lexiara

Recital 42

Digital Omnibus on AI

(42) The use of artificial intelligence in machinery can help foster innovation and improve the efficiency of those machines. The application of Regulation (EU) 2023/1230 of the European Parliament and of the Council (18) and Regulation (EU) 2024/1689 might lead to overlaps. At the same time, it is important to ensure a level of protection with regard to risks related to the use of artificial intelligence in machinery that is consistent with the level of protection provided in Regulation (EU) 2024/1689 with regard to high-risk AI systems. Given the specific nature of machinery and the machinery sector, and in order to address the need to simplify the regulatory framework for AI-enabled machinery, it is appropriate to move to a sectoral approach by moving Regulation (EU) 2023/1230 from Section A to Section B of Annex I to Regulation (EU) 2024/1689. Accordingly, first, the application of Regulation (EU) 2024/1689 to those machines should be limited to the provisions referred to in Article 2(2) of that Regulation. The reference to Directive 2006/42/EC should be moved from Section A to Section B of Annex I to Regulation (EU) 2024/1689 and updated so as to refer to Regulation (EU) 2023/1230. Second, it is crucial to ensure that Regulation (EU) 2023/1230 incorporates essential health and safety requirements for high-risk AI systems classified pursuant to Article 6(1) of Regulation (EU) 2024/1689 and used as a safety component in machinery or high-risk AI systems constituting machinery that ensure a level of protection consistent with Regulation (EU) 2024/1689. To that end, the Commission should be required to adopt delegated acts amending Annex III to Regulation (EU) 2023/1230 in order to reflect the relevant requirements set out in Chapter III, Section 2, and Articles 17, 19, 72 and 73 of Regulation (EU) 2024/1689. To avoid a legal gap and ensure alignment with the entry into application of the relevant high-risk AI system rules set out in Regulation (EU) 2024/1689, those delegated acts should apply by 2 August 2028. For the same reasons, manufacturers should be free to rely on harmonised standards or common specifications referenced or adopted pursuant to Regulation (EU) 2024/1689 that cover the relevant essential requirements for the presumption of conformity within the meaning of Article 20 of Regulation (EU) 2023/1230 until harmonised standards or common specifications regarding AI are referenced or adopted pursuant to Regulation (EU) 2023/1230.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-14 · Text as adopted (Official Journal); later amendments are not incorporated in this text.