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.
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. The SCCS adopted its preliminary Opinion in May 2025, validating the safe use of the concentrations proposed by industry.
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
• Hydroxyapatite in oral products: preliminary Opinion of the SCCS, CosmeticOBS, 7 April 2025
This Opinion has been subject to a commenting period from 3 April to 30 May 2025. Comments received during this period were considered by the SCCS.
For the final document, main changes occurred in the following sections: Table 6 (Section 3.1.9.2.: Hydroxyapatite (nano) in Cell Culture Media) and a summary Table has been added to describe the in vitro biocompatibility and irritation of biomimetic hydroxyapatite nanoparticles on human oral epithelium (Section 3.2.2: Other studies on toxicokinetics).
The final Opinion
a) In view of …
