SCCS Scientific Advice on the Safety of Triclocarban and Triclosan
The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. The deadline for comments was set at 27 May 2022.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

TRICLOCARBAN AND TRICLOSAN

Triclocarban and Triclosan are ingredients used widely as preservatives in cosmetics and personal care products. They are both included in Annex V (list of preservatives allowed in cosmetic products) of the European Cosmetics Regulation (No. 1223/2009).

Triclocarban (CAS number: 101-20-2) can be used as a preservative up to a concentration of 0.2% in ready for use preparation, subject to purity criteria (Annex V, entry 23). This ingredient is also included in the list of substances which cosmetic products must not contain except subject to the restrictions laid down (Annex III, entry 100). For use other than as a preservative, Triclocarban may be used in rinse-off products up to a maximum concentration of 1.5%, subject to purity criteria.

Triclosan (CAS number: 3380-34-5) can only be used as a preservative in cosmetics. It may be used up to a concentration of 0.2% in mouthwashes and up to 0.3% in other products like toothpastes, hand soaps, body soaps, deodorants (non-spray), face powders, etc. (Annex V, entry 25).

Both Triclosan and Triclocarban have been assessed several times by the European Commission’s Scientific Committee on Consumer Safety (SCCS) and previous committees. These SCCS opinions resulted in the existing regulatory measures that allow different concentration of these ingredients based on the type of product and function.

In early 2019, a priority list of 28 potential endocrine disruptors (not already covered by the bans of cosmetic regulation) was established by the Commission. From these 28 substances, 14 were considered as higher priority (Group A) and the other 14 were included in the low priority group (Group B). The public call for data for the considered higher priority substances was carried out in 2019. Triclocarban and Triclosan were included in the mentioned group for which the call of data took place. (see previous post)

During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of Triclocarban and Triclosan in cosmetic products. The European Commission asked the SCCS to carry out a safety assessment on these two substances considering the information provided.

SCCS SCIENTIFIC ADVICE ON THE SAFETY OF TRICLOCARBAN AND TRICLOSAN

At its plenary meeting on 15-16 March, the SCCS adopted the preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products.

Based on the available information, including the potential endocrine effects of these ingredients, the SCCS stated that the use of Triclocarban as a preservative in cosmetic products is safe up to a maximum concentration of 0.2% and that this ingredient is also safe up to a maximum concentration of 1.5% in rinse-off products when used individually or in combination, when used with a function other than preservative.

Regarding the use of Triclosan, the SCCS considers that it is safe as a preservative when used individually or in combination up to a maximum concentration of 0.03% in shower gel and hand soap, 0.2% in mouthwash and 0.3% in toothpaste, deodorant stick, face powder and blemish concealer. The SCCS concluded that Triclosan up to a concentration of 0.3% is not safe as preservative in body lotion, but it is safe if its concentration does not exceed 0.03% in this type of cosmetic products.

The SCCS preliminary opinion is open for comments until 27 May 2022.

If you wish to get more information on the safety of cosmetic ingredients, feel free to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Scientific Committee on Consumer Safety (SCCS). Scientific Advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. SCCS/1643/22. 2022.

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