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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Arch Chemicals and Arch Timber Protection v Commission [2011] EUECJ T-400/04 (20 September 2011) URL: http://www.bailii.org/eu/cases/EUECJ/2011/T40004.html Cite as: [2011] EUECJ T-400/04, [2011] EUECJ T-400/4

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JUDGMENT OF THE GENERAL COURT (Second Chamber)

20 September 2011 (*)

(Health policy – Placing on the market of biocidal products – Identification of active substances on the market – Decision refusing amendment of certain provisions of the legislation – Actions for failure to act – Obligation to act – Actions for annulment – Not individually concerned – Inadmissibility)

In Joined Cases T-�400/04, T-�402/04 to T-�404/04,

Arch Chemicals, Inc., established in Norwalk, Connecticut (United States),

Arch Timber Protection Ltd, established in Castleford, West Yorkshire (United Kingdom),

represented by K. Van Maldegem and C. Mereu, lawyers,

applicants in Case T-�400/04,

Rhodia UK Ltd, formerly Rhodia Consumer Specialities Ltd, established in Watford, Hertfordshire (United Kingdom), represented by K. Van Maldegem and C. Mereu, lawyers,

applicant in Case T-�402/04,

Sumitomo Chemical (UK) plc, established in London (United Kingdom), represented by K. Van Maldegem and C. Mereu, lawyers,

applicant in Case T-�403/04,

Troy Chemical Co. BV, established in Vlaardingen (Netherlands), represented by K. Van Maldegem and C. Mereu, lawyers,

applicant in Case T-�404/04,

v

European Commission, represented initially by X. Lewis and D. Recchia, and subsequently by P. Oliver and G. Wilms, acting as Agents,

defendant,

ACTION, firstly, seeking a declaration of the Commission’s failure to act in that it unlawfully refrained from amending certain provisions 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) and of Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8 and amending Regulation (EC) No 1896/2000 (OJ 2003 L 307, p. 1) and, in the alternative, action for annulment of the Commission’s letter of 20 July 2004 refusing to grant the applicants’ requests and, secondly, action for compensation for the loss which the applicants suffered as a result of the Commission’s failure to act and, in the alternative, action for compensation for the loss caused by the Commission’s letter of 20 July 2004,

THE GENERAL COURT (Second Chamber),

composed of N.J. Forwood, President, F. Dehousse and J. Schwarcz (Rapporteur), Judges,

Registrar: N. Rosner, Administrator,

having regard to the written procedure and further to the hearing on 15 December 2010,

gives the following

Judgment

 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). The purpose of Directive 98/8 is to establish Community rules for the authorisation and placing on the market for use of biocidal products.

2        Under Article 2(1)(a) of Directive 98/8, biocidal products are defined as active substances 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 and any requirements laid down in those annexes are fulfilled.

4        Annex I to Directive 98/8 contains the list of active substances and related requirements agreed at Community level for inclusion in biocidal products; Annex IA relates to the active substances and related requirements agreed at Community level for inclusion in low-risk biocidal products; Annex IB concerns basic substances and related requirements agreed at Community level.

5        Article 11 of Directive 98/8 defines the procedure for inclusion of an active substance in Annex I, IA or IB.

6        Article 12(1) of Directive 98/8 provides that Member States are not to make use of information supplied by the first applicant for a marketing authorisation for a biocidal product, in particular that relating to the active substance contained in the biocidal product, for the benefit of a second or subsequent applicant.

7        Article 16(2) and (3) of Directive 98/8, entitled ‘Transitional measures’ provides:

‘2.      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 ... 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.

…

3.      Following such a decision to include or not to include an active substance in Annex I, IA or IB, Member States shall ensure that authorisations or, where relevant, registrations for biocidal products containing the active substances and complying with the provisions of this Directive are granted, modified or cancelled as appropriate.’

8        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). Regulation No 1896/2000 is designed to initiate the systematic examination of all active substances in biocidal products already on the market on 14 May 2000, those active substances being defined as existing active substances under Article 2(a) of that regulation. As indicated in recital 2 in the preamble to Regulation No 1896/2000, ‘[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]’.

9        Under Article 6(1) of Regulation No 1896/2000, a regulation is to be adopted in accordance with the procedure laid down in Article 28 of Directive 98/8, containing, in particular, an exhaustive list of existing active substances for which the Commission has accepted at least one notification or that Member States have ‘indicated their interest’ or for which Member States, alone or collectively, have agreed to provide the necessary data to carry out evaluations for possible inclusion in Annex IB to Directive 98/8.

10      Article 6(2) of Regulation No 1896/2000 provides:

‘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.’

11      On 4 November 2003, the Commission adopted Regulation (EC) No 2032/2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8 and amending Regulation No 1896/2000 (OJ 2003 L 307, p. 1).

