Articles 40 to 42: standards, common specifications and presumption of conformity

Article 40(1) provides: 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. Paragraph 2 provides: 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. Paragraph 3 provides: 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.

Article 41(1) provides: The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following conditions have been fulfilled: (a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter, or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and: (i) the request has not been accepted by any of the European standardisation organisations; or (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or (iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or (iv) the harmonised standards do not comply with the request; and (b) no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period. When drafting the common specifications, the Commission shall consult the advisory forum referred to in Article 67. Paragraph 2 provides: Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers the conditions laid down in paragraph 1 of this Article to be fulfilled. Paragraph 3 provides: High-risk AI systems or general-purpose AI models which are in conformity with the common specifications referred to in paragraph 1, or parts of those specifications, shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, to comply with the obligations referred to in Sections 2 and 3 of Chapter V, to the extent those common specifications cover those requirements or those obligations.

Article 41(4) provides: Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the publication of its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter or, as applicable, the same obligations set out in Sections 2 and 3 of Chapter V. Paragraph 5 provides: Where providers of high-risk AI systems or general-purpose AI models do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the requirements referred to in Section 2 of this Chapter or, as applicable, comply with the obligations set out in Sections 2 and 3 of Chapter V to a level at least equivalent thereto. Paragraph 6 provides: Where a Member State considers that a common specification does not entirely meet the requirements set out in Section 2 or, as applicable, comply with obligations set out in Sections 2 and 3 of Chapter V, it shall inform the Commission thereof with a detailed explanation. The Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification concerned.

Article 42(1) provides: High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be used shall be presumed to comply with the relevant requirements laid down in Article 10(4). Paragraph 2 provides: High-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 and the references of which have been published in the Official Journal of the European Union shall be presumed to comply with the cybersecurity requirements set out in Article 15 of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those requirements.

The word everything turns on is presumed. A presumption of conformity is not proof of compliance and it is rebuttable: it shifts who has to demonstrate what, and nothing more. If a market surveillance authority shows that your system in fact does not meet a requirement of Section 2, the standard you applied does not stop that. Two limits set out in the text itself come on top. The first is the coverage limit: the presumption operates only in so far as the standard or the specification covers the requirements or obligations concerned. EN 18286 shows exactly what that means, because the coverage statement accompanying that standard expressly excludes Article 17(2) to (4) and Article 72; whatever falls outside the coverage you substantiate yourself. The second is the publication limit: without a reference in the Official Journal of the European Union no presumption arises, however complete the standard may be. That is why all twelve standard objects in data/ai-act/graph/standards.ts carry guidance and not applicable. So anyone hearing a supplier say that his product meets the European standard and is therefore AI Act compliant is hearing two leaps at once: from coverage to completeness, and from standard to legal effect.

Article 41 is often dismissed as an emergency valve that will never be used, and that is the wrong call. The European standards under standardisation request M/613 are not all available yet: the standards layer in data/ai-act/graph/standards.ts shows one completed EN and six deliverables still at drafting or enquiry stage. That is precisely the state described by the conditions of Article 41(1), point (a)(ii), and point (b), and so the common specification route remains practically relevant. For you that means two things. First, an implementing act may appear for a requirement of Section 2 that you did not see coming and that touches your design choices; those acts are adopted under the examination procedure of Article 98(2) and not in consultation with individual providers. Second, there is then a paragraph that asks something of you directly: paragraph 5. If you do not apply the common specification, you must duly justify that your technical solution is at least equivalent. That is the only place in these three Articles where you have to write something yourself, and the text does not say where. In practice that justification belongs in the technical documentation, because that is the file that has to be handed over upon a reasoned request. Article 42 is narrower than it looks and is overrated for that reason. Paragraph 1 touches only Article 10(4) and not the rest of the data governance of Article 10; paragraph 2 touches only the cybersecurity requirements of Article 15 and only where the references of the scheme under Regulation (EU) 2019/881 have been published in the Official Journal. A certificate under a scheme not yet published yields no presumption, and a presumption on Article 15 says nothing about your Article 9, 11, 12, 13 or 14.