Keywords
Summary

Keywords

Agriculture - Uniform legislation - Maximum residue limits of veterinary medicinal products in foodstuffs of animal origin - Procedure for establishing limits - Regulation No 2377/90 - Possibility for the Commission to include references to the therapeutic indications permitted for clenbuterol

(Council Regulation No 2377/90, Annex III; Commission Regulation No 1312/96; Council Directive 96/22)

Summary

$$The references to the permitted therapeutic indications for clenbuterol which appear in Annex III 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, as amended by Regulation No 1312/96, must be regarded as merely declaratory, and not having, in themselves, the character of legislation.

In the first place, those references cannot be understood as having the object or effect of laying down a prohibition on the marketing and use of clenbuterol, subject to the therapeutic indications mentioned by them, which is independent of the prohibition laid down by Directive 96/22. Nor can those references be understood as having the object or effect of placing a limitation on the validity of the maximum residue limits (MRLs) established for clenbuterol in the context of Regulation No 2377/90. The Commission did not therefore need authorisation from Regulation No 2377/90 in order to be able to insert references to the permitted therapeutic indications for clenbuterol in Annex III to that regulation, as amended by Regulation No 1312/96, for the purposes of recalling the relevant provisions of Directive 96/22.

The Court of First Instance therefore erred in law by holding that the Commission could not lawfully base the limitation of the validity of the MRL established for clenbuterol on the provisions of Directive 96/22, when, first, the references to permitted therapeutic indications for clenbuterol did not have the object or effect of limiting the validity of the MRL established by Regulation No 1312/96, and, second, no provision prohibited the Commission from inserting in Annex III to Regulation No 2377/90, as amended by Regulation No 1312/96, a reminder of the effects of the provisions of Directive 96/22 in relation to the permitted therapeutic uses of clenbuterol.

( see paras 53-57 )