62003CC0244_EN
Opinion of the Advocate-General
Opinion of the Advocate-General
I – Introduction
1. In the present action brought under Article 230 EC, the French Republic seeks the annulment of Article 1(2) of Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 in so far as it introduces a new Article 4a into Directive 76/768/EEC of the Council on the approximation of the laws of the Member States relating to cosmetic products. (2)
II – Legislative background
A – EC cosmetics legislation and the contested provision
Legislative history
2. National laws relating to cosmetic products were harmonised by Directive 76/768, which aimed at determining ‘at Community level the regulations which must be observed as regards the composition, labelling and packaging of cosmetic products’. This Directive did not originally contain any provision relating to animal testing. (3)
3. Directive 93/35/EEC introduced a new Article 4(1)(i) into Directive 76/768, by which Member States were obliged to prohibit from 1 January 1998 the marketing of cosmetic products containing ingredients that had been tested on animals in order to meet the requirements of that Directive. (4) This deadline was subsequently postponed to 30 June 2000 and then to 30 June 2002 as insufficient alternative methods of testing had been scientifically validated. (5)
4. The legislative procedure culminating in the adoption of the contested provision was as follows.
5. In April 2000, the Commission presented a proposal for the amendment for the seventh time of Directive 76/768. (6) As the legal basis of this proposal was Article 95 EC, the legislative procedure followed was the co‑decision procedure set out in Article 251 EC.
6. In its proposal, the Commission put forward, inter alia, the introduction of a permanent and definitive prohibition on the performance of experiments on animals for finished cosmetic products in the territory of Member States of the European Union. In addition, the Commission proposed the removal of the marketing ban from the Directive.
7. In its Common Position of February 2002 on the proposed amendment, the Council reinstated a marketing ban on cosmetic products where the final product or its ingredients have been subject to animal testing, while making the implementation of the marketing ban dependent on the existence of alternative testing methods accepted within the framework of the Organisation for Economic Co‑operation and Development (‘OECD’) and adopted at Community level. The Common Position did not include deadlines for the implementation of the marketing ban. (7)
8. In June 2002, the Parliament adopted its position on the Council’s Common Position. Among the amendments it suggested was the introduction of a marketing ban as and when alternatives are available, with a definitive date after which no products could be marketed if tested on animals, whether or not there were validated alternatives at that time. (8)
9. In July 2002, the Commission adopted its Opinion on the Parliament’s amendments to the Council’s Common Position, in which it rejected the reintroduction of the marketing ban as proposed by the Parliament. (9)
10. As the Council was unable fully to accept the amendments of the Parliament to the Council’s Common Position, the conciliation committee of the Council and Parliament was convened in October 2002. An agreement on the contested provision was arrived at in the second meeting of the conciliation committee in November 2002, following a first meeting in which attempts to reach agreement were unsuccessful. (10) The joint text was subsequently approved by the Council and Parliament, representing a compromise between the respective positions of the two institutions.
The contested provision
11. Testing and marketing ban.
Article 1(2) of Directive 2003/15 amends Directive 76/768 by, inter alia, introducing a new Article 4a providing for a testing and marketing ban for cosmetics products and ingredients that have been tested on animals, to take effect within a fixed deadline. The text of this prohibition is found in 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 (11) 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 … or in Annex IX to this Directive…’. (12)
12. Article 2 of Directive 76/768, as referred to in the contested provision, contains one of the Directive’s fundamental principles: ‘Cosmetic products put on the market within the Community must not be liable to cause damage to human health when they are applied under normal conditions of use’.
13. In sum, Article 4a provides for a testing and marketing ban to enter into effect six years after the directive enters into force for the majority of testing methods, with the Commission to draw up timetables for gradual ending of the various types of test by 2009 at the latest. Validation and confirmation of alternative testing methods is to be undertaken at Community level, with developments in the OECD being taken into consideration.
14. Timetables . Article 4a(2) provides that the Commission shall establish timetables for the implementation of the provisions under Article 4a(1)(a), (b) and (d), to be made available to the public not later than 11 September 2004. These timetables were to be established following consultation of the Scientific Committee on Cosmetic Products and Non‑Food Products intended for Consumers (SCCNFP) and the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the OECD. (13) Article 4a(1)(c), prohibiting animal experiments for finished cosmetic products, must be implemented by 11 September 2004, while Article 4a(1)(a), (b) and (d) must be implemented by March 2009. As regards tests concerning repeated‑dose toxicity, reproductive toxicity and toxicokinetics, however, for which there are no alternatives yet under consideration, Article 4a(1)(a) and (b) must be implemented by 2013. (14)
15. Article 4a(2.2) provides that the Commission shall study possible technical difficulties in complying with the ban in relation to tests for which there are no alternatives yet under consideration. Information about the provisional and final results of these studies should form part of annual reports to be presented by the Commission to the European Parliament and the Council. (15) In addition, on the basis of these annual reports, the timetables established in accordance with paragraph 2 may be adapted within the relevant maximum time‑limit (i.e., 6 or 10 years). The timetables may only be altered after consultation of SCCNFP and ECVAM.
16. Pursuant to Article 4a(2.3), in the event that the Commission’s studies conclude, at the latest by March 2007, that for technical reasons one or more of the alternative tests referred to in paragraph 2.1 will not be developed and validated by March 2009, it shall inform the European Parliament and the Council and shall put forward a legislative proposal in accordance with Article 251 of the Treaty.
17. Derogation procedure. Article 4a(2.4) provides that, in exceptional circumstances where ‘serious concerns arise as regards the safety of an existing cosmetic ingredient’, a Member State may request the Commission to grant a derogation from Article 4a(1). The Commission may, after consultation of SCCNFP and by means of a reasoned decision, authorise the derogation in accordance with the procedure referred to in Article 10(2) of Directive 76/768. (16) The decision on the authorisation, the conditions associated with it and the final result achieved shall be part of the Commission’s annual report.
18. Other provisions of Directive 2003/15. Aside from the contested provision, Directive 2003/15 also provides, inter alia, for: (a) The annulment of Article 4(1)(i) of Directive 76/768 (which provided for a separate ban on the marketing of cosmetic products containing ingredients tested on animals) with retroactive effect from 1 July 2002; (17) (b) The prohibition of the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction; (18) and (c) Compulsory labelling of certain cosmetic products with a date of ‘minimum durability’ and a list of ingredients. (19)
19. Article 3 of Directive 2003/15 requires Member States to bring into force implementing legislation before 11 September 2004. (20)
B – Other Community legislation
20. In addition to the above rules that apply solely to cosmetic products, a number of Community rules of general application, including outside the cosmetics sector, exist regarding animal testing.
21. In this regard, common rules for the use of animals for experimental purposes within the Community were established in Council Directive 86/609, as amended. (21) This Directive lays down the conditions under which such experiments must be carried out in the territory of the Member States. In particular, Article 7 of that Directive requires that animal experiments be replaced by alternative methods, when such methods exist and are scientifically satisfactory. This Directive does not, however, contain any deadline for replacement of animal experiments.
22. In addition, a Protocol on protection and welfare of animals was annexed by the Treaty of Amsterdam to the Treaty establishing the European Community. This Protocol provides that,
‘Desiring to ensure improved protection and respect for the welfare of animals as sentient beings … in formulating and implementing the Community’s agriculture, transport, internal market and research policies, the Community and the Member States shall pay full regard to the welfare requirements of animals while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage’.
C – Articles III.4 and XX(b) GATT
23. Article III.4 GATT contains the principle of non‑discrimination against imports to internal regulations:
‘The products of the territory of any contracting party imported into the territory of any other contracting party shall be accorded treatment no less favourable than that accorded to like products of national origin in respect of all laws, regulations and requirements affecting their internal sale, offering for sale, purchase, transportation, distribution or use …’.
24. Article XX(b) GATT, read with the Article XX chapeau, provides for the following derogation from GATT:
‘Subject to the requirement that such measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail, or a disguised restriction on international trade, nothing in this Agreement shall be construed to prevent the adoption or enforcement by any contracting party of measures … necessary to protect human, animal or plant life or health’.
25. In this regard, the concept of ‘necessity’ has been interpreted as meaning that a measure cannot be justified within the meaning of this provision if another measure was reasonably available that was less inconsistent with GATT rules. (22)
III – Procedure before the Court
26. The present action for annulment was lodged at the Registry of the Court of Justice by the French Government on 10 June 2003.
This was followed by the lodgement of defences by the Council and the European Parliament, the reply of the French Government and the rejoinders of the defendants.
27. By letter dated 15 November 2004, the Court asked the parties to develop, by way of written answer, their arguments as regards the compatibility of Article 4a of Directive 76/768 with the rules of the WTO, without prejudice to their respective positions on whether WTO rules can be invoked in the present case. Following lodgement of these written answers, the written procedure was closed.
