Case C-365/03 P(R)


Industrias Químicas del Vallés SA
v
Commission of the European Communities

«(Appeal – Procedure for interim relief – Application for suspension of operation – Plant-protection products – Active substances – Metalaxyl)»

Order of the President of the Court, 21 October 2003
I - 0000
    

Summary of the Order

1..
Appeals – Grounds – Error of law on the part of the Judge hearing the application – Effect on the validity of the interlocutory order

(Statute of the Court of Justice, Art. 57(2); Council Directive 91/414, Annex I)

2..
Applications for interim measures – Suspension of operation of a measure – Interim measures – Conditions for granting – Prima facie case – Serious and irreparable harm – Balancing of all the interests in issue – Commission's general interest in having Community legislation applied before the decision on the merits – Assessment

(Arts 242 EC and 243 EC; Commission Regulation No 3600/92)

1.
Where, in circumstances in which a producer is the only undertaking to support the inclusion of an active substance in Annex I to Directive 91/414 concerning the placing of plant protection products on the market, but another producer concerned, the only producer to have submitted an essentially complete dossier, has withdrawn from the procedure, although the rapporteur Member State agreed to continue the examination procedure based on that dossier, the Judge hearing the application, in his findings as to the serious nature of the pleas put forward, has not ruled out the possibility that that undertaking is not required to provide a complete dossier within a certain time-limit, he cannot, at the same time, without committing an error of law, consider that the fact that it has not produced a complete dossier is a factor against it, in the context of his assessment of the interests at stake. Since the other factors examined by the Judge hearing the application for interim measures in the course of that assessment do not alone justify a conclusion that the result of the assessment is unfavourable to that undertaking and since, moreover, the urgency of the application and the serious nature of the pleas of fact and of law put forward were recognised in the order under appeal, that error of law is sufficient reason to set aside that order. see paras 12-13

2.
In the context of an application for suspension of the operation of a decision concerning the non-inclusion of an active substance in Annex I to Directive 91/414 concerning the placing of plant protection products on the market and the withdrawal of authorisations for plant protection products containing that active substance, the harm to the Commission's general interest in having Community legislation, in particular Regulation No 3600/92, laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Directive 91/414, applied before the decision on the merits must be put into perspective in the assessment of the interests at stake, since other substances referred to by Article 8(2) continue to be authorised for a limited period, without being subject to the scientific assessment laid down by the directive. see paras 17, 23




ORDER OF THE PRESIDENT OF THE COURT
21 October 2003 (1)


((Appeal – Procedure for interim relief – Application for suspension of operation – Plant-protection products – Active substances – Metalaxyl))

In Case C-365/03 P(R),

Industrias Químicas del Vallés SA, established in Barcelona (Spain), represented by C. Fernández Vicién and J. Sabater Marotias, abogados,

applicant,

APPEAL against the order of the President of the Court of First Instance of the European Communities of 5 August 2003 in Case T-158/03 R Industrias Químicas del Vallés v Commission [2003] ECR II-3041, seeking to have that order set aside,

the other party to the proceedings being:

Commission of the European Communities, represented by B. Doherty and S. Pardo Quintillán, acting as Agents, with an address for service in Luxembourg,defendant at first instance,



THE JUDGE HEARING APPLICATIONS FOR INTERIM MEASURES,



acting in lieu of the President of the Court, in accordance with the second paragraph of Article 85 of the Rules of Procedure of the Court of Justice, which applies to appeal proceedings by virtue of Article 118 thereof, after hearing the views of Advocate General Tizzano, makes the following



Order



1
By application lodged at the Registry of the Court of Justice on 22 August 2003, Industrias Químicas de Vallés SA ( IQV) brought an appeal under Article 225 EC and the second paragraph of Article 57 of the Statute of the Court of Justice against the order of the President of the Court of First Instance of 5 August 2003 in Case T-158/03 R Industrias Químicas del Vallés v Commission [2003] ECR II-3041 ( the order under appeal), by which he dismissed IQV's application for suspension of the operation of Commission Decision 2003/308/EC of 2 May 2003 concerning the non-inclusion of metalaxyl in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant-protection products containing this active substance (OJ 2003 L 113, p. 8) ( the contested decision).

