JUDGMENT OF THE GENERAL COURT (Second Chamber)
20 September 2011 (*)
(Action for annulment – Health policy – Marketing of biocidal products – Regulation (EC) No 1451/2007 – Not individually concerned – Inadmissibility – Default procedure)
In Case T‑120/08,
Arch Chemicals, Inc., established in Norwalk, Connecticut (United States),
Arch Timber Protection Ltd, established in Castleford, West Yorkshire (United Kingdom),
Rhodia UK Ltd, established in Watford, Hertfordshire (United Kingdom),
Sumitomo Chemical (UK) plc, established in London (United Kingdom),
Troy Chemical Co. BV, established in Vlaardingen (Netherlands),
represented by K. Van Maldegem and C. Mereu, lawyers,
applicants,
supported by
European Chemical Industry Council (CEFIC), established in Brussels (Belgium), represented initially by Y. van Gerven and V. Terrien, and subsequently by Y. van Gerven, lawyers,
intervener,
v
European Commission, represented by P. Oliver and E. Kružíková, acting as Agents,
defendant,
ACTION for annulment of Article 3(2), Article 4, Article 7(3), the second subparagraph of Article 14(2), Article 15(3), Article 17 of and Annex II to Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, (OJ 2007 L 325, p. 3),
THE GENERAL COURT (Second Chamber),
composed of N.J. Forwood, President, F. Dehousse and J. Schwarcz (Rapporteur), Judges,
Registrar: E. Coulon,
gives the following
Judgment
Legal context
1 Under Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ 1998 L 123, p. 1), the Commission of the European Communities was tasked with commencing a 10-year programme of work for the systematic examination of all active substances already on the market on 14 May 2000 (‘the existing active substances’). The initial phase of the programme was laid down in 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 (OJ 2000 L 228, p. 6).
2 Pursuant to Articles 3 and 4 of Regulation No 1896/2000, existing active substances had to be identified and those to be evaluated with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8 in one or more product types had to be notified no later than 28 March 2002. That time-limit was subsequently extended for certain substances.
3 Under Articles 3 and 4 of Regulation No 1896/2000, the identification and notification of existing active substances consist of submitting to the Commission the information referred to in Annexes I and II to that Regulation respectively and must be carried out by the producers or formulators of the substances in question or by associations of them. The Commission is to accept a notification if it has been made within the time-limit prescribed and if it complies with the requirements of Annex II to Regulation No 1896/2000, including the obligation to associate the existing active substance to one or more of the 23 types of biocidal products listed in Annex V to Directive 98/8. Acceptance of a notification gives the notifier the possibility of supplying to the authority of the designated Rapporteur Member State all the data and information necessary for evaluation of the existing active substance with a view to its possible inclusion in Annex I or IA to Directive 98/8 during the second phase of the work programme referred to in Article 16(2) of that directive (‘the work programme’).
4 Under Article 5 of Regulation No 1896/2000, Member States may, within a certain time-limit, identify additional existing active substances and indicate their interest in the possible inclusion in Annex I or Annex IA to Directive 98/8 of existing active substances for which no notification has previously been accepted by the Commission.
5 Article 6 of Regulation No 1896/2000 provides that a regulation implementing the second phase of the work programme is to be adopted containing an exhaustive list of existing active substances validly identified or for which equivalent information has been submitted in a notification and an exhaustive list of substances for which the Commission has accepted at least one notification in accordance with Article 4 of Regulation No 1896/2000 or for which a Member State has indicated its interest in accordance with Article 5 of that regulation.
6 The lists in question were drawn up pursuant to Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the work programme and amending Regulation (EC) No 1896/2000 (OJ 2003 L 307, p. 1).
7 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the work programme (OJ 2007 L 325, p. 3) repeals and replaces Regulation No 2032/2003.
8 Under Article 1 thereof, Regulation No 1451/2007 is intended to lay down detailed rules for the implementation of the work programme for the systematic examination of all existing active substances.
