PlannedDraft measure, not yet adopted

Nano-hydroxyapatite: higher limits for a specified particle type

Entry 372 for Hydroxyapatite (nano) is replaced: up to 29.5% in toothpaste and 10% in mouthwash, but only for rod-shaped, uncoated particles meeting new size criteria.

What changes

Since Regulation (EU) 2024/858, nano-hydroxyapatite has been limited to 10% in toothpaste and 0.465% in mouthwash. Following a new SCCS opinion (26 June 2025), the draft raises the limits to 29.5% in toothpaste and 10% in mouthwash, but only for rod-shaped particles (at least 87% with an aspect ratio of 3 or less, the rest not above 9) that are not coated or surface-modified, with a maximum length of 122 ± 43 nm. Use in products that could be inhaled remains prohibited. Brands must check that their raw material matches the new specification.

Key dates

Not yet adopted. The draft was notified to the WTO on 8 July 2026 (comments until 6 September 2026), backed by the Standing Committee on Cosmetic Products and sent to the Council on 21 September 2026 for the three-month scrutiny period of the regulatory procedure with scrutiny. It will enter into force 20 days after publication in the Official Journal; non-compliant products may not be placed on the market from 12 months after entry into force and may not be made available (sold) from 24 months after entry into force. If published around January 2027, that means roughly early 2028 and early 2029. Exact dates are unconfirmed until publication.

Affected ingredients

Products in our database containing these ingredients

55 products in INCIMondo contain at least one of these ingredients.

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Topics

This is a consumer-oriented summary, not legal advice. Only the text published in the Official Journal of the EU is legally binding.

All regulation changes