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  • Writer's pictureDaniel Jiménez

SCCS Cosmetic Products, Final Statement on Hexyl Salicylate

On March 11, 2024, the final verdict of the Scientific Committee for Consumer Safety (SCCS) on Hexyl Salicylate was unveiled, through the document identified as SCCS/1658/23.

This component, used in the cosmetics industry, had previously been suggested by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) in March 2022 to be classified as a potential risk of Carcinogenicity, Mutagenicity, or Reproductive Toxicity (CMR) category 2.

Following the submission of additional evidence by stakeholders arguing for its safety, the European Commission tasked the SCCS with a detailed review of its safety profile.

The SCCS's conclusion, after reviewing the new evidence and assessing concerns about endocrine-disrupting effects, is that Hexyl Salicylate can be considered safe for use in cosmetics up to the following concentration limits:

  • For alcohol-based fragrances, a limit of 2%

  • For products that require rinsing after use, a limit of 0.5%

  • For direct-use products without rinsing, a limit of 0.3%

  • For oral hygiene products, such as toothpastes and mouthwashes, a limit of 0.001%

The committee also addressed the lack of specific information about the application of cosmetics on children, as well as considering differences in exposure according to age. Despite this, based on a high Margin of Safety (MoS) observed in adults, a considerable MoS for children between 3 and 10 years is inferred, suggesting safe use in this age group.

It should be noted that the analysis carried out by the SCCS does not include aspects related to the environmental impact of Hexyl Salicylate, as this assessment focuses solely on safety for human use.

For more information, please contact our team of EU Regulatory Agents.

SCCS Cosmetics Products, Final Statement on Hexyl Salicylate
SCCS Cosmetics Products, Final Statement on Hexyl Salicylate

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