 3 % of that same turnover, whichever is higher, and enumerates: obligations of providers pursuant to Article 16, of authorised representatives pursuant to Article 22, of importers pursuant to Article 23, of distributors pursuant to Article 24, point (da) inserted by Regulation (EU) 2026/1744, obligations of providers and operators pursuant to Article 25(2) and (4), obligations of deployers pursuant to Article 26, requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34, and transparency obligations for providers and deployers pursuant to Article 50. Paragraph 5 sets, for the supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in reply to a request, fines of up to EUR 7 500 000 or, if the offender is an undertaking, up to 1 % of that same turnover, whichever is higher. Paragraph 6 provides that in the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount referred to in paragraphs 3, 4 and 5, whichever thereof is lower. The paragraph 6a inserted by Regulation (EU) 2026/1744 provides that in the case of SMCs, each fine referred to in paragraphs 4 and 5 shall be up to the percentages or amount referred therein, whichever is lower. Paragraph 7 enumerates what is taken into account when deciding whether to impose a fine and when deciding on the amount: the nature, gravity and duration of the infringement and of its consequences, whether administrative fines have already been applied by other market surveillance authorities to the same operator for the same infringement, whether other authorities have already fined that operator for infringements of other Union or national law resulting from the same activity or omission, the size, annual turnover and market share of the operator, any other aggravating or mitigating factor such as financial benefits gained or losses avoided, the degree of cooperation with the national competent authorities, the degree of responsibility of the operator taking into account the technical and organisational measures it implemented, the manner in which the infringement became known to the authorities and whether the operator notified it, the intentional or negligent character of the infringement, and any action taken by the operator to mitigate the harm suffered by the affected persons. Paragraph 8 provides that each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities and bodies established in that Member State. Paragraph 9 provides that, depending on the legal system of the Member State, the rules may be applied in such a manner that fines are imposed by competent national courts or by other bodies, with equivalent effect. Paragraph 10 subjects the exercise of these powers to appropriate procedural safeguards in accordance with Union and national law, including effective judicial remedies and due process. Paragraph 11 requires Member States to report annually to the Commission on the administrative fines they issued and on any related litigation or judicial proceedings. Chapter XII, which contains Article 99, has applied since 2 August 2025, with the exception of Article 101; the amendments to Article 99 have applied since 27 July 2026.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_locator":"Article 99(1)-(11)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Regulation (EU) 2026/1744, Article 1, point (38)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_locator":"Article 113, third paragraph, point (b)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Regulation (EU) 2026/1744, Article 1, point (40)"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 101(1) provides that the Commission may impose on providers of general-purpose AI models fines not exceeding 3 % of their annual total worldwide turnover in the preceding financial year or EUR 15 000 000, whichever is higher, where it finds that the provider intentionally or negligently infringed the relevant provisions of this Regulation, failed to comply with a request for a document or for information pursuant to Article 91 or supplied incorrect, incomplete or misleading information, failed to comply with a measure requested under Article 93, or failed to make available access to the model with a view to conducting an evaluation pursuant to Article 92. In fixing the amount of the fine or periodic penalty payment, regard shall be had to the nature, gravity and duration of the infringement, taking due account of the principles of proportionality and appropriateness, and the Commission shall also take into account commitments made in accordance with Article 93(3) or made in relevant codes of practice in accordance with Article 56. Paragraph 2 requires the Commission to communicate its preliminary findings to the provider and give it an opportunity to be heard before adopting the decision. Paragraph 3 provides that fines imposed shall be effective, proportionate and dissuasive. Paragraph 4 provides that information on fines imposed shall also be communicated to the Board as appropriate. Paragraph 5 gives the Court of Justice of the European Union unlimited jurisdiction to review decisions of the Commission fixing a fine and provides that it may cancel, reduce or increase the fine. Paragraph 6 requires the Commission to adopt implementing acts containing detailed arrangements and procedural safeguards for proceedings that may lead to a decision under paragraph 1. Article 101 is excluded from the earlier application of Chapter XII and has therefore applied since 2 August 2026. Alongside this regime, Article 100 carries its own scheme for Union institutions, bodies, offices and agencies: the European Data Protection Supervisor may impose administrative fines on them of up to EUR 1 500 000 for non-compliance with the prohibition in Article 5 and up to EUR 750 000 for non-compliance with other requirements or obligations under this Regulation. Regulation (EU) 2026/1744 did not amend Articles 100 and 101.