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On April 3, 2025, EU Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion on Hydroxyapatite (CAS No. 1306-06-5) in nano form, following the industry's fourth submission of a safety assessment dossier for the ingredient. Comments are invited until May 30, 2025.1
Background of Substance Assessment
Hydroxyapatite is included in CosIng with reported functions such as abrasive, bulking agent, oral care agent, and skin-conditioning agent. It was assessed for safety by SCCS in 2015, 2021, and most recently in 2023. In its March 2023 opinion, SCCS concluded that Hydroxyapatite (nano) was safe for use at concentrations of up to 10% in toothpaste, and up to 0.465% in mouthwash, provided it consisted of rod-shaped particles—at least 95.8% (by number) with an aspect ratio below 3, and the remaining particles not exceeding an aspect ratio of 4.9—and was neither coated nor surface-modified.
Following this conclusion, Commission Regulation (EU) 2024/858 was introduced, adding Hydroxyapatite (nano) to the restricted ingredients list with limits reflecting the SCCS opinion. While the regulation was being prepared, stakeholders submitted new evidence supporting its safe use at higher concentrations in oral care products. The European Commission has therefore requested SCCS to conduct a further safety assessment considering the newly submitted evidence.
Conclusions from the Latest Opinion
In light of new evidence, SCCS updates the conclusions outlined in its March 2023 opinion, indicating that higher concentrations of Hydroxyapatite (nano) can be safely used in oral care products. Specifically, the substance is considered safe for use at concentrations of up to 29.5% in toothpaste, and up to 10% in mouthwash. The opinion applies only to Hydroxyapatite (nano) with the following specifications:
- Composed of rod-shaped particles of which at least 87% (in particle number) have an aspect ratio of 3 or less, and the remaining 13% have an aspect ratio not exceeding 9;
- The particles are not coated or surface modified.
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