To strengthen the management of safety risk substances in cosmetics, on Mar. 10, 2022, China National Institutes for Food and Drug Control (NIFDC) released an announcement seeking public comments on benzene (CAS No. 71-43-2) limitation requirements. According to the risk assessment results, the limit of benzene in cosmetics is proposed to be 2mg/kg. ¹ Stakeholders can send suggestions to hzpbwh@nifdc.org.cn before Mar. 31, 2022.

Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin, and it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening. ² Trace amounts of benzene introduced into cosmetics can pose a potential hazard to human health.

In China, benzene is included in the List of Prohibited Ingredients Used in Cosmetics, and shall not be employed in producing cosmetic products. Previously, China did not have a limit for benzene residues in cosmetics. But in the post-market inspection, benzene was detected in some sunscreen products, causing concerns among related companies and consumers.

The limit of 2mg/kg proposed by China NIFDC is in line with the residue limits for benzene in pharmaceutical products set out in the ICH Guidelines Q3C (R6) on Impurities: Guideline for Residual Solvents of the European Medicines Agency. If the limit takes effect in the future, when benzene is present in cosmetics as an impurity, which during the production process cannot be technically avoided, the content shall not exceed 2 mg/kg.

According to Inna Fu, Technical Lead of REACH24H Cosmetic Division, it may also be necessary to test for benzene levels or identify the hazards of benzene when conducting cosmetics safety assessment.

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Reference Link: ChemLinked