28. An oral hearing was held on 18 January 2004, in which all of the parties participated.
IV – Observations of the parties
A – The French Government
29. As a preliminary matter, the French Government contends that its action is admissible. In response to the defendants’ arguments that partial annulment of Directive 2003/15 is not possible as Article 1(2) is not severable from Article 1(1), the French Government recognises that the effect of the partial annulment requested would be that animal testing for cosmetics would no longer be prohibited. In its contention, however, this does not affect the severability of Article 1(2) as the other provisions of the Directive would ‘continue to produce legal effects’ and there is no necessary legal link between the two paragraphs.
30. In this regard, the French Government relies on the Court’s ruling in Germany
v Parliament and Council (23) to argue that the subjective intention of the Community legislature as to whether it would have adopted the Directive without the provision in cause is irrelevant: the relevant question is, instead, whether partial annulment would affect the substance of the Directive. In the French Government’s view, this is not the case here. Further, it argues that the objective of protection of animals would continue to be respected by Directive 86/609, and that it would have been illogical for it to include a request for annulment of Article 1(1) in the present action because this would have reinstated Article 4(1)(i) of Directive 76/768, which fixed 30 June 2002 as the deadline for the marketing ban on cosmetics tested on animals.
31. On substance, the French Government raises five principal arguments in support of its action.
32. First, it alleges that the contested provision breaches the principle of legal certainty. In its contention: (a) The wording of Article 4a prohibiting tests performed ‘in order to meet the requirements of this Directive’ is unclear in that it is not certain from the wording of the Directive whether this ban applies to tests performed for the purposes of complying with other legislation. It is thus unclear whether results achieved from tests performed for the purposes of other legislation can also be used by the cosmetics industry; (b) It is unclear whether new cosmetic products which are themselves not tested on animals, but which use the results of tests already existing, are banned; (c) It is unclear whether animal testing on Member State territory is banned if its purpose is to satisfy third country regulations or if the products are destined for export; and (d) It is unclear whether ingredients and products that may have been tested on animals outside the EU may be marketed within the EU, as these tests would not have been performed ‘in order to meet the requirements of’ the Directive. Although the French Government recognises that the interpretations condoned by the Council and the Parliament in their submissions are possible, and in some cases the most likely, they are in its contention not clear enough to satisfy the requirements of legal certainty.
33. In the French Government’s contention, these uncertainties mean that Member States may transpose the Directive in very different ways, and result in unacceptable lack of legal certainty for cosmetics companies. In this regard, the French Government draws attention to the fact that French cosmetics companies, who lead the Community cosmetic sector, earn on average more than half of their turnover from exportation. Furthermore, the principal countries importing Community cosmetics, including China, Japan, Korea and, to a certain extent, the United States, require cosmetic companies to provide proof that their products are safe for animals before granting marketing authorisation. As a result, it is argued, legal certainty is required in order to maintain the competitive position of the European cosmetics industry. The contested provision will mean that the number of substances usable in the cosmetic sector will progressively diminish.
34. Second, the French Government argues that the Directive violates the principle of freedom of exercise of a professional activity. (24) In its contention, the protection of animals does not constitute a Community objective of general interest sufficient to justify a restriction of this freedom. Further, even if the protection of animals were a valid objective to pursue in this regard, the French Government argues that the restriction of this freedom entailed by Article 4a is disproportionate to the aim pursued. In particular, the contested provision will, it is argued, unduly disadvantage European industry as against its competitors from non‑EU Member States. In the event that a strict interpretation were taken of the situations of uncertainty posited above, this would, it is contended, force cosmetics companies to move their research centres to outside the Community, a step that would prove very difficult for many small‑ and medium‑sized enterprises.
35. Third, the French Government argues that the Directive infringes the principle of proportionality in that the adverse effects caused by the implementation of its provision would be disproportionate to its aim. In support of this argument, the French Government alleges that the benefit to animals of the contested provision is extremely limited, as only 0.3% of animal tests are carried out for cosmetic products. This is not, it is argued, sufficient to justify the restrictions entailed by the Directive for freedom of professional establishment, described above, as well as the risks caused to human health due to the absence of alternative methods at present.
36. Further, the French Government contends that the derogation clause provided for by Article 4a(2.4) is insufficient to remedy these risks for human health as the strict conditions of the derogation means that the clause would take effect too late to respond properly to the need to prevent risks for human health.
37. Fourth, it is argued that the contested provision violates the principle of precaution. Referring in particular to the judgment of the Court of First Instance in Pfizer, (25) the French Government argues that the Directive entails unacceptable risks for human health, for the reasons set out above concerning proportionality. In particular, it is contended that the Community legislature committed a manifest error of appreciation in failing to take account of scientific reports of the SCCNFP and the ECVAM, according to which not all the alternative methods would be available by the deadlines laid down by the Directive, i.e., 2009 and 2013.
38. Fifth, the French Government contends that Article 4a constitutes a violation of the principle of non‑discrimination. In its view, in the event that the hypotheses raised in its arguments on legal certainty were valid interpretations of the Directive, this could amount to discrimination between: (a) Companies active purely in the cosmetics sector and companies active in other sectors, in that the latter may use ingredients in their cosmetics that have been tested on animals for the purpose of other regulations; (b) Companies that export their cosmetics and companies that do not, in the event that the Directive should be interpreted as authorising tests for products destined to be exported; or (c) Companies that carry out all of their activities in the Community and those that also operate within third countries, in the event that the Directive should be interpreted as authorising tests carried out, whether within or without the Community, for the purpose of complying with third country regulations.
39. Finally, in response to the Court’s request that the parties clarify their arguments in relation to the compatibility of the contested provision with WTO rules, the French Government notes that, according to the Court’s jurisprudence, the legality of acts of Community institutions cannot be reviewed for compliance with the WTO agreement or its annexes, due to the nature of this agreement. Further, the French Government is of the view that the contested provision does not fall under either of the two exceptions established by the Court to this principle. (26)
40. However, the French Government asks the Court to consider the relevance of the GATT rules to the present case in the light of the principle of ‘harmonious interpretation’, namely, the principle that ‘the primacy of international agreements concluded by the Community over secondary community legislation demands that the latter, in so far as possible, be interpreted in conformity with these agreements’. (27) In this regard, the French Government points to the fact that the Commission limited its original proposal to the prohibition of the performance of animal tests on Member States’ territory in order to comply with WTO rules. On this basis, the French Government argues that the contested provision, and in particular the marketing prohibition, is incompatible with GATT rules for the following reasons.
41. First, it alleges that the marketing prohibition is incompatible with Article III.4 GATT, because: (a) The prohibition is a measure affecting the sale of cosmetic products in the sense of Article III.4; (b) Cosmetic products or ingredients tested by alternative methods validated at Community level, and those tested by other methods, constitute ‘similar’ products in the sense of this Article, with regard to their physical properties, their final use, consumer habits and preferences, and their tariff classification; and (c) Under the Directive, imports are subjected to less favourable treatment than Community products in that Article 4a of the Directive authorises the marketing of cosmetic products only if the test used is an ‘alternative methods after such alternative method has been validated and adopted at Community level …’.
42. In addition, the French Government denies that the general exception set out in Article XX (b) GATT applies to the contested provision. Although it recognises that the marketing prohibition constitutes a policy aimed at protecting animal life and health, in its view the prohibition is not necessary to attain this objective, as other measures would have attained the same objective without being incompatible with WTO law. (28) Further, the French Government contends that the marketing prohibition fails to satisfy the ‘introductive’ sentences of Article XX GATT, in that it amounts to an economic embargo to force other members to adopt essentially the same global regulations in order to achieve an objective defined on Community territory. (29) The French Government contends that such an extra‑territorial aim can clearly be seen from the exchanges between the Parliament and the Commission and is in fact the ‘principal justification for the marketing prohibition on Community territory’.
43. On the basis of these arguments, the French Government concludes that the prohibition on marketing contained in the contested provision is incompatible with WTO law.
B – The Council of the European Union
44. The Council puts forward the following arguments in its defence.
45. On admissibility, the Council, in the oral procedure before the Court, indicated its concurrence with the Parliament’s argument that the present action is inadmissible on the ground that it is impossible to sever Article 1(2) from Article 1(1). (30) In the Council’s view, such a partial annulment would result in a wholly different text and would deprive Directive 2003/15 of its substance.
46. On the alleged violation of the principle of legal certainty, the Council maintains that the expression ‘in order to meet the requirements of this Directive’ in the contested provision refers simply to the objective of Directive 76/768, namely, the protection of public health. In the Council’s contention, the contested provision clearly means that only alternative methods that do not resort to animal testing may be used as evidence that a cosmetic ingredient or product is safe for public health. As a result, the Council argues, the carrying out of animal tests within the EU on cosmetic products or ingredients destined for export is clearly prohibited; the prohibition on ‘marketing’ extends to making such products or ingredients available to third parties, including export or import; and the marketing prohibition extends to cosmetic products for which animal tests have been used outside the Community for the purpose of compliance with third country legislation. As a result, in the Council’s submission, the French Government’s allegations of legal uncertainty are unfounded.
