In Case T-339/00 R,
Bactria Industriehygiene-Service GmbH, established at Kirchheimbolanden (Germany), represented by K. Van Maldegem and C. Mereu, lawyers, with an address for service in Luxembourg,
applicant,
v
Commission of the European Communities, represented by R. Wainwright and L. Ström, acting as Agents, with an address for service in Luxembourg,
defendant,
APPLICATION for suspension of operation of Article 6(2) and (3) and Article 7(1) of Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products (OJ 2000 L 228, p. 6),
THE PRESIDENT OF THE COURT OF FIRST INSTANCE
OF THE EUROPEAN COMMUNITIES
makes the following
Order
Legal context
1 On 16 February 1998 the European Parliament and the Council adopted Directive 98/8/EC concerning the placing of biocidal products on the market (OJ 1998 L 123, p. 1), which introduced Community rules for the authorisation and placing on the market of biocidal products proposed for use.
2 The authorisation procedures provided for thereunder enable account to be taken of the specific nature of biocidal products and the risks associated with their use.
3 According to the 12th recital in the preamble to Directive 98/8, it is necessary to establish a Community list of active substances permitted for inclusion in biocidal products, and a Community procedure for assessing whether or not a particular active substance may be entered in that list; it is also necessary to specify the information that interested parties must submit in order to have an active substance entered in the list. The recital then states that the list should be reviewed periodically, and, if appropriate, the substances on the list should be compared with each other under specific conditions, so that developments in science and technology can be taken into account.
4 Article 5(1)(a) of Directive 98/8 provides that Member States are to authorise a biocidal product only if the active substance(s) included therein are listed in Annex I or IA and any requirements laid down in these Annexes are fulfilled. Annex I to the Directive is to contain a list of active substances with requirements agreed at Community level for inclusion in biocidal products. Annexes IA and IB concern, respectively, low-risk biocidal products and basic substances.
5 Article 9 of Directive 98/8 requires Member States to prescribe that, where a substance is an active substance for use in biocidal products, it may not be placed on the market for such use unless, in particular, a dossier satisfying the requirements laid down in Article 11(1) has been forwarded to one of the Member States, together with a declaration that the active substance in question is intended for inclusion in a biocidal product.
6 Article 11 of Directive 98/8 lays down the procedure for inclusion of an active substance in Annex I, IA or IB. An application must be submitted before an active substance can be included in one of those lists, or subsequent changes made. Under Article 11(1)(a), the applicant must forward to the competent authority of one of the Member States a dossier on the active substance which satisfies the requirements of the appropriate annex - Annex IIA, IIIA or IVA - as well as a dossier on at least one biocidal product containing the active substance which satisfies the requirements of Article 8 of the Directive. On completion of certain formalities, the dossier is to be sent, inter alia, to the Commission and a decision is to be taken in accordance with the procedure provided for in Article 28 of Directive 98/8 as to whether that substance may be listed in Annex I, IA or IB.
7 Article 12 of Directive 98/8 provides, under the heading Use of data held by competent authorities for other applicants, that:
1. Member States shall not make use of the information referred to in Article 8 [requirements for authorisation] for the benefit of a second or subsequent applicant:
...
(c) in the case of an active substance already on the market on the date referred to in Article 34(1):
(i) for a period of 10 years from the date referred to in Article 34(1) for any information submitted for the purposes of this Directive, except where such information is already protected under existing national rules relating to biocidal products. In such cases, the information shall continue to be protected in that Member State until the expiry of any remaining period of data protection provided for under national rules, up to a maximum of 10 years from the date referred to in Article 34(1);
....
8 Under Article 16(1) of Directive 98/8, Member States may, for a period of 10 years from 14 May 2000, derogate from the following requirements: that authorisation be obtained in accordance with the Directive in respect of any biocidal product (Article 3(1)); that active substances be listed in Annex I or IA (Article 5(1)); that applicants submit certain information (Article 8(2) and (4)); and, lastly, the requirement laid down in Article 8(1). Article 16(1) also provides that a Member State may, in particular, according to its national rules, authorise the placing on the market in its territory of a biocidal product containing [existing] active substances not listed in Annex I or IA for that product type. That possibility of derogation is available to Member States subject to restrictions or limitations in accordance with Article 16(2) and (3).
9 Article 16(2) of Directive 98/8 provides:
Following the adoption of this Directive, the Commission shall commence a 10-year programme of work for the systematic examination of all active substances already on the market on the date referred to in Article 34(1) as active substances of a biocidal product for purposes other than those defined in Article 2(2)(c) and (d). A Regulation, adopted according to the procedure laid down in Article 28(3), will provide for all provisions necessary for the establishment and implementation of the programme including the setting of priorities for the evaluation of the different active substances and a timetable. No later than two years before completion of the work programme, the Commission shall forward to the European Parliament and the Council a report on the progress achieved with the programme.
During that 10-year period and from the date referred to in Article 34(1), it may be decided pursuant to the procedure laid down in Article 28(3) that an active substance shall be included in Annexes I, IA or IB and under which conditions, or, in cases where the requirements of Article 10 [relating to inclusion on the lists] are not satisfied or the requisite information and data have not been submitted within the prescribed period, that such active substance shall not be included in Annex I, IA or IB.
10 On 7 September 2000 the Commission adopted Regulation (EC) No 1896/2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8 (OJ 2000 L 228, p. 6; hereinafter the contested Regulation). Its purpose was to initiate the first phase of a programme of work for the review of all active substances of biocidal products already on the market on 14 May 2000 (hereinafter the review programme). As indicated in the second recital in the preamble to the Regulation, [t]he first phase of the review programme is intended to enable the Commission to identify existing active substances of biocidal products and specify those which should be evaluated for a possible inclusion in Annex I, Annex IA or Annex IB to ... Directive [98/8].
11 The term existing active substance is defined as an active substance on the market before 14 May 2000 as an active substance of a biocidal product for purposes other than those referred to in Article 2(2)(c) and (d) of the Directive.
12 Under that Regulation, each producer of an existing active substance of a biocidal product is to identify that active substance by submitting to the Commission the information on that substance referred to in Annex I to the Regulation, and any formulator - that is to say, the manufacturer or a person established within the Community designated as his representative - may identify an existing active substance (fourth recital and Article 3). The Member States, for their part, may identify existing active substances in addition to those included in the list of all active substances which have been identified (Article 5(1) and (2)).
13 Under the first subparagraph of Article 4(1) of the contested Regulation, [p]roducers, formulators and associations wishing to apply for the inclusion in Annex I or Annex IA to ... Directive [98/8] of an existing active substance in one or more product types shall notify that active substance to the Commission by submitting the information referred to in Annex II to this Regulation.
14 The contested Regulation provides that, in consequence of notification, a regulation is to be adopted in accordance with the procedure laid down in Article 28 of Directive 98/8, containing an exhaustive list of existing active substances to be reviewed during the second phase of the review programme (hereinafter the review list). That list is to contain, inter alia, the existing active substances in respect of which notification has been accepted or in which the Member States have indicated an interest (Article 6(1)(b)).
15 Article 6 goes on to provide:
2. Without prejudice to Article 16(1), (2) or (3) of the Directive, all producers of an active substance included in the [review list] and all formulators of biocidal products containing that active substance may start or continue to place on the market the active substance, as such or in biocidal products, in the product type or types for which the Commission has accepted at least one notification.
3. In accordance with the procedure laid down in Article 28(3) of the Directive, Decisions addressed to Member States shall be adopted stating that the following active substances shall not be included in Annex I, Annex IA or Annex IB to the Directive under the review programme and that these active substances, solely or in biocidal products, shall no longer be placed on the market for biocidal purposes:
(a) active substances not included in the list referred to in paragraph 1(b);
(b) active substances included in the list referred to in paragraph 1(b) in product types for which the Commission has not accepted at least one notification.
However if the active substance is included in the list of existing active substances referred to in paragraph 1(a), a reasonable phase-out period shall be allowed of not more than three years from the date on which the Decision referred to in the first subparagraph takes effect.
16 Lastly, Article 7(1) of the contested Regulation provides that existing active substances of biocidal product types 8 (wood preservatives) and 14 (rodenticides) per Annex V to Directive 98/8, which are included in the list referred to in Article 6(1)(b) of the Regulation are to be included in the first list of existing active substances to be reviewed. Notifiers whose notifications have been accepted by the Commission in accordance with Article 4(2) of the Regulation are to submit complete dossiers in accordance with Article 11(1)(a) of Directive 98/8 with a view to the inclusion of active substances in those product types in Annex I, IA or IB thereto. The dossiers referred to in Article 11(1)(a)(ii) of Directive 98/8 are to cover representative uses of the product, specifically as regards the exposure of humans or the environment to the active substance.
Facts and procedure
17 The applicant, a company governed by German law, manufactures and sells peracetic acid, which is an active substance used in certain biocidal products.
18 By application lodged at the Registry of the Court of First Instance on 8 November 2000, the applicant brought an action under the fourth paragraph of Article 230 EC for annulment of the contested Regulation.
19 By separate document, lodged at the Registry of the Court of First Instance on 12 January 2001, it also applied, under Article 242 EC, for suspension of operation of that Regulation until final judgment is given on the substance.
20 On 18 January 2001 the Commission raised an objection as to admissibility, under Article 114 of the Rules of Procedure of the Court of First Instance, in respect of the application for annulment.
21 On 14 February 2001 the Commission submitted its observations on the application for interim relief.
22 The parties presented oral argument at the hearing on 9 March 2001. In the course of that hearing, the applicant produced a version of the application for interim relief which differed from the original application in that it contained additional elements, and later requested that some of those elements be given confidential treatment. The Commission raised no objection to that request.
23 At the end of the hearing, the President of the Court of First Instance asked the applicant to provide certain information concerning its financial situation within two weeks. This information was produced on 23 March 2001 in the form of a memorandum, together with a statement by Mr Gutknecht and 25 annexes.
24 On 29 March 2001 and 2 April 2001 the Commission lodged the observations which it had been asked to submit with regard to the version of the application for interim relief produced at the hearing and the information provided thereafter by the applicant.
Purpose of the application for interim relief
25 In its application for interim relief, the applicant sought suspension of operation of the contested Regulation.
26 At the hearing, however, the applicant stated that it sought suspension of operation only of Article 6(2) and (3) and Article 7(1) of the contested Regulation.
Law
27 Under Articles 242 EC and 243 EC, read together with Article 4 of Council Decision 88/591/ECSC, EEC, Euratom of 24 October 1988 establishing a Court of First Instance of the European Communities (OJ 1988 L 319, p. 1), as amended by Council Decision 93/350/Euratom, EEC, ECSC of 8 June 1993 (OJ 1993 L 144, p. 21), the Court of First Instance may, if it considers that the circumstances so require, order suspension of operation of the contested measure or prescribe the necessary interim measures.
