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| An EU ban on animal testing of finished cosmetics will soon be extended to include the testing of cosmetic ingredients. © istock.com |
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What substances are considered cosmetics?
Cosmetics include personal care products, such as skin creams, soaps, deodorants, shampoos, sunscreens and toothpastes, as well as perfumes, hair dyes, and other beauty products.
Who are the major cosmetics manufacturers in Europe?
Among the largest cosmetic companies in Europe are L’Oréal, Proctor & Gamble, Johnson & Johnson, GlaxoSmithKline, Unilever, Henkel, Estée Lauder, Colgate-Palmolive, Avon and Mary Kay. Many of these companies are members of the EU-level lobby group, COLIPA (European Cosmetic Toiletry and Perfumery Association).
How are cosmetics regulated in the EU?
The sale of cosmetics in the EU is regulated under Directive 76/768/EEC [PDF], which stipulates that “[a] cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use….” This legislation is administered by the European Commission Directorate General for Enterprise and Industry, with independent advice from the Scientific Committee on Consumer Products (SCCP).
What animal tests are carried out on cosmetic ingredients?
The Cosmetics Directive does not impose specific testing requirements for either finished cosmetic products or their raw ingredients, although some ingredients may fall within the scope of other legal frameworks, such as the REACH chemicals regulation. However, the SCCP has published rigorous guidance notes [PDF], which recommend extensive testing of all “new to the world” cosmetic ingredients, including the following types of toxicity tests:
- Acute lethality study in rodents or rabbits
- Eye and skin irritation (rabbit or in vitro)
- Skin allergy in mice or guinea pigs
- Skin absorption
- Sunlight-induced “photo”-toxicity
- Absorption, distribution, metabolism and elimination studies in rodents
- Repeated-dose (1, 3 and/or 12 month) general toxicity studies in rodents and/or dogs
- Reproductive toxicity in at least two generations of rodents
- Prenatal developmental toxicity in rodents and/or rabbits
- Genetic toxicity studies of at least 3 varieties (rodent and/or in vitro)
- Lifetime (18-24 month) cancer studies in rats and/or mice
How many animals are used in the testing of cosmetic ingredients?
Some of the tests above consume hundreds or thousands of animals per study. In 2005, pesticide testing in the EU consumed slightly over 5,000 animals, or approximately 0.5 percent of all animals used in toxicological and other safety evaluations, according to European Commission statistics [PDF].
Are animal tests accurate predictors of potential health hazards to people?
Not necessarily. Animal tests may under- or over-estimate the hazards of cosmetic ingredients.
What are the alternatives?
A number of in vitro and other alternative methods germane to cosmetic safety assessment have been endorsed as scientifically valid by the European Centre for the Validation of Alternative Methods (ECVAM) and its counterparts worldwide for toxic effects including skin and eye irritation, acute lethality, skin allergy, genetic mutation, and toxicity to the developing embryo.
Hasn’t the EU already banned the testing of cosmetics on animals?
Under the 7th Amendment of the Cosmetics Directive [PDF], an EU-wide ban on animal testing of finished cosmetic products and the sale of animal tested finished products has been in place since 2004. Additionally, as of 11 March 2009, animal testing of cosmetic ingredients is also illegal within the EU, as is the marketing of cosmetic products whose ingredients have been tested on animals on or after that date.
However, the Cosmetics Directive contains a loophole that allows for a delay of up to four years (i.e. until March 2013) in implementing the marketing ban if non-animal replacement methods for repeated-dose toxicity, reproductive toxicity and toxicokinetics are unavailable by the 2009 cut-off date. Additionally, cosmetics companies and even some European regulators have begun to claim that a number of other animal tests—including skin sensitisation, UV-induced toxic effects, photo-allergy, and carcinogenicity—constitute "repeated dose" toxicity studies and should therefore not be banned until 2013. However, Humane Society University and Humane Society International (HSI) Europe [PDF], together with influential MEP Dr Caroline Lucas, are challenging this opportunistic re-interpretation of the Cosmetics Directive, and are pressing the Commission and Member States to enforce a strict ban on the sale of any cosmetics containing ingredients that have been animal tested subsequent to the March 2009 cut-off, consistent with both the letter and spirit of the 7th Amendment.
Are there other developments that could impact cosmetics testing on animals?
France and a group of cosmetics ingredients manufacturers have already made an unsuccessful attempt to overturn the 7th Amendment, claiming that that the ban on animal testing breaches the principle of "freedom to pursue a professional activity," because it constitutes "excessive and intolerable interference.” It is also possible that the United States and/or other countries may likewise attempt to challenge the test and marketing bans through the World Trade Organisation as the 2013 cut-off date draws nearer.
Another challenge is the emerging use of nanomaterials in cosmetic products. The ultra-tiny nature of these substances raises unique toxicological questions and concerns, which some stakeholders have suggested can only be answered through long-term animal testing.
What is HSI Europe doing to help animals used in cosmetics testing?
HSI Europe has been at the forefront of lobbying efforts to ensure that all available, validated non-animal methods and testing strategies achieve regulatory acceptance in order to be fully utilised in advance of deadlines prescribed in the Cosmetics Directive. Additionally, HSI Europe and affiliate organisations The Humane Society of the United States and Humane Society Legislative Fund have assumed a leading role in supporting implementation of the vision of “twenty-first century toxicology” articulated by the U.S. National Research Council, which would see animal tests that are decades old, costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and human-relevant non-animal methods. HSI Europe is calling for a “big biology” project to meet this challenge, akin to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder consortium make this landmark vision a reality as quickly as possible.
How can I help?
No animal should be made to suffer for the sake of vanity or “innovation,” no matter how flawless the new anti-wrinkle cream, how absorbant the sunscreen, or how shimmery the nano-silver laced eye shadow. Animal testing of cosmetics could end immediately if companies simply made the choice to rely on the many hundreds of proven, safe ingredients until such time as the safety of new-to-the-world ingredients can be assured using only non-animal test methods. For assistance in identifying truly cruelty-free cosmetics, visit LeapingBunny.org.
Updated March 19, 2009