47. As regards the alleged violation of the principle of freedom of exercise of a professional activity, the Council notes that the prohibition on marketing within the Community extends not only to those products for which animal tests have been carried out within the Community, but also for which animal tests have been carried out outwith the Community. In the Council’s contention, it would be premature to suppose that, within the timescales laid down in the contested provision, alternative methods will not be adopted at Community level or that third countries will refuse to recognise these alternative methods. It would be similarly premature to presume that European industry will be disadvantaged as opposed to its competitors established in third countries. (31) In any event, the Council argues, any restriction of the principle of freedom of exercise of professional activity would be justified by an essential interest of the Community, namely animal welfare.
48. Concerning the allegations of infringement of the proportionality principle, the Council contests the allegation that the contested provision is manifestly inappropriate with regard to its objective. In particular, it argues, the prohibition cannot result in the circulation of products presenting grave risks to human health, as all products marketed within the Community must still satisfy the requirements of public safety set out in Directive 76/768.
49. As regards the alleged violation of the precautionary principle, the Council contends that the contested provision cannot be qualified as a manifest error of appreciation. On the contrary, it represents part of a compromise adopted following a complex evaluation of all the scientific evidence available to the Community legislature at the time of its adoption.
50. In addition, the Council contests the French Government’s allegation that the contested provision represents unlawful discrimination betwe en companies within the cosmetic sector, on grounds similar to those invoked as regards the allegation of legal uncertainty. In other words, as the ban on marketing within the Community applies to all cosmetic companies, regardless of place of establishment or the location of animal testing, any argument of discrimination must be rejected.
51. Finally, as regards the arguments put forward by the French Government concerning the relevance of WTO rules to the present case, the Council argues that non‑animal‑tested cosmetic products are not ‘similar’ to animal‑tested cosmetic products under Article III.4 GATT, due to different consumer preferences for each category. As regards Article XX(b) GATT, the Council repeats that the marketing prohibition applies to all animal‑tested cosmetic products marketed in the Community without discrimination according to origin. Further, no alternative measures exist that would be less restrictive under GATT law. In addition, unlike the policy at issue in the US‑Shrimp case relied upon by the French Government, the present policy is not a rigid one, leaving other contracting parties free to choose how to fulfil the requirement that cosmetic products should not be tested on animals. The Council notes that, under the Directive, the Commission and Community Member States shall take all appropriate measures to facilitate the acceptance of Community‑validated alternative methods by the OECD.
C – The European Parliament
52. The Parliament echoes many of the arguments expounded in the defence of the Council. Additional points raised include the following.
53. On admissibility, the Parliament contests the suggestion that the contested provision is severable from Article 1(1) of Directive 2003/15. The Parliament notes that, in the case of this Directive, the negotiations in the conciliation committee were ‘particularly difficult and delicate’, and the final text represents a ‘global compromise’ arrived at by COREPER, the Parliament and the Commission and it would be impossible to separate Article 1(1) and 1(2) of the Directive. (32) The partial annulment requested by the French Republic would amount to an ‘attempt to legislate by judicial means’ as Article 1(1) would never have been adopted by the legislature without the simultaneous adoption of Article 1(2).
54. In the Parliament’s view, this case is wholly different from that of Germany
v Parliament and Council, Case C‑376/98, as that was a case where the Commission admitted the provision at issue was severable, but contested the partial annulment action simply on the ground that it would not have adopted the relevant Directive without this provision. Further, the Parliament refutes the French Government’s argument that a finding of inadmissibility would amount to a denial of justice, on the ground that it had been open to France to challenge Directive 93/95, which contained similar language to that complained about in Directive 2003/15.
55. On substance, first, as regards legal certainty the Parliament contends that, in the absence of a violation of the principle of legitimate expectations, the principle of legal certainty cannot in itself give rise to the annulment of a Community act.
56. Second, the Parliament questions the true objective of the French Government’s arguments on legal certainty, suggesting that this may in fact be to obtain a favourable (i.e., restrictive) interpretation of the Directive by way of an action for annulment of the Directive. In the Parliament’s view, this would constitute an abuse of procedure.
57. Third, the Parliament rejects the contention that the Directive would give rise to a disaster for the European cosmetic industry, pointing to the considerable number of cosmetic companies that had already implemented policies compliant with the Directive prior to its adoption.
58. Finally, as concerns the relevance of WTO rules to the present case, the Parliament echoes the Council’s argument that non‑animal tested and animal‑tested cosmetics are not ‘similar’ in the sense of WTO law. Further, the Parliament rejects the suggestion that the Community legislature sought to conceal a protectionist policy behind the Directive, noting that the Community cosmetic industry occupies a greater proportion by volume of the world cosmetics market than the US or Japan. In its view, this belies the argument that the Directive results in ‘less favourable’ treatment in the sense of Article III 4 GATT, as well as the argument that it is discriminatory in the sense of Article XX GATT.
V – Analysis
Admissibility
59. The first issue to be considered is whether the present action for partial annulment should be held inadmissible on the ground that the contested provision cannot be severed from the first paragraph of Article 1 of Directive 2003/15, which the French Government does not seek to annul. As is well known, partial annulment of a legislative act or of a decision is possible only if the elements whose annulment is sought may be severed from the remainder of the act or decision. (33)
60. In assessing this issue, it is pertinent to recall the Court’s jurisprudence on the appreciation of the severability of provisions of a legislative measure in an action for partial annulment. Three cases in particular are, in my view, especially relevant.
61. The first is Germany
v Commission, which concerned an action for annulment of Article 5(5) of Regulation No 690/2001 on special market support measures in the beef sector, in so far as that provision required each Member State concerned to finance 30% of the price of the meat purchased under that regulation. (34) In that case, the Court requested the parties to state their views on the admissibility of the action in the light of the principle that partial annulment of a Community act is possible only if the elements whose annulment is sought may be severed from the remainder of the act. The Court concluded that the contested provision was severable from the remainder of the Regulation ‘because the annulment of that provision would not alter the substance of the regulation’. (35) It reasoned that, as the substance of the regulation consisted in the establishment of a special purchase scheme for beef in order to respond to the BSE crisis, annulment of the provision requiring each Member State concerned to finance 30% of the price of the meat purchased would ‘leave the substance of that regulation completely intact, since it would give rise only to financial compensation as between the Community and the Member States concerned’. (36) Rejecting the Commission’s argument that, without the contested provision, it would probably not have adopted the other provisions of the regulation in their current version – and in particular a provision that proceeds from sales of products in conformity with the regulation should belong to the Member State concerned (37) – the Court stated that, ‘whether partial annulment would alter the substance of the contested measures is an objective criterion, and not a subjective criterion linked to the political intention of the authority which adopted the measure at issue’.(38)
62. The issue was also considered by Advocate General Fennelly in Germany v Parliament and Council
(‘ Tobacco Advertising ’). (39) That case concerned an action to annul Directive 98/43/EC, which purported to ban all forms of tobacco advertising and sponsorship. After concluding that the Community legislature was not competent to adopt the Directive on the grounds invoked in so far as it related to advertising in media which exclusively contained tobacco advertising, but would have been competent to do so in relation to media with other independent content and in which there was a distinct service element or trade (e.g. newspapers and radio broadcasting), Advocate General Fennelly went on to consider whether the Court could consider partial annulment of the Directive. Referring to the Court’s judgments in Working Time
and in actions for partial annulment of Commission decisions in competition proceedings, (40) he observed,
‘The Court has not laid down any general guidelines on the question of the severability of the valid and invalid parts of a legislative measure. None the less, it seems to me that it has chosen the route of partial annulment where two conditions are satisfied: first, where a particular provision is discrete and, thus, severable without altering the remaining text; and, secondly, where the annulment of that provision does not affect the overall coherence of the legislative scheme of which it forms a part’. (41)
63. He concluded that partial annulment was not a valid option on the ground that, because the Directive did not distinguish between media exclusively containing tobacco advertising and independent service-related media, for the Court to insert that distinction would amount to creative judicial rewriting of the Directive. In particular, he observed that, ‘the preserved parts would represent only part of the subject matter of the ban which was clearly conceived of in global terms by the Community legislature. The Court would bring the axe to the tree but seek to allow some of the branches to survive …’. (42)
64. A final case of relevance is Commission
v Council, in which the Commission sought partial annulment of the Council’s decision approving the accession of the European Atomic Energy Community to the Nuclear Safety Convention. (43) In particular, the Commission sought annulment of the final paragraph of the Declaration by the EAEC attached to that decision, which indicated the extent of the Community’s competence in the area of the Convention, on the ground that certain areas of Community competence had been omitted from this indication. In rejecting the Council’s argument on inadmissibility based on non‑severability, the Court reasoned that, the requested partial annulment would ‘not alter the substance of the contested decision’ as it would ‘in no way affect the legal scope of the provisions on which the Council has already taken a view’ (semble: as to Community competence). (44) In his Opinion in that case, Advocate General Jacobs contrasted the facts in cause with actions for partial annulment of non‑legislative decisions in the competition sphere, such as Transocean Marine Paint
and Kali und Salz, (45) in which annulment of the contested conditions of the decisions ‘might have affected the nature of the decision itself’. (46)
65. The above jurisprudence demonstrates, in my estimation, that an action for partial annulment of a legislative act is inadmissible if annulment of the contested provision would, in view of the fundamental legislative aims at issue, deprive the scheme of the legislation of its essence. This is so even if, from a purely formal logical perspective, the contested provision may be viewed as discrete from the rest of the legislation (for instance, in the absence of explicit cross-references between the contested provision and the rest of the legislative act). To hold otherwise would subvert the objective aim of the Community legislature and would lead to the independent maintenance of legislative provisions intended to be merely ancillary. Viewed independently, it is not inconceivable that, in some instances, these ancillary provisions could harm the original legislative goal.
