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The validation of alternatives to animal testing

European Commission - MEMO/09/200   27/04/2009

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MEMO/09/200

Brussels, 27 April 2009

The validation of alternatives to animal testing

1. What is ECVAM?

The European Centre for Validation of Alternative Methods (ECVAM) is hosted by the Institute for Health and Consumer Protection (IHCP), which is part of the European Commission's Joint Research Centre (JRC). Its mission is the validation of alternative methods which have the potential to replace, reduce and refine animal-based tests needed for the safety assessment of chemicals that are used in many consumer products, including cosmetics.

ECVAM was created following a Communication from the Commission to the Council and the Parliament in October 1991 (SEC 91/1794) referring to a requirement in the Directive on the protection of animals used for experimental and other scientific purposes (86/609/EEC).

Since its implementation in 1992, ECVAM has coordinated many scientific validation studies, often at international level, for example in cooperation with similar bodies in the US and Japan. It has also acted as a focal point for the exchange of information on alternative approaches, for instance by setting-up and maintaining databases on alternative test methods and through the promotion dialogue among stakeholders. In addition, ECVAM supports the scientific and regulatory acceptance of validated alternative methods.

ECVAM is a source of expert advice on:

  • theoretical and practical aspects of the validation of new tests which aim to replace, to reduce and to refine tests on animals used for regulatory purposes
  • the current state of development and validation of alternative methods for use in toxicology and the biosciences in general
  • in vitro tests for human health endpoints such as topical toxicity, developmental/reproductive toxicity, genotoxicity, carcinogenicity, sensitisation, systemic toxicity (acute/subchronic and chronic toxicity) as well as 'endpoints' for ecotoxicity

Moreover, ECVAM provides a publicly available database service on various aspects of alternative methods at each stage of development and/or validation.

2. What are the 'Three Rs'?

Alternative methods to animal testing can be divided to three broad categories known as 'the Three Rs': Replacement, Reduction, and Refinement.

Replacement means replacing animal tests (in vivo) with tests based on cell/tissue cultures (in vitro tests) or tests involving computational approaches (in silico).

Reduction refers to decreasing the number of animals used in the required tests and/or reducing the overall number of tests required.

Refinement can be described as procedures which alleviate or minimize the potential pain, distress and other adverse effects inflicted on the animals that undergo testing.

3. Do alternative testing methods compromise product safety?

Alternative methods do not compromise product safety since they are always selected carefully. Their adequacy is ensured by the independent evaluation of their relevance and reliability for specific purposes. This validation process is coordinated by ECVAM at European level.

4. Are alternative methods going to replace animal testing?

Some important kinds of testing can not be done without animals. In some cases in vivo testing is still needed in the foreseeable future. However, the Commission's intention is to reduce animal testing substantially in Europe. This progress is also taken forward in other parts of the world, and due to the new agreement the availability of methods is given new impetus.

5. What significance has the new agreement signed with US, Japan and Canada?

The agreement establishes enhanced international cooperation and coordination on the scientific validation and evaluation of alternative testing methods. Strengthened collaboration among the signatories will ensure that alternative methods are reproducible, based on sound science and able to accurately identify health hazards. This in turn should facilitate that test methods are more readily considered and accepted by regulatory bodies in the EU, US, Japan, Canada and internationally by the OECD, for example.

6. What is the impact of REACH legislation to the use of alternative methods?

The new EU chemicals legislation (REACH) entered into force on 1 June 2007. REACH envisages tests on more than 30,000 substances, encouraging the use alternative methods whenever possible. While for the time being alternative methods do not permit the full replacement of animal testing in all cases, REACH allows the use of 'partial' information generated through in vitro methods in the assessment of risks associated with chemical substances. Further work on integrated testing strategies, combining in vitro methods with, for example, computer modelling, is expected to pave the way towards replacing animal testing for the more complicated endpoints, such as repeated dose toxicity.

More information available at:http://ecvam.jrc.it/

See also IP/09/643


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