28 Under the first subparagraph of Article 104(1) of the Rules of Procedure of the Court of First Instance, an application to suspend the operation of any measure is admissible only if the applicant is challenging that measure in proceedings before the Court of First Instance. That rule is no mere formality; rather, it means that the main action, on which the application for interim relief depends, must be admissible.
29 Article 104(2) of the Rules of Procedure provides that applications for interim measures must state the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the measures applied for. Those conditions are cumulative; accordingly, if one of them is not established, the application for interim measures must be dismissed (order in Case C-268/96 P(R) SCK and FNK v Commission [1996] ECR I-4971, paragraph 30). The court hearing the application must also, where appropriate, balance the interests involved (order in Case C-107/99 R Italy v Commission [1999] ECR I-4011, paragraph 59).
30 In the context of that overall examination, the court hearing the application has a wide discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of Community law imposing a pre-established scheme of analysis within which the need to order interim measures must be analysed and assessed (order in Case C-363/98 P(R) Emesa Sugar v Council [1998] ECR I-8787, paragraph 50).
Arguments of the parties
Admissibility
31 The applicant maintains that the contested Regulation is in reality a decision addressed to a limited group of persons to which it belongs. That group is composed of the manufacturers of existing active substances - that is to say, active substances on the market before 14 May 2000 - and the product formulators using such substances.
32 Moreover, since the applicant may be differentiated from all other traders, it must be regarded as individually concerned by the contested Regulation (Case 100/74 CAM v Commission [1975] ECR 1393 and Case C-309/89 Codorniu v Council [1994] ECR I-1853). The applicant is also distinguishable by virtue of certain characteristics (Case 231/82 Spijker Kwasten v Commission [1983] ECR 2559, paragraph 8, and Case T-266/94 Skibsværftsforeningen and Others v Commission [1996] ECR II-1399, paragraph 46).
33 Lastly, at the invitation of the Commission, the applicant actively participated in the adoption of the contested Regulation, through the European Chemical Industry Council, because it had a specific interest in the adoption of that measure. Specifically, the preamble to Directive 98/8 referred to the cooperation between the Commission and the industry concerned.
34 On those grounds, the applicant maintains that it is individually concerned by the contested Regulation.
35 Since the Regulation is directly applicable, its provisions are of direct concern to the applicant.
36 The Commission contends that the application for interim relief must be dismissed on the ground that the principal action on which that application depends is manifestly inadmissible.
37 First, the contested Regulation is of general application. This is clear from the fact that it applies to all manufacturers, formulators, importers, associations and Member States which wish to identify and/or notify existing active substances. The general application, and thus the legislative nature, of a measure is not called in question by the fact that it is possible to determine more or less precisely the number or even the identity of the persons to whom it applies at any given time (see Codorniu, cited above, and the order in Case T-113/99 Galileo and Galileo International v Council [2000] ECR II-4141).
38 Secondly, the applicant has failed to establish that it is distinguished from other producers of active substances. In particular, the closed category of producers alleged by the applicant does not exist, since it is always possible for any producer to start placing on the market active substances already existing before 14 May 2000 and for any formulator to use existing active substances in biocidal products. As for the applicant's participation in the adoption of the contested Regulation, that cannot be described as active participation, nor was it provided for by Community law.
39 Lastly, the applicant is not directly concerned by the contested Regulation. The causal link between that measure and the legal effects contested has not been established in respect of all the provisions of the contested Regulation.
The existence of a prima facie case
40 With a view to establishing a prima facie case, the applicant argues first that the Commission is not competent to adopt a regulation which infringes certain provisions of Directive 98/8 concerning the protection of information. The contested Regulation deprives notifiers of the legal protection conferred by Article 12(1)(c)(i) of Directive 98/8 in respect of existing data on existing active substances, such as peracetic acid, for the period from 14 May 2000 to 14 May 2010, or for periods in respect of which the only protection remaining is that provided by national law.
41 Secondly, the contested Regulation is incompatible with the Treaty, because it distorts competition and infringes the Community rules on competition. It enables undertakings which do not participate in the registration procedure to benefit from the notifications made by those who do; it allows too long a phase-out period - up to three years - for existing active substances which have not been notified or which have been notified incorrectly; and it encourages joint notifications.
42 Lastly, the contested Regulation infringes the right of data ownership, the principles of proportionality, legal certainty, the protection of legitimate expectations, the uniform application of Community law and the supremacy of international agreements.
43 The Commission contends that those arguments are without foundation. The applicant is really contesting the fact that there is no provision prohibiting the marketing of a substance or product by a producer or formulator who has not carried out notification or identification.
44 In particular, the applicant's argument that the contested Regulation effectively eliminates the data protection granted by Article 12(1)(c)(i) of Directive 98/8 cannot be accepted. The contested Regulation does not frustrate Article 12 of the Directive. The information provided for in Annexes I and II to the contested Regulation must be submitted to the Commission. The information which a notifier provides at the same time to a Member State pursuant to the fourth subparagraph of Article 3(1) and the fourth subparagraph of Article 4(1) of the contested Regulation is protected by virtue of Article 12 of the Directive.
45 The fact that producers of an active substance or formulators of a biocidal product containing that substance may start or continue to place it on the market, even though they have not carried out notification or identification, does not constitute an infringement of the provisions of the Directive relating to the protection of information.
