EFSA Journal 2011;9(7):2293 SCIENTIFIC OPINION Statement on toothkind juice drinks 1 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) 2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver advice in relation to toothkind juice drinks. The Panel was requested to consider whether conclusions for the substantiation of the beneficial effect, i.e. reduction of tooth demineralisation, can be drawn on the basis of studies which do not measure directly net demineralisation but measure the potential for demineralisation of enamel, e.g. reduced ph on dental plaque. The Panel considers that reduction of plaque ph immediately (within about 10 min) following a single consumption of a beverage is an appropriate measure of the potential of beverages for demineralisation of dental enamel. Toothkind drinks have little or no potential for enamel demineralisation by this process, while typical sugar-containing non-alcoholic beverages do have the potential for demineralisation of dental enamel. However, the beneficial effect (reducing net tooth demineralisation) of replacing typical sugar-containing non-alcoholic beverages with toothkind juice drinks was only shown to occur at a frequency of consumption of typical sugar-containing non-alcoholic beverages of 7 times daily. The Panel was also requested to consider whether the beneficial effect is shown or expected to be shown for less frequent consumers of conventional juice drinks and typical sugar-containing non-alcoholic beverages. The Panel considers that for people who consume conventional juice drinks or sugar-containing non-alcoholic beverages and who are also frequent consumers of sugars and/or acids from other beverages and foods that can contribute to tooth demineralisation, a beneficial effect on maintaining tooth mineralisation may be expected by substitution of one or more servings of conventional juice drinks or sugar-containing non-alcoholic beverages with an equivalent number of servings of toothkind juice drink. In the context of the claim, reduction of tooth demineralisation has a similar meaning to maintenance of tooth mineralisation. European Food Safety Authority, 2011 KEY WORDS Dental erosion, sugar, tooth mineralisation, toothkind, health claims. 1 On request from the European Commission, Question No EFSA-Q-2011-00781, adopted on 30 June 2011. 2 Panel members: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen. Correspondence: nda@efsa.europa.eu Suggested citation: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion - Statement on toothkind juice drinks. EFSA Journal 2011;9(7):2293. [7 pp.] doi:10.2903/j.efsa.2011.2293. Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority, 2011
SUMMARY Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver advice in relation to toothkind juice drinks. The Panel was requested to consider whether conclusions for the substantiation of the beneficial effect, i.e. reduction of tooth demineralisation, can be drawn on the basis of studies which do not measure directly net demineralisation but measure the potential for demineralisation of enamel, e.g. reduced ph on dental plaque. The Panel considers that reduction of plaque ph immediately (within about 10 min) following a single consumption of a beverage is an appropriate measure of the potential of beverages for demineralisation of dental enamel. Toothkind drinks have little or no potential for enamel demineralisation by this process, as they do not lower the ph to 5.7 or less, while typical sugarcontaining (8-12 g sugars/ 100 ml) non-alcoholic beverages do have the potential for demineralisation of dental enamel. However, the beneficial effect (reducing net tooth demineralisation) of replacing typical sugar-containing non-alcoholic beverages with toothkind juice drinks was only shown to occur at a frequency of consumption of typical sugar-containing non-alcoholic beverages of 7 times daily. The Panel was also requested to consider whether the beneficial effect is shown or expected to be shown for less frequent consumers of conventional juice drinks and typical sugar-containing nonalcoholic beverages with substitution, in particular of at least one serving of typical juice drinks and typical sugar-containing non-alcoholic beverages with an equivalent serving of toothkind juice drink. The Panel considers that for people who consume conventional juice drinks or sugar-containing nonalcoholic beverages and who are also frequent consumers of sugars and/or acids from other beverages and foods that can contribute to tooth demineralisation, a beneficial effect on maintaining tooth mineralisation may be expected by substitution of one or more servings of conventional juice drinks or sugar-containing non-alcoholic beverages with an equivalent number of servings of toothkind juice drink. With regard to the wording, the Panel considers that in the context of the claim, reduction of tooth demineralisation has a similar meaning to maintenance of tooth mineralisation. EFSA Journal 2011;9(7):2293 2
TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background and Terms of reference as provided by the European Commission... 4 Evaluation... 5 1. Introduction... 5 2. Comments on the specific questions... 6 2.1. Whether conclusions for the substantiation of the beneficial effect, i.e. reduction of tooth demineralisation, can be drawn on the basis of studies which do not measure directly net demineralisation but measure the potential for demineralisation of enamel, e.g. reduced ph on dental plaque... 6 2.2. Whether the beneficial effect is shown or expected to be shown for less frequent consumers of conventional juice drinks and typical sugar-containing non-alcoholic beverages with substitution, in particular of at least one serving of typical juice drinks and typical sugar-containing non-alcoholic beverages with an equivalent serving of toothkind juice drink... 6 2.3. Wording of the claim... 7 Conclusions... 7 Documentation provided to EFSA... 7 EFSA Journal 2011;9(7):2293 3
