(b)

the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rights, and that risk is equivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred to in Annex III.

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Source: EUR-Lex CELLAR · retrieved 2026-08-26 · Text as adopted (Official Journal); later amendments are not incorporated in this text.