R (on the application of the European Federation for Cosmetic Ingredients) v Secretary of State for Business, Innovation and Skills and the Attorney General, British Union for the Abolition of Vivisection and the European Coalition to End Animal Experiments (intervening)  EWHC 4222 (Admin) 12 December 2014 – read judgment
Conscientious shoppers who check the labelling of shampoos and other cosmetic products for the “not tested on animals” legend may not be aware that there is in place an EU Regulation (“the Cosmetics Regulation”), enforceable by criminal sanctions, prohibiting the placing on the market of any product that has been tested on laboratory animals. Any comfort drawn from this knowledge however may be displaced by the uncertainty concerning the status of cosmetics whose ingredients have been tested on animals in non-EU or “third” countries. (Incidentally the Cruelty Cutter app is designed to enable consumers to test, at the swipe of a smart phone, whether the product they are contemplating purchasing has been tested on animals.)
This case concerned the question of whether, and if so in what circumstances, that Regulation would prohibit the marketing of products which incorporate ingredients which have undergone testing on animals in third countries. It was a claim for judicial review seeking declarations relating to the marketing of cosmetic ingredients which had been thus tested.
The claimant was a trade association, the European Federation for Cosmetic Ingredients. It represented the manufacturers of chemical and natural ingredients used in the cosmetics industry. In this application, the Federation sought declarations that certain types of conduct did not fall within the prohibition and so would not involve the commission of a criminal offence. In particular, the claimant contended that where ingredients are tested in third countries for the purpose of satisfying the legislative or regulatory requirements of that third country, not that of the EU, and therefore the use of ingredients in cosmetics placed on the market in the European Union would not involve a contravention of the prohibition.
Countries outside the European Union, such as China and Japan, require cosmetic ingredients to undergo tests on animals, to demonstrate the safety of those ingredients. There are three companies, who are members of the claimant association, which have carried out tests on animals in countries outside the European Union and generated animal test data on cosmetic ingredients after the material provisions of the Cosmetics Regulation came into force. The data obtained from these tests was required in order to enable these ingredients to be used in cosmetic products to be sold in Japan or in China. The three companies belonging to the Federation testified that they carried out the tests for the purpose of third country legislation relating to cosmetics and the tests were not performed to meet the requirements of the Cosmetics Regulation. There was uncertainty about whether placing cosmetic products incorporating these ingredients upon the market in the United Kingdom, or the rest of the European Union, would involve a breach of the prohibition imposed by Article 18(1)(b) of the Cosmetics Regulation. To properly appreciate what was at issue in this case, it is necessary to reproduce the section of the Article that was material to the arguments:
1. Without prejudice to the general obligations deriving from Article 3, the following shall be prohibited:
(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 has been validated and adopted at community level with due regard to the development of validation within the OECD.
Two issues confronted the court.
- Was this, as a matter of domestic law, is this case an appropriate case in which to consider granting declaratory relief?
- If so, should this court refer questions on the interpretation of Article 18(1)(b) of the Cosmetics Regulation to the Court of Justice of the European Union for a preliminary ruling pursuant to the Treaty on the Functioning of the European Union (“the TFEU”)?
On the first question, Lewis J observed that in general, the courts have been reluctant to grant declarations, often referred to as advisory declarations, giving general rulings on points of law divorced from the facts of a current live dispute. As Lord Denning once said, judges should not “flap the air in vain”. In this case, Lewis J was satisfied that a genuine issue of law, concerning the proper interpretation of Article 18(1)(b) of the Cosmetics Regulation, did arise and that it was necessary to resolve that issue in order to give judgment.
Arguments before the Court
The claimant contended that the prohibition only applied to cosmetic products incorporating ingredients tested “in order to meet the requirements of this Regulation”, and that therefore the prohibition in Article 18(1)(b) only applied where the testing has been undertaken for the purpose of meeting one or more of the requirements of the Cosmetics Regulation itself, such as the need to obtain data to demonstrate that the product is safe for human health in accordance with Articles 3 and 10 of the Cosmetic Regulation. It submitted that where ingredients were subject to animal testing outside the European Union, in order to meet the legislative or regulatory requirements of a third country, the ingredients had not been the subject of testing “in order to meet the requirements of” the Cosmetics Regulation and placing cosmetics products which include such ingredients on the Community market is not, therefore, prohibited.
The Defendants maintained that the prohibition in Article 18(1)(b) should be interpreted so that it prohibited the placing on the market of cosmetic products including ingredients which had been tested in order to meet the requirements of the Cosmetics Regulation and equivalent third country legislation.
The interveners (pressure groups who were largely responsible for getting the ban passed by the EU in the first place) took the view that the purpose of the prohibition in Article 18(1)(b) was to prohibit the placing on the market of cosmetic products which included any ingredients which had undergone any animal testing. They considered that the marketing of cosmetic products including such ingredients was prohibited whether or not it was 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. They relied on what they saw to be the purpose of the prohibition, and on Article 18(1) of the Cosmetics Regulation read as a whole, and on observations in the opinion of Advocate General Geelhoed, at paragraphs 84 and 86 in particular, in Case C-244/03 France v Council and Parliament  ECR I-4012, where he said:
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. 
… 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. 
The Court’s ruling
This was, in the judge’s opinion, a real issue of law; otherwise it would be necessary to wait for a manufacturer to place on the market products containing ingredients tested on animals in third countries, thus risking prosecution under the UK Regulations implementing the Cosmetics Regulation. A declaration should therefore be made, following an interpretation by the European Court of Justice. This was, in other words, an appropriate case for a reference to the Court of Justice for a preliminary ruling as a matter of discretion pursuant to Article 267(2) of the TFEU:
the Court of Justice is able to consider submissions from the European Union institutions, and the Member States. Given the legislative history, there is a real possibility that different views may well emerge as to the purpose and scope of the Cosmetics Regulation.
This claim involved a real issue, arising out of particular facts, as to the proper interpretation of Article 18(1)(b) of the Cosmetics Regulation and the prohibition on the placing on the Community market of cosmetic products containing ingredients which had been tested on animals outside the European Union to meet the legislative or regulatory requirements of third countries. A ruling on the questions of interpretation that arose was necessary to enable this court to give judgment in relation to the claim for a declaration.
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