**Target:** Proposal for a regulation — Article 7 — paragraph 2 — point c

## Text proposed by the Commission

(c) the extent to which the use of an AI system has already caused harm to the health and safety or adverse impact on the fundamental rights or has given rise to significant concerns in relation to the materialisation of such harm or adverse impact, as demonstrated by reports or documented allegations submitted to national competent authorities;

(c)

(c)

## Amendment of the European Parliament

(c) the extent to which the use of an AI system has already caused harm to health and safety , has had an adverse impact on fundamental rights , the environment, democracy and the rule of law or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact, as demonstrated for example by reports or documented allegations submitted to national supervisory authorities , to the Commission, to the AI Office, to the EDPS, or to the European Union Agency for Fundamental Rights ;

the extent to which the use of an AI system has already caused harm to the health and safety or adverse impact on the fundamental rights or has given rise to significant concerns in relation to the materialisation of such harm or adverse impact, as demonstrated by reports or documented allegations submitted to national competent authorities;

the extent to which the use of an AI system has already caused harm to health and safety , has had an adverse impact on fundamental rights , the environment, democracy and the rule of law or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact, as demonstrated for example by reports or documented allegations submitted to national supervisory authorities , to the Commission, to the AI Office, to the EDPS, or to the European Union Agency for Fundamental Rights ;