EU law protects the EU market from cosmetic products containing ingredients which have been tested on animals
Placing that product on the EU market may be prohibited where that testing has been conducted outside the EU in order to market the product in third countries and where the results of that testing are used to prove the safety of the product
Click here to the full text of the judgement
The European Federation for Cosmetic Ingredients (
‘EFfCI’) is a trade association representing the manufacturers within the EU of ingredients for use in cosmetic products. Three of its members conducted animal testing outside the EU in order that the cosmetic products containing certain ingredients could be sold in China and Japan.
The EFfCI brought an action before the British courts to establish whether the three companies concerned would incur criminal penalties if they were to place on the British market cosmetic products containing ingredients that have been tested on animals.
The Regulation on cosmetic products
1 prohibits the marketing of products containing ingredients which have been tested on animals in order to meet the requirements of that regulation. One of those requirements is that the cosmetic product is safe for human health, that safety having to be assessed on the basis of the relevant information and be the subject of a report included in the product information file.
The EFfCI claims that the regulation is not infringed if the animal testing has been conducted in order to comply with the laws of third countries. Hearing that dispute, the High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court), UK, questions the Court of Justice on that subject.
In today’s judgment, the Court examines whether the words
‘in order to meet the requirements of … the Regulation’ may cover such animal testing as that conducted in the present case.
Taking into account the context and objects pursued by the regulation, the Court considers that the objective of the regulation is to establish the conditions for access to the EU market for cosmetic products and to ensure a high level of protection of human health, whilst also ensuring the wellbeing of animals by prohibiting animal testing. Access to the EU market is conditional upon compliance with the prohibition of animal testing.
In that regard, the Court states that only the results of animal testing relied on in the cosmetic product safety report may be considered to concern testing conducted in order to meet the requirements of the regulation. It is irrelevant in that regard that the animal testing was required in order to market the product in third countries.
The Court states next that EU law makes no distinction depending on where the animal testing was carried out. The regulation seeks to promote the use of non-animal alternative methods to ensure the safety of cosmetic products. The attainment of that objective would be seriously compromised if the prohibitions laid down in EU law could be circumvented by carrying out the animal testing in third countries.
The Court concludes that the placing on the EU market of cosmetic products containing some ingredients that have been tested on animals outside the EU in order to market those products in third countries may be prohibited2 if the data resulting from that testing is used to prove the safety of the products concerned for the purposes of placing them on the EU market.
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NOTE: A reference for a preliminary ruling allows the courts and tribunals of the Member States, in disputes which have been brought before them, to refer questions to the Court of Justice about the interpretation of European Union law or the validity of a European Union act. The Court of Justice does not decide the dispute itself. It is for the national court or tribunal to dispose of the case in accordance with the Court’s decision, which is similarly binding on other national courts or tribunals before which a similar issue is raised.
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1Regulation (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).
2The Court states that the placing on the market is solely prohibited if the animal testing has been carried out after the deadlines for the phasing out of the various tests. 