European Federation for Cosmetic Ingredients v Secretary of State for Business, Innovation and Skills and Attorney General.

• Jurisdiction: European Union
• Celex Number: 62014CJ0592
• ECLI: ECLI:EU:C:2016:703
• Docket Number: C-592/14
• Court: Court of Justice (European Union)
• Procedure Type: Reference for a preliminary ruling
• Date: 21 September 2016

JUDGMENT OF THE COURT (First Chamber)

21 September 2016 ( *1 )

‛Reference for a preliminary ruling — Approximation of laws — Cosmetic products — Regulation (EC) No 1223/2009 — Article 18(1)(b) — Cosmetic products containing ingredients, or a combination of ingredients, which have been the subject of animal testing ‘in order to meet the requirements of this Regulation’ — Prohibition of marketing within the European Union — Scope’

In Case C‑592/14,

REQUEST for a preliminary ruling under Article 267 TFEU from the High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) (United Kingdom), made by decision of 15 December 2014, received at the Court on 19 December 2014, in the proceedings

European Federation for Cosmetic Ingredients

v

Secretary of State for Business, Innovation and Skills,

Attorney General

intervening parties:

Cruelty Free International, formerly British Union for the Abolition of Vivisection,

European Coalition to End Animal Experiments,

THE COURT (First Chamber),

composed of R. Silva de Lapuerta, President of the Chamber, A. Arabadjiev, J.-C. Bonichot, C.G. Fernlund (Rapporteur) and E. Regan, Judges,

Advocate General: M. Bobek,

Registrar: L. Hewlett, Principal Administrator,

having regard to the written procedure and further to the hearing on 9 December 2015,

after considering the observations submitted on behalf of:

— European Federation for Cosmetic Ingredients, by D. Abrahams, Barrister, and by R. Cana, and I. de Seze, avocats,

— Cruelty Free International, and European Coalition to End Animal Experiments, by D. Thomas, Solicitor and A. Bates, Barrister,

— the United Kingdom Government, by L. Barfoot, acting as Agent, and by G. Facenna QC, and J. Holmes, Barrister,

— the Greek Government, by S. Charitaki and A. Magrippi, acting as Agents,

— the French Government, by D. Colas and J. Traband, acting as Agents,

— the European Commission, by L. Flynn and P. Mihaylova, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 17 March 2016,

gives the following

Judgment

1 This request for a preliminary ruling concerns the interpretation of Article 18(1)(b) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ 2009, L 342, p. 59).

2 The request has been made in proceedings between the European Federation for Cosmetic Ingredients (‘EFfCI’), on the one hand, and the Secretary of State for Business, Innovation and Skills (‘Secretary of State for Business’) and the Attorney General, on the other, with Cruelty Free International, formerly the British Union for the Abolition of Vivisection and the European Coalition to End Animal Experiments intervening, concerning the scope of the prohibition of marketing laid down in that provision.

Legal context

EU law

3 Recitals 4, 38 to 42, and 45 and 50 of Regulation No 1223/2009 state: ‘(4) This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health. ... (38) The Protocol on protection and welfare of animals annexed to the Treaty provides that the Community and the Member States are to pay full regard to the welfare requirements of animals in the implementation of Community policies, in particular with regard to the internal market. (39) 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] established common rules for the use of animals for experimental purposes within the Community and laid 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, where such methods exist and are scientifically satisfactory. (40) The safety of cosmetic products and their ingredients may be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, where such methods offer an equivalent level of protection to consumers. (41) The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain. Provisions prohibiting animal testing of finished cosmetic products should therefore be laid down. … (42) It will gradually become possible to ensure the safety of ingredients used in cosmetic products by using non-animal alternative methods validated at Community level, or approved as being scientifically validated, by the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the Organisation for Economic Cooperation and Development (OECD). After consulting the [Scientific Committee for Consumer Safety (SCCS)] as regards the applicability of the validated alternative methods to the field of cosmetic products, the Commission should immediately publish the validated or approved methods recognised as being applicable to such ingredients. In order to achieve the highest possible degree of animal protection, a deadline should be set for the introduction of a definitive prohibition. ... (45) The recognition by third countries of alternative methods developed in the Community should be encouraged. In order to achieve this objective, the Commission and the Member States should take all appropriate steps to facilitate acceptance of such methods by the OECD. The Commission should also endeavour, within the framework of European Community cooperation agreements, to obtain recognition of the results of safety tests carried out in the Community using alternative methods so as to ensure that the export of cosmetic products for which such methods have been used is not hindered and to prevent or avoid third countries requiring the repetition of such tests using animals. ... (50) In the safety assessment of a cosmetic product it should be possible to take into account results of risk assessments that have been carried out in other relevant areas. The use of such data should be duly substantiated and justified.’

4 Under Article 1 of Regulation No 1223/2009, headed ‘Scope and objective’, that ‘Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.’

5 Article 3 of that regulation, headed ‘Safety’, provides: ‘A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, …’

6 Article 10 of that regulation, headed ‘Safety assessment’, lays down: ‘1. In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I. The responsible person shall ensure that: (a) the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment; (b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources; (c) the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market. ...’

7 Article 11 of Regulation No 1223/2009, headed ‘Product information file’, provides that ‘[w]hen a cosmetic product is placed on the market, the responsible person shall keep a product information file for it’ and that that file is to contain inter alia ‘the cosmetic product safety report referred to in Article 10(1)’ and ‘data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries’.

8 Article 18 of that regulation, headed ‘Animal testing’, reads as follows: ‘1. Without prejudice to the general obligations deriving from Article 3, the following shall be prohibited: (a) the placing on the market of cosmetic products where the final formulation, in order to meet the requirements of this Regulation, 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 placing on the market of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Regulation, have been the subject of animal testing using a method other than an alternative method after such alternative method...