Article 6(1a) to (1c): the tightened classification route

Regulation (EU) 2026/1744 inserts three paragraphs into Article 6. Paragraph 1a: "For the purposes of this Regulation, including paragraph 1 of this Article, AI systems that are solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control shall not qualify as safety components." Paragraph 1b: "Notwithstanding paragraph 1a, AI systems the failure or malfunctioning of which would endanger health and safety shall qualify as safety components." Paragraph 1c: "A product that is required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, shall not be considered as fulfilling the condition in paragraph 1, point (b)."

The same Regulation amends the definition in Article 3, point (14). As amended it reads: "safety component" means a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property; for the purposes of this definition, a component fulfils a safety function where its intended purpose is to prevent or mitigate risks to the health and safety of persons or property. Article 3 sits in Chapter I, which under Article 113, third paragraph, point (a), has applied since 2 February 2025. This amended definition therefore operates from the entry into force of the amending Regulation on 27 July 2026 and not only from some later application date.

The amended Article 113, third paragraph, point (c), provides that Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5), shall apply from: (i) 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III; and (ii) 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. The added point (d) provides that Articles 102 to 110 shall apply from 27 July 2026. Annex III, point 2, uses the notion of safety component for critical digital infrastructure, road traffic and the supply of water, gas, heating or electricity; that route falls under the 2 December 2027 date.

The same Regulation moves machinery out of Chapter III. In Annex I, Section A, point 1 (the reference to Directive 2006/42/EC) is deleted and Section B gains point 21: Regulation (EU) 2023/1230 on machinery. The amended Article 2(2) reads that for AI systems classified as high-risk in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Article 60a and Articles 102 to 112 shall apply. The amended Article 43(3) adds that the classification of a product as a high-risk AI system in accordance with Article 6(1) does not affect the choice of the conformity assessment procedure provided to manufacturers of products covered by Annex I, Section A, and that those manufacturers are not required to choose a procedure involving third-party conformity assessment only because the product includes a high-risk AI system as a safety component, if the Section A legislation does not require it. The new Article 2(13) provides that specific requirements or obligations under Articles 9 to 15 and 17 to 25 may be limited where Section A legislation provides an equivalent or higher level of protection, and obliges the Commission to adopt delegated acts on this by 2 August 2027.

What changes in practice is what the discussion is about. Until now it was about whether your product falls under Annex I and whether a third party is involved. Those two questions remain, but a third one belongs in front of them: what function does your AI component actually perform. A recommendation model that optimises when a machine is serviced, or a model that improves throughput on a line, sits in the list in paragraph 1a, and such functions often ended up classified as safety components simply because they ran inside a regulated product. Be careful with quality control as an example: paragraph 1a names only the non-safety related aspects of it, and in many regulated products a vision model that flags deviations is safety QC. Paragraph 1b draws the line: as soon as failure or malfunctioning would endanger health and safety, the exclusion does not count. The question therefore moves from your product file to your failure analysis, and at most providers that analysis is recorded nowhere. Paragraph 1c is narrower: anyone who needed a third party only because of radio spectrum or electromagnetic interference does not meet paragraph 1, point (b), by that route. That paragraph too requires a weighing, because it works only if the third party is mandatory solely on account of those other risks; where your product falls under several Annex I acts, a second act may still satisfy the condition on health and safety grounds. Two things finally that move the stakes. Machinery no longer runs through this route: Regulation (EU) 2023/1230 now sits in Annex I, Section B, and for those products the amended Article 2(2) means Chapter III does not apply at all. And for Section A products the same Regulation pushes the other way: the amended Article 43(3) says expressly that classification under Article 6(1) does not affect the choice of conformity assessment procedure and pushes nobody towards a notified body who was not already headed there. So build your failure analysis as your own file, not as something you will have to put in front of a notified body anyway.