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 the Council, and in particular Article 13(2)(b) 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). Those opinions consist of a scientific risk assessment and risk management considerations.
(2)
When carrying out scientific risk assessments and drawing up risk management recommendations, EMA is required to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species or MRLs established in one or more species for other species in extrapolation, in order to increase the availability of authorised veterinary medicinal products for conditions affecting food producing animals.
(3)
Extrapolation of MRLs involves the process by which residue levels in tissues or food commodities of a food producing species for which MRLs exist are used to estimate residue levels and establish MRLs in a tissue or a food commodity of another species or another tissue or food commodity of the same species for which no, or no complete, conventional residue data is available. For proper application of Regulation (EC) No 470/2009 principles and minimum criteria for extrapolation should be established.
(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: