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Article 40

Harmonised Standards and Standardisation Deliverables

Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

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.

[Previous version]

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

1. High-risk AI systems 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 Chapter IV of this Regulation, to the extent that those standards cover those requirements or obligations.

2. The Commission shall issue standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, obligations set out in Chapter IV of this Regulation, in accordance with Article 10 of Regulation (EU) No 1025/2012, without undue delay. 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 other resources consumption 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 AI systems or AI models placed on the market or put into service in the Union meet the relevant requirements 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, and shall 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 shall 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.

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

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) 1025/2012 shall be presumed to be in conformity with the requirements set out in Chapter 2 of this Title or, as applicable, with the requirements set out in [Chapter on GPAI], to the extent those standards cover those requirements.

2. The Commission shall issue standardisation requests covering all requirements of Title II Chapter III and as applicable [GPAI Chapter] of this Regulation, in accordance with Article 10 of Regulation EU (No)1025/2012 without undue delay. The standardisation request shall also ask for deliverables on reporting and documentation processes to improve AI systems resource performance, such as reduction of energy and other resources consumption of the high-risk AI system during its lifecycle, and on energy efficient development of general-purpose AI models. When preparing 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 consistent, including with the existing and future standards developed in the various sectors for products covered by the existing Union safety legislation listed in Annex II, clear and aimed at ensuring that AI systems or models placed on the market or put into service in the Union meet the relevant requirements laid down in this Regulation.

The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil the above objectives in accordance with Article 24 of Regulation EU 1025/2012.

1c The actors involved in the standardisation process shall seek to promote investment and innovation in AI, including through increasing legal certainty, as well as competitiveness and growth of the Union market, and 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 enhance multi- stakeholder governance ensuring a balanced representation of interests and effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012.

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