Article 49 - Principles of legality and proportionality of criminal offences and penalties
Key facts of the case:
Request for a preliminary ruling — Internal market — Regulation No 1223/2009 — Article 18(1)(b) — Cosmetic products — Cosmetic ingredients — Ban on the marketing of cosmetic ingredients having been tested on animals
Results (sanctions) and key consequences of the case:
Question 1: Article 18(1)(b) of Regulation (EC) No 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products should not be interpreted as prohibiting the placing on the EU market of cosmetic products containing ingredients, or a combination of ingredients, by the mere fact that such ingredients 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. The same provision, however, prevents reliance on the results of animal testing for the purpose of meeting the requirements of the Cosmetics Regulation, subject to the relevant cut off-dates.
Question 2(a): The marketing ban contained in Article 18(1)(b) of the Cosmetics Regulation may be triggered if the safety assessment carried out under Article 10 of the Cosmetics Regulation to demonstrate that the cosmetic product is safe for human health prior to it being made available on the EU market involves the reliance on data resulting from the animal testing performed outside the European Union. This depends on the other conditions for the marketing ban being met, in particular that the testing is carried out after the relevant cut-off date. The reliance on data in the safety assessment must, moreover be distinguished from mere inclusion in the product information file.
Question 2(b): It is irrelevant whether or not the legislative or regulatory requirements of the third countries relate to the safety of cosmetic products.
Question 2(c): It is irrelevant whether or not it was reasonably foreseeable, at the time that the animal testing was performed outside the Union, that any person might seek to place a cosmetic product including that ingredient at some stage on the EU market.
Question 2(d): The date on which the animal testing was conducted is relevant in light of the entry into force of the marketing ban. Only the reliance on the results of animal testing conducted after the relevant cut-off dates will trigger the ban.