Court of Justice of the European Communities (including Court of First Instance Decisions)

(Appeal - Directive 2003/15/EC - Action for annulment - Cosmetic products - Protection of public health - Experiments on animals - Prohibition of substances which are carcinogenic, mutagenic or toxic for reproduction - Appeal in part clearly inadmissible and in part clearly unfounded)

In Case C-113/05 P,

APPEAL under Article 56 of the Statute of the Court of Justice lodged on 25 February 2005,

European Federation for Cosmetic Ingredients (EFfCI), established in Brussels (Belgium), represented by K. Van Maldegem and C. Mereu, avocats,

appellant,

the other parties to the proceedings being:

European Parliament, represented by K. Bradley and M. Moore, acting as Agents, with an address for service in Luxembourg,

Council of the European Union, represented by E. Karlsson and C. Giorgi Fort, acting as Agents,

defendants at first instance,

composed of A. Rosas (Rapporteur), President of the Chamber, J. Malenovský, J.-P. Puissochet, A. Borg Barthet and A. Ó Caoimh, Judges,

Advocate General: L.A. Geelhoed,

Registrar: R. Grass,

after hearing the Advocate General,

makes the following

1. By its appeal, the European Federation for Cosmetic Ingredients ('the EFfCI' or 'the appellant') requests the annulment of the order of the Court of First Instance of the European Communities of 10 December 2004 in Case T-196/03 EFfCI v Parliament and Council (not yet published in the ECR) ('the contested order'), by which the Court of First Instance declared inadmissible its action for partial annulment of Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (OJ 2003 L 66, p. 26; 'the contested directive') in so far as it (1) inserts a new Article 4a(2) and (2.1) and a new Article 4b in, and (2) adds a new subparagraph to Article 6(3) of, Directive 76/768 (OJ 1976 L 262, p. 169; 'the disputed provisions').

Legal context

2. Article 1 of the contested directive provides:

'Directive 76/768/EEC is hereby amended as follows:

...

2. the following articles shall be inserted:

Article 4a

1. Without prejudice to the general obligations deriving from Article 2, Member States shall prohibit:

(a) the marketing of cosmetic products where the final formulation, in order to meet the requirements of this directive, has been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;

(b) the marketing of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this directive, have been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;

(c) the performance on their territory of animal testing of finished cosmetic products in order to meet the requirements of this directive;

(d) the performance on their territory of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this directive, no later than the date on which such tests are required to be replaced by one or more validated alternative methods listed in Annex V to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances ... or in Annex IX to this directive.

No later than 11 September 2004 the Commission shall, in accordance with the procedure referred to in Article 10(2) and after consultation of the Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers (SCCNFP), establish the contents of Annex IX.

2. The Commission, after consultation of the SCCNFP and of the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the OECD, shall establish timetables for the implementation of the provisions under paragraph 1(a), (b) and (d), including deadlines for the phasing-out of the various tests. The timetables shall be made available to the public not later than 11 September 2004 and be sent to the European Parliament and the Council. The period for implementation shall be limited to a maximum of six years after the entry into force of Directive 2003/15/EC in relation to paragraph 1(a), (b) and (d).

2.1. In relation to the tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration, the period for implementation of paragraph 1(a) and (b) shall be limited to a maximum of 10 years after the entry into force of Directive 2003/15/EC.

...

Article 4b

The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction, of categories 1, 2 and 3, under Annex I to Directive 67/548/EEC shall be prohibited. To that end the Commission shall adopt the necessary measures in accordance with the procedure referred to in Article 10(2). A substance classified in category 3 may be used in cosmetics if the substance has been evaluated by the SCCNFP and found acceptable for use in cosmetic products.-�

...

5. the last sentence of Article 6(3) shall be deleted and the following subparagraph shall be added:

Furthermore, the manufacturer or the person responsible for placing the product on the Community market may take advantage, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the product, of the fact that no animal tests have been carried out only if the manufacturer and his suppliers have not carried out or commissioned any animal tests on the finished product, or its prototype, or any of the ingredients contained in it or used any ingredients that have been tested on animals by others for the purpose of developing new cosmetic products. Guidelines shall be adopted in accordance with the procedure referred to in Article 10(2) and published in the Official Journal of the European Union. The European Parliament shall receive copies of the draft measures submitted to the Committee.-�

...'

3. Article 13 of Directive 76/768 provides:

'Precise reasons shall be stated for any individual measures placing a restriction or ban on the marketing of cosmetic products taken pursuant to this directive. It shall be notified to the party concerned together with particulars of the remedies available to him under the laws in force in the Member States and of the time-limits allowed for the exercise of such remedies.'

Background to the dispute

4. The EFfCI is a European Economic Interest Group comprising more than 60 European manufacturers of cosmetic ingredients and represents the interests of several chemical companies in France, Germany, Italy, Sweden and Switzerland, which provide chemical substances to cosmetic companies.
5. Before the adoption of the contested directive, the EFfCI made its concerns known to the Community institutions. In September 2001, it sent the European Parliament a summary entitled 'Submission in support of a realistic and effective approach to the implementation of the 7th amendment to the Cosmetics Directive'. In that document, it stated that the statutory prohibition on animal experiments should come into force in all of the relevant sectors rather than only in the cosmetic ingredients sector, that as soon as alternative methods had been validated it would adopt them and, finally, that any deadline for the complete abolition of animal experiments was not scientifically justifiable.
6. The EFfCI also expressed reservations concerning affixing labels to cosmetic products stating that they had not been tested on animals. Such statements would, it maintained, be liable to mislead consumers.
7. In May and June 2002, the EFfCI again communicated to the relevant members of the European Parliament its concerns regarding the proposed ban on the testing of cosmetic ingredients on animals and the ban on the marketing of cosmetics containing ingredients tested on animals after the expiry of a deadline.
8. The EFfCI also submitted that the Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers concluded in two memoranda adopted on 4 June and 29 July 2002 respectively that insufficient progress had been made in the development of satisfactory alternative methods. In particular, it stated that despite reasonable efforts those alternative methods had not been scientifically validated as offering consumers an equivalent level of protection, having regard to the OECD (Organisation for Economic Cooperation and Development) guidelines on toxicity testing.
9. These concerns were also expressed by the European Cosmetic, Toiletry and Perfumery Association. In a summary dated 11 October 2002, entitled 'Development of alternative methods: state of play and perspectives', the association concluded that there was a lack of information on the short-, medium- and long-term perspectives for the development, validation and regulatory acceptance of alternative methods. In addition, it expressed the view that the dates in Table 12.1 of the ECVAM report could not be interpreted as mandatory.
10. The EFfCI also sent several letters to the Commission of the European Communities, in particular to the relevant directorates to inform them of its concerns before the adoption of the contested directive.

The contested order

11. By an application lodged at the Registry of the Court of First Instance on 3 June 2003, the EFfCI brought an action for the partial annulment of the contested directive.
12. By documents of 17 July and 14 August 2003, the Council and the Parliament raised two objections of inadmissibility under Article 114 of the Rules of Procedure of the Court of First Instance.
13. The EFfCI submitted its observations on these objections on 29 September 2003.
14. Under Article 114(1) of its Rules of Procedure, the Court of First Instance decided to rule on inadmissibility without going into the substance of the case and considered that there was no need to open oral proceedings under Article 114(3) of those rules, as it considered that it had sufficient information from the documents of the case.
15. At paragraph 43 of the contested order, the Court of First Instance held that the admissibility of an action for annulment brought by an association set up to promote the collective interests of a category of persons depends, without prejudice to its own interest in bringing proceedings, on the question whether its members could have brought that action individually. At paragraph 61 of the contested order, it held that that requirement had not been met.
16. Moreover, at paragraphs 65 and 68 of the contested order, the Court of First Instance took the view that the fact of having voluntarily participated in the preparation of an act of a legislative nature, in the context of a procedure not providing for any intervention by individuals, cannot, in contrast to participation in a procedure providing for such intervention, give rise to a right to bring proceedings against that measure. It also noted that the EFfCI did not submit that the associations which it represents or the undertakings forming part of these associations were vested with special procedural rights which would make the action for annulment admissible.
17. The Court of First Instance concluded that the disputed provisions were not of individual concern to the EFfCI and, by order of 10 December 2004, dismissed the action as inadmissible.