46 First, Article 12 of Directive 98/8 prohibits Member States from making use of the information referred to in Article 8, supplied by an applicant for authorisation, for the benefit of a second or subsequent applicant. Throughout the period fixed for protection of such information, the latter are to have no access to it for the purposes of their applications. Article 6(2) of the contested Regulation governs a different matter, namely the right of all producers or formulators to place on the market a substance or product in the product type or types for which the Commission has accepted a notification.
47 Secondly, the Commission points out that the legal context relevant to the present case is provided by Article 16(1) of Directive 98/8, which concerns transitional measures and provides that Member States may, for a period of 10 years from 14 May 2000, continue to apply their current systems or practices of placing biocidal products on the market, provided that the products contain an active substance which was on the market by that date and is not yet listed in Annexes I or IA in accordance with the procedures laid down in the Directive.
48 Thirdly, Article 6(2) of the contested Regulation merely confirms the situation created by those transitional arrangements, that is to say, that the Member States must allow market access for active substances and biocidal products of a product type notified with a view to their inclusion in the various annexes. The Commission notes on this point that, according to the information in its possession, eight producer-importers of peracetic acid are registered in respect of quantities in excess of 10 tonnes per annum. Provided that one of them notifies the substance with a view to its inclusion in the appropriate annex to Directive 98/8, the other producer-importers - including the applicant - may, if they wish, continue to place peracetic acid on the Community market during the transitional period.
49 Fourthly, in normal circumstances, a biocidal product containing peracetic acid which is already on the market in a Member State does not require fresh authorisation during the transitional period, depending on the practice of that Member State. If it does, because the Member State in question so requires or if a new producer-importer wishes during that period to start marketing a biocidal product containing peracetic acid, Article 12 of Directive 98/8 prohibits the authorities of that Member State from making use of the information provided by the applicant/notifier for the purposes of obtaining authorisation.
Urgency
50 The applicant maintains that, if operation of the provisions of the contested Regulation is not suspended, it will suffer serious and irreparable damage.
51 Suspension of operation is needed as a matter of urgency, first because of the obligation under Article 4 of the contested Regulation to submit before 28 March 2002 the information referred to in Annex II, which is required for notification of the peracetic acid it produces. Some of the studies which must be carried out in order to collect the data required have to be carried out over a period of several months; moreover, the cost of preparing and submitting the notification dossier has been estimated at approximately EUR 180 000.
52 The cost of preparing the notification dossier will necessitate an increase in the price of the peracetic acid sold by the applicant, which will in turn lead to a loss of contracts. This will entail considerable financial loss and a reduction in the applicant's share of the Community market in peracetic acid.
53 At the beginning of the 1990s, the applicant's share of the Community peracetic acid market was approximately [...% ], but because of the forthcoming review programme this will probably fall to [...%] in 2001. As a result of the costs entailed by the review programme, the applicant's principal customer [...] terminated a supply contract concluded with the applicant in 1999, with a phase-out period until the end of 2000. Similarly, at the end of 1998, [...] terminated contracts concluded with the applicant. In 1997 those two customers together accounted for [...%] of the total volume of acid sold by the applicant. Thus the cumulative loss estimated for the years 1999 to 2001 amounts to DEM [...].
54 The [...%] fall in turnover (as compared with the 1998 figures) already suffered by the applicant is irreversible in the highly specialised market segment of disinfectants. Moreover, certain undertakings established in central Europe have been instructed not to buy from the applicant, and some of its customers established in the Community have refused to accept slight price increases.
55 In consequence of this situation, the appplicant has had to shed employees: numbers have fallen from 13 in 1997 and 1998 to 9 in 1999, to 7 in 2000 and to 5 in 2001 (see Annex 23 to the observations lodged at the hearing).
56 In the long term, the notification procedure undertaken by the applicant may cause it to lose its entire share in the peracetic acid market to undertakings which, because of the applicant's notification, will benefit free of cost from the inclusion of that substance in Annex I to the Directive. It is also very likely that loss of market share will compel the applicant to abandon the market, which would lead to bankruptcy.
57 Lastly, under the notification procedure a complete dossier must subsequently be submitted for the second phase of the review, at an estimated cost of between EUR 2 million and 5 million.
58 Secondly, the contested Regulation eliminates the data protection granted by Directive 98/8 to existing data on existing active substances for the relevant review period. Whereas Article 12(1)(c)(i) of Directive 98/8 ensures that information will be protected throughout the first review period - from 14 May 2000 until 14 May 2010 - or during periods which remain under the protection of national law, the contested Regulation deprives notifiers of any such protection.
59 Thirdly, the applicant submits that until peracetic acid is listed in Annex I to the Directive, rival undertakings may, without having to bear notification costs, continue to sell products, which are cheaper and more risky, containing the same active substance. The applicant also asserts that competing active substances, other than peracetic acid, which are not deemed to require Community registration may continue to be sold during transitional periods which are unreasonably long.
60 Fourthly, the legal uncertainty created by the absence of technical notes for guidance - despite the fact that these are provided for in Article 33 of Directive 98/8 - has made it impossible for the applicant to start preparing and costing the dossiers. There is no system for the identification of companies which may be interested in making a joint notification of the active substance; nor is there any guidance as to how to submit a joint notification.
