The intended functions of cosmetic products are diverse. The European Commission and US Food and Drug Administration (FDA) have each defined these products as articles designed to clean, protect, beautify and perfume (or correct the odour of) the external parts of the human body, or the gums and teeth. The team of toxicologists at bibra has over 40 years of experience in providing toxicological support to many industrial sectors. We have conducted literally thousands of hazard and risk assessments on a diverse range of products, including cosmetic ingredients and cosmetic products.

Cosmetics are very often mixtures, and frequently contain complex natural products like essential oils. It is misleading to consider these naturals as single, uniform cosmetic ingredients. Rather, they themselves are multi-constituent ‘mixtures within mixtures’, potentially contributing numerous individual chemical compounds to the overall ‘makeup’ of the cosmetic. In addition, cosmetic products often include other substances with unique properties that require specific consideration (e.g. polymers and nano-materials), and, as the testing of cosmetics on animals is subject to legal restriction (e.g. it is banned in the European Union) and ethical concerns, safety assessors need to think outside of the box, using techniques such as read-across and (Q)SAR.

As such, the safety assessment of cosmetics can be more complicated than it initially appears, but the general process is the same as for any of our hazard and risk assessments, namely:

1)      exposure estimation for the cosmetic product and its individual ingredients (including constituents of natural products) (see exposure modelling) – anticipated exposures and reasonably-anticipated exposures for all relevant age groups should be considered

2)      toxicity data gathering for all relevant exposure routes and endpoints of toxicological interest (see literature searching). We are highly skilled in comprehensively searching the available literature for publicly-available toxicological data, and have unique access to our in-house toxicity database, TRACE

3)      summarising relevant ADME and hazard data on individual ingredients, producing substance-specific toxicity profiles for each constituent

4)      if appropriate, and where data-gaps are identified, supplementing the substance-specific toxicity profile with data generated using non-testing approaches like read-across and (Q)SAR

5)      concluding on risk (including a consideration of the potential mixtures effects, e.g. additive toxicity from ingredients with common modes of action) by comparing critical effect levels from the key toxicity data with anticipated and reasonably anticipated exposures (e.g. by a margin-of-safety (MoS) approach). TTC-based approaches may be considered, if appropriate

For cosmetics marketed within the European Union, the process above is required as part of  the preparation of “Cosmetic Product Safety Reports” (CPSRs) under Regulation (EC) 1223/2009.


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