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, 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)
An application for an opinion to establish the MRL is submitted to EMA. It is necessary to provide a standard format for submitting such applications and to list the information requested to accompany such applications.
(3)
Under certain circumstances, the Commission, a Member State, an interested party or organisation may submit a request to EMA for an opinion to establish the MRL. It is necessary to provide a standard format for such requests and to list the information that should accompany them.
(4)
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: