[Updated] EU SCCS Issues Final Opinions on Three Cosmetic Ingredients

Editor's note: This article was originally published on August 2, 2024, and was updated on October 28, 2024, as per the latest developments. The updated contents are marked in red below.

On August 1, 2024, EU Scientific Committee on Consumer Safety (SCCS) released two preliminary opinions regarding three cosmetic ingredients. One opinion focuses on Biphenyl-2-ol and Sodium 2-biphenylolate, while the other addresses HC Yellow No. 16.^1-2 Following the commenting period, SCCS issued final opinions on these ingredients on October 25, 2024, which included a clarification to the initial conclusions.^3-4 

Opinion on Biphenyl-2-ol and Sodium 2-biphenylolate

Biphenyl-2-ol (CAS No. 90-43-7) is currently regulated under the permitted preservatives list in Regulation (EC) No 1223/2009 (Cosmetics Regulation), with a maximum concentration of 0.2% (as phenol) allowed in rinse-off products, and 0.15% (as phenol) in leave-on products. In December 2022, the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) recommended classifying it as a "Carcinogen of Category 2". Considering the existing prohibition of CMR substances (those classified as carcinogenic, mutagenic or toxic for reproduction) in the Cosmetics Regulation, such classification may potentially lead to a ban on Biphenyl-2-ol in cosmetics.

In December 2023, the European Commission received a dossier defending the safety of Biphenyl-2-ol and its sodium salt, Sodium 2-biphenylolate, as preservatives in cosmetics. The Commission subsequently requested SCCS to assess the safety of these ingredients. In light of the provided information, SCCS considers the use of the Biphenyl-2-ol and Sodium 2-biphenylolate in cosmetics is safe as shown below: 

Opinion on HC Yellow No. 16

HC Yellow No. 16 (CAS No. 1184721-10-5), listed as a hair dye in CosIng, may be used in both oxidative and non-oxidative hair dye formulations. In March 2016, SCCS issued the opinion SCCS/1568/15, which introduced safe use concentrations for this ingredient. The opinion also called for additional data on its purity and impurities, as these were not adequately quantified.

In February 2024, SCCS received supplementary information on the purity of HC Yellow No. 16. Based on this information, SCCS conducted another safety assessment and issued a revised opinion. This revised opinion upholds the safe use concentrations from SCCS/1568/15, confirming the safety of HC Yellow No. 16 at 1% in oxidative hair dye formulations, and 1.5% in non-oxidative hair dye formulations. 

Further Reading

• EU to Implement a Union-wide Ban on PFHxA in Cosmetics

• EU Safety Gate Flags 521 Batches of Non-compliant Cosmetics in H1 2024, with 484 Batches Containing BMHCA

• An Overview of Cosmetics Regulations in Nordic Countries