Regulation

Regulation (EU) 2024/858 · SCCS opinions · Reviewed 27 September 2026

Is nano-hydroxyapatite banned in Europe?

No. Nano-hydroxyapatite is restricted in the EU, not banned. Under Regulation (EU) 2024/858, it's allowed in toothpaste up to 10% and in mouthwash up to 0.465%, but only if the particles are rod-shaped, uncoated, and meet a set shape specification. It isn't allowed in products that could be inhaled, such as sprays.

In June 2025, the EU's Scientific Committee on Consumer Safety (SCCS) considered a specified nano-HAp material safe at up to 29.5% in toothpaste. An SCCS opinion is scientific advice; the legal limit changes only if the European Commission amends the regulation. Non-nano (micro) hydroxyapatite isn't covered by the nano entry.

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EU toothpaste limit 10% nano-HAp Rod-shaped, uncoated particles only, under Regulation (EU) 2024/858.

01

Restricted, with conditions

The EU permits nano-HAp in toothpaste up to 10%, limited to rod-shaped, uncoated particles that meet an aspect-ratio specification.

02

Sprays are out

The regulation bars nano-HAp in products that could expose the lungs by inhalation.

03

Opinions come before law

The 2025 SCCS opinion supports higher limits for one material. Check the current EU text before assuming the limit has changed.

Nano-hydroxyapatite restriction

EU rules and scientific opinions on nano-hydroxyapatite in oral care
Source	Content What it says	Status What it means
SCCS opinion, March 2023	Safe up to 10% in toothpaste and 0.465% in mouthwash for rod-shaped, uncoated particles	Scientific advice behind the regulation
Regulation (EU) 2024/858	Adds nano-HAp to Annex III: 10% toothpaste, 0.465% mouthwash, shape limits, no inhalable uses	Binding law
Compliance dates	Non-compliant products barred from sale from 1 February 2025, and off shelves from 1 November 2025	In force
SCCS opinion, June 2025	Safe up to 29.5% in toothpaste and 10% in mouthwash for a specified material; not needle-shaped particles	Scientific advice; law changes only if Annex III is amended
Micro (non-nano) HAp	Not a nanomaterial, so the nano entry doesn't apply	Regulated like other cosmetic ingredients

Based on Regulation (EU) 2024/858 on EUR-Lex and the SCCS opinions, reviewed 27 September 2026. EU rules can change; check EUR-Lex for the current Annex III entry. This is general information, not legal advice, and it does not claim EU compliance for any product.

Sources behind this answer

Primary EU sources. The regulation is the law; SCCS opinions are the science the Commission relies on.

Regulation (EU) 2024/858 · EUR-Lex
Nano-hydroxyapatite restriction
Adds hydroxyapatite (nano) to Annex III: up to 10% in toothpaste and 0.465% in mouthwash, rod-shaped uncoated particles only, and no uses that could expose the lungs by inhalation.
Read Regulation (EU) 2024/858
EU Scientific Committee on Consumer Safety · June 2025
Hydroxyapatite (nano), Submission IV
Adopted 26 June 2025, the opinion considers a specified nano-HAp safe at up to 29.5% in toothpaste and 10% in mouthwash. It does not apply to needle-shaped particles.
Read the 2025 SCCS opinion
Current Klyyr label
One+ formula facts
One+ publishes a combined 10% nano + micro hydroxyapatite blend, 16 ingredients, 0 ppm fluoride, no SLS, RDA 62, and a 120 g tube.
Read the One+ product page

What this means for you

If you're in the EU

Nano-HAp toothpaste on EU shelves should stay within the 10% limit and shape rules. Check the label and the brand's safety information.

If you're in the US

EU limits don't apply to US products, and US rules treat fluoride-free HAp toothpaste as a cosmetic.

If nano worries you

Micro-hydroxyapatite pastes avoid the nano question. Compare particle sizes on the label.

The Klyyr One+ formula

One+ is fluoride-free toothpaste with a clearly disclosed 10% nano + micro hydroxyapatite blend, 16 listed ingredients, peppermint + spearmint, no SLS, and no artificial dyes.

01
10% hydroxyapatite
Combined nano + micro hydroxyapatite, disclosed on the label. Ten percent is not a universal efficacy threshold.
02
16 listed ingredients
Water, Sorbitol, Glycerin, Potassium Sorbate, Hydroxyapatite (nano & micro), Xylitol, Sodium Cocoyl Glutamate, Cellulose Gum, Xanthan Gum, Zinc Citrate, Aloe Vera, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Menthol, Sodium Benzoate, Stevia Rebaudiana Leaf/Stem Extract.
03
What is not in it
0 ppm fluoride. No SLS. No artificial dyes. Sodium cocoyl glutamate is the surfactant.
04
120 g aluminum tube
4.23 oz, approximately 90 brushings. Aluminum tube, HDPE cap. Recycle where accepted locally.

In short

Europe didn't ban nano-hydroxyapatite. It set a concentration cap and a particle specification, and it keeps reviewing the science.

01 Is nano-hydroxyapatite banned in the EU?

No. Regulation (EU) 2024/858 allows it in toothpaste up to 10% and mouthwash up to 0.465%, within particle-shape rules. It's banned only in products that could be inhaled.

02 Why did the EU restrict nano-hydroxyapatite?

The SCCS reviewed safety data for a specific nano-HAp material and found it safe within set concentrations and particle shapes. The regulation turned those limits into law.

03 What did the 2025 SCCS opinion say?

Adopted 26 June 2025, it considered a specified nano-HAp safe at up to 29.5% in toothpaste and 10% in mouthwash. It doesn't apply to needle-shaped particles, and it isn't law by itself.

04 Does the EU restrict micro-hydroxyapatite?

The nano entry covers nano-hydroxyapatite only. Micro-hydroxyapatite isn't a nanomaterial.

05 Is One+ nano-hydroxyapatite?

One+ uses a combined 10% blend of nano (20–100 nm) and micro (5–10 µm) hydroxyapatite. See nano vs micro hydroxyapatite.

Read the full FAQ →

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