Commission Implementing Regulation (EU) 2025/1103 of 3 June 2025 amending Implementing Regulation (EU) 2017/12 as regards the requirements for applications and requests for the establishment of a n...

Official Journal of the European Union 2025/1103 4.6.2025 COMMISSION IMPLEMENTING REGULATION (EU) 2025/1103 of 3 June 2025 EN L series amending Implementing Regulation (EU) 2017/12 as regards the requirements for applications and requests for the establishment of a ‘no MRL required’ classification for chemical-unlike biological substances (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), and in particular Article 13(1) thereof, Whereas: (1) Pharmacologically active substances are classified on the basis of opinions on maximum residue limits (MRLs) issued by the European Medicines Agency (EMA). (2) Commission Implementing Regulation (EU) 2017/12 (2) sets out the form and content of the applications and requests submitted to EMA requesting the opinion to establish MRLs. (3) Commission Regulation (EU) 2018/782 (3) establishes the methodological principles for the risk assessment and risk management recommendations to be applied by EMA...