The Scientific Committee on Consumer Safety (SCCS) issued its final opinion on Benzyl Salicylate (CAS No. 118-58-1) on November 6, 2023. The European Commission had directed the SCCS to evaluate the safety of substances with potential endocrine-disrupting properties, leading to this conclusion.
SCCS Final Opinion on Benzyl Salicylate: The Background
The European Commission updated Regulation (EC) No 1223/2009 concerning cosmetic products in November 2018. This regulation concentrates on substances with endocrine-disrupting (ED) characteristics. Although the Cosmetics Regulation does not explicitly mention EDs, it does provide a framework for protecting human health at a high level. The REACH Regulation deals with environmental concerns.
Following this update, the Commission pledged to prioritize potential EDs that are not already subject to bans or restrictions under the Cosmetics Regulation. After consulting stakeholders, they created a list of 28 potential EDs in early 2019. In 2019, a public data collection initiative focused on 143 substances, including Benzyl Salicylate, to prepare for subsequent safety evaluations.
Understanding Benzyl Salicylate
Known as an established contact allergen, Benzyl Salicylate naturally occurs in plants and is used as a fragrance in various products. The EU Cosmetic Regulation (Annex III-entry 75) allows its use in cosmetics and personal care items, with the requirement of being listed as an ingredient when it exceeds certain concentrations. It also has applications as a UV absorber.
During the data collection phase, stakeholders submitted scientific evidence affirming the safety of Benzyl Salicylate as a cosmetic fragrance ingredient. Consequently, the Commission has asked the SCCS to conduct a thorough safety assessment, considering the provided data and the maximum usage concentrations in different cosmetic product categories.
| 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 |
Conclusions
After evaluating various aspects such as physicochemical properties, toxicokinetics, exposure, and toxicological and safety evaluations, the SCCS concluded:
Benzyl Salicylate is considered safe for use in cosmetics at the concentrations listed in Table 1, despite concerns regarding potential endocrine disruption.
While there are indications of an endocrine mode of action in Benzyl Salicylate, there is no evidence of adverse endocrine effects. The SCCS’s assessment does not encompass environmental safety, as their mandate does not extend to environmental issues.
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References:
- SCCS/1656/23 Final Opinion. https://health.ec.europa.eu/system/files/2023-11/sccs_o_277.pdf
