SCCS publishes Scientific Opinion on children’s exposure to Salicylic Acid (SCCS/1675/25)
Ingredient: Salicylic Acid

Date of publication: 30 april 2025

The SCCS concluded that Salicylic Acid at 0.5% is not safe for children aged 3-10 years when used in combination, establishing new limits: 0.5% in rinse-off products, 0.15% in leave-on products, and 0.1% in oral care products.

What’s new?

On 30 April 2025, the SCCS adopted a final opinion on children’s exposure to Salicylic Acid, following public consultation initiated in January 2025. The assessment built upon previous opinion SCCS/1646/22 on children’s exposure to this ingredient.

Salicylic acid is currently regulated under Annex III Entry 6 and Annex V Entry 3 of the EU Cosmetics Regulation, with maximum concentration of 0.5% as preservative and up to 3.0% in rinse-off products for other uses.

The assessment considered potential endocrine effects and serious eye irritation.

Main conclusions

As preservative at 0.5%:

  • Not safe when used in product combinations for children aged 3-10 years
  • Safe in individual product categories (except body lotion)
  • Potential to cause serious eye damage

For other uses (non-preservative):

  • Not safe at 3.0% in rinse-off hair products
  • Not safe at 2.0% in selected dermal products
  • Not safe at 0.5% in body lotion

Proposed safe concentrations:

  • 0.5% in rinse-off products
  • 0.15% in leave-on products
  • 0.1% in oral care products

What now?

Expected timeline for regulatory implementation:

  • Final opinion published
  • Amendments to Annexes III and V of EU Cosmetics Regulation expected
  • Cumulative exposure assessment to salicylates ongoing by SCCS

References

SCCS (Scientific Committee on Consumer Safety), Opinion on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3)- children exposure, preliminary version of 10 January 2025, final version of 30 April 2025, SCCS/1675/25

other REGULATORY UPDATES

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.

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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.

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Any REGULATORY QUESTION?

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.

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