SCIENTIFIC OPINION. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) 2, 3. European Food Safety Authority (EFSA), Parma, Italy

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1 SCIENTIFIC OPINION 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/ ABSTRACT EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) 2, 3 European Food Safety Authority (EFSA), Parma, Italy Following an application from GlaxoSmithKline, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data related to toothkind drinks and reduction of tooth demineralisation. The food constituent, toothkind juice drinks, which is the subject of the health claim, is sufficiently characterised. The Panel considers that reduction of tooth demineralisation is a beneficial physiological effect. The applicant identified 25 human intervention trials and 10 in vitro studies as being pertinent to the health claim. In weighing the evidence for reduced potential of toothkind juice drinks for demineralisation of dental enamel by reducing plaque ph, the Panel considers that toothkind juice drinks reduced tooth demineralisation when compared to sugar solution (10 g/100 ml) at an exposure frequency of seven times daily. No evidence has been presented for an effect at lower exposure frequencies. In weighing the evidence for reduced erosive potential, the Panel considers that toothkind juice drinks reduced tooth demineralisation when compared to typical conventional juice drinks at an exposure frequency of four times daily. No evidence has been presented for an effect at lower exposure frequencies. The Panel concludes that a cause and effect relationship has been established between the consumption of toothkind juice drinks and reduction of tooth demineralisation when compared to typical conventional juice drinks at an exposure frequency of four times daily and when compared to typical sugar-containing acidic nonalcoholic beverages at an exposure frequency of seven times daily. European Food Safety Authority, 2010 KEY WORDS Toothkind drinks, tooth demineralisation, tooth caries, tooth erosion, health claim. 1 On request from the Competent Authority of the United Kingdom following an application by GlaxoSmithKline, Question No EFSA-Q adopted on 12 November 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 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen for the preparatory work on this scientific opinion. For citation purposes: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); 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/ [13 pp.] doi: /j.efsa Available online: European Food Safety Authority,

2 SUMMARY Following an application from GlaxoSmithKline submitted pursuant to Article 13(5), of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to toothkind drinks and reduction of tooth demineralisation. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data. The food that is the subject of the claim is toothkind drinks which are described as a range of modified non-alcoholic beverages. The applicant specifies three parameters characterising these products: a. Fermentable carbohydrate content is less than 1 g per 100 ml (specification g carbohydrate/100 ml); b. Minimum ph is 3.7 (specification ). According to the applicant the upper limit is determined by microbiological and taste considerations, and ph below 3.7 would be less effective. c. Calcium to acid molar ratio is between 0.3 and 0.8. According to the applicant less calcium would lead to a loss in efficacy, while a calcium content higher than the upper limit may lead to calcium precipitation. In practice, the amount of added calcium is based on measurement of titratable acidity of the product to calculate the range of calcium that needs to be added to achieve the above mentioned calcium to acid molar ratio. The comparator products for the claim are sugar-containing acidic non-alcoholic beverages ( soft drinks and fruit juices) which have typically a ph range of and a calcium:acid molar ratio of and a carbohydrate (typically sugars) content of 8-12 g/100 ml. The Panel notes that while fruit juices contain mainly organic acids, soft drinks may contain acids other than organic acids. The Panel considers that toothkind juice drinks which are the subject of the health claim, and the proposed comparator products, typical conventional juice drinks and sugar-containing acidic nonalcoholic beverages, are sufficiently characterised in the context of the proposed claimed effect. The claimed effect is reduction of tooth demineralisation. The target population is the general population. The Panel considers that reducing tooth demineralisation is a beneficial physiological effect. In weighing the evidence for reduced potential of toothkind juice drinks for demineralisation of dental enamel by reducing plaque ph, the Panel took into account that in two out of three human studies exposure to toothkind juice drinks resulted in significantly less net demineralisation than sucrose solution (10 g/100 ml) at an exposure frequency of seven times daily, that in ten human studies consumption of toothkind drinks showed a significantly lower potential for demineralisation of enamel, but not of net demineralisation, in comparison to sucrose solution (10 g/100 ml), and that in one human study consumption of toothkind drinks showed a significantly lower potential for demineralisation of enamel, but not of net demineralisation, in comparison to a conventional juice drink (4.5 g sugars/100 ml). The Panel considers that consumption of toothkind juice drinks reduced tooth demineralisation when compared to sugar solutions (10 g/100 ml) at an exposure frequency of seven times daily. The Panel notes that no evidence has been presented for an effect at lower exposure frequencies. In weighing the evidence for reduced erosive potential, the Panel took into account that in nine out of ten human studies toothkind juice drinks showed significantly less erosive potential compared to 2

