Hydroxyapatite (nano or not): toothpaste and care

Q: What is hydroxyapatite?

It is a mineral calcium phosphate with the formula Ca₅(OH)(PO₄)₃, INCI name HYDROXYAPATITE and CAS 1306-06-5. CosIng says it is obtained from pearl oyster shells, salmon bone, phosphate rock or by synthesis. In cosmetics, it is used mainly in toothpastes and mouthwashes.

Q: Is nano hydroxyapatite allowed in the EU?

Yes, but only in toothpaste (10% maximum) and mouthwash (0.465% maximum). This is entry 372 of annex III, introduced by Regulation (EU) 2024/858. The particles must be rod-shaped (at least 95.8% by number with an aspect ratio below 3, the rest not exceeding 4.9), not coated or surface-modified, and the product must not expose the lungs through inhalation.

Q: How do you know if a hydroxyapatite is "nano"?

The regulation defines a nanomaterial as an intentionally manufactured insoluble or biopersistent material with one or more external dimensions, or an internal structure, between 1 and 100 nm. The particle size of the batch decides: it is documented with the supplier. An ingredient present in nano form must appear in the ingredients list, followed by the word "nano" in brackets.

Q: What does the SCCS say about nano-hydroxyapatite?

In 2021, it could not conclude, for lack of data ruling out a genotoxicity concern. Its 2023 opinion judges it safe up to 10% in toothpaste and 0.465% in mouthwash, for the form described in entry 372. It covers neither needle-shaped particles nor sprayed products.

Q: Does a hydroxyapatite toothpaste work?

Reviews report a favorable effect on caries against placebo, with no significant advantage over fluoride. Several of these reviews have co-authors linked to a toothpaste manufacturer. The results concern dental health and are not product claims.

Q: Can you use hydroxyapatite in face care?

The nano form is only allowed in toothpaste and mouthwash. For a non-nano form, CosIng cites a "skin conditioning" function, but no skin study is kept in this page: it does not allow us to speak of an effect on the skin.

Q: Can you manufacture a hydroxyapatite toothpaste for my brand?

Our catalog does not yet include a hydroxyapatite toothpaste. Our ISO 22716 certified lab can study it as a custom formula, starting from a material whose particle size is documented to comply with entry 372 if it is nano. Free samples are included.

Hydroxyapatite is a mineral calcium phosphate, used mainly in toothpastes and mouthwashes1 7. Its nano form is allowed in the EU only in these two products, at 10% and 0.465% maximum, with uncoated rod-shaped particles (annex III, entry 372)2. The SCCS judged it safe under these conditions in 20234.

Mohamed El HjoujiFounder and CEO · Updated November 3, 2026 · Reading time 8 min

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Hydroxyapatite at a glance

Entry from our cosmetic ingredient glossary. Regulatory data from the European Commission's CosIng database1, the consolidated Regulation (EC) 1223/20092 and SCCS opinions4 5. Copy the identifiers in one click for your files.

INCI name: HYDROXYAPATITENano form: the name becomes "Hydroxyapatite [nano]" on the label2. The INCI name CALCIUM HYDROXYAPATITE, with the same CAS, is a separate CosIng entry1
Other names: Hydroxylapatite, durapatite"Durapatite" is the international common name, "Hydroxylapatite" the CosIng chemical name1
CAS number: 1306-06-5
EC number: 215-145-7
Formula: Ca₅(OH)(PO₄)₃Formula given by CosIng1
Origin: Mineral or syntheticCosIng: pearl oyster shells, salmon bone, phosphate rock, or synthesis1
CosIng functions: Abrasive, bulking, oral care, skin conditioning"Abrasive", "Bulking", "Oral care" and "Skin conditioning"1
EU status: Nano form restricted: annex III, entry 372Toothpastes 10%; mouthwashes 0.465%. No application that could expose the lungs through inhalation. Only rod-shaped particles are allowed, at least 95.8% (by number) with an aspect ratio below 3 and the remaining 4.2% at most 4.9, not coated or surface-modified2. Entry introduced by Regulation (EU) 2024/8583
Non-nano form: No entry in the annexesAbsent from annexes II to VI consolidated on May 1, 2025. Whether it is nano depends on particle size: an insoluble or biopersistent material of 1 to 100 nm2
Allergen to declare: No
Safety: SCCS opinion 2023: safe within entry 372Safe at 10% maximum in toothpaste and 0.465% in mouthwash for the form described; opinion not applicable to needle-shaped particles or sprays4

What the research says

Each result shows the protocol and the level of evidence. The higher the level, the better the result carries over to a finished formula.

