Scientific Opinion on the substantiation of health claims related to
sugar-free chewing gum with fluoride and maintenance of tooth
mineralisation (ID 1154) pursuant to Article 13(1) of Regulation (EC)
No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Chewing gum
fluoride
health claims
mineralisation
sugar-free
1. Charakterystyka żywności / składnika
The food that is the subject of the health claim is sugar-free chewing gum with fluoride.
The composition of the gum, i.e. gum base and sweetening agent, is unspecified. The characteristic components of chewing gums are the gum base, which may comprise a complex mixture of elastomers, natural and synthetic resins, fats, emulsifiers, waxes, antioxidants, and filler, together with sweetening and flavouring agents (Imfeld, 1999; Rassing, 1996). The common characteristic of sugar- free chewing gums is the absence of fermentable carbohydrates (Edgar, 1998; Ly et al., 2008). The ingredients are well characterised, can be measured by established methods, and the principles of the manufacturing process have been described (Rassing, 1996). Many of the ingredients in the gum base and most of the sweetening agents used in sugar-free chewing gums occur naturally in foods.
Fluoride is a well-characterised component, which is added to various food products mostly as sodium fluoride. Fluoride occurs naturally in water and foods, and is added to various dental products. The proposed conditions of use require that an unspecified number of pellets/sticks/tabs of gum per day should deliver 0.75 mg of fluoride. Fluoride content in gums on the market varies between 0.1 and 0.5 mg/piece.
The Panel considers that the food, sugar-free chewing gum with fluoride, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect.
2. Znaczenie oświadczenia dla zdrowia człowieka
The claimed effect is “increases resistance of enamel to acid attacks and rate of remineralisation”. The Panel assumes that the target population is the general population above 6 years of age.
In the context of the proposed wordings, the Panel notes that the claimed effect refers to the promotion of a beneficial balance between de- and remineralisation of tooth enamel and dentin.
The Panel considers that maintenance of tooth mineralisation is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
A claim on fluoride and maintenance of tooth mineralisation has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009a). The Panel considers that the scientific substantiation of the claimed effect and the conditions of use for the claim also apply to sugar-free chewing gum containing fluoride.
A claim on sugar-free chewing gum and maintenance of tooth mineralisation has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009b). The Panel considers that the scientific substantiation of the claimed effect and the conditions of use for the claim also apply to sugar-free chewing gum containing fluoride.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food, sugar-free chewing gum with fluoride, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect.
The claimed effect is “increases resistance of enamel to acid attacks and rate of remineralisation”. The target population is assumed to be the general population above 6 years of age. Maintenance of tooth mineralisation is a beneficial physiological effect.
A claim on fluoride and maintenance of tooth mineralisation has already been assessed with a favourable outcome, as well as a claim on sugar-free chewing gum and maintenance of tooth mineralisation. The scientific substantiation of the claimed effects, and the conditions of use for the claims, also apply to sugar-free chewing gum containing fluoride.
