Recital 7

(7) The notion of a ‘safety component’ is crucial for the classification of certain AI systems as high-risk according to Regulation (EU) 2024/1689. Thus, the notion should be targeted to include only the AI systems which could have an adverse impact on the health and safety of persons or property, in line with the risk-based approach of that Regulation. The definition set out in Article 3, point (14) of Regulation (EU) 2024/1689 does not provide the necessary clarity to allow providers of AI systems to determine whether an AI system qualifies as a safety component and, as a result, risks extending the high-risk classification of AI systems beyond what is justified by the risk-based approach of that Regulation. It is therefore necessary to amend that definition. First, it is necessary to provide clarity on the concept of a ‘safety function’. The safety function should be an intended purpose of the system, which is determined by the provider of the system. An AI system fulfils a safety function where its intended purpose, as determined by the provider, is to prevent or mitigate risks to the health and safety of persons or property. In particular, this does not include AI systems which are intended to solely fulfil functions related to user assistance, performance optimisation, service efficiency, automation, convenience, or non-safety related aspects for quality control operations. The mere fact that an AI system is integrated into or operates within a product that is subject to Union harmonisation legislation does not, in itself, mean that it fulfils a safety function.

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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.