SCCS/1654/23: Methyl Salicylate in Children's Cosmetics Reassessed

The SCCS (Scientific Committee on Consumer Safety, the scientific committee for consumer safety of the EU Commission) has published a scientific opinion on children's exposure to methyl salicylate. The opinion carries the number SCCS/1654/23, was adopted on 14 September 2023 and published on 22 September 2023. It assesses the concentrations at which the substance is considered safe in children's cosmetics.

Which substance is concerned

Methyl salicylate (INCI: Methyl Salicylate, also Methyl 2-hydroxybenzoate) is a fragrance and flavouring substance found in cosmetics, among other things in oral care and in leave-on as well as rinse-off products. The assessment is based on Regulation (EC) No 1223/2009 on cosmetic products.

The current opinion follows on from an earlier assessment. In opinion SCCS/1633/21, the committee concluded that methyl salicylate in toothpaste for children under 6 years is safe if a maximum concentration of 2.52 percent is not exceeded. In SCCS/1654/23, the committee now considers additional product categories and aggregate exposure, that is the sum of the intake from several products.

What the SCCS establishes for the age group 0.5 to 3 years

For children aged 0.5 to 3 years, the committee considers the use of methyl salicylate up to a maximum concentration of 0.02 percent to be safe. This applies to the following product types:

• Shower gel
• Hand soap
• Shampoo
• Body lotion
• Face cream
• Hand cream
• Lip products
• Hair conditioner

For toothpaste, the committee considers a maximum concentration of up to 2.52 percent to be safe.

An explicit limitation is important here: no specific data from the applicant was available to the committee for children under 6 months. This age group was therefore not taken into account in the safety assessment. The opinion thus makes no statement for children younger than 6 months.

What applies to the age group 3 to 6 years

For children aged 3 to 6 years, the committee considers the use of methyl salicylate in the same product categories to be safe, but here up to the respective permitted maximum concentrations, which are set out in Table 1 of the opinion. This again concerns shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products and hair conditioner. For this age group too, a maximum concentration of up to 2.52 percent is assessed as safe for toothpaste.

The specific product-related maximum values for the age group 3 to 6 years are set out in Table 1 of the opinion. In its assessment, the SCCS explicitly refers to the conclusions from SCCS/1633/21 and to aggregate exposure.

An opinion is not a regulation

An important point of classification: an SCCS opinion is a scientific assessment, not a legal act. It provides the EU Commission with the technical basis to decide on possible adjustments to the annexes of Regulation (EC) No 1223/2009. Whether and when this results in binding maximum values or restrictions in the annexes is not regulated by the opinion itself. It does not specify a deadline for this.

For manufacturers, this means: the values stated in SCCS/1654/23 describe what the committee classifies as safe from a toxicological point of view. They are a key reference point for the safety assessment, but they do not replace checking the current text of the regulation and the annexes in force at any given time.

What manufacturers of children's products should check now

Anyone formulating or placing on the market cosmetic products for children containing methyl salicylate can keep the following points in mind:

• Does the formulation contain methyl salicylate, including from fragrance compositions or essential oils in which the substance may occur naturally?
• Which target age group is the product intended for, and does the use concentration match the values assessed as safe by the SCCS?
• Is aggregate exposure taken into account, that is the simultaneous use of several products by the same child?
• Are products for children under 6 months affected? The opinion makes no statement for this age group.

The full opinion is available as a PDF (SCCS/1654/23) on the website of the European Commission. It contains Table 1 with the product-specific figures.

Sources and further information

You can find the original opinion here: SCCS Scientific Advice, children exposure on Methyl salicylate (SCCS/1654/23). An overview of all SCCS opinions is provided by the SCCS Opinions page.

Whether and how the values from SCCS/1654/23 need to be taken into account for a specific product in the safety assessment (CPSR, Cosmetic Product Safety Report under Annex I of Regulation (EC) No 1223/2009) depends on the respective formulation and target group. This assessment is carried out by a qualified safety assessor.