Parliamentary questions
26 February 2009
P-1404/09
WRITTEN QUESTION by Caroline Lucas (Verts/ALE) to the Commission

 Subject: Tests covered under March 2009 marketing ban on cosmetics with animal-tested ingredients
 Answer(s) 

The 7th Amendment of Directive 76/768/EEC(1) requires that Member States prohibit, by or before 11 March 2009, the performance of animal testing of cosmetic ingredients, as well as the marketing of cosmetic products containing ingredients which have been subject to animal testing. Provision is also made for a derogation of up to four years should non-animal replacement methods not be available for three specific study types: ‘repeated-dose toxicity, reproductive toxicity and toxicokinetics.’

It has been noted, however, that Commission Services have begun to list studies such as skin sensitisation, UV-induced toxic effects, photo-allergy, and carcinogenicity as being subject to the 2013 deadline rather than 2009(2). Can the Commission confirm that an error has been made in its reports and that animal testing for the aforementioned health effects will, in fact, be subject to the 2009 deadline? Alternatively, if the Commission believes that because these studies may involve more than one experimental manipulation of animals they can be counted as ‘repeated dose toxicity studies,’ could it please answer the following:

— Does the Commission dispute the definition put forward by the SCCP that ‘Repeated dose toxicity comprises the adverse general (excluding reproductive, genotoxic and carcinogenic effects) toxicological effects occurring as a result of repeated daily dosing with, or exposure to, a substance for a specific part of the expected lifespan of the test species’(3)?
— If ‘repeated dose toxicity’ was intended to be a catch-all term under the Cosmetics Directive, why list reproductive toxicity and toxicokinetics separately in the derogation?
— Likewise, why are sensitisation, phototoxicity and carcinogenicity all consistently listed separately from ‘repeated dose toxicity’ in (i) SCCP guidance, (ii) REACH testing Annexes VII‑X, (iii) testing Annexes II‑III of agrochemicals Directive 91/414/EEC(4), (iv) Commission animal use statistics, and (v) EU and international test guidelines and guidance documents?

Could the Commission also please detail

— the steps it has taken to monitor Member State enforcement of the 2004 ban on the marketing of cosmetics containing ingredients tested on animals where accepted alternative methods for the relevant endpoints are available,
— the measures it plans to implement to monitor Member State enforcement of the 2009 bans?

(1)OJ L 262, 27.9.1976, p. 169.
(2)http://ec.europa.eu/enterprise/cosmetics/doc/antest/sec_2004_1210_en.pdf
(3)http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf
(4)OJ L 230, 19.8.1991, p. 1.

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