12      Article 2 of Regulation No 2032/2003 introduces the notion of ‘participant’, which means a producer, formulator or association which has submitted a notification that has been accepted by the Commission in accordance with Article 4(2) of Regulation No 1896/2000 or a Member State which has indicated an interest in accordance with Article 5(3) of that regulation.

13      Article 3 of Regulation No 2032/2003, entitled ‘Identified and notified existing active substances’, provides:

‘1.      Annex I contains the exhaustive list of existing active substances which have been identified in accordance with the requirements of Article 3(1) or 5(2) of [Regulation No 1896/2000] or in respect of which equivalent information has been provided in a notification submitted in accordance with Article 4(1) of that Regulation.

2.      Annex II contains the exhaustive list of existing active substances in respect of which:

(a)       at least one notification has been accepted by the Commission …, or

(b)      a Member State has indicated an interest …

That list specifies, for each notified existing active substance included, the product type(s) in respect of which notification has been accepted or a Member State has expressed an interest.

3.      Annex III contains the list of existing active substances that have been identified but in respect of which there has been neither an accepted notification nor an expression of interest by a Member State.’

14       Article 4(2) of Regulation No 2032/2003 provides:

‘Without prejudice to Article 8 of [Directive 98/8], the date with effect from which Member States shall, in accordance with Article 16(3) of [Directive 98/8], cancel existing authorisations or registrations for biocidal products containing the active substances listed in Annex III, and ensure that such biocidal products are not placed on the market in their territory, shall be 1 September 2006.

In the case of an active substance listed in Annex II, the first subparagraph shall also apply to that substance in relation to any product type for which no notification has been accepted.’

15      Article 5(3) of Regulation No 2032/2003, entitled ‘Review of notified existing active substances’, provides:

‘Without prejudice to Article 8 of this Regulation, 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 an existing active substance which has been notified, or in which a Member State has indicated an interest, in relation to a product type specified in Annex V to this Regulation shall submit a complete dossier within the time period specified in that Annex for that [active] substance/product type combination.’

16      The dossiers submitted by participants are evaluated by the ‘Rapporteur Member State’ which, in accordance with the second subparagraph of Article 10(2) of Regulation No 2032/2003, is to take into account additional information submitted by persons other than the ‘participant’ only if that information satisfies certain conditions.

17      Article 11(3) of Regulation No 2032/2003 provides:

‘In the case of an existing active substance which, despite a recommendation for inclusion pursuant to Article 10(7) of this Regulation, still gives rise to concern, as referred to in Article 10(5) of Directive [98/8], the Commission may, without prejudice to Article 12 of that Directive, take into account the finalisation of the evaluation on other existing active substances applied for the same use.’

18      Article 13 of Regulation No 2032/2003, concerning the ‘[s]uspension of procedures’, provides:

‘Where, in respect of an active substance listed in Annex II to this Regulation, the Commission presents a proposal to the European Parliament and to the Council, pursuant to Directive 76/769/EEC, for the prohibition of its placing on the market or its use, including use for biocidal purposes, in certain or all product types, the procedures provided for in this Regulation concerning that substance for use in the product type(s) concerned may be suspended pending a decision on that proposal.’

19      On 4 December 2007, the Commission adopted Regulation (EC) No 1451/2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8 (OJ 2007 L 325, p. 3), which, pursuant to Article 18 thereof, repealed Regulation No 2032/2003.

 Background to the dispute

20      The applicants, Arch Chemicals, Inc. and Arch Timber Protection Ltd (Case T-�400/04), Bactria Industriehygiene-Service Verwaltungs GmbH & Co. KG (Case T-�401/04), Rhodia UK Ltd, formerly Rhodia Consumer Specialities Ltd (Case T-�402/04), Sumitomo Chemical (UK) plc (Case T-�403/04) and Troy Chemical Co. BV (Case T-�404/04), are producers and sellers of active biocidal substances and biocidal products containing those active substances.

21      Under Article 4(1) of Regulation No 1896/2000, the applicants notified a number of active substances to the Commission.

22      The ‘[active] substance/product type’ combinations notified having been accepted by the Commission, in accordance with Article 4(2) of Regulation No 1896/2000, those active substances are listed in Annex II to Regulation No 2032/2003 and the applicants, in accordance with the provisions of Article 2 of Regulation No 2032/2003, have the status of participant in the review programme for each of their notified ‘[active] substance/product type’ combinations.

23      On 19 and 20 January 2004, the applicants each sent the Commission a letter in which they asked it to protect ‘the rights and legitimate expectations’ conferred on them by Directive 98/8 and to adopt the measures necessary to bring the regulatory framework into line with the provisions of Directive 98/8 and to ensure fair competition between participants and non-participants.

24      By letters dated 29 January and 10 February 2004, the Commission responded to the applicants, stating that their requests required ‘careful examination’. It therefore considered that such an examination could not be carried out within the 15-day period requested by the applicants.

