3-(N-Hexadecyl-N-2-hydroxyethylammonio)propylbis(2-hydroxyethyl) ammonium difluoride in EU cosmetics: Annex III, entry 37
3-(N-Hexadecyl-N-2-hydroxyethylammonio)propylbis(2-hydroxyethyl) ammonium difluoride: the maximum concentrations and conditions are in the entry below. Annex III, entry 37, consolidated 18 May 2026.
- Annex
- III: List of substances which cosmetic products must not contain except subject to the restrictions laid down
- Reference number
- 37
- Chemical name/INN
- 3-(N-Hexadecyl-N-2-hydroxyethylammonio)propylbis(2-hydroxyethyl) ammonium difluoride
- Version
- Consolidated version of 18 May 2026
- Official source
- Regulation (EC) No 1223/2009, consolidated text
Official wording: restrictions
- Product type, body parts: Oral products | Maximum concentration in ready for use preparation: 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Official wording: conditions of use and warnings
Contains 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride.
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.’
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