Order — ECLI:EU:T:2003:116
Date: 2003-04-11
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Agriculture and Fisheries;Animal feedingstuffs;Approximation of laws
Concepts: Application for interim measures: suspension of operation of the contested measure and other interim measures;Applications by natural or legal persons;Health problems;Powers of the Community institutions;Precautionary principle
Procedure: Action for annulment;Application for interim measures - unfounded
Origin: Netherlands

Summary of the Order 
1. Actions for annulment — Natural or legal persons — Measures of direct and 
individual concern to them — Regulation providing for withdrawal of marketing 
authorisation for the additive Nifursol in animal feedingstuffs — Admissibility 
(Art. 230, fourth para., EC; Council Regulation No 1756/2002) 
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SUMMARY — CASE T-392/02 R 
2. Agriculture — Common agricultural policy — Implementation — Taking account 
of the precautionary principle — No express reference — Not relevant — Appli­
cation of the principle — Scope — Limits 
(Arts 152 EC and 174 EC; Council Regulation No 1756/2002; Commission Regulation 
No 2430/1999; Council Directive 70/524, Art. 3a(b)) 
3. Agriculture — Common agricultural policy — Re-evaluation of an additive in animal 
feedingstuffs expressly not subject to re-evaluation — Renewal of marketing auth­
orisation — Withdrawal of authorisation — Obligation of the Commission to serve 
formal notice on the person responsible for bringing the additive into circulation — 
Limits 
(Council Directives 70/524, Art. 9m, second and fifth indents, 3a(b) and 9h and 96/51) 
4. Applications for interim measures — Suspension of operation of a measure — 
Interim relief — Conditions for granting — Urgency — Assessment criteria — 
Decision to adjudicate on the substance of the action under an expedited procedure 
within the meaning of Article 76a of the Rules of Procedure of the Court of First 
Instance — Not relevant 
(Rules of Procedure of the Court of First Instance, Art. 76a(1)) 
5. Applications for interim measures — Suspension of operation of a measure — 
Suspension of operation of a regulation providing for withdrawal of marketing 
authorisation for an additive in animal feedingstuffs — Conditions for granting — 
Serious and irreparable damage — Damage of a financial nature — Scope — Limits 
6. Applications for interim measures — Suspension of operation of a measure — 
Conditions for granting — Balancing of all the interests at stake — Priority to be 
given to protection of public health over economic considerations — Priority to be 
given to the protection of human health over that of animal health 
(Art. 30 EC; Rules of Procedure of the Court of First Instance, Art. 108) 
1. The fourth paragraph of Article 230 
EC is designed in particular to prevent 
the Community institutions from being 
able, merely by choosing the form of a 
regulation, to preclude an individual 
from bringing an action against a 
decision which concerns him directly 
and individually and thus to make it 
clear that the nature of a measure 
cannot be changed by the form chosen. 
Given that the sole aim of Regulation 
No 1756/2002 amending Directive 
70/524/EEC concerning additives in 
feedingstuffs as regards withdrawal of 
the authorisation of an additive and 
amending Commission Regulation 
(EC) No 2430/1999 was to withdraw 
marketing authorisation for the addi­
tive Nifursol, of which the trader is the 
sole holder, and given that the latter is 
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SOLVAY PHARMACEUTICALS v COUNCIL 
also — as is apparent from Annex I to 
Regulation No 2430/1999 — the 'per­
son responsible for putting it into 
circulation', it seems prima facie, even 
if that regulation were to be regarded 
as a measure of general application, 
that that trader should be regarded as 
directly and individually concerned by 
it. 
(see paras 56-57) 
2. In accordance with Article 174 EC, the 
precautionary principle is one of the 
principles on which Community policy 
on the environment is based; this 
includes the policy relating to the 
protection of human health. The prin­
ciple is also established in Article 152 
EC as forming a constituent part of the 
Community's other policies, amongst 
them the common agricultural policy. 