25      By applications lodged at the Registry of the Court on 17 February 2004 (Cases T-�75/04 to T-�79/04; ‘the first series of actions’), the applicants brought actions pursuant to Article 230 EC for the annulment of Article 3, Article 4(2), Article 5(3), the second subparagraph of Article 10(2), Article 11(3), Article 13 and Article 14(2) of and Annex II to Regulation No 2032/2003. In addition, by virtue of Article 241 EC, they raised a plea of illegality against, firstly, Article 9(a), Article 10(3), Article 11 and Article 16(1) of Directive 98/8 and, secondly, Article 6(2) of Regulation No 1896/2000. Finally, under Article 288 EC, they sought compensation for the loss suffered following the adoption of Regulation No 2032/2003.

26      By letter dated 21 April 2004, the Commission informed the applicants that, in its opinion, the first series of actions essentially concerned the same provisions as those called into question in the letters of 19 and 20 January 2004 and that, consequently, it regarded it as preferable, ‘for reasons of coherence and clarity’, not to reply to those letters, but to present its arguments in the framework of the first series of actions.

27      On 27 May 2004, each of the applicants sent a new letter to the Commission, in which it repeated its request that the Commission intervene and adopt the measures necessary to preserve ‘[its] rights and legitimate expectations’ under Directive 98/8.

28      Thus, the applicants requested that the Commission:

‘–      amend Article 6(2) of Regulation No 1896/2000 because it goes against the legal basis provided by the EC Treaty and Directive 98/8 by allowing non-participating companies to start and/or continue selling [the applicants’] notified active substances/product types, as listed in Annex II [to] Regulation No 2032/2003, in a way which is at odds with the currently applicable data protection provisions of Directive 98/8 and which distorts competition in violation of the EC Treaty;

–        in application of the data protection granted by Directive 98/8, amend Article 4 of Regulation No 2032/2003, by requiring the Member States to withdraw any current biocidal product authorisations which they granted under their national legislation to free-riding non-participating companies, because the latter have no access to the data which was submitted by [the applicants] for the purpose of Directive 98/8 in [their] accepted notification or complete dossiers and which is protected, under Directive [98/8], in all Member States between 14 May 2000 and 14 May 2010;

–        in application of the data protection granted by [Directive 98/8], have it confirmed and make it binding upon all Member States that the proprietary data included in [their] notification and complete dossiers for each of [their] notified active substances/product types which was used to secure their Annex I (lA or lB) listing under [Directive 98/8], will also receive EU-wide effective data protection after such listing occurs, such that these data can then exclusively be used in support of … [their] product authorisations or of authorisations in support of which [they grant] a letter of access;

–        in application of the data protection granted by [Directive 98/8], establish a transparent link between [them], as … [participants], and the active substances/products types notified by [them] and make their Annex I (IA or IB) listing nominative, as is the case in other similar regulatory schemes, so that after such listing Member States … are only allowed to grant biocidal product authorisations if [they] gave the applicant access to [their] protected data that was used to secure such Annex I (IA or IB) listing, and … must cancel those biocidal product authorisations for which [they withdraw] access to [their] data;

–        ensure that [their] rights and legitimate expectations, for each of the active substance/product type combinations where [they are] recognised [participants], are respected and on that basis amend Regulation No 2032/2003 so as to ensure that … no comparative assessment is conducted between [their substances] and other active substances when these are recommended for Annex I (IA or IB) listing, but before such listing takes place; [secondly,] no predominance is given to the hazard-based risk assessment of Directive 76/769 above the risk assessment established by Directive 98/8, and [thirdly,] no account is taken of any data submitted by “applicants” or third parties against and above the notification and complete active substance dossiers submitted by [them] (all of these unlawful provisions have been introduced by [Regulation No 2032/2003]); and

–        in application of its duty of sound administration, take all measures necessary to ensure that Member States have regulatory systems and human resources in place to ensure the adequate implementation of [Directive 98/8] as regards the protection of [their] rights as [participants] (for example, for withdrawing product authorisations during the transitional period, or for having adequate databases to apply data protection), including, if necessary, enforcement actions against such Member States.’

29      By letter of 20 July 2004, the Commission replied to the applicants, stating that, since their claims were already the subject-matter of the first series of actions, until the Court had determined in a final manner that the relevant provisions of Directive 98/8, Regulation No 1896/2000 and Regulation No 2032/2003 should be annulled or declared illegal, the Commission would not take the measures requested.

 Procedure and forms of order sought by the parties

30      By applications lodged at the Registry of the Court on 1 October 2004, the applicants brought the present actions.

