SCCS publishes Final Opinion on children’s exposure to Methyl Salicylate

Ingredients: METHYL SALICYLATE

Date of publication: 14/09/2023

On 14 September, 2023, the Scientific Committee on Consumer Safety (SCCS) published its Final Opinion on the safety of Methyl Salicylate as used in cosmetic products intended to children.

BACKGROUND

Methyl Salicylate (CAS No. 119-36-8) is the ester of methyl alcohol and salicylic acid, used in cosmetics and personal care products as a denaturant, flavouring, oral care, perfuming and soothing agent.

Methyl Salicylate has been classified as toxic for reproduction (CMR substance, category 2) under Regulation (EC) No. 1272/2008 (CLP), but it was not included in the Annexes to Regulation (EC) No. 1223/2009.

WHAT’S NEW?

Following the preliminary opinion on May 16, 2023, the Scientific Committee on Consumer. Safety (SCCS) published its final opinion and scientific advice on children exposure on Methyl Salicylate.

In light of the data provided and taking under consideration the conclusions of SCCS/1633/21 and the aggregate exposure, the SCCS considers the use of Methyl Salicylate as safe in:

Toothpaste up to a maximum concentration of 2.52%.
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.
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 the following table:

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

References:

Scientific Committee on Consumer Safety (SCCS) – Scientific Advice – Children exposure on Methyl salicylate (methyl 2-hydroxybenzoate), SCCS/1654/23, Final Version.

other REGULATORY UPDATES

French labelling requirement for leave-on products containing Phenoxyethanol repealed

Ingredients: PHENOXYETHANOL

The EU Court of Justice repealed the French requirement for the labelling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age” on leave-on cosmetic products containing Phenoxyethanol. Therefore, the labelling restriction related to Phenoxyethanol is officially not mandatory for products imported into France.

Butylphenyl Methylpropional (Lilial) ban in cosmetics comes into force in Great Britain

Ingredients: BUTYLPHENYL METHYLPROPIONAL

Date of application: 15/12/2022

Due to its classification as toxic to reproduction, Butylphenyl Methylpropional is prohibited in cosmetic products placed in the Great Britain market as of December 15, 2022.

Italy and France – Environmental Labelling of Cosmetic Products

PACKAGING WASTE MANAGEMENT

Date of application:01/01/2023

Although the European Cosmetics Regulation is applicable to every cosmetic product made available in the European Union market, some national legislations may also apply. Environmental regulations in Italy and France specify mandatory labelling requirements applicable to packaged products marketed in these countries.

Regulation (EU) 2022/1531 – OMNIBUS ACT V – applicable as of 17 December 2022

Ingredients: METHYL SALICYLATE, SODIUM HYDROXYMETHYLGLYCINATE, DBMC, MIBK

Date of publication: 15/09/2022

Date of application: 17/12/2022

The European Commission has published the Commission Regulation (EU) 2022/1531, which amends the Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as CMR, by adding new entries to Annex II and Annex III and revising an entry in Annex V.

Update on the classification and labelling of Titanium Dioxide in powder form

Ingredients: TITANIUM DIOXIDE

Date of publication: 23/11/2022

The EU General Court annuls the Commission Delegated Regulation of 2019 in so far as it concerns the harmonised classification and labelling of Titanium Dioxide as a carcinogenic substance by inhalation in certain powder forms.

SCCS consultation on opinion about Salicylic Acid

Ingredients: SALICYLIC ACID

Date of publication: 15/12/2022

On December 15, 2022, the EU Scientific Committee on Consumer Safety (SCCS) released the preliminary opinion on Salicylic Acid (CAS No. 69-72-7). This opinion is open for comments until February 17, 2023.