The appeal

18. By its appeal, the EFfCI asks the Court to annul the contested order, to rule on the substance of the case or, alternatively, to refer the case back to the Court of First Instance, and to order the Parliament and the Council to pay the costs.
19. The Parliament and the Council contend that the Court should dismiss the appeal and order the EFfCI to pay the costs.
20. By document lodged at the Registry of the Court on 29 August 2005, the EFfCI requested a hearing.
21. Under Article 119 of its Rules of Procedure, where the appeal is, in whole or in part, clearly inadmissible or clearly unfounded, the Court may at any time, acting on a report from the Judge-Rapporteur, after hearing the Advocate General, dismiss it in whole or in part by reasoned order without initiating the oral procedure (see the order in Case C-360/02 P Ripa di Meana v Parliament [2004] ECR I-10339, paragraph 18).

The first plea in law, concerning the application of Article 114(4) of the Rules of Procedure of the Court of First Instance

Arguments of the parties

22. In its first plea, which comprises three parts, the EFfCI challenges paragraph 16 of the contested order and submits that the Court of First Instance wrongly dismissed its request to examine the substance before ruling on admissibility or, alternatively, to reserve any decision until judgment on the substance. It claims, in fact, that that dismissal is based on a misinterpretation of Article 114(4) of the Rules of Procedure of the Court of First Instance. In addition, the decision not to initiate the oral procedure failed to pay due regard to the principle of effet utile. Finally, the contested order was not supported by sufficient reasons on this point.
23. The Parliament submits that paragraphs 13, 14 and 15 of the contested order provide ample reasoning for the decision made by the Court of First Instance to decide on admissibility without examining the substance and that the latter took care to explain why the particular exceptional circumstances which were present in Case C-23/00 P Council v Boehringer [2002] ECR I-1873 served to distinguish that case from the present case.
24. The Council disputes the appellant's claims and also takes the view that, in paragraphs 12 to 17 of the contested order, the Court of First Instance sufficiently motivated its decision not to address the substance of the case.

Findings of the Court

25. It must first of all be noted that Article 114(1) to (3) of the Rules of Procedure of the Court of First Instance provides that, if a party applies to it for a decision on admissibility, on lack of competence or other preliminary plea not going to the substance of the case, the President of the Court of First Instance is to prescribe a period within which the opposite party may lodge a document containing a statement of the form of order sought by it and its pleas in law, and that, unless the Court of First Instance decides otherwise, the remainder of the proceedings is to be oral. In accordance with Article 114(4) of those rules, the Court of First Instance, after hearing the Advocate General, decides on the application or reserves its decision for the final judgment.
26. It is clearly apparent from these provisions that the Court of First Instance is under no duty to hold a hearing and that it has exclusive jurisdiction to decide whether to rule immediately on the objection of inadmissibility or to reserve its decision for the final judgment. It follows that the Court of First Instance, in deciding in this case to rule on the objection of inadmissibility raised by the Council, without initiating the oral procedure on the ground that it considered itself sufficiently informed by the documents before it, correctly applied Article 114(4) of its Rules of Procedure, without in any way misinterpreting the principle of effet utile (see, to that effect, the order in Ripa diMeana v Parliament, paragraph 35) and, at paragraphs 13 to 15 of the contested order, provided sufficient reasons for its decision.
27. The first plea, in all three parts, must therefore be dismissed as clearly unfounded.

The second plea in law, alleging an error of law in the legal assessment of the facts