66. Applying this principle to the present case, it is clear from, inter alia, the preamble to Directive 2003/15 that one of its overarching objectives is the abolition of animal testing for cosmetic products. Thus, for instance, paragraph 4 of its preamble reads that, ‘it is essential that the aim of abolishing animal experiments for testing cosmetic products be pursued and that the prohibition of such experiments becomes effective in the territory of the Member States’. Paragraphs 1 to 11 of the preamble concern this objective.
67. As the French Government explicitly recognises, if their action for partial annulment were to succeed, the result would be that, through the deletion of Article 4(1)(i) of Directive 76/768, (47) the marketing of animal‑tested cosmetic products would be unconditionally permitted within the Community.
68. It follows from the above that such a result would in fact constitute the converse of the Community legislature’s objective aim and of the essence of the Directive. It is clear that the purpose of Article 1(1) was purely ancillary to the contested provision: indeed Article 4a of Directive 76/768, inserted by the contested provision, was intended to replace Article 4(1)(i) of Directive 76/768. The effect of partial annulment would thus be the opposite of what was evidently intended.
69. Further, I note that other provisions of Directive 2003/15, in particular Article 1(7), would also seem to have been conceived by the legislature in the light of Article 1(2).
70. For these reasons, I am of the view that Article 1(2) of Directive 2003/15 is not severable from the rest of the Directive, and in particular from Article 1(1), and that the present action should be declared inadmissible. However, on the hypothesis that the Court should come to the contrary conclusion, I turn now to consider the merits of the parties’ arguments on substance.
Substance
A – Legal certainty
71. The French Government argues that the contested provision should be annulled because it is not sufficiently clear and precise. It contends that the new Article 4a is open to a variety of interpretations, meaning that it may be transposed by Member States in different ways, which may result in legal uncertainty for companies.
72. As a preliminary matter, I note that, although the parties in their submissions refer to the ‘principle of legal certainty’, this term may be confusing in that it is often used to refer to a selection of different, though related, legal concepts. These are: the principle of non‑retroactivity of Community legislation; the principle of respect for legitimate expectations, in the sense of a reasonable expectation based upon an act or representation of a Community institution; and the concept of respect for the binding authority of Community norms. (48) In the present case, the French Government’s arguments are confined to an alleged lack of clarity in the wording and effects of the contested provision, and do not extend to any of the senses listed above.
73. Before examining the substance of these arguments, it is in my view important to consider as a matter of principle the circumstances in which the unclear or vague nature of a Directive’s wording can, in itself, amount to a ground for its annulment.
74. In this regard, the first point to be made is that, it would, to my mind, be extremely unusual to find a Community legislative act of general application that is open to only one unequivocal interpretation. It is inherent in the nature of any such act, and in particular one agreed upon at the highest level in the Community legislative system, that not every term employed can, or should, be exhaustively and definitively defined within the act itself. To strive for such exhaustive definition would in most cases be simply impracticable, and in many cases impossible and inappropriate. This flows not only from the difficulty of providing in advance for every possible scenario in which a Directive may apply, but also more generally from the linguistic indeterminacy of law. (49)
75. Thus Community, and indeed Member State, laws are rife with legislative concepts the details and application of which have been deliberately left to the judiciary or administration. Obvious examples in secondary Community law would include the exceptions to the equal treatment principle set out in Article 2 of Directive 76/207, the concept of ‘social advantage’ contained in Article 7(2) of Regulation No 1612/68, and the public policy, security and health derogations from the right to free movement formerly found in Directive 64/221, replaced by Directive 2004/38. (50)
76. It follows that, where a situation arises in judicial proceedings for which the applicable legislation has not explicitly provided, it is for the courts to interpret and apply this legislation to the case in point. In Community law, for example, the principle that legislative interpretation and application form part of the core functions of the Court of Justice is reflected by the wording of Article 220 EC. In carrying out this function, the Court must bea r in mind that the effect of Community norms should be clear and predictable for those who are subject to it. (51) This factor has been decisive in many cases in which the Court was called upon to interpret or apply Community law. (52)
77. While this observation holds true for all Community legislative acts of general application, it is especially relevant in the case of directives. I find the reasoning of Advocate General Jacobs in Netherlands
v Parliament and Council
of particular interest in this regard. (53) In rejecting the argument of the Netherlands Government that Directive 98/44 on the legal protection of biotechnological inventions should be annulled on the ground of infringement of legal certainty, Advocate General Jacobs observed that Article 249 EC provides that a directive is to be binding upon each Member State as to the result to be achieved but shall leave to the national authorities the choice of form and methods. He continued,
‘Directives are thus inherently liable not to deal exhaustively with the detail of matters within their scope. While that does not of course mean that unclear drafting is appropriate, it does suggest that the mere fact that a directive confers some discretion on the Member States is not in itself a ground for invalidating it. Even where a provision of a directive is open to different interpretations, as the Netherlands alleges in the present case, I do not consider that that in itself is grounds for annulment. In recent cases in which the Court has held that a member State, in incorrectly implementing an imprecisely drafted provision of a directive, gave the provision a meaning which it was reasonably capable of bearing, there has been no suggestion that the directive (or even the provision) should be regarded as invalid merely because it was imprecise and hence open to more than one interpretation.
Similarly the Court in formulating the principle that only those provisions of directives which are clear and unambiguous may have direct effect has not to my knowledge suggested that all provisions not so precise and unconditional are thereby invalid …’. (54)
78. I would respectfully concur with this reasoning. While it is true that, as already observed and as argued by the French Government, the effect of Community norms should be clear and predictable for those who are subject to it, this does not and should not lead to the conclusion that any legislation open to more than one interpretation must be annulled. For the reasons given above, lack of clarity in my view constitutes a ground of annulment for Community legislation, or part thereof, only in those extreme cases where the legislation is internally clearly inconsistent, or where no logical meaning whatsoever can be attributed to the provision at issue. (55)
79. Applying these considerations to the case in point, the French Government’s arguments of legal uncertainty centre around the concept that only animal tests performed ‘in order to meet the requirements of the Directive’ fall under the prohibitions therein. This phrase appears in each of the four types of prohibition contained in the Directive.
80. I am not convinced by these arguments. In my estimation, the Directive satisfies the requirements of legal clarity and predictability set out in my observations above, for the following reasons.
81. As observed by the Council, the phrase ‘in order to meet the requirements of this Directive’ must be read in the context of the overriding objective of Directive 76/768 to which Article 4a is expressly subject, namely, the protection of public health. As noted above, this principle is expressed in Article 2 of the Directive: ‘Cosmetic products put on the market within the Community must not be liable to cause damage to human health when they are applied under normal conditions of use’.
82. It is to my mind clear that the phrase at issue thus expresses the legislature’s intention that animal tests to which the prohibitions apply must be aimed at achieving the public health requirements for cosmetics set out in Directive 76/768. Furthermore, it seems to me reasonable to suppose that, in the cosmetics sector, practically all animal tests would be performed for this purpose, and this has not been denied by the French Government. It bears mention in this regard that this phrase first appeared in Article 4 of Directive 76/768 as a result of the amendment introduced by Directive 93/35. Although the entry into force of this provision was, as described above, postponed, the French Government does not seem to have objected to the formulation or alleged its lack of clarity in the interim.
83. Read in this light, each of the alleged uncertainties raised by the French Government seems illusory.
84. First, it seems clear that the ban on animal tests applies equally to tests performed for the purposes of complying with other legislation, in so far as substances that have been the subject of such tests may not be used as or in cosmetic products. This interpretation seems necessary for the effet utile
of the Directive and is consistent with the intention expressed in the preparatory documents leading up to its adoption. (56)
85. Second, it follows in my view from the wording of the contested provision that it applies to the performance of animal testing of cosmetic products or ingredients on a Member State’s territory, irrespective of whether this testing is for products destined for export. This interpretation is also suggested by Article 1(7) of Directive 2003/15. (57)
86. Third, it follows equally from this wording that cosmetic products and ingredients subject to animal tests outside the Community are subject to the marketing ban. Such tests would by their nature have been performed in order to meet public health requirements, thus falling within the prohibition. (58)
87. In my estimation, therefore, the contested provision does not provide an unacceptable level of legal certainty for cosmetics undertakings. I would add that, in the event of questions of interpretation arising, it is open to such undertakings to seize their national courts, which may in turn refer these questions to the Court under Article 234 EC.
B – Proportionality
88. As is well known, the principle of proportionality requires that measures implemented through Community provisions should be appropriate for attaining the objective pursued and must not go beyond what is necessary to achieve it. (59) Thus, when there is a choice between several appropriate measures, recourse must be had to the least onerous. (60)
89. I wish to make a number of preliminary remarks on the standard of review to be applied by the Court in situations such as the present case.
90. It is constant case‑law that, in areas of complex policy choices where the Community legislature enjoys a broad discretionary power, substantive judicial review of legislative acts is limited. In such cases, a legislative act should be annulled only if the act manifestly exceeded the limits of the legislature’s competence. (61) Thus, in the case of a Community prohibition on tobacco for oral use, the Court has held that,
‘With regard to judicial review of the conditions referred to in the previous paragraph, the Community legislature must be allowed a broad discretion in an area such as that concerned in the present case, which involves political, economic and social choices on its part, and in which it is called on to undertake complex assessments. Only if a measure adopted in this field is manifestly inappropriate in relation to the objective which the competent institutions are seeking to pursue can the lawfulness of such a measure be affected’. (62)
91. As is evident, the restricted nature of substantive judicial review of such legislative acts stems primarily from the fundamental principle of institutional equilibrium and separation of powers. It is inherent in this equilibrium that the Court should respect the ‘political responsibilities’ (63) conferred by the Treaty on the Community legislature, and should refrain from substituting its judgment on such policy matters . (64)
92. In my view, it follows from this principle of institutional equilibrium, as from the democratic principle itself, that the Court should be particularly cautious in reviewing the legality of a legislative act promulgated jointly by the Council and Parliament by way of the co‑decision procedure. The Court should be especially slow to annul on substantive grounds the legislative policy decisions of a directly and democratically elected body representing the Community’s citizens. I would add that this concern for maximum respect for democratic principles has been a feature of the Court’s jurisprudence on numerous other occasions. (65)
93. Applying these considerations to the present case, it is clear that the prohibition of animal testing for cosmetic products and ingredients represents a policy decision of considerable sensitivity, which necessitated a delicate and global analysis of the advantages and disadvantages of the envisaged system by the Commission, Council and Parliament. As recounted above, agreement was reached on the Directive following a lengthy and complex co‑decision procedure, including multiple ‘tri‑partite’ meetings with the Commission and, it would seem, numerous consultations of interested third parties. (66) Final agreement was reached only through the convening of the conciliation committee.
94. It is noteworthy that, as set out above, during the legislative process a strong impetus for the introduction of a deadline for the prohibition of animal testing for cosmetics came from the Parliament. (67) The Parliament describes the Directive as representing ‘the fruit of a legislative process of almost ten years, is a legislative act of great importance and of great political sensitivity’. (68)
95. In principle, therefore, judicial review of the substantive legality of the contested provision, and in this case its conformity with the proportionality principle, should be particularly limited.
96. In order to carry out this review, it is necessary first to identify the aim of the contested provision. This is expressly set out in the preamble to Directive 2003/15, which provides that, ‘In order to achieve the highest possible degree of animal protection, a deadline must be set for the introduction of a definitive prohibition’. (69) Thus in the proposal for the Directive, the Commission stated that,
‘The reduction of pain inflicted on animals during tests, of the number of tests and, wherever and as soon as possible, the elimination of animal suffering is an objective that is common to all parties involved in this issue. This aim corresponds to ethical requirements regarding respect for life, supported by public opinion and the expressed wishes of the European Parliament. This aim is also included in Directive 86/609 regarding the protection of animals used for experimental and other scientific purposes’.
97. There is no doubt that this is a valid objective of Community legislation. This is confirmed by the Protocol on protection and welfare of animals annexed to the EC Treaty. (70) Contrary to the French Government’s arguments, I do not find that the Court’s ruling in Jippes
leads to the opposite conclusion. (71) On the contrary, in that case, consideration of whether the Community legislature had taken full account of the requirements of animal welfare formed an important step in the Court’s assessment whether the Community policy at issue was proportionate. (72)
98. The second stage in reviewing proportionality requires an analysis whe ther the contested provision constitutes an appropriate means of achieving this aim. In this case, it is difficult to contest that the institution of a definitive prohibition on animal testing for cosmetic products and ingredients within the Community does not constitute a means for furthering animal welfare, and the French Government does not attempt to do so.
99. The third stage in reviewing proportionality is an assessment of whether the contested provision goes beyond what is necessary to achieve its aim. It is at this stage that the limited nature of judicial review becomes most relevant.
100. It is clear from the documents produced in the course of the legislative procedure that, in formulating the contested provision, the Community legislature sought to achieve a delicate balance of the requirements of animal protection with the other interests at stake, including public health and the need to respect international commitments. After considering a range of alternatives – including that put forward in the proposal of the Commission, which did not include a marketing ban – the contested provision was selected as the most appropriate balance following intense discussions. (73) Thus, in its Common Position, the Council noted that,
‘While the Council agrees with the aim of abolishing also animal testing on ingredients for cosmetic products as soon as possible, it considers that this objective should be pursued without compromising the health and safety of consumers’. (74)
101. There are numerous illustrations in the contested provision, and in Directive 2003/15 as a whole, of the concern to arrive at this balance, and the final text represents a carefully crafted compromise to this effect.
102. The overriding concern to safeguard public safety and protect consumers, for example, is evident from Article 4a(1), which provides that the prohibitions contained therein are without prejudice to the general public safety obligations deriving from Article 2. (75) Indeed, the concern to maintain public safety is present throughout Directive 2003/15, including the provision for a derogation from the prohibition in case of substantiated specific human health problems; (76) the possibility for the Commission to put forward a legislative proposal if insufficient alternative tests have been validated; (77) the special provision for extended deadlines for tests concerning repeated‑dose toxicity, reproductive toxicity and toxicokinetics; (78) and the provision in the preamble for the
development of guidelines by the Commission, in consultation with the Member States, to ensure that common criteria are applied in assessing claims that cosmetic products have not been tested on animals, in order to avoid misleading consumers. (79)
103. Likewise, the Directive exhibits a clear concern to take into account the interests of cosmetics businesses in the context of its animal protection and public safety objectives. For example, Article 9 of Directive 76/768, as amended, states that the annual report presented by the Commission to the Parliament and Council shall cover progress made by the Commission in its efforts to obtain OECD acceptance of alternative methods validated at Community level and recognition by third countries of the results of tests carried out in the Community using alternative methods, as well as ‘the manner in which the specific needs of small and medium sized enterprises have been taken into account’. In addition, alternative methods validated or approved at Community level are to be published immediately. (80) These provisions clearly aim at facilitating Community undertakings and increasing transparency.
104. Furthermore, in response to the French Government’s argument concerning the alleged insufficiency of alternative methods available, suffice to say that, on all the evidence, the legislature was well aware of the state of development of alternative methods and took this fully into account in its final compromise. (81)
105. It is evident from the above that the contested provision represents a careful and considered balance by the Community legislature between the interests at stake. In my estimation, and particularly in view of the limited nature of judicial review appropriate in such a case, this suffices to dismiss the French Government’s contention that the contested provision should be annulled for breach of the principle of proportionality.
C – Principle of precaution
106. As I recalled in my recent Opinion in Arnold André, the Court has summarised the principle of precaution in the following terms:
‘When it is impossible to determine with certainty the existence or the scope of an alleged risk due to the insufficient, inconclusive, or imprecise nature of results or studies, but the probability of real damage to public health persists in the case that the risk would materialise, the principle of precaution justifies the adoption of restrictive measures’. (82)
107. In particular, in order to justify application of the precautionary principle, the risk alleged must be proved to be more than hypothetical. (83)
108. In the present case, the French Government seeks to invoke the principle to impugn the contested provision on the ground that it poses a risk to public health, in that it is not certain whether sufficient alternative methods will be developed within the timeframe set out in the deadlines provided.
