SODIUM FLUORIDE
Official label name (INCI name, EU glossary of cosmetic ingredient names), No 26616
- Allowed with restrictions (Annex III)
SODIUM FLUORIDE: Allowed with restrictions, with limits depending on the product type (Annex III, entry 31), under Regulation (EC) No 1223/2009.
In plain words
What it is used for
Functions declared by manufacturers:
Antiplaque: helps protect against plaque.
Oral care: provides cosmetic effects to the oral cavity, e.g. cleansing, deodorising, protecting.
What the rules say
Allowed, with restrictions: Annex III sets a maximum concentration, the product types allowed and a warning to be printed on the packaging. Ingredient lists do not give quantities, so the concentration cannot be checked on the label; the warning can.
The text of the annexes
Allowed with restrictions
This entry covers the same substance as SODIUM FLUORIDE (same CAS number in the CosIng inventory): its conditions apply.
- Entry
- Annex III, No 31
- Substance
- Sodium fluoride
- CAS
- 7681-49-4
- EC
- 231-667-8
- Product type
- Oral products
- Maximum concentration
- 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
- Warnings
- Contains sodium fluoride For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."
Dates in the act (3)
- Entry into force on 15 May 2013
- Application from 11 July 2013
It shall apply from 11 July 2013.
- Entry into force on 11 July 2013
Excerpts from the English text published in the Official Journal. A date may concern only some substances of the act: the excerpt says so.
Identity
- CosIng identifier
- 37869
- CAS (according to CosIng)
- 7681-49-4
- EC (according to CosIng)
- 231-667-8
- Declared functions
- Antiplaque, Oral care
- Wikidata
- Q407520
- PubChem
- 5235
- ECHA InfoCard
- 100.028.789
- InChIKey
- PUZPDOWCWNUUKD-UHFFFAOYSA-M
Classified hazard (CLP Regulation)
A classification describes an intrinsic hazard, not a risk: the risk depends on the dose, the form and the exposure.
sodium fluoride
No harmonised CMR classification
- Hazard classes
- Acute Tox. 3 *
Eye Irrit. 2
Skin Irrit. 2 - Hazard statements
- H301 H319 H315
EU product alerts (Safety Gate)
1 alert on cosmetic products cite this name in their hazard description. An alert targets a specific product, not the ingredient itself; each alert states the reason (prohibited substance, limit exceeded, missing labelling, and so on).
- 29 January 2021: Teeth whitening kit, DMC, Finland (“Serious risk”) alert
Elsewhere in the world
Information on other jurisdictions. What is covered, and what is not yet.
United Kingdom (Great Britain)
- Allowed with restrictions (Annex III)
Same entries as in the European Union. Conditions (concentrations, warnings) may differ: they are not compared here.
Switzerland
Regulation (EC) No 1223/2009 applies in Switzerland (Article 54 of the Ordinance on Foodstuffs and Utility Articles).
United States, federal rules
None of the integrated sections of the federal code (21 CFR 700.11 to 700.27 and 250.250) targets this name. The FDA does not publish a list of allowed ingredients.
Recorded cosmetics that contain it
781 recorded products list it, according to Open Beauty Facts contributors. Records are dated: the formula may have changed. See the list (page in French).
Glossary: Commission Implementing Decision (EU) 2025/1175. Page updated on 21 October 2026.