62000B0339(01)

1. Actions for annulment - Natural or legal persons - Measures of direct and individual concern to them - Regulation on biocidal products - Action brought by a producer - Inadmissible

(Art. 230, fourth para., EC; Commission Regulation No 1896/2000, Art. 6(2); Parliament and Council Directive 98/8, Art. 16(2))

2. Actions for annulment - Natural or legal persons - Possible absence of remedies - No effect on the system of remedies and the conditions for admissibility of an annulment action

1. The action brought by a producer of biocidal products against Regulation No 1896/2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8 on biocidal products is inadmissible.

The Regulation is addressed to all those who have an interest in the identification and notification of existing active substances and biocidal products containing those substances and not only operators who placed a biocidal product containing existing active substances on the market before 14 May 2000. In particular, Article 6(2) of the Regulation allows all producers and formulators to continue or to begin marketing existing active substances and biocidal products containing those substances for the product type(s) for which the Commission has accepted at least one notification. Since access to the identification procedures and/or notification procedures is not reserved exclusively for the operator serving a specific part of the market, the Regulation cannot be regarded as being of individual concern to the applicant.

( see paras 48, 50, 55 )

2. The possible absence of remedies cannot justify an amendment by way of judicial interpretation of the system of remedies and procedures laid down in the Treaty. In no case does it allow an annulment action brought by a natural or legal person to be declared admissible where it does not satisfy the conditions laid down by the fourth paragraph of Article 230 EC.

( see para. 54 )

In Case T-339/00,

Bactria Industriehygiene-Service Verwaltungs GmbH, established in Kirchheimbolanden (Germany), represented by K. Van Maldegem and C. Mereu, lawyers, with an address for service in Luxembourg,

applicant,

supported by

Eurobrom BV, established in Rijswijk (Netherlands),

Lonza GmbH, established in Wuppertal (Germany),

Arch Chemicals SA, established in Paris (France),

Troy Chemical Company BV, established in Maassluis (Netherlands),

represented by K. Van Maldegem and C. Mereu, lawyers, with an address for service in Luxembourg,

interveners,

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 the annulment 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 COURT OF FIRST INSTANCE

OF THE EUROPEAN COMMUNITIES (Second Chamber),

composed of: R.M. Moura Ramos, President, J. Pirrung and A.W.H. Meij, Judges,

Registrar: H. Jung,

makes the following

Order

Legal framework

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, the Directive). The purpose of the Directive is to establish Community rules for the authorisation and placing on the market of biocidal products proposed for use.

2 In Article 2(1)(a) of the Directive biocidal products are defined as active substances and preparations containing one or more active substances which are put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.

3 Article 5(1)(a) of Directive 98/8 provides that Member States may authorise a biocidal product only if the active substance(s) included therein are listed in Annex I or IA [to the Directive] and any requirements laid down in these Annexes are fulfilled. Annex I contains the list of active substances and the relevant approved Community requirements for inclusion in biocidal products, Annex IA concerns low-risk biocidal products, while Annex IB relates to basic substances.

4 Article 11 of the Directive defines the procedure for inclusion of an active substance in Annexes I, I A or I B. Inclusion, or subsequent changes to the inclusion, of an active substance require the lodging of an application. Under Article 11(1)(a) of the Directive, an applicant must forward to the competent authorities of a Member State a dossier for the active substance satisfying, where appropriate, the requirements of Annexes II A, III A or IV A to the Directive and a dossier for at least one biocidal product containing the active substance, which satisfies the requirements of Article 8 of the Directive. After evaluation, the dossier must be sent to the Commission and a decision taken as to the inclusion of the active substance in Annexes I, I A or I B according to the procedure laid down in Article 28 of the Directive.

5 Article 12 of the Directive contains provisions governing the competent authorities' use, for other applicants, of information communicated by the applicant.

6 Article 16(2) of the Directive reads as follows:

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) [i.e. 14 May 2000] 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 is included in Annexes I, IA or IB and under which conditions or, in cases where the requirements of Article 10 [concerning the inclusion] 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.

7 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 the Directive (OJ 2000 L 228, p. 6, the Regulation). The Regulation is designed to initiate the first phase of the programme of work for the evaluation of all the active substances in biocidal products already on the market on 14 May 2000 (the review programme). As indicated in the second recital in the preamble to the Regulation, the 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 the Directive.

8 An existing active substance is defined by Article 2(a) of the Regulation 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.

9 According to Article 3(1) of the Regulation, each producer of an existing active substance placed on the market for use in biocidal products must identify the active substance by presenting the Commission with the information on the active substance referred to in Annex I to the Regulation, and any formulator of a biocidal product, that is to say the manufacturer or his representative in the Community, may identify an existing active substance.

10 Under the first subparagraph of Article 4(1) of the Regulation producers, formulators and associations wishing to apply for the inclusion in Annex I or Annex IA to the Directive 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.

11 Under Article 5(2) and (3) of the Regulation, Member States may identify existing active substances other than those mentioned on the list of all existing active substances and may indicate their interest in the possible inclusion in Annex I or Annex I A to the Directive of an existing active substance used in product types for uses which the Member State considers essential, in particular for the protection of human health or of the environment, and for which no notification has been accepted by the Commission.

12 Article 6(1)(b) of the Regulation provides, following identification and notification, and in accordance with the procedure under Article 28 of the Directive, for the adoption of a regulation containing, inter alia, the exhaustive list of existing active substances to be examined in the second phase of the review programme (the review list). The review list contains, among other things, the existing active substances for which notification has been accepted or which are the subject of an indication of interest on the part of the Member States.

13 Article 6 of the Regulation continues as follows:

2. Without prejudice to Article 16(1), (2) or (3) of the Directive, all producers of an active substance included in the list referred to in paragraph 1(b) 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.

Facts and procedure

14 The applicant produces and markets the active substance peracetic acid and biocidal products containing that active substance.

15 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 the annulment of the Regulation. It argues, essentially, that the Regulation must be annulled because it is incompatible with its legal basis, namely the Directive, in that it goes beyond the provisions relating to data protection contained in the Directive by ignoring the protection provided for by the Directive of commercially sensitive and valuable information on active substances during the review period of those active substances, and because it distorts competition in breach of the EC Treaty as it enables companies not participating in the review process to profit without cost from the notifications made by participating diligent companies such as the applicant.

16 In a separate application, lodged at the Registry of the Court of First Instance on 12 January 2001, the applicant also brought an action for suspension of operation of the Regulation pending a ruling on the substance by the Court of First Instance.

17 On 18 January 2001, the Commission raised an objection of inadmissibility against the application for annulment under Article 114(1) of the Rules of Procedure of the Court of First Instance.

18 The applicant submitted its observations on the objection of inadmissibility on 28 February 2001.

19 By order of the President of the Court of First Instance of 15 June 2001, the application for interim relief was dismissed and the costs were reserved.

20 By order of 11 July 2001 of the President of the Second Chamber of the Court of First Instance, Eurobrom BV, Lonza GmbH, Arch Chemicals SA and Troy Chemical Company BV were granted leave to intervene in support of the forms of order sought by the applicant and the costs were reserved. The interveners were requested first to set out their pleas and arguments on the question of the admissibility of the action.

21 The Court of First Instance took measures of organisation of procedure by asking the parties to the main proceedings to answer written questions. The parties complied with those requests.

22 The interveners lodged their statements in intervention at the Registry of the Court of First Instance on 5 September 2001.

23 The Commission submitted its observations on the statements in intervention on 28 November 2001.

Forms of order sought by the parties

24 The applicant claims that the Court of First Instance should:

- declare the application admissible and founded;

- annul the Regulation on the basis of the fourth paragraph of Article 230 EC;

- order the Commission to pay all the costs of the proceedings.

25 The interveners, in their statements in intervention, claim that the Court of First Instance should declare the application admissible.

26 The Commission submits that the Court of First Instance should:

- dismiss the application as inadmissible;

- order the applicant and the interveners to pay the costs.

Law

27 Under Article 114(1) of the Rules of Procedure, on the application of one of the parties, the Court of First Instance may rule on the objection of inadmissibility without going to the substance of the case. Article 114(3) provides that the remainder of the proceedings are to be oral unless the Court of First Instance decides otherwise. In this case, the Court considers that it has sufficient information from the documents in the case to rule on the application without opening the oral procedure.

Arguments of the parties

28 The applicant argues that the action is admissible.

29 First, the applicant argues that the Regulation, although referred to as such, is in fact a decision which concerns it directly and individually. The Regulation imposes detailed and direct obligations on it, without any power of review by a third party and without requiring the Member States to take any additional measures to comply. According to the applicant, it belongs to a closed category of companies to which the Regulation - which determines the procedure to be followed by producers of existing active substances - applies, that is, the companies which placed on the Community market before 14 May 2000 a biocidal product containing active substances. Therefore, the Regulation is addressed to a specific category of persons, clearly and voluntarily limited in number and time and not susceptible of enlargement after the adoption of the Regulation. The applicant refers to, inter alia, the judgments of the Court of Justice in Case 25/62 Plaumann v Commission [1963] ECR 95, Case C-358/89 Extramet Industrie v Council [1991] ECR I-2501 and Case C-309/89 Codorniu v Council [1994] ECR I-1853.

30 Second, the applicant argues that it has actively participated through the European Chemical Industry Council (ECIC) in the process leading to the adoption of the Regulation. In support of this argument, it cites, inter alia, the judgment in Extramet v Council, cited above, and the judgment of the Court of Justice in Case C-321/95 P Greenpeace and Others v Commission [1998] ECR I-1651.

31 Third, although the Commission was aware of the applicant's specific interests and was obliged to take them into consideration, it adopted a regulation which denied the applicant's property rights with respect to peracetic acid, which are none the less protected by Community law and in particular by Article 12 of the Directive on the protection of existing data, and which thus enables its competitors who do not have to comply with the Directive to obtain access to the applicant's data at no cost. In that context, it refers to the judgments of the Court of Justice in Case 11/82 Piraiki-Patraiki and Others v Commission [1985] ECR 207 and of the Court of First Instance in Joined Cases T-480/93 and T-483/93 Antillean Rice Mills and Others v Commission [1995] ECR II-2305.

32 Finally, the applicant argues that the Court of First Instance is the only court before which its rights can be protected and vindicated.

33 The interveners essentially support the applicant's arguments. Moreover, they argue that only those who placed a biocidal product on the Community market before 14 May 2000 are authorised to participate in the review programme of biocides on the ground that they alone can submit evidence establishing that the biocidal product was placed on the market before that date and that they alone can forward the other data listed in Annex II to the Regulation, which sets out the conditions of notification.

34 The interveners also argue that the applicant is individually concerned by the Regulation as it is the only producer of peracetic acid in a position to notify the peracetic acid used in liquid-cooling and liquid-processing systems, being the only producer of peracetic acid to market the peracetic acid intended for this market segment before the cut-off date of 14 May 2000.

35 The Commission argues that the action is inadmissible.

36 First, it points out that the applicant is seeking the annulment of the Regulation in its entirety and does not limit itself to the provisions of Article 6(2) and the second subparagraph of Article 6(3), which appear to be central to its concern.

37 According to the Commission, the action is inadmissible because the Regulation is not a decision which directly and individually concerns the applicant. The Regulation, it argues, is of general application, as it is addressed to all producers, formulators, importers, associations and Member States interested in identifying and/or notifying existing active substances.

38 The Commission goes on to argue that a limited circle of producers of existing active substances does not exist, the only closed category to which the Regulation relates being that of the existing active substances.

39 In answer to the specific arguments put forward by the interveners, the Commission points out that the Regulation does not require evidence that the notifier placed a substance on the market before 14 May 2000 and adds that each interested operator is, in principle, entitled to submit data listed in Annex II to the Regulation.

40 On the question of active participation in the process of the adoption of the Regulation, the Commission argues that its formulation did not require participation by individuals, and that consultation of the association of which the applicant is a member took place on a voluntary basis and purely for information purposes.