61 Lastly, in the observations submitted at the hearing, the applicant maintains that it is not the only undertaking to be affected by those lacunae in the contested Regulation. The four undertakings which sought leave to intervene in the main proceedings and, more generally, those involved in the biocide industry in Europe, are uncertain as to whether the investments entailed by notification are adequately protected.
62 The Commission contends that the condition relating to urgency has not been satisfied.
63 First, much of the damage alleged results, not from the contested Regulation, but from the review programme established by Directive 98/8.
64 Secondly, the allegations concerning the cost of the data needed for notification purposes and the reduction in the applicant's market share have not been established. The Commission points out that, according to established case-law, financial loss alone is not sufficient to establish urgency if it may subsequently be made good. Exceptions to that principle are allowed only where it would be difficult to quantify the financial damage alleged for the purposes of reparation or to reverse the market developments following upon the immediate implementation of the contested act (see the order in Case T-65/98 R Van den Bergh Foods v Commission [1998] ECR II-2641, paragraphs 65 and 66).
65 In the present case, the damage suffered pending a decision in the main proceedings would amount to EUR 180 000, plus the loss of the contract with [...] as from November 2000. The situation is quite different, therefore, from the situation under consideration in Van den Bergh Foods, cited above.
66 Lastly, according to the Commission, the free rider benefit for the applicant's competitors will come into effect only after adoption of the list of active substances referred to in Article 6(1)(b) of the contested Regulation, that is to say, some time after the deadline - 28 March 2002 - for notification with a view to the inclusion of peracetic acid in Annex I or IA to Directive 98/8.
The balance of interests
67 According to the applicant, its interest in obtaining suspension of operation of the contested Regulation outweighs all the other interests at stake. In support of that assertion, the applicant relies, in particular, on its contribution to the development of environmentally friendly biocidal products and on its professional and business ethics.
68 The high level of protection of man and the environment sought by Directive 98/8 would be jeopardised during the period covered by the review programme, that is to say, between 14 May 2000 and 14 May 2010, and probably for a longer period in so far as the contested Regulation authorises and encourages the placing on the market of biocidal products which are hazardous. For instance, if the Regulation's operation is not suspended, sales of chlorine will rise, and although that is a cheaper substance than peracetic acid, it is more hazardous from an ecological point of view.
69 For the same reasons, the contested Regulation is also at odds with the superior environmental and public health principles enshrined in the Responsible Care programme of the chemicals industry, in which the applicant is an active participant.
70 The Commission contends that, on the assumption that the applicant is correct in maintaining that its market share will fall pending the decision in the main proceedings, by its own admission that loss will benefit other producer-importers of peracetic acid which will profit from the applicant's involvement in the notification procedure. During that period, therefore, there is no reason to assume that consumers will shift their preferences from peracetic acid to other substances which are allegedly cheaper but more hazardous. That likelihood would arise, according to the applicant's own arguments, only if the cost of submitting a dossier for peracetic acid were to discourage, not only the applicant, but also all other interested parties from applying to have peracetic acid entered in the review list. In those circumstances, demand would inevitably shift to other substances after the phase-out period referred to in the second subparagraph of Article 6(3) of the contested Regulation - certainly, that is to say, after judgment has been given in the main proceedings.
71 As regards the interests of other producers/formulators, the Commission estimates that there are approximately 2 000 active substances on the market for use in biocidal products, manufactured by some 50 undertakings. Those substances are used in between 10 000 and 20 000 biocidal products, manufactured by a large number of undertakings. According to the Commission, a good many of those undertakings (like the applicant with respect to peracetic acid) have already taken the initial steps necessary to submit the information referred to in Annex II by 28 March 2002. If operation of the Regulation is suspended, their efforts and the related expenditure will have been in vain, at least in the medium term.
72 Lastly, the Comission relies on the general interest vested in implementation of the review programme provided for by the contested Regulation. As is mentioned in Article 6(1) thereof, the Regulation introduces the first phase of the review programme and will be followed by another regulation and all the decisions relating to the listing of the various active substances in one or other of the annexes to the Directive. Thus suspension of operation would compromise the review timetable desired by the Community legislature as a necessary element of its policy of protecting human and animal health as well as the environment.
Findings of the President of the Court of First Instance
Admissibility of the application for interim relief
73 It is settled case-law that, in principle, the issue of the admissibility of the main action should not be examined in proceedings for interim relief, so as not to prejudge the Court's decision on the substance of the case. It may nevertheless appear necessary, when, as in this case, it is contended that the main application to which the application for interim measures relates is manifestly inadmissible, to establish whether there are any grounds for concluding prima facie that the main application is admissible (see the orders in Case 376/87 R Distrivet v Council [1988] ECR 209, paragraph 21; Case C-300/00 P(R) Federación de Cofradías de Pescadores de Guipúzcoa and Others v Council [2000] ECR I-8797, paragraph 34; and Case T-13/99 R Pfizer Animal Health v Council [1999] ECR II-1961, paragraph 121).
74 In the present case, the President of the Court of First Instance considers it appropriate to determine whether the action for annulment is manifestly inadmissible.