BACKGROUND AND TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION In its Scientific Opinion on the substantiation of a health claim related to toothkind drinks and reduction of tooth demineralisation pursuant to Article 13(5) of Regulation (EC) No 1924/2006 (Question No EFSA-Q-2010-00784), the EFSA Panel on Dietetic Products, Nutrition and Allergies concluded, based on the studies submitted, that: A cause and effect relationship has been established between the consumption of typical conventional juice drinks at an exposure frequency of four times daily and tooth demineralisation due to erosive potential. A cause and effect relationship has been established between the consumption of typical sugarcontaining beverages (8-12 g sugars/100 ml) at an exposure frequency of seven times daily and tooth demineralisation by reducing plaque ph. In the opinion it was stated that no evidence has been presented showing an effect at lower exposure frequencies than in the two cases listed above. Nevertheless, it has been pointed out during consultations that some studies submitted in the initial application for the authorisation of the particular health claim investigated the effects of toothkind drinks on reduced plaque ph with less frequent exposure than seven and four times daily. Therefore, taking into account that plaque ph was quoted in the opinion to be an indirect measure of the potential for demineralisation, the Commission asked EFSA to advise and comment on: Whether conclusions for the substantiation of the claimed effect, i.e. reduction of tooth demineralisation, can be drawn on the basis of studies which do not measure directly net demineralisation but measure the potential for demineralisation of enamel, e.g. reduced ph on dental plaque. Whether the beneficial effect is shown or expected to be shown for less frequent consumers of conventional juice drinks and typical sugar-containing non-alcoholic beverages with substitution, in particular of at least one serving of typical juice drinks and typical sugar-containing nonalcoholic beverages with and equivalent serving of toothkind juice drink. Health claims foreseen in Article 13(5) of Regulation (EC) No 1924/2006, are in essence function claims as referred to in Article 13(1) of that Regulation. Although the application was submitted for an Article 13(5) claim, the beneficial physiological effect is defined as reduction of tooth demineralisation. Taking into account that tooth demineralisation is a recognised risk factor in the development of dental disease (caries), it is considered appropriate to examine alternative wordings that would not lead to misinterpretation by the consumer regarding the type of health claim. Therefore, EFSA is asked to advise if, in the context of the specific application submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the beneficial physiological effect can be understood and has the same meaning as referring to the maintenance of tooth mineralisation. EFSA Journal 2011;9(7):2293 4
EVALUATION 1. Introduction In its Scientific Opinion on the substantiation of a health claim related to toothkind drinks and reduction of tooth demineralisation pursuant to Article 13(5) of Regulation (EC) No 1924/2006 (Question No EFSA-Q-2010-00784), the EFSA Panel on Dietetic Products, Nutrition and Allergies concluded, based on the studies submitted, that: A cause and effect relationship has been established between the consumption of typical conventional juice drinks at an exposure frequency of four times daily and tooth demineralisation due to erosive potential. A cause and effect relationship has been established between the consumption of typical sugarcontaining beverages (8-12 g sugars/100 ml) at an exposure frequency of seven times daily and tooth demineralisation by reducing plaque ph. In the opinion it was stated that no evidence has been presented showing an effect at lower exposure frequencies than in the two cases listed above. Nevertheless, it has been pointed out during consultations that some studies submitted in the initial application for the authorisation of the particular health claim investigated the effects of toothkind drinks on reduced plaque ph with less frequent exposure than seven and four times daily. Therefore, taking into account that plaque ph was quoted in the opinion to be an indirect measure of the potential for demineralisation, the Commission asked EFSA to advise and comment on: Whether conclusions for the substantiation of the claimed effect, i.e. reduction of tooth demineralisation, can be drawn on the basis of studies which do not measure directly net demineralisation but measure the potential for demineralisation of enamel, e.g.reduced ph on dental plaque. Whether the beneficial effect is shown or expected to be shown for less frequent consumers of conventional juice drinks and typical sugar-containing non-alcoholic beverages with substitution, in particular of at least one serving of typical juice drinks and typical sugar-containing nonalcoholic beverages with and equivalent serving of toothkind juice drink. Health claims foreseen in Article 13(5) of Regulation (EC) No 1924/2006, are in essence function claims as referred to in Article 13(1) of that Regulation. Although the application was submitted for an Article 13(5) claim, the beneficial physiological effect is defined as reduction of tooth demineralisation. Taking into account that tooth demineralisation is a recognised risk factor in the development of dental disease (caries), the Member States and the Commission considered appropriate to examine alternative wordings that would not lead to misinterpretation by the consumer regarding the type of health claim. Therefore, EFSA was asked to advise if, in the context of the specific application submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the beneficial physiological effect can be understood and has the same meaning as referring to the maintenance of tooth mineralisation. EFSA Journal 2011;9(7):2293 5
