EvidenceApplicablev1.0.0

Necessity file for bias testing

Per processing operation: the system or model, the paragraph of Article 4a relied on, the justification why synthetic or anonymised data do not suffice, the technical and organisational safeguards applied, the access list, the confirmation that no other party can reach the data, and the deletion date. This is also the text that paragraph 1, point (f), requires in the record of processing activities.

The official source remains authoritative. This is general information about obligations and not legal advice. See this object on the map

Address and citation

This object has an address of its own that is never renamed or reused. Store the identifier in your own file, not the title or the link.

Identifier: praxikon:eu:ai-act:evidence:bias-testing-necessity-record
Payload hash (sha256): eaa43374278cdd83d1669e545e106c809a21f4eddf225586fe7e7ac9f553651c

Citation line

Praxikon, "Necessity file for bias testing", praxikon:eu:ai-act:evidence:bias-testing-necessity-record@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-09-06T00:00:00.000Z, sha256 eaa43374278cdd83d1669e545e106c809a21f4eddf225586fe7e7ac9f553651c

Version: 1.0.0
Legal time (effective_at): 27 July 2026
Knowledge time (known_at): 14 August 2026
Closed on: Not closed
Topics: fundamental-rights, high-risk-requirements

Review status: Editorially reviewed (14 August 2026). Next check due by 10 February 2027. The check date is the knowledge date of this version; no later recheck has been recorded.

What this object links to

Every relation appears below as a path: from the source with its locator, through the conditions and exceptions of the object carrying the relation, to the consequence. A locator belongs to a statement in the data and not to a relation, so the source is the source anchor of the carrying object.

The obligation this hangs off

1 of 1 shown

The object belongs to this obligation. The source line it hangs off sits there.

Source
This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point 6, inserting Article 4a: Article 4a(1), points (a) to (f), and Article 4a(2), points (a) and (b)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point 6 (insertion) and point 9 (Article 10 amended, paragraph 5 deleted)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point 2(b), replacing Article 2(7)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Recital 9, Article 4 (entry into force) and Article 1, point 40(a), replacing Article 113, third paragraph, point (a)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ObligationArticle 4a: legal basis for bias testing with special categories of personal data
  praxikon:eu:ai-act:obligation:article-4a-bias-testing-legal-basis

What this object is about

3 of 3 shown

The object is about this role. Undifferentiated: it does not follow that the duty rests on this role.

Source
This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point 6, inserting Article 4a: Article 4a(1), points (a) to (f), and Article 4a(2), points (a) and (b)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point 6 (insertion) and point 9 (Article 10 amended, paragraph 5 deleted)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point 2(b), replacing Article 2(7)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Recital 9, Article 4 (entry into force) and Article 1, point 40(a), replacing Article 113, third paragraph, point (a)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ActorDeployer
  praxikon:eu:ai-act:actor:deployer
- ActorProvider of a GPAI model
  praxikon:eu:ai-act:actor:gpai-model-provider
- ActorProvider of an AI system
  praxikon:eu:ai-act:actor:provider

What points at this object

Where this evidence comes from

2 of 2 shown

This is what has to be in the file to show that the action was carried out.

Source
Official fact on this object, with its locator.
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point 6 (insertion) and point 9 (Article 10 amended, paragraph 5 deleted)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
Via
No condition or exception recorded on this object.
Relation recorded on: Article 4a inserted, Article 10(5) deleted
Consequence
- ChangeArticle 4a inserted, Article 10(5) deleted
  praxikon:eu:ai-act:change:2026-07-27-article-4a-inserted
Source
Official fact on this object, with its locator.
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point 6, inserting Article 4a: Article 4a(1), points (a) to (f), and Article 4a(2), points (a) and (b)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point 6 (insertion) and point 9 (Article 10 amended, paragraph 5 deleted)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point 2(b), replacing Article 2(7)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Recital 9, Article 4 (entry into force) and Article 1, point 40(a), replacing Article 113, third paragraph, point (a)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
Via
- Condition | allParagraph 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.
- Condition | allParagraph 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.
- Condition | allThe 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.
- ExceptionParagraph 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.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Relation recorded on: Article 4a: legal basis for bias testing with special categories of personal data
Consequence
- ObligationArticle 4a: legal basis for bias testing with special categories of personal data
  praxikon:eu:ai-act:obligation:article-4a-bias-testing-legal-basis

When this applies

No condition recorded on this object.

When this does not apply

No exception recorded on this object.

Referring to this object

Citation block

Copy this reference into your advice, article or file. The identifier, the version and the hash keep the statement findable later, even once the dataset has moved on.

Reference

Praxikon, "Necessity file for bias testing",
praxikon:eu:ai-act:evidence:bias-testing-necessity-record@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0),
effective_at 2026-07-27T00:00:00.000Z, known_at 2026-08-14T00:00:00.000Z,
sha256 eaa43374278cdd83d1669e545e106c809a21f4eddf225586fe7e7ac9f553651c,
https://www.praxikon.com/en/verkenner/evidence/bias-testing-necessity-record
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aevidence%3Abias-testing-necessity-record&effective_at=2026-07-27&known_at=2026-08-14&lang=en, accessed 2026-09-20)

Short form

praxikon:eu:ai-act:evidence:bias-testing-necessity-record@1.0.0 (sha256 eaa43374)

BibTeX

@misc{praxikon-eu-ai-act-evidence-bias-testing-necessity-record-1-0-0,
  author       = {{Praxikon}},
  title        = {Necessity file for bias testing},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:evidence:bias-testing-necessity-record},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.2.0, schema 1.5.0},
  note         = {effective_at 2026-07-27T00:00:00.000Z; known_at 2026-08-14T00:00:00.000Z; sha256 eaa43374278cdd83d1669e545e106c809a21f4eddf225586fe7e7ac9f553651c},
  url          = {https://www.praxikon.com/en/verkenner/evidence/bias-testing-necessity-record},
  urldate      = {2026-09-20},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:evidence:bias-testing-necessity-record@1.0.0",
    "type": "dataset",
    "title": "Necessity file for bias testing",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:evidence:bias-testing-necessity-record",
    "URL": "https://www.praxikon.com/en/verkenner/evidence/bias-testing-necessity-record",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          14
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          9,
          20
        ]
      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0; schema 1.5.0; effective_at 2026-07-27T00:00:00.000Z; known_at 2026-08-14T00:00:00.000Z; sha256 eaa43374278cdd83d1669e545e106c809a21f4eddf225586fe7e7ac9f553651c; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aevidence%3Abias-testing-necessity-record&effective_at=2026-07-27&known_at=2026-08-14&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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