Cosmetics & Personal Care

European legislation and US research activities towards ‘21st century toxicology’ are setting the standards for animal-free toxicological assessments and the cosmetics industry has been the first to feel the effects. As per EU Regulation 1223/2009, animal testing of cosmetic ingredients and finished products is currently banned in the EU, as is the marketing of finished cosmetic products and the ingredients contained therein which were tested on animals for cosmetic safety assessment purposes.

These bans hold irrespective of the availability of validated alternative methods. The law further prohibits marketing of any cosmetic products in the EU that involve new animal testing. The marketing ban is creating a global ripple effect, as non-EU based companies that employ animal testing are no longer able sell their cosmetics in the EU. The ban on animal testing does not imply that safety testing is unnecessary but rather that scientifically sound, proven methods using cellular and computational models serve as a replacement.

Although this bold vision was originally designed to address the toxicity of environmental agents, it has far-reaching applicability, including cosmetic and drug safety evaluation. Currently, neither the US Consumer Product Safety Commission nor the FDA requires animal testing for cosmetics.

In many cases, due to pressure to meet the legislative demands and deliver safe products to the market, cosmetics companies have formed a partnership with laboratories, like IIVS, specializing in in vitro and in silico safety tools. In general, the in vitro methods have been developed by industry thought leaders or as part of an industry consortium. After some initial success, the method must be verified for transferability, robustness and predictive power.

Once the assays are verified by ECVAM or other national validation authorities to be adequate as replacements of the animal tests, OECD test guidelines may be adopted. Several in vitro assays addressing relevant endpoints for cosmetics, including eye and skin irritation, percutaneous penetration, and photo-toxicity, have achieved partial or full animal replacement status.

Although there has been significant focus on the regulatory applicability of non-animal methods, the most routine use of the assays is screening during product development and evaluating products which do not require pre-market approval. Since cosmetics do not require pre-market approval, companies may choose how to design their testing strategies to ensure the safety of their products. Some companies may use the assays as a screening tool before initiating a clinical test, while others may use a single in vitro assay or a combination of assays to assess a single endpoint without further clinical confirmation.

IIVS has extensive expertise in these assays and can help clients address specific needs and the overall goal of delivering safe products to market.  Our scientists can provide guidance on the appropriate in vitro assays needed to inform decision-making.

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