Water-soluble zinc salts used in oral hygiene products - Submission II

SCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1657/23
Adopted on: 26 October 2023

Conclusion of the opinion:

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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Keywords:

SCCS, scientific opinion, water-soluble zinc salts, oral hygiene products, zinc acetate CAS: 557-34-6 EC: 209-170-2, zinc chloride CAS: 7646-85-7 EC: 231-592-0, zinc gluconate CAS: 4468-02-4 EC:/, zinc citrate CAS: 546-46-3 EC:/, zinc sulphate/zinc sulphate monohydrate/zinc sulphate heptahydrate CAS: 7733-02-0/7446-19-7/7446-20-0 EC:/, SCCS/1586/17, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on water-soluble zinc salts used in oral hygiene products - Submission II, preliminary version of 3 July 2023, final version of 26 October 2023, SCCS/1657/23.