31      The applicants claim that the Court should:

–        declare the present actions admissible and well founded or, in the alternative, join the issue of admissibility to the examination of the substance of the action or, in the further alternative, reserve its decision on standing until judgment in the ‘main proceedings’;

–        order the Commission to respond to their requests;

–        or, in the alternative, order the annulment of the letter of 20 July 2004;

–        order the Commission to compensate them, provisionally, in the amount of EUR 1 for damages suffered as a result of its failure to act in that it failed to respond to them, or, in the alternative, as a result of the letter of 20 July 2004, as well as any applicable interests, pending the exact calculation and determination of the exact amount;

–        order the Commission to pay the costs.

32      The Commission contends that the Court should:

–        dismiss the actions for failure to act as inadmissible;

–        dismiss the actions for annulment against its letter of 20 July 2004 as inadmissible or, in the alternative, as unfounded;

–        dismiss the actions for damages as inadmissible or, in the alternative, as unfounded;

–        order the applicants to pay the costs;

–        order the applicants to pay the avoidable costs, in accordance with Article 90 of the Rules of Procedure of the Court.

33      By application lodged at the Registry of the Court on 6 March 2008 and registered as Case T-�120/08, the applicants jointly sought the annulment of Article 3(2), Article 4, Article 7(3), the second subparagraph of Article 14(2), Article 15(3) and Article 17 of Regulation No 1451/2007 and Annex II thereto. They also pleaded the illegality of 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.

34      In the context of measures of organisation of procedure, on 8 May 2008 the Court invited the parties to give their views on the conclusions to be drawn from the adoption of Regulation No 1451/2007, concerning the continuation of the proceedings in the present actions. The applicants and the Commission responded on 26 May 2008.

35      In the context of measures of organisation of procedure, on 22 September 2009 the Court invited the applicants to give their views on the conclusions which they draw from the decision by the Court to allow them, in the first series of actions, to reformulate their claims for annulment following the adoption of Regulation No 1451/2007. The applicants stated that they wish the procedure in the present actions to continue in the normal way.

36      By document lodged at the Court Registry on 30 October 2009, Bactria Industriehygiene-Service Verwaltungs GmbH & Co. KG discontinued all its proceedings in Case T-�401/04. By order of the President of the Seventh Chamber of the Court of 16 December 2009, Case T-�401/04 was removed from the Court Register.

37      By order of the President of the Seventh Chamber of the Court of 6 August 2010, Cases T-�400/04 and T-�402/04 to T-�404/04 were joined for the purposes of the oral procedure and the judgment in accordance with Article 50 of the Rules of Procedure.

38      Upon a change in the composition of the Chambers of the Court, the Judge-Rapporteur was assigned to the Second Chamber, to which the present cases were consequently allocated.

 Law

 The scope and subject-matter of the dispute

39      Firstly, by document lodged at the Court Registry on 8 December 2010, the applicants stated that they discontinued the actions for damages. The Commission did not submit observations on that point at the hearing. The Court therefore records that discontinuance.

40      Secondly, although the claims in the applications seek an order from the Court that the Commission reply to the applicants’ requests, which the Court cannot make, the Court considers nevertheless that, in the circumstances of the present case, those claims can be interpreted as impliedly seeking a declaration of the unlawfulness of the Commission’s alleged failure to act (see, to that effect and by analogy, Case T-�65/91 White v Commission [1994] ECR-�SC I-�A-�9 and II-�23, paragraph 83).

 The merits of the applications for a declaration of failure to act

 Arguments of the parties

41      The applicants submit that, on the basis of the principle of sound administration, the Commission was required to act upon their requests of 27 May 2004 by implementing Directive 98/8 through legislation which does not prejudice the rights and expectations of the parties concerned. To that extent, the Commission should have assessed and remedied the adverse effects of the regulations at issue on the applicants’ legal position.

42      The Commission also had an obligation under Article 24 of Directive 98/8 to act in response to the applicants’ requests. Thus, the Commission is required to ascertain the manner in which Directive 98/8 is implemented by the Member States and to draft a report on that subject. In the applicants’ view, such an obligation should have led the Commission to respond to their requests by adopting mandatory provisions or, at least, non-binding guidelines or recommendations addressed to Member States.

43      The applicants argue that Article 211 EC also constitutes the legal basis for the Commission’s obligation to act, as the Commission has infringed that article by going beyond the limits set in Directive 98/8, in particular in Article 16 and Article 28(3) thereof, in respect of organising the review of the ‘active substance/product type’ combinations.

44      With regard to the illegality on account of which the contested provisions should be amended, the applicants refer in particular to their letters of 27 May 2004, in which they called upon the Commission to make the requested amendments. None the less, they briefly summarise the pleas which they are putting forward in support of the actions.

45      In the first place, the applicants argue that Article 6(2) of Regulation No 1896/2000 departs from Directive 98/8 in so far as that article allows non-participants to benefit from the applicants’ notifications in order to remain on the market and obtain a competitive advantage by not bearing the costs of notification in order to obtain future authorisation. That measure amended the data protection provisions of Directive 98/8 in a manner neither authorised nor justified.