3 conventional juice drinks, that in one human study the erosive potential of toothkind carbonated drink was not significantly different from that of conventional carbonated drinks, and that results of in vitro studies are supportive for a reduced erosive potential of toothkind juice drinks compared to conventional juice drinks. The Panel considers that consumption of toothkind juice drinks reduced tooth demineralisation when compared to typical conventional juice drinks at an exposure frequency of four times daily. The Panel notes that no evidence has been presented for an effect at lower exposure frequencies. The Panel concludes 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 and that consumption of toothkind juice drinks in replacement of conventional juice drinks may contribute to reduced tooth demineralisation. The Panel also concludes that a cause and effect relationship has been established between the consumption of typical sugar-containing beverages (8-12 g sugars/100 ml) at an exposure frequency of seven times daily and tooth demineralisation by reducing plaque ph and that consumption of toothkind juice drinks in replacement of typical sugar-containing non-alcoholic beverages may contribute to reduced tooth demineralisation. The Panel could not have reached the conclusions related to toothkind juice drinks without considering the studies claimed by the applicant as proprietary. The Panel considers that the following wording reflects the scientific evidence: Frequent consumption of typical juice drinks and sugar-containing, acidic, non-alcoholic beverages may contribute to tooth demineralisation; consumption of toothkind juice drinks in replacement of typical juice drinks and sugar-containing, non-alcoholic beverages may help to reduce tooth demineralisation. The Panel notes that the conditions of use proposed by the applicant are for substitution of a serving of a conventional, acidic non-alcoholic beverage with an equivalent serving of toothkind juice drink. However, no evidence has been presented for daily consumption frequencies less than four for an effect of typical conventional juice drinks on tooth demineralisation due to erosive potential or less than seven for an effect of typical sugar-containing, acidic, non-alcoholic beverages on tooth demineralisation, or for a comparatively lower effect of toothkind juice drinks on tooth demineralisation due to reduced plaque ph. The Panel concludes that the conditions of use of the claim are for substitution of a serving of typical juice drinks and typical sugar-containing (8-12 g/100 ml) non-alcoholic beverages with an equivalent serving of toothkind juice drink in frequent consumers of conventional juice drinks and typical sugar-containing (8-12 g/100 ml) non-alcoholic beverages. The Panel notes that the scientific assessment of the claim has been performed as a comparison of the effect of toothkind juice drinks with typical conventional juice drinks and typical sugar-containing acidic non-alcoholic beverages, as proposed by the applicant. 3

4 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 4 Background as provided by the European Commission... 5 Terms of reference as provided by the European Commission... 5 EFSA Disclaimer... 5 Information provided by the applicant... 6 Assessment Characterisation of the food/constituent Relevance of the claimed effect to human health Scientific substantiation of the claimed effect Panel s comments on the proposed wording Conditions and restrictions of use Conclusions Documentation provided to EFSA References

5 BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION Regulation (EC) No 1924/ harmonises the provisions that relate to nutrition and health claims and establishes rules governing the Community authorisation of health claims made on foods. As a rule, health claims are prohibited unless they comply with the general and specific requirements of that Regulation and are authorised in accordance with this Regulation and included in the lists of authorised claims provided for in Articles 13 and 14 thereof. In particular, Article 13(5) of that Regulation lays down provisions for addition of claims (other than those referring to the reduction of disease risk and to children s development and health), which are based on newly developed scientific evidence or include a request for the protection of proprietary data, to the Community list of permitted claims referred to in Article 13(3). According to Article 18 of that Regulation, an application for authorisation shall be submitted by the applicant to the national competent authority of a Member State, who will make the application and any supplementary information supplied by the applicant available to the European Food Safety Authority (EFSA). Steps taken by EFSA: The application was received on 13/04/2010. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data. The scientific evaluation procedure started on 10/05/2010. On 25/06/2010, the NDA Panel agreed on a list of questions which requested the applicant to provide additional particulars to accompany the application by 27/07/2010. The applicant submitted the responses to the NDA Panel s list of questions on 27/07/2010. During the meeting on 12/11/2010, the NDA Panel, after having evaluated the overall data submitted, adopted an opinion on the scientific substantiation of a health claim related to toothkind drinks and reduction of tooth demineralisation. TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION EFSA is requested to evaluate the scientific data submitted by the applicant in accordance with Article 16(3) of Regulation (EC) No 1924/2006. On the basis of that evaluation, EFSA will issue an opinion on the scientific substantiation of a health claim related to toothkind drinks and reduction of tooth demineralisation. EFSA DISCLAIMER The present opinion does not constitute, and cannot be construed as, an authorisation to the marketing of toothkind drinks, a positive assessment of its safety, nor a decision on whether toothkind drinks are, or are not, classified as a foodstuff. It should be noted that such an assessment is not foreseen in the framework of Regulation (EC) No 1924/2006. It should also be highlighted that the scope, the proposed wording of the claim and the conditions of use as proposed by the applicant may be subject to changes, pending the outcome of the authorisation procedure foreseen in Article 18(4) of Regulation (EC) No 1924/ European Parliament and Council (2006). Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Official Journal of the European Union OJ L 404, Corrigendum OJ L 12, , p

6 INFORMATION PROVIDED BY THE APPLICANT Applicant s name and address: GlaxoSmithKline Services Unlimited, Royal Forest Factory, Coleford, Gloucestershire GL16 8JB, United Kingdom. The application includes a request for the protection of proprietary data: Adams et al. NHCMA0303, UK (2004); Hollas et al., NMA0501, UK (2005); Adams, NHCMA0301 (2003); Adnitt et al., NHCMA0302, UK (2005); Broughton et al., NHCMA0401, UK (2006); De Ath et al., N , UK (2002a); De Ath et al., N , UK (2002b); De Ath et al., N , UK (2002c); De Ath et al., N , UK (2003); Gard ner et al., N , UK (2003a); Gard ner et al., N , UK (2003b); May et al., N , UK (1998a); May et al., N , UK (1998b); May et al., N UK, (1998c); May et al., N UK (1999) in accordance with Article 21 of Regulation (EC) No 1924/2006). Food/constituent as stated by the applicant According to the applicant, a toothkind drink is a non-alcoholic beverage which has been modified to meet the following criteria: At the ready for consumption state (where applicable made up according to the manufacturer s instructions) the product must contain: o Less than 1g fermentable carbohydrate per 100 ml o Calcium in a range from 0.3 to 0.8 mol per mol acidulant o Display a minimum ph of 3.7 (The calcium to acid ratio is based on the amount of added calcium to acid available in the drink prior to the adjustment of the ph). Currently, the toothkind range consists only of fruit juice-containing soft drinks, with the juice contributing all the carbohydrate to the product as well as often the majority of the acidity. Health relationship as claimed by the applicant According to the applicant, modern diet can have a negative impact on dental health in several ways. Most well known is the link between caries and the amount and frequency of fermentable carbohydrate consumption. In recent years more attention has been paid to dental erosion, a condition that is induced in the oral environment by the presence of acids e.g. dietary acids. The dissolution of tooth mineral is a key factor in both disorders. To be considered toothkind a non-alcoholic beverage needs to display minimal erosive and cariogenic potential. This is achievable through the control of the amount of fermentable carbohydrate, the ph and the calcium to acid molar ratio of the drink as shown by the body of work presented. The modified drink helps to maintain healthy teeth when used as a substitute for conventional drinks in this category, within a balanced diet. Wording of the health claim as proposed by the applicant The applicant proposed the following wording for the health claim: Toothkind drinks help to maintain healthy teeth. Specific conditions of use as proposed by the applicant According to the applicant, the product is to be used as a substitute for conventional non-alcoholic beverages not matching the criteria for a toothkind drink. The target population for the intended health claim is the general population, both adults and children. The beneficial health effect described can be achieved through substitution of a serving of a conventional, acidic non-alcoholic beverage with an equivalent serving of a modified drink within a balanced diet through reduced exposure to acid and sugar, although greater benefit will be achieved through an increased level of substitution. 6

