Using Human Biomonitoring Data to Support Risk Assessment of Cosmetic Ingredients-A Case Study of Benzophenone-3.

Christophe Rousselle,Jenna Wildeman,Marjolijn Woutersen,Matthieu Meslin,Qasim Chaudhry,Tamar Berman,Wieneke Bil

doi:10.3390/toxics10020096

Abstract

Safety assessment of UV filters for human health by the Scientific Committee on Consumer Safety (SCCS) is based on the estimation of internal dose following external (skin) application of cosmetic products, and comparison with a toxicological reference value after conversion to internal dose. Data from human biomonitoring (HBM) could be very useful in this regard, because it is based on the measurement of real-life internal exposure of the human population to a chemical. UV filters were included in the priority list of compounds to be addressed under the European Human Biomonitoring Initiative (HBM4EU), and risk assessment of benzophenone-3 (BP-3) was carried out based on HBM data. Using BP-3 as an example, this study investigated the benefits and limitations of the use of external versus internal exposure data to explore the usefulness of HBM to support the risk assessment of cosmetic ingredients. The results show that both approaches did indicate a risk to human health under certain levels of exposure. They also highlight the need for more robust exposure data on BP-3 and other cosmetic ingredients, and a standardized framework for incorporating HBM data in the risk assessment of cosmetic products.

Highlights

IntroductionUV filters in sunscreens are regulated in Europe in the Cosmetic Product Regulation (CPR), which provides a broad regulatory framework for restricting chemicals with potential risks to human health
UV filters are used in sunscreen and other cosmetic products to protect the skin by absorbing or reflecting potentially harmful UVA and UVB rays.UV filters in sunscreens are regulated in Europe in the Cosmetic Product Regulation (CPR), which provides a broad regulatory framework for restricting chemicals with potential risks to human health
Previous safety assessments of BP-3 by the European Scientific Committees [13,14,15] concluded that BP-3 can be safely used as a UV-filter up to 6% in cosmetic sunscreen products and up to 0.5% in all types of cosmetic products it has the potential for contact allergy and photoallergy

Summary

Introduction

UV filters in sunscreens are regulated in Europe in the Cosmetic Product Regulation (CPR), which provides a broad regulatory framework for restricting chemicals with potential risks to human health. The internal exposure dose is compared to a reference value that is either derived from human or experimental data This toxicological reference value (TRV) is used by the SCCS to calculate a margin of safety (MoS) [3]. In this context, human biomonitoring (HBM) can provide a very useful tool because it provides real-life internal exposure of the human population to a given chemical in terms of measured concentrations in human samples, such as blood and urine. The use of HBM in risk assessments has been uneven across different frameworks; for example, compared to pesticides, biocides, and heavy metals, the use of HBM data has been scarce in cosmetics safety assessments

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