Communication on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics

Author (Corporate)
Series Title
Series Details (2013) 135 final (11.3.13)
Publication Date 11/03/2013
Content Type ,

The Cosmetics Directive foresees a phasing-out of animal testing for cosmetic products. Animal testing of finished cosmetic products in the Union has been prohibited since 2004 and of cosmetic ingredients since March 2009 ("testing ban"). As from 11 March 2009, it is also prohibited to market in the Union cosmetic products and their ingredients which have been tested on animals in order to meet the requirements of the Directive ("2009 marketing ban"). This marketing ban applies to all but the most complex human health effects ("endpoints") to be tested to demonstrate the safety of cosmetic products (repeated-dose systemic toxicity, skin sensitisation, carcinogenicity, reproductive toxicity and toxicokinetics), for which the European Parliament and the Council extended the deadline to 11 March 2013 ("2013 marketing ban").

The Cosmetics Regulation, which repeals and replaces the Cosmetics Directive as of 11 July 2013, contains the same provisions. Data from animal testing that has been carried out before the respective implementation dates of the marketing ban (11 March 2009/11 March 2013) can continue to be relied on in the safety assessment of cosmetic products.

The testing and marketing bans in the Cosmetics Directive/Regulation apply even in case alternative methods to animal testing are not yet available. This reflects a sector-specific political choice by the European Parliament and the Council. Other Union legislation recognises that animal testing is still needed in the absence of alternative methods to ensure the protection of human health and the environment, but sets very high animal welfare standards for such testing and requires that whenever possible testing is replaced, reduced and refined.

This Communication has a twofold purpose:

– It informs the European Parliament and the Council of the Commission's decision not to propose any changes in the animal testing related provisions in Directive 76/768/EEC (Cosmetics Directive) and in Regulation 1223/2009/EC (Cosmetics Regulation), the reasons why and the way forward.

– It presents the yearly report in accordance with Article 9 of the Cosmetics Directive and as such the tenth Commission report on the development, validation and legal acceptance of alternative methods to animal tests in the field of cosmetics.

Source Link
Related Links
EUR-Lex: COM(2013)135: Follow the progress of this communication through the decision-making procedure
EUR-Lex: SWD(2013)66: Impact assessment on the animal testing provisions in Regulation (EC) 1223/2009 on cosmetics
EUR-Lex: SWD(2013)67: Executive summary of the impact assessment
ESO: Background information: Full EU ban on animal testing for cosmetics enters into force

Subject Categories
Subject Tags
Cosmetics Directive / Regulation - Cosmetic products
Countries / Regions