7 ASSESSMENT 1. Characterisation of the food/constituent The food that is the subject of the claim is toothkind drinks which are described as a range of modified non-alcoholic beverages. The applicant specifies three parameters characterising these products: a. Fermentable carbohydrate content is less than 1 g per 100 ml (specification g carbohydrate/100 ml); b. Minimum ph is 3.7 (specification ). According to the applicant the upper limit is determined by microbiological and taste considerations, and a ph below 3.7 would be less effective. c. Calcium to acid molar ratio is between 0.3 and 0.8. According to the applicant less calcium would lead to a loss in efficacy, while a calcium content higher than the upper limit may lead to calcium precipitation. In practice, the amount of added calcium is based on measurement of titratable acidity of the product to calculate the range of calcium that needs to be added to achieve the above mentioned calcium to acid molar ratio. The toothkind drinks which are the subject of the claim do not contain significant amounts of other nutrients (e.g. fluoride) which could contribute to the claimed effect. The toothkind range consists only of fruit juice-containing soft drinks, with the juice contributing all the carbohydrate to the product as well as often the majority of the acidity. The comparator products for the claim are sugar-containing acidic non-alcoholic beverages ( soft drinks and fruit juices) which have typically a ph range of , a calcium:acid molar ratio of and a carbohydrate (typically sugars) content of 8-12 g/100 ml. The Panel notes that while fruit juices contain mainly organic acids, soft drinks may contain acids other than organic acids. The Panel considers that toothkind juice drinks which are the subject of the health claim, and the proposed comparator products, conventional juice drinks and sugar-containing acidic non-alcoholic beverages, are sufficiently characterised in the context of the proposed claimed effect. 2. Relevance of the claimed effect to human health The claimed effect originally proposed by the applicant was maintaining healthy teeth. Upon request for clarification, the applicant indicated that the claimed effect related to reduction of tooth demineralisation. The target population is the general population. Demineralisation of tooth tissues follows acid production through the fermentation of carbohydrates by acid-producing bacteria in dental biofilms. The effects may be balanced by remineralisation when ph is neutralised and a state of calcium and phosphate supersaturation is met. If demineralisation is not balanced by remineralisation then net demineralisation of tooth tissues results which, if sustained, can lead to dental caries. Demineralisation of tooth tissues can also occur as a result of consumption of dietary acids in foods or beverages and frequent consumption can lead to dental erosion. Dental caries and dental erosion are diseases with a high prevalence in the EU. The Panel considers that reducing tooth demineralisation is a beneficial physiological effect. 3. Scientific substantiation of the claimed effect The applicant performed a literature search in Food Sci.&Tech.Abs, Foodline, Medline, Biosis Previews and FSTA. Search strategy including used keywords, inclusion and exclusion criteria was presented. Inclusion criteria comprised published and unpublished data describing a relationship between dental erosion or its surrogate marker and simultaneous modifications to the ph and calcium content of an acidic beverage and describing the relationship between dental caries or its surrogate 7

8 marker and simultaneous limitation of the level of fermentable carbohydrates to less than 1 %. Papers presented as abstracts as well as summaries lacking critical evaluation or lacking meta-analyses of the presented area were excluded. Hand searching was used to select only references in line with inclusion and exclusion criteria. A total of 35 pertinent studies were identified by the applicant, consisting of 25 human intervention studies (ten published and 15 unpublished) and ten non-human studies. The potential of beverages for demineralisation of dental enamel by reducing plaque ph was assessed in fourteen randomised, controlled, cross-over in situ studies. In three studies the effects of beverages or sugar solutions on demineralisation (measured as microhardness) of enamel on plaque covered slabs which were placed in the mouth for up to 21 days was assessed by ex vivo exposure to beverages for two minutes 7 times per day. Exposure to toothkind juice drink (0.8 g/100 ml fruit sugars) resulted in significantly less enamel softening than exposure to a sucrose solution (10 g/100 ml) and was similar to that of a sorbitol solution (10 g/100 ml) after 14 and 21 days (Adnitt et al., 2005). Exposure to toothkind juice drink (0.7 g/100 ml fruit sugars) resulted