9 Annex I to Regulation No 1451/2007 contains the exhaustive list of existing active substances identified under the first phase of the work programme. Annex II to Regulation No 1451/2007 contains an exhaustive list of existing active substances, each one related to one or more types of products, for which either a notification has been accepted by the Commission or a Member State has indicated its interest under Regulation No 1896/2000, or for which a dossier, which has been accepted as a complete dossier, has been submitted to one of the Member States before 1 March 2006.
10 Pursuant to Article 4 of Regulation No 1451/2007, biocidal products containing existing active substances not included in Annex II to that regulation or in Annex I or IA to Directive 98/8 are no longer placed on the market. The same applies to biocidal products containing existing active substances listed in Annex II to Regulation No 1451/2007, but for which no notification has been accepted in relation to them. Moreover, an active substance which has not been identified cannot be regarded as an existing active substance.
11 Examination of each existing active substance listed in Annex II to Regulation No 1451/2007 for the type or types of biocidal products in association with which it has been notified is carried out by a Rapporteur Member State. Under Articles 7, 8 and 9 of Regulation No 1451/2007, that examination is carried out on the basis of a complete dossier complying with the requirements set out in Annex III to that regulation. That dossier is submitted to the Rapporteur Member State within the time period specified in Article 9 to the regulation by one or more producers, formulators or associations which have submitted a notification accepted by the Commission or by a Member State which has indicated interest, which are designated, for the purposes of the further procedure, as ‘participants’ under Article 2 of that regulation.
12 In order to avoid duplication of effort and to reduce testing on vertebrate animals, Article 8 of Regulation No 1451/2007 provides that participants are to make all reasonable efforts to avoid duplication of testing on those animals and to establish collective complete dossiers, failing which each individual dossier is to detail the efforts made to secure co-operation and the reasons for the non-participation of certain participants. In addition, the Rapporteur Member States are required, under the same provision, to inform participants that other participants are seeking review of a particular active substance.
13 In the same context, Article 10 of Regulation No 1451/2007 provides that a producer, formulator or association, by mutual agreement, can join or replace a participant.
14 Furthermore, Article 12 of Regulation No 1451/2007 lays down the conditions under which an operator or a Member State can take over the role of participant in the place of a participant which has unilaterally withdrawn.
15 Article 7(3) of Regulation No 1451/2007 provides that an applicant who is not a participant and who wishes to apply, in accordance with Article 11 of Directive 98/8, for the inclusion in Annex I, IA or IB thereto of a combination of an existing active substance and a product type specified in Annex II to that regulation may submit a complete dossier within the time period specified in Article 9 of that regulation for that substance/product type combination. It is also stated that that possibility exists without prejudice to any submission of a collective dossier under Article 10 of Regulation No 1451/2007 (see paragraph 13 above).
16 Under Article 14 of Regulation No 1451/2007, if the Rapporteur Member State considers a dossier to be complete within the meaning of Article 9 of that regulation, it is to carry out the evaluation in accordance with Article 11(2) of Directive 98/8 and prepare a report on that evaluation, making a recommendation as to whether the existing active substance in question should be included or not in Annex I, IA or IB to Directive 98/8. The Commission is to take a decision in accordance with the procedures set out in Article 15 of Regulation No 1451/2007 and Articles 27 and 28 of Directive 98/8.
Facts
17 Arch Chemicals, Inc., Arch Timber Protection Ltd, Bactria Industriehygiene‑Service Verwaltungs GmbH & Co. KG, Rhodia UK Ltd, Sumitomo Chemical (UK) plc and Troy Chemical Co. BV are producers of active substances used in biocidal products and of biocidal products containing those substances.
18 The applicants notified the Commission of the active substances in association with different product types in accordance with Article 4(1) of Regulation No 1896/2000.
19 The notifications in question were accepted by the Commission and those substances are listed in Annex II to Regulation No 1451/2007, the applicants having thereby become participants in respect of each of the active substance/product type combinations notified.
