The SCCS recently finalised its evaluation of Benzyl Salicylate as an ingredient in cosmetics. Read on to learn background and implications of this regulatory update.
Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9), also known as 2-hydroxybenzoic acid phenylmethyl ester, occurs naturally in various plants. It can be artificially manufactured and is often found in cosmetics, household items, and medicines. In cosmetics, it plays a vital role as a fragrance.
The SCCS last reviewed Benzyl Salicylate in 2012 and has been confirmed as an allergen in humans. Presently, Benzyl Salicylate is listed as an allergen in Annex III of the EU Cosmetics Regulation (entry 75). This means if its concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products, it must be explicitly listed in the ingredients on the label.
Are you new to cosmetic regulation and want to learn about regulations and testing? Check out our online video guides.
Recently, and as per the SCCS process, interested parties submitted toxicological evidence on the safety of Benzyl Salicylate as a fragrance ingredient in cosmetic products. In response, the Commission tasked the SCCS with conducting a safety assessment, considering the provided information. This assessment was to factor in the maximum concentrations of Benzyl Salicylate across different categories of cosmetic products, detailed in the table below.
In consideration of the available data, the SCCS believes Benzyl Salicylate as safe up to the maximum concentrations outlined in the table above. Despite the presence of data suggesting an endocrine mode of action, no conclusive evidence indicates that this translates into observable endocrine effects.
Manufacturers must ensure cosmetics on the UK and EU market that contain Benzyl Salicylate adopt the findings of the SCCS and re-formulate in line with the recommendations. If reformulation is necessary, the safety cosmetic assessment must be amended by the cosmetic safety assessor and the PIF updated.
Get in touch if you have questions regarding this update.