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(Not only) Nanomaterials pose a Challenge for alternative Safety Testing of Cosmetic Ingredients

The European Commission’s Scientific Committee on Consumer Safety (SCCS) has published a Memorandum on Alternative Test Methods in Human Health Safety Assessment of Cosmetic Ingredients in the European Union. The memorandum aims at summarising the actual status of officially validated 3R-alternatives for human health safety assessment.

The current EU cosmetics legislation (Council Directive 76/768/EEC2) establishes a prohibition to test finished cosmetic products and cosmetic ingredients on animals (testing ban), and a prohibition to market in the European Community, finished cosmetic products and ingredients included in cosmetic products which were tested on animals (marketing ban) (EU 1976). The testing ban on finished cosmetic products applies since 11 September 2004, whereas the testing ban on ingredients or combination of ingredients applies as of 11 March 2009, irrespective of the availability of alternative non-animal tests. The marketing ban also applies since 11 March 2009 for cosmetic products containing ingredients tested on animals.

Current Status of validated 3R Methods for Human Health Safety Assessment:
Validated alternatives are those methods that are in compliance with the validation process, as set up by ECVAM and its independent Advisory Committee ESAC11...OECD-accepted alternative methods are also considered to be validated.

Experience has shown that, once an alternative method has passed the validation procedure, the SCCS still may have some doubts on its applicability for the safety assessment of cosmetic ingredients.

Further considerations:
Nanomaterials as cosmetic ingredients (eg. UV-filters nano- ZnO and TiO2) pose a special challenge for safety testing (e.g. as for all validated 3R-alternative tests, nanoparticle materials have never been included in the reference compounds during the validation process). This field needs special attention (SCCP/1147/07). Work is also ongoing at the SCCS and at the OECD level (i.e. [t]here is an upcoming OECD report on the adequacy of the current guidelines to nanomaterials. Further information will become available in due course after the testing of 14 nanomaterials).

Only for 5 endpoints validated replacement alternatives are available. However, for the human health risk assessment of cosmetic ingredients other endpoints are also crucial and these are not covered by meaningful and resilient replacement testing methods. [...] Thus, a full human health risk assessment cannot be performed.


Follow these links to download the full memorandum, to find out more about the current OECD Working Party on Manufactured Nanomaterials (WPMN) activities on The Role of Alternative Methods in Nanotoxicology (OECD WPMN Steering Group 7), or find out more about the OECD Sponsorship Programme for the Testing of Manufactured Nanomaterials.

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