75 Under the fourth paragraph of Article 230 EC, the admissibility of an action brought by a natural or legal person for annulment of a regulation is subject to the condition that the regulation contested be in reality a decision which is of direct and individual concern to the applicant. According to settled case-law, the test to be applied in order to distinguish between a regulation and a decision is whether or not the act in question is of general application (orders in Case C-10/95 P Asocarne v Council [1995] ECR I-4149, paragraph 28; Case C-87/95 P CNPAAP v Council [1996] ECR I-2003, paragraph 33; and Case T-114/96 Biscuiterie-Confiserie LOR and Confiserie du Tech v Commission [1999] ECR II-913, paragraph 26). A measure is of general application if it applies to objectively determined situations and produces its legal effects with respect to categories of persons envisaged in the abstract (see Case T-482/93 Weber v Commission [1996] ECR II-609, paragraph 55).
76 The contested Regulation lays down the provisions necessary for the establishment and implementation of the first phase of the review programme referred to in Article 16(2) of Directive 98/8. The first phase was intended to enable an exhaustive list of existing active substances to be drawn up. For that purpose, under the rules governing the identification procedure, producers must, and formulators may, provide the Commission with information on the existing active substances in biocidal products. The contested Regulation also introduces a notification procedure, so that producers and formulators can inform the Commission that they wish to seek registration of an existing active substance in Annex I, IA or IB to Directive 98/8 in respect of one of more product types and that they undertake to provide all the information required so that the active substance can be correctly evaluated and a decision taken in its regard.
77 In consequence, the contested Regulation applies to objectively determined situations and produces its legal effects with respect to categories of persons envisaged in the abstract, namely all the producers and formulators in a position to identify existing active substances and all the producers, formulators and associations who wish to apply for the inclusion in one of the annexes to Directive 98/8 of an existing active substance in respect of one or more product types. The Regulation is therefore a measure of general application for the purposes of the second paragraph of Article 249 EC.
78 However, it is possible for a provision which by nature and application is general in character to concern natural or legal persons individually where it adversely affects them by reason of certain attributes which are peculiar to them or by reason of circumstances which differentiate them from all other persons and thereby distinguish them individually in the same way as the person to whom a measure is addressed (Case C-358/89 Extramet Industrie v Council [1991] ECR I-2501, paragraph 13; Codorniu, cited above, paragraph 19; order in Biscuiterie-Confiserie LOR and Confiserie du Tech, cited above, paragraph 30; and Case T-158/95 Eridania and Others v Council [1999] ECR II-2219, paragraph 56).
79 In the light of that case-law, it must be determined whether in the present case there are factors to suggest that it is possible that the applicant may be concerned by the contested regulation by reason of certain attributes peculiar to the applicant or by reason of circumstances which, with regard to the Regulation, differentiate the applicant from all other persons.
80 First, it should be borne in mind that the fact that the number or even the identities of the persons to whom a measure applies at any given time may be ascertained more or less precisely is not sufficient to call into question the general application, and thus the legislative nature, of that measure and by no means implies that it must be regarded as being of individual concern to those persons so long as it is established that the measure is applicable as a result of an objective legal or factual situation which the measure defines with reference to its purpose (orders in Case C-131/92 Arnaud and Others v Council [1993] ECR I-2573, paragraph 13, and Case T-100/94 Michailidis and Others v Commission [1998] ECR II-3115, paragraph 58). On that point, it is sufficient to note that, in the present case, the contested Regulation is not specifically directed towards the applicant.
81 Secondly, even if the entry into force of the contested Regulation has a particular impact on the applicant's financial situation, and even if the Regulation is such as to affect the applicant's financial situation by reason of the consequences which it entails, that is not enough to differentiate the applicant from all other persons. In fact, the contested Regulation is of concern to the applicant only by reason of its objective status as an undertaking producing and selling peracetic acid, in the same way as any other economic agent in the same situation within the European Community (order in Joined Cases T-14/97 and T-15/97 Sofivo and Others v Council [1998] ECR II-2601, paragraph 37).
82 Furthermore, the fact that a legislative measure may have different specific effects for the various persons to whom it applies is not sufficient to differentiate those persons from all the other economic operators concerned, so long as such application takes effect by virtue of an objectively determined situation (order in Case C-409/96 P Sveriges Betodlares and Henrikson v Commission [1997] ECR I-7531, paragraph 37).
83 Lastly, in so far as the applicant maintains that it belongs to a closed category of economic operators composed of all the producers of active substances existing on 14 May 2000, it should be borne in mind that an individual may be regarded as individually concerned as a member of a limited class of traders only if the institution from which the measure originated had an obligation to take account of the particular situation of those traders when adopting the measure (Federación de Cofradías de Pescadores de Guipúzcoa and Others, cited above, paragraph 46).
84 However, the contested Regulation is designed specifically to enable existing active substances to be identified with a view to their systematic review on the basis of information which must be provided by economic operators belonging to a number of categories, one of which comprises the producers of existing active substances.
85 The Regulation adopts the provisions necessary for the establishment and implementation of the programme referred to in Article 16(2) of Directive 98/8. According to the 23rd recital in the preamble to that Directive:
the implementation of this Directive, the adaptation of its Annexes to the development of technical and scientific knowledge and the inclusion of active substances in the appropriate Annexes necessitate close cooperation between the Commission, the Member States and the applicants ....
86 Moreover, the procedure for the notification of active substances provides for the participation, inter alia, of producers of active substances and requires them - if they apply for the inclusion of an existing active substance in Annex I, IA or IB to the Directive in respect of one or more product types - to undertake to provide all the information needed for the correct evaluation of that substance and the adoption of a decision in its regard (fifth recital in the preamble to the contested Regulation and Articles 4 and 7(1) thereof).
