{"meta":{"dataset_id":"praxikon:sys:registry:dataset:ai-act-implementation-graph","dataset_version":"2.2.0","schema_version":"1.5.0","lang":"en","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","count":9,"filters":{"id":null,"type":null,"role":null,"duty_holder":"credit-or-insurance-deployer","topic":null},"identifiers":{"canonical_namespace":"praxikon","canonical_form":"praxikon:<jurisdiction>:<regulation>:<type>:<slug>","legacy_namespace":"raip","legacy_resolution":"permanent","resolved":{"id":null,"role":null,"duty_holder":null}}},"data":[{"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. First, the cut off date. The amended paragraph 2 refers not to a date but to the date of application of Chapter III referred to in Article 113, and since the Digital Omnibus Article 113, third paragraph, point (c) gives two: 2 December 2027 for Annex III and 2 August 2028 for Annex I. We therefore read the cut off as route dependent. A defensible alternative reading is that the reference points at the general application date of Chapter III as a whole, that is 2 August 2026, because Sections 4 and 5 of that Chapter were not deferred; on that reading the cut off would effectively still be 2 August 2026. We follow the route dependent reading because point (c) expressly names Sections 1, 2 and 3, and those are the Sections carrying the requirements the grace period exists for. Second, the notion of a significant change in the design. 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-26-deployer-obligations","legacy_id":"raip:obligation:article-26-deployer-obligations","type":"obligation","slug":"article-26-deployer-obligations","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"0269a6f883187fb177f26dc8563b035927e5d2ae021e35254c98fce04d637f0c","label":"Article 26: obligations of deployers of high-risk AI systems","summary":"Twelve paragraphs governing day-to-day use: use in line with the instructions, human oversight by competent people, input data, monitoring and notification, log retention, informing workers before deployment, registration by public authorities and informing the people about whom decisions are made.","topics":["high-risk-requirements"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:public-law-body"],"duty_holder_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:public-law-body"],"affected_actor_ids":[],"oversight_actor_ids":["praxikon:eu:ai-act:actor:market-surveillance-authority"],"evidence_owner_ids":["praxikon:eu:ai-act:actor:deployer","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:appoint-and-empower-human-oversight"],"evidence_ids":["praxikon:eu:ai-act:evidence:deployer-use-dossier"],"control_ids":["praxikon:eu:ai-act:control:deployer-suspension-and-incident-control"],"template_ids":["praxikon:eu:ai-act:template:article-26-deployer-obligations-legal-text"],"conditions":[{"id":"article-26-deployer-obligations-scope","operator":"all","description":"Applies as soon as you use a high-risk AI system under your own authority (Article 3(4)), whether you built it yourself or procured it. For the standalone Annex III route (Article 6(2)) the date is 2 December 2027; for the embedded Annex I route (Article 6(1)) the date is 2 August 2028."}],"exceptions":[{"id":"article-26-deployer-obligations-exception","operator":"not","description":"Article 2(10) excludes natural persons using an AI system in the course of a purely personal, non-professional activity. For deployers that are financial institutions subject to internal governance requirements under Union financial services law, the monitoring obligation in paragraph 5 is deemed fulfilled by complying with those rules, and the logs under paragraph 6 are maintained as part of the documentation kept under that law."}],"statements":[{"kind":"official_fact","text":"Article 26 imposes twelve paragraphs on deployers of high-risk AI systems. Paragraph 1 requires appropriate technical and organisational measures to ensure use in accordance with the accompanying instructions for use. Paragraph 2 requires assigning human oversight to natural persons who have the necessary competence, training and authority, as well as the necessary support. Paragraph 3 leaves other obligations and the freedom to organise one's own resources unaffected. Paragraph 4 requires, to the extent the deployer exercises control over the input data, that such data is relevant and sufficiently representative in view of the intended purpose. Paragraph 5 requires monitoring on the basis of the instructions for use and informing the provider in accordance with Article 72; where there is reason to consider that use may result in a risk within the meaning of Article 79(1), the deployer shall without undue delay inform the provider or distributor and the relevant market surveillance authority and suspend use, and upon identifying a serious incident shall immediately inform first the provider and then the importer or distributor and the market surveillance authorities. Paragraph 6 requires keeping the automatically generated logs under the deployer's control for a period appropriate to the intended purpose and of at least six months, unless Union or national law provides otherwise. Paragraph 7 requires deployers who are employers to inform workers' representatives and the affected workers, before putting into service or using the system at the workplace, that they will be subject to its use. Paragraph 8 imposes the registration obligations of Article 49 on public authorities and Union institutions, bodies, offices and agencies and prohibits use of a system not registered in the EU database referred to in Article 71. Paragraph 9 links the information provided under Article 13 to the data protection impact assessment under Article 35 of Regulation (EU) 2016/679. Paragraph 10 sets additional conditions for post-remote biometric identification in law enforcement. Paragraph 11 opens with the words without prejudice to Article 50 of this Regulation and requires deployers of Annex III systems that make or assist in making decisions related to natural persons to inform those persons that they are subject to the use of the system; for high-risk AI systems used for law enforcement purposes Article 13 of Directive (EU) 2016/680 applies. The transparency obligations of Article 50 have applied since 2 August 2026 and are separate from the date on which paragraph 11 starts to apply. Paragraph 12 requires cooperation with the competent authorities.","citations":[{"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":"source_checked"}},{"kind":"editorial_interpretation","text":"The 2 December 2027 date invites postponement, but two elements are preparation work today. Paragraph 7 requires you to inform workers' representatives and the affected workers before the system is put into service at the workplace, and that information is provided, where applicable, in line with existing rules and practice on informing workers. That touches employee participation, and such a process takes months rather than weeks in practice, so a system that must go live in 2027 is discussed in 2026. Paragraph 2 also connects to the human oversight that Article 14 imposes on system design: you must designate natural persons with competence, training, authority and support. That is emphatically not the same as the measures obligation in Article 4. Article 4 requires measures supporting AI literacy and does not require you to guarantee a particular level for individuals; Article 26(2) requires identifiable overseers with a mandate. Conflating the two leaves you believing a generic e-learning is enough while still having no overseer with room to decide. A third underestimated element is paragraph 11: informing the people about whom an Annex III system makes or helps make decisions is visible customer or candidate communication that you have to design across your own organisation.","citations":[{"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":"Draw up now a list of the systems likely to qualify as high-risk from 2 December 2027 and add three columns: who exercises human oversight and with what mandate, when you will inform the works council and the affected workers, and how the persons concerned will receive the notice under paragraph 11. Plan the employee participation process a year ahead.","citations":[{"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-26-deployer-obligations","label":"Open the human explanation"},{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 26 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-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-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-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-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. 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