46      In the second place, the applicants claim that Article 3 of and Annex II to Regulation No 2032/2003 should be amended so that that annex, which contains the list of active substances to be reviewed during the second phase of the review programme, is nominative. Indeed, the fact that the participants are not identified in Regulation No 2032/2003 infringes ‘the rights and legitimate expectations’ of the applicants to have their ‘[active] substance/product type combinations listed in Annex I, IA or IB and protected against ‘free-riding’ undertakings.

47      In the third place, the applicants take the view that Article 4(2) of Regulation No 2032/2003, which does not require Member States to cancel authorisations to place biocidal products on the market that are held by undertakings which do not participate in the review programme, is contrary to Article 12 of Directive 98/8, relating to data protection.

48      In the fourth place, the applicants submit that Article 5(3) of Regulation No 2032/2003 has no basis in Directive 98/8 and discriminates between ‘participants’ and ‘applicants’. In their view, that provision is illegal in that it is inconsistent with the obligation to notify ‘[active] substance/product type’ combinations, as laid down in Regulation No 1896/2000. Furthermore, that provision discriminates against ‘participants’, by allowing ‘applicants’ to submit their complete dossiers for review to the Member State of their choice.

49      In the fifth place, Article 10(2) of Regulation No 2032/2003, which enables the Rapporteur Member State to take into consideration data submitted by persons other than participants, is contrary to Directive 98/8, which does not allow the comparative assessment of data.

50      In the sixth place, Article 11(3) of Regulation No 2032/2003, which allows the Commission to conduct a comparative assessment of the ‘active substance/product type’ combinations notified by participants before they are listed on Annex I, IA or IB, has no basis in Directive 98/8 and runs counter to Article 10(5) thereof.

51      In the seventh place, in the applicants’ submission, Article 13 of Regulation No 2032/2000, which enables the Commission to suspend or stop the review of ‘[active] substance/product type’ combinations notified by participants and to present a proposal under Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (OJ 1976 L 262, p. 201) for the prohibition of their marketing or use, is contrary to the risk assessment laid down by Directive 98/8.

52      In the eighth place, the applicants consider that Article 14(2) of Regulation No 2032/2003, which deletes the first three subparagraphs of Article 4(4) of Regulation No 1896/2000, retroactively undermines one of the decisive conditions that prevented them from notifying certain active substances.

53      In the ninth place, the applicants submit that the Commission knowingly failed to ensure that the Member States implement Directive 98/8 without prejudicing the applicants’ situation. The Commission failed, in particular, to take into consideration the interpretation put forward by certain Member States, according to which, where authorisation is granted for a biocidal product containing an active substance listed in Annex I, IA or IB, that substance may be replaced by an active substance produced by a manufacturer other than that which participated in the review programme, without the need for that manufacturer or for the holder of the authorisation to show access to the protected data of the participant in the review programme.

54      In the tenth place, the applicants submit that the implementation of Directive 98/8 by the Commission is contrary to the principles of legal certainty, the protection of legitimate expectations and proportionality.

55      The parties having been questioned by the Court, at the hearing, on the standards which, in the present case, form the basis of the obligation on the Commission to act, the Commission replied that no such obligation followed from Article 24 of Directive 98/8.

 Findings of the Court

56      First of all, it must be borne in mind that it is for the Court to assess whether in the circumstances of the case the proper administration of justice justifies a ruling on the substance of the action without ruling on the pleas of inadmissibility raised by the Commission (Case C-23/00 P Council v Boehringer [2002] ECR I-�1873, paragraph 52; Case T-415/03 Cofradía de pescadores ‘San Pedro de Bermeo’ and Others v Council [2005] ECR II-�4355, paragraph 32; and Case T-�264/07 CSL Behring v Commission and EMA [2010] ECR II-�0000, paragraph 23). In the present case, it is possible to rule on the substance without ruling on the pleas of inadmissibility.

57      In order to rule on the merits of the claim for a declaration of failure to act, it is necessary to ascertain whether, at the time when the Commission was called upon to act pursuant to Article 232 EC, it was under any obligation to act (Case T-�95/96 Gestevisión Telecinco v Commission [1998] ECR II-�3407, paragraph 71, and Case T-�127/98 UPS Europe v Commission [1999] ECR II-�2633, paragraph 34).

58      In the opinion of the applicants, the Commission was under an obligation to amend Regulation No 1896/2000 and Regulation No 2032/2003 on the basis of both primary law and Directive 98/8. As regards primary legislation, they rely on Article 211 EC, the principle of sound administration and the necessary implementation of Directive 98/8 in such as way as not adversely to affect ‘their rights and legitimate expectations’. In addition, they submit that Article 24 of Directive 98/8 requires the Commission to ascertain the manner in which that directive is implemented by the Member States and to draft a report on that subject.

