Scientific Opinion on the substantiation of health claims related to
sugar-free chewing gum with pyro- and triphosphates and reduction of
calculus formation (ID 1309) 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:
Sugar-free
calculus
chewing gum
health claims
pyrophosphates
triphosphates
1. Charakterystyka żywności / składnika
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Ograniczenie powstawania kamienia nazębnego w miejscach, które są najważniejsze dla zdrowia zębów
The food that is the subject of the health claim is sugar-free chewing gum with pyro- and triphosphates.
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 sweetening agents used in sugar-free chewing gums occur naturally in foods.
Various forms of pyrophosphates (E 450) and triphosphates (E 451) are authorised for addition to foods, including chewing gum in an amount quantum satis6, and can be measured in foods by standard methods.
The Panel considers that the food, sugar-free chewing gum with pyro- and triphosphates, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect.
2. Znaczenie oświadczenia dla zdrowia człowieka
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Ograniczenie powstawania kamienia nazębnego w miejscach, które są najważniejsze dla zdrowia zębów
The claimed effect is “contrasts calculus/tartar formation, gums health”. The Panel assumes that the target population is the general population.
The Panel assumes that the claimed effect is related to the reduction of calculus formation.
Dental plaque is found on the tooth surface and consists of a biofilm of microorganisms embedded in a matrix of polymers of host and bacterial origin. Plaque can also become mineralised and form calculus (tartar), a form of hardened dental plaque which provides a medium for further plaque
formation. Fermentation of carbohydrates in the mouth by oral bacteria increases the formation of a type of dental plaque that may contribute to dental caries as well as increase the proportion of cariogenic bacteria in the plaque (Marsh and Nyvad, 2008). Dental plaque and calculus can contribute to adverse effects on dental health (e.g. in relation to approximal caries, gingivitis, and periodontitis) when it occurs at sites such as at the cervical third and interdentally below the approximal contact point between teeth, along the gingival margin, and in the fissures and pits of the teeth.
The Panel considers that reduction of calculus formation at sites which are most important for dental health is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Ograniczenie powstawania kamienia nazębnego w miejscach, które są najważniejsze dla zdrowia zębów
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Ograniczenie powstawania kamienia nazębnego w miejscach, które są najważniejsze dla zdrowia zębów
Among the references provided were some general reviews on the reduction of calculus formation by different agents which did not contain any primary data which could be used for the scientific substantiation of the claim. Some human intervention studies examined the effect of toothpastes containing pyrophosphates on calculus formation. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Two human intervention studies with a randomised cross-over design and which addressed the effect of xylitol-sweetened sugar-free chewing gum with pyro- and triphosphates on supragingival calculus deposits compared to xylitol-sweetened chewing gum without pyro- or triphosphates (Porciani and Grandini, 2003) or to no treatment (Porciani et al., 2003) have been provided. Calculus deposits were scored using a modified Volpe-Manhold Calculus Index with a periodontal probe graduated in millimetres. However, the sites where changes in calculus deposits were measured were not reported. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of a claim on the reduction of calculus formation at sites which are most important for dental health (e.g. gingival margin or between teeth).
The Panel notes that no human studies have been provided from which conclusions can be drawn for the scientific substantiation of a claim on the use of sugar-free chewing gum with pyro- and triphosphates and the reduction of calculus formation in sites which are most important for dental health (e.g. gingival margin or between teeth).
The Panel concludes that a cause and effect relationship has not been established between the use of sugar-free chewing gum with pyro- and triphosphates and reduction of calculus formation at sites which are most important for dental health.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food, sugar-free chewing gum with pyro- and triphosphates, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect.
The claimed effect is “contrasts calculus/tartar formation, gums health”. The target population is assumed to be the general population. Reduction of calculus formation at sites which are most important for dental health is a beneficial physiological effect.
A cause and effect relationship has not been established between the use of sugar-free chewing gum with pyro- and triphosphates and reduction of calculus formation at sites which are most important for dental health.
