cosmetics-restricted-subs

Cosmetic Products Regulation, Annex III - Restricted Substances

EU. Restricted Substances: Annex III, Regulation 1223/2009/EC on Cosmetic Products, as amended by Regulation (EU) 2022/2195, OJ L 292, 11 November 2022

This list contains substances whose use in cosmetic products in the European Union is banned, except under certain conditions as indicated in Annex III. The list specifies the field of application or use, maximum allowable concentration limits in finished products, and any additional limitations.

RELEVANT LEGISLATION
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Ammonium hexafluorosilicate

EC / List no: 240-968-3 CAS no: 16919-19-0
Ref No.
42
Restrictions Product type, body parts
Oral products
Maximum Threshold
0.15 %
Restriction(s)
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15 %
Expressed As
As F
Warning Label
Contains ammonium fluorosilicate. 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 contraindicated 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.' case of intake of fluoride from other sources consult a dentist or doctor.'