Case C-592/14, European Federation for Cosmetic Ingredients – ingredients tested on animals [judgment 2016, ECLI:EU:C:2016:703]

In countries like China and Japan, the ingredients that go into cosmetics must be tested on animals. However, EU law bans cosmetics whose ingredients have been tested on animals. The question is: can a company still put onto the EU market those cosmetics which contain ingredients that have been tested on animals because the reason why they were tested was to comply with the laws of third countries?

Background
The claimant trade association, the European Federation for Cosmetic Ingredients, includes among its members three companies that supply ingredients which are used in cosmetics.

However, those three companies have had their ingredients tested on animals. They were obliged to do this because their ingredients go into cosmetics which are sold in countries like China and Japan.

The trade association is seeking a legal declaration from a court in England that it is legal to put cosmetic ingredients which have been tested on animals, onto the market in the EU.

The success of their application turns on the correct interpretation being given to Article 18(1)(b) of the EU’s Cosmetics Regulation 1223/2009. The provision expressly prohibits:

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 has been validated and adopted at community level with due regard to the development of validation within the OECD;

The claimants interpret this provision to mean that it applies only to cosmetic products that incorporate ingredients tested “in order to meet the requirements of this Regulation”. They say that is not the case here: the testing was done in order to meet the requirements of third countries, not the Regulation. Accordingly, it is not prohibited to place on the Community market cosmetic products which include tested ingredients. They also support their submissions by referring to the legislative history of the EU provision.

The force of that legal argument is however denied by both the Secretary of State for Business, Innovation and Skills and the Attorney General. They interpret the EU provision in light of the purpose of the Cosmetics Regulation as expressed by the EU Commission in a Communication dated 11 March 2013:

The Commission considers that the marketing ban is triggered by the reliance on the animal data for the safety assessment under the Cosmetics Directive/Regulation, not by the testing as such. In case animal testing was carried out for compliance with cosmetic requirements in third countries, this data can not be relied on in the Union for the safety assessment of cosmetics.

Before Mr Justice Lewis decided to make a reference to the CJEU, interventions were also heard from both the British Union for the Abolition of Vivisection, and the European Coalition to end Animal Experiment.

They submitted that the marketing of cosmetic products that include tested ingredients is prohibited irrespective of whether it is necessary to use the data obtained from testing in third countries to demonstrate that the product is ‘safe for human health’ under Articles 3 and 10 of the Cosmetics Regulation.

In that context, they rely on comments made by Advocate General Geelhoed in Case C-244/03 France v Council and Parliament [2005] ECR I-4012, ECLI:EU:C:2005:178:

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.[footnote 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. [footnote 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. [footnote 58]

Aware that the Regulation was intended to harmonise the rules within the EU to achieve an internal market for cosmetic products, and conscious of the possibility that the EU institutions and the Member States might hold different views as to the purpose and scope of the Cosmetics Regulation, Mr Justice Lewis decided to make a preliminary reference to the CJEU.

Questions Referred
According to the Bailii website, the Queen’s Bench Division of the High Court of England and Wales has asked:

1. Is 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 to be interpreted as prohibiting the placing on the Community market of cosmetic products containing ingredients, or a combination of ingredients, which have been the subject of animal testing where that testing was performed outside the European Union to meet the legislative or regulatory requirements of third countries in order to market cosmetic products containing those ingredients in those countries?

2. Does the answer to question (1) depend on: –
(a) whether the safety assessment carried out in accordance with Article 10 of that Regulation to demonstrate that the cosmetic product is safe for human health prior to it being made available on the Community market would involve the use of data resulting from the animal testing performed outside the European Union;

(b) whether the legislative or regulatory requirements of the third countries for which the animal testing was undertaken relate to the safety of cosmetic products;

(c) whether it was reasonably foreseeable, at the time that an ingredient was subjected to animals testing outside the European Union, that any person might seek to place a cosmetic product including that ingredient at some stage on the Community market; and/or

(d) any other factor, and if so, what factor?