On August 1, 2024, the Scientific Committee on Consumer Safety (SCCS) released its opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate in cosmetic products. These ingredients, also known as o-Phenylphenol and Sodium o-Phenylphenate, are commonly used as preservatives. The evaluation was prompted by concerns over their potential classification as Category 2 carcinogens.
Biphenyl-2-ol and Sodium 2-biphenylolate: Background
o-Phenylphenol and its sodium salt have been approved for use in cosmetics at concentrations up to 0.15% in leave-on products and 0.2% in rinse-off products under Annex V of the Cosmetics Regulation (EC) No. 1223/2009. However, recent scientific evaluations, including opinions from the Risk Assessment Committee (RAC) of ECHA, raised concerns about their safety due to the potential carcinogenicity of o-Phenylphenol.
Biphenyl-2-ol and Sodium 2-biphenylolate: Regulatory Framework
The European Commission requested the SCCS to assess the safety of o-Phenylphenol and its sodium salt following the RAC's recommendation to classify o-Phenylphenol as a Category 2 carcinogen. According to the Cosmetics Regulation (EC) No. 1223/2009, CMR Category 2 substances are prohibited in cosmetics unless proven safe by the SCCS.
SCCS Conclusions
The SCCS concluded that o-Phenylphenol and Sodium o-Phenylphenate are safe as preservatives in cosmetic products at concentrations up to 0.2% in rinse-off products and 0.15% in leave-on products. No additional scientific concerns were identified, provided these concentration limits are adhered to.
Impact on the Cosmetics Industry
This favorable opinion allows the continued use of o-Phenylphenol and its sodium salt as preservatives in cosmetics, within the specified concentration limits. Cosmetics manufacturers should review their product formulations to ensure compliance with the SCCS's recommendations and be prepared for potential regulatory updates following the public comment period ending on September 27, 2024.
Conclusion
The SCCS's assessment underscores the importance of adhering to established concentration limits to ensure consumer safety. The cosmetics industry must remain vigilant for regulatory changes and ensure that products comply with current and future regulations.
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