87 It follows that, in so far as it may be shown that the applicant belongs to a closed category in relation to the contested Regulation, that measure may arguably be of individual concern to the applicant as a member of a category of traders whose specific interests had to be taken into account by the Commission when adopting the contested Regulation, a fact which entails for those traders certain obligations.
88 Moreover, the applicant is directly concerned by the contested Regulation, which directly refers to an active substance which the applicant produces and in respect of which the Regulation requires the completion of certain formalities.
89 In those circumstances, it cannot be wholly ruled out that the applicant is directly and individually concerned by the contested Regulation and may therefore bring an action for its annulment under the fourth paragraph of Article 230 EC. The present application for interim relief must therefore be declared admissible.
90 In the circumstances of the case, the President of the Court of First Instance considers it appropriate to determine, first, whether the condition concerning urgency has been satisfied.
Urgency
91 It should be noted at the outset that any damage alleged by the applicant to have been caused to third parties (see paragraph 61 above), may be taken into consideration only when the court hearing the application comes to balance the interests at stake (order in Pfizer Animal Health, cited above, paragraph 136).
92 It is settled law that the purpose of the procedure for interim measures is to ensure that the judgment in the main action may be given full effect. In order to attain that objective, the measures sought must be urgent, in the sense that it is necessary, in order to prevent serious and irreparable damage to the applicant, that those measures be ordered and that they produce their effects before judgment is given in the main proceedings. The applicant argues, in essence, that it has no guarantee that the costs which it must invest for the purposes of submitting the notification dossier will be adequately protected; also that the cost of preparing the dossier will impair its position on the Community market in peracetic acid.
93 Specifically, application of the contested Regulation entails certain financial consequences leading to the termination of contracts which the applicant had concluded with acid purchasers and enables undertakings which have not notified the active substance to the Commission to indulge in unfair competition against the applicant.
94 However, according to established case-law, damage of a purely pecuniary nature cannot, save in exceptional circumstances, be regarded as irreparable or even as being reparable only with difficulty, if it can ultimately be the subject of financial compensation (orders in Case C-213/91 R Abertal and Others v Commission [1991] ECR I-5109, paragraph 24, and Case T-168/95 R Eridania and Others v Council [1995] ECR II-2817, paragraph 42).
95 According to those principles, the suspension of operation sought in the present case would be justifiable only if it appeared that, failing such a measure, the applicant would find itself in a situation likely to jeopardise its very existence or to impair its market share irreversibly.
96 In the present case, the allegations concerning the cost of the data necessary for the purposes of notification, the loss of contracts arising from this and the reduction in the applicant's market share do not support the conclusion that the very existence of the applicant is in jeopardy or that its market share is irrecoverable.
97 The applicant argues that two important customers, [...] and [...], have terminated purchasing contracts. Even if the decision to terminate the contracts with the applicant (which pre-dated the adoption of the contested Regulation) were based solely on the prospect of an increase in the price of peracetic acid, that would not be sufficient to demonstrate that the applicant would be unable to continue its activities on the market at issue until such time as the Court of First Instance makes a ruling on the legality of the contested Regulation.
98 In order to demonstrate the financial impact of the contested Regulation on its business activities, the applicant has produced a table illustrating its sales for the years 1997 to 2000 and its projected sales for the year 2001. This shows that sales of peracetic acid in 2000 enabled the applicant to achieve a turnover of DEM [...], of which DEM [...] was accounted for by [...]. It shows, above all, that the applicant estimates its turnover for the year 2001 at DEM [...], of which DEM [...] would be accounted for by sales to those two customers. It cannot therefore be accepted that the applicant is unable to continue its business activities without those customers. Furthermore, it must also be noted that the turnover accounted for by acid sales to other clients, as predicted for the year 2001, shows even a very slight increase ([DEM ...]). This demonstrates that the alleged unfair competition from economic operators who have not notified the active substance in question to the Commission produces only limited effects, contrary to the assertions made by the applicant's accountant in his brief statement. On that point, it should be noted that that statement is framed in very general terms and is based on the assumption that the applicant's market share will continue to fall.
99 Moreover, the reliance placed by the applicant on the difficulties involved in financing the information dossier required for notification purposes is not sufficient to establish the existence of those difficulties. In particular, the applicant has failed to provide any statements from banking institutions confirming, for instance, a refusal to extend credit in that connection.
100 Furthermore, as was stated at the hearing, it is not certain that the applicant will be the only undertaking to notify to the Commission the active substance that it manufactures. It has not even ruled out the possibility of a joint notification, as provided for by the contested Regulation, by those members of the European Chemical Industry Council which sell peracetic acid; in fact, it is endeavouring to do this by means of a task force organised with a joint notification in mind.
101 Lastly, notification of the active substance by an economic operator other than the applicant would enable the applicant to benefit from the consequences of that notification. However, for reasons of professional and business ethics, the applicant decided to make a notification. The fact that it took this position may have led its competitors on the market to refrain from notifying the active substance, that is to say, the applicant may have helped trigger the damage of which it complains. However, a finding that interim measures are urgently required cannot be based on an attitude observed by the applicant; it must be based only on the actual effects of the measure contested.
102 The applicant also invokes damage which is not of a purely pecuniary nature, arising as a result of the legal uncertainty created, in particular, by the absence of technical guidelines as provided for by Directive 98/8 and the loss of the data protection provided for by Article 12(1)(c)(i) of the Directive in respect of existing data regarding existing active substances.