59      In the present case, the actions for failure to act are based on the premiss that, Regulation No 1896/2000 and Regulation No 2032/2003 being unlawful, the Commission, put on formal notice, was under an obligation to amend them in order to remove the unlawful provisions complained of. Such a situation can, by itself, form the basis of an institution’s obligation to act only if a provision or general principle of Community law provided for such an obligation. That was not the case here, however.

60      Firstly, the applicants rely on Article 211 EC to allege that the Commission was required to reply to their request for amendment of Regulation No 1896/2000 and Regulation No 2032/2003. Indeed, the first indent of that article provides that the Commission is to ‘ensure that the provisions of the Treaty and the measures taken by the institutions pursuant thereto are applied’. However, such a provision cannot form the basis of an obligation on the Commission to withdraw or amend a measure of general application, such as a regulation, nor, in the event of its not acting, a ground for the applicant to bring an action before the Court to have that lack of action declared unlawful. The first indent of Article 211 EC refers to the power conferred on the Commission to ensure that the institutions, Member States and third parties comply with Community law, and not to the power to amend an existing regulation, a prerogative which falls within the power to take decisions that stems directly from either the relevant provisions of the Treaty or, as regards the Commission, the measures which confer such power on it.

61      In addition, it follows from the very wording of the third paragraph of Article 232 EC that a natural or legal person may not complain to the Courts of the European Union that an institution of the Community has failed to address to that person a recommendation or an opinion. In the present case, in order to argue that there was an obligation on the Commission to amend Regulation No 1896/2000 and Regulation No 2032/2003, the applicants thus cannot usefully rely on the provisions of the second indent of Article 211 EC, which provide that the Commission is to ‘formulate recommendations or deliver opinions on matters dealt with in this Treaty, if it expressly so provides or if the Commission considers it necessary’.

62      Also on the basis of Article 211 EC, the applicants complain that the Commission has disregarded the provisions of the fourth indent thereof by failing to act in response to their formal notice. The fourth indent of Article 211 EC provides that the Commission is to exercise the powers conferred on it by the Council for the implementation of the rules laid down by the latter. Certainly, by Article 16(2) of Directive 98/8, the Parliament and the Council gave power to the Commission to adopt all the provisions necessary for the preparation and implementation of the review programme. However, it is clear that the Commission took implementing measures under Article 16(2) of Directive 98/8 by adopting Regulation No 1896/2000 and Regulation No 2032/2003, thus fulfilling the obligation to act laid down in that provision. The Commission has not therefore failed to act on the basis of the fourth indent of Article 211 EC.

63      In reality, the applicants rely upon that provision in support of their argument that the regulations adopted by the Commission do not comply with the rules on the basis of which they were adopted, namely not only Article 16(2) of Directive 98/8 but also other provisions of that directive, such as Article 28(3) thereof. Such an argument seeks to show that, even though the implementing measures on the basis of the power conferred on the Commission by the fourth indent of Article 211 EC were adopted, it is possible to complain that the Commission did not fulfil its obligation to adopt an act, on the ground that those measures, or some of their provisions, are unlawful, and subsequently to put the institution on formal notice to amend those measures or those provisions. By such an argument, the applicants exceed the actual scope of an action for failure to act – which is to obtain a ruling that an institution’s lack of action is unlawful – in seeking, by the present action, a declaration that provisions of an existing regulation are unlawful, against which the remedy of an action for annulment is available.

64      Secondly, the applicants state that the Commission was required to act and therefore to amend Regulation No 1896/2000 and Regulation No 2032/2003 by application of the principle of sound administration. Thus, the Commission should have ensured that the application of Directive 98/8 did not run counter to its objectives and, more specifically, that it did not affect the rights and expectations of the interested parties.

65      It must be borne in mind that the European Union Courts take the principle of sound administration into consideration to ascertain whether the failure to act by the institution is unlawful because it constitutes a breach of that principle (Case 64/82 Tradax Graanhandel v Commission [1984] ECR 1359, paragraph 22, and Joined Cases T-�79/96, T-�260/97 and T-�117/98 Camar and Tico v Commission and Council [2000] ECR II-�2193, paragraph 151). Moreover, the case-law applies the notion of sound administration, in the context of actions for a declaration of failure to act, to ascertain whether the examination which the institution is required to carry out following a request to act, submitted under precise provisions, is conducted diligently and impartially and within a reasonable time (Case C-�367/95 P Commission v Sytraval and Brink’s France [1998] ECR I-�1719, paragraph 62; Gestevisión Telecinco v Commission, paragraph 57 above, paragraphs 72 to 75; and Case T-�395/04 Air One v Commission [2006] ECR II-�1343, paragraph 61).

