Altex 25, 3/08 147 Food for Thought … on Alternative Methods for Cosmetics Safety Testing Thomas Hartung eU JRC, tRiVA unit, Ispra, Italy This is the frst article of this series pub- lished after I changed responsibility (see ALTEX 2, 2008). Thus, I considered whether it is appropriate to continue this series. Since the contributions are written in a clearly personal way and a (thought) provocative style, they can hardly be mistaken as offcial positions of the Eu- ropean Commission. Most probably, half of the ideas expressed are wrong any- way (but nobody knows which half). If you consider, however, that about 30% of scientifc articles are not reproducible and that the scientifc publishing culture usually does not permit the putting for- ward of concepts and ideas without ex- perimental proof, this difference in “pro- portion of truth” might be compensated for the reader. Together with the editor of ALTEX, I decided to continue this se- ries – I have been working in the feld for more than 20 years now and consider my views as those of an individual scientist imprinted by the experiences of the last few years. However, I will refrain from any discussions of ECVAM’s future work as a validation body. I appreciated very much that my predecessor at EC- VAM, Michael Balls, at the time gave me the opportunity to give things “my spin” without any interference, and once again I will try to follow his role model here. the 7 th amendment (directive 2003/15/ EC) of the cosmetics directive (Directive 76/768/EEC) was my “welcome present” when I started at ECVAM in late 2002. Beside REACH, which started only just now on 1 st of June 2008 with the agency taking over, this amendment has shaped the landscape of alternative methods dra- matically. It represented a prime oppor- tunity to give alternative methods a new, enlarged role and the incentive for sup- port by a major industry. Recital 5 of the directive reads: “Cur- rently, only alternative methods which are scientifcally validated by the Euro- pean Centre for the Validation of Alter- native Methods (ECVAM) or the Organi- sation for Economic Cooperation and Development (OECD) and applicable to the whole chemical sector are systemati- cally adopted at Community level. How- ever, the safety of cosmetic products and their ingredients may be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, when such methods offer an equivalent level of protection to consumers.” This clearly indicates that the legislator wants to uncouple this industry from the possi- bly slower progress in other areas of ap- plication of alternative methods. Key features of the directive with re- gard to alternative approaches are the deadlines for phasing out testing and their reinforcement by marketing bans. To recapitulate, there are four deadlines: • A deadline of 11 September 2004 for the testing of fnished products (rein- forced by a marketing ban) • An immediate testing ban for ingredi- ents if an alternative method is “validat- ed and adopted at Community level with due regard to the development of vali- dation within the OECD”. This leaves some room for interpretation. Depend- ing on the view, this means after the validity statement by ECVAM’s Scien- tifc Advisory Committee, after this “ad- vice” is taken and adopted by ECVAM and the European Commission, after its acceptance by DG SANCO’s Scientifc Committee on Consumer Products (SC- CP) or acceptance and inclusion in the EU test guideline regulation (formerly Annex V of the Dangerous Substance Directive, currently transformed into an independent legislation) or even accept- ance as an OECD test guideline. • A general testing ban on cosmetic ingre- dients from 11 March 2009, reinforced for 10 animal test requirements by an instant marketing ban. • A marketing ban from 11 March 2013 for the more complex endpoints (those requiring repeated substance applica- tion, e.g. repeat dose toxicity, sensiti- zation, reproductive toxicity and car- cinogenicity as well as toxicokinetics, which is actually no typical testing de- mand). Noteworthy, the legislation does foresee a review of the feasibility of the 2013 deadline in 2011 and can further postpone this in a co-decision proce- dure. The legislation is in many ways unique as it, for example, phases out essential safety tests before alternatives are availa- ble. This “incentive for change” probably refects the legislators’ discontent that the 6 th amendment of 1993 led only to two postponements of the already foreseen phasing out of animal testing. The 6 th amendment introduced a marketing ban on cosmetic products tested on animals from 1 January 1998, provided that al- ternative testing methods had been vali- dated and accepted by that date. The mar- keting ban has been postponed twice by the EU, on the grounds that insuffcient progress had been made in developing and validating alternatives to the animal tests used for assessing cosmetic safety. Noteworthy, the 7 th amendment permits from 2009/2013 onwards only the use of replacement alternatives.