2
By document lodged at the Court Registry on 16 September 2003, the Commission submitted its observations.

3
Since the written observations of the parties and the documents in the file contain all the information necessary for a decision in the present appeal, there is no need to hear the parties.

4
The legal background of the dispute and of the application for suspension of the operation of the contested decision is set out in paragraphs 1 to 16 of the order under appeal, to which reference is made. The relevant texts are Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1) and Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414 (OJ 1992 L 366, p. 1).

5
The facts of the dispute and the procedure before the Court of First Instance and the Judge hearing the application for interim measures are set out in paragraphs 17 to 41 of the order under appeal, to which reference is made.

The order under appeal

6
In paragraphs 59 to 76 of the order under appeal the Judge hearing the application for interim measures acknowledged the urgency, from IQV's point of view, of obtaining the suspension of operation sought. He considered that, in the absence of suspension, IQV would probably suffer serious and irreparable damage in so far as the contested decision involves the withdrawal, before 3 November 2003, of authorisations for the plant-protection products containing metalaxyl marketed by IQV. In the absence of suspension, IQV might find it difficult, within a short period, to offer alternative products to its clients and would run the risk of suffering irreparable loss of market shares given the conditions of competition on the market in question.

7
In paragraphs 84 to 101 of the order under appeal the Judge hearing the application for interim measures also accepted that certain pleas of fact and law relied on by IQV could, at first sight, justify suspension of the operation of the contested decision (prima facie case). He found IQV's plea alleging an infringement of the principle of proportionality was of a serious nature, in particular because the Commission had not given it sufficient time to lodge a complete dossier, as defined in Article 6(3) of Regulation No 3600/92, to permit a full scientific assessment of metalaxyl. The statement of reasons in the contested decision did not show whether the Commission interrupted the assessment procedure in respect of metalaxyl because that procedure could no longer be completed within the legally binding time-limit, or whether it was a purely administrative decision (paragraph 95 of the order under appeal). The Judge hearing the application also held that, although, in principle, it was not clear that the Commission should have amended the regulation so as to extend the time-limit laid down for the presentation of the study reports necessary for the assessment of metalaxyl, that point nevertheless raised difficult issues of principle requiring a thorough examination which could not be resolved at the stage when an application for interim measures was examined (paragraph 100). Finally, in paragraph 101 of the order under appeal, the Judge hearing the application held: It is also appropriate to take account of the fact that Regulation No 3600/92 is a measure which is difficult to apply, the relevant provisions of which have been amended several times and it does not expressly take account of the applicant's situation as the only undertaking to support the inclusion of an active substance in Annex I to Directive 91/414, albeit after another producer concerned, who was the only producer who lodged a substantially complete dossier, withdrew from the procedure in question, while the rapporteur Member State agreed to continue with the assessment procedure on the basis of that dossier. Accordingly, in order to resolve the issues raised by the application in the main proceedings there must be a thorough investigation of the factual and legal context resulting from that situation, to be carried out once the arguments of both parties have been heard. The Court therefore considers that the pleas raised by the applicant cannot be dismissed as manifestly unfounded at the stage of the examination of the application for interim relief.

8
In paragraphs 105 to 118 of the order under appeal the Judge hearing the application for interim measures assessed the interests at stake. First of all, he observed that the contested decision had not been taken because of serious risks posed by metalaxyl to human health or to the environment. He therefore considered that the grant of suspension of the operation of the contested decision would not give rise to such risks (paragraph 108 of the order under appeal). On the other hand, he put into perspective the damage that IQV would suffer if its application for suspension of operation were dismissed, pointing out that IQV could continue to sell the products at issue in nine States which were not part of the Community (paragraph 109 of the order under appeal). Next, the Judge hearing the application held that IQV had itself contributed in large measure to the damage which it claimed it would suffer by failing, without objective justification, to make adequate arrangements to lodge in good time a complete dossier, as defined in Article 6(3) of Regulation No 3600/92. He dismissed the possibility that during the procedure which led to the contested decision IQV might have received assurances of such a kind as to lead it to believe that it would not be required to lodge such a dossier (paragraphs 111 to 113 of the order under appeal). He held that, although the Member State designated as the rapporteur in respect of the application for inclusion of metalaxyl in Annex I to Directive 91/414 appeared to have contributed to a large extent to the situation because of its disregard of a number of time-limits applicable to that procedure, IQV, which was aware of that deficiency, should have taken measures enabling it nevertheless to lodge a complete dossier in good time (paragraphs 114 and 115 of the order under appeal). The Judge hearing the application also observed that grant of the suspension sought would directly affect the general interest of the Commission in having Community legislation, in particular Regulation No 3600/92, applied (paragraph 116 of the order under appeal). Finally, he held that even if IQV were entitled to express the interest of certain producers situated outside the Community which use metalaxyl, and even if the ban on the producers concerned importing into the Community their products treated with metalaxyl derived directly from the contested decision, those producers could probably use a substitute for that substance. Therefore, the Judge hearing the application held that IQV had not demonstrated the existence of damage caused to the producers concerned by the obligation to have recourse to such a substitute (paragraph 117 of the order under appeal). He concluded that his assessment of the interests at stake weighed in favour of a refusal to grant suspension of the operation of the contested decision.