109. As I have already explained, however, full respect for public safety is an inherent part of Directive 2003/15, as with Directive 76/768. In particular, the prohibitions set out in Article 4a are expressly subject to a Member State’s general obligation to ensure that cosmetics marketed within the Community are not liable to cause damage to human health when they are applied under normal conditions of use. As set out in paragraphs 100‑102 above, therefore, the objective of public safety is clearly safeguarded. As the French Government has not adduced any evidence of any ‘more than hypothetical’ risk to public health, this argument may be dismissed.
D – Non‑discrimination
110. The French Government’s arguments on non‑discrimination are each premissed on the validity of its hypotheses raised with a view to showing that the contested provision falls foul of the requirements of legal certainty. I have considered these hypotheses above and have concluded that these hypotheses are based on invalid readings of the contested provision. (84) For the same reasons, the arguments on non‑discrimination should be dismissed.
E – Restriction to free exercise of professional activity
111. The Court summarised the Community law principle of freedom to pursue professional activity in Metronome Musik :
‘According to settled case‑law, the freedom to pursue a trade or profession, and likewise the right to property, form part of the general principles of Community law. However, those principles are not absolute but must be viewed in relation to their social function. Consequently, the exercise of the right to property and the freedom to pursue a trade or profession may be restricted, provided that any restrictions in fact correspond to objectives of general interest pursued by the European Community and do not constitute in relation to the aim pursued a disproportionate and intolerable interference, impairing the very substance of the rights guaranteed …’. (85)
112. As is evident from the above extract, the nature of the analysis concerning restrictions on the freedom to exercise professional activity is analogous to that performed in assessing compliance with the proportionality principle. (86)
113. As a result, although it is clear that any prohibition on product testing or marketing is very likely to restrict professional activity in some sense, for the reasons set out in detail above (87) I consider that, in the present case, the restriction entailed does not represent a disproportionate interference with the freedom to pursue a profession.
F – Relevance of WTO law
114. As regards the arguments put forward on the compatibility of the contested provision with WTO law, the first issue to decide is the extent to which such arguments may be taken into account in reviewing the legality of the contested provision.
115. As recognised by the French Government, the Court has held that, having regard to their nature and structure, the WTO Agreement and the annexes thereto are not in principle among the rules in the light of which the Court is to review measures of the Community institutions. (88) Nor, as is also accepted, does the present case fall under either of the exceptions to this principle posited by the Court, namely, where the Community intended to implement a particular obligation assumed in the context of the WTO, or where the Community measure refers expressly to the precise provisions of the WTO agreements. (89)
116. In the present case, however, as part of its request that the contested provision should be annulled, the French Government asks the Court to find that the marketing prohibition contained therein is incompatible with the GATT agreement. The French Government asks the Court to make such a finding based on what may be called the principle of ‘harmonious interpretation’ as expressed in Community case‑law. This principle, in its original form, provides that: ‘The primacy of international agreements concluded by the Community over provisions of secondary Community legislation means that such provisions must, so far as is possible, be interpreted in a manner that is consistent with those agreements’. (90) As is evident, this mirrors the principle that, where the wording of secondary Community legislation is open to more than one interpretation, preference should be given as far as possible to the interpretation which renders the provision consistent with the Treaty. (91) Thus the Court has held that, since the Community is a party to the TRIPs agreement, it is under an obligation to interpret its trademark legislation, as far as possible, in the light of the wording and purpose of that agreement. (92)
117. In the present case, the French Government contends that the reason for the incompatibility of the present provision with GATT
is its very nature as a marketing prohibition of all animal tested cosmetic products that use a method ‘other than an alternative method after such alternative method has been validated and adopted at Community level’. (93) The French Government argues that this constitutes less favourable treatment within the meaning of Article III.4 GATT, in that importers into the Community are obliged to have their alternative method validated at Community level.
118. This, however, is the express wording of the Directive. For example, on any logical reading, and as observed by the Council, there is no scope whatsoever for interpreting this to mean that alternative methods adopted at OECD level will also suffice. In my estimation, therefore, this is not a case where an alternative, allegedly ‘more GATT‑compliant’, interpretation can be read into the provision. The essence of the principle of harmonious interpretation is, as stated above, that this may be done only ‘as far as possible’ with a view to the express wording of the legislation at issue. I would add that the reality of what the French Government is seeking is, in my view, not an interpretation of Directive 2003/15, but its annulment. I note that it puts forward no possible interpretation of the marketing prohibition that would result, in its contention, in compatibility with GATT.
119. Further, and in any event, I am not convinced, on the basis of the arguments made in the present case, that the contested provision is incompatible with GATT. As the French Government’s arguments in this regard were not sufficiently developed to enable a comprehensive assessment of the issue, I will confine myself to the following remarks.
120. As regards Article III.4 GATT, although it is in my view probable that, in the present state of development of the market, animal‑tested and non‑animal‑tested cosmetics qualify as ‘similar’ products in the light of their current competitive relationship from a consumer perspective, (94) I find it questionable that the requirement that alternative methods be validated at Community level would result in less favourable treatment for imported cosmetic products. While it is clear that this requirement is not discriminatory in law, being indistinctly applicable to Community and third country manufacturers, it is equally not wholly evident to me that the effect of such a requirement would in practice impose a greater competitive burden on third country manufacturers than on EU companies. (95) Every cosmetics company will be subject to this requirement as a precondition for marketing their products within the EU. I do not see why the process of obtaining approval for a given alternative method should be more difficult for non‑EU companies (in comparison to, say, obtaining this approval at OECD level), nor has the French Government put forward any arguments why this should be so.
121. In addition, there are in my estimation powerful arguments that the requirement of EU level validation of alternative methods is justifiable under Article XX(b) GATT. In particular, it seems to me that this requirement fulfils the criterion of necessity within the meaning of this provision. On the evidence before me, I find it hard to see that another measure was reasonably available to the EU that would qualify as ‘less inconsistent’ with GATT, within the meaning of GATT case‑law. (96)
122. While the French Government maintains that a requirement that alternative methods should be validated at OECD level would constitute such a measure, it is clear that the Community legislature was aware of this possibility and rejected it, on what would appear to be reasonable grounds, as insufficiently effective to achieve the Directive’s aim. Thus, in its Proposal of 2000, the Commission emphasises the necessity of Community level approval of alternative methods:
‘While the Commission must make efforts to convince the OECD to accept alternative methods validated by ECVAM, experience has shown that it has sometimes taken several years for an existing method to be accepted by all OECD members. In this situation, because of the moral importance of animal welfare it is not possible to wait for such acceptance by the OECD. Action is needed at Community level given the existence of alternative methods which have been validated or endorsed as being scientifically valid by ECVAM and endorsed by the ECVAM Scientific Advisory Committee. Therefore, a new approach is put forward in the proposed directive, in that regulatory acceptance at a European level will be sufficient to permit legislative proposals for cosmetic testing in the European Union’.
123. For similar reasons, I am of the view that the requirement of EU‑level approval satisfies the conditions set out in the chapeau
to Article XX, in that it does not constitute a means of arbitrary or unjustified discrimination or a disguised restriction on international trade. In this regard, contrary to the view of the French Government, the present case is in my opinion distinguishable from the Shrimp case, in which the Appellate Body found that a requirement that other countries adopt a specific regulatory programme that was essentially the same as the Member’s own, without enquiring into whether it was appropriate in view of the conditions in those countries, would amount to arbitrary and unjustifiable discrimination. (97) In the present case, however, the requirement of EU‑level approval was, as explained above, adopted in good faith, constituted in the Community legislature’s view the only means of effectively achieving the Directive’s goal of animal protection, and had the explicit aim of maximising acceptance of EU‑approved alternative methods at OECD level. (98)
124. For these reasons, the French Government’s arguments based on alleged incompatibility with GATT should, in my opinion, be dismissed.
VI – Conclusion
125. In the light of the foregoing considerations, I propose that the Court should:
(1)	Dismiss the action brought by the French Republic for the annulment of Article 1(2) of Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 in so far as it introduces a new Article 4a into Directive 76/768/EEC of the Council on the approximation of the laws of the Member States relating to cosmetic products;
(2)	Order the French Republic to pay the costs.
(1) .
(2)
–	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.
(3)
–	Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, OJ 1976 L 262, p. 169.
(4)
–	Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, OJ 1993 L 151, p. 32. Article 4(1) of Directive 76/768, as amended, specified that ‘if there has been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection for the consumer, taking into account OECD toxicity test guidelines, the Commission shall by 1 January 1997 submit draft measures to postpone the date of implementation of this provision for a sufficient period and, in any case, for no less than two years…’.
(5)
–	Commission Directive 97/18/EC of 17 April 1997 postponing the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic products, OJ 1997 L 114, p. 43; 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.
(6)
–	Proposal for a Directive of the European Parliament and of the Council amending for the seventh time Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, COM (2000) 189.
