The European Commission (EC) and US Food and Drug Administration (FDA) have each defined cosmetic products as articles designed to clean, protect, beautify or perfume (or correct the odour of) external parts of the human body, or the gums or teeth. The team of toxicologists at bibra has over 40 years’ experience in providing toxicological support to many industrial sectors and 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 ingredients such as essential oils. It is misleading to consider these naturals as single substances. Rather, they are multi-constituent ‘mixtures within mixtures’, potentially adding numerous chemicals to the overall cosmetic ‘makeup’. In addition, cosmetics often include substances with properties requiring specific toxicological consideration, e.g. polymers and nanomaterials. The testing of cosmetics on animals is also subject to legal and ethical restrictions. All of this means that safety assessors need to think outside the box when evaluating the safety of these materials, including the use of techniques such as read-across and (Q)SAR.

The scientists at bibra are used to dealing with such problems. Even outside our cosmetics work, we understand that laboratory testing is a last resort, and while the safety assessment of cosmetics can be more complicated than it initially appears, the general process is the same as for any of our chemical hazard and risk assessments, and is as follows:

1)      estimating exposures to the cosmetic product and its individual ingredients (including the constituents of natural products) (see exposure modelling). Anticipated exposures and reasonably-anticipated exposures for all relevant age groups and routes 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 potential mixtures effects) by comparing hazard and exposure data (e.g. with a margin-of-safety (MoS) approach). TTC-based methodologies 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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