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STATEMENT

8 July 2004

OECD ACCEPTANCE OF IN VITRO TEST METHODS Brussels, 8 July 2004 - COLIPA, the European Cosmetic, Toiletry and Perfumery Association1 welcomes the endorsement of four new alternative test methods by the OECD (Organisation for Economic Co-operation and Development). The accepted methods allow evaluating the toxicity of chemicals in regard to skin corrosion, phototoxicity and dermal absorption. Their official publication as OECD Guidelines makes them part of the most widely internationally accepted standards for safety testing. COLIPA, via its Steering Committee on Alternatives to Animal Testing (SCAAT), and its Members have made significant contributions during the development, promotion, validation and acceptance of these methods. Two of the accepted methods are concerning skin corrosion (a chemicals ability to cause severe and irreversible skin damage) and there are now three new validated in vitro tests based on the two methods. Prevalidation and validation of these alternative tests for replacing the in vivo test for skin corrosion was conducted between 1996 and 2000 under the auspices of ECVAM (the European Centre for the Validation of Alternative Methods) with the participation of several laboratories from COLIPA companies. The third method identifies the phototoxic potential (damage caused to cells when exposed to certain chemicals and light). This non-animal test has been deve loped by the Cosmetic Industry. The test has been validated in a fruitful joint EU-COLIPA project in cooperation with Competent Authorities. The in vitro method for assessing dermal absorption and penetration of chemicals through the skin was promoted by COLIPA since 1994 and COLIPA assisted in the submission of the first draft OECD guideline. Following successful collaboration with ECVAM, ZEBET(Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergnzungsmethoden zu Tierversuchen) , ECPA (European Crop Protection Association), FDA (US Food and Drug Administration, Health Canada, NIEHS (National Insititute of Environmental Health Sciences, USA) and submission of cosmetic industry data to the OECD, the method was formally adopted in the EU and is now also accepted at OECD level. Ingredients must be adequately tested to identify potential hazards to human and animal health, and to the environment. The European Cosmetic Industry is firmly committed to develop and use alternative testing methods. It finances substantial research projects to support the development of new alternatives for safety testing of chemicals . OECD approval is the final milestone for world-wide usage of an alternative method, which has now been achieved in the case of the above mentioned areas.2 ***END***

Editors Notes

1. Colipa is the European Trade Association representing the interests of the cosmetic, toiletry and perfumery industry. Its full membership consists of 22 national associations of the EU Member States and beyond, 25 major international companies and 10 associated members. All in all, Colipa represents more than 2000 companies in the 25 EU Member States. For more information about Colipa please consult our website: www.colipa.com 2. Media contacts should speak with Sebastian Marx, Communications Manager, Colipa (smarx@colipa.be)

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