Judgment — ECLI:EU:C:2008:418
Date: 2008-07-17
Language of the case: German
Court formation: First Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Agriculture and Fisheries;Veterinary legislation
Concepts: Medicinal products for veterinary use
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary of the Judgment Agriculture – Uniform legislation – Maximum residue limits of veterinary medicinal products in foodstuffs of animal origin – Determination procedure – Regulation No 2377/90 (Council Regulation No 2377/90, Annex II; Commission Regulation No 1873/2003; Council Directive 96/22) Having regard both to the extent of the Commission’s discretion and to all the factual circumstances in light of which Regulation No 1873/2003 amending Annex II to Regulation No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin was adopted, it does not appear that the approach followed by the Commission, by restricting inclusion of progesterone in Annex II to that regulation to a specific method of administration, taking account both of considerations of protection of human health and of requirements based on the principle of proportionality, disregarded the limits of the Commission’s discretion. Although it is true that Article 3 of Regulation No 2377/90 does not expressly provide for the possibility of including a substance in Annex II thereto for only some of its methods of administration, that fact cannot prevent the Commission from nevertheless making such an inclusion. That approach may appear particularly appropriate where, on the one hand, the substance in question cannot be included in Annex I or III to that regulation, but where, on the other, certain limitations on the methods of administration of that substance can make it possible to ensure that the presence of residues in animal tissue does not constitute a risk for human health, so that a total prohibition on marketing that substance following its inclusion in Annex IV to that regulation would be disproportionate. That conclusion is in no way called into question by the provisions of Directive 96/22 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of Beta-agonists, as amended by Directive 2003/74, which allow Member States to authorise the administration of progesterone by intramuscular injection. The conditions under which Article 4 of that directive allows Member States to authorise the administration of progesterone to farm animals include that of compliance with the requirements relating to placing on the market laid down in Directive 81/851, which was repealed subsequently by Directive 2001/82 on the Community code relating to veterinary medicinal products. That provision, read in conjunction with Article 6 of Directive 2001/82, permits Member States to authorise administration of progesterone to farm animals only if that substance is included in Annex I, II or III to Regulation No 2377/90 in accordance with the provisions thereof. (see paras 31, 34, 42-43, 45)