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EU Regulation Update: Tackling the Animal Testing Ban
By: Annelie Struessman, PhD, CONUSBAT
Posted: May 10, 2010
page 2 of 2
With these considerations, seven frequently asked questions4 are raised in the position paper that further clarify how to deal with the marketing and testing bans. For example, question five: I must test my substance used exclusively in cosmetics in order to comply with the EU REACH regulation. Can I perform the animal tests in the EU? The answer given is: Yes, because the testing is not performed to meet the requirements of the EU Cosmetics legislation. With each of these answers, however, EFfCI alerts companies that they should be aware that certain enforcement authorities may have a different view.
In spite of this practical guidance the conflict remains that if testing is needed, the legislation requires use of non-animal methods. Even if these alternatives are not available, animal methods are not permitted. The unavailability of validated alternative protocols was acknowledged by the EU Commission’s Scientific Committee on Consumer Safety (SCCS1294/105 memorandum from December 2009. Furthermore, while the SCCS considers “(Q)SAR and other in silico alternatives as valuable tools for screening purposes,” they also conclude that “currently these fail to deliver the required level of knowledge for a full quantitative risk assessment.” Therefore, while the existing animal testing toolbox was removed, the new toolbox for assessment of ingredient safety using non-animal methods is not yet available.
1. Directive 2003/15/EC, 7th Amendment to Council Directive 76/768/EEC (Cosmetics Directive), available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:066:0026:0035:en:PDF or http://ec.europa.eu/enterprise/sectors/cosmetics/documents/directive/ (accessed May 10, 2010)
2. EU Regulatory Update January 2010: Recast of the Cosmetics Directive Published, available at R www.cosmeticsandtoiletries.com/regulatory/region/europe/81240592.html (accessed May 7, 2010)
3. The European Federation for Cosmetic Ingredients (EFfCI) Web site, available at www.effci.org/index.php?id=2 (accessed May 7, 2010)
4. EFfCI Opinion on the Animal testing and Marketing Bans, available at www.effci.org/assets/files/EFFCI_PS/Amendment.pdf (accessed May 7, 2010)
5. SCCS: Memorandum on Alternative Test Methods, December 2009, available at http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_001.pdf (accessed May 7, 2010)