Benzene and REACH Regulation: Strengthening public health through regulatory compliance assessment

Abstract Background Benzene is a volatile organic compound widely used as a precursor in the chemical industry. It is classified as a Category 1A carcinogen and 1B mutagen under the CLP Regulation (EC No 1272/2008). Its toxic effects are well documented through occupational epidemiology and in vivo studies, highlighting risks even at low exposure levels. To address these concerns, the REACH Regulation (EC No 1907/2006) introduced strict limits on benzene in various matrices. Annex XVII restricts its use or placing on the market in substances or mixtures at concentrations between 0.00005% and 0.1% by weight in products intended for public sale. These measures follow a precautionary approach to minimize public exposure. Methods To assess compliance with current legislation for articles and cosmetic products, we developed and validated, according to ISO/IEC 17025, specific in-house methods based on Headspace Gas Chromatography coupled with Mass Spectrometry (HS-GC/MS). These methods were applied to matrices such as glues, toys, tattoo inks, textiles, e-liquids, scented mixtures and cosmetics. Results The HS-GC/MS methods proved sensitive and specific, enabling accurate benzene quantification. Performance characteristics included detection limits (0.000007-0.0018% w/w), quantification limits (0.000024-0.0059% w/w), intermediate precision (4.7-11.8%), recovery (91-110%), measurement uncertainty (10.5-19.9%), as well as good linearity, sensitivity, and specificity. The validated methods were then applied to commercial samples collected from Italian retail stores. Conclusions The integration of toxicological evidence into regulatory frameworks like REACH underscores the importance of aligning chemical safety with public health objectives. Reducing benzene exposure through restriction, monitoring, and substitution contributes to cancer prevention and highlights REACH's role in environmental health policy. Key messages • Validated HS-GC/MS methods enable precise benzene detection in consumer products, supporting REACH compliance and public health protection. • This work bridges toxicology and regulation, reinforcing the role of analytical science in reducing benzene exposure and preventing health risks.