May 1, 2003
Trade War Looms Due To Animal Test Ban
Eurobusiness
The provisions of the 7th Amendment to the Cosmetics Directive 76/768/EEC on animal testing are likely to have far reaching consequences for the global cosmetics industry, in particular with respect to trade between the US and the EC.
For finished products, animal testing is banned from the date of implementation of the Directive by Member States, which must be before 11 September 2004. For ingredients, there will be a ban on both testing and marketing of ingredients tested on animals within 6 years i.e. by March 2009. The Commission has to set deadlines within this 6-year period for the prohibition of animal tests as soon as alternative tests become available. The only exception to this is where there are no alternative tests yet under consideration (repeated-dose toxicity, reproductive toxicity and toxico-kinetics) where the deadline is 10 years.
The 7th Amendment mandates that alternative methods of testing shall be developed, validated and adopted at Community level "with due regard to the development of validation within the OECD", a tacit recognition that this Amendment has international implications. Once methods have been validated by the European Centre for Validation of Alternative Methods (ECVAM) and approved by the Scientific Committee for Cosmetic Products and Non-Food Products (SCCNFP), these will be published by the Commission and must be used to test ingredients. In exceptional circumstances, where serious concerns arise over the safety of an existing cosmetic ingredient which cannot be replaced, derogation from the testing ban may be permitted by the Commission after consultation with the SCCNFP. Producers will be able to claim on the labelling that no animal testing has been carried out in relation to the development of their product.
The provisions of the 7th Amendment have their origins in the 6th Amendment of June 1993, which provided for animal testing to be eliminated within 5 years, but allowed for the possibility of extending the deadline to take account of development of alternative tests. Had the 6th Amendment not been repealed by the provisions of the 7th Amendment, a total ban on marketing of products tested on animals would have come into force in June 2002. The provisions relating to animal testing were introduced into the 6th Amendment at the last minute at the request of the European Parliament and have been a bone of contention between the Commission and Parliament ever since. The Commission has always believed that the marketing ban imposed by the 6th Amendment was not tenable in the light of WTO Rules and has made great efforts to avoid the implementation of a marketing ban in the 7th Amendment.
Requirement for safety testing outside the EC
The problem arises because the testing requirements for cosmetics are different in the EC and the US. In the US some cosmetics are also classified as drugs (dandruff shampoos, fluoride toothpastes, anti-perspirant deodorants, sunscreens, moisturizers/foundations containing sunscreen) and therefore must be shown to be safe and efficacious prior to marketing. Whilst the Food Drug and Cosmetics Act does not specifically mandate animal testing, the FDA requires manufacturers to conduct whatever tests are deemed appropriate to ensure the safety of their products. In effect, this means that many products have to be tested on animals and therefore, once the provisions of the 7th Amendment come into force, it will not be possible to import them into Europe.
Development of alternative tests
The cosmetics industry has known for a number of years that it had to develop alternatives to animal testing and considerable efforts have been made but currently only two tests have been validated by ECVAM and approved by the SCCNFP. It is recognised that the development of alternative methods is fraught with difficulty, not least because of the dearth of reliable in vivo data needed for validation. Unless alternative methods can be developed which are acceptable to regulatory authorities internationally, barriers to trade will inevitably arise. This cuts both ways: the marketing ban will prevent sale in the EC of products tested in animals elsewhere but, conversely, if non-EC regulatory authorities do not consider that the alternative methods offer the level of safety to consumers that they demand, products tested using alternative methods in Europe will not be marketable elsewhere. This is particularly likely to be a problem in the US where the current view of the FDA is that, until a method has been proven to be reliable and accepted by the scientific community, the use of animals remains necessary to ensure the safety of cosmetic ingredients and products.
For finished products, animal testing is banned from the date of implementation of the Directive by Member States, which must be before 11 September 2004. For ingredients, there will be a ban on both testing and marketing of ingredients tested on animals within 6 years i.e. by March 2009. The Commission has to set deadlines within this 6-year period for the prohibition of animal tests as soon as alternative tests become available. The only exception to this is where there are no alternative tests yet under consideration (repeated-dose toxicity, reproductive toxicity and toxico-kinetics) where the deadline is 10 years.
The 7th Amendment mandates that alternative methods of testing shall be developed, validated and adopted at Community level "with due regard to the development of validation within the OECD", a tacit recognition that this Amendment has international implications. Once methods have been validated by the European Centre for Validation of Alternative Methods (ECVAM) and approved by the Scientific Committee for Cosmetic Products and Non-Food Products (SCCNFP), these will be published by the Commission and must be used to test ingredients. In exceptional circumstances, where serious concerns arise over the safety of an existing cosmetic ingredient which cannot be replaced, derogation from the testing ban may be permitted by the Commission after consultation with the SCCNFP. Producers will be able to claim on the labelling that no animal testing has been carried out in relation to the development of their product.
The provisions of the 7th Amendment have their origins in the 6th Amendment of June 1993, which provided for animal testing to be eliminated within 5 years, but allowed for the possibility of extending the deadline to take account of development of alternative tests. Had the 6th Amendment not been repealed by the provisions of the 7th Amendment, a total ban on marketing of products tested on animals would have come into force in June 2002. The provisions relating to animal testing were introduced into the 6th Amendment at the last minute at the request of the European Parliament and have been a bone of contention between the Commission and Parliament ever since. The Commission has always believed that the marketing ban imposed by the 6th Amendment was not tenable in the light of WTO Rules and has made great efforts to avoid the implementation of a marketing ban in the 7th Amendment.
Requirement for safety testing outside the EC
The problem arises because the testing requirements for cosmetics are different in the EC and the US. In the US some cosmetics are also classified as drugs (dandruff shampoos, fluoride toothpastes, anti-perspirant deodorants, sunscreens, moisturizers/foundations containing sunscreen) and therefore must be shown to be safe and efficacious prior to marketing. Whilst the Food Drug and Cosmetics Act does not specifically mandate animal testing, the FDA requires manufacturers to conduct whatever tests are deemed appropriate to ensure the safety of their products. In effect, this means that many products have to be tested on animals and therefore, once the provisions of the 7th Amendment come into force, it will not be possible to import them into Europe.
Development of alternative tests
The cosmetics industry has known for a number of years that it had to develop alternatives to animal testing and considerable efforts have been made but currently only two tests have been validated by ECVAM and approved by the SCCNFP. It is recognised that the development of alternative methods is fraught with difficulty, not least because of the dearth of reliable in vivo data needed for validation. Unless alternative methods can be developed which are acceptable to regulatory authorities internationally, barriers to trade will inevitably arise. This cuts both ways: the marketing ban will prevent sale in the EC of products tested in animals elsewhere but, conversely, if non-EC regulatory authorities do not consider that the alternative methods offer the level of safety to consumers that they demand, products tested using alternative methods in Europe will not be marketable elsewhere. This is particularly likely to be a problem in the US where the current view of the FDA is that, until a method has been proven to be reliable and accepted by the scientific community, the use of animals remains necessary to ensure the safety of cosmetic ingredients and products.