(7)
–	Common Position (EC) No 29/2002 of 14 February 2002 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, OJ 2002 C 113 E/06.
(8)
–	Recommendation for a second reading on the common position adopted by the Council with a view to adopting a European Parliament and Council Directive amending Council Directive 76/768/EEC, PE 232.072/DEF.
(9)
–	COM (2002) 435(01).
(10)
–	Report on the joint text approved by the Conciliation Committee for a European Parliament and Council directive of the European Parliament and of the Council amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (PE‑CONS 3668/2002 – C5‑0557/2002 – 2000/0077(COD)).
(11)
– Paragraph 3 of Article 4a defines ‘finished cosmetic product’ as the cosmetic product in its final formulation, as placed on the market and made available to the final consumer, or its prototype (in turn, defined as a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed).
(12)
– Article 4a provides that the contents of Annex IX to Directive 2003/15 shall be established by the Commission no later than 11 September 2004, 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). See Commission Directive 2004/94/EC of 15 September 2004 amending Council Directive 76/768/EEC as regards Annex IX, OJ 2004 L 294, p. 28.
(13)
–	See Commission Staff Working document of 1 October 2004, SEC(2004) 1210, Timetables for the phasing‑out of animal testing in the framework of the 7th Amendment to the Cosmetics Directive (Council Directive 76/768/EEC).
(14)
–	Article 4a(2.1).
(15)
–	See Article 9, Directive 76/768, as amended by Article 1(9), Directive 2003/15, by which these annual reports shall also cover progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by non-member countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries; and the manner in which the specific needs of small and medium-sized enterprises have been taken into account.
(16)
–	Paragraph 2.4 of Article 4a provides that this authorisation ‘shall lay down the conditions associated with this derogation in terms of specific objectives, duration and reporting of the results. A derogation shall only be granted if: (a) the ingredient is in wide use and cannot be replaced by another ingredient able to perform a similar function; (b) the specific human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research Protocol proposed as the basis for the evaluation’.
(17)
–	Article 1(1), Directive 2003/15.
(18)
–	Article 1(2), Directive 2003/15 (introducing a new Article 4b into Directive 76/768).
(19)
–	Article 1(3) and (4), Directive 2003/15. By Article 2 of Directive 2003/15, Member States are obliged to take ‘all necessary measures’ to ensure that
from 11 March 2005 neither manufacturers nor importers established within the Community place on the market cosmetic products which fail to comply with these requirements.
(20)
–	However, in the interests of legal certainty, the Directive provides for the retrospective application of Article 1(1), which deletes Article 4(1)(i) of Directive 76/768 (i.e., the 30 June 2002 deadline for prohibition of animal testing for cosmetics).
(21)
–	Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, OJ 1986 L 358, p. 1.
(22)
–	See, for example, the Appellate Body report in EC‑Asbestos, WT/DS135/AB/R, 2001, adopted 5 April 2001.
(23)
–	Case C‑376/98 Germany
v Parliament and Council, [2000] ECR I‑8419.
(24)
–	See, for example, Case C‑200/96 Metronome Musik
[1998] ECR I‑1953, paragraph 21.
(25)
–	Case T‑13/99 Pfizer Animal Health v Council [2002] ECR II‑3305.
(26)
–	Case C‑149/96 Portugal v Council
[1999] ECR I‑8395.
(27)
–	Case C‑61/94 Commission
v Germany [1996] ECR I‑3989.
(28)
–	See, for example, Appellate Body report in Korea‑Various Measures on Beef, WT/DS161/AB/R, WT/DS169/AB/R, adopted 10 January 2001.
(29)
–	See Appellate Body report in US‑Shrimp, WT/DS58/AB/R, adopted 6 November 1998.
(30)
–	See paragraph 53 below.
(31)
–	In this regard, the Council draws attention to paragraph 10 of the preamble to the Directive.
(32)
–	The Parliament refers in this regard to Case C‑68/94 France
v Commission
(‘ Kali und Salz ’) [1998] ECR I‑1375.
(33)
–	See Case 17/74 Transocean Marine Paint
[1974] ECR 1063, paragraph 21, Kali und Salz, note 32 above, paragraph 256, Case C‑29/99 Commission
v Council [2002] ECR I‑11221, paragraph 45.
(34)
–	Case C‑239/01 [2003] ECR I‑10333.
(35)
–	Ibid., paragraph 34.
(36)
–	Ibid., paragraph 35.
(37)
–	Article 10 of the regulation at issue.
(38)
–	Case C‑239/01, note 34 above, paragraph 37.
(39)
–	Case C‑376/98 Germany
v Parliament and Council
[2000] ECR I‑8419.
(40)
–	In particular, Joined Cases 56/64 and 58/64 Consten and Grundig
[1966] ECR 299 and Case 17/74 Transocean Marine Paint, note 33 above.
(41)
–	Paragraph 122.
(42)
–	Paragraph 128.
(43)
–	Case C‑29/99 Commission
v Council, note 33 above.
(44)
–	Paragraph 46.
(45)
–	See note 33 above.
(46)
–	Paragraph 75.
(47)
–	This provides that Member States shall prohibit the marketing of cosmetic products tested on animals from 30 June 2002: see paragraph 3 above.
(48)
–	On the various meanings of legal certainty in Community law, see J.‑P. Puissochet and H. Legal, ‘Le principe de sécurité juridique dans la jurisprudence de la Cour de justice des Communautés européennes’, Les Cahiers du Conseil Constitutionnel, No 11/2001, p. 98.
(49)
–	That is, the idea that the plurality of possible legislative interpretations follows from the innate indeterminacy of language itself. See, e.g., Ronald Dworkin, 1986, Law’s Empire, Fontana Press, London.
(50)
–	Council Directive 76/207/EEC of 9 February 1976 on the implementation of the principle of equal treatment for men and women as regards access to employment, vocational training and promotion, and working conditions, OJ 1976 L 39, p. 40; Regulation (EEC) No 1612/68 of the Council of 15 October 1968 on freedom of movement for workers within the Community, OJ 1968 L 257, p. 2; Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC, OJ [2004] L 158, p. 77.
(51)
–	See, for example, Case 325/85 Ireland
v Commission [1987] ECR 5041 and Case T‑115/94 Opel Austria
[1997] ECR II‑39, paragraph 124 and additional cases cited therein.
(52)
–	See, for example, the jurisprudence of the Court in which respect for the principle of legal certainty was held to be a factor militating towards a particular outcome or interpretation, e.g., Case 169/80 Administration des douanes
v Société anonyme Grondrand Frères
[1981] ECR 1931 (legal certainty requires the products in question to be entered under a particular subheading of the Common Customs Tariff); Case 325/85 Ireland
v Commission, note 51 above (legal certainty requires that unilateral proposal made by the Commission in relation to fish quotas to Ireland could not be regarded as Community rules); Case 257/86 Commission v Italy
[1988] ECR 3249 (legally uncertain nature of Italian rules meant that these were being applied in a manner in breach of Community law); Case C‑325/91
France
v Commission
[1993] ECR 3283 (legal certainty requires that each provision of Community law should derive its binding nature from a legal basis).
(53)
–	Case C‑377/98 Netherlands
v Parliament and Council [2001] ECR I‑7079.
(54)
–	Paragraphs 87‑88. The action was ultimately dismissed.
(55)
–	A rare example of one such case is Opel Austria, in which the applicant claimed annulment of a Council Regulation of December 1993 establishing a 4.9% import duty on certain gearboxes it produced, on the ground inter alia that this conflicted with the EEA Agreement, which entered into force on 1 January 1994 and which prohibits customs duties on imports and any charges having equivalent effect. The Court of First Instance held that, by adopting the contested regulation, ‘the Council knowingly created a situation in which, with effect from January 1994, two contradictory rules of law would coexist. Consequently, the contested regulation cannot be regarded as Community legislation which is certain and its operation/application cannot be regarded as foreseeable by those subject to it’. The regulation was duly annulled. Case T‑115/94 Opel Austria, note 51 above, paragraph 125.
(56)
–	See, for example, the Commission’s proposal for the Directive, note 6 above, paragraph 2.4, which provides that, ‘To improve the information provided to the consumer, this proposal also foresees the possibility for the manufacturer or the person responsible for placing the product on the market to claim that no animal tests have been carried out (directly or indirectly). However to avoid an abuse of these claims, the Commission, in collaboration with the Member States, will produce guidelines to define their use. These guidelines will need to include specific provisions which would require that the finished product and the ingredients have never been tested on animals, including for purposes outside the scope of this Directive’.
(57)  –	This article provides that, ‘the date on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of non‑member countries’ should for control purposes be kept readily accessible to the competent authorities of the Member State concerned by the manufacturer or his agent or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market.
(58)  –	See also, the Commission’s proposal for this Directive, note 6 above, paragraph 1.2.3: ‘The current wording of Article 4(1)(i) of Directive 76/768 specifies that the member states must prohibit the marketing of cosmetic products containing ingredients tested on animals after 30 June 2000, whether such products are manufactured in the European Union or imported from third countries’.
(59)
–	Case C‑434/02 Arnold André, judgment of 14 December 2004, not yet reported in the ECR, paragraph 45; Case C‑491/01 BAT [2002] ECR I‑11453, paragraph 122. See also, inter alia, Case 137/85 Maizena
[1987] ECR 4587, paragraph 15; Case C‑339/92 ADM Ölmühlen
[1993] ECR I‑6473, paragraph 15, and Case C‑210/00 Käserei Champignon Hofmeister
[2002] ECR I‑6453, paragraph 59.
(60)
–	Case C‑331/88 Fedesa
[1990] ECR 4023, paragraph 13. See Opinion of Advocate General Ruiz‑Jarabo Colomer of 16 December 2004, Case C‑110/03 Belgium v Commission, paragraph 71; Case C‑15/00 Commission
v EBI
[2003] ECR I‑7281; Case C‑491/01 BAT, note 59 above; Case 137/85 Maizena, note 59 above; Case 122/78 Buitoni, paragraph 1 [1979] ECR 677.
(61)
–	See my Opinion in BAT, note 59 above, paragraph 225.
(62)
–	Case C‑434/02 Arnold André, note 59 above, paragraph 46; Case C‑491/01 BAT, note 59 above, paragraph 123. See, to that effect, Case C‑84/94 United Kingdom
v Council
[1996] ECR I‑5755, paragraph 58; Case C‑233/94 Germany
v Parliament and Council
[1997] ECR I‑2405, paragraphs 55 and 56, and Case C‑157/96 National Farmers’ Union and Others
[1998] ECR I‑2211, paragraph 61; Case C‑331/88 Fedesa, note 60 above, paragraph 14.
(63)
–	See, for example, Case C‑331/88 Fedesa, note 60 above, paragraph 14; Case C‑280/93 Germany
v Council
[1994] ECR I‑4973, paragraph 89.
(64)
–	This can be distinguished from the rationale underlying restricted judicial review of administrative decisions taken by the Commission, i.e., the economic and technical complexity of the analysis leading to the act.
(65)
–	See, for example, Case 294/83 Parti Ecologiste ‘Les Verts’
v Parliament
[1983] ECR 1339; Case C‑70/88 Parliament
v Council ( ‘Chernobyl’)
[1991] ECR I‑4529.
(66)
–	Thus, the Parliament notes that eight ‘tripartite’ meetings were held between COREPER, representatives of the Parliament and the Commission with a view to reaching a compromise: see paragraph 10 above.
(67)
–	See also, the text of the Parliament’s proposal for amendment of the directive at the second reading, note 8 above, paragraph 12: ‘Public opinion demands that animal testing for cosmetic products should be forbidden’.
(68)
–	Letter of 20 February 2004 of the European Parliament to the Court confirming its wish to be heard in the oral procedure.
(69)
–	Preamble to the Directive, paragraph 7.
(70)
–	See paragraph 22 above.
(71)
–	Case C‑189/01 Jippes
[2001] ECR I‑5689.
(72)
–	Paragraph 85.
(73)
–	For example, the Commission’s proposal for the directive, note 6 above, paragraph 2.3, took a different approach: ‘… the European Union will need to accept data from studies conducted on animals, that may be used as supporting data for cosmetic ingredients/products. Such studies would have been conducted to satisfy the legislative demands of third countries in any case. Mutual recognition is the key to this approach – it would be inappropriate for the European Union to demand the repetition of a test using an alternative method, as this would set up a barrier to trade and may impact upon any favourable position taken upon the acceptability of European in vitro data. This approach also obviates the criticism that the new, WTO‑compliant legislative measures on animal testing in the sector of cosmetic products simply “export” the problem. Rather, it is a genuine initiative to gain regulatory acceptance of alternative methods on a global scale’.
(74)
–	Note 7 above, paragraph 10.
(75)
–	See paragraph 12 above.
(76)
–	Article 4a(2.4).
(77)
–	Article 4a(2.3).
(78)
–	Article 4a(2.1).
(79)
–	Preamble, paragraph 11.
(80)
–	Preamble, paragraph 7.
(81)
–	See, for example, the preamble, paragraph 5, which provides that the Commission should establish guidelines in order to facilitate the application, in particular by small and medium sized enterprises, of methods which do not involve the use of animals for assessing the safety of finished cosmetic products. See also, the March 2004 report for establishing the timetable for phasing out animal testing for the purpose of the cosmetics directive, written by an ad hoc group set up by the Commission consisting of representatives from Commission services, stakeholder representatives for industry, animal welfare and consumer associations, and the OECD, available at http://pharmacos.eudra.org/F3/cosmetic/AnimalTest.htm.
(82)
–	Case C‑434/02, paragraph 100, citing from Case C‑192/01 Commission
v Denmark [2003] ECR I‑9693.
(83)
–	Case C‑434/02 Arnold André, note 59 above, paragraph 98.
(84)
–	See paragraphs 71‑87 above.
(85)
–	Case C‑200/96 Metronome Musik, note 24 above, paragraph 21. See also, Joined Cases C‑184/02 and C‑223/02 Spain
and Finland
v Parliament
and Council, judgment of the Court (First Chamber) of 9 September 2004, not yet reported in the ECR, paragraph 52; Joined Cases C‑37/02 and C‑38/02 Di Lenardo Adriano and Dilexport v Ministero del Commercio con l’Estero, Judgment of the Court (Second Chamber) of 15 July 2004, paragraph 82.
(86)
–	As expressed by Advocate General Maduro in his Opinion in Case C‑327/02 Lili Georgieva Panayotova
and Others
v Minister voor Vreemdelingenzaken en Integratie, not yet reported in the ECR, ‘the test of interference with the substance of the right is not simply dependent on an analysis of the impact of the restrictive measure on the right itself. It also depends on the objective pursued by the measure and the appropriateness of the measure to attain it. Although the test does not impose a judgment on the proportionality or even the existence of a less restrictive alternative (necessity) of the measure, it still requires an assessment of the appropriateness or adequacy of means and ends’. Case C‑327/02 Lili Georgieva Panayotova and Others
v Minister voor Vreemdelingenzaken en Integratie, Opinion of Mr Advocate General Poiares Maduro delivered on 19 February 2004, paragraph 43.
(87)
–	See paragraphs 88‑105 above.
(88)
–	See Case C‑149/96 Portugal
v Council, note 26 above, paragraph 47; Joined Cases C‑300/98 and C‑392/98 Dior [2000] ECR I‑11307, paragraph 43.
(89)
–	See Case C‑69/89 Nakajima
v Council [1991] ECR I‑2069, paragraph 31; Portugal
v Council, note 26 above, paragraph 49.
(90)
–	Case C‑61/94 Commission
v Germany, note 27 above, paragraph 52.
(91)
–	Ibid.
(92)
–	Case C‑245/02 Anheuser‑Busch, judgment of 16 November 2004, not yet reported, paragraph 42; see also Case C‑53/96 Hermès International
[1998] ECR I‑3603 and Case C‑300/98 Dior, note 88 above.
(93)
–	Article 4a(1)(a).
(94)
–	See the principles set out in the Appellate Body report Japan‑Alcoholic Beverages II, WT/DS8/AB/R, WT/DS11/AB/R, adopted 1 November 1996, and Appellate Body report EC‑Asbestos, note 22 above.
(95)
–	See further, Appellate Body reports Korea – Various Measures on Beef, note 28 above, paragraph 142, in which it directed panels to look for the ‘fundamental thrust and effect of the measure’; US‑FSC (Article 21.5‑EC), WT/DS108/AB/RW, adopted 29 January 2002, paragraph 215. For an example of an indistinctly applicable measure that was found to contravene Article III.4, see the panel report in Canada‑Provincial Liquor Boards (US), BISD 39S/27, adopted 18 February 1992.
(96)
–	See, for example, Appellate Body report on Korea‑Various Measures on Beef, note 28 above.
(97)
–	In that case, the US obliged Members to adopt the same regulatory programme for turtle protection in order to export shrimps into the US: Report of Appellate Body on United States‑import prohibition of certain shrimp and shrimp products, note 29 above.
(98)
–	See, for example, the wording of Article 4a itself, which includes for each limb of the prohibition the phrase ‘with due regard to the development of validation within the OECD’; Article 1(9) of the Directive, which provides that the annual report of the Commission must include progress made by Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by non‑member countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries; paragraph 10 of the preamble to the Directive, which provides that the recognition by non‑member countries of alternative methods developed in the Community should be encouraged, and that the Commission and the Member States should take all appropriate steps to facilitate acceptance of such methods by the OECD.