Testing of Cosmetic Products according to the European Directive 76/768/EEC
Cosmetic products are defined according to the European Directive 76/768/EEC as follows:
“A ‘cosmetic product’ shall mean any substance or M60 mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”.
Cosmetic products are exempt from the authorization requirement, but certain ingredients such as coloring agents, preservatives and UV filters are subject to approval. The European Directive 76/768/EEC regulates the marketing of cosmetics and also contains the prohibited and permitted substances for the manufacture of the products. According the legislation animal testing should be avoided, if accepted in vitro studies are available.
We provide you with alternative methods to animal experiments and offer you together with our partner laboratories the complete range of tests according to the principles of Good Laboratory Practice (GLP) with the following services:
- Chemical and Physical Specifications
- In vitro Skin Corrosion and Irritation
- OECD 431 in vitro Skin Corrosion Test (EpiDerm)
- OECD 435 Membran Barrier Test - Corrositex Test
- OECD 439 in vitro Skin Irritation Test (EpiDerm)
- In vitro Eye Irritation
- OECD 437 BCOP Test
- OECE 492 EpiOcularTM Eye Irritation Test
- HET Cam Test
- In vitro Sensitisation
- Direct Peptide Reactivity Assay - DPRA Test
- Dentritic Cell Line Activation Assay – h-CLAT
- ARE Reporter Assay - LuSens
- Mutagenicity and Genotoxicity
- OECD 471 Ames Test
- OECD 487 in vitro Micronucleus Test
Evaluation of the Potential for Mutagenicity of Cosmetic Substances within the EU
In April 2014 the 8th Revision of the Addendum to the SCC`s Notes of Guidance (NoG) for the Testing of Cosmetic Ingredients was adopted, which includes a general recommendation for the evaluation of the potential for mutagenicity of cosmetic substances within the EU:
Addendum to the SCCS`s Notes of Guidance (NoG) for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th Revision, SCCS/1501/12, 9. April 2014.
According to the document two different genotoxic endpoints should be tested:
- Mutagenicity (Gene mutation)
Bacterial Reverse Mutation Test - Ames Test [OECD 471]
- Structural and numerical chromosome aberrations (clastogenicity and aneuploidy)
in vitro Micronucleus Test [OECD 487]
If the results of both studies should differ the performance of an in vitro Comet Assay is recommended.
In case of biocidal compounds, antibiotics or nanomaterials instead of a bacterial reverse mutation test a gene mutation test in mammalian cells should be performed like the HPRT Test or the Mouse Lymphoma Assay.
The following figure shows four different possible scenarios for testing the mutagenicity: