CELEX: 62003TO0196
Language: en
Date: 2004-12-10 00:00:00
Title: Order of the Court of First Instance (Third Chamber) of 10 December 2004. # European Federation for Cosmetic Ingredients (EFfCI) v European Parliament and Council of the European Union. # Manifest inadmissibility - Concept of measure of individual concern to an applicant - European Economic Interest Group - Contracts being performed - Intellectual property rights. # Case T-196/03.

Case T-196/03
      European Federation for Cosmetic Ingredients (EFfCI)
      v
      European Parliament and Council of the European Union
      (Manifest inadmissibility – Concept of measure of individual concern to an applicant – European Economic Interest Grouping – Contracts being performed – Intellectual property rights)
      Order of the Court of First Instance (Third Chamber), 10 December 2004  
      Summary of the Order
      1.     Actions for annulment – Natural or legal persons – Measures of direct and individual concern to them – Legislative measure
            – Directive 
      (Arts 230, fourth para., EC and 249 EC)
      2.     Actions for annulment – Action brought by a European Economic Interest Grouping – Admissibility – Conditions 
      (Art. 230, fourth para., EC; Council Regulation No 2137/85)
      3.     Actions for annulment – Natural or legal persons – Measures of direct and individual concern to them – Directive on the approximation
            of the laws of the Member States relating to cosmetic products – Action by a European Economic Interest Grouping combining
            associations of manufacturers of chemical products – Inadmissible 
      (Art. 230, fourth para., EC; European Parliament and Council Directive 2003/15)
      4.     Actions for annulment – Natural or legal persons – Measures of direct and individual concern to them – Directive on the approximation
            of the laws of the Member States relating to cosmetic products – Measure capable of being of direct and/or individual concern
            to certain operators because of contracts made prior to its entry into force – Conditions 
      (Art. 230, fourth para., EC; European Parliament and Council Directive 2003/15)
      5.     Actions for annulment – Natural or legal persons – Measures of direct and individual concern to them – Action brought by an
            association of undertakings which took part in the procedure for adopting the measure – Admissibility – Conditions 
      (Art. 230, fourth para., EC)
      6.     European Communities – Judicial review of the legality of acts of the institutions – Measures of general scope – Obligation
            for national courts to apply national procedural rules in a way that enables the legality of Community acts of general application
            to be challenged – Availability of an action for annulment before the Community judicature in the event of an insurmountable
            obstacle at the level of national procedural rules – Excluded 
      (Art. 230, fourth para., EC)
      1.     Although the fourth paragraph of Article 230 EC makes no express provision regarding the admissibility of actions brought
         by individuals for annulment of a directive, that fact alone is insufficient for such actions to be declared inadmissible.
         Moreover, the Community institutions cannot, merely by the choice of the form of the act in question, exclude the judicial
         protection afforded to individuals under that provision of the Treaty. Therefore, the fact that the contested measure is,
         by its nature, of general scope and does not constitute a decision within the meaning of Article 249 EC is not sufficient
         in itself to preclude an action for its annulment being brought by an individual.
      
      (see paras 34, 37)
      2.     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 the members of
         such an association could have brought that action individually. That rule also applies to a European Economic Interest Grouping
         (EEIG), the purpose of which, as is clear from Article 3 of Regulation No 2137/85 on the EEIG, is solely to facilitate or
         develop the economic activities of its members to enable them to increase the results thereof, so that it is merely auxiliary
         to them.
      
      (see para. 43)
      3.     An action for annulment, by a European Economic Interest Grouping combining two associations of manufacturers of chemical
         products, of Directive 2003/15 amending Directive 76/768 on the approximation of the laws of the Member States relating to
         cosmetic products, is inadmissible.
      
      The harmful effects that the prohibitions introduced by that directive and the labelling authorised by it concerning the absence
         of animal experimentation would have on the competitive position of the undertakings represented by the associations in question
         do not distinguish them from the other undertakings which do not supply the cosmetics sector or limit themselves to that market
         but do not test their ingredients on animals or do not use substances classified as carcinogenic, mutagenic or toxic for reproduction.
         In that regard, it is not sufficient that certain operators are economically more affected by a measure of general scope than
         their competitors for that measure to be of individual concern to them.
      
      Moreover, the fact that the same undertakings are, in certain countries, the most important in the sector is not a basis for
         inferring that they belong to a class of traders individually identifiable on the basis of criteria relating to the products
         in question or the business activities carried on, since a commercial activity is a priori  capable of being carried on by any undertaking, actually or potentially liable to find itself in the same position as those
         operators.
      
      Likewise, the existence of legal protection, such as a patent, for know-how and business secrets of undertakings represented
         by the associations that are members of the applicant grouping is not capable of distinguishing them from all other manufacturers
         of chemicals concerned by Directive 2003/15. First, they too may claim such protection for their benefit, since the manufacture
         and marketing of products is frequently covered by intellectual property rights. Second, whilst each patent identifies the
         product that it protects, that directive does not impede the use of a specific patent, so that any impact on intellectual
         property rights is attributable only to the fact, not specific to any person, of producing substances for use by the cosmetics
         industry.
      
      (see paras 46-47, 49, 57)
      4.     For the claim concerning contractual commitments to render an action for annulment of a legislative measure, such as Directive
         2003/15 amending Directive 76/768 on the approximation of the laws of the Member States relating to cosmetic products, admissible
         under the fourth paragraph of Article 230 EC, first, a rule of law superior to the measure in question must have required
         the institutions to take account of the specific situation of the applicant undertakings as compared with that of any other
         person concerned by that measure. Second, those undertakings must be parties to contracts already concluded, the performance
         of which, planned to take place during the period of application of the contested measure, is prevented wholly or in part.
      
      (see para. 53)
      5.     Whist the fact that an association of undertakings played a role in a procedure which led to the adoption of a measure of
         general scope may justify the admissibility of an action for annulment brought by that association against such a measure
         even where it is not of direct and individual concern to the member undertakings of that association, the fact of voluntarily
         participating in the preparation of a measure 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.
      
      (see paras 63-65)
      6.     Apart from the fact that it is the Member States that bear the responsibility for providing a system of remedies and procedures
         facilitating observance of the right to effective judicial protection and for compensating for any inadequacies of the Treaties
         in that connection, an interpretation of the rules on admissibility laid down in Article 230 EC to the effect that an action
         for annulment must be declared admissible if it is shown, following an examination by the Community Court of the national
         procedural rules, that those rules do not allow the individual to bring proceedings to contest the validity of the Community
         measure at issue is not acceptable. Indeed, such an interpretation would require the Community Court, in each individual case,
         to examine and interpret national procedural law, which would go beyond its jurisdiction when reviewing the legality of Community
         measures.
      
      (see para. 70)

      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
            
            ORDER OF THE COURT OF FIRST INSTANCE (Third Chamber)10 December 2004(1)
            
            
         
            (Manifest inadmissibility  –  Concept of measure of individual concern to an applicant  –  European Economic Interest Grouping  –  Contracts being performed  –  Intellectual property rights)
            
          In Case T-196/03,
         
         
         European Federation for Cosmetic Ingredients (EFfCI), established in Brussels (Belgium), represented by K. Van Maldegem and C. Mereu, lawyers,
         
         
         applicant,
         
         v
         European Parliament,  represented by J.L. Rufas Quintana, M. Moore and K. Bradley, acting as Agents, with an address for service in Luxembourg,
         andCouncil of the European Union, represented by E. Karlsson and C. Giorgi Fort, acting as Agents, 
         
         defendants,
         
          application for the annulment of:
         
         –
          Article 1(2) 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),
         in so far as it inserts in Directive 76/768 a new Article 4a(2) and (2.1) and a new Article 4b,
         
         –
          Article 1(5) of Directive 2003/15, in so far as it adds a new subparagraph to Article 6(3) of Directive 76/768,
         
         
         
         
         
         
         THE COURT OF FIRST INSTANCEOF THE EUROPEAN COMMUNITIES (Third Chamber)
         
         
          composed of J. Azizi, President, M. Jaeger and F. Dehousse, Judges, 
         
          Registrar: H. Jung,
         
         makes the following
         
         
         Order
            
               Legal, factual and procedural background
            
         
         1
            
          Before the adoption of the contested measure, Article 4(1) of Council Directive 76/768/EEC on the approximation of the laws
         of the Member States relating to cosmetic products (OJ 1976 L 262, p. 169),
         
         
         
          
         –
            had been supplemented by Council Directive 93/35/EEC of 14 June 1993, amending, for the sixth time, Directive 76/768 (OJ 1993
               L 151, p. 32) which had inserted therein a subparagraph (i),
            
         
         
         
         
          
         –
            the latter itself having been amended most recently by Commission Directive 2000/41/EC of 19 June 2000, postponing for a second
               time the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic products
               (OJ 2000 L 145, p. 25).
            
         
         
          Article 4(1), first subparagraph, of Directive 76/768 was consequently worded as follows:
         ‘Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic
         products containing: 
         ...
         (i)     ingredients or combinations of ingredients tested on animals after 30 June 2002 in order to meet the requirements of this
         Directive.’ 
         
         
         
         2
            
          Likewise, prior to the adoption of the contested measure, Directive 76/768
         
         
         
          
         –
            had been supplemented by the addition of an Article 6(3) inserted by Article 1 of Council Directive 88/667/EEC of 21 December
               1988, amending, for the fourth time, Directive 76/768 (OJ 1988 L 382, p. 46),
            
         
         
         
         
          
         –
            the latter article having been supplemented by Article 1(9) of Directive 93/35.
         
         
          Consequently, Article 6(3) of Directive 76/768 provided:
         ‘Member States shall take all measures necessary to ensure that, in the labelling, putting up for sale and advertising of
         cosmetic products, text, names, trade marks, pictures and figurative or other signs are not used to imply that these products
         have characteristics which they do not have. Furthermore, any reference to testing on animals must state clearly whether the
         tests carried out involved the finished product and/or its ingredients.’
         
         
         
         3
            
          On 27 February 2003, the European Parliament and the Council adopted Directive 2003/15/EC amending Directive 76/768 (OJ 2003
         L 66, p. 26).
         
         
         
         4
            
          Article 1 of Directive 2003/15 provides:
         ‘Directive 76/768/EEC is hereby amended as follows:
         ...
         
         (2)
            the following Article shall be inserted:
         
         
               “Article 4a
                  
               
         
         
         
               1.
                  Without prejudice to the general obligations 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 4(b)
                  
               
         
         
         
               The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction, of category 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.”
                  
                  
               
         
         ...’
         
         
         
         5
            
          The applicant is a European Economic Interest Grouping (EEIG) comprising two associations of undertakings which manufacture
         chemicals.
         
         
         
         6
            
          By application lodged at the Registry of the Court of First Instance on 3 June 2003, the applicant brought the present action
         for the partial annulment of Directive 2003/15.
         
         
         
         7
            
          By separate documents lodged at the Registry of the Court of First Instance on 17 July and 14 August 2003 respectively, the
         defendants submitted two objections of inadmissibility under Article 114 of the Rules of Procedure of the Court of First Instance.
         The applicant submitted its observations on those objections on 29 September 2003.
         
         Forms of order sought
         
         8
            
          The applicant claims that the Court of First Instance should:
         
         
         
          
         –
            declare the application admissible and well founded or, in the alternative, join the questions on admissibility to the examination
               of the substance;
            
         
         
         
         
          
         –
            annul Article 1 of Directive 2003/15 in so far as it inserts in Directive 76/768 Article 4a(2) and (2.1) and Article 4b and
               a new subparagraph in Article 6(3);
            
         
         
         
         
          
         –
            order the defendants to pay the costs.
         
         
         
         
         
         9
            
          The Council of the European Union and the European Parliament contend that the Court of First Instance should:
         
         
         
          
         –
            dismiss the action as inadmissible;
         
         
         
         
          
         –
            order the applicant to pay the costs.
         
         
         
         Procedure
          1. Consideration of the objections of inadmissibility at the same time as the substanceArguments of the parties
         
         10
            
          The Council and the Parliament request that, under Article 114(1) of the Rules of Procedure, the Court should give a ruling
         on the admissibility of the action without considering the substance.
         
         
         
         11
            
          For its part, the European Federation for Cosmetic Ingredients (EFfCI) asks the Court ‘to examine the substance before ruling
         on admissibility, or in the alternative to reserve any decision until judgment in the main proceedings’. The EFfCI maintains
         that ‘the present case involves a highly sophisticated area of law, where [its] legal position … is closely connected with
         … the underlying substance’. The complexity of the case is evidenced by the incorrect description of the pleas on which the
         application is based which the Parliament set out in its plea of inadmissibility. The Court should therefore examine the substance
         ‘before or at the same time as the admissibility issue’. The EFfCI adds that such a possibility is expressly provided for
         in Article 114(4) of the Rules of Procedure. It is moreover illustrated by the judgment of the Court of First Instance in
         Joined Cases T-125/96 and T-152/96 Boehringer  v Council and Commission [1999] ECR II‑3427. 
         
         Findings of the Court
         
         12
            
          Pursuant to the first subparagraph of Article 114(4) of its Rules of Procedure, the Court of First Instance may decide on
         an objection of inadmissibility raised by a party in accordance with Article 114(1) or reserve its decision for the final
         judgment.
         
         
         
         13
            
          According to the judgment of the Court of Justice in Case C-23/00 P Council v Boehringer [2002] ECR I‑1873, paragraph 52, it is for the Court of First Instance to assess what constitutes sound administration of
         justice in the circumstances of the case. Thus, in that case, the Court of First Instance properly chose, by way of exception,
         to examine the legality of one of the contested measures before the admissibility of the first of the two joined applications,
         for the sake of economy of procedure (Boehringer v Council and Commission, cited in paragraph 11 above).
         
         
         
         14
            
          Such economy of procedure does not appear attainable in the present case. The EFfCI’s argument that the application raises
         extremely complex questions of law, on the contrary, is conducive to avoiding an examination of the substance if, in the event
         of the application being inadmissible, that can be done. In that connection, the argument that that complexity and the impossibility
         of giving an immediate decision on the admissibility of the application derive from a misunderstanding by the Parliament of
         the pleas set out in the application cannot be accepted. The Parliament does not base its pleas of inadmissibility on the
         manner in which it understood those pleas, so that, even if wrong, its understanding of them does not make it necessary to
         join those issues to the substance of the case.
         
         
         
         15
            
          In those circumstances, the EFfCI’s contention cannot be upheld. An application for annulment cannot be downgraded so as to
         become a mere legal consultation on the legality of the contested directive, since to do so would constitute a misapplication
         of Article 230 EC.
         