66      In the opinion of the applicants, it is, essentially, due to the alleged unlawfulness of the provisions of Regulation No 1896/2000 and Regulation No 2032/2003 that the principle of sound administration required the Commission to respond to their requests for amendment. Although, as has been stated in the previous paragraph, the principle of sound administration constitutes a standard against which the lawfulness of the acts or inaction of the institutions are examined, it cannot of itself form the basis of an obligation on the Commission to act when a request for amendment of a regulation, which is a measure of general application, is made to it. As has been pointed out in paragraph 60 above, the power to amend such a measure, which falls within the decision-making power of the institutions, stems directly from the relevant provisions of the Treaty or, as regards the Commission, from the measures which confer such power upon it.

67      Thirdly, the same conclusion should be raised against the applicants insofar as the view must be taken that they are relying on the principles of protection of legitimate expectations and legal certainty as bases for the obligation on the Commission to act. Although those principles, in the same way as the principle of sound administration, are standards against which the allegedly unlawful conduct of the institution, that is to say the refusal to act, must be examined, they cannot, on the same grounds as those set out in paragraph 66 above, constitute the basis of an obligation on the Commission to amend a regulation.

68      Fourthly, the applicants argue that the Commission had an obligation to act under Article 24 of Directive 98/8. Required under that article to ascertain the manner in which the Member States are implementing Directive 98/8 and to prepare a report thereon, the Commission should have responded to their request, by adopting mandatory provisions or, at least, non-binding guidelines or recommendations addressed to the Member States.

69      Article 24 of Directive 98/8 provides:

‘Member States shall take the necessary arrangements for biocidal products which have been placed on the market to be monitored to establish whether they comply with the requirements of this Directive.

Every three years after the date referred to in Article 34(1), Member States shall forward to the Commission by 30 November of the third year a report on their action in these matters together with information on any poisonings involving biocidal products. The Commission shall within one year of receipt of this information prepare and publish a composite report.’

70      By virtue of those provisions, the Commission is required to prepare and publish a report within one year of its receipt of information from the Member States on the necessary provisions which they have adopted to monitor whether biocidal products on the market comply with the requirements laid down in Directive 98/8. The only obligation placed on the Commission by Article 24 of Directive 98/8 is the presentation of a composite report. Accordingly, it is in no way possible for Article 24 to form the basis of an obligation on the Commission to amend Regulation No 1896/2000 and Regulation No 2032/2003 because of allegations of unlawfulness affecting certain of their provisions.

71      It follows from the foregoing that the applicants have not shown that the Commission was under an obligation to act as regards the requested amendments to Regulation No 1896/2000 and Regulation No 2032/2003.

72      Consequently, the action for a declaration of failure to act is unfounded.

 Admissibility of the pleas seeking annulment

 Arguments of the parties

73      The Commission submits that the pleas seeking annulment are inadmissible, on the one hand, because, since the object and effect of those pleas are identical to those of the actions for annulment of the first series of actions, they are a duplication of those actions and, on the other hand, because the requested amendment would have to be adopted in the form of a generally applicable act which would not be of direct and individual concern to the applicants.

74      The Commission states that the applicants essentially wish it to adopt or propose legislation which would affect the legal situation of other operators and that the legal position of the applicants would not be affected by such measures. By analysing each of the pleas raised by the applicants, it seeks to show that the aim of all the arguments in support of the pleas seeking annulment is the adoption of a measure which would affect economic operators other than the applicants. As a result, the applicants would not be directly and individually concerned by the amendments which they request to the legislation.

75      The applicants claim that the letter of 20 July 2004 is addressed directly to them, that it defines the final position of the institution with respect to their requests and is definitive in nature. By analogy with Commission decisions to take no action or reject a complaint, or even to open State aid proceedings under Article 88(2) EC, decisions which the Courts of the European Union have held to contain definitive measures and against which those Courts have conferred standing to bring proceedings on persons challenging them, the applicants consider that their applications for annulment are admissible.

76      The applicants argue that they have an interest in requesting the amendment of the provisions of the regulatory framework, since those provisions affect their position on the market. They point out that they operate on the same market as undertakings which have not notified ‘active substance/product type’ combinations and that it is therefore in their direct interest that the legislation should ensure that the various operators are subject to the same conditions on the relevant market.

77      As regards their standing to bring proceedings, firstly, the applicants counter the Commission’s argument that the requested measures are of general application by stating that it is settled case-law that the general application of a measure does not prevent persons from having an interest in its annulment or amendment.

78      Secondly, the applicants submit that if, in order to take account of their request for increased protection of their data, the Commission were to adopt a measure addressed to the Member States, that would not preclude them from having an interest in the adoption of such measures, which would directly affect their position on the market and their data protection rights granted under Directive 98/8.

