SCCS publishes final opinions on cosmetic ingredients

Following the latest meeting of EU’s Scientific Committee on Consumer Safety (SCCS) on 26 October 2023 the Committee published its final opinions on the fragrance benzyl salicylate, the preservative butylparaben, the nanomaterial fullerenes in cosmetic ingredients, and water-soluble zinc salts used in oral hygiene products.  

SCCS Final Opinions  

Benzyl salicylate: The SCCS considers benzyl salicylate to be safe when used up to maximum concentrations, based on data and concerns about potential endocrine disrupting properties. However, there is no evidence of endocrine effects, and the SCCS mandates do not address environmental aspects, so this assessment does not assess the safety of benzyl salicylate for the environment. 

Butyl paraben: The SCCS concluded that the use butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% is safe based on the available data and concerns about endocrine activity. However, due to the lack of exposure data for children, potential safety concerns cannot be excluded. 

Water soluble zinc salts: The SCCS has concluded that the use of zinc in toothpaste and diet is safe, except for children under 1 year of age, as the intake exceeds the upper limit level. For children aged 6 months to 1 year, a safe concentration of 0.72% is recommended. Mouthwash with 0.1% zinc is safe for all ages over 6 years. 

Fullerenes: The Safety Commission for Cosmetics (SCCS) cannot conclude on the safety of fullerenes and (hydrated) hydroxylated forms of fullerenes due to uncertainties and data gaps in physicochemical, toxicokinetic, and toxicological aspects. The SCCS cannot exclude the potential for genotoxicity of fullerenes (C60 and C70) and hydrated forms of hydroxylated fullerenes, which are genotoxic. The SCCS has concerns about the presence of impurities, heavy metals, contaminants, organic solvents, stability, ability to induce free oxygen radicals, phototoxicity, sensitizing potential, dermal absorption, systemic availability, and potential distribution to organs. The available evidence is not sufficient to exclude the genotoxic/carcinogenic potential of any of the materials assessed in this Opinion. 

Even discussed at the SCCS meeting 

The SCCS also published the preliminary opinion on hydroxypropyl-p-phenylenediamine-and-its-dihydrochloride-salt and hexyl salicylate. Based on animal studies, the SCCS considers hydroxypropyl p-phenylenediamine and its dihydrochloride salt safe for use in oxidative hair colouring products at 2% on-head concentration but warns of mild to moderate eye irritation and moderate skin sensitizer. More details about the consultation on the preliminary opinion on the use of hydroxypropyl p-phenylenediamine and its dihydrochloride salt can be found here. 

Silver zinc zeolite and methyl paraben will be further discussed in the next working group meeting, together with the SCCS responses to the comments received.