in significantly less enamel softening than a sucrose solution (10 g/100 ml) but was greater than that of mineral water after 21 days of dosing (Broughton et al., 2006, unpublished). Exposure to a solution of monosaccharides (0.7 g/100 ml) resulted in significantly less enamel softening than exposure to a sucrose solution (10 g/100 ml) after 14 days, but not at 21 days (Adams et al., 2003). In these studies, the level of softening increased over the duration of the studies for both the sucrose solution and the toothkind juice drinks. The Panel notes that the design of all studies relates to an exposure frequency of seven times daily and lower exposure frequencies were not investigated. In eleven studies the effects of beverages on plaque ph were assessed (De Ath et al., 2002a, b, c, unpublished; De Ath et al., 2003, unpublished; Gard ner et al., 2003a, b, unpublished; May et al., 1998a, b, c, unpublished; May et al., 1999, unpublished; Toumba et al., 1999). Plaque ph is reduced by acids produced in plaque as a result of carbohydrate fermentation and is an indirect measure of the potential for demineralisation. The two main measures used were the mean plaque ph measured 10 minutes after exposure and the mean minimum plaque ph. In ten studies consumption of toothkind juice drinks (<1 g sugars/100 ml) resulted in a significantly smaller reduction in plaque ph in comparison to a sucrose solution (10 g/100 ml). Consumption of toothkind juice drinks (<1 g sugars /100 ml) resulted in a significantly smaller reduction of plaque ph than conventional juice drink (4.5 g sugars/100 ml) (Toumba et al., 1999), but not when compared to a conventional juice drink with <1 g sugars/100 ml (De Ath et al., 2002a,b,c unpublished; Toumba et al., 1999). Toothkind juice drinks did not depress the measured mean minimum plaque ph (or the mean plaque ph measured 10 minutes after exposure) below 5.7 which is considered a conservative estimate of the critical ph for enamel demineralisation below which dissolution of enamel may occur. The mean minimum plaque ph with sucrose solution (10 g/100 ml) was in the range The Panel considers that these studies indicate that a 10 % sugar solution has the potential for demineralisation of enamel; however, the studies did not measure net demineralisation. The erosive potential of beverages was assessed in ten randomised, controlled, cross-over in situ studies in subjects with dental enamel samples placed in the mouth for the duration of the exposures. In the majority of studies participants were asked to consume 1 L of drink divided into 4 servings of 250 ml over the course of a working day while wearing an appliance containing enamel samples. The erosive potential of the drinks was established at pre-determined intervals ranging from 1 to 15 days by measuring enamel loss using profilometry (nine studies) and nanoindentation (one study, Finke et al., 2001). In nine studies toothkind juice drinks showed significantly less erosive potential compared to conventional juice drinks (Adams et al., 2004; Finke et al., 2001 Hollas et al., 2005; Hughes et al., 1999a, b, 2002; West et al., 1999, 2003, 2004), while in a study comparing toothkind carbonated drinks and conventional carbonated drinks the differences were not statistically significant (Hunter et 8

9 al., 2003). The difference in the level of erosion observed between toothkind juice drinks and conventional juice drinks increased with the number of days of exposure to the drinks. The erosive potential of toothkind juice drinks was either similar to or slightly higher than water. The Panel notes that the design of all studies relates to an exposure frequency of four times daily and lower exposure frequencies were not investigated. One in vivo study (Bartlett et al. 2003) measured changes in ph at the tooth surface during the consumption of 250 ml of toothkind juice drinks or conventional juice drinks and up to 15 minutes afterwards. The Panel considers that no conclusions can be drawn from this study for the substantiation of the claim as the evidence provided does not establish that this is an appropriate method to establish the erosive potential of the drinks. Ten in vitro studies showed that the erosive potential of toothkind juice drinks and toothkind carbonated drinks was lower than that of conventional juice or carbonated drinks (Hemingway et al., 2006; Hughes et al., 1999a; Hunter et al., 2003; Jensdotter et al. 2005; Mahoney et al., 2003; Finke et al., 2000; Barbour et al., 2006; Cairns et al., 2002; Lippert et al., 2004; Shellis et al., 2005). The Panel considers that results of the in vitro studies on juice drinks are supportive of the evidence from in situ studies for a reduced erosive potential of toothkind juice drinks compared to conventional juice drinks. The Panel notes that the results of the in vitro studies on carbonated drinks for a reduced erosive potential of toothkind carbonated drinks compared to conventional carbonated drinks are not supported by evidence from in situ studies. In weighing the evidence for a reduced potential of toothkind juice drinks for demineralisation of dental enamel by reducing plaque ph, the Panel took into account