SCCS/1676/25: New Safe Maximum Levels for Methyl Salicylate in Children's Products

The Scientific Committee on Consumer Safety (SCCS) adopted a revised opinion on methyl salicylate on 30 April 2025. It carries the number SCCS/1676/25 and revises the earlier opinion SCCS/1654/23. At its core is the question of what maximum concentration of methyl salicylate in products for children aged 0 to 3 years is considered safe.

What is methyl salicylate?

Methyl salicylate (INCI: Methyl Salicylate, chemically methyl 2-hydroxybenzoate) is a fragrance and flavouring substance used in cosmetic products. The European Commission had asked the SCCS to re-evaluate the safe maximum concentration for this substance in products for children aged 0 to 3 years. The re-evaluation was based on the conclusions of opinion SCCS/1658/23 as well as the aggregated exposure, i.e. the total burden from multiple sources.

Important for context: an SCCS opinion is a scientific statement. It is not yet applicable law. Regulation (EC) No 1223/2009 on cosmetic products will only be amended once the Commission issues a corresponding amending regulation based on such an opinion. Whether and when this will happen is not stated in the available source material.

The new maximum levels in detail

In SCCS/1676/25, the SCCS reaches a clear conclusion. According to the opinion, two values apply to the concentration of methyl salicylate considered safe in products for children aged 0 to 3 years:

In the SCCS's view, the concentration of methyl salicylate should not exceed 0.4 % in toothpaste and 0.02 % in other products in order to be considered safe when used in products for children aged 0 to 3 years.

Who is affected by the assessment?

The re-evaluation is directed at all manufacturers and distributors who use methyl salicylate in products intended for children aged 0 to 3 years. This includes in particular toothpaste, for which a separate, higher value is given, as well as all other cosmetic products for this age group, for which the significantly lower value of 0.02 % applies.

The SCCS also expressly points out the limits of its mandate. SCCS mandates do not address environmental aspects. The assessment therefore does not cover the safety of methyl salicylate for the environment. Regarding the Commission's second question, whether the SCCS has any further scientific concerns regarding the use of methyl salicylate in cosmetic products and children's exposure, the opinion refers to this environmental caveat.

Status and deadlines

The opinion was drafted in the version of 17 January 2025 and adopted in its final version on 30 April 2025. The publication date is 2 May 2025. It is cited as: SCCS (Scientific Committee on Consumer Safety), Scientific Advice on Methyl Salicylate (methyl 2-hydroxybenzoate) - children exposure, version of 17 January 2025, final version of 30 April 2025, SCCS/1676/25.

Since this is a scientific opinion, the source material does not specify a transition period or a date of entry into force for any legal implementation. Such deadlines would only arise with a subsequent amending regulation from the Commission. Whether such a regulation will follow cannot be determined from the opinion.

What manufacturers can check now

Even without an immediately applicable legal change, the opinion provides important technical guidance. It is advisable to systematically review your own product portfolio:

• Do products for children aged 0 to 3 years contain methyl salicylate, for example as part of a fragrance composition?
• What is the actual concentration of methyl salicylate in the respective formulation?
• Does the value exceed 0.4 percent for toothpaste or 0.02 percent for other products?
• Is aggregated exposure taken into account, i.e. the contribution of multiple products to the total burden?

Methyl salicylate can also enter a formulation as a minor constituent of a perfume oil. A look at the specifications and safety data sheets from raw material suppliers helps assess the actual content.

The full opinion is available as a PDF on the website of the European Commission. You can find it via the publication page for the SCCS opinion as well as in the overview of SCCS opinions.

Practical implications

For the safety assessment under Annex I of Regulation (EC) No 1223/2009, the so-called CPSR (Cosmetic Product Safety Report), SCCS opinions are a central scientific basis. Even though the maximum values mentioned are not yet legally binding within the annexes of the regulation, current SCCS assessments feed into the technical argumentation of a safety assessment. Anyone developing or placing children's products containing methyl salicylate on the market should therefore incorporate the new values into their own product development and documentation at an early stage. For questions regarding the assessment of a specific formulation, we support the preparation of the relevant documentation.