Arguments of the parties

28. Concerning the first part of the second plea, the EFfCI submits that the Court of First Instance erred in the legal assessment of the facts by finding that the anti-competitive effects produced by the contested directive on the appellant did not distinguish it from other undertakings.
29. It submits that the Parliament and the Council were obliged, under Article 3(1)(g) EC, to take such negative effects into account and to ensure that competition in the internal market was not distorted.
30. Moreover, the EFfCI submits that the Court implicitly misinterpreted the judgment in Case C-358/89 Extramet Industrie v Council [1991] ECR I-2501 and erred in law by not considering its very similar, although not identical, situation as equivalent to that in the abovementioned judgment, in which the Court of Justice took the view that the applicant was individually concerned.
31. Further, according to the second part of that plea, the Court erred in law by taking the view that Article 13 of Directive 76/768 did not confer on the EFfCI any right to participate in the drafting of the contested directive and related only to information subsequently provided to undertakings affected by individual measures adopted for the implementation of that directive.
32. Concerning the third part of the same plea, the appellant submits that the Court also erred in law in its assessment of the legal consequences of the patents held by the EFfCI. The latter submits, in this respect, that the contested directive has had the effect of preventing it from enjoying an exclusive right to market specific compositions obtained through particular processing methods. Thus the effect of that directive, which makes use of its patented products in trade immediately and definitively unlawful, is that the EFfCI is individually concerned within the meaning of the case-law of the Court as set out in Case C-309/89 Codorniu v Council [1994] ECR I-1853.
33. Concerning the fourth part of the same plea, the EFfCI submits that the Court of First Instance interpreted the judgment in Case 53/85 AKZO Chemie v Commission [1986] ECR 1965 in a very restrictive manner and that, by analogy, the very special protection afforded to intellectual property rights should have led the Court to consider that the appellant is individually concerned by the contested directive.
34. The Parliament and the Council consider that the Court of First Instance did not err in law in any of these ways and did not misinterpret any of the abovementioned judgments.
35. Concerning more particularly the first part of this plea, they submit that the appellant's claim alleging infringement of Article 3(1)(g) EC is a new plea which is, for that reason, inadmissible.

Findings of the Court

36. In the context of the first part of the second plea, concerning firstly the appellant's claim that the Parliament and the Council were required by Article 3(1)(g) EC to take account of the negative effects of the contested directive and to ensure that competition in the internal market was not distorted, it should be noted that, according to settled case-law, in an appeal the Court's jurisdiction is confined to review of the findings of law on the pleas argued before the Court of First Instance (see the order in Case C-180/03 P Latino v Commission [2004] ECR I-1587, paragraphs 41 and 42). It is clear from the documents before the Court that this claim is raised here for the first time and is, therefore, for that reason, inadmissible.
37. Concerning, secondly, the other claims invoked in the context of the first part of the second plea, a preliminary point to note is that, as the Court of First Instance correctly stated at paragraph 38 of the contested order, a legislative measure applying to all the economic operators concerned may be of individual concern to some of them 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 an addressee of a decision (see, in particular, Case 26/86 Deutz andGeldermann v Council [1987] ECR 941, paragraph 9; Extramet Industrie v Council, paragraphs 13 and 16; Codorniu v Council, paragraphs 19 and 20; and Case C-263/02 P Commission v Jégo-Quéré [2004] ECR I-3425, paragraph 45).
38. In that respect, it is apparent from paragraphs 36, 47, 48 and 49 of the contested order that the Court of First Instance, in the context of its assessment of the legal scope of the contested directive, noted that the latter applies to situations that are determined objectively and to classes of persons considered in general and in the abstract, including undertakings producing substances used in the manufacture of cosmetic products.
39. The appellant was not able to demonstrate to the Court of First Instance that the contested directive affected it by reason of special characteristics or a factual situation which distinguishes it from the other undertakings concerned by that directive.
40. Consequently, the Court rightly stated that the mere fact of being economically more affected by the contested directive is not sufficient to consider that the appellant is individually concerned.
41. The first part of the second plea is, consequently, in part clearly inadmissible and in part clearly unfounded.
42. Concerning the second part of the second plea, the EFfCI submits that the Court of First Instance was wrong to take the view that Article 13 of Directive 76/768 relied on by the appellant in order to participate in the procedure leading to the adoption of the contested directive only related to information subsequently provided to undertakings affected by individual measures adopted for the implementation of that directive. However, it is clear from that article that it governs the reasons to be given for, and the procedure for the notification of, these individual measures.
43. Consequently, the Court was able, without incurring that complaint, to take the view that Article 13 of Directive 76/768 did not confer on the EFfCI the right to participate in the drafting of the contested directive.
44. The second part of the second plea is, therefore, clearly unfounded.
45. Concerning the third part of the second plea, it is true that at paragraphs 21 and 22 of the judgment in Codorniu v Council the Court recognised that the company concerned in that case was in a situation for the purposes of the legislative provision of general scope in question which differentiated it from all other traders, in so far as that provision prevented the company from using its graphic trade mark in trade.
46. However, as the Court stated at paragraphs 57 to 60 of the contested order, the contested directive does not impede the exercise of exclusive rights resulting from specific patents owned by the members of the EFfCI or deprive them of these rights, which, moreover, are not exclusive rights for the production of cosmetics and capable, therefore, of differentiating the undertakings concerned from others.
47. It follows from the foregoing that the Court of First Instance was entitled to rule that the exclusive rights enjoyed by the undertakings which are members of the EFfCI by virtue of the patents held by them do not distinguish them from other economic operators with the same rights and that they are not, therefore, individually concerned within the meaning of the judgment in Codorniu v Council.
48. The third part of the second plea is, consequently, clearly unfounded.
49. Concerning the fourth part of the second plea, it is true that at paragraph 28 of the judgment in AKZO Chemie v Commission the Court ruled that business secrets are afforded very special protection in the context of competition policy, pursuant to Articles 19(3) and 21(2) of Council Regulation No 17, First Regulation implementing Articles 85 and 86 of the Treaty (OJ, English Special Edition 1959-1962, p. 87), which deal with the Commission's obligations in regard to hearings and the publication of decisions.
50. However, the appellant did not demonstrate to the Court of First Instance that the contested directive had the aim or effect of depriving it, as the case may be, of that protection as regards the intellectual property rights which it holds.
51. Consequently, the Court was entitled to take the view that the fact that the appellant held intellectual property rights did not support the conclusion that it was individually concerned by the contested directive.
52. The fourth part of the second plea is, therefore, clearly unfounded.
53. It follows from the foregoing that the second plea must be dismissed in all its parts as in part clearly inadmissible and in part clearly unfounded.

