China NIFDC Consults on Limitation of Benzene in Cosmetics

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 [email protected] 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.

Engineers believe that the introduction of benzene into the product may be due to the following reasons ³:

• Some cosmetic ingredients contain benzene ring structures, which may leave traces of benzene in the process of synthesis or chemical reaction;

• Organic propellants are generally added to aerosol products (such as Propane, butane, etc.), these organic propellants may have residues of benzene;

• Cosmetic ingredients may come into contact with benzene during storage and transportation, and then bring benzene into cosmetics;

• …

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.

Limits for Other Common Risk Substances in Cosmetics