20 By separate applications lodged at the Court Registry on 17 February 2004 and registered as Cases T‑75/04 to T‑79/04, the applicants brought an action under Article 230 EC by which they seek annulment of Article 3, Article 4(2), Article 5(3), the second subparagraph of Article 10(2), Article 11(3), Article 13, Article 14(2) of and Annex II to Regulation No 2032/2003 and compensation for the loss suffered following the adoption of that regulation.
21 By letters of 13 March 2008, the applicants sought leave, in Cases T‑75/04 to T‑79/04, to reformulate their claims and pleas in law, following the adoption of Regulation No 1451/2007, by withdrawing their claims seeking annulment in part of Regulation No 2032/2003 and replacing them with claims seeking annulment of Article 3(2), Article 4, Article 7(3), the second subparagraph of Article 14(2), Article 15(3), Article 17 of and Annex II to Regulation No 1451/2007 (‘the contested provisions’).
Procedure and forms of order sought by the parties
22 By application lodged at the Court Registry on 6 March 2008, the applicants brought the present action.
23 The applicants claim that the Court should:
– declare the action admissible and well-founded or, in the alternative, reserve the decision on the questions as to its admissibility or the decision on standing until the judgment in the main proceedings;
– annul the contested provisions;
– declare that Article 9(a), Article 10(3), Article 11 and Article 16(1) of Directive 98/8 and Article 6(2) of Regulation No 1896/2000 are unlawful;
– order the Commission to pay the costs.
24 The Commission has not filed a defence within the period prescribed for it to do so. No extension of that period has been requested.
25 By applications lodged at the Registry of the Court on 29 May and 7 October 2008, respectively, the Council of the European Union and the Parliament sought leave to intervene in the present case in support of the form of order sought by the Commission.
26 By document lodged at the Court Registry on 15 July 2008 the European Chemical Industry Council (CEFIC) sought leave to intervene in these proceedings in support of the form of order sought by the applicants.
27 By document lodged at the Court Registry on 26 September 2008, the applicants applied to the Court, in accordance with Article 122(1) of its Rules of Procedure, for judgment by default.
28 When the Judge-Rapporteur initially designated could no longer act as a result of ceasing to hold office, the President of the Court appointed a new Judge‑Rapporteur, by decision of 16 October 2009.
29 In reply to a question from the Court, the applicants informed the Court, by a document lodged at the Court Registry on 30 October 2009, that they were withdrawing their applications to reformulate their claims and pleas in law in Cases T‑75/04 and T‑77/04 to T‑79/04.
30 By document lodged at the Court Registry on 30 October 2009, Bactria Industriehygiene-Service Verwaltungs discontinued its action in the present case. By order of the President of the Seventh Chamber of the Court of 12 January 2010 that applicant was removed from the Court Register in the present case.
31 The composition of the chambers of the General Court having been modified, the Judge-Rapporteur was assigned to the Second Chamber, to which this case was therefore allocated.
32 By order of 14 January 2011, the President of the Second Chamber of the Court granted CEFIC leave to intervene and ordered that it should receive a confidential version of the procedural documents lodged by the parties.
33 Under Article 122(2) of the Rules of Procedure of the General Court, it is for the Court, before giving judgment by default, to consider whether the application initiating proceedings is admissible and whether the application appears well founded.
Law
34 In accordance with the fourth paragraph of Article 230 EC, any natural or legal person may, under the same conditions, 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.
35 In accordance with settled case-law, the objective of that provision is in particular to prevent the European Union institutions from being in a position, merely by choosing the form of a regulation, to exclude an application by an individual against a decision which concerns him directly and individually; it therefore makes clear that the choice of form cannot change the nature of a measure (judgment of the Court of Justice in Joined Cases 789/79 and 790/79 Calpak and Società Emiliana Lavorazione Frutta v Commission [1980] ECR 1949, paragraph 7; orders of the Court of First Instance in Case T‑12/96 Area Cova and Others v Council and Commission [1999] ECR II‑2301, paragraph 24, and in Case T‑447/05 SPM v Commission [2007] ECR II‑1, paragraph 61).