41 Finally, the Commission argues that, in contrast to the circumstances in Piraiki-Patraiki and Others v Commission and Antillean Rice Mills and Others v Commission, cited above, it was under no obligation, when adopting the Regulation, to give priority to measures which would give rise to the least disturbance or to enquire into possible negative effects.

Findings of the Court

42 Under the fourth paragraph of Article 230 EC any natural or legal person may institute proceedings against a decision addressed to that person or against a decision which, although in the form of a regulation or a decision addressed to another person, is of direct and individual concern to the former.

43 First of all, the applicant challenges the fact that the contested act is a regulation, arguing essentially that it must be regarded as a decision addressed to the applicant as a member of a closed and limited circle of affected economic operators.

44 It must first be recalled that the criterion for distinguishing a regulation from a decision is whether the contested act is or is not of general application, and an act is of general application if it applies to objectively determined situations and produces its legal effects with respect to categories of persons envisaged in a general and abstract manner (Case T-482/93 Weber v Commission [1996] ECR II-609, paragraph 55, and the case-law cited therein).

45 In the present case, the Regulation lays down the provisions necessary for the elaboration and implementation of the first phase of the review programme referred to in Article 16(2) of the Directive. The purpose of the first phase is to enable an exhaustive list of all existing active substances to be drawn up. For this purpose the rules governing the identification procedure require producers, and allow formulators and Member States, to provide information on existing active substances in biocidal products to the Commission. The Regulation introduces a notification procedure enabling producers, formulators, associations and Member States to inform the Commission of their wish to request the inclusion of an existing active substance in Annex I, Annex I A or Annex I B to the Directive for one or several product types and that they agree to provide all the requisite information in order for that active substance to be correctly evaluated and a decision taken on it. The Regulation provides in Article 6(2) that all producers of active substances included on the review list and all formulators of biocidal products containing that active substance may place on the market or continue to market that active substance either in its pure form or in biocidal products for the product type(s) for which the Commission has accepted at least one notification.

46 It is clear that the Regulation applies to objectively determined situations and produces legal effects in respect of persons considered in a general and abstract manner, that is, all producers and formulators who might identify existing active substances, all producers, formulators and associations wishing to seek inclusion in one of the annexes to the Directive of an existing active substance for one or several product types, and finally all producers of an active substance included on the review list and all formulators of biocidal products containing that active substance. The Regulation, by virtue of its general application, has a normative character and does not constitute a decision within the meaning of Article 249 EC.

47 However, the normative character of the Regulation does not exclude it from being of direct and individual concern to certain natural or legal persons within the meaning of the fourth paragraph of Article 230 EC (Codorniu v Council, paragraph 19, Antillean Rice Mills and Others v Commission, paragraph 66, and Joined Cases T-481/93 and T-484/93 Exporteurs in Levende Varkens and Others v Commission [1995] ECR II-2941, paragraph 50). That is the case if the act in question affects natural or legal persons because of certain attributes which are particular to them or by reason of circumstances in which they are differentiated from all other persons and by virtue of these factors distinguishes them individually just as in the case of the person addressed (Plaumann v Commission, at p. 107, and Codorniu v Council, paragraph 20).

48 In this regard, it must be held that the applicant's argument that the Regulation applies to the closed category of companies which have placed a biocidal product containing existing active substances on the Community market cannot be accepted. The Regulation is addressed to all those who have an interest in the identification and notification of existing active substances and biocidal products containing those substances and not only operators who placed a biocidal product containing existing active substances on the market before 14 May 2000. In particular, Article 6(2) of the Regulation - to which the applicant appears to make particular reference - allows all producers and formulators to continue or to begin marketing existing active substances and biocidal products containing those substances for the product type(s) for which the Commission has accepted at least one notification.

49 In that context it must be pointed out that notification of an existing active substance may be made by any operator which can provide evidence that the active substance was placed on the market before 14 May 2000, and that that evidence does not in any way mean that that operator itself marketed the active substance or a biocidal product containing that active substance before 14 May 2000. Similarly, the other data listed in Annex II to the Regulation may, in principle, be provided by any interested operator.

50 It follows that access to the identification procedures and/or notification procedures is not reserved exclusively for the operator serving a specific part of the market. The argument advanced by the interveners, to the effect that the applicant is individually concerned by the Regulation in that it is the sole producer of peracetic acid in a position to notify the peracetic acid used in liquid-cooling and liquid-treatment systems, cannot therefore be accepted. The Regulation is intended to identify all the existing active substances of biocidal products as defined by Article 2(a) of the Regulation, with the help of the information provided by all of the producers and formulators concerned.

51 The applicant's argument that it participated in the process leading to the adoption of the Regulation is equally untenable. In the first place, it was not the applicant which participated in an individual capacity in this process, but rather the ECIC, an association to which the applicant belongs. In addition, it is clear from the case-law that the fact that a person participates, in one way or another, in the process leading to the adoption of a Community act does not distinguish him individually in relation to the act in question unless the relevant Community legislation has laid down specific procedural guarantees for such a person (Case T-60/96 Merck and Others v Commission [1997] ECR II-849, paragraph 73, and the case-law cited). In the circumstances of the present case, there are no provisions requiring the Commission, before the adoption of the Regulation, to follow procedures under which persons such as the applicant are accorded the right to put forward any claim they may have or even to be heard. In this connection, the only provision relied on by the applicant is recital 23 in the preamble to the Directive, under which its implementation, the adaptation of its Annexes to the development of technical and scientific knowledge and the inclusion of active substances in the appropriate annexes require close cooperation between the Commission, the Member States and the applicants, and under which, where it is applicable, the procedure of the Standing Committee on Biocidal Products provides a suitable basis for cooperation. That provision does not confer procedural rights on the applicant.

52 The applicant's argument that the Commission was obliged to take into account its specific interests when adopting the Regulation, with the result that it has a right of action in this case, cannot be accepted either. Unlike the cases which led to the judgments in Piraiki-Patraiki v Commission and Antillean Rice Mills and Others v Commission, there is no provision in this case that requires the Commission to take account of the consequences which the act it is planning to adopt may have for the position of any particular individuals.

53 The question whether the provisions of the Regulation infringe the applicant's property rights, as protected by Article 12 of the Directive, is one relating to the substance of the case. In any event, that alleged infringement, supposing it were established, is not sufficient to distinguish the applicant individually in relation to any other operator who gives notification of an existing active substance.

54 Finally, with regard to the applicant's argument that the present action is the only legal remedy open to it, it must be held that the possible absence of remedies, supposing it is established, cannot justify an amendment by way of judicial interpretation of the system of remedies and procedures laid down in the Treaty. In no case does it allow an annulment action brought by a natural or legal person to be declared admissible where it does not satisfy the conditions laid down by the fourth paragraph of Article 230 EC (Case T-138/98 ACAV and Others v Council [2000] ECR II-341, paragraph 68).

55 It follows that the Regulation cannot be regarded as being of individual concern to the applicant. As the applicant thus fails to satisfy one of the conditions of admissibility laid down by the fourth paragraph of Article 230 EC, the action must be dismissed as inadmissible.

Costs

56 Under Article 87(2) of the Rules of Procedure, the unsuccessful party must be ordered to pay the costs if they have been applied for in the successful party's pleadings. As the applicant has been unsuccessful, it must be ordered, in accordance with the Commission's application, to pay the costs, including those relating to the proceedings for interim measures, but with the exception of those attributable to the interventions.

57 In accordance with Article 87(4) of the Rules of Procedure, the interveners must pay their own costs. Under Article 87(2) of the Rules of Procedure, they must pay, jointly and severally, the costs incurred by the Commission as a result of their interventions.

On those grounds,

THE COURT OF FIRST INSTANCE (Second Chamber)

hereby orders:

1. The action is dismissed as being inadmissible.

2. The applicant shall pay its own costs and those of the Commission, including those relating to the proceedings for interim measures, but with the exception of those attributable to the interventions.

3. The interveners shall pay their own costs, and shall jointly and severally pay those incurred by the defendant as a result of their interventions.