Nano-hydroxyapatite (n-HAp) on your skin: a safety profile
Moderate risk(People-specific data is limited; this page draws from human adult context.) Biocompatible mineral identical to tooth/bone mineral. Used in remineralizing toothpaste as fluoride alternative. Japan has used since 1980s. EU SCCS (2023) concluded needle-shaped n-HAp is potentially genotoxic but rod/spherical forms are safe in oral care at ≤10%. The shape matters.
What is nano-hydroxyapatite (n-hap)?
The IUPAC name is pentacalcium;hydroxide;triphosphate.
Also known as: Durapatite, 1306-06-5, Calcium hydroxyapatite, Radiesse.
- IUPAC name
- pentacalcium;hydroxide;triphosphate
- CAS number
- 1306-06-5
- Molecular formula
- Ca5HO13P3
- Molecular weight
- 502.3 g/mol
- SMILES
- [OH-].[O-]P(=O)([O-])[O-].[O-]P(=O)([O-])[O-].[O-]P(=O)([O-])[O-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2]
- PubChem CID
- 14781
Risk for people
Moderate riskBiocompatible mineral identical to tooth/bone mineral. Used in remineralizing toothpaste as fluoride alternative. Japan has used since 1980s. EU SCCS (2023) concluded needle-shaped n-HAp is potentially genotoxic but rod/spherical forms are safe in oral care at ≤10%. The shape matters.
Regulatory consensus
3 regulatory and scientific bodies have classified Nano-hydroxyapatite (n-HAp). The classifications differ — that's the data.
| Agency | Year | Classification | Notes |
|---|---|---|---|
| EU SCCS | 2023 | Safe in oral cosmetics (non-nano or rod-shaped nano ≤10%); needle-shaped nano form potentially genotoxic — not safe | |
| Japan | 1980 | Approved dental ingredient since 1980s (Sangi/Apagard) | |
| Canada | 2024 | Under Health Canada assessment for cosmetic use |
Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.
Where you encounter nano-hydroxyapatite (n-hap)
- Personal Care
- Medical Device
Safer alternatives
Lower-risk approaches that achieve a similar outcome to Nano-hydroxyapatite (n-HAp):
-
Fluoride (sodium fluoride, stannous fluoride)
Trade-offs: Well-established efficacy but fluorosis risk at high intake. Nano-HAp may be preferred in fluoride-restricted markets (Japan).Relative cost: 0.1× nano-HAp
-
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP)
Trade-offs: Milk protein derivative — not suitable for dairy-allergic patients. Prescription product in some markets.Relative cost: 2× fluoride toothpaste
Frequently asked questions
Why do regulators disagree about nano-hydroxyapatite (n-hap)?
Nano-hydroxyapatite (n-HAp) has been classified by 3 agencies including EU SCCS, Japan, Canada, with differing conclusions. Regulators apply different standards of evidence (animal data weighting, exposure-pattern assumptions, epidemiological power thresholds), which is why two scientific bodies can review the same data and reach different conclusions. See the regulatory consensus table on this page for the full picture.
See Nano-hydroxyapatite (n-HAp) in the body app
Look up products containing nano-hydroxyapatite (n-hap), compare to alternatives, and explore the full data record.
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Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →