C-352/98

5. Commission Decision 78/45/EEC of * Original language: English. 19 December 1977 4 established a Scientific 1 — Case T-199/96 [1998] ECR II-2805, hereinafter 'the con- tested judgment'. 2 — OJ 1976 L 262, p. 169. 3 — OJ 1993 L 151, p. 32. 4 — OJ 1978 L 13, p. 24.

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Committee on Cosmetology (hereinafter the urgency of the matter. Article 10(3) 'the Scientific Committee') attached to the provides as follows: Commission. Under Article 2 of that deci- sion, the Committee's task is to give the Commission an opinion on any problem of a scientific or technical nature in the field of cosmetic products and particularly on sub- stances used in the preparation of cosmetic '(a) The Commission shall adopt the pro- products and on the conditions of use of posed measures when they are in these products. The members of the Scien- accordance with the opinion of the tific Committee are to be appointed by the Committee. Commission from among 'highly qualified leading scientific figures with competence in the field [of cosmetic products]' (Arti- cle 4); the representatives of the Commis- sion departments concerned are to attend (b) Where the proposed measures are not the meetings of the Committee (Arti- in accordance with the opinion of the cle 8(2)); the Commission may also invite Committee, or if no opinion is adopted, 'leading figures with special qualifications the Commission shall without delay in the subjects under study' to attend those propose to the Council the measures to meetings (Article 8(3)); and the Scientific be adopted. The Council shall act by Committee may also form working parties qualified majority. which are to meet when convened by the Commission (Articles 7 and 8).

9. One of Bergaderm's products was Ber- gasol, a sun oil containing, in addition to vegetable oil and filters, bergamot essence. In sun protection and bronzing products, Some of the molecules to be found in furocoumarines shall be below 1 mg/kg.' bergamot essence are 'psoralens', otherwise known as 'furocoumarines'. One of these is 'bergapten', scientifically called 5-methox- ypsoralen (hereinafter '5-MOP'). 5-MOP strongly induces photodynamism, with the result that the presence of bergamot essence Article 2 of the contested Directive requires in Bergasol greatly accelerates the tanning the Member States to take all the necessary process. 6 However, 5-MOP, in its chemi- measures to ensure that, as from 1 July cally pure state, is suspected of being 1996, neither manufacturers nor importers carcinogenic. Different studies have been established in the Community place on the carried out to determine whether the 5- market products which do not comply with MOP present in the bergamot essence used that directive and that, as from 1 July in a tanning product is also carcinogenic. These studies have produced widely differ- 1997, such products can no longer be sold ing conclusions. 7 or otherwise supplied to the final consumer.

10. In March 1987, Germany asked the I I — Facts Commission to consider the possibility of restricting the maximum level of naturally occurring psoralens in sun oil. The Com- mission sought the opinion of the Scientific 8. The first appellant, Laboratoires Phar- Committee. The study carried out by one of maceutiques Bergaderm (hereinafter 'Ber- gaderm'), is a company whose activities at t h e Scientific C o m m i t t e e ' s m e m b e r s con- the relevant time consisted of the manufac- 6 — See further paragraph 8 of the contested judgment. ture, purchase and sale of sun creams and 7 — See paragraphs 11 and 12 of the contested judgment.

11. The appellants organised a seminar in June 1991 on the effects of psoralens which culminated in a number of scientists signing a document stating that the risk of photo- 13. At a meeting on 16 February 1995, the mutagenic and photocarcinogenic effects working party on 'cosmetic products', was negligible where 5-MOP was com- which was composed of all the members bined with other sun filters. Subsequently, of both the Scientific Committee and the the Scientific Committee invited a number Adaptation Committee, voted, with the of outside experts to a meeting on 24 Sep- sole exception of the French representative, tember 1991 to discuss the results of this to endorse a maximum level of psoralens of seminar. After describing their research on 1 mg/kg in sun products. On 28 April sun oils with bergamot essence containing 1995, the Adaptation Committee recom- 15 to 50 mg/kg of 5-MOP, a number of mended that the level of psoralens in such scientists suggested that sun products con- products should not exceed 1 mg/kg. All taining sunscreens and 5-MOP were no less the delegations within the Committee voted safe than other such products, or were in favour of that opinion save for the possibly safer. 9None the less, the Scientific French delegation. The Finnish delegation Committee confirmed its earlier recom- was absent. The Commission adopted the mendation on 4 November 1991. contested Directive on 10 July 1995.

14. During the administrative procedure 12. The Adaptation Committee first dis- which led to the adoption of the contested cussed psoralens as ingredients in sun oils Directive, the appellants regularly submit- on 17 December 1991, without reaching ted observations on their own initiative, sending the Commission and members of 8 — See the reference to Mr Fielder's study at paragraph 12 of the contested judgment. 9 — See paragraphs 16 to 18 of the contested judgment. 10 — See paragraph 22 of the contested judgment.

'48 Under the second paragraph of Arti- cle 215 of the Treaty and the general 16. The appellants submitted before the principles to which that provision Court of First Instance that the contested refers, Community liability depends Directive was in reality an administrative on fulfilment of a set of conditions act, as it exclusively concerned the product regarding the unlawfulness of the con- Bergasol. They alleged that the Commis- duct alleged against the institution sion had committed two procedural errors. concerned, the fact of damage and the First, it had failed to submit its proposal to existence of a causal link between the impose a maximum level of psoralens in conduct in question and the damage sun products to the Council when, as the complained of (Case C-257/90 Italso¬ appellants allege, the Adaptation Commit- lar v Commission [1993] ECR I-9, tee delivered an unfavourable opinion on paragraph 33, and Case T-336/94 Efi-

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a measure adversely affecting that per- institutions may take protective measures son, 13 but that it did not apply in the without having to wait until the reality and context of the legislative process 14 except seriousness of those risks have become fully in exceptional cases expressly provided apparent. 18 for. 1 5 No such provision was made in the Cosmetics Directive. In any event, it was clear from the facts that the appellants had ample opportunity to express their views to the Scientific Committee and the Commis- sion and that they were allowed to address the ad hoc group of experts. V — The appeal

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obliged rival producers to abandon pro- 24. Thirdly, the appellants consider that duction of sun oil containing 5-MOP. It is the Court of First Instance failed to also material that the titles of certain acknowledge three breaches by the Com- reports of the Scientific Committee refer mission of superior rules of law for the expressly to Bergasol. The Commission protection of individuals. The Court of replies that the contested Directive only First Instance should have condemned as affects the appellants because of their such a breach the Commission's failure to involvement in a commercial activity open submit its proposal to the Council, as the to all undertakings. They had not proved Adaptation Committee had adopted a the existence of the relevant patents and the negative opinion on 1 June 1992. In addi- prohibition of other undertakings from tion, it failed to condemn a flagrant breach making or marketing sun creams contain- of the rights of the defence. This was ing 5-MOP. Furthermore, a patent was of compounded by the participation in the limited duration and could be made the Adaptation Committee of Austrian and subject of compulsory licensing. In any Swedish representatives, although they event, the Community institutions could had not been involved in earlier discussions not be prevented from responding by way before the 1995 enlargement of the Com- of legislation to the health risks posed by a munity. Finally, the Commission had brea- product simply because patents had been ched the principles of proportionality and granted in respect of that product. of legitimate expectations by excluding Bergasol from the market without any public-health justification. This was all the more serious because the Commission had failed to take into account the interests of a distinct group of economic opera- tors. 19

basis that the appellants have merely reit- protection of individuals is a condition of a erated arguments already submitted to the successful claim for damages flowing from Court of First Instance. I have already a legislative measure. On the other hand, criticised, in my Opinion in Carbajo Fer- any kind of illegality may give rise to rerò v Parliament, 20 over-liberal recourse liability to pay compensation for damage to this argument. As in that case, the appeal caused by an administrative act. in the present case identifies, in respect of each ground of appeal, those elements of the contested judgment with which the appellants take issue, and outlines — some- times at length, sometimes rather laconi- cally — their reasons for doing so.21That this is sufficient to satisfy the requirements of admissibility emerges clearly from the judgment in Carbajo Ferrero v Parliament, in which the Court held the main ground of appeal to be admissible. 22

20 — Case C-304/97 P [1999] ECR I-1749, paragraph 8 of my Opinion. 2 3 — Case 70/83 Kloppenburg v Finanzamt Leer [1984] 21 — T h e sole exceptions are the argument of proportionality ECR 1075, paragraph 1 1 ; Case 160/88 R Fédération presented as part of the third ground of appeal, which is Européenne de la Santé Animale and Others v Council substantially identical to the second ground of appeal, and [1988] ECR 4121 (hereinafter 'Fedesa'), paragraph 28; a new argument of breach of the principle of legitimate Case C-298/89 Gibraltar v Council [1993] ECR I-3605 expectations which was also submitted as part of the third (hereinafter 'Gibraltar'], paragraph 16. ground of appeal. I recommend below that the latter 24 — Fedesa, paragraph 28; Gibraltar, paragraphs 19 to 2 3 . argument be rejected as inadmissible pursuant to Arti- 25 — Case 138/88 Flourez and Others v Council [1988] cle 113(2) of the Rules of Procedure of the Court of Justice. ECR 6393 (hereinafter 'Flourez'), paragraphs 10 to 12; Asocarne v Council, op. cit. (hereinafter 'Asocame'), 22 — Ibid., paragraphs 25 to 2 8 . paragraphs 31 and 32.

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28. The Court has also held that measures which are of general application, and are, thus, of a legislative character, may, none the less, be of individual concern to certain interested economic agents, thereby permit­ ting such persons to seek their annul­ ment. 2 8 A case in point is Codorniu v Council. Codorniu, a Spanish producer of sparkling wines which held a graphic trade mark including the words 'Gran Cremant', 29. It does not follow from the exceptional was held to be individually concerned by a recognition of standing to seek the annul­ regulation which confined the use of the ment of legislative measures that such term 'cremant' to certain sparkling wines measures can, by the same token, be treated produced in France and Luxembourg. The as being administrative in character for the regulation prevented Codorniu from using purposes of determining the applicable criteria for Community liability in an action for damages under Article 215, 2 6 — See Plourez, p a r a g r a p h 1 1 ; Asocarne, paragraph 32. second indent, of the EC Treaty. The Although the Court expressly declined to address the reasons for the grant of standing to natural question in Asocarne, the Court of First Instance has interpreted the judgments in Gibraltar and Asocarne as and legal persons to bring annulment indicating that 'it is clear from the case-law... that the mere fact that the contested measure is a directive is not proceedings under Article 173 of the EC sufficient to render such an action [for annulment] Treaty (now, after amendment, Article 230 inadmissible' in Case T-135/96 UEAPME v C o u n c i l [19981 ECR II-2335, paragraph 63. EC) in respect of decisions addressed to 27 — Fedesa, paragraph 27. them and other acts of direct and individual 28 — See Joined Cases 239/82 and 275/82 Allied Corporation v Commission [1984] ECR 1005, p a r a g r a p h 1 1 ; Case concern to them differ from those for C - 3 5 8 / 8 9 Extramet Industrie v Council [1991] ECR I-2501, paragraphs 13 and 14; Case C-309/89 Codorniu v Council [1994] ECR I-1853, paragraphs 17 to 19; Asocarne, paragraph 4 3 ; Case C-87/95 P CNPAAP 29 — O p . cit., paragraphs 17 to 22. v Council [1996] ECR I-2003, paragraph 36; see also the judgment of the Court of First Instance in Joined Cases 30 — Asocarne, paragraph 4 3 ; CNPAAP v Council, op. cit., T-480/93 and T-483/93 Antillean Rice Mills and Others v paragraph 36. Commission [1995] ECR II-2305, paragraph 66. 31 — O p . cit., paragraph 19.

distinguishing between legislative and that measure has been declared null and administrative measures in the context of void.' 33 actions for damages. The Court made a comparative survey of national laws in HNL v Council and Commission 32 and observed that public authorities in the Member States can only exceptionally and in very special circumstances incur liability for legislative measures which are the result of choices of economic policy, and contin- ued: 30. The Court has since made clear that the fact that an action by a natural or legal person for the annulment of a measure of general application is admissible because of its individual effects on that person does not mean that it will be treated as admin- istrative in character in an action for damages by the same person. Thus, in 'This restrictive view is explained by the Sofrimport v Commission, 34 the Court consideration that the legislative authority, annulled in part certain Commission reg- even where the validity of its measures is ulations at the suit of a closed group of subject to judicial review, cannot always be importers whose goods were in transit to hindered in making its decisions by the the Community when the regulations were prospect of applications for damages when- adopted and whose interests should have ever it has occasion to adopt legislative been taken into account, but applied the measures in the public interest which may test for liability in respect of legislative adversely affect the interests of individuals. measures in the parallel action for damages. In Antillean Rice Mills and Others v Commission, 35 the Court of First Instance annulled part of a Commission decision addressed to the Member States at the suit of certain traders because, notwith- standing its legislative nature inasmuch as that decision applied to all the traders concerned, taken as a whole, it was of individual concern to the applicant traders It follows from these considerations that (who had already entered into contracts) as individuals may be required, in the sectors persons whose interests the Commission coming within the economic policy of the was required to take into account. None Community, to accept within reasonable the less, the Court confirmed on appeal the limits certain harmful effects on their economic interests as a result of a legisla- tive measure without being able to obtain 33 — Ibid., paragraphs 5 and 6. The measure in question had compensation from public funds even if already been declared void pursuant to a request for a preliminary ruling on this point in Case 114/76 Bela- Mühle v Crows-Farm [1977] ECR 1211. 34 —Case C-152/88 [1990] ECR I-2477, paragraphs 10 to 13 32 — Joined Cases 83/76, 94/76, 4/77, 15/77 and 40/77 [1978] and 25. ECR 1209, paragraph 5. 35 — Op. cit. at footnote 28 above.

31. It is clear to me that the contested Directive is legislative in character in so far as it affects the present proceedings. As the Court of First Instance rightly observed, it is a measure of general application. It affects, by reference to generally prescribed objective criteria, all traders operating in the sector in question. Thus, undertakings such as Bioderma and Klorane, which the appellants state had at one stage produced 32. Such an outcome seems to me to be and marketed sun products containing 5- consistent with the above-quoted explana- MOP in contravention of Mr Goupil's tion of the different approaches to Com- claimed patent rights, were potentially munity liability in respect of legislative and affected just as much as Bergaderm. Had administrative measures. Just as in the case Mr Goupil licensed the right to produce of the exercise of Community competences and market sun products containing citric in the economic field, the protection of public health and the need to adapt rapidly 36 — Case C-390/95 P [1999] ECR I-769, paragraphs 56 to 61; see paragraphs 189 to 194 of the judgment of the Court of First Instance, op. cit. 38 — See paragraph 50 of the contested judgment; Gibraltar, 37 — Op. cit., paragraph 60. paragraph 17; Asocarne, paragraph 30.

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33. Thus, there does not appear to me to be any reason to question the decision of the Court of First Instance to classify the contested Directive as a legislative measure of general application and I recommend that the Court reject the first ground of 35. As regards the second limb of this appeal. ground of appeal, the Court of First Instance did not, in my view, commit an error of law in invoking the precautionary principle already cited by the Court in National Farmers' Union. The argument based on that principle is, if anything, even more compelling in the circumstances of the present case. National Farmers' Union concerned an emergency measure tempora- C — The second ground of appeal rily banning cattle and beef exports from the United Kingdom because of uncertainty as to the risks posed by bovine spongiform encephalopathy (BSE) to human consumers 34. In my view, the first limb of the second of beef products. The measure referred ground of appeal is inadmissible, by virtue expressly in its preamble to the need for additional detailed scientific study.

