Children’s exposure to Methyl Salicylate: Preliminary SCCS Scientific Advice – Submission II

Ingredients: METHYL SALICYLATE

Date of publication: 16/05/2023

On May 16, 2023, the EU Scientific Committee on Consumer Safety (SCCS) published a preliminary opinion on the use of Methyl Salicylate in cosmetics intended for children. The draft is open for comments until June 19, 2023.

On May 16, 2023, the EU Scientific Committee on Consumer Safety (SCCS) published a draft opinion on the use of Methyl Salicylate (CAS No. 119-36-8) in cosmetics intended for children. The draft is open for comments until June 19, 2023.

Background

Methyl Salicylate (CAS number: 119-36-8) is the ester of methyl alcohol and salicylic acid and is used, in cosmetics and personal care products, as a denaturant, flavouring, oral care, perfuming and soothing agent. This substance was classified as toxic for reproduction (CMR substance, category 2) under the CLP Regulation, but it was not included in the Annexes to Regulation (EC) No 1223/2009.

In October 2021, the SCCS issued its final opinion on Methyl Salicylate. The Committee concluded that Methyl Salicylate is considered safe when used in cosmetics up to the maximum concentration provided in the dossier submitted. Considering its classification as a CMR substance of category 2 and the SCCS opinion, the European Commission concluded that Methyl Salicylate should be added to the List of Substances Restricted in Cosmetic Products (Annex III to Regulation, entry 324), in accordance with the following table:

What’s new?

In the SCCS/1633/21 Opinion, the SCCS 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%.

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

The preliminary opinion is open for comments until June 19, 2023.

References:

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

other REGULATORY UPDATES

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.

SCCS Revision of the Scientific Opinion on Vitamin A

Ingredients: RETINOL, RETINYL PALMITATE, RETINYL ACETATE, RETINYL LINOLEATE, RETINAL

Date of publication: 25/10/2022

The Scientific Committee on Consumer Safety has issued a final version of the Scientific Opinion on Vitamin A, concluding that exposure to Vitamin A derived from cosmetics can be a concern for higher exposure consumers, and since cosmetics alone do not exceed the upper limit the SCCS cannot suggest maximum concentration limits that take into account contributions from other sources.

Regulation (EU) 2022/2195 – Updates to cosmetic ingredients use requirements

Ingredients: BHT, ACID YELLOW 3, HOMOSALATE, HAA299 and RESORCINOL

Date of publication: 11/11/2022

Date of application: 01/07/2023

Commission Regulation (EU) 2022/2195 of November 2022 amends Regulation (EC) No 1223/2009, restricting the use of BHT, Acid Yellow 3, Homosalate, HAA299 and Resorcinol, in cosmetic products.

SCCS Preliminary Opinion on Sodium Bromothymol Blue (C186) as hair dyeing

Ingredients: SODIUM BROMOTHYMOL BLUE (C186)

Date of publication: 28/10/2022

Following the request from the EU Commission for a scientific opinion on the hair dye Sodium Bromothymol Blue (C186), on October 2022 the Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion. In light of the data provided, when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5%, the SCCS is of the opinion that the complete safety of Sodium Bromothymol Blue could not be assessed.

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.

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.