SCIENTIFIC ADVICE ON the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products - SCCS/1643/22 - Scientific Advice – Final version
Résumé
The SCCS concludes the following:
In light of the information submitted via the call for data, the currently available scientific
literature, relevant in silico tools and SCCS’ expert judgement and taking under consideration
in particular the concerns related to potential endocrine disrupting properties, the SCCS is
requested:
1. To identify and justify specific concerns regarding the safe use of triclocarban and triclosan
in cosmetic products
Based on the safety assessment carried out in consideration of all available information,
including the potential endocrine effects, the SCCS is of the opinion that:
For Triclocarban
• The use of triclocarban as a preservative in dermally applied cosmetic product is
safe up to a maximum concentration of 0.2% for both children (0.5-18 years) and
adults, when used individually or in combination.
• In addition to the preservative function, the use of triclocarban is also safe up to a
maximum concentration of 1.5% in rinse-off product when used individually or in
combination for both children (0.5-18 years) and adults.
• However, the use of triclocarban to a maximum concentration of 0.2% in mouthwash
is not safe for adults and children and in toothpaste is not safe for children below 6
years old.
• This assessment does not include exposure of babies through wipes.
For Triclosan
• The use of Triclosan as a preservative at the concentrations reported in entry 25 of
Annex V in dermally applied cosmetic product is safe except for body lotions, when
used individually or in combination, for both adults and children (0.5-18 years).
• The use of Triclosan as a preservative in toothpaste is safe at the concentration of
0.3% when used individually for both adults and children (0.5-18 years) but it is not
safe when used in combinations for children below 3 years old.
• For adults, the use of Triclosan as a preservative in mouthwash is safe at the
concentration of 0.2% when used individually but not when used in combination. For
children and asdolescents, it is not safe at 0.2%, even when used individually.
2. To highlight if there is a potential risk for human health from the use of triclocarban and
triclosan in cosmetic products.
The SCCS is not aware of the use of triclocarban and triclosan together in a single product,
and, therefore, this has not been assessed.
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