36 In addition, a measure of general application can be of individual concern to natural and legal persons only if it affects them by reason of certain attributes peculiar to them, or by reason of a factual situation which differentiates them from all other persons and thereby distinguishes them individually in the same way as the addressee (see order of the Court of Justice in Case C‑258/02 P Bactria v Commission [2003] ECR I‑15105, paragraph 34 and the case-law cited).
37 A measure is of general application if it applies to objectively determined situations and produces legal effects with respect to categories of persons envisaged in general and in the abstract (Case T‑13/99 Pfizer Animal Health v Council [2002] ECR II‑3305, paragraph 82; Case T‑70/99 Alpharma v Council [2002] ECR II‑3495, paragraph 74; and Case T‑139/01 Comafrica and Dole Fresh Fruit Europe v Commission [2005] ECR II‑409, paragraph 87).
38 Furthermore, where the contested measure affects a group of persons who were identified or identifiable when that measure was adopted by reason of criteria specific to the members of the group, those persons may be individually concerned by that measure inasmuch as they form part of a limited class of economic operators (Joined Cases C‑182/03 and C‑217/03 Belgium and Forum 187 v Commission [2006] ECR I‑5479, paragraph 60).
39 In the present case, it must be borne in mind that Regulation No 1451/2007 is intended, pursuant to Article 1 thereof, to lay down detailed rules for the implementation of the second phase of the programme of work for the systematic examination of all existing active substances. In that context, the regulation in question contains, in particular, provisions on the organisation of that examination, such as those governing the classification of those substances, the designation of Rapporteur Member States and their responsibilities with regard to the completeness of the dossiers submitted and the thorough evaluation of the dossiers (see paragraphs 11 and 16 above).
40 In that context, it is true that, in accordance with Article 6(4) of Regulation No 1896/2000 and Article 4(3) of Regulation No 1451/2007, with effect from the entry into force of the latter regulation, only those active substances listed in Annex I to that regulation can be regarded as ‘existing’ and, in accordance with Article 7(1) of Regulation No 1451/2007, only ‘existing’ active substances listed in Annex II to that regulation will be subject to review on the basis of a complete dossier.
41 None the less, those circumstances do not have the effect of distinguishing the applicants as members of a limited class of economic operators to which the provisions of Regulation No 1451/2007 apply, including the contested provisions, for each of the following reasons.
42 In that regard, it must be borne in mind that Articles 10 and 12 of Regulation No 1451/2007 make it possible for a producer, a formulator or an association to join or replace a participant by mutual agreement or, failing such agreement, where a participant unilaterally withdraws and no other participant has requested review of the same active substance in combination with the same product type or types (see paragraphs 13 and 14 above). There is even provision, in that event, for the time-limits for submission of a complete dossier to be extended.
43 Furthermore, Article 7(3) of Regulation No 1451/2007 provides that a person who has not submitted a notification accepted by the Commission may submit a complete dossier to the Rapporteur Member State for evaluation of an existing active substance with a view to its inclusion in Annex I, IA or IB to Directive 98/8 (see paragraph 15 above).
44 In those circumstances, clearly the provisions of Regulation No 1451/2007 on existing active substances which have been notified in association with one or more types of biocidal products, stated in general terms and laying down the means of implementation of the second phase of the work programme, do not concern only participants falling within the meaning of Article 2 of that regulation, but also any operator who could join or replace a participant pursuant to Articles 10 and 12 of that regulation or who could take part in the review procedure by submitting a complete dossier to the Rapporteur Member State under Article 7(3) thereof.
45 In addition, Article 4 of Regulation No 1451/2007 concerns in particular producers and formulators of biocidal products containing active substances which have been identified but which have not been the subject of a notification accepted by the Commission, an indication of interest by a Member State, or of a dossier, accepted as a complete dossier, submitted to one of the Member States before 1 March 2006, and producers and formulators of types of biocidal products which have not been the subject of any notification accepted by the Commission in combination with an existing active substance.
