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Applicablev1.0.0

Article 4a: legal basis for bias testing with special categories of personal data

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).

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.

Praxikon tracks Article 4a: legal basis for bias testing with special categories of personal data under the EU AI Act, checked against the official source on 14 August 2026, citing the source for every statement.

Status
Applicable
Application date
Not recorded
Version
1.0.0
Last reviewed
14 August 2026

Review status: placed against the official source (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.

From source to evidence

Why this obligation applies, what it asks of you, and what you show for it.

Applies

Applicable · Not recorded

For whom

  • Deployer
  • Provider of a GPAI model
  • Provider of an AI system

What you do

Justify and record your reliance on Article 4a

What you record

Necessity file for bias testing

Who this is relevant to

When this applies

  • Deployer

    An organisation using an AI system under its authority, excluding personal non-professional use.

  • Provider of a GPAI model

    A party that places a general-purpose AI model on the Union market.

  • Provider of an AI system

    A party that develops or has an AI system developed and places it on the market under its own name.

  1. 1Paragraph 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.
  2. 2Paragraph 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.
  3. 3The 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.

What the official source establishes

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.

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.

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.

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.

Our interpretation

The official source remains authoritative. This general interpretation is not legal advice.

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.

What you can do now

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.

  1. 01

    Justify and record your reliance on Article 4a

    Only for those who themselves decide to process special categories of personal data for bias testing. In that case record which paragraph of Article 4a you rely on and whether that paragraph is open to your role, why other data do not suffice, which safeguards apply, who has access and when the data are deleted. Replace old references to Article 10(5) while you are there.

What to retain

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.

Control and reassessment

  • Access and deletion control for bias testing

    The control that ensures the special categories stay with authorised people, are not transmitted, transferred or otherwise accessed by other parties, and are actually deleted once the bias has been corrected or the retention period ends, instead of lingering because nobody watches the deadline.

Public tools

  • Full text of Article 4a

    The full text of Article 4a as inserted and published in the Official Journal of 24 July 2026.

Conditions and exceptions

  • 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.

Official sources and locators

  • Digital Omnibus on AI 2026/1744

    European Parliament and Council | official-journal-2026-07-24

    Source locator: Article 1, point 6, inserting Article 4a: Article 4a(1), points (a) to (f), and Article 4a(2), points (a) and (b)

  • Digital Omnibus on AI 2026/1744

    European Parliament and Council | official-journal-2026-07-24

    Source locator: Article 1, point 6 (insertion) and point 9 (Article 10 amended, paragraph 5 deleted)

  • Digital Omnibus on AI 2026/1744

    European Parliament and Council | official-journal-2026-07-24

    Source locator: Article 1, point 2(b), replacing Article 2(7)

  • Digital Omnibus on AI 2026/1744

    European Parliament and Council | official-journal-2026-07-24

    Source locator: Recital 9, Article 4 (entry into force) and Article 1, point 40(a), replacing Article 113, third paragraph, point (a)

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, "Article 4a: legal basis for bias testing with special categories of personal data",
praxikon:eu:ai-act:obligation:article-4a-bias-testing-legal-basis@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 ffee7eb28c48cc8a2586f097f3abec38cbe7590c73e15b9845f9295f8f095d4c,
https://www.praxikon.com/en/verplichtingen/article-4a-bias-testing-legal-basis
(https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-4a-bias-testing-legal-basis&effective_at=2026-07-27&known_at=2026-08-14&lang=en, accessed 2026-09-15)

Short form

praxikon:eu:ai-act:obligation:article-4a-bias-testing-legal-basis@1.0.0 (sha256 ffee7eb2)

BibTeX

@misc{praxikon-eu-ai-act-obligation-article-4a-bias-testing-legal-basis-1-0-0,
  author       = {{Praxikon}},
  title        = {Article 4a: legal basis for bias testing with special categories of personal data},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:obligation:article-4a-bias-testing-legal-basis},
  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 ffee7eb28c48cc8a2586f097f3abec38cbe7590c73e15b9845f9295f8f095d4c},
  url          = {https://www.praxikon.com/en/verplichtingen/article-4a-bias-testing-legal-basis},
  urldate      = {2026-09-15},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:obligation:article-4a-bias-testing-legal-basis@1.0.0",
    "type": "dataset",
    "title": "Article 4a: legal basis for bias testing with special categories of personal data",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:obligation:article-4a-bias-testing-legal-basis",
    "URL": "https://www.praxikon.com/en/verplichtingen/article-4a-bias-testing-legal-basis",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          14
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          9,
          15
        ]
      ]
    },
    "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 ffee7eb28c48cc8a2586f097f3abec38cbe7590c73e15b9845f9295f8f095d4c; retrieved_from https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-4a-bias-testing-legal-basis&effective_at=2026-07-27&known_at=2026-08-14&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

How to verify a reference later is set out in the methodology. Terms

What changed in this

Moments when this obligation took effect, moved or received official guidance.

  • 2026-07-27 | binding law

    Article 4a inserted, Article 10(5) deleted

    Since 27 July 2026 the legal basis for bias detection using special categories of personal data sits as Article 4a in Chapter I and no longer as Article 10(5) in Chapter III. The circle has widened from providers of high-risk systems alone to providers and deployers of other AI systems and models and deployers of high-risk systems, on the same conditions.

See the full timeline

Version history

  1. v1.0.0

    27 July 2026

    Article 4a: legal basis for bias testing with special categories of personal data

    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).

Corrections to this obligation

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Zahed Ashkara, jurist and freelance AI & Privacy Consultant

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Zahed Ashkara

Freelance AI & Privacy Consultant, jurist

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