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Annex III Entry 37 14/05/2013

3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride

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Key data

CAS
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EC
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Annex
III
Entry number
37

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Record details

Chemical name

3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride

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 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")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

Regulatory information

Regulation

(EC) 2013/344

SCCS opinions

  • Opinion concerning the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 years
  • Opinion on the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 Years
  • Clarification on the Opinions SCCNFP/0653/03 and SCCP/0882/05 on the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 Years

About this record

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