         
         
         16
            
          Consequently, it is appropriate to give a decision on inadmissibility without considering the substance, in accordance with
         Article 114(1) of the Rules of Procedure.
         
         
         
         17
            
          Moreover, pursuant to Article 114(3) of the Rules of Procedure, the remainder of the proceedings is to be oral unless the
         Court decides otherwise. In this case, the Court considers that it has sufficient information from the documents in the file
         to give a decision on the applications made by the defendants without opening the oral procedure.
         
         
          2. The request for confidentiality
         
         18
            
          On 29 September 2003, the EFfCI requested, pursuant to Article 116(2) of the Rules of Procedure, that certain documents should
         be treated as confidential.
         
         
         
         19
            
          It appears from that provision that an application for confidential treatment is associated with intervention. Since there
         is no intervention in this case, the application is premature. Accordingly, it is inappropriate to give a decision thereon.
         
         The inadmissibility of the application
          1. Arguments of the parties
         
         20
            
          The defendants consider that the application is inadmissible on the ground that the contested provisions are not of individual
         concern to the applicant within the meaning of the fourth paragraph of Article 230 EC.
         
         
         
         21
            
          It cannot be inferred, in their view, that the applicant is individually concerned by the fact that the undertakings it represents
         are economically more affected than others by the contested measure, since the measure does not affect them on account of
         certain characteristics which are specific to them. 
         
         
         
         22
            
          Moreover, the defendants submit that, in its judgment in Case C-309/89 Codorniu v Council [1994] ECR I‑1853, the Court did not infer that a person was ‘individually concerned’ merely because his intellectual property
         rights were affected by the contested measure. Rather, it concluded that the application was admissible by reason of the fact
         that Codorniu was confronted with rules which reserved the term ‘crémant’ to certain French and Luxembourg wine producers,
         that is to say a clearly defined circle of producers, even though that same term constituted part of its registered trade
         mark. On the other hand, the fact that the EFfCI represents and defends the interests of a large number of companies which
         hold patents entitling them to market substances involved in the manufacture of cosmetic products is not sufficiently distinctive.
         The formulation of most cosmetic products will in practice involve some intellectual property rights. 
         
         
         
         23
            
          Moreover, to consider that the fact of representing an entire industry fulfilled the condition of being individually concerned
         would deprive that criterion of any meaning. 
         
         
         
         24
            
          According to the defendants, finally, it is clear from the case-law that it is for the Member States to ensure, when giving
         effect to Community provisions, the availability of the complete and effective judicial protection to which an applicant is
         entitled. 
         
         
         
         25
            
          For its part, the EFfCI contends that it is individually concerned, as compared with any other economic operator, because
         the business activities of the manufacturers of ingredients used in cosmetic products would be particularly affected by the
         prohibition to market cosmetic products tested an animals or containing substances classified as carcinogenic, mutagenic or
         toxic for reproduction (hereinafter ‘CMR substances’). 
         
         
         
         26
            
          The EFfCI states that the contested provisions will prohibit, first, the testing on animals of chemical substances used in
         the manufacture of cosmetic products and, second, any marketing of finished chemical products or substances used in their
         composition which have been tested in that way. Those prohibitions would apply even if the animal experiments had been carried
         out to comply with other regulations. According to the EFfCI, they affect its competitive situation in that the companies
         which it represents are placed at a disadvantage as compared with other undertakings not operating in the cosmetics sector
         or as compared with others which market ingredients used solely in that industry but not tested on animals. The disadvantage
         derives from the fact that the undertakings represented by the EFfCI carry on a range of different businesses. They therefore
         have also to comply with other regulatory requirements which necessitate testing on animals. The impact of those prohibitions
         is particularly great, according to the applicant, because innovation is essential to maintain the competitive position of
         cosmetic companies. They thus constantly need new chemical substances which ‘for purposes of the dangerous substances directive
         must be subject to extensive animal testing’. 
         
         
         
         27
            
          The EFfCI then claims that ‘the [second] contested measure has a clear effect on [its] legal situation in that [it] will no
         longer be able to use substances that are classified as carcinogenic, mutagenic or toxic for reproduction Category 1, 2 or
         3, in cosmetic product formulations. Here too, the applicant’s member companies currently manufacture and supply chemicals
         falling within those categories to the cosmetics industry’. 
         
         
         
         28
            
          According to the EFfCI, the companies it represents are affected by the third contested measure, in that it allows the manufacturers
         of cosmetic products to use a label stating that no animal tests have been carried out in the development of their cosmetic
         products and of the ingredients used therein. Given that virtually all chemicals have been tested on animals and alternative
         methods will not be available for many years, the EFfCI contends that, as from the entry into force of the contested directive,
         the companies whose interests it defends will only rarely be able to claim that such testing has not taken place. The undertakings
         in question will thus be placed at a disadvantage by comparison with other economic operators that are able to use such an
         indication. Moreover, they will be subject to a ‘competitive disadvantage against other cosmetic manufacturers who will use
         a misleading label stating that no animal tests have been carried out’. 
         