Forms of order soughtby the parties

9
IQV claims that the Court should:

─
set aside the order under appeal;

─
grant suspension of the operation of the contested decision;

─
in the alternative, refer the application for suspension back to the Court of First Instance for examination; and

─
order the Commission to pay the costs of the appeal and the procedure for interim relief before the Court of First Instance.

10
The Commission contends that the Court should:

─
dismiss the appeal as inadmissible and, in the alternative, as unfounded;

─
in the alternative, in the event that the appeal is upheld, dismiss the application for suspension of the operation of the contested decision; and

─
order IQV to pay the costs of both sets of proceedings.

The appeal

11
IQV puts forward several grounds in support of its appeal, in particular, that the Judge hearing the application for interim measures erred in law by failing properly to balance the interests at stake. On that basis it submits essentially that, given the circumstances of the case, in particular the fact that the assessment procedure for metalaxyl was instituted with the participation of another notifier who withdrew from that procedure only after having lodged in good time a complete dossier, within the meaning of Article 6(3) of Regulation No 3600/92, the Judge hearing the application should not, in assessing the interests at stake, have accepted as a factor unfavourable to its application the fact that IQV was not itself also able to produce a complete dossier in good time. The Judge hearing the application attributed too much weight to that factor, without taking account of the involvement of a third party in that procedure.

12
It should be pointed out that in paragraph 101 of the order under appeal, set out in paragraph 7 of the present order, the Judge hearing the application, in his findings as to the serious nature of the pleas put forward by IQV, did not rule out the possibility that in such circumstances a notifier who remains after the withdrawal of another notifier is not required to provide a complete dossier within a certain time-limit. Therefore, the Judge hearing the application could not, at the same time, without committing an error of law, consider that the fact that IQV had not produced a complete dossier was a factor against it, in the context of his assessment of the interests at stake.

13
Since the other factors examined by the Judge hearing the application for interim measures in the course of that assessment do not alone justify a conclusion that the result of the assessment is unfavourable to IQV and since, moreover, the urgency of the application and the serious nature of the pleas of fact and of law put forward were recognised in the order under appeal, that error of law is sufficient reason to set aside that order without there being any need to examine the other grounds of appeal.

14
Under the first paragraph of Article 61 of the Statute of the Court of Justice, if the appeal is well founded, the Court is to quash the decision of the Court of First Instance. It may then itself give final judgment in the matter, where the state of the proceedings so permits, or refer the case back to the Court of First Instance for judgment. Since the state of the proceedings so permits, it is appropriate to make an order on the application for suspension of operation of the contested decision.

The application for suspension of operation

15
At this stage of the proceedings, the Commission disputes only the recognition of the pleas in law put forward by IQV against the contested decision as serious in nature.

16
The Commission argues, in answer to IQV's plea alleging infringement of the principle of proportionality, that the Judge hearing the application for interim measures accepted, in paragraph 94 of the order under appeal, that the aim of Directive 91/414 is not only to carry out a full scientific assessment of the substances subject to the procedure laid down in Article 8(2), but also to do so within a given time-limit. The Commission points out that the Judge hearing the application went on, in paragraph 95 of the order under appeal, to cast doubt on whether the contested decision had been taken on that ground, because its reasoning was ambiguous. The Commission denies that the statement of reasons was inadequate and takes the view that, in any event, that cannot affect the legality of the contested decision, given the overall conclusion reached by the Judge hearing the application in paragraph 94 of the order under appeal.