that in two out of three human studies exposure to toothkind juice drinks resulted in significantly less net demineralisation than exposure to a sucrose solution (10 g/100 ml) at an exposure frequency of seven times daily, that in ten human studies consumption of toothkind drinks showed a significantly lower potential for demineralisation of enamel but not for net demineralisation in comparison to a sucrose solution (10 g/100 ml), and that in one human study consumption of toothkind drinks showed a significantly lower potential for demineralisation of enamel, but not for net demineralisation, in comparison to a conventional juice drink (4.5 g/100 ml sugars). The Panel considers that consumption of toothkind juice drinks reduced tooth demineralisation when compared to a sugar solution (10 g/100 ml) at an exposure frequency of seven times daily. The Panel notes that no evidence has been presented for an effect at lower exposure frequencies. In weighing the evidence for a reduced erosive potential, the Panel took into account that in nine out of ten human studies toothkind juice drinks showed significantly less erosive potential compared to conventional juice drinks, that in one human study the erosive potential of toothkind carbonated drink was not significantly different from that of conventional carbonated drinks, and that results of in vitro studies are supportive for a reduced erosive potential of toothkind juice drinks compared to conventional juice drinks. The Panel considers that consumption of toothkind juice drinks reduced tooth demineralisation when compared to typical conventional juice drinks at an exposure frequency of four times daily. The Panel notes that no evidence has been presented for an effect at lower exposure frequencies. The Panel concludes 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 and that consumption of toothkind juice drinks in replacement of conventional juice drinks may contribute to reduced tooth demineralisation. The Panel also concludes that a cause and effect relationship has been established between the consumption of typical sugar-containing beverages (8-12 g sugars/100 ml) at an exposure frequency of seven times daily and tooth demineralisation by reducing plaque ph and that consumption of toothkind juice drinks in replacement of typical sugar-containing non-alcoholic beverages may contribute to reduced tooth demineralisation. 9

10 The Panel notes that the conditions of use proposed by the applicant are for substitution of a serving of a conventional, acidic non-alcoholic beverage with an equivalent serving of toothkind juice drink. However, no evidence has been presented for daily consumption frequencies less than four for an effect of typical conventional juice drinks on tooth demineralisation due to erosive potential or less than seven for an effect of typical sugar-containing, acidic, non-alcoholic beverages on tooth demineralisation, or for a comparatively lower effect of toothkind juice drinks on tooth demineralisation due to reduced plaque ph. The Panel considers that the evidence available supports the proposed conditions of use of the claim only in frequent consumers of conventional juice drinks and typical sugar-containing (8-12 g/100 ml) non-alcoholic beverages. The Panel notes that the scientific assessment of the claim has been performed as a comparison of the effect of toothkind juice drinks with typical conventional juice drinks and typical sugar-containing acidic non-alcoholic beverages, as proposed by the applicant. The Panel could not have reached the conclusions related to toothkind juice drinks without considering the studies claimed by the applicant as proprietary. 4. Panel s comments on the proposed wording The Panel considers that the following wording reflects the scientific evidence: Frequent consumption of typical juice drinks and sugar-containing, acidic, non-alcoholic beverages may contribute to tooth demineralisation; consumption of toothkind juice drinks in replacement of typical juice drinks and sugar-containing, acidic, non-alcoholic beverages may help to reduce tooth demineralisation. 5. Conditions and restrictions of use The claim relates to toothkind juice drinks with the following characteristics: a. Acidic juice beverages (ph ), b. Less than 1 g fermentable carbohydrate per 100 ml (sugars and other carbohydrates except polyols), c. Calcium in a range from 0.3 to 0.8 mol per mol acidulant. The proposed comparator beverages for the claim are: typical conventional juice drinks and typical sugar-containing acidic non-alcoholic beverages which have typically a ph range of , a typical calcium:acid molar ratio of and a carbohydrate (sugars) content of 8-12 g/100 ml. The Panel considers that the conditions of use of the claim are for substitution of a serving of typical juice drinks and typical sugar-containing (8-12 g/100 ml) non-alcoholic beverages with an equivalent serving of toothkind juice drink in frequent consumers of conventional juice drinks and typical sugar-containing (8-12 g/100 ml) non-alcoholic beverages. CONCLUSIONS The Panel concludes that, on the basis of data presented: Toothkind juice drinks which are the subject of the health claim, and the proposed comparator products, conventional juice drinks and sugar-containing, acidic, non-alcoholic beverages, are sufficiently characterised in the context of the claimed effect. The claimed effect is maintaining healthy teeth by reduction of tooth demineralisation when compared to typical sugar-containing, acidic, non-alcoholic beverages. The target population is the general population. The Panel considers that reducing tooth demineralisation is a beneficial physiological effect. 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 10

11 demineralisation due to erosive potential. Consumption of toothkind juice drinks in replacement of conventional juice drinks may contribute to reduced tooth demineralisation. A cause and effect relationship has been established between the consumption of typical sugar-containing beverages (8-12 g sugars/100 ml) at an exposure frequency of seven times daily and tooth demineralisation by reducing plaque ph. Consumption of toothkind juice drinks in replacement of typical sugar-containing non-alcoholic beverages may contribute to reduced tooth demineralisation. The Panel could not have reached this conclusion without considering the studies claimed by the applicant as proprietary. The following wording reflects the scientific evidence: Frequent consumption of typical juice drinks and sugar-containing, acidic, non-alcoholic beverages may contribute to tooth demineralisation; consumption of toothkind juice drinks in replacement of typical juice drinks and sugar-containing, acidic, non-alcoholic beverages may help to reduce tooth demineralisation. The conditions of use of the claim are for substitution of a serving of typical juice drinks and typical sugar-containing (8-12 g/100 ml) non-alcoholic beverages with an equivalent serving of toothkind juice drink in frequent consumers of conventional juice drinks and typical sugar-containing (8-12 g/100 ml) non-alcoholic beverages. The Panel notes that the scientific assessment of the claim has been performed as a comparison of the effect of toothkind juice drinks with typical conventional juice drinks and sugar-containing acidic non-alcoholic beverages, as proposed by the applicant. DOCUMENTATION PROVIDED TO EFSA Health claim application on toothkind drink and reduction of tooth demineralisation pursuant to Article13(5) of Regulation (EC) No 1924/2006 (Claim serial No: 0279_UK). March Submitted by GlaxoSmithKline. REFERENCES Adams G, North M, De Ath J. Principal Investigator: West NX, An investigation into the Erosive Effect of Hot Drinks. GlaxoSmithKline Report NHCMA0303, UK, (unpublished). Adams G, North M. Principal Investigator Duggal MS, Development of Intra-Oral Cariogenicity (ICT) Model #3. GlaxoSmithKline Report NHCMA0301, UK, (unpublished). Adnitt C, Adams G, North M. Principal Investigator Toumba KJ., Development of Intra-Oral Cariogenicity (ICT) Model #4. GlaxoSmithKline Report NHCMA0302, UK, (unpublished). Barbour ME, Finke M, Parker DM, Hughes JA, Allen GC, Addy M., The relationship between enamel softening and erosion caused by soft drinks at a range of temperatures. Journal of Dentistry, 34, Bartlett DW, Bureau GP, Anggiansah A, Evaluation of the ph of a new carbonated soft drink beverage : An in vivo investigation. Journal of Prosthodontics, 12, Broughton J, North, M, Roman L. Principal Investigator Toumba KJ., Development of Intra- Oral Cariogenicity (ICT) Model #5. GlaxoSmithKline Report NHCMA0401, UK, (unpublished). Cairns AM, Watson M, Creanor SL, Foye RH, The ph and titratible acidity of a range of diluting drinks and their potential effect on dental erosion. Journal of Dentistry, 30,

12 De Ath, J, North M, Smith S. Principal Investigator: Ong TJ., 2002a. A single blind, four-way crossover study to investigate the effect of two formulations of fruit drinks in comparison to a positive control (sucrose) and a negative control (sorbitol) on the ph of dental plaque. GlaxoSmithKline Report N , UK, (unpublished). De Ath J, North M, Smith S. Principal Investigator: Jackson R, 2002b. A single blind, four-way crossover study to investigate the effect of two formulations of fruit drinks in comparison to a positive control (sucrose) and a negative control (sorbitol) on the ph of dental plaque. GlaxoSmithKline Report N , UK, (unpublished). De Ath J, North M, Smith S. Principal Investigator: Preston A, 2002c. A single blind, four-way crossover study to investigate the effect of two formulations of fruit drinks in comparison to a positive control (sucrose) and a negative control (sorbitol) on the ph of dental plaque. GlaxoSmithKline Report N , UK, (unpublished). De Ath J, Moohan M, Smith S. Principal Investigator: Toumba KJ, A single blind, four-way crossover study to investigate the effect of two formulations of fruit drinks in comparison to a positive control (sucrose) and a negative control (sorbitol) on the ph of dental plaque. GlaxoSmithKline Report N , UK, (unpublished). Finke M, Hughes JA, Parker DM, Jandt KD, Mechanical properties of in situ demineralised human enamel measured by AFM nanoindentation. Surface Science, 491, Finke M, Jandt KD, Parker DM, The early stages of native enamel dissolution studied with atomic