         
         
         29
            
          The EFfCI also maintains that the companies it represents are differentiated by the patents which they hold. Those patents
         confer on them, in its view, an exclusive right to use the products covered and place them on the market. That right, according
         to the applicant, is afforded special protection, similar to that referred to by the Court of Justice in its judgment in Case
         53/85 AKZO Chemie  v Commission [1986] ECR 1965. The directive at issue will have negative repercussions on the advantages that the manufacturers can derive
         therefrom. Referring to the judgment in Codorniu v Council (paragraph 22 above), the EFfCI asserts that the right to market on an exclusive basis products resulting from inventions
         pre-dating the adoption of the directive at issue is identical to the right which the Codorniu company held by virtue of the
         registration of the trade mark ‘crémant’, by virtue of which its application was held to be admissible. 
         
         
         
         30
            
          The EFfCI also maintains that, in certain cases, the companies whose interests it represents are obliged to break contractual
         agreements previously entered into with customers, leading to heavy losses of mutual trust and market share. 
         
         
         
         31
            
          The applicant also refers to the fact that it ‘participated in the administrative process by submitting scientific data and
         offering [its] comments all along the adoption process’ for the directive in question. It considers that it is also afforded
         special protection by Article 13 of Directive 76/768, which requires that interested parties are to be provided with precise
         reasons ‘for any individual measures placing a restriction or ban on the marketing of cosmetic products taken pursuant to
         this directive’. 
         
         
         
         32
            
          Finally, the applicant claims that its ‘ability to protect [its] intellectual property (patent) rights and [its] ability to
         defend [its] products under existing Community legislation (right of defence) is a superior principle of law, which must be
         observed in any situation where individual rights and freedoms are at stake’. That principle, it continues, ‘is inspired by
         Articles 6 and 13 of the European Convention for the Protection of Human Rights and Fundamental Freedoms [(ECHR), signed in
         Rome on 4 November 1950]’. 
         
         
          2. Findings of the CourtGeneral considerations
         
         33
            
          Under the fourth paragraph of Article 230 EC, ‘[a]ny natural or legal person may … institute proceedings against a decision
         addressed to that person or against a decision which, although in the form of a regulation or a decision addressed to another
         person, is of direct and individual concern to the former’.
         
         
         
         34
            
          Although the fourth paragraph of Article 230 EC makes no express provision regarding the admissibility of actions brought
         by individuals for annulment of a directive, it is clear none the less from the case-law that that fact alone is insufficient
         for such actions to be declared inadmissible (Case T-135/96 UEAPME v Council [1998] ECR II‑2335, paragraph 63; orders of the Court of First Instance of 10 September 2002 in Case T-223/01 Japan Tobacco and JT International  v Parliament and Council [2002] ECR II‑3259, paragraph 28, and of 6 May 2003 in Case T-321/02 Vannieuwenhuyze-Morin  v Parliament and Council [2003] ECR II‑1997, paragraph 21). Moreover, the Community institutions cannot, merely by the choice of the form of the act
         in question, exclude the judicial protection afforded to individuals under that provision of the Treaty (orders of the Court
         of First Instance of 14 January 2002 in Case T‑84/01 Association contre l’heure d’été  v Parliament and Council [2002] ECR II-99, paragraph 23, Japan Tobacco and JT International  v Parliament and Council, paragraph 28, and Vannieuwenhuyze-Morin  v Parliament and Council, paragraph 21). It is therefore necessary to verify whether the directive at issue is of ‘direct and individual concern’
         to the applicant, within the meaning of the fourth paragraph of Article 230 EC.
         
         
         
         35
            
          Since those two conditions must both be fulfilled, the Court of First Instance considers that it is appropriate to examine
         first whether the applicant is individually concerned, since, if it is not, it would be otiose to consider whether it was
         directly affected by the directive at issue.
         
         The condition that the measure must be of individual concern to the applicant
         
         36
            
          In this case, it is undisputed that Articles 4a, 4b and the second subparagraph of Article 6(3), inserted in Directive 76/768
         by the contested provisions, are framed in general terms. Those provisions apply to situations that are determined objectively
         and involve legal effects for the undertakings producing substances used in the manufacture of cosmetic products, that is
         to say for a class of legal persons considered in general and in the abstract.
         
         
         
         37
            
          However, the fact that the contested measure is, by its nature, of general scope and does not constitute a decision within
         the meaning of Article 249 EC is not sufficient in itself to preclude an action for its annulment being brought by an individual
         (Codorniu v Council, paragraph 19, Case C-451/98 Antillean Rice Mills  v Council [2001] ECR I-8949, paragraph 49; orders of the Court of First Instance in Japan Tobacco and JT International  v Parliament and Council, paragraph 29, and of 21 March 2003 in Case T-167/02 Établissements Toulorge  v Parliament and Council [2003] ECR II-1111, paragraph 26).
         
