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Article 40: Harmonised standards and standardisation deliverables

Article 40, Regulation (EU) 2024/1689 as amended by Regulation (EU) 2026/1744

High-risk AI systems
Amended by Regulation (EU) 2026/1744

The text below is the consolidated version, with the Digital Omnibus changes applied. Each change is listed under Amendments further down this page.

1. 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.

2. 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.

3. 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.

Amendments under Regulation (EU) 2026/1744 (1)

insert

Requires the Commission to request, without undue delay, European standardisation deliverables facilitating joint compliance and presumption of conformity with Chapter III Sections 2 and 3 and the corresponding requirements of Annex I legislation.

Read the amended text

‘The Commission shall request, in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council

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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.’

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Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (

OJ L 316, 14.11.2012, p. 12

, ELI:

http://data.europa.eu/eli/reg/2012/1025/oj

)."

Implementing this provision is a skill, not a lookup.

The EU AI Act Implementation Expert program teaches the working practice behind every article: classification, conformity, documentation, and the judgment to defend your decisions.

Mechanically consolidated from the official OJ texts of Regulations (EU) 2024/1689 and 2026/1744 (the Digital Omnibus, in force 27 July 2026); unofficial pending the official EUR-Lex consolidation. Study aid, not legal advice; the official texts on EUR-Lex are authoritative.