French Republic v European Parliament and Council of the European Union.

• Jurisdiction: European Union
• Court: Court of Justice (European Union)
• Writing for the Court: Schiemann
• ECLI: ECLI:EU:C:2005:178
• Docket Number: C-244/03
• Date: 17 March 2005
• Procedure Type: Recours en annulation - irrecevable

OPINION OF ADVOCATE GENERAL

GEELHOED

delivered on 17 March 2005 (1)

Case C-244/03

French Republic

v

European Parliament

and

Council of the European Union

(Direct actions – Annulment of Article 1(2) of Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 (OJ 2003 L 66, p. 26) in so far as it introduces a new Article 4a into Council Directive 76/768/EEC (OJ 1976 L 53, p. 30) on the approximation of the laws of the Member States relating to cosmetic products)

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...