Conclusion of the Opinion:
(1) In light of the data provided, and taking into consideration the CMR Category 2 classification (to be included in Annex VI of Reg. 1272/2008), does the SCCS consider Hexyl Salicylate safe for children under three years of age when used at the maximum concentrations indicated in the dossier? Based on the evaluation of the provided data, taking into account the CMR Category 2 classification (Annex VI of EC/1272/2008), and considering all toxicological endpoints, including potential endocrine-disrupting effects, the SCCS considers Hexyl Salicylate safe for children up to three years of age when used at the following maximum concentrations:
0.1% (w/w) for shower gel, hand soap, shampoo, hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm, fragrance products
0.001% (w/w) for toothpaste
(2) Alternatively, what is the maximum concentration of Hexyl Salicylate considered safe by the SCCS for children under three years of age? / (This question is not answered in the provided text, as indicated by the "/")
(3) Does the SCCS have any further scientific concerns regarding the use of Hexyl Salicylate in cosmetic products and children's exposure?
The results of the baby survey, presented in draft form to the SCCS by Cosmetics Europe, indicate that a significant proportion of infants experience "skin problems," and children with damaged skin may be exposed to cosmetic products containing Salicylates. This is a concern for the SCCS because the absorption of chemicals can be enhanced through damaged skin. Furthermore, Hexyl Salicylate is classified as Category 1 for skin sensitization. In addition, it is not known whether Salicylic Acid is present in the products as an impurity or arises from the degradation of hexyl salicylate. It is important to note that Salicylic Acid is not permitted in cosmetic products intended for children under three years of age. If present as an impurity, it should be kept at a technically unavoidable trace level. The amount of toothpaste ingested by children under three years of age, considered for the MoS (Margin of Safety) calculation in this Opinion, has been adapted based on available data and is now much higher than that used in previous Opinions on Salicylates in cosmetic products used by children (e.g., Methyl Salicylate, SCCS/1654/23). This may raise concerns regarding their safety in the context of exposure to other salicylates, especially for those where the MoS is close to 100. This opinion does not apply to any sprayable products (including mouth sprays) that could lead to exposure of the end-user's lungs by inhalation. SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Hexyl Salicylate for the environment.
Source: European Commission