Judgment — ECLI:EU:T:1998:141
Date: 1998-06-25
Language of the case: English
Court formation: Third Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Agriculture and Fisheries;Veterinary legislation
Concepts: General;Medicinal products for veterinary use
Procedure: Action for annulment - successful
Origin: United Kingdom

Summary of the Judgment
1. Actions for annulment — Actionable measures — Acts intended to have binding legal effects
— Rejection by the Commission of a request for the inclusion of a certain substance in one of
the annexes to Regulation No 2377/90 — Decision addressed to the trader making the request
— Standing of the trader to bring an action
(EC Treaty, Art. 173; Council Regulation No 2377/90)
2. Agriculture — Uniform legislation — Maximum residue limits of veterinary medicinal prod­
ucts in foodstuffs of animal origin — Procedure for establishing such limits — Regulation No
2377/90 — Refusal by the Commission to include a certain substance in one of the annexes
despite the favourable opinion issued by the Committee on Veterinary Medicinal Products —
Illegality
(Council Regulations Nos 2377/90, Art. 6(1), and 2309/93; Council Directive 81/851)
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SUMMARY — CASE T-120/96
1. Any measure which produces binding
legal effects and is such as to affect the
interests of an applicant by bringing
about a distinct change in his legal pos­
ition is an act or decision which may be
the subject of an action under Article 173
of the Treaty for a declaration that it is
void.
This is so in the case of a Commission
decision rejecting a request from a trader
for inclusion of a certain pharmacologi­
cally active substance in one of the
annexes 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. Such a decision
constitutes the final stage in the pro­
cedure initiated by the trader on the basis
of that regulation and, whilst it is true
that, if the moratorium on BST intro­
duced by the Council were to be lifted,
the Commission might decide to recon­
sider its decision, the fact remains that,
until then, the decision establishes the
Commission's position definitively.
Furthermore, if the decision is addressed
to the trader making the request, he has
standing to bring proceedings for annul­
ment of the decision. The decision must
also have been taken in a procedure
which is clearly defined by a Community
regulation, under which the Commission
is required to rule on a request made by
an individual pursuant to that regulation.
2. Where, under the Community procedure
set up by Regulation No 2377/90 for the
establishment of maximum residue limits
of veterinary medicinal products in food­
stuffs of animal origin, the Committee on
Veterinary Medicinal Products has given
a favourable opinion on a request for the
inclusion of a substance in Annex II, sub­
mitted under Article 6(1) of the regu­
lation, the Commission is under an obli­
gation to draw up a draft regulation
including that substance in Annex II and
to submit it to the Adaptation Committee
for approval pursuant to Article 6(4) and
(5). The Commission is in breach of the
regulation if it rejects such a request on
the ground that the marketing of the
substance is banned because of a morato­
rium set up by the Council on its market­
ing and administration in the Community
and that the conditions in Article 6(1) of
the regulation are therefore not met.
That provision does not make the inclu­
sion of a substance subject to the con­
dition that a product containing the
substance should be capable of being used
and marketed at once, as the procedure
for the establishment of maximum resi­
due limits under Regulation No 2377/90
is independent of and distinct from the
procedures laid down in Directive 81/851
and Regulation No 2309/93 which govern
respectively the issue of national and
Community authorisations for the mar­
keting of veterinary medicinal products.
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