Information Circular Number 169/CD Date: 10/10/2008
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The toothpaste with fluoride for children have been, at the European level, the relatively recent reassessment of the risk, culminating in the implementation of the relevant Directive (Directive 2007/53/EC of 29 August 2007) to the Decree-Law No. 189/2008 of 24 September. Indeed, the development of tooth enamel in pre-eruptive phase may be altered by several factors, including excess fluoride. Fluoride absorbed in excess can cause fluorosis, manifesting itself in the appearance of white spots and brown glaze that is irreversible.
Given that in children under 6 years and without adequate parental supervision, the swallowing of toothpaste contributes to the amount of fluoride ingested, it was decided to add the following warning in the labeling of toothpaste, unless it is contraindicated for children:
"Children aged under 6 years: Use an amount the size of a pea, with supervised brushing to minimize swallowing. If the intake of fluoride from other sources, consult your dentist or doctor."
The manufacturers, the person on whose behalf the product is manufactured or the person responsible for marketing must ensure that, as of March 19, 2009, may only be available to consumers toothpaste containing from 0.1 to 0.15 % fluorine, which include the warning that, unless already included in the statement, for example, "Only for adults." INFARMED, IP alert health professionals and consumers on the need for verification of information contained in the toothpaste containing fluoride.
Health Products Directorate (Fax: 21 798 7281; pchc@infarmed.pt)
The Board Luisa Carvalho
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Tomorrow I'll buy a tube of toothpaste at a pharmacy and see if the law is actually being accomplished. Want to find out if the pharmacy is marketing the toothpaste inside or outside the law.
This may entail an attack on public health if the law is not being strictly enforced and monitored by competent authorities.
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