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ANNEXU.K.

In column ‘f’ corresponding to reference numbers 26 to 43, 47 and 56 of Part 1 of Annex III to Directive 76/768/EEC, the text after the first sentence is replaced by the following sentences:

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”.