17
That argument must be rejected. Even if Directive 91/414 requires the scientific assessment of the active substances subject to the procedure laid down in Article 8(2) to be carried out within a certain time-limit, when the Court examines the legality of the decision, in deciding the merits of the case, it may examine whether the grounds set out in the contested decision reflect such legal reasoning. It is possible, in the light of its wording and of the context in which it was taken, that the decision was based more on considerations of overall management of the dossiers relating to the active substances subject to the procedure than on intangible legal constraints. It must be observed, in that regard, that a certain number of active substances falling within the scope of Directive 91/414 have had the period originally laid down for their assessment in the light of the requirements of that directive extended. Such was the case when the Commission adopted Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Council Directive 91/414 and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these substances (OJ 2002 L 319, p. 3).

18
The Commission goes on to state, in response specifically to IQV's argument that the Commission could either have had the complete dossier lodged by another notifier distributed to all the Member States so that the assessment procedure for metalaxyl could proceed without delay, or allowed IQV a reasonable period in which to reconstitute such a dossier, that the Judge hearing the application for interim measures rejected those two solutions on the ground that the Commission did not have a legal basis for requiring the rapporteur Member State to distribute the dossier and that it was too late for IQV to gather the additional data which might have been required, given that that data should have been available on 25 May 2002, pursuant to Article 7(4) of Regulation No 3600/92. The Commission submits that having reached those conclusions, in paragraphs 98 and 99 of the order under appeal, the Judge hearing the application could not examine of his own motion, in paragraph 100, a third possibility, namely that the Commission amend Regulation No 3600/92 in order to postpone the date of 25 May 2002, and consider that it was conceivable that it should have chosen that solution.

19
That argument must also be rejected. It appears that, contrary to the Commission's submissions, the President did not raise an issue of his own motion but simply examined the complaint raised by IQV that the Commission could have allowed it further time.

20
In any event, the reasons set out in paragraph 101 of the order under appeal, set out in paragraph 7 of this order, are sufficient for it to be conceivable in the circumstances of the case that it was not possible to require IQV to produce certain information and a complete dossier within the time-limit laid down. The serious nature of the ground of appeal alleging an infringement of the principle of proportionality is accordingly established.

21
Certain grounds of fact and law relied on by IQV therefore justify, at first sight, suspension of the operation of the contested decision (prima facie case).

22
Moreover, there appears to be no reason of such a kind as to cast doubt on the assessment of urgency as set out in paragraph 6 of the present order.

23
Finally, in the light of all the factors taken into account by the Judge hearing the application for interim relief at first instance, summarised in paragraph 8 of this order, apart from the finding that IQV itself contributed to its own injury by not submitting a complete dossier within the time-limit laid down in Article 6(3) of Regulation No 3600/92, assessment of the interests at stake indicates that suspension of operation of the contested decision should be granted. In particular, the evidence provided to the Judge hearing the application shows that the suspension of operation of the contested decision would not lead to a serious risk to human health or to the environment. Moreover, regarding the general interest of the Commission in having Community legislation, in particular Regulation No 3600/92, applied before the decision on the merits, the harm to that interest must be put into perspective since, under Regulation No 2076/2002, substances other than metalaxyl which are also subject to the procedure laid down in Article 8(2) of Directive 91/414 continue to be authorised until 31 December 2005, without being subject to the scientific assessment laid down by that directive.

On those grounds,

THE JUDGE HEARING APPLICATIONS FOR INTERIM RELIEF

hereby orders:

1.
The order of the President of the Court of First Instance of the European Communities of 5 August 2003 in Case T-158/03 R Industrias Químicas del Vallés v Commission [2003] ECR II-3041 is set aside.

2.
The operation of Commission Decision 2003/308/EC of 2 May 2003 concerning the non-inclusion of metalaxyl in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant-protection products containing this active substance is suspended until delivery of the judgment of the Court of First Instance of the European Communities in the main proceedings in Case T-158/03.

3.
The costs are reserved.

Luxembourg, 21 October 2003.

R. Grass

J.-P. Puissochet

Registrar

Judge hearing applications for interim measures in lieu of the President

1 –
Language of the case: Spanish.