Regulation (EC) No 1223/2009 of the European ... - Mattilsynet

ReferencenumberaChemical name/INNbName of CommonIngredients GlossarycSubstance identificationCAS numberdEC numbereProduct type, body partsfRestrictionsMaximum concentration inready for use preparationgOtherhWording of conditions ofuse and warningsi22.12.200942 AmmoniumhexafluorosilicateAmmoniumfluorosilicate16919-19-0 240-968-3 Oral products 0,15 % (as F). Whenmixed with otherfluorine compoundspermitted under thisAnnex, total Fconcentration must notexceed 0,15 %Contains ammoniumfluorosilicateFor any toothpaste containing0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for children(e.g. ‘for adult useonly’) the followinglabelling is obligatory:EN43 Magnesium hexafluorosilicateMagnesium fluorosilicate16949-65-8 241-022-2 Oral products 0,15 % (as F). Whenmixed with other fluorinecompounds permittedunder this Annex,total F concentrationmust not exceed 0,15 %‘Children of 6 years andyounger: Use a pea sizedamount for supervisedbrushing to minimizeswallowing. In case ofintake of fluoride fromother sources consult adentist or doctor’Contains magnesiumfluorosilicateFor any toothpaste containing0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for children(e.g. ‘for adult useonly’) the followinglabelling is obligatory:‘Children of 6 years andyounger: Use a pea sizedamount for supervisedbrushing to minimizeswallowing. In case ofintake of fluoride fromother sources consult adentist or doctor’Official Journal of the European Union L 342/147