Clinical trialReview or consensusLaboratory

Teeth and mouthOral care

Enamel and dentine remineralization in the laboratory

Laboratory

Nano-hydroxyapatite toothpastesBovine teethArtificial lesions, 2 and 5 weeks

Dentine remineralization is higher than with an amine fluoride toothpaste, but so is that of the group with no toothpaste. On enamel, only pure nano-hydroxyapatite (7%) exceeds the fluoride toothpaste, with no difference from the other groups7.

Caries: 17% protection in a meta-analysis of three trials

Review

2021 systematic review22 studies kept, 5 caries trials, 4 randomized

The meta-analysis of three randomized trials shows 17% protection. The other 17 studies use indirect endpoints, and some trials show hydroxyapatite products not inferior to fluoride ones8.

Update: a favorable effect, with no superiority over fluoride

Review

2024 review18 studies, 5 clinical trials and 8 in situ studies

According to the independent commentary on this review, hydroxyapatite toothpastes do better than placebo (pooled odds ratio of 2.51). Against fluoride, the advantage is not significant (1.1)9 10.

Triple-blind trial in 610 children

Clinical trial

Hydroxyapatite with fluoride versus monofluorophosphate610 children aged 4 to 724 monthsTriple blind, randomized

Toothpastes combining hydroxyapatite and fluoride significantly reduced enamel lesions compared with the standard fluoride toothpaste (p < 0.01). Hydroxyapatite is not tested alone: the effect of the active itself is not isolated11.

Whiter teeth: preliminary evidence

Review

2023 systematic review17 studies including 13 in vitro

In vitro and in vivo results point the same way, with enamel whitening. The six clinical trials remain preliminary12.

Safety of the nano formRegulation

2021: the SCCS cannot conclude

Regulatory opinion

SCCS/1624/20Rods, oral care

The data do not rule out a concern about genotoxic potential. Needle-shaped particles are a concern and must not be used in cosmetics5.

2023: safe in toothpaste and mouthwash, under conditions

Regulatory opinion

SCCS/1648/22Toothpaste ≤ 10%Mouthwash ≤ 0.465%

The SCCS judges nano-hydroxyapatite safe for uncoated rods with a defined aspect ratio. The opinion applies neither to needle-shaped particles nor to sprayed products, for lack of inhalation data4.

A risk estimated as very low in normal use

Review

2018 reviewNanoscale calcium phosphates

No toxicity specific to calcium phosphate nanoparticles. The oral risk is nil because they dissolve quickly in the stomach, and very low through the skin or mucous membranes6.

This page summarizes published literature on a cosmetic ingredient. It does not describe the effect of a finished product, which depends on its formula, and it is not medical advice. Trials on hydroxyapatite use dental health endpoints (caries, remineralization): these are study results, not claims that can be used as is on a label. Several reviews have co-authors employed by a toothpaste manufacturer; this is shown in the sources. No skin study was kept.

Concentrations used in studies

The concentrations on this scale are the regulatory limits of the nano form2, plus the concentration tested in the laboratory7. They do not apply to the non-nano form.

0.465%Mouthwash limit, nano form2

7%Laboratory trial7

10%Toothpaste limit, nano form2

0%36912%

Which products can use hydroxyapatite?

No formula in our white label catalog features hydroxyapatite yet. Our formulation lab can add it to a custom formula or to a catalog formula. Its common uses:

Raw materials and more

Toothpastes and mouthwashes, the main use of the ingredient. In skincare, no skin study is kept and the nano form is not allowed there.

Frequently asked questions about hydroxyapatite

What is hydroxyapatite?

It is a mineral calcium phosphate with the formula Ca₅(OH)(PO₄)₃, INCI name HYDROXYAPATITE and CAS 1306-06-5. CosIng says it is obtained from pearl oyster shells, salmon bone, phosphate rock or by synthesis1. In cosmetics, it is used mainly in toothpastes and mouthwashes.

Is nano hydroxyapatite allowed in the EU?

Yes, but only in toothpaste (10% maximum) and mouthwash (0.465% maximum). This is entry 372 of annex III, introduced by Regulation (EU) 2024/8582 3. The particles must be rod-shaped (at least 95.8% by number with an aspect ratio below 3, the rest not exceeding 4.9), not coated or surface-modified, and the product must not expose the lungs through inhalation2.

How do you know if a hydroxyapatite is "nano"?

The regulation defines a nanomaterial as an intentionally manufactured insoluble or biopersistent material with one or more external dimensions, or an internal structure, between 1 and 100 nm2. The particle size of the batch decides: it is documented with the supplier. An ingredient present in nano form must appear in the ingredients list, followed by the word "nano" in brackets2.