2. Comments on the specific questions 2.1. Whether conclusions for the substantiation of the beneficial effect, i.e. reduction of tooth demineralisation, can be drawn on the basis of studies which do not measure directly net demineralisation but measure the potential for demineralisation of enamel, e.g. reduced ph on dental plaque For demineralisation of enamel caused by reducing plaque ph (due to fermentation of sugars in beverage), reduction of plaque ph immediately (within about 10 min) following a single consumption of a beverage is considered an appropriate measure of the potential of beverages for demineralisation of dental enamel. In the opinion, conclusions for substantiation of the claim were drawn from the studies of this type (which are cited in the Annex to the Commission s request for advice) relating to the effects of a single consumption of beverages on plaque ph. These show that toothkind drinks have little or no potential for enamel demineralisation by this process, as they do not lower the ph to 5.7 or less, while typical sugar-containing (8-12 g sugars/100 ml) non-alcoholic beverages do have the potential for demineralisation of dental enamel. However, a single daily consumption of typical sugar-containing non-alcoholic beverages is not sufficient to cause net tooth demineralisation (because of the capacity for repair of enamel) and multiple daily intakes are required (e.g. 7 times per day was shown in the studies which measured net demineralisation). Thus, the adverse effect of typical sugar-containing non-alcoholic beverages (net tooth demineralisation) was only shown at a frequency of intake of 7 times daily. Consequently, from the evidence provided, the beneficial effect (reducing net tooth demineralisation) of replacing typical sugar-containing non-alcoholic beverages with toothkind juice drinks was only shown to occur at a frequency of consumption of typical sugar-containing non-alcoholic beverages of 7 times daily. For demineralisation of enamel caused by acids in a beverage, an appropriate measure of the erosive potential of beverages is the net demineralisation of enamel observed in in situ studies in subjects with dental enamel samples placed in the mouth for a period of days/weeks during which the beverages are consumed with a defined daily frequency. Studies of the effect of beverages on net demineralisation of dental enamel in vitro do not provide an appropriate measure of erosive potential if considered alone; however, findings from such studies may be used to support the evidence from in situ studies. In the opinion, substantiation of the reduction of tooth demineralisation by toothkind juice drinks due to their low erosive potential, compared to conventional juice drinks, at a consumption frequency of four times daily, was based primarily on evidence for erosive potential shown by net enamel demineralisation in in situ studies, supported by evidence of net demineralisation from in vitro studies. 2.2. Whether the beneficial effect is shown or expected to be shown for less frequent consumers of conventional juice drinks and typical sugar-containing non-alcoholic beverages with substitution, in particular of at least one serving of typical juice drinks and typical sugar-containing non-alcoholic beverages with an equivalent serving of toothkind juice drink For people who consume conventional juice drinks or sugar-containing non-alcoholic beverages and who are also frequent consumers of sugars and/or acids from other beverages and foods that can contribute to tooth demineralisation, a beneficial effect on maintaining tooth mineralisation may be expected by substitution of one or more servings of conventional juice drinks or sugar-containing nonalcoholic beverages with an equivalent number of servings of toothkind juice drink. EFSA Journal 2011;9(7):2293 6
2.3. Wording of the claim Statement on toothkind juice drinks In the context of the claim, reduction of tooth demineralisation has a similar meaning to maintenance of tooth mineralisation. CONCLUSIONS The Panel considers that: Reduction of plaque ph immediately (within about 10 min) following a single consumption of a beverage is considered an appropriate measure of the potential of beverages for demineralisation of dental enamel due to fermentation of sugars in the beverage. Toothkind drinks have little or no potential for enamel demineralisation by this process, as they do not lower the ph to 5.7 or less, while typical sugar-containing non-alcoholic beverages do have the potential for demineralisation of dental enamel. The beneficial effect (reducing net tooth demineralisation) of replacing typical sugar-containing non-alcoholic beverages with toothkind juice drinks was only shown to occur at a frequency of consumption of typical sugar-containing non-alcoholic beverages of 7 times daily. An appropriate measure of the erosive potential of beverages is the net demineralisation of enamel observed in in situ studies in subjects with dental enamel samples placed in the mouth for a period of days/weeks during which the beverages are consumed with a defined daily frequency. Findings from in vitro studies may be used to support the evidence from in situ studies. For people who consume conventional juice drinks or sugar-containing non-alcoholic beverages and who are also frequent consumers of sugars and/or acids from other beverages and foods that can contribute to tooth demineralisation, a beneficial effect on maintaining tooth mineralisation may be expected by substitution of one or more servings of conventional juice drinks or sugarcontaining non-alcoholic beverages with an equivalent number of servings of toothkind juice drink. In the context of the claim, reduction of tooth demineralisation has a similar meaning to maintenance of tooth mineralisation. DOCUMENTATION PROVIDED TO EFSA Request to the EFSA for advice in relation to the authorisation procedure for health claims pursuant to Regulation (EC) No 1924/2006 on nutrition and health claims made on foods toothkind drinks EFSA-Q-2011-00781. EFSA Journal 2011;9(7):2293 7