Chapter III · High-risk AI systems
Article 6 — Classification rules for high-risk AI systems
Amended
This article has been amended by Regulation (EU) 2026/1744 (Digital Omnibus). Paragraphs marked “text pending” are not yet reproduced here.
Applies from
- Annex III systems
- Annex I products
Article 6 decides which AI systems are high-risk, and everything in Chapter III follows from that answer. It sets out two independent routes. A system is high-risk if it is a safety component of, or is itself, a product covered by the Union harmonisation legislation in Annex I that needs third-party conformity assessment; or if it falls within one of the eight use-case areas in Annex III. Each route carries exceptions, and the exceptions carry counter-exceptions: an Annex III system escapes the classification when it poses no significant risk and performs only a narrow, improving, pattern-detecting or preparatory task — unless it profiles natural persons, in which case it is high-risk whatever it does. Escaping the classification is not free: the provider must document the assessment, register the system, and hand the documentation to the national authority on request.
Official text
Each paragraph records where its wording comes from. Only text reproduced unchanged from the Official Journal is authentic; consolidated text is editorial and has no legal value. Paragraphs, subparagraphs and points each have their own link.
Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:
- (a)
the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I;
- (b)
the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.
Authentic — as published in the Official Journal
For the purposes of this Regulation, including paragraph 1 of this Article, AI systems that are solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control shall not qualify as safety components.
Consolidated text — no legal value · amended by Regulation (EU) 2026/1744 (Digital Omnibus)
Notwithstanding paragraph 1a, AI systems the failure or malfunctioning of which would endanger health and safety shall qualify as safety components.
Consolidated text — no legal value · amended by Regulation (EU) 2026/1744 (Digital Omnibus)
A product that is required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, shall not be considered as fulfilling the condition in paragraph 1, point (b).
Consolidated text — no legal value · amended by Regulation (EU) 2026/1744 (Digital Omnibus)
In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be considered to be high-risk.
Authentic — as published in the Official Journal
By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be high-risk where it does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not materially influencing the outcome of decision making.
The first subparagraph shall apply where any of the following conditions is fulfilled:
- (a)
the AI system is intended to perform a narrow procedural task;
- (b)
the AI system is intended to improve the result of a previously completed human activity;
- (c)
the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is not meant to replace or influence the previously completed human assessment, without proper human review; or
- (d)
the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III.
Notwithstanding the first subparagraph, an AI system referred to in Annex III shall always be considered to be high-risk where the AI system performs profiling of natural persons.
Authentic — as published in the Official Journal
A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service. Such provider shall be subject to the registration obligation set out in Article 49(2). Upon request of national competent authorities, the provider shall provide the documentation of the assessment.
Authentic — as published in the Official Journal
The Commission shall, after consulting the European Artificial Intelligence Board (the ‘Board’), and no later than 2 February 2026, provide guidelines specifying the practical implementation of this Article in line with Article 96 together with a comprehensive list of practical examples of use cases of AI systems that are high-risk and not high-risk.
Authentic — as published in the Official Journal
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by adding new conditions to those laid down therein, or by modifying them, where there is concrete and reliable evidence of the existence of AI systems that fall under the scope of Annex III, but do not pose a significant risk of harm to the health, safety or fundamental rights of natural persons.
Authentic — as published in the Official Journal
The Commission shall adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by deleting any of the conditions laid down therein, where there is concrete and reliable evidence that this is necessary to maintain the level of protection of health, safety and fundamental rights provided for by this Regulation.
Authentic — as published in the Official Journal
Any amendment to the conditions laid down in paragraph 3, second subparagraph, adopted in accordance with paragraphs 6 and 7 of this Article shall not decrease the overall level of protection of health, safety and fundamental rights provided for by this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and take account of market and technological developments.
Authentic — as published in the Official Journal
The formal analysis of Article 6
15 norm nodes · 73 competency questions · 31 unanswered · 70 % coverage
Article 6 is formalised node by node: each rule as a deontic position with its operator, each exception with its rank, each predicate resolved against the definitions in Article 3.
One finding, in fullUnder review
Article 6(4) obliges a provider to hand the assessment documentation to a national competent authority on request. It sets no deadline. That is not an oversight — the position structure of the provision explains why no deadline can exist there. The reasoning, and the other thirty gaps, sit behind sign-in.
What members get, per article
- the rule logic: every norm as a formal position, with the defeater chain that decides which exception wins
- the competency questions and their answers, every unanswered one marked as a gap and named
- the ontology: predicates bound to AISV (AI Standardisation Vocabulary) and to the definitions they depend on, exportable as JSON-LD and OWL
- the documentation: the Article 6(4) assessment record generated from a fact set, with its derivation and the version of the law it was decided against
Built for providers claiming the 6(3) derogation, for the counsel who has to defend that claim, and for the auditor who reads it afterwards.
Access is invite-only and opening in stages. Article 6 is formalised first; the remaining articles follow.
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Cross-references
Commentary in preparation
The official text above is complete. The editorial layer for this article — duties, the roles bound by them, the AISV concepts that model them, and the European standards written to support them — is in preparation, in the same form as the articles already published.
See the published articles