On April 3, 2025, Scientific Committee on Consumer Safety (SCCS) released a Preliminary Opinion for public comment on the safety of Hydroxyapatite (nano) in oral cosmetic products, including toothpaste and mouthwash. The deadline for submitting comments is May 30, 2025.
Based on the scientific data provided, the SCCS considers Hydroxyapatite (nano) safe for use in toothpaste at concentrations up to 29.5% and in mouthwash up to 10%, under reasonably foreseeable exposure conditions. This conclusion is drawn from available evidence indicating that Hydroxyapatite (nano) does not present a mutagenic hazard, cytotoxicity, or inflammatory effects, even when tested at high concentrations using a buccal mucosa cell model.
The SCCS further states that any uptake of Hydroxyapatite (nano) by buccal mucosa is negligible, and epithelial cells that internalize particles will be naturally shed over time. Any unintentional ingestion of Hydroxyapatite (nano) during the use of oral care products will undergo rapid dissolution in gastric fluid, mitigating any potential nano-specific safety concerns.
The safety evaluation is applicable only to Hydroxyapatite (nano) particles that meet the following specifications:
-Composed of rod-shaped particles, with at least 87% (in particle number) having aspect ratios of 3 or less.
-The remaining 13% of particles should have aspect ratios not exceeding 9.
-The Hydroxyapatite particles must not be coated or surface-modified.
The SCCS also clarifies that this opinion does not apply to any Hydroxyapatite (nano) materials composed of or containing needle-shaped particles.
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European Union
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European Union