Article 40

Harmonised standards and standardisation deliverables

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.

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.

Frequently Asked Questions

Harmonised standards are guidelines officially recognized by the European Union to ensure AI systems meet safety and reliability requirements; compliance with these standards means the product automatically meets specific EU legal obligations, simplifying the approval process for innovative AI systems or models introduced into the European market.
Harmonised standards for AI are developed by recognised European standardisation organisations after receiving specific requests from the European Commission, who consults various stakeholders, such as experts and advisory groups, ensuring the standards clearly align with European regulations, industry best practices, international standards and principles that protect people’s basic rights and interests.
These standards help developers and companies by providing clear guidelines about how to design and use AI safely and legally, giving businesses the confidence and certainty needed to innovate, encouraging investment in new technologies, and promoting Europe as a competitive player in the international AI market.
Yes, the European Commission specifically requests standard-setting bodies to create guidelines that promote energy-efficient development and usage of AI, including strategies to lower energy use and other resources throughout an AI system’s lifecycle, helping reduce environmental impact and supporting sustainability goals for technology development.

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