Frequently asked questions
- Which process must a cosmetic product follow to be placed on the EU market?
The Cosmetics Directive is the main regulatory framework for the placing of cosmetic products on the Community market according to which no pre-market authorization is required to put cosmetics on the European market. However, the manufacturer or importer has to ensure the safety of the cosmetic product placed on the Community market. To this end, a "safety-file" which includes inter alia an assessment of the safety of the product for human health has to be kept readily accessible for control purposes to the competent authorities concerned. In addition, each product has to be notified to the competent authority in the Member State where the product is manufactured or first imported (cf. Art. 7a Cosmetics Directive).
Moreover, the Cosmetics Directive contains in particular lists of substances which are either prohibited (Annex II) or subject to other restrictions, for example concentration limits (Annex III). The Cosmetics Directive contains also so-called "positive lists" indicating that only substances listed in Annex IV (colorants), Annex VI (preservatives), and in Annex VII (UV-filters) can be used in cosmetics.
- Which requirements must a cosmetic product meet with regard to animal testing?
Since 11 September 2004 the performance of animal testing of finished cosmetic products has been prohibited within the European Union (testing ban). The testing ban on ingredients or combination of ingredients applies since 11 March 2009.
The marketing ban applies since 11 March 2009 for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity and toxicokinetics. For these specific health effects the marketing ban applies since 11 March 2013, irrespective of the availability of alternative non-animal tests.
The interpretation of the full marketing ban with effect from 11 March 2013 was clarified in the Commission Communication adopted on the same day. The interpretation clarifies that the EU approach aims at prohibiting tests done for the cosmetics purpose after the deadlines. Accordingly:
- Animal data generated before the respective deadlines (2009/2013) can be relied on in the cosmetics safety assessment without triggering the marketing ban;
- Animal data generated for compliance with other, non-cosmetics legal frameworks (EU and non-EU) can be relied on in the cosmetics safety assessment without triggering the marketing ban;
- Animal data generated for substances that are exclusively used in cosmetics cannot be relied on in the cosmetics safety assessment without triggering the marketing ban;
- Data generated for compliance with third country cosmetics legislation cannot be relied on in the cosmetics safety assessment without triggering the marketing ban. It does however not trigger the marketing ban if not relied on.