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 warningsi22.12.200935 Tin difluoride Stannous fluoride 7783-47-3 231-999-3 Oral products 0,15 % (as F). Whenmixed with otherfluorine compoundspermitted under thisAnnex, total Fconcentration must notexceed 0,15 %Contains stannous fluorideFor 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:EN36 Hexadecyl ammoniumfluorideCetylamine hydrofluoride3151-59-5 221-588-7 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 CetylaminehydrofluorideFor 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 342/143