SCCS OPINION on water-soluble zinc salts used in oral hygiene products - Submission II - SCCS/1657/23 - Preliminary version U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz The SCCS adopted this Opinion by written procedure on 3 July 2023 (23 pages) Mise en ligne : 4 July 2023 https://health.ec.europa.eu/publications/water-soluble-zinc-salts-used-oral-hygiene-products-submission-ii_en https://health.ec.europa.eu/system/files/2023-07/sccs_o_279.pdf Details Publication date : 4 July 2023 Author : Scientific Committee on Consumer Safety (SCCS) Description 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-SCCS@ec.europa.eu On request from: European Commission SCCS Number: SCCS/1657/23 Adopted on: 3 July 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 up to 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. (2) Does the SCCS consider that the contribution of the cosmetic products among the overall/total exposure to zinc is still of concern? / 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 adopted on 3 July 2023, SCCS/1657/23.