# Recital (46)

High-risk AI systems should only be placed on the Union market, put into service or used if they comply with 
certain mandatory requirements. Those requirements should ensure that high-risk AI systems available in the Union 
or whose output is otherwise used in the Union do not pose unacceptable risks to important Union public interests 
as recognised and protected by Union law. On the basis of the New Legislative Framework, as clarified in the 
Commission notice ‘The “Blue Guide” on the implementation of EU product rules 2022’ (20), the general rule is that 
more than one legal act of Union harmonisation legislation, such as Regulations (EU) 2017/745 (21) and (EU) 
2017/746 (22) of the European Parliament and of the Council or Directive 2006/42/EC of the European Parliament 
and of the Council (23), may be applicable to one product, since the making available or putting into service can take 
2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 
93/42/EEC (OJ L 117, 5.5.2017, p. 1).
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
95/16/EC (OJ L 157, 9.6.2006, p. 24).

place only when the product complies with all applicable Union harmonisation legislation. To ensure consistency 
and avoid unnecessary administrative burdens or costs, providers of a product that contains one or more high-risk 
AI systems, to which the requirements of this Regulation and of the Union harmonisation legislation listed in an 
annex to this Regulation apply, should have flexibility with regard to operational decisions on how to ensure 
compliance of a product that contains one or more AI systems with all applicable requirements of the Union 
harmonisation legislation in an optimal manner. AI systems identified as high-risk should be limited to those that 
have a significant harmful impact on the health, safety and fundamental rights of persons in the Union and such 
limitation should minimise any potential restriction to international trade.

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Source: Regulation (EU) 2024/1689 (Artificial Intelligence Act) as amended by Regulation (EU) 2026/1744, consolidated text of 27 July 2026 (Official Journal of the EU). This page is AI-generated legal information, not legal advice. Verify against the Official Journal.
Canonical: https://euaiactlaw.com/recital/46