Cosmetics
Ban on animal testing
The provisions to ban animal testing for cosmetics purposes are contained in the cosmetics regulation, which replaced the cosmetics directive as of 11 July 2013. The Regulation articles and Annexes on animal testing ban are: 11, 18, 20, 25 and 35. Annex IV and VIII.
it establishes:
What is banned
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.
Note: In general, animals are protected by EU against scientific purposes by Directive 2010/63/EU.
it establishes:
- a testing ban – prohibition to test finished cosmetic products and cosmetic ingredients on animals
- a marketing ban – prohibition to market finished cosmetic products and ingredients in the EU which were tested on animals
What is banned
- 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.
Note: In general, animals are protected by EU against scientific purposes by Directive 2010/63/EU.
European Centre for the Validation of Alternative Methods
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.
- EURL ECVAM progress report on the development, validation and regulatory acceptance of alternative methods prepared in the framework of the cosmetics regulation
- ECVAM activities: EURL ECVAM survey on in vitro methods for estimating human hepatic metabolic clearance/stability
- TSAR: tracking system for alternative test methods review, validation and approval in the context of EU regulations on chemicals
Research on alternative methods to animal testing
See an overview of research activities supported by the Commission in the AXLR8 progress reports:
See an overview of research activities supported by the Commission in the AXLR8 progress reports:
European partnership to alternative approaches to animal testing
The European partnership for alternative approaches to animal testing (EPAA) is a joint initiative between the Commission, European trade associations from 7 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.
International cooperation
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).
An important outcome is the cooperation of international validation bodies in the framework for international cooperation on alternative test methods (ICATM).
