SCCS/1668/24: Addendum on Hexyl Salicylate and Children Under 3 Years

The SCCS (Scientific Committee on Consumer Safety, the EU Commission's scientific committee for consumer safety) has published an addendum on hexyl salicylate. It supplements the earlier opinion SCCS/1658/23 and specifically addresses exposure of children under 3 years of age. The document bears the number SCCS/1668/24 and was adopted on 25 October 2024. A corrigendum followed on 18 December 2024, correcting values in Table 6 concerning the calculated relative daily exposure.

Which substance is concerned

The substance under evaluation is hexyl salicylate (CAS/EC No. 6259-76-3 / 228-408-6), a salicylic acid ester used as a fragrance ingredient in cosmetics. The addendum was prompted by the classification of the substance as CMR Cat. 2 (substances suspected of being carcinogenic, mutagenic, or toxic for reproduction). According to the source material, this classification is to be included in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). The SCCS was asked to assess whether hexyl salicylate is safe for children under 3 years at the maximum concentrations stated in the dossier.

The safe maximum levels according to the SCCS

Taking into account all toxicological endpoints, including possible endocrine-disrupting effects, the SCCS considers hexyl salicylate safe for children up to 3 years of age provided the following maximum concentrations are not exceeded:

Important: this is a scientific opinion of the SCCS, not yet an amended piece of legislation. The source material does not specify whether and when these values will be incorporated into the annexes of Regulation (EC) No 1223/2009.

Concerns explicitly raised by the SCCS

Despite the stated maximum levels, the committee raises several reservations. These concern the particular situation of young children:

• An infant survey by Cosmetics Europe, available to the SCCS in draft form, shows that a significant proportion of babies had skin problems. Children with compromised skin may be exposed to salicylate-containing products. Absorption of substances through compromised skin may be increased.
• Hexyl salicylate is classified as a skin sensitizer Category 1.
• It is not known whether salicylic acid is present as an impurity in the product or forms through degradation of hexyl salicylate. Salicylic acid is not approved for use in cosmetics for children under 3 years. If present as an impurity, it must be kept at a technically unavoidable trace level.
• The amount of ingested toothpaste assumed for children under 3 years in the MoS (Margin of Safety) calculation has been adjusted based on available data and is now significantly higher than in earlier opinions on salicylates in children's products (such as methyl salicylate, SCCS/1654/23). This may raise questions regarding safety in the context of exposure to other salicylates, particularly where the MoS is close to 100.

Two further limitations should be noted: the opinion does not apply to spray products (including mouth sprays) that may lead to lung exposure through inhalation. Environmental aspects are not covered by the SCCS mandate; environmental safety was therefore not assessed.

Who is affected and what to do now

The addendum is relevant primarily for manufacturers and marketers offering products for the 0 to 3 years age group, or whose products are in practice used by this group, and that contain hexyl salicylate. Fragrance ingredients such as hexyl salicylate are often part of perfume oils and do not always appear obviously in formulations. It is therefore advisable to review the composition of the fragrance oil used.

It makes sense to check the following points: Is hexyl salicylate contained in the formulation, and at what concentration? Does it fall within the levels assessed as safe by the SCCS? Is there any indication of possible cumulation with other salicylates in products for the same target group? And is there a specification documenting the salicylic acid content as an impurity?

Such an assessment forms part of the safety assessment under Annex I of Regulation (EC) No 1223/2009. The final judgment in the specific product context is the responsibility of the safety assessor. We support the preparation of the CPSR (Cosmetic Product Safety Report, safety report under Annex I) and the product information file, and monitor SCCS opinions such as this one.

Assessment

The addendum SCCS/1668/24 reflects a recurring pattern: stricter standards apply to children under 3 years due to differing exposure scenarios and sensitive skin. While the SCCS specifies concrete maximum levels, it links them to clear reservations regarding compromised skin, sensitization, and the combined effect of multiple salicylates. Whether and in what form the EU Commission will legally establish these values is not specified in the source material. The full opinion is available from the EU Commission: SCCS/1668/24 on hexyl salicylate. An overview of all SCCS opinions can be found here.