103 However, the applicant does not show how the alleged uncertainty constitutes itself serious damage. It has in no way established that the provisions of the contested Regulation are not sufficient to enable the applicant to make proper notification of the active substance which it manufactures with a view to its inclusion on the lists. The fact that the Commission has not yet drawn up technical notes for guidance to facilitate the day-to-day implementation of ... Directive [98/8] (Article 33(3) of that Directive) is irrelevant, since the question of urgency falls to be appraised by reference to the effects produced by the contested measure.
104 Moreover, the applicant cannot claim to have been unable to prepare the dossier and to estimate the costs entailed, since, at its request, the Scientific Consulting Company (Chemisch-Wissenschaftliche Beratung GmbH) produced a global estimate of the costs entailed in collating the necessary data and preparing the dossier, together with guidance as to the information required.
105 Lastly, as regards the damage arising from the lack of data protection as provided for under Article 12(1)(c)(i) of Directive 98/8 in respect of existing data on existing active substances, this would arise only if the contested Regulation disregarded that provision of the Directive. That question must be addressed in the context of the appraisal as to whether a prima facie case has been established, in so far as the applicant has entered a plea in law alleging, in essence, infringement of Article 12(1)(c)(i) of Directive 98/8 (see paragraphs 107 to 110 below).
106 Subject to the outcome of that appraisal, it follows from the foregoing that the applicant has failed to establish that, if the interim measures applied for are not granted, it will suffer serious and irreparable damage.
Prima facie infringement of Article 12(1)(c)(i) of Directive 98/8
107 It is not for the court hearing an application for interim relief, in the context of deciding whether a prima facie case has been made for suspension of operation of a measure, to rule definitively on the interpretation of the provisions at issue in the dispute (order in Case C-478/00 P(R) Commission v Roussel and Roussel Iberica [2001] ECR I-3079, paragraph 76).
108 By this plea, as was clarified at the hearing, the applicant maintains that Article 6(2) of the contested Regulation - in so far as it allows producers of an active substance and formulators of biocidal products containing it to start or continue to place on the market that active substance, as such or in biocidal products, in the product type or types for which the Commission has accepted at least one notification - infringes Article 12(1)(c)(i) of Directive 98/8, which prohibits Member States from making use of the information on existing active substances which comes into their possession during the period for review of the substances.
109 In that connection, it should be noted that the consequences of notification, set out in Article 6(2) of the contested Regulation, are not to be confused with the use of information in the possession of the competent authorities for the benefit of other applicants, which is the situation contemplated by Article 12 of Directive 98/8. The two provisions govern different situations. In particular, the fact that economic operators who have not notified an existing active substance to the Commission may nevertheless start or continue to place it on the market does not frustrate the provision for the protection of the information provided by the applicant for authorisation.
110 Without prejudice to the appraisals to be made in the main proceedings as to whether or not the contested Regulation is lawful, the evidence produced by the applicant in the proceedings for interim relief is not sufficient to establish a prima facie case.
111 However, even if the applicant had sufficiently established that it would suffer serious and irreparable damage if operation of the contested Regulation were not suspended, the balance of interests in the present case inclines in favour of the application for interim relief being dismissed. The interests to be weighed are, on the one hand, the applicant's interest in having operation of the contested Regulation suspended and, on the other, the public interest in implementation of a legislative measure and the interests of third parties directly affected by suspension of the Regulation at issue (see, to that effect, the orders in Case T-96/92 R CCE des Grandes Sources and Others v Commission [1992] ECR II-2579, paragraph 39; Case T-88/94 R Société Commerciale des Potasses et de l'Azote et Entreprise Minière et Chimique v Commission [1994] ECR II-263, paragraph 44; Case T-322/94 R Union Carbide v Commission [1994] ECR II-1159, paragraph 36; and Case T-342/00 R Petrolessence and SG2R v Commission [2001] ECR II-67, paragraph 51).
112 The purpose of the contested Regulation is to initiate the first phase of the review programme. It is clear, in particular, from the eighth recital in the preamble of Directive 98/8 that it is necessary, when biocidal products are being authorised, to make sure that, in the light of current scientific and technical knowledge, there is no unacceptable effect on the environment and, in particular, on human or animal health. It is settled law that, in principle, requirements for the protection of public health must, without any doubt, be given priority over considerations of an economic nature (orders in Case C-180/96 R United Kingdom v Commission [1996] ECR I-3903, paragraph 93, and Case C-329/99 P(R) Pfizer Animal Health v Council [1999] ECR I-8343, paragraph 102).
113 Furthermore, in a situation such as that in the present case, where the interim measure applied for may seriously affect the rights and interests of third parties, - in particular, the producers of existing active substances who have already initiated the studies necessary for notification purposes in accordance with Article 4 of the contested Regulation - which, not being parties to the proceedings, have not been able to make their views known, such measures can be justified only if it appears that, without them, the applicant would be exposed to a situation liable to compromise its very existence (order in Case T-12/93 R CCE Vittel and CE Pierval v Commission [1993] ECR II-785, paragraph 20).
114 In the present case it is clear, as explained in paragraph 98 above, that the applicant does not find itself in such a situation.
115 It is clear from all the foregoing considerations that the conditions for granting suspension of operation of the contested Regulation have not been satisfied in the present case. The application must therefore be dismissed.
On those grounds,
THE PRESIDENT OF THE COURT OF FIRST INSTANCE
hereby orders:
1. The application for interim relief is dismissed.
2. Costs are reserved.
