The Cosmetics Directive provides the regulatory framework for the phasing out of animal testing for cosmetics purposes.
Specifically, it establishes:
The same provisions are contained in the Cosmetics Regulation, which replaced the Cosmetics Directive as of 11 July 2013.
The testing ban on finished cosmetic products applies since 11 September 2004; 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.
According to Article 4a (2.3) of the Cosmetics Directive, the European Commission was required to analyse whether one or more of the complex tests covered by the 2013 marketing ban will not be developed and validated before 11 March 2013 for technical reasons. In the case that alternative methods would not be made available, the Commission had to assess whether to make a legislative proposal in relation to the 2013 marketing ban.
First, the Commission assessed the availability of alternative methods to animal testing by 2013. A Technical Report was prepared, based on wide scientific expertise, subject to a public consultation, and coordinated by the Commission’s Joint Research Centre. On the basis of this Technical Report, the Commission reported to the European Parliament and the Council of the European Union in September 2011 that alternative methods will not yet be available by 2013.
Second, the Commission carried out an impact assessment to assess whether to make a legislative proposal given that the full replacement of animal tests by alternatives is not yet possible. A targeted stakeholder consultation was carried out between 7 December 2010 and 15 April 2011.
On 11 March 2013, the Commission finalised the review process by adopting a Communication on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics. This Communication confirms the Commission’s commitment to maintaining the 2013 deadline and outlines how it intends to further support research and innovation in the area while promoting animal welfare worldwide. In addition, the EURL-CVAM Technical Report 2013 provides a more detailed overview of progress made in the development, validation, and regulatory acceptance of alternatives.
The Commission Communication was accompanied by an Impact Assessment, which consists of:
The European Centre for the Validation of Alternative Methods (ECVAM) plays a key role in the development, validation, and international recognition of alternative methods which reduce, refine, or replace the use of animals in testing. It is hosted by the Joint Research Centre's Institute for Health and Consumer Protection (IHCP) located in Ispra, Italy. Since 2011, ECVAM has become the European Union reference laboratory for alternatives to animal testing (EURL ECVAM), established under Directive 2010/63/EC on the protection of animals used for scientific purposes.
ECVAM hosts two important databases in relation to alternative methods:
An overview of research activities supported by the Commission can be found in the AXLR8 Progress Reports:
The SEURAT project is a joined research project between the Commission and the cosmetics industry.
The European Partnership for Alternative Approaches to Animal Testing (EPAA) is a joint initiative between the Commission, European trade associations from seven industry sectors, and individual companies. It was launched in November 2005 to promote the development and implementation of new 3Rs methods (replace, reduce, refine) and modern alternative approaches in safety testing.
Alternative methods to animal testing are one of the focuses of the “International Cooperation on Cosmetics Regulation” (ICCR).
An important outcome is the cooperation of international validation bodies in the Framework for International Cooperation on Alternative Test Methods (ICATM) (27 kB).