46 It follows from paragraphs 42 to 45 above that the provisions of Regulation No 1451/2007 concern an indeterminate number of economic operators who could seek inclusion in Annex I, IA or IB to Directive 98/8 of an existing active substance listed in Annex II to that regulation or who could form part of one of the groups described in the preceding paragraph. The provisions in question do not, therefore, concern only producers, formulators or associations which have submitted a notification accepted by the Commission in accordance with Article 4(2) of Regulation No 1896/2000 or affect the applicants in a particular way by reason of their belonging to that group of operators. Regulation No 1451/2007 cannot therefore be regarded either as a bundle of individual decisions or as an act affecting the applicants individually, either in its entirety or as regards the contested provisions (see, to that effect, the order in Bactria v Commission, paragraph 36 above, paragraphs 34 and 36).
47 The fact that the participants are individually identified in Annex II to Regulation No 1451/2007 by virtue of a footnote referring to an internet site where their names and details appear is of no consequence to the conclusion reached in the preceding paragraph, since such identification seeks to encourage cooperation between the participants and the submission of joint dossiers (see paragraphs 12 and 13 above).
48 Moreover, contrary to the applicants’ submissions, Articles 3 and 4 of Regulation No 1896/2000 do not grant them any particular protection such as to distinguish them individually for the purpose of the contested provisions or Regulation No 1451/2007 in its entirety. Article 4 of Regulation No 1896/2000, the only provision relevant to the matter, since the applicants claim to be individually concerned as participants within the meaning of Article 2 of Regulation No 1451/2007, merely lays down the procedure enabling operators which wish to apply for inclusion of an existing active substance in Annex I or IA to Directive 98/8 to submit, by way of a notification, the data required for that purpose. Article 4 of Regulation No 1896/2000 and, a fortiori, Article 3 thereof are therefore neither intended to nor have the effect of granting the applicants, as future participants, particular protection of any sort, or to require the Commission to take account of their position in order to grant them a particular status in the context of Regulation No 1451/2007 in comparison to other operators covered by Article 7(3) or Articles 10 and 12 of that regulation.
49 With regard to the alleged particular status from which the applicants benefit on the ground that Regulation No 1451/2007 was drawn up on the basis of active substances notified and accepted by the Commission, it must be noted that the fact that a person is involved in the process of adoption of a European Union act distinguishes him individually as regards the act in question only in the event that procedural guarantees were provided for in favour of that person by the European Union legislation. Thus, once a provision of European Union law requires that, in adopting a decision, a procedure must be followed in which a natural or legal person may claim any rights, including the right to be heard, the special legal position which that person enjoys has the effect of differentiating him individually within the meaning of the fourth paragraph of Article 230 EC (order of the Court of Justice in Case C 483/07 P Galileo Lebensmittel v Commission [2009] ECR I‑959, paragraph 53).
50 In that regard, it is sufficient to note that the participation of the applicants in the process of adoption of Regulation No 1451/2007 is not in any way intended to enforce a procedural right, by the exercise of which they would have been likely to affect the content of the substantive provisions of that regulation. In accordance with the system instituted by Regulation No 1896/2000, notifications made by the applicants under Article 4 thereof merely enabled determination, pursuant to Article 6(1) of that regulation, of the annex of Regulation No 1451/2007 in which the active substances should be included and, consequently, whether one of the provisions of Article 4 of that regulation would apply to them or whether, on the other hand, they were to be included in the existing active substances notified under Article 7 thereof. In those circumstances, the participation of the applicants in the process of adoption of Regulation No 1451/200 does not distinguish them individually for the purposes of the fourth paragraph of Article 230 EC.