The absence of express reference to the 
precautionary principle in the recitals 
of Regulation No 1756/2002 amending 
Directive 70/524/EEC concerning addi­
tives in feedingstuffs as regards with­
drawal of the authorisation of an 
additive and amending Commission 
Regulation (EC) No 2430/1999 is not 
enough to preclude the relevance of 
that principle to the interpretation, in 
the present case, of the term 'adversely 
affect' referred to in Article 3a(b) of 
Directive 70/524, as amended. It fol­
lows prima facie that the Community 
institutions may, in the course of 
applying Directive 70/524 , as 
amended, adopt measures on the basis 
of Article 3a(b), which take account of 
that principle, but are not necessarily 
required, when they adopt them, to 
make express reference to it. 
However, a preventive measure may be 
taken only if the risk, although the 
reality and extent thereof have not 
been 'fully' demonstrated by conclusive 
scientific evidence, appears neverthe­
less to be adequately backed up by the 
scientific data available at the time the 
measure was taken. Even if the judg­
ment in Case C-121/00 Hahn justified 
the legislature in adopting zero or 
near-zero tolerance, that presupposes 
that the risk in question is well-estab­
lished. Although the fact that the 
scientific data concerning the extent 
of a risk are uncertain docs not, in 
Community law, preclude the risk from 
being regarded as established, it seems 
that a minimum level of scientific 
knowledge is still required. 
(see paras 71-72, 80-81) 
3. The interpretation of the second and 
fifth indents of Article 9m, and of 
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SUMMARY — CASE T-392/02 R 
Article 3a(b), on the one hand, and of 
Article 9h, on the other, of Directive 
70/524 concerning additives in feed-
ingstuffs, as amended by Directive 
96/51, does not justify precluding, at 
first sight, that, when the Commission 
re-evaluates an additive which is 
expressly not made subject to re-evalu­
ation by the Community legislature in 
Directive 96/51 and subsequently 
renews the authorisation for a period 
of 10 years pursuant to the amend­
ments introduced by that directive, it 
should be required — except in urgent 
cases in which a new, clear and serious 
risk suddenly appears — by itself, or 
through the Member State which is the 
rapporteur of the file, to send formal 
notice to the person responsible for 
bringing the additive concerned into 
circulation. Such a notice should con­
tain a short but specific indication of 
the scientific doubts justifying re-evalu­
ation and be sent during the re-evalu­
ation procedure or, at least, before the 
Commission proposes the withdrawal 
of the authorisation of the additive. 
Accordingly, in the absence of any 
communication in the nature of such 
formal notice, the President of the 
Court cannot exclude the possibility 
that the regulation withdrawing auth­
orisation of an additive expressly not 
made subject to re-evaluation is unlaw­
ful owing to an infringement of the 
fifth indent of Article 9m of Directive 
70/524, as amended, during the pro­
cedure which preceded its adoption. 
(see paras 85-87) 
4. The fact that the Court of First Instance 
decided to reject the applicant's request 
that the Court adjudicate on the sub­
stance of the action under an expedited 
procedure cannot influence either the 
assessment of urgency or, should it 
prove necessary, the balancing of the 
interests concerned by the Judge hear­
ing the application for interim meas­
ures. The relevant criteria for the exist­
ence of a 'particular urgency' which, 
under Article 76(a)(1) of the Rules of 
Procedure of the Court of First 
Instance, are to be satisfied if the Court 
is to adjudicate under an expedited 
procedure and those which, according 
to the case-law, govern the assessment 
of the condition of urgency that must 
be satisfied before the Judge hearing an 
application for interim measures is able 
to adopt such measures are only partly 
the same. Furthermore, the grant of an 
application for a case to be decided 
under an expedited procedure lies 
within the discretion of the Court, as 
is apparent from the use of the word 
'may' in the first subparagraph of 
Article 76a(1) of the Rules of Pro­
cedure and requires that account also 
be taken of other circumstances, 
including the impact which the grant 
will have on the length of the proceed­
ings in other cases. 
(see para. 104) 
5. Damage of a purely pecuniary nature 
cannot, save in exceptional circum­
stances, be regarded as irreparable or 
even as being reparable only with 
difficulty, if it can ultimately be the 
subject of financial compensation. 
