National Anti-vivisection Society

Animal Defenders InternationalLord Dowding Fund for humane research

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National Antivisection Society

EU Cosmetics Testing Ban Update

Posted: 6 December 2007


Directive 2003/15/EC of 27 February 2003, amending Council Directive 76/768/EEC, better known as the Cosmetics Directive, was a major victory. For the first time, new legislation introduced a ban on the use of animals for an entire sector of products, albeit using a step-by-step approach. After a 20-year campaign dating back to the strategy devised by NAVS and other groups in 1982 for the UK’s Animals (Scientific Procedures) Act 1986, we had new European legislation.

In 1982, when the government of the day outlined its plans for new legislation on animal experiments (excluding antivivisection groups from discussions), the NAVS, along with our sister organisations, identified a list of key demands for any new legislation: a ban on cosmetic, tobacco and alcohol experiments; a ban on the Draize eye irritancy test; a ban on the LD50 poisoning test; a ban on psychological/behavioural experiments; a ban on warfare experiments; and the reconstitution of the Home Office Advisory committee to exclude those with a vested interest in the continuation of animal experiments (now the Animal Procedures Committee).

The NAVS, Lord Dowding Fund and ADI have always campaigned with a ”step-bystep” approach, cognisant of the reality that the vested interests in the vivisection industry are huge, and public and political acceptance of animal tests has to be shifted by replacement of animal tests with scientifically superior methods as well as exposure of the failings of animal models.

Progress has been made over the years, with, for example, special scrutiny under the UK’s Animals (Scientific Procedures) Act on the use of primates, smoking experiments and eventually the UK cosmetics test ban. Tests replacing the use of animals have been accepted by the OECD (Organisation for Economic Cooperation and Development – the international standards body for governments), including agreement to move away from the cruel LD50 poisoning test. The European Centre for the Validation of Alternative Methods (ECVAM) has been established.
The NAVS’ and ADI’s recent campaign for a ban on the use of primates in research is part of this ongoing strategy. As the European Commission is about to make proposals for a revision of Directive 86/609/EEC on the use of animals in experiments, it is important to revisit the Cosmetics Directive to learn some lessons from it, as well as to identify its flaws.

Indeed, in spite of the EU’s efforts, animal testing in the cosmetics industry is not over yet. According to the latest statistics, about 9,000 animals were used in tests carried out for the safety of cosmetics products in 2004, a jump of more than 500% from 2003 (1,618 animals used). These tests were concentrated in three EU countries: France (5,496 animals used), Spain (3,480) and Denmark (12), and the species used were mice, rats, guinea pigs and rabbits.
Although the testing ban on finished products has been in force since 11 September 2004, the ban on ingredients or combinations of ingredients is being introduced step-by-step, as alternatives to vivisection are validated by ECVAM. Nonetheless, the Directive imposes a final cutoff date of six years after entry into force, i.e., 11 March 2009, irrespective of the availability of alternative, nonanimal tests.

However, the Directive goes further than a testing ban and includes a ban on the marketing of products tested on animals within the EU. This aims at preventing the sale of cosmetics that have been tested outside the EU by European or non-European companies. It follows the testing ban, with implementation step-by-step as soon as alternatives methods are validated ”with due regard to the development of validation within the OECD”. This signals that the EU wants to implement the ban without antagonising its trading partners. The same cutoff date, 11 March 2009, applies, with the exception of repeated-dose toxicity, reproductive toxicity and toxicokinetics. For these specific health effects, a ten-year deadline applies, i.e., March 2013, again, irrespective of the availability of alternative nonanimal tests.

The latest report from the European Commission on the progress of the validation and acceptance of alternative methods, published on 3 May 2007, provides several explanations for the sudden increase in cosmetics testing.
First of all, Spain failed to provide its data for 2003, so the number of animals used in 2003 was probably already well above 1,618. Another statistical difficulty cited by the Commission is that chemicals are rarely tested solely for their use as ingredients for cosmetics. Although this certainly does not fully account for the increase of tests carried out by French laboratories from about 1,600 in 2003 to 5,496 in 2004. The French government stated that the increase was caused by ”three additional test protocols carried out by two laboratories” for two clients based in the EU.

According to the latest report on this issue by the Health and Consumer Protection Directorate-General (a DG is to the Commission what a Ministry is to national governments), there are now a number of validated methods to replace, at least partially, tests in relation to skin corrosion, skin irritation, dermal absorption, mutagenicity/genotoxicity and photoinduced toxicity. Reduction and refinement methods are validated for acute toxicity and skin sensitisation. The report states that there are no validated alternatives for tests relative to eye irritation, repeated dose toxicity, carcinogenicity, reproductive toxicity and toxicokinetics. It concludes that ”it is unlikely that the deadlines of 2009 and 2013 can be met” and discusses concerns expressed by various committees.

However, last year’s ECVAM technical report is at odds with these conclusions. Indeed, ECVAM states that, considering the recent progress in the development of alternatives, the 2009 deadline can be met, although not the 2013 deadline. ECVAM validated three methods in April this year, relevant to skin and eye irritation and skin sensitisation.

What both reports fail to acknowledge, however, is the lack of commitment of the cosmetics industry as a whole to the replacement of animal testing. With industry sales reaching €65 billion in 2004 for the EU market alone, animal protection groups must relay public opinion to the industry and demand a greater commitment. The recent rise in animal testing for cosmetics products is unacceptable, and the Commission must defend the 2009 deadline.
In order to accelerate the development of alternatives by the private sector the Commission launched the European Partnership to Alternative Approaches to Animal Testing (EPAA) in November 2005, an initiative regrouping major companies affected by the Cosmetics Directive as well as the REACH Regulation. NAVS and ADI attended the launch and hope to see more commitment and more action.

It is important to note that the deadlines included in the Cosmetics Directive apply, irrespective of the availability of alternatives to animal tests. It means that from 2009, cosmetics companies will have no choice but to use alternative methods if they want to sell new products: This should be the strongest incentive for progress.
Although the number of animals used in cosmetics is arguably small compared to the 10 million used in scientific experiments overall, it is important that the phaseout works, as this could serve as a model for future progress, including a ban on the use of primates in research.

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