- Regulatory framework
- Scientific and technical assessment
- Cosmetic ingredients database - CosIng
- Cosmetic Products Notification Portal (CPNP)
- cmr substances
- Ban on animal testing
- Market Surveillance
Ban on animal testing
The Cosmetics Directive provides the regulatory framework for the phasing out of animal testing for cosmetics purposes. It establishes a prohibition to test finished cosmetic products and cosmetic ingredients on animals (testing ban), and a prohibition to market in the European Union finished cosmetic products and ingredients included in cosmetic products which were tested on animals for cosmetics purposes (marketing ban). The same provisions are contained in the Cosmetics Regulation, which replaces 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.
Timetable for phasing out of animal testing
Documents related to animal testing:
The Commission was required, according to Article 4a (2.3) of the Cosmetics Directive, to analyze whether for technical reasons one or more of the complex tests covered by the 2013 marketing ban will not be developed and validated before 11 March 2013. In case alternative methods would not be 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. Based on this Technical Report the Commission reported to the European Parliament and the Council in September 2011 that alternative methods for the respective endpoints 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. See the consultation document and the answers received.
Commission Communication - 11 March 2013
On 11 March 2013 the Commission finalized the review process by adopting a Commission Communication to the European Parliament and the Council, which confirms the Commission's commitment to maintain the 2013 deadline and outlines how it intends to further support research and innovation in this area while promoting animal welfare world-wide. The EURL-ECVAM 2013 Technical Report provides in addition a more detailed overview of progress made in the development, validation and regulatory acceptance of alternatives.
- Commission Communication on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics. English text, French text, German text
- ECVAM Technical Report 2013
The Commission Communication was accompanied by an Impact Assessment, which consists of:
- Executive Summary of the Impact Assessment on the Animal Testing Provisions in Regulation (EC) 1223/2009 on Cosmetics. English text, French text, German text
- Impact Assessment on the Animal Testing Provisions in Regulation (EC) 1223/2009 on Cosmetics
European Centre for the Validation of Alternative Methods (ECVAM)
ECVAM plays a key role in the development, validation and international recognition of alternative methods. It is hosted by the Joint Research Centre, Institute for Health and Consumer Protection (IHCP) located in Ispra, Italy. Since 2011 ECVAM has become the European Union reference laboratory for alterniativas to animal testing (EURL ECVAM), established under Directive 2010/63/EC on the protection of animals used for scientific purposes.
- EURL ECVAM progress report on the development, validation and regulatory acceptance of alternative methods prepared in the framework of the Cosmetics Regulation
ECVAM hosts tow important databanks in relation to alternative methods:
- TSAR: traking System for Alternative test methods review, validation and approval in the context of EU Regulations on Chemicals
- DB-ALM: DataBase on Alternative Methods
Research on Alternative Methods to Animal Testing
The Commission actively supports research in this field. An overview of research activities can be found in the AXLR8 Progress Reports:2009 - Alternative Testing Strategies Progress Report 2009
- 2010 - Alternative Testing Strategies Progress Report 2010
- 2011 - Alternative Testing Strategies Progress Report 2011
- 2012 - Alternative Testing Strategies Progress Report 2012
The SEURAT project is a joined research project between the Comission and the Cosmetics Industry.
European Partnership to Alternative Approaches to Animal Testing
The European Partnership for Alternative Approaches to Animal Testing (EPAA) is a joint initiative from the European Commission, European trade associations from seven industry sectors and individual companies. It was launched in November 2005 with the purpose to promote the development and implementation of new 3Rs methods (replace, reduce, refine) and modern alternative approaches in the field of safety testing.
The EPAA website also contains information on the annual conferences.
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)
For an overview on the different activities to elaborate alternative testing methods: