SCCS Scientific Advice – children exposure on Methyl salicylate (methyl 2-hydroxybenzoate)

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle (Rapporteur), M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfenati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1654/23
Adopted on: 14 September 2023

Conclusion of the opinion:

In the SCCS/1633/21 Opinion, the Committee concluded that Methyl Salicylate in toothpaste is safe for children under 6 years of age when used up to the maximum concentration of 2.52%.

(1) In light of the data provided and taking under consideration the conclusions of SCCS/1633/21 and the aggregate exposure, does the SCCS consider Methyl Salicylate safe for children of age 0-3, when used up to a maximum concentration of 0.02% in all of the currently regulated cosmetic products included in Table 1 (except toothpaste in which up to 2.52% can be used)?

In view of the conclusions of SCCS/1633/21 and the aggregate exposure, the SCCS considers the use of Methyl Salicylate as safe in cosmetic products intended for children of age 0.5-3 years when used up to a maximum concentration of 0.02% in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products and hair conditioner. For toothpaste up to a maximum concentration of 2.52% methyl salicylate is considered safe.

As no specific data were provided by the applicant for children below 6 months, the SCCS has not considered this age category in this safety assessment.

(2) In light of the data provided and taking under consideration the conclusions of SCCS/1633/21 and the aggregate exposure, does the SCCS consider Methyl Salicylate safe for children of age 3-6, when used up to the allowed maximum concentrations for each of the currently regulated cosmetic products included in Table 1 (except toothpaste in which up to 2.52% can be used)?

In view of the conclusions of SCCS/1633/21 and the aggregate exposure, the SCCS considers the use of Methyl Salicylate as safe in cosmetic products intended for children of age 3-6 years in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products, and hair conditioner up to the allowed maximum concentrations indicated in Table 1. For toothpaste up to a maximum concentration of 2.52% methyl salicylate is considered safe.

Keywords:

SCCS, scientific advice, methyl salicylate, methyl 2-hydroxybenzoate, children exposure, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Scientific Advice on methyl salicylate (methyl 2-hydroxybenzoate) – children exposure, preliminary version of 16 May 2023, final version of 14 September 2023, SCCS/1654/23.