39 — See the third and ninth recitals in the preamble to the Cosmetics Directive. 41 — Paragraph 63 or the contested judgment. 40 — National Farmers' Union, op. cit. at footnote 18 above, especially paragraph 63. 42 — Loc. cit.

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37. In any event, I share the Court of First Instance's assessment that the Commission was entitled to withdraw its proposal in a 36. This ground of appeal concerns alleged situation where the members of the Adap- breaches by the Commission of superior tation Committee were evenly divided over rules of law for the protection of indivi- the merits of two alternative proposals, and duals. Since the contested Directive is a to submit a new proposal after further legislative measure, proof of such a breach study. The appellants' case is based on an is, as I have already said, essential to the unduly literal reading of Article 10 of the success of the appellants' claim. The first Cosmetics Directive. It would be absurd if limb relates to the Commission's alleged the fact that a particular type of measure non-observance of the requirement that its can only be adopted by a prescribed proposal be submitted to the Council after procedure were held to imply that that the Adaptation Committee gave an unfa- procedure, once commenced, must be pur- vourable opinion on 1 June 1992. It is clear to me that non-compliance with Article 10 of the Cosmetics Directive, which sets out 43 —Council Decision 87/373/EEC of 13 July 1987 laying down the procedures for the exercise of implementing the relevant procedure, would not consti- powers conferred on the Commission, OJ 1987 L 197, p. 33. tute such a breach of a superior rule as to 44 — Case C-282/90 [19921 ECR I-1937, paragraph 20. impose liability for damages in respect of a 45 — Ibid., paragraph 21.

sued to the end even if the party proposing reject the appellants' arguments in this the measure wishes to reconsider its appro- regard. priateness, or its chances of adoption, in the course of the procedure. The appellants' argument would entail that the Commis- sion would be bound to adopt measures which it no longer favoured in circum- stances where both the Adaptation Com- mittee and the Council failed to act. Article 189a of the EC Treaty (now Arti- cle 250 EC) provides that '[a]s long as the 38. The second limb of this ground of Council has not acted, the Commission appeal relates to the appellants' alleged may alter its proposal at any time during right to be heard.

Their arguments are, therefore, Pharos v Commission, the Court stated, in inadmissible to the extent that they contest relation to a legislative procedure materi- this finding. In so far as they may be taken ally identical to that provided for by to argue that they were entitled to an even Article 10 of the Cosmetics Directive, that greater degree of participation in the legis- 'where the measures proposed by the lative procedure, they have not submitted Commission are not in conformity with any argument which would lead me even to the opinion of the Adaptation Committee doubt the analysis of the Court of First [on Veterinary Medicinal Products], or Instance, which accords with the Court's where no opinion is delivered, the Com- consistent case-law. mission is not obliged to submit the same measures, without amendment, to the Council'. 46 By the same token, in the circumstances of the present case, the Commission could withdraw its proposal and submit a fresh one after further exam- ination of the scientific issues by the Scientific Committee.

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40. The appellants' contention regarding Court of First Instance. The appellants' breach of the principle of protection of pleadings on appeal on the proportionality legitimate expectations is new, and, thus, point contain nothing liable to undermine inadmissible by virtue of Article 113(2) of my conclusion in respect of the second the Rules of Procedure of the Court of ground of appeal, namely that the Com- Justice. Its arguments regarding propor- mission was entitled to give effect to the tionality before the Court of First Instance factual and scientific assessments of the and on appeal are substantially the same as Scientific Committee in order to protect those in respect of the Commission's public health. I recommend, therefore, that alleged manifest error of assessment of the the Court also reject this aspect of the facts and were addressed together by the appeal as unfounded.

VII — Conclusion

4 1 . In the light of the foregoing, I recommend that the Court:

(1) Reject the appeal; and