What obligations does the provider of an AI system have under Article 6(1a) to (1c) of the AI Act?

Question

Article 6(1a) to (1c) of the AI Act covers the tightened classification route. The Digital Omnibus inserts three paragraphs into Article 6 that draw the notion of safety component more tightly: which AI systems do not qualify as safety components, which still do despite that exclusion because failure would endanger health and safety, and which mandatory third-party conformity assessment does not count. Paragraph 1a is written for the purposes of the Regulation as a whole and therefore bears on both the Annex I route and Annex III, point 2. The duty sits with the provider of an AI system. This obligation has applied since 2 December 2027.

Accepted Answer

Your question is about Article 6(1a) to (1c): the tightened classification route. That obligation applies today. Whether your system actually falls under it depends on conditions you assess yourself. Article 6(1a) to (1c) of the AI Act covers the tightened classification route. The Digital Omnibus inserts three paragraphs into Article 6 that draw the notion of safety component more tightly: which AI systems do not qualify as safety components, which still do despite that exclusion because failure would endanger health and safety, and which mandatory third-party conformity assessment does not count. Paragraph 1a is written for the purposes of the Regulation as a whole and therefore bears on both the Annex I route and Annex III, point 2. The duty sits with the provider of an AI system. This obligation has applied since 2 December 2027. Still to determine: Applies where it must be determined whether an AI system is intended to be used as a safety component of a product, or is itself a product, covered by the Union harmonisation legislation listed in Annex I, and whether that product is required to undergo a third-party conformity assessment. Because paragraph 1a writes itself for the purposes of this Regulation, the delimitation also bears on Annex III, point 2, where the notion of safety component is used for critical digital infrastructure, road traffic and the supply of water, gas, heating or electricity. For the consequences under Chapter III only Annex I, Section A, counts. For products under Section B, including machinery since Regulation (EU) 2023/1230 was moved there, the amended Article 2(2) means that only Article 6(1), Article 60a and Articles 102 to 112 apply. Paragraph 1a provides that AI systems solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control do not qualify as safety components. Paragraph 1b takes that exclusion back: AI systems the failure or malfunctioning of which would endanger health and safety do qualify as safety components. Paragraph 1c provides that a product 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, is not considered as fulfilling the condition in paragraph 1, point (b). First step: Determine and record whether your AI component is a safety component. Relevant provisions: Article 6(1a) to (1c): the tightened classification route. First actions: Determine and record whether your AI component is a safety component. Describe, per AI component inside a product under Annex I, Section A, which function it performs, whether that is a safety function, what happens on failure or malfunctioning, and whether the mandatory third-party conformity assessment rests on health and safety risks or only on other risks. A recommended practice, not a legal duty. To record: Record of the safety component assessment.

What obligations does the provider of an AI system have under Article 6(1a) to (1c) of the AI Act?

This applies now

Your first actions

Record this

Source and locator

Record role and classification for each AI system

Zahed Ashkara