The third plea in law, alleging infringement of the right to complete and effective judicial protection and of the right to a fair hearing

Arguments of the parties

54. The EFfCI submits that the Court of First Instance, in finding that its action for partial annulment was partly inadmissible, infringed its right to complete and effective judicial protection and to be heard. The respect of its rights should, according to the appellant, have led the Court of First Instance to take the view that it was individually concerned by the contested directive and to declare its action admissible.
55. The Parliament and the Council submit that the right to complete and effective legal protection is ensured by the legal remedies allowing the national courts to request the Court of Justice to give a ruling on the validity of the contested directive pursuant to Article 234 EC.

Findings of the Court

56. It should be noted that, according to the system of review of the legality of Community acts established by the EC Treaty, a natural or legal person may bring an action challenging such acts of general scope only if that person is concerned not only directly but also individually. The latter condition is interpreted by the Court in the light of the principle of effective judicial protection by taking account of the various circumstances that may distinguish an applicant individually; this interpretation cannot, however, have the effect of setting aside the condition in question, expressly laid down in the Treaty, without going beyond the jurisdiction conferred by the Treaty on the Community Courts (see Case C-50/00 P Unión de PequeñosAgricultores v Council [2002] ECR I-6677, paragraph 44).
57. Moreover, in the context of the national systems of legal remedies and procedures which ensure observance of the right to effective legal protection, it is for the national courts, so far as possible, to interpret and apply national procedural rules governing the exercise of rights of action in a way that enables natural and legal persons to challenge before the courts the legality of any decision or other national measure concerning the application to them of a Community act of general application, by pleading the invalidity of such an act (see Unión de Pequeños Agricultores v Council, paragraph 42).
58. The third plea is, therefore, clearly unfounded.
59. It follows from all of the foregoing that the EFfCI's appeal must be dismissed, as the pleas are in part clearly inadmissible and in part clearly unfounded.

Costs

60. Under Article 69(2) of the Rules of Procedure of the Court of Justice, which applies to appeal proceedings by virtue of Article 118 thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party's pleadings. Since the Parliament and the Council have applied for costs and the appellant has been unsuccessful, the latter must be ordered to pay the costs.

On those grounds, the Court (Third Chamber) hereby orders:

1. The appeal is dismissed.

2. The European Federation for Cosmetic Ingredients shall pay the costs.

[Signatures]

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* Language of the case: English.