Following the final opinion of the SCCS in March 2023, and the restrictions on the substance adopted by the European Commission, the cosmetics industry has provided additional information in support of its safe use in higher percentages in oral products. The SCCS has just published its preliminary Opinion on this subject. It is open for comments until May 30, 2025.
Background
Following a regulatory proposal by the Commission services to restrict the use of Hydroxyapatite (nano) in cosmetics (subsequently published via Regulation 2024/858), industry submitted evidence to demonstrate its safety at higher concentrations in oral products.
For an exhaustive background information, see the articles
• Hydroxyapatite: new request for an Opinion to the SCCS (oral products), CosmeticOBS, 27 November 2023
• Regulation 2024/858: 12 nanos banned, Hydroxyapatite subject to restrictions, CosmeticOBS, 18 March 2024
The SCCS Opinion
a) In view of the above, and taking into account the scientific data provided, does the SCCS consider Hydroxyapatite (nano) safe when used in toothpaste up to a maximum concentration of 29.5 % and in mouthwash up to a maximum concentration of 10 % according to the specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions?
Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 29.5% in toothpaste, and up to 10% in mouthwash.
This conclusion is based on the available evidence, which shows that hydroxyapatite (nano) does not pose a mutagenic hazard or cytotoxicity or inflammatory effects even when tested at …