 Findings of the Court

79      It is settled case-law that an act of the Commission which amounts to a rejection must be appraised in the light of the nature of the request to which it constituted a reply (Joined Cases C-�15/91 and C-�108/91 Buckl and Others v Commission [1992] ECR I-�6061, paragraph 22). In particular, a Community institution’s refusal to withdraw or amend an act is in itself an act the legality of which can be reviewed under Article 230 EC only where the act which the Community institution refuses to withdraw or amend could itself be challenged under that provision (Case T-�83/92 Zunis Holding and Others v Commission [1993] ECR II-�1169, paragraph 31; and the orders in Case T-�139/02 Institouto N. Avgerinopoulou and Others v Commission [2004] ECR II-�875, paragraph 57; and Case T-�369/03 Arizona Chemical and Others v Commission [2005] ECR II-�5839, paragraph 64). Questioned at the hearing on the implications of the judgment in Zunis Holding and Others v Commission (paragraph 31) for the present case, the applicants replied that their claim for annulment of the letter of 20 July 2004 is admissible.

80      Firstly, it must be noted that the applicants wish the Commission to amend Article 6(2) of Regulation No 1896/2000. The action for annulment of Regulation No 1896/2000 was dismissed by the Court as inadmissible, since that regulation cannot be regarded as being of individual concern to the applicant (order in Case T-�339/00 Bactria v Commission [2002] ECR II-�2287, paragraph 55). In that order, it was held, in particular, that Regulation No 1896/2000 applied to objectively determined situations and produced legal effects in respect of persons considered in a general and abstract manner and that consequently, that regulation, by virtue of its general application, had a normative character and did not constitute a decision within the meaning of Article 249 EC (order in Bactria v Commission, paragraph 46).

81      Furthermore, in the context of the present actions, the applicants are, as regards Regulation No 1896/2000, in the same position as the applicant in the action which gave rise to the order in Bactria v Commission. They are companies which placed biocidal products containing existing active substances on the market, a fact which does not enable them to be regarded as individually concerned by Regulation No 1896/2000 (see, to that effect, order in Bactria v Commission, paragraph 48). In addition, there were no provisions requiring the Commission, before the adoption of Regulation No 1896/2000, to follow procedures under which persons such as the applicant were accorded the right to put forward any claim they may have had or even to be heard (see, to that effect, order in Bactria v Commission, paragraph 51). Nor was there any provision that required the Commission to take account of the consequences which the act it was planning to adopt might have for the position of any particular individuals (see, to that effect, order in Bactria v Commission, paragraph 52). Finally, an alleged infringement of the applicant’s property rights, as protected by Article 12 of Directive 98/8, supposing it were established, was not sufficient to distinguish economic operators such as the applicants individually in relation to any other operator who gave notification of an existing active substance (see, to that effect, order in Bactria v Commission, paragraph 53).

82      Thus, it must be held that, placed in the same situation as the applicant in the case which gave rise to the order in Bactria v Commission as regards Regulation No 1896/2000, the applicants are no more entitled than that applicant to seek its annulment, since they are not individually concerned.

83      Accordingly, by application of the case-law cited in paragraph 79 above, the applicants do not have standing to seek the annulment of the letter of 20 July 2004, in as much as the Commission rejected their request for amendment of Regulation No 1896/2000 in that letter.

84      Secondly, as regards the provisions of Regulation No 2032/2003 which, in its letter of 20 July 2004, the Commission refused to amend, they have all been contested in the first series of actions. The applicants expressly requested, in the letters of 27 May 2004, the amendment of Article 4 of Regulation No 2032/2003. It is clear from the letters of 27 May 2004 that an amendment was sought of paragraph 2 of that provision. Furthermore, the applicants, without having specified the articles referred to, also wanted the Commission to amend Article 3, Article 5(3), the second subparagraph of Article 10(2), Article 11(3), Article 13 of and Annex II to Regulation No 2032/2003, and also Article 14(2) thereof.

85      The Court has dismissed the first series of actions as inadmissible, since the applicants were not individually concerned by any of the provisions referred to in the preceding paragraph (judgment of the Court delivered today in Joined Cases T-�75/04, T-�77/04 to T-�79/04 Arch Chemicals and Others v Commission).

86      Accordingly, by application of the case-law cited in paragraph 79 above, the applicants’ have no standing to request annulment of the letter of 20 July 2004, in as much as the Commission rejected their request for amendment of Regulation No 2032/2003 in that letter.

87      In consequence, the claim for annulment of the letter of 20 July 2004 must be dismissed as inadmissible.

 Costs, including those incurred by the Court

88      Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. As the applicants have been unsuccessful, they must be ordered to pay the costs, in accordance with the form of order sought by the Commission.

89      However, there is no reason, in the circumstances of the present case, to order the applicants to refund to the Court, under Article 90(a) of the Rules of Procedure, the avoidable costs which it has incurred.

On those grounds,

THE GENERAL COURT (Second Chamber)

hereby:

1.      Dismisses the actions;

2.      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 and to pay the costs incurred by the European Commission.

Delivered in open court in Luxembourg on 20 September 2011.

[Signatures]

* Language of the case: English.