Supplement to the SCCS`s Final Opinion on Hexyl Salicylate - reference to products for children under the age of 3 years

07/08/2024

Addendum to the SCCS`s Final Opinion on Hexyl Salicylate 

 

⚠️ On 29th July 2024, the Scientific Committee on Consumer Safety (SCCS) published an addendum to its opinion on Hexyl Salicylate, assessing safety of this ingredient in products for children under the age of 3 years.

 

🤔 What is Hexyl Salicylate?

 

Hexyl Salicylate, aka hexyl 2-hydroxybenzoate, is an ester of Salicylic Acid and 1-hexanol, with the former one being its metabolite. It is a fragrance and cosmetic ingredient that gives a floral, fruity and sweet characteristics. It is commonly used in the formulation of floral-scented products.

 

🤔 What are the main concerns about Hexyl Salicylate?

 

It all started in March 2022 when the recommendation of the Risk Assessment Committee (RAC) of the European Chemical Agency (ECHA) was published. This recommendation shed light on Hexyl Salicylate and its potential to act as endocrine disruptor, thus proposing to classify it as “Toxic for Reproduction Category 2” and "Skin sensitizer Category 1". 

 

Following that, the European Commission asked the SCCS to analyze and assess the safety of this ingredient. 

 

🤔 And what exactly is an “endocrine disruptor”?

 

Endocrine disruptors are types of compounds that can mimic natural hormones and thus affect the functioning of the endocrine system and the entire body. 

 

⚠️ Wait! That's not all. There are more doubts on Hexyl Salicylate.

 

Another concern arises from the chemical nature of Hexyl Salicylate. 

 

As I mentioned earlier, Hexyl Salicylate is classified as ester and one of the most typical properties of such compounds is their ability to be hydrolyzed. Consequently, Hexyl Salicylate can easily decompose (or be metabolized) to Salicylic Acid or Salicylates.

 

And that means that Salicylic Acid may be present in cosmetic formula either as an impurity or as a breakdown product of Hexyl Salicylate. 

 

Since Salicylic Acid is classified as a skin sensitiser Category 1 and banned from the use in cosmetics for children under the age of 3 years, Hexyl Salicylate and its chemical nature raised reasonable questions and concerns. 

 

✅ What is the final SCCS`s opinion?

 

Taking all safety concerns into account, the SCCS concluded that Hexyl Salicylate can be considered safe for use in products for children < 3 years old, only when appropriate concentration limits are maintained.

 

For products like shower gels, hand soaps, shampoos, hair conditioners, body lotions, face creams, hand creams, lipstick/lip balms, fragrance products the maximum concentration of Hexyl Salicylate can be 0.1 % (w/w).

 

Whereas, for toothpastes it is recommended to limit the use of Hexyl Salicylate to 0.001 % (w/w).

 

Does your product contain Hexyl Salicylate? Maybe you are planning to work with this ingredient when creating a new product?

 

 

 

✉️ Contact me if you have any questions or doubts. 

 

 

 

*Reference 

SCCS (Scientific Committee on Consumer Safety), Addendum to the Scientific Opinion on Hexyl Salicylate SCCS/1658/23 (CAS/EC No. 6259-76-3/228-408-6) – children exposure 0-3 y.o., SCCS/1668/24, preliminary version of 26 July 2024.