Content area
Full text
Caries Res 2001;35(suppl 1):2225
Is the Fluoride Concentration Limit of 1,500 ppm in Cosmetics (EU Guideline) Still Up-to-Date?
A. Bloch-Zupan
Department of Paediatric Dentistry, Eastman Dental Institute for Oral Health Care Sciences, University College London, UK; Strasbourg Faculty of Dentistry, Louis Pasteur University, Strasbourg, France
Key Words
Caries, dental W Fluorides W Toxicity
Abstract
The 1,500 ppm fluoride (F) concentration limit set up for European cosmetic toothpaste needs to be considered in terms of effectiveness and toxicity. There is clear evidence for a dose-response relationship between F concentration and caries-preventive effect (2530% caries reduction achieved with a 1,000 ppm F dentifrice). Clinical significance of higher F concentration has not been totally proven. Low F toothpastes (!500 ppm F) have been marketed to reduce F ingestion by young children in order to minimize the risk of dental fluorosis. Their effectiveness is, however, unclear. Fluoride intake and caries risk assessment should be performed by dental professionals and prescription of topical fluoride should be adjusted individually.
Copyright 2001 S. Karger AG, Basel
The cosmetic directive of the European Union has set up a definition for a cosmetic product: any substance or preparation intended for placing in contact with the var-
ious external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours. This product must not be liable to cause damage to human health when applied under normal conditions of use [COLIPA, 1995]. Toothpastes but also other oral hygiene aids like mouth rinses or gels certainly belong to this category of products. However, some of their components like fluorides (F) are considered therapeutic agents [Mandel, 1998]. F has external modifying effects on dental caries initiation and progression. The EEC directive fixes the limit for F maximum concentration in the finished cosmetic product at 0.15%. This limit needs to be discussed in terms of effectiveness and toxicity.
Dental caries is a dietobacterial disease needing at least three factors to develop: a susceptible host, cariogenic micro-organisms of the dental plaque and carbohydrates. Plaque control is an essential anticaries measure [Axelsson, 1993]. Rational use of...