(fra kommisjonsforordningen)

(1) In accordance with Article 3 of Regulation (EC) No 470/2009, pharmacologically active substances intended for use in the Union in veterinary medicinal products administered to food-producing animals are subject to an opinion of the European Medicines Agency (‘the Agency’) regarding their maximum residue limits (‘MRLs’). 

(2) Commission Regulation (EU) 2018/782 lays down the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009. 

(3) Section I.6 of Annex I to Regulation (EU) 2018/782 provides that biological substances, other than those identified in Article 1(2), point (a), of Regulation (EC) No 470/2009, are subject to either an evaluation of all elements set out in Article 6 of Regulation (EC) 470/2009 (‘full MRL evaluation’) if chemical-like or a case-by-case evaluation if chemical-unlike. 

(4) In accordance with section I.7. of Annex I to Regulation (EU) 2018/782, the Agency is to assess chemical-unlike biological substances to determine whether there is a need for a full MRL evaluation. 

(5) Chemical-unlike biological substances which are not considered to need for a full MRL evaluation are not currently included in Table 1 of the Annex to Commission Regulation (EU) No 37/2010, which sets out pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin (allowed substances). Instead, they are included in a list that is published and updated by the Agency. 

(6) The case-by-case evaluation conducted by the Agency ensures that chemical-unlike biological substances falling within the scope of Regulation (EC) No 470/2009 are assessed in line with the objectives of that Regulation. In most cases, residues of those substances fall into groups of substances that are normal constituents of food, such as amino acids, lipids, and carbohydrates, and do not pose risks to public health. Consequently, such chemical-unlike biological substances could be classified as ‘no MRL required’ in accordance with Article 14(2), point (c), of Regulation (EC) No 470/2009. 

(7) Section I.7 of Annex I to Regulation (EU) 2018/782, should therefore be amended to require the Agency to determine whether, for a given chemical-unlike biological substance, the classification ‘no MRL required’ is appropriate. 

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,