What does the SCCS say about nano-hydroxyapatite?

In 2021, it could not conclude, for lack of data ruling out a genotoxicity concern5. Its 2023 opinion judges it safe up to 10% in toothpaste and 0.465% in mouthwash, for the form described in entry 372. It covers neither needle-shaped particles nor sprayed products4.

Does a hydroxyapatite toothpaste work?

Reviews report a favorable effect on caries against placebo, with no significant advantage over fluoride9 10. Several of these reviews have co-authors linked to a toothpaste manufacturer8 9. The results concern dental health and are not product claims.

Can you use hydroxyapatite in face care?

The nano form is only allowed in toothpaste and mouthwash2. For a non-nano form, CosIng cites a "skin conditioning" function1, but no skin study is kept in this page: it does not allow us to speak of an effect on the skin.

Can you manufacture a hydroxyapatite toothpaste for my brand?

Our catalog does not yet include a hydroxyapatite toothpaste. Our ISO 22716 certified lab can study it as a custom formula, starting from a material whose particle size is documented to comply with entry 372 if it is nano. Free samples are included.

Sources

Peer-reviewed studies and official regulatory sources, checked on November 3, 2026.

European Commission. CosIng, entry HYDROXYAPATITE (CAS 1306-06-5, EC 215-145-7; entry "Hydroxyapatite (nano)", reference 372). ec.europa.eu/growth/tools-databases/cosing
Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, consolidated version of May 1, 2025: annex III, entry 372 "Hydroxyapatite (nano)"; Article 2(1)(k) (definition of nanomaterial); Article 19(1)(g) ("nano" mention). eur-lex.europa.eu
Commission Regulation (EU) 2024/858 of 14 March 2024, identified in the consolidated text as the act introducing entry 372 of annex III (nano hydroxyapatite). eur-lex.europa.eu
SCCS (Scientific Committee on Consumer Safety). Opinion on Hydroxyapatite (nano), SCCS/1648/22, final opinion adopted on 21 and 22 March 2023. health.ec.europa.eu
SCCS. Opinion on Hydroxyapatite (nano), SCCS/1624/20, final opinion adopted on 30 and 31 March 2021. health.ec.europa.eu
Epple M. Review of potential health risks associated with nanoscopic calcium phosphate. Acta Biomater. 2018;77:1-14. doi:10.1016/j.actbio.2018.07.036
Tschoppe P, Zandim DL, Martus P, Kielbassa AM. Enamel and dentine remineralization by nano-hydroxyapatite toothpastes. J Dent. 2011;39(6):430-437. doi:10.1016/j.jdent.2011.03.008
Limeback H, Enax J, Meyer F. Biomimetic hydroxyapatite and caries prevention: a systematic review and meta-analysis. Can J Dent Hyg. 2021;55(3):148-159. PMID 34925515Dr. Kurt Wolff GmbH (two co-authors)
Pawinska M, Paszynska E, Amaechi BT, et al. Clinical evidence of caries prevention by hydroxyapatite: an updated systematic review and meta-analysis. J Dent. 2024;151:105429. doi:10.1016/j.jdent.2024.105429Dr. Kurt Wolff GmbH (two co-authors)
Gugnani N, Gugnani S. Do we have enough evidence to recommend hydroxyapatite toothpaste for preventing dental caries? Evid Based Dent. 2025;26(1):38-39. doi:10.1038/s41432-025-01123-w
Cocco F, Salerno C, Wierichs RJ, et al. Hydroxyapatite-fluoride toothpastes on caries activity: a triple-blind randomized clinical trial. Int Dent J. 2025;75(2):632-642. doi:10.1016/j.identj.2024.09.037
Limeback H, Meyer F, Enax J. Tooth whitening with hydroxyapatite: a systematic review. Dent J (Basel). 2023;11(2):50. doi:10.3390/dj11020050Dr. Kurt Wolff GmbH (two co-authors)

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Hydroxyapatite at a glance

What the research says

Teeth and mouthOral care

Enamel and dentine remineralization in the laboratory

Caries: 17% protection in a meta-analysis of three trials

Update: a favorable effect, with no superiority over fluoride

Triple-blind trial in 610 children

Whiter teeth: preliminary evidence

Safety of the nano formRegulation

2021: the SCCS cannot conclude

2023: safe in toothpaste and mouthwash, under conditions

A risk estimated as very low in normal use

Concentrations used in studies

Which products can use hydroxyapatite?

Raw materials and more

Frequently asked questions about hydroxyapatite

Further reading

Sources

Tell us about your project