51 It must be noted that, with regard to the other procedural guarantees relied on by the applicants, Article 27 of Directive 98/8 concerns the stage following submission to the Commission of the evaluation by the Rapporteur Member State. Accordingly, assuming that that provision gives procedural guarantees, they will benefit all applicants, that is to say, both participants within the meaning of Article 2 of Regulation No 1451/2007 and other operators who have joined the procedure under Article 7(3) or Articles 10 and 12 of that regulation.
52 The same is true of Articles 8 and 13 of Regulation No 1451/2007 which, apart from the fact that they do not give procedural guarantees in the context of the drafting of that regulation, apply, by their object, not only to participants within the meaning of Article 2 thereof, but also to all other applicants who have joined the procedure under Article 7(3) or Articles 10 and 12 thereof.
53 Those findings are also valid as regards the alleged individual concern under Article 12 of Directive 98/8, which sets the periods during which Member States are prohibited from making use of the information submitted by the applicant for authorisation of a biocidal product for the benefit of a second applicant or any later applicants, with regard in particular to the information concerning the existing active substances. That provision does not restrict the right to protection of such data only to the participants within the meaning of Article 2 of Regulation No 1451/2007, but also confers it on all other applicants having joined the procedure under Article 7(3) or Articles 10 and 12 thereof. Consequently, the right conferred in Article 12 of the directive does not distinguish the applicants individually as participants within the meaning of Article 2 of Regulation No 1451/2007.
54 With regard to harm to the alleged exclusive and pre-existing intellectual property rights of the applicants, it must be borne in mind that Regulation No 1451/2007 is intended to establish the procedures for the implementation of the second phase of the work programme. Accordingly, it does not affect, as such, the validity of the patents covering the applicants’ existing active substances, or the rights deriving therefrom.
55 Even if, as the applicants point out, a decision not to include an existing active substance in one of the annexes to Directive 98/8 would have the consequence of that substance being withdrawn from the market and thus would affect the value of any intellectual property rights, so that the applicants and the proprietors of those rights would, in that event, be individually concerned by that decision, the fact remains that Regulation No 1451/2007 does not constitute such a decision.
56 Furthermore, as is apparent from Article 6(1)(b) and Article 6(2) of Regulation No 1896/2000, read in conjunction with Article 3(2) of Regulation No 1451/2007, all producers of an active substance listed in Annex II to the latter regulation and all formulators of biocidal products containing that active substance can put it on the market or continue to sell it as such or in biocidal products, for the product type or types for which the Commission has accepted at least one notification. The applicants’ notifications were all accepted by the Commission (see paragraph 18 above), so that Regulation No 1451/2007 does not affect either the alleged established rights or the continuation of the markets for biocidal products sold by the applicants, which those notifications are supposed to guarantee.
57 Consequently, the present action must be dismissed as inadmissible since the applicants are not individually concerned and, in those circumstances, it must be held that there is no need to adjudicate on the applications for leave to intervene made by the Parliament and the Council in support of the form of order sought by the Commission.
Costs
58 Since the Commission did not respond to the application in the manner and within the period prescribed, it is sufficient to hold that the applicants, who fail in their heads of claim, are to bear their own costs, in accordance with Article 87(1) of the Rules of Procedure.
59 The third subparagraph of Article 87(4) of the Rules of Procedure provides that the Court may order an intervener other than those referred to in the second subparagraph of Article 87(4) to bear its own costs. In the present case, CEFIC must therefore be ordered to bear its own costs.
On those grounds,
THE GENERAL COURT (Second Chamber)
hereby:
1. Dismisses the action;
2. Declares that there is no need to adjudicate on the applications for leave to intervene made by the European Parliament and the Council of the European Union;
3. Orders Arch Chemicals, Inc., Arch Timber Protection Ltd, Rhodia UK Ltd, Sumitomo Chemical (UK) plc and Troy Chemical Co. BV to bear their own costs;
4. Orders the European Chemical Industry Council (CEFIC) to bear its own costs.
Forwood | Dehousse | Schwarcz |
Delivered in open court in Luxembourg on 20 September 2011.
[Signatures]