Editor's Notes: This article was originally published on July 5, 2023, and was updated on November 7, 2023, as per the latest developments.
On November 6, EU Scientific Committee on Consumer Safety (SCCS) finalized the refined scientific opinion on water-soluble zinc salts used in oral hygiene products. Compared to the preliminary opinion introduced this July, the finalized one includes additional clarification in its conclusion, which is marked in red in the following article.1
Water-soluble zinc salts are commonly used in oral cosmetic products to reduce the formation of oral malodor, tartar, and plaque. To ensure the safe use of these substances, SCCS released the opinion SCCS/1586/17 in June 2018, confirming the safety of up to 1% water-soluble zinc salts (as zinc) in toothpaste and up to 0.1% (as zinc) in mouthwash. In this opinion, SCCS also indicated that exposure to zinc might occur from sources other than cosmetics, such as daily dietary intake, which was not taken into account in the assessment.
In May 2021, the personal care association Cosmetics Europe submitted a new assessment dossier that included a review of the tolerable upper intake level(UL) of zinc, which is the maximum level of chronic intake from all sources that is unlikely to pose a risk of adverse health effects in humans. In response, SCCS conducted another safety assessment, and compiled this refined opinion. According to the latest assessment results, the use of water-soluble zinc salts is safe
Up to 1% in toothpaste except for children under one year of age. For children between six months and one year of age, SCCS additionally recommends a safe concentration of 0.72% in toothpaste;
Up to 0.1% in mouthwash across all age groups above six years of age.
Request a Demo

We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 





