The European Commission has asked the Scientific Committee to assess the safety of the fragrance ingredient “Benzyl Salicylate” included in the priority list of 28 potential Endocrine Disruptors (EDs) in cosmetics. On 3 February 2022, this mandate has been accepted by the SCCS and the Committee has nine months to deliver its Opinion.
Background
Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) with the chemical name ‘2- hydroxybenzoic acid phenylmethyl ester’ is produced naturally in a variety of plants and plant extracts where it can be extracted. In addition, Benzyl Salicylate can be synthesised for use, typically as a fragrance ingredient, in a range of manufactured goods (cosmetics, household goods, and medicines). In cosmetics, Benzyl Salicylate is used for its fragrance/perfuming function.
Benzyl Salicylate was assessed by the SCCNFP in 1994 and by SCCS in 20125 and it is considered an established contact allergen in humans. It is currently regulated for labeling purposes as an allergen in entry 75 of Annex III to the Cosmetics Regulation. In particular, “its presence must be indicated in the list of ingredients when its concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products”. During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of Benzyl Salicylate as a fragrance ingredient in cosmetic products.
Questions to be addressed by SCCS
The Commission requests the SCCS to carry out a safety assessment on Benzyl Salicylate in view of the information provided, taking into account the maximum concentration of Benzyl Salicylate in the different categories of cosmetic products listed in the table below.
| Type of cosmetic product exposure | Maximum % concentration used |
| Hydroalcoholic-based fragrances (spray and non-spray) | 4 |
| Rinse-off skin & hair products (except rinse off body products) | 0.5 |
| Rinse off body products | 1.3 |
| Leave on skin & hair products (non-spray/non-aerosol)(except body lotion | 0.5 |
| Leave on hair products (spray/aerosol) | 0.5 |
| Leave on body products (non-spray/spray/aerosol) | 0.7 |
| Face make-up products and make-up remover | 0.2 |
| Oral care | 0.004 |
| Deodorant products (spray/aerosol) | 0.91 |
Therefore, SCCS needs to investigate the following:
- In light of the data provided and taking into consideration the concerns related to potential endocrine-disrupting properties of Benzyl Salicylate, does the SCCS consider Benzyl Salicylate safe when used up to the maximum concentrations provided in the dossier submission by the Benzyl Salicylate Consortium?
- Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Benzyl Salicylate in cosmetic products?
- Does the SCCS have any further scientific concerns with regard to the use of Benzyl Salicylate in cosmetic products?