Abstract
Cosmetic ingredients based on more or less refined biological matter (plants, fungi, bacteria, etc.) are gaining popularity. Advances in green chemistry and biotechnology are supporting this general trend further. Following numerous bans on the use of newly generated animal testing data in cosmetic safety assessments, and the worldwide demand for “cruelty-free” products, many alternative methods have been developed to assess the toxicity of ingredients. Whilst great strides have been, and continue to be, made, the area of systemic toxicity is one where international harmonisation and regulatory acceptance is still evolving. A strategy for the fractional assessment of biological matter is suggested to make approaches, such as threshold of toxicological concern (TTC) methodology, fit for purpose. Within this strategy, analytical data are used to generate compound classes which are quantified and assessed separately. Whilst this strategy opens new windows for assessing the safety of complex mixtures with a lack of toxicological data, it also raises awareness of the increasing complexity of cosmetic formulations and the general problem of additivity/synergy being rarely addressed. Extremely complex mixtures are and will be a growing challenge for safety assessors.
Highlights
Cosmetic products may contain a plethora of chemical compounds which themselves may originate from different sources
Public perspective, international trade and advances in green chemistry and biotechnology are creating a shift towards more biological matter from plants, fungi, algae and bacteria as ingredients for consumer goods, such as cosmetics [1,2,3]
The threshold of toxicological concern (TTC) is a popular way to justify safety of biological matter, such as plant extracts or ferments, with regard to systemic toxicity. This manuscript asks critically whether the current TTC approach or derivatives thereof are fit for purpose and suggests further refinements which allow for more flexibility based on the available data
Summary
Cosmetic products may contain a plethora of chemical compounds which themselves may originate from different sources These sources refer to biological matter from plants, fungi, animals, bacteria and algae and mineral matter, such as fractions from mineral oil or pigments, and derivatives and combinations due to chemical reactions and biotechnological processes. It is easy to imagine how difficult safety assessments might become when products are assessed containing multiple botanicals and related materials Such challenges did not become easier by voluntary and mandatory animal testing bans, because these are limiting toxicological testing batteries. The TTC is a popular way to justify safety of biological matter, such as plant extracts or ferments, with regard to systemic toxicity This manuscript asks critically whether the current TTC approach or derivatives thereof are fit for purpose and suggests further refinements which allow for more flexibility based on the available data
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