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_locator":"Article 101(1)-(6)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_locator":"Article 100(1)-(3)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_locator":"Article 113, third paragraph, point (b)"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"Article 75c(4), inserted by Regulation (EU) 2026/1744, provides that a decision of the AI Office may be accompanied by the imposition of penalties in accordance with Article 99(3) to (7), which provisions apply mutatis mutandis to the Office in the execution of its supervision and enforcement tasks referred to in Article 75(1). In particular, the following are subject to administrative fines as referred to in Article 99(4): infringement of any applicable provision of this Regulation, including those not listed in Article 99(4); failure to comply with decisions or measures adopted pursuant to Article 14(4) or Article 16(3) of Regulation (EU) 2019/1020 and the powers specified in Article 75a; and failure to comply with a commitment made binding pursuant to Article 75b. The supply of incorrect, incomplete or misleading information to the Office is subject to the fines of Article 99(5). Paragraph 5 additionally allows the Office to impose periodic penalty payments to compel, among other things, submission to an investigation, compliance with an information request, submission to an inspection or compliance with a binding commitment; those payments shall not exceed 5 % of the average daily income or worldwide annual turnover in the preceding financial year per day. Paragraph 6 gives the Court of Justice unlimited jurisdiction over decisions of the Office fixing a fine or periodic penalty payment, and paragraph 8 subjects the powers of the Office to a limitation period of five years, with the same period for the power to enforce decisions taken. Note: the two authentic language editions of Regulation (EU) 2026/1744 diverge here. The English edition states five years in both subparagraphs of Article 75c(8); the Dutch edition states three years in both subparagraphs of Article 75 quater(8). This statement renders in each language what the edition in that language says and makes no silent choice. The implementing act under Article 75d(3) is to specify both subparagraphs, including the circumstances in which the limitation periods are interrupted; until it exists, the divergence remains an open question of interpretation.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Regulation (EU) 2026/1744, Article 1, point (32)"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The ceiling follows the provision, not the harm. That is the point routinely missed in boardrooms: a single amount gets budgeted for \"the AI Act fine\", while operators face three bands in Article 99 and there are separate regimes on top for Union institutions and for providers of general-purpose AI models. The highest band, EUR 35 million or 7 percent, belongs to Article 5 alone. Until recently that was a list of practices you either engage in or do not, but since the amendment of Article 5 that is no longer true: for the new prohibitions on sexual imagery, placing on the market is also prohibited where such generation is a reasonably foreseeable and reproducible outcome and the system lacks reasonable and adequate technical safety measures and safeguards. That is a duty to take measures inside the highest band, and it applies from 2 December 2026. The middle band, EUR 15 million or 3 percent, belongs to the enumeration in paragraph 4: the role duties of the provider, the authorised representative, the importer, the distributor and the deployer, since 27 July 2026 also Article 25(2) and (4), plus Article 50. What is not named there is at least as interesting: Article 4 and Article 27 do not appear, and the requirements of Chapter III reach the ceiling at most through Article 16 and Article 26. Note that Article 72 and Article 73 do come within reach for the deployer, because Article 26(5) obliges it to inform in accordance with Article 72 and declares Article 73 applicable mutatis mutandis, and Article 26 is named in paragraph 4. Two further things. Paragraph 5 turns answering an information request badly into its own fine category at 1 percent, independently of the underlying infringement. And paragraph 7 is not a discount scheme: it works both ways, because its opening words concern the decision whether or not to impose a fine and point (e) expressly names aggravating factors such as financial benefits gained. What you can steer are the factors you can evidence: your technical and organisational measures, your notification behaviour, your cooperation, and what you did after an incident to mitigate the harm suffered by affected persons. Two dates that matter in practice: the prohibition in Article 5 has applied since 2 February 2025 but Chapter XII only since 2 August 2025, so for conduct in between there is no administrative fine under Article 99(3). That gap does not return for the new Article 5 prohibitions of 2 December 2026: Chapter XII will by then have applied for well over a year, so the penalty regime exists on the day those prohibitions start to apply. And whoever falls within the competence of the AI Office must drop the idea that the enumeration in paragraph 4 is closed: Article 75c(4) places infringement of any applicable provision in the EUR 15 million or 3 percent band there, expressly including provisions not listed in paragraph 4.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_locator":"Article 99(1)-(11)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Regulation (EU) 2026/1744, Article 1, point (7)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Regulation (EU) 2026/1744, Article 1, point (32)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_locator":"Article 113, third paragraph, point (b)"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Add a column to your obligations register carrying the ceiling that belongs to each entry, with three values: Article 99(3), Article 99(4), or national law under Article 99(1). Determine per general-purpose AI model that you provide yourself whether the Commission's Article 101 regime is added on top, and determine whether you fall under Article 75(1), because the Article 75c regime with periodic penalty payments then applies as well. Also record, per obligation, which of the factors in Article 99(7) you could actually show, in particular the technical and organisational measures implemented, your notification behaviour, your cooperation with the authority and the steps you take to mitigate harm to affected persons, because that is the part of the amount you can influence yourself. This is our recommendation and not a duty under the Regulation: Article 99 addresses the Member States and imposes no deadline whatsoever on an operator.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_locator":"Article 99(1)-(11)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_locator":"Article 101(1)-(6)"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_locator":"Regulation (EU) 2026/1744, Article 1, point (32)"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":null,"timing_basis":null,"high_risk_regime_from":null,"links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/article-99-101-penalties","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 99, 100 and 101 on EUR-Lex"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","label":"Regulation (EU) 2026/1744, the amendment of Article 99"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-14T00:00:00.000Z","next_review_due_at":"2027-02-10T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:conformity-ce-registration","legacy_id":"raip:obligation:conformity-ce-registration","type":"obligation","slug":"conformity-ce-registration","version":"2.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"e2ba6e413ff6670e5896f31ee36839ff048b04b714b4c13decc1ed8e0d2f9186","label":"Articles 43-49: conformity assessment, CE and registration","summary":"The route from assessment to CE marking and EU database registration before market placement of high-risk AI.","topics":["conformity"],"actor_ids":["praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:conformity-ce-registration-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:conformity-ce-registration-record"],"control_ids":["praxikon:eu:ai-act:control:conformity-ce-registration-control"],"template_ids":["praxikon:eu:ai-act:template:conformity-ce-registration-legal-text"],"conditions":[{"id":"conformity-ce-registration-scope","operator":"all","description":"The provider places a high-risk system on the market; public deployers also register their use."}],"exceptions":[{"id":"conformity-ce-registration-exception","operator":"not","description":"For most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking."}],"statements":[{"kind":"official_fact","text":"Article 43 governs the conformity assessment, Article 47 the EU declaration of conformity, Article 48 the CE marking and Article 49 the registration in the EU database before market placement or putting into service, including registration of the Article 6(3) assessment.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 43, 47, 48 and 49","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"This provision is named in none of the three points of Article 113, third paragraph, and therefore falls under the general application date in the second paragraph: 2 August 2026. The move to 2 December 2027 and 2 August 2028 in point (c) concerns only Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5). When a high-risk AI system that this provision addresses can practically exist is a second question: through Article 6(2) and Annex III that is 2 December 2027, and through Article 6(1) and Annex I 2 August 2028. That practical date sits in high_risk_regime_from and not in deadline_at. This is how decision D1 of 6 September 2026 is recorded; see data/ai-act/review/decision-d1-application-dates.json.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"For buyers this is the simplest supplier check there is: ask for the declaration of conformity and the registration number. No declaration means the system may not be there by 2 December 2027.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 43, 47, 48 and 49","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Plan the conformity route backwards from 2 December 2027: standards selection, assessment, declaration and registration together take months, not weeks.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 43, 47, 48 and 49","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","timing_basis":"text_date","high_risk_regime_from":"2027-12-02T00:00:00.000Z","links":[{"relation":"public_page","href":"https://www.praxikon.com/en/verplichtingen/conformity-ce-registration","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 43-49 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-09-06T00:00:00.000Z","next_review_due_at":"2027-03-05T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:obligation:value-chain-representative","legacy_id":"raip:obligation:value-chain-representative","type":"obligation","slug":"value-chain-representative","version":"1.0.0","effective_at":"2026-07-27T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"38342a3db27dd0959f29e10415d9217331e2056d163b17a95fef284213092d52","label":"Articles 22-25: value chain and authorised representative","summary":"Role shifts in the AI value chain and the mandatory representative for non-EU providers.","topics":["value-chain"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":["praxikon:eu:ai-act:actor:provider"],"affected_actor_ids":["praxikon:eu:ai-act:actor:deployer"],"oversight_actor_ids":[],"evidence_owner_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":[],"change_ids":[],"action_ids":["praxikon:eu:ai-act:action:value-chain-representative-act"],"evidence_ids":["praxikon:eu:ai-act:evidence:value-chain-representative-record"],"control_ids":["praxikon:eu:ai-act:control:value-chain-representative-control"],"template_ids":["praxikon:eu:ai-act:template:value-chain-representative-legal-text"],"conditions":[{"id":"value-chain-representative-scope","operator":"all","description":"A high-risk system is supplied, modified, rebranded or placed on the Union market from outside the EU."}],"exceptions":[{"id":"value-chain-representative-exception","operator":"not","description":"Those acting solely as distributor or importer without the Article 25 triggers remain in that lighter role, with their own verification duties."}],"statements":[{"kind":"official_fact","text":"Article 25 provides that a distributor, importer, deployer or third party becomes the provider when it puts its name on a high-risk system, substantially modifies it or changes its intended purpose so it becomes high-risk; Article 22 obliges third-country providers to appoint a written authorised representative in the Union.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 22 and 25","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"official_fact","text":"For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.","citations":[{"source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The most dangerous role switch is the unintended one: your own layer on top of a procured model, your own brand on a tool, and you suddenly carry the full provider duties. 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