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SOLVAY PHARMACEUTICALS v COUNCIL 
Under that principle, suspension of a 
regulation withdrawing authorisation 
of an additive in animal feedingstuffs 
could be justified only if it appeared 
that, if the measure were not granted, 
the applicant would be placed in a 
situation which would endanger its 
very existence or irremediably affect 
its market share. 
As regards the first of these hypotheses, 
assessment of an applicant's economic 
circumstances can be made by taking 
into account, for example, the char­
acteristics of the group of which, by 
virtue of its shareholding structure, it 
forms part. 
Concerning the second hypothesis, the 
risk of the introduction of a marketing 
prohibition, comparable to that intro­
duced by the contested regulation, on 
certain markets in non-member Euro­
pean countr ies cannot validly be 
invoked to establish the urgency for 
suspending such a Community meas­
ure. If there are no obstacles of a 
structural or legal nature preventing 
the manufacturer of a product, who is 
required to have a marketing auth­
orisation, from regaining a significant 
proportion of its market share with the 
help inter alia of appropriate publicity 
measures, it cannot be ruled out that 
the loss caused by a withdrawal of its 
authorisation is essentially of a finan­
cial nature. That would be so in the 
case of the loss arising from withdra­
wal of authorisation for Nifursol in 
animal feedstuffs. However, the Presi­
dent of the Court cannot wholly 
exclude the possibility that such argu­
ments underestimate the difficulties 
which the applicant would have, prob­
ably at each level of the production 
chain and above all at the levels of the 
farmers and large retailers, in relaunch­
ing its product in two years at least. 
Furthermore, and more significantly, it 
is difficult to exclude the possibility 
that the structure of the Community 
market for the sale of turkey-meat 
might be permanently and significantly 
altered between now and the date on 
which judgment is given on the sub­
stance by an increase in imports from 
non-member countries. 
In those circumstances, the risk of 
damage which is serious and partly 
irreparable or reparable only with dif­
ficulty following the withdrawal of 
Nifursol during the course of the main 
proceedings cannot be ruled out. 
(see paras 106-108, 110, 113-120) 
6. When balancing the interests, the Judge 
hearing the application for interim 
relief has to determine whether the 
annulment of the contested measure by 
the court hearing the main action 
would enable the situation brought 
about by its immediate implementation 
to be reversed and, conversely, whether 
suspension of the operation of that 
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SUMMARY — CASE T-3 92/02 R 
measure would be such as to prevent its 
being fully effective in the event of the 
main application being dismissed. 
In that respect, the requirements of the 
pro tec t ion of public heal th must 
undoubtedly take precedence over 
economic considerations. It follows 
that, where a serious risk to human 
health is invoked by a defendant Com­
munity institution, the Judge hearing 
the application for interim relief, not­
withstanding his formal discretion in 
balancing the interests, will almost 
inevitably lean in favour of protecting 
public health. That is the case even if 
the urgency justifying the grant of the 
interim measure requested is obvious. 
Moreover, the protection of the inter­
ests of Community turkey-meat pro­
ducers, although commendable, cannot 
outweigh the damage which might be 
caused by the suspension of Regulation 
N o 1756/2002 amending Directive 
70/524 concerning additives in feed-
ingstuffs as regards withdrawal of the 
au thor i sa t ion of an addit ive and 
amending Regulation No 2430/1999 
if the reality of the risk on which the 
Council based the regulation is con­
firmed. The fact that the Council (or 
the Commission) may have recourse to 
Article 108 of the Rules of Procedure of 
the Court of First Instance, should the 
requested suspension be granted and/or 
more scientific data be available before 
the judgment on the substance, in order 
to justify the withdrawal ordered by 
the contested regulation does nothing 
to alter the situation, as it is not enough 
to eliminate the risks presented in the 
meantime by the transmission to con­
sumers of potentially genotoxic resi­
dues. 
As for the protection of animal health 
although it is true that an increase in 
morbidity and mortality in Community 
turkey-farming caused by more fre­
quent and disastrous outbreaks of 
histomoniasis is foreseeable from now 
on, the protection of animal health — 
the importance of which is, admittedly, 
acknowledged in Community law, par­
ticularly in Article 30 EC — cannot 
outweigh the pre-eminent nature of the 
requirements related to human health. 
(see paras 122-127) 
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