         
         
         38
            
          In certain circumstances, even a legislative measure applying to all the economic operators concerned may be of individual
         concern to some of them, therefore constituting a decision as far as they are concerned (Case C-358/89 Extramet Industrie  v Council [1991] ECR I‑2501, paragraph 13, Codorniu v Council, paragraph 19; and the order in Japan Tobacco and JT International  v Parliament and Council, paragraph 29). That is the case where the measure in question 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 the decision (Case 25/62 Plaumann v Commission [1963] ECR 126 and Case C-263/02 P Commission v Jégo-Quéré [2004] ECR I-0000, paragraph 45). 
         
         
         
         39
            
          It is therefore necessary to determine whether, in this case, it can be considered, on the basis of the information in the
         file, that those conditions are satisfied. 
         
         
         
         40
            
          The first question which arises is how the fact that the EFfCI is a European Economic Interest Grouping may affect the admissibility
         of the application.
         
         
         
         41
            
          According to settled case-law of the Court of Justice, it is not possible to accept the principle that an association, in
         its capacity as representative of a category of operators, is individually concerned by a measure affecting the general interests
         of that category (Joined Cases 16/62 and 17/62 Confédération nationale des producteurs de fruits et légumes and Others  v Council [1962] ECR 487; Case 72/74 Union syndicale and Others  v Council [1975] ECR 401; Case 135/81 Groupement des agences de voyages  v Commission [1982] ECR 3799; Case 282/85 DEFI v Commission [1986] ECR 2469; order of the Court of Justice of 5 November 1986 in Case 117/86 UFADE v Council and Commission [1986] ECR 3255; order of the Court of First Instance of 28 October 1993 in Case T‑476/93 FRSEA and FNSEA  v Council [1993] ECR II‑1187, paragraph 25, and Joined Cases T-447/93 to T-449/93 AITEC and Others  v Commission [1995] ECR II‑1971, paragraph 54).
         
         
         
         42
            
          Nethertheless, actions brought by associations may be admissible in at least three types of situations:
         
         
         
          
         –
            where a legal provision expressly confers on professional associations a number of powers of a procedural nature;
         
         
         
         
          
         –
            where the association represents the interests of undertakings which, for their part, have locus standi;
            
         
         
         
         
          
         –
            where the association is differentiated by reason of the impact on its own interests as an association in particular because
               its position as a negotiator was affected by the measure of which the annulment is sought (order of the Court of First Instance
               of 23 November 1999 in Case T-173/98 UPA v Council [1999] ECR II‑3357, paragraph 47).
            
         
         
         
         
         
         43
            
          It follows 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. That rule also applies to an EEIG. It is clear from Article 3 of Council
         Regulation (EEC) No 2137/85 of 25 July 1985 on the European Economic Interest Grouping (EEIG) (OJ 1985 L 199, p. 1) that the
         purpose of such a grouping is solely to facilitate or develop the economic activities of its members to enable them to increase
         the results thereof, so that it is merely auxiliary to them.
         
         
         
         44
            
          It is therefore necessary to consider whether the contested measure is of individual concern to the members of the grouping.
         
         
         
         45
            
          The Court observes in that connection that the applicant’s members are themselves associations of undertakings. Consequently,
         the question whether those associations would have had standing to bring the present action depends, in turn, in accordance
         with the case-law referred to in paragraph 42 above, on particular circumstances or the question whether the undertakings
         which they comprise are individually concerned by the contested measure.
         
          Whether the undertakings in the sector are individually concerned
         
         – Impact of the directive on the competitive position of the undertakings in the sector
         
         
         46
            
          The EFfCI refers to the harmful effects that the prohibitions introduced by Directive 2003/15 and the labelling authorised
         by it concerning the absence of animal experimentation would have on the competitive position of the undertakings represented
         by the two associations of which the EFfCI is composed. 
         
         
         
         47
            
          However, those effects do not distinguish them from the other undertakings which do not supply the cosmetics sector or limit
         themselves to that market but do not test their ingredients on animals or do not use CMR substances. It is not sufficient
         that certain operators are economically more affected by a measure than their competitors for that measure to be of individual
         concern to them (order of the Court of First Instance of 15 September 1999 in Case T-11/99 Van Parys and Others  v Commission [1999] ECR II‑2653, paragraphs 50 and 51).
         
         
         
         48
            
          Moreover, the undertakings in question would be affected only by reason of their objective status as companies producing substances
         used by both cosmetics undertakings and others, in the same way as any other operator in the same situation in the European
         Community (see, to that effect, orders of the Court of First Instance of 25 June 1998 in Joined Cases T-14/97 and T-15/97
         Sofivo and Others  v Council [1998] ECR II‑2601, paragraph 37, and of 15 January 2004 in Case T-393/03 Valenergol v Council, not reported, paragraph 19). 
         
         
         
         49
            
          Moreover, the fact that the undertakings concerned are, in certain countries, the most important in the sector is not a basis
         for inferring that they belong to a class of traders individually identifiable on the basis of criteria relating to the products
         in question or the business activities carried on. A commercial activity is a priori  capable of being carried on by any undertaking, actually or potentially liable to find itself in the same position as those
         operators (Case 11/82 Piraiki-Patraiki and Others  v Commission [1985] ECR 207, paragraphs 12 to 14).
         
         
         
         50
            
          Finally, the Court cannot take account of the fact that the members of the association represented by the applicant would
         be subject to a competitive disadvantage by reason of the fact that they might be confronted by other cosmetics manufacturers
         using ‘misleading labelling’. That argument is based on a mere unsupported hypothesis to the effect that operators would not
         comply with their legal obligations. Even if such a hypothetical situation arose, the applicant would not thereby be exempted
         from the requirement of meeting the conditions of admissibility laid down by the fourth paragraph of Article 230 EC.
         
         
         
         51
            
          It is therefore necessary to verify whether, in this case, other circumstances exist which characterise the undertakings that
         are members of the EFfCI.
         
         
         – The existence of contractual commitments
         
         
         52
            
          Referring to the judgments of the Court of Justice in Piraiki-Patraiki and Others  v Commission  and Case C-152/88 Sofrimport v Commission [1990] ECR I‑2477, the applicant suggests that the prohibition of animal testing and of CMR substances would force the members
         of the associations it represents to break contractual agreements previously entered into with customers, leading to heavy
         economic losses. 
         
         
         
         53
            
          However, as the Court of First Instance has already pointed out in its order in Établissements Toulorge  v Parliament and Council (cited in paragraph 37 above, paragraph 64), the Court had verified, in each of those cases, whether proof had been produced
         of the existence of certain attributes peculiar to them or of a factual situation differentiating the applicants from all
         other persons and thereby distinguishing them individually in the same way as the addressee of a decision. More specifically,
         it is clear from those judgments and from the judgment in Case C-142/00 P Commission v Nederlandse Antillen [2003] ECR I‑3483 that two cumulative conditions must be fulfilled for the claim concerning contractual commitments to render
         an action for annulment admissible. First, a rule of law superior to the legislative measure in question must have required
         the institutions to take account of the specific situation of the applicants as compared with that of any other person concerned
         by that measure. Second, the applicants must be parties to contracts already concluded, the performance of which, planned
         to take place during the period of application of the contested measure, is prevented wholly or in part.
         
         
         
         54
            
          In this case, the applicant, first, does not refer to any binding provision superior to the directive at issue which might
         have compelled the Parliament and the Council to take account of the negative repercussions which the directive was liable
         to have on the economic situation of the members of the associations represented by it.
         
         
         
         55
            
          Second, the existence of contracts validly entered into, the performance of which would be rendered impossible as a result
         of the adoption and entry into force of the contested measure, has not been established in any way.
         
         
         – The impact of intellectual property rights
         
         
         56
            
          The EFfCI also maintains that its members are differentiated by the specific nature of the rights deriving from the patents
         held by them, since, it claims, those patents confer on them the exclusive right to use and market the products covered by
         them.
         
         
         
         57
            
          However, it must be observed that the existence of legal protection for know-how and business secrets of undertakings claimed
         by the associations that are members of the EFfCI is not capable of distinguishing them from all other manufacturers of chemicals
         concerned by the directive at issue. They too may claim such protection for their benefit, since the manufacture and marketing
         of products is frequently covered by intellectual property rights. Moreover, whilst each patent identifies the product that
         it protects, the directive at issue does not impede the use of a specific patent, so that any impact on intellectual property
         rights is attributable only to the fact, not specific to any person, of producing substances for use by the cosmetics industry.
         
         
         
         58
            
          In that connection, the circumstances underlying the Codorniu v Council judgment cited in paragraph 22 above must be distinguished from the present case. The rules at issue in that case reserved
         the description ‘crémant’ to an identified class of producers, even though the applicant undertaking had registered that same
         designation as a trade mark and had used it over a long period before the adoption of the contested regulation. It was thus
         clearly distinguished from all other economic operators. Rather than the enjoyment in the abstract of an intellectual right,
         it was the specificity of the designation which that right protected and which the contested measure had, in a way, expropriated
         from the applicant, that gave rise to the solution adopted in Codorniu v Council. The directive at issue here, on the other hand, does not aim to reserve a specific intellectual right to certain operators
         to the detriment of the undertakings whose interests are defended by the applicant.
         
         
         
         59
            
          The EFfCI nevertheless invokes the fact that it defends the interests of associations whose members are companies which hold
         patents that are enforceable against third parties and protect know-how obtained as a result of constant innovative endeavours,
         which are essential in order to preserve their competitive positions. 
         
         
         
         60
            
          The Court observes, however, that the necessity to innovate in order to remain competitive is not, in a market economy, capable
         of differentiating the undertakings concerned. Finally, at least in the present case, the enforceability of patents against
         third parties does not individually identify the rights which they protect as compared with other rights ordinarily held by
         economic operators, which produce the same effect. Thus, that enforceability does not distinguish economic operators owning
         patents from other operators.
         
