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Scientific Opinion on the substantiation of health claims related to sugar-free chewing gum with calcium phosphoryl oligosaccharides and maintenance of tooth mineralisation (ID 337) 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   calcium phosphoryl oligosaccharides   chewing gum   health claims   tooth mineralisation  
ID:    337  
Produkty: Gumy do żucia bez cukru z fosforylowanymi oligosacharydami i wapniem  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is calcium phosphoryl oligosaccharides.
In the context of the references provided, the Panel assumes that the food, which is the subject of the health claim, is sugar-free chewing gum with calcium phosphoryl oligosaccharides.
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.
The phosphoryl oligosaccharides (POs) in the sugar-free chewing gum that is the subject of the claim are produced from potato starch using bacterial liquefying α-amylase (EC 3.2.1.1), glucoamylase (EC 3.2.1.3) and pullulanase (EC 3.2.1.41). Fraction PO-1 is the major component of the POs and is composed of maltotriose, maltotetraose and maltopentaose to which one phosphoryl group is attached. Fraction PO-2 is predominantly composed of maltopentaose and maltohexaose to which at least two phosphoryl groups are attached. The average degree of polymerisation of dephosphorylated PO-1 and PO-2 is 4.02 and 5.82, respectively (Kamasaka et al., 2003). From the references provided, the Panel assumes that the POs in the sugar-free chewing gum that is the subject of the claim contain 5 w% calcium and are added to chewing gum in concentrations of 2.45-2.60 % (Inaba et al., 2002a; Inaba et al., 2002b; Inaba et al., 2003; Kamasaka et al., 2002).
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), 2009).
From the references provided, the Panel assumes that the claim refers to an effect of sugar-free chewing gum with calcium phosphoryl oligosaccharides (Ca-POs) on maintenance of tooth
mineralisation beyond the well established effect that other sugar-free chewing gums (i.e. without calcium phosphoryl oligosaccharides) have on tooth mineralisation.
The Panel considers that the food, sugar-free chewing gum with calcium phosphoryl oligosaccharides, which is the subject of the health claim, and the comparison food, sugar-free chewing gum without calcium phosphoryl oligosaccharides, are both sufficiently characterised in relation to the claimed effect.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “dental health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to 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 - Wpływ na mineralizację zębów

Among the references provided were three reviews on the production and application of calcium phosphoryl oligosaccharides, one company request on the possible novel food status of calcium phosphoryl oligosaccharides and the subsequent reply of the national Competent Authority, all of which did not contain any original data which could be used for the scientific substantiation of the claim. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Three human in situ studies were provided which investigated the effect of sugar-free chewing gum with calcium phosphoryl oligosaccharides on enamel or dentin remineralisation.
In all three studies the enamel and dentin disks used were cut from the crown parts of bovine incisors and artificial caries-like lesions were produced by immersing the disks for two (Inaba et al., 2002a) or three weeks (Inaba et al., 2002b; Inaba et al., 2003) in a 0.1 M lactic acid gel containing 6 w% carboxymethylcellulose. The demineralised disks were kept in the oral cavity for the duration of chewing plus an additional time equal to the chewing time in the respective study. They were then removed and stored in a container with 100 % humidity. Lesion depths and mineral loss values were measured by microradiography.
Two of the intervention studies were conducted in a double-blind, cross-over manner (Inaba et al., 2002a; Inaba et al., 2003) and one used a double-blind, parallel design (Inaba et al., 2002b). In each trial, 12 healthy adult volunteers (mean age 21 and 22 years) were recruited. Each volunteer wore a palatal appliance containing demineralised enamel (Inaba et al., 2002b; Inaba et al., 2003) or demineralised enamel and dentin (Inaba et al., 2002a) disks. In the cross-over study by Inaba et al. (2002a) subjects chewed sugar-free chewing gum containing 48.5 % xylitol and sugar-free chewing gum containing 46 % xylitol plus 2.6 % Ca-POs four times a day for ten minutes for two weeks each. The design of the cross-over study by Inaba et al. (2003) was similar but included an additional period with a chewing gum containing 62 % sucrose and the test chewing gum only contained 2.45 % Ca-POs. In the parallel design study by Inaba et al. (2002b) subjects were randomised to use sugar-free chewing gum containing 47.5 % xylitol, sugar-free chewing gum containing 45 % xylitol plus 2.5 % Ca-POs, or a chewing gum containing 62 % sucrose four times a day for 20 minutes for four weeks.
The Panel notes that in all of the studies enamel and dentin disks were only worn during the time of gum-chewing plus a period equal to the chewing time and that this study design is not appropriate to assess a balance between de- and remineralisation of tooth enamel and dentin in normal eating conditions. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
Two in vitro studies addressed the effect of calcium phosphoryl oligosaccharides on remineralisation of enamel (Inaba et al., 2002c; Kamasaka et al., 2002). The Panel considers that evidence provided in in vitro studies is not sufficient to predict an effect of the use of sugar-free chewing gum with calcium phosphoryl oligosaccharides on maintenance of tooth mineralisation in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the use of sugar-free chewing gum with calcium phosphoryl oligosaccharides and maintenance of tooth mineralisation over and above the well established role of sugar-free chewing gum on the maintenance of tooth mineralisation.
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), 2009).

Wnioski

On the basis of the data presented, the Panel concludes that:
The food, sugar-free chewing gum with calcium phosphoryl oligosaccharides, which is the subject of the health claim, and the comparison food, sugar-free chewing gum without calcium phosphoryl oligosaccharides, are both sufficiently characterised in relation to the claimed effect.
The claimed effect is “dental health”. The target population is assumed to be the general population. In the context of the proposed wordings, it is assumed that the claimed effect refers to a beneficial balance between de- and remineralisation of tooth enamel and dentin. Maintenance of tooth mineralisation is a beneficial physiological effect.
A cause and effect relationship has not been established between the use of sugar-free chewing gum with calcium phosphoryl oligosaccharides and maintenance of tooth mineralisation over and above the well established role of sugar-free chewing gum on the maintenance of tooth mineralisation.
A claim on sugar-free chewing gum and maintenance of tooth mineralisation has already been assessed with a favourable outcome.