force microscopy. Journal of Colloid Interface Science, 232, Gard ner K, Moohan M, Smith S. Principal Investigator: Ong TJ, 2003a. A single blind, four-way crossover study to investigate the effect of two formulations of fruit drinks in comparison to a positive control (sucrose) and a negative control (sorbitol) on the ph of dental plaque. GlaxoSmithKline Report N , UK, (unpublished). Gard ner K, Moohan M, Smith S. Principal Investigator: Jackson R, 2003b. A single blind, four-way crossover study to investigate the effect of two formulations of fruit drinks in comparison to a positive control (sucrose) and a negative control (sorbitol) on the ph of dental plaque. GlaxoSmithKline Report N , UK, (unpublished). Hemingway CA, Parker DM, Addy M Barbour ME, Erosion of enamel by noncarbonated soft drinks, with and without toothbrushing abrasion. British Dental Journal, 201, Hollas M, McAuliffe T, Finke M. Principal Investigator: West NX, An investigation into the effect of a modified blackcurrant drink on tooth enamel with and without additional tooth brushing. GlaxoSmithKline Report NMA0501, UK., (unpublished). Hughes JA, West NX, Parker DM, Newcombe RG, Addy M, 1999a. Development and evaluation of a low erosive blackcurrant juice drink in vitro and in situ. 1. Comparison with orange juice. Journal of Dentistry, 27: GlaxoSmithKline, UKReport NH/96/01, UK. Hughes JA, West NX, Parker DM, Newcombe RG, Addy M, 1999b. Development and evaluation of a low erosive blackcurrant juice drink 3. Final drink and concentrate, formulae comparisons in situ and overview of the concept. Journal of Dentistry, 27, GlaxoSmithKline Report N , UK. Hughes JA, Jandt KD, Baker N, Parker D, Newcombe RG, Eisenburger M, Addy M, Further Modification of soft drinks to minimise erosion. Caries Research, 36, GlaxoSmithKline Report NHC2000-1, UK. 12

13 Hunter ML, Hughes JA, Parker DM. West NX, Newcombe RG, Addy M, Development of low erosive carbonated fruit drinks. 1. Evaluation of two experimental orange drinks in vitro and in situ. Journal of Dentistry, 31, , UK. GlaxoSmithKline Report N , UK. Jensdottir T, Bardow A, Holbrook P, Properties and modification of soft drinks in relation to their erosive potential in vitro. Journal of Dentistry, 33, Lippert F, Parker DM, Jandt KD., Susceptibility of deciduous and permanent enamel to dietary acid-induced erosion studied with atomic force microscopy nanoindentation. European Journal of Oral Sciences, 112, Mahoney E, Beattie J, Swain M, Kilpatrick N., Preliminary in vitro assessment of erosive potential using the ultra-micro-indentation system Caries Research, 37, May R, and Hughes JM. Principal Investigator: Toumba KJ, 1998c. A single blind, five-way crossover study to investigate the effect of three new formulations of fruit drinks in comparison to a positive control (sucrose) and a negative control (sorbitol) on the ph of dental plaque. GlaxoSmithKline Report N , UK, (unpublished). May R, and Moohan M. Principal Investigator: Duggal MS, A single blind, three-way crossover study to investigate the effect of a new formulation of fruit drink in comparison to a positive control (sucrose) and a negative control (sorbitol) on the ph of dental plaque in children. GlaxoSmithKline Report N , UK, (unpublished). May R, Darby-Dowan A, Smith S. Principal Investigator: Curzon M, 1998a. A single blind, five-way crossover healthy volunteer study to investigate the effect of a new orange and a new strawberry formulation of fruit drink in comparison to a blackcurrant fruit drink and two control treatments on the ph of dental plaque. GlaxoSmithKline Report N , UK, (unpublished). May R, Hughes JM. Principal Investigator: Duggal MS, 1998b. A single blind, five-way crossover study to investigate the effect of three new formulations of fruit drinks in comparison to a positive control (sucrose) and a negative control (sorbitol) on the ph of dental plaque. GlaxoSmithKline Report N , UK, (unpublished). Shellis RP, Finke M, Eisenburger M, Parker DM, Addy M, Relationship between enamel erosion and liquid flow rate. European Journal Oral Science, 113, Toumba KJ, Duggal MS, A single blind, six-way crossover healthy volunteer study to investigate the effect of two new formulations of blackcurrant drink in comparison to two conventional marketed fruit drinks, and two control treatments on the ph of dental plaque. British Dental Journal, 186, GlaxoSmithKline Report N , UK. West NX, Hughes JA, Parker D, Weaver LJ, Moohan M, De Ath J, Addy M, Modification of soft drinks with xanthan gum to minimise erosion: a study in situ. British Dental Journal 196, GlaxoSmithKline Report N , UK. West NX, Hughes JA, Parker DM, Moohan M, Addy M, Development of low erosive carbonated fruit drinks 2. Evaluation of an experimental carbonated blackcurrant drink compared to a conventional carbonated drink. Journal of Dentistry, 31, GlaxoSmithKline Report N , UK. West NX, Hughes JA, Parker DM, Newcombe RG, Addy M, Development and evaluation of a low erosive blackcurrant juice drink 2. Comparison with a conventional blackcurrant juice drink and orange juice. Journal of Dentistry, 27, GlaxoSmithKline Report NH/96/02. 13

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