SCCS Addendum to the Scientific Opinion on Hexyl Salicylate SCCS/1658/23 (CAS/EC No. 6259-76-3/228-408-6) - Children exposure 0-3 years old

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfenati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz (Rapporteur) 
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1668/24
Adopted on: 25 October 2024

Conclusion of the opinion:

(1) In light of the data provided and taking under consideration the CMR Cat.2 classification (to be introduced in Annex VI to Reg. 1272/2008), does the SCCS consider Hexyl Salicylate safe for children below 3 years of age when used up to the maximum concentrations provided in the dossier?

Based on the assessment of data provided, given the CMR Cat. 2 classification (Annex VI EC/1272/2008)) and taking into consideration all toxicological endpoints, including potential endocrine disrupting effects, the SCCS considers Hexyl Salicylate safe for children up to 3 years old when used up to the maximum concentrations as below:

• 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 according to the SCCS the maximum concentration of Hexyl Salicylate that is considered safe for children below 3 years of age?

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(3) Does the SCCS have any further scientific concerns with regard to the use of Hexyl Salicylate in cosmetic products and children’s exposure?

The results of the infant survey by Cosmetics Europe that have been made available as draft to the SCCS show that a significant proportion of babies had “skin issues” and that children with damaged skin could be exposed to cosmetic products containing Salicylates. This raises concern to the SCCS, since there may be enhanced uptake of chemical substances through damaged skin. Also, Hexyl Salicylate is classified as a skin sensitiser Category 1. Furthermore, it is not known whether Salicylic Acid may be present in the products as an impurity or resulting from the breakdown of hexyl salicylate. It is notable that Salicylic Acid is not permitted in cosmetic products used by children under the age of 3 years. If it is present as an impurity, it must be kept at a technically unavoidable trace level.

The amount of toothpaste ingested by children below 3 years old considered in this Opinion for the calculation of the MoS has been adapted based on available data and now is much higher than the one used in previous Opinions on Salicylates in cosmetic products used by children (e.g. Methyl salicylates, SCCS/1654/23). This may raise concerns about their safety in the context of exposure to other salicylates, especially for salicylates for which the MoS is close to 100.

This Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of the end-user’s lungs by inhalation.

The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Hexyl Salicylate for the environment.

Keywords:

SCCS, scientific opinion, addendum, Hexyl Salicylate, CAS/EC No. 6259-76-3/228-408-6, children exposure, SCCS/1658/23, SCCS/1668/24, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Addendum to the Scientific Opinion on Hexyl Salicylate SCCS/1658/23 (CAS/EC No. 6259-76-3/228-408-6) – children exposure 0-3 y.o., SCCS/1668/24, preliminary version of 26 July 2024, final version of 25 October 2024.