SCCS Issued Final Opinion on the Safety of Water-soluble Zinc Salts

On November 6, 2023, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued final opinion(SCCS/1657/23) on water-soluble zinc salts. The preliminary opinion on the safety of water-soluble zinc salts in cosmetics was released on July 4, 2023.

The SCCS concludes the following:

In light of the data provided and taking under consideration the aggregate exposure (including diet) and the concerns on the Tolerable Daily Upper Intake,

(1) Does the SCCS consider that water soluble zinc salts are safe up to 1 % (as zinc) in toothpaste and 0.1% (as zinc) in mouthwash, for both adults and children? If not, the SCCS is requested to provide safe concentrations for each age group.

The SCCS has calculated aggregate exposure to water-soluble zinc salts via toothpaste at the concentrations of 1% and from diet, and concluded that the use of zinc in toothpaste is safe per se except for children under the age of 1 year because the intake exceeds the upper limit level. For children between 6 months and 1 year of age, the SCCS recommends a safe concentration of 0.72% for soluble zinc salts (as zinc) in toothpaste.

The inclusion of zinc in mouthwash at 0.1% Zn is considered safe across all age groups above 6 years.

(2) Does the SCCS consider that the contribution of the cosmetic products among the overall/total exposure to zinc is still of concern?

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Further Information

SCCS/1657/23