Alternatives to animal testing
EDANA welcomes the use of alternative test methods to animal testing and the members support what is known as the “Three R’s” principle (Replacement, Reduction and Refinement of animal experiments) in research. We are committed to continuing the development, validation and adoption of new test methods which will remove the need for animal tests.
Our members support research for fully validated alternative methods as long as specific legal or regulatory requirements are met. They will continue to work with scientists and regulators to ensure acceptance and implementation of scientifically valid alternative methods.
What is the status?
EDANA members are active in the work on alternative methods to animal testing
- Many EDANA members are part of the EPAA; a partnership between the European Commission, trade associations, and companies in various industries on alternative methods
- Members use alternative methods which include in vitro tests such as cytotoxicity tests or on tests on human volunteers (skin testing, including human patch tests)
OECD, the Organisation for Economic Co-operation and Development, is the primary source of validated test methods on alternative approaches to animal testing
ISO, the International Standardisation Organisation, has addressed animal welfare related to standards on medical devices.
EDANA member companies do not perform animal testing unless there is a specific legal or regulatory requirement to do so. Countries and regions with such requirements include:
- In the EU, several requirements require this under specific regulations
- In Brazil, there are some requirements for certain types of product registration
- In the USA, certain requirements must be followed for medical devices (See for example US Pharmacopeia)
Future outlook
EDANA member companies will continue to put safe products on the market and support research and development to bring innovative products to consumers.
This includes a commitment to the” Three Rs” Principle as demonstrated by members’ involvement in the OECD work.
The EU has promoted alternatives to animal testing, such as the ban on animal testing in the Cosmetic Products Regulation and has been a source of inspiration for countries outside the EU. EDANA welcomes these developments.
More information on alternative animal testing
EU regulation and guidance
European Commission’s “Recommendation 2006/406/EC Establishing Guidelines on the use of claims referring to the absence of tests on animals pursuant to Council Directive 76/768/EEC”
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes
“Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products”, see article 18
ECHA: Guidance on the interface between REACH and the Cosmetic Products Regulation
European Union Reference Laboratory for alternatives to animal testing (ECVAM)
Global regulation and guidance
Information from the National Toxicology Program in the US Department of Health and Human Services
OECD Guidelines, Section 4 on animal tests
Information from the US Food and Drug Administration on medical devices
US Pharmacopeia on Class VI testing for medical devices: “Biological Reactivity Tests, In Vivo”
China’s rules for cosmetic products
India’s ban on animal testing for cosmetic products
India’s Animal Welfare Board
UK’s road-map to non-animal technologies
Other associations and networks
- European Partnership for Alternative Approaches to Animal Testing