Chapter III · High-risk AI systems
Article 40 — Harmonised standards and standardisation deliverables
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.
High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of this Regulation, to the extent that those standards cover those requirements or obligations.
Authentic — as published in the Official Journal
In accordance with Article 10 of Regulation (EU) No 1025/2012, the Commission shall issue, without undue delay, standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation requests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shall also ask for deliverables on reporting and documentation processes to improve AI systems’ resource performance, such as reducing the high-risk AI system’s consumption of energy and of other resources during its lifecycle, and on the energy-efficient development of general-purpose AI models. When preparing a standardisation request, the Commission shall consult the Board and relevant stakeholders, including the advisory forum.
When issuing a standardisation request to European standardisation organisations, the Commission shall specify that standards have to be clear, consistent, including with the standards developed in the various sectors for products covered by the existing Union harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems or general-purpose AI models placed on the market or put into service in the Union meet the relevant requirements or obligations laid down in this Regulation.
The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil the objectives referred to in the first and the second subparagraph of this paragraph in accordance with Article 24 of Regulation (EU) No 1025/2012.
The Commission shall request, in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council and without undue delay, the European standardisation organisations to develop standardisation deliverables, including, as appropriate, harmonised standards, to facilitate the joint compliance and presumption of conformity with the requirements or obligations set out in Chapter III, Sections 2 and 3 of this Regulation, and the relevant requirements and obligations laid down in the Union harmonisation legislation listed in Annex I to this Regulation.amended by Regulation (EU) 2026/1744
Consolidated text — no legal value · amended by Regulation (EU) 2026/1744
The participants in the standardisation process shall seek to promote investment and innovation in AI, including through increasing legal certainty, as well as the competitiveness and growth of the Union market, to contribute to strengthening global cooperation on standardisation and taking into account existing international standards in the field of AI that are consistent with Union values, fundamental rights and interests, and to enhance multi-stakeholder governance ensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012.
Authentic — as published in the Official Journal
The formal analysis of Article 40
Article 6 is formalised first. The remaining articles follow.
Article 40 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.
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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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