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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 Councilnote, 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) 2017/12note sets out the form and content of the applications and requests submitted to EMA requesting the opinion to establish MRLs.
(3)Commission Regulation (EU) 2018/782note establishes the methodological principles for the risk assessment and risk management recommendations to be applied by EMA when preparing opinions on the MRLs. Section I.7 of Annex I to Regulation (EU) 2018/782 was amended by Commission Regulation (EU) 2025/1101note to introduce a requirement for EMA to determine whether for a given chemical-unlike biological substance a classification ‘no MRL required’ is appropriate.
(4)The content of particulars and documents accompanying an application or a request for a ‘no MRL required’ classification for chemical-unlike biological substances should thus be clearly specified.
(5)Implementing Regulation (EU) 2017/12 should therefore be amended accordingly.
(6)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,
HAS ADOPTED THIS REGULATION:
Article 1#
In Article 1(2) of Implementing Regulation (EU) 2017/12, the following subparagraph is added:‘However, with regard to requests for a ‘‘no MRL required’’ classification for chemical-unlike biological substances, the particulars and documents shall be those specified in section I.7, first paragraph, points (a) to (e), of Annex I to Commission Regulation (EU) 2018/782note.note
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