EU scientific committee updates guidance on safe levels for oral hygiene and personal care chemicals

13 Nov 2023 --- In a comprehensive safety review of various cosmetic ingredients, the European Commission’s Scientific Committee on Consumer Safety (SCCS) has recently assessed the safety of water-soluble zinc salts, benzyl salicylate, hydroxypropyl p-phenylenediamine, butylparaben and fullerenes in personal care and beauty products.

In its assessment of water-soluble zinc salts — used in oral hygiene products to reduce oral malodor, tartar formation and bacteria — the SCCS concluded these are safe for use in toothpaste at up to 1% concentration for adults and children over one year of age, and 0.72% concentration for children under one year of age.

For mouthwash, water-soluble zinc salts are considered safe up to 0.1% concentration for all age groups.

The SCCS also noted that zinc salts have been shown to be effective in reducing gingivitis.

Further safety assessments
The SCCS has also released safety assessments for several other chemicals used in cosmetic products.

The committee concluded that benzyl salicylate is safe for use in cosmetic products at the specified concentrations shown in Table 1. However, the SCCS expressed some concerns about the potential endocrine disrupting properties of benzyl salicylate.Table 1 (Image credits: SCCS).

Hydroxypropyl p-phenylenediamine and its dihydrochloride salt are deemed safe when used in oxidative hair coloring products up to a maximum on-head concentration of 2%.

Acknowledging concerns related to endocrine activity of butylparaben, the SCCS states that the use of butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid) is safe.

Assessment of fullerenes
The SCCS has raised concerns about the safety of fullerenes, hydroxylated fullerenes and hydrated forms of hydroxylated fullerenes, which are used for their antioxidant properties in cosmetic products.

Despite a thorough assessment, the SCCS cannot conclusively determine their safety due to uncertainties and data gaps related to physicochemical, toxicokinetic and toxicological aspects.

“Notably, the committee cannot rule out the genotoxicity potential of fullerenes (C60 and C70), and evidence suggests that hydrated forms of hydroxylated fullerenes are genotoxic, leading the SCCS to deem them unsafe for cosmetic use,” states SCCS.

“Additionally, concerns include potential impurities, phototoxicity, sensitizing potential, dermal absorption and systemic distribution of nanoparticles, with insufficient evidence to exclude genotoxic/carcinogenic potential.”

The SCCS calls for further scientific assessment to identify potential risks to human health associated with these materials in cosmetic products.

The full text of the safety assessment for each of the ingredients highlighted above can be found on the European Commission’s website.

By Benjamin Ferrer