Xylitol chewing gum/pastilles and reduction of the risk of tooth decay - Scientific substantiation of a health claim related to xylitol chewing gum/pastilles and reduction the risk of tooth decay pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies
Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof, Hannu Korhonen, Pagona
Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Andreu
Palou, Hildegard Przyrembel, Seppo Salminen, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens,
Henk van den Berg, Hendrik van Loveren, and Hans Verhagen.
Acknowledgment
The European Food Safety Authority wishes to thank Ingegerd Johansson and the members of
the Working Group for the preparation of this opinion: Jean-Louis Bresson, Albert Flynn,
Marina Heinonen, Hannu Korhonen, Ambroise Martin, Andreu Palou, Hildegard Przyrembel,
Seppo Salminen, Sean (J.J.) Strain, Inge Tetens, Henk van den Berg, Hendrik van Loveren and
Hans Verhagen.
No abstract available
Following an application from LEAF Int, Leaf Holland and Leaf Suomi Oy submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to xylitol chewing gum/pastilles and reduction of the risk of tooth decay.
The scope of the application was proposed to fall under a health claim referring to disease risk reduction.
The present health claim refers to chewing gum sweetened with 100% xylitol and pastilles sweetened with at least 56% xylitol, for which full description of the manufacturing process and stability information are provided. The Panel considers that chewing gum sweetened with 100% xylitol and pastilles sweetened with at least 56% xylitol are sufficiently characterised.
The claimed effect ‘reduces the risk of tooth decay’ relates to reduction of dental caries development. The target population is the general population. The Panel considers that reducing the risk of tooth decay is beneficial to health.
The applicant has identified 31 publications reporting human intervention studies, two reporting human observational studies, one systematic review and 16 other review publications as being pertinent to the health claim under evaluation. The Panel considers that the health claim under evaluation, i.e ‘xylitol chewing gum/pastilles might reduce the risk of development of caries’, implies that habitual intake of chewing gum/pastilles with xylitol may reduce the risk of developing dental caries when added to the usual diet. This evaluation considers only the effects of chewing gums sweetened with 100% xylitol and of pastilles/candies sweetened with at least 56% xylitol as compared to no treatment.
Five studies have been presented investigating the effects of chewing gums sweetened with 100% xylitol as compared to no treatment in children. Most studies consistently report significantly less caries increment from baseline measured as decayed, missing and filled surfaces (DMFS) in the intervention group than in controls. The Panel notes some limitations in the studies presented: the studies were not fully randomised for practical reasons (concealed allocation was used in most cases), nor were sufficiently controlled for confounders that could potentially have affected the outcome (e.g., background diet and standard caries preventive measures were not fully assessed and reported). For one study only the per protocol analysis was presented and direct comparison between the chewing gum sweetened with 100% xylitol and the control groups was not reported. Nevertheless, considering the high number of studies, subjects and observation years presented, as well as the consistency of the results and the magnitude of the effect, the Panel considers that a cause and effect relationship has been established between the consumption of chewing gum sweetened with 100% xylitol and the reduction of the risk of tooth decay in children.
Three studies are presented on the effects of pastilles sweetened with at least 56% xylitol on caries incidence rate. Two of the studies report significantly less caries increment from baseline measured as DMFS in the intervention group than in controls. However, the Panel considers that the weaknesses of these studies (e.g., no direct comparison between the pastilles groups and controls in one study, lack of randomisation in the other, and insufficient control for confounders that could potentially have affected the outcome in both studies) greatly limit their value as a source of data to substantiate the claimed effect. In the third study, no differences between intervention and control groups in caries incidence rate were observed at the end of the intervention. The Panel considers that a cause and effect relationship between the consumption of pastilles sweetened with at least 56% xylitol and a reduction on the risk of tooth decay has not been established.
The following wording reflects the scientific evidence: “xylitol chewing gum reduces the risk of caries in children”.
The scientific justification of the claim is related to the consumption of 2-3g of chewing gum sweetened with 100% xylitol at least three times per day after meals. This quantity of chewing gum sweetened with 100%xylitol can easily be consumed as part of a balanced diet.
There is a risk of osmotic diarrhoea at excessive intakes of xylitol. The use of chewing gum should be avoided in children less than three years of age owing to a high choking hazard of chewing gum in this age group.
Xylitol, chewing gum, pastilles, caries risk, tooth decay, adults, children
