EU scientific body deems safe use of triclocarban and triclosan in cosmetics, flags potential endocrine-disrupting properties

07 Nov 2022 --- The Scientific Committee on Consumer Safety (SCCS) is presenting its final opinion on the safe use of triclocarban and triclosan as cosmetic substances with potential endocrine-disrupting properties.

Leveraging currently available scientific literature, relevant in silico tools and SCCS’ expert judgment, the Committee has identified and justified concerns regarding the safety and risks.

Triclocarban: Preservative, mouthwash and toothpaste
Triclocarban, as a preservative in dermally applied cosmetics, has been deemed safe up to a maximum concentration of 0.2% for children (6 months to 18 years) and adults, individually or in combination.

“The SCCS has noted that triclocarban is a weak skin irritant but not an eye irritant. Data show no evidence of skin sensitization or photoallergenicity,” shares the report.

Additionally, for the same use in rinse-off products when used individually or in combination, triclocarban is safe up to a maximum concentration of 1.5% for children and adults.Triclocarban poses a moderate potential of estrogenic and androgenic disruption.

However, triclocarban is not safe for children and adults when used at a concentration of 0.2% in mouthwash – and in toothpaste is not safe for children below six years old.

Moreover, the SCCS assessment did not include exposure of babies through wipes nor the potential risk of using triclocarban and triclosan together in a product.

Triclosan concentrations to consider
Triclosan concentrations as a cosmetic preservative reported in entry 25 of Annex V for dermally applied cosmetic product is safe except for body lotions – when used individually or in combination for children and adults.

“Triclosan at a concentration of 0.3% is not a skin or oral mucosal irritant, whereas, at one to 10% concentrations, it can produce slight, reversible irritation in the rabbit eye. Triclosan has a low sensitization potential in humans. Possible photo contact allergy has been rarely reported,” outlines the report.

Triclosan as a preservative in toothpaste has been deemed safe at 0.3% when used individually for children and adults. However, it is unsafe when used in combinations for children aged below three, flags the SCCS.

Moreover, triclosan as a preservative in mouthwash is safe at the concentration of 0.2% but not when combined. “For children and adolescents, it is not safe at 0.2%, even when used individually,” highlights the Committee.

Toxicity?
The SCCS has found that triclocarban is not mutagenic or carcinogenic. The report details that: “In-silico and in-vitro studies provide evidence for a moderate estrogenic and androgenic potential of triclocarban, with the further indication of a weak affinity for thyroid receptors.”

“There is also evidence of the endocrine activity of triclocarban from in-vivo animal studies. The human studies do not provide robust evidence of disruptive endocrine effects of triclocarban.”

On the other hand, triclosan was also not found to be mutagenic or carcinogenic. However, the SCCS highlights that triclosan is a peroxisome proliferator in mice liver (inducer of rodent liver cancer).

“Several studies have demonstrated estrogenic and anti-androgenic activity of triclosan, confirming the androgen- and estrogen-mediated activity of triclosan. There is also evidence of endocrine activity of triclosan from in-vivo animal studies,” continues the report.There is evidence of endocrine activities of triclosan from in-vivo animal studies.

Additionally, human studies are noted not to provide strong evidence of the disruptive endocrine effects of triclosan. This is due to inconsistent findings on the impact of triclosan on the thyroid hormones and “statistically non-significant associations between triclosan and birth outcomes.”

Regulation updates
Last month, the SCCS shared its final opinion on the use of the aglycone form of genistein and daidzein in cosmetics while factoring in its potential endocrine-disrupting properties. The compounds are currently used in cosmetics as antioxidants, skin protectants and skin and hair conditioning agents.

Moreover, the European Committee (EC) is seeking SCCS’ opinion on the safe use of the hair dye Hydroxypropyl p-phenylenediamine and its dihydrochloride salt.

The EC is also restricting the use of Methyl Salicylate, an agent used for its fragrant, flavoring and soothing properties in cosmetics, due to its potential to cause irritations and acute toxicity.

The French requirement to label leave-on cosmetic products containing phenoxyethanol with the precautionary measure, “not to be used on the nappy-skin area of children under three years of age” was repealed last week. The ingredient is frequently used as a preservative or stabilizer.

By Venya Patel