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In recent years, progress has been made with regard to alternative methods to animal testing, which are capable of assessing the safety of cosmetic products. However, according to a memorandum published on 22 January by the Standing Committee on Cosmetics1, a full human health safety assessment of finished cosmetic products is far from being assured.

The Cosmetics Directive2 places a ban on testing finished cosmetic products on animals from March 2004 and on testing ingredients or combinations of ingredients included in cosmetic products from March 2009.


Exceptions are tests for repeated dose toxicity, reproductive toxicity and toxicokinetics, which are authorised, until March 2013. Furthermore, these prohibitions apply irrespective of the availability of alternative non-animal tests.

Stressing that test development, prevalidation, validation, regulatory acceptance and the use of alternative methods is quite extensive, the committee believes that these delays inexorably affect the assessment of certain risks. In fact, a full assessment of the toxicological risks guaranteeing the same level of safety as that assured by animal testing has not been achieved.

For the time being, only five toxicological risks may be detected by alternative methods based on the 3R principle' (replace, reduce and refine). These are risks of skin corrosion and irritation, mutagenicity/genotoxicity, phototoxicity and dermal absorption. For each of these, the committee specifies the limitations and efforts currently under development. The committee also underlines that no validated in vitro alternatives are available for detecting absorption of a substance through the inhalation and oral route, two recurrent phenomena.

The committee points out that a large number of risks cannot be detected via alternative methods. This is the case for risks of eye irritation, for which just one assessment method for serious risks has been validated. With regard to risks of acute toxicity, while alternatives are combined refinement and reduction methods, they are not replacement methods for animal testing, notes the committee.Finally, no alternative is available to assess reproductive toxicity, toxicokinetics and the systemic toxicity in repeated doses. On this latter risk, the Commission launched a call for research project, on 31 July 2009 (deadline: 3 February3)

(1) The document is available at Directive 76/768/EEC amended several times and replaced, in November 2009, by Regulation 1223/2009(3)The call is available at and Europolitics 3807


The 3R principle' (replace, reduce and refine) underpins several legislative EU texts on the subject, in particular the Directive on the protection of animals used for scientific purposes, the REACH Regulation (on chemical substances and their use) and the Cosmetics Directive. Over 20 years, states the Commission, the EU's contribution to research on substitution measures, financed under the Framework Programme for Research and Technological Development, has totalled approximately 200 million euro. The Joint Research Centre (JRC) also accommodates the European Centre for the Validation of Alternative Methods (ECVAM).
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Publication:Europe Environment
Date:Feb 19, 2010

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