Monitoring report · published 18 September 2025 · reflects the rules at that date

SCCS issues Scientific Opinion on Hydroxyapatite (nano) – Submission IV

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What’s new?

The Scientific Committee on Consumer Safety (SCCS) has published its final opinion (SCCS/1677/25) on Hydroxyapatite (nano) following Submission IV, representing the fourth assessment of this nanomaterial for oral cosmetic applications.

This opinion follows a regulatory proposal by the European Commission to restrict hydroxyapatite (nano) use in cosmetics via Regulation 2024/858, which prompted industry to submit additional safety evidence to support higher concentrations in oral products.

The assessment was conducted following a public consultation period from April 3 to May 30, 2025, where the preliminary opinion was open for stakeholder comments.

The SCCS evaluated new scientific data to determine whether Hydroxyapatite (nano) can be safely used at concentrations significantly higher than previously approved levels for toothpaste and mouthwash applications.

Main conclusions

The SCCS concluded that hydroxyapatite (nano) is safe when used at the following concentrations in oral cosmetic products:

Toothpaste: Up to 29.5%
Mouthwash: Up to 10%

Scientific rationale supporting safety conclusion:

No mutagenic hazard demonstrated even at high concentrations
No cytotoxicity or inflammatory effects observed in buccal mucosa cell model testing
Negligible uptake by buccal mucosa with epithelial cells containing internalized particles being shed over time
Rapid dissolution of any unintentionally ingested nanoparticles in gastric fluid eliminates nano-specific safety concerns

Specific technical specifications required:

Rod-shaped particles with at least 87% (by particle number) having aspect ratios ≤3, and remaining 13% not exceeding aspect ratios of 9 (opinion does not apply to needle-shaped hydroxyapatite (nano) particles)
Hydroxyapatie (nano) particles must not be coated or surface modified
Maximum length of particles of 122 ± 43 nm

What now?

The SCCS opinion is effective immediately as scientific guidance. Future regulatory updates to EU Cosmetics Regulation may incorporate these conclusions into amended restrictions.