Opinion of the Advocate General — ECLI:EU:C:2001:512
Date: 2001-10-04
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Agriculture and Fisheries;Veterinary legislation
Procedure: Action for annulment;Appeal - successful
Origin: Germany

Summary of the Judgment 
Agriculture — Uniform legislation — Maximum residue limits of veterinary medicinal 
products in foodstuffs of animal origin — Procedure for establishing limits — Regu­
lation No 2377/90 — Possibility for the Commission to include references to the 
therapeutic indications permitted for clenbuterol 
(Council Regulation No 2377/90, Annex HI; Commission Regulation No 1312/96; 
Council Directive 96/22) 
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SUMMARY — CASE C-32/00 P 
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 food­
stuffs 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 auth­
orisation from Regulation No 2377/90 in 
order to be able to insert references to the 
permitted therapeutic indications for clen­
buterol 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 clen­
buterol on the provisions of Directive 
96/22, when, first, the references to per­
mitted therapeutic indications for clenbute­
rol 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 clen­
buterol. 
(see paras 53-57) 
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