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Monday, July 10, 2023Regulation

Water-soluble zinc salts in oral products: the preliminary Opinion of the SCCS

Sels de zinc hydrosolubles dans les produits bucco-dentaires : l'Opinion préliminaire du CSSC

Following the submission of new data by Cosmetics Europe, the European Commission has requested the SCCS to re-evaluate the safety of water-soluble zinc salts in oral products. The Scientific Committee on Consumer Safety has just published its preliminary Opinion. Its is open for comments until until 8 September 2023.

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Background

In June 2018, the SCCS concluded that the use of zinc in toothpaste and mouthwash per se is safe. However, SCCS highlighted that the dietary intake was not taken under consideration and the committee “cannot advise which portion of the upper limit should be allocated to exposure from cosmetic products.” The SCCS also added that any additional source of exposure may lead to exceeding the upper limits.
In May 2021, Cosmetics Europe submitted a dossier including considerations on dietary exposure, absorption kinetics and consumer use of oral products as a function of age.

For an exhaustive background information, see the articles
Zinc salts, UV-Filter S87, Hair dye A164: Three Opinions of SCCS, CosmeticOBS, 22 March, 2017
Water-soluble zinc salts: new request for Opinion to the SCCS, CosmeticOBS, 13 February 2023

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 …

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