         
         
         61
            
          It follows from all the foregoing considerations that the undertakings whose interests are defended by the applicant are not
         individually concerned by the contested provisions of Directive 2003/15.
         
         
         
         62
            
          That conclusion is not undermined by the judgment in AKZO Chemie  v Commission (cited in paragraph 29 above, paragraph 28) according to which ‘business secrets are … afforded very special protection’.
         The protection referred to in that judgment related to non-disclosure of secrets in the context of competition policy, pursuant
         to Article 19(3) and Article 21(2) of Council Regulation No 17/62, First Regulation implementing Articles 85 and 86 of the
         Treaty (OJ, English Special Edition 1959–1962, p. 205). No inference can be drawn therefrom as to the admissibility of the
         application in the light of the condition that an applicant must be individually concerned. Contrary to the applicant’s contention,
         the judgment in AKZO Chemie  v Commission does not therefore support the conclusion that any person holding an intellectual property right is individually concerned
         by a legislative provision liable to affect it.
         
          The existence of special procedural rights
         
         – As regards the applicant
         
         
         63
            
          According to the case-law, special circumstances may justify the admissibility of an action for annulment brought by an association
         against a measure of general scope even where it is not of direct and individual concern to the members of that association.
         That is the case in particular where the association played a role in a procedure leading to the adoption of that measure
         (order of the Court of First Instance of 2 April 2004 in Case T-231/02 Gonnelli and AIFO  v Commission [2004] ECR II-0000).
         
         
         
         64
            
          The applicant claims in that connection that it took part in the procedure leading to the adoption of the directive at issue
         by providing scientific data and giving its views on the matters discussed.
         
         
         
         65
            
          However, the fact of voluntarily participating in the preparation of a measure 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 (order of the Court of Justice of 23
         November 1995 in Case C-10/95 P Asocarne v Council [1995] ECR I‑4149).
         
         
         
         66
            
          Furthermore, Article 13 of Directive 76/768, on which the applicant relies, does not confer on it any right to participate
         in the drawing up of the contested measure. It relates only to information subsequently provided by undertakings affected
         by individual measures adopted for the implementation of that directive. 
         
         
         
         67
            
          Since the EFfCI does not cite other provisions in support of its argument, it must be concluded that the action taken by it
         was of an informal nature and cannot justify admissibility of action for annulment.
         
         
         – As regards the associations which are members of the applicant or undertakings forming part of those associations
         
         
         68
            
          It need merely be stated that the applicant has not submitted that the associations which are members of it or the undertakings
         forming part of those associations are vested with special procedural rights.
         
          The question of effective judicial protection
         
         
         69
            
          The EFfCI puts forward a last argument relating to the requirements of effective judicial protection.
         
         
         
         70
            
          In that connection, it must be borne in mind that it is the Member States that bear the responsibility for providing a system
         of remedies and procedures facilitating observance of the right to effective judicial protection and for compensating for
         any inadequacies of the Treaties in that connection. Moreover, the Court has held that it is not acceptable to adopt an interpretation
         of the rules on admissibility laid down in Article 230 EC to the effect that an action for annulment must be declared admissible
         if it is shown, following an examination by the Community Court of the national procedural rules, that those rules do not
         allow the individual to bring proceedings to contest the validity of the Community measure at issue. Indeed, ‘[s]uch an interpretation
         would require the Community Court, in each individual case, to examine and interpret national procedural law. That would go
         beyond its jurisdiction when reviewing the legality of Community measures’ (Case C-50/00 P Unión de Pequeños Agricultores  v Council [2002] ECR I‑6677, paragraph 43, and Commission v Jégo-Quéré, paragraph 33). That assessment must a fortiori  be adopted where, as in this case, the applicant does not claim that, in its internal law, there are no remedies enabling
         the national courts to challenge the validity of the directive at issue (order in Établissements Toulorge  v Parliament and Council, paragraph 61).
         
         Conclusion
         
         71
            
          It follows that the contested provisions are not of individual concern to the applicant. Consequently, the application must
         be declared inadmissible, without there being any need to examine either the condition whereby an applicant must be directly
         concerned by the contested measure or the other pleas of inadmissibility raised by the defendants.
         
         
         Costs
         72
            
          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 pleading. Since the applicant has been unsuccessful, it must be ordered to pay the costs,
         as applied for by the defendants.
         
         
         On those grounds,
         
         
         
            
            THE COURT OF FIRST INSTANCE (Third Chamber)
         
         
          Hereby orders:
         
            
            
             
               1.
                  The application is dismissed.
               
            
            
            
             
               2.
                  The applicant is ordered to bear its own costs and to pay those of the defendants.
               
            
             Luxembourg,10 December 2004.
         
         
         
                  H. Jung
               
               
                  J. Azizi
               
            
         
         
         
                  Registrar
               
               
                  President
               
            
      
      
          1 –
            
            Language of the case: English.