SCIENTIFIC OPINION. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) 2, 3 ABSTRACT. 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 sugar-free chewing gum and neutralisation of plaque acids which reduces the risk of dental caries pursuant to Article 14 of Regulation (EC) No 1924/ EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) 2, 3 European Food Safety Authority (EFSA), Parma, Italy This scientific output, published on 5 October 2010, replaces the earlier version published on 1 October ABSTRACT Following an application from Wrigley GmbH submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of 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 sugar-free chewing gum and neutralisation of plaque acids which reduces the risk of dental caries. Sugar-free chewing gum is sufficiently characterised. The Panel considers that plaque acid neutralisation might be a beneficial physiological effect in the context of reducing the risk of caries. The applicant identified a total of 47 publications as being pertinent to the health claim. In weighing the evidence, the Panel took into account that many human studies of sugar-free chewing gum consumption were consistent in showing neutralisation of plaque acid, that almost all clinical trials on sugar-free chewing gum consumption showed a reduction in caries incidence, and that there was strong evidence supporting the biological plausibility for the effect. The Panel concludes that a cause and effect relationship has been established between the consumption of sugar-free chewing gum and plaque acid neutralisation and a reduction in incidence of caries. Plaque acid production may contribute to increased risk of caries. In order to obtain the claimed effect, 2-3 g of sugar-free chewing gum should be chewed for 20 minutes at least three times per day after meals. This quantity and pattern of use of chewing gum can easily be included within a balanced diet. European Food Safety Authority, 2010 KEY WORDS Chewing gum, sugar-free, teeth, plaque acids, caries, health claims. 1 On request from Wrigley GmbH, Question No EFSA-Q , adopted on 10 September 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 Ingegerd Johansson and 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. 4 After publication of the scientific output, EFSA noticed an error in the question number cited in footnote 1. This has been corrected in the present version. Suggested citation: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to sugar-free chewing gum and neutralisation of plaque acids which reduces the risk of dental caries pursuant to Article 14 of Regulation (EC) No 1924/ [14 pp.]. doi: /j.efsa Available online: European Food Safety Authority,

2 SUMMARY Following an application from Wrigley GmbH submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of 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 sugar-free chewing gum and neutralisation of plaque acids which reduces the risk of dental caries. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The food, which is the subject of the health claim, is sugar-free chewing gum containing both bulk sweeteners (typically xylitol, sorbitol and mannitol) and high intensity sweeteners that are authorised for use in the EU. Typical proportions used for manufacturing sugar-free chewing gum are described by the applicant. The ingredients are well characterised and can be measured by established methods. The Panel considers that the food, sugar-free chewing gum, which is the subject of the health claim, is sufficiently characterised. The claimed effect is sugar-free chewing gum neutralises plaque acids which reduces the risk of dental caries. The target population is the general population. The Panel considers that plaque acid neutralisation might be a beneficial physiological effect in the context of reducing the risk of caries. The applicant identified a total of 47 publications, which included 31 human intervention studies, one human observational study, one meta-analysis, one systematic review, eight other review publications, and five guidelines/consensus opinions. A total of 18 studies, which reported on plaque acid neutralisation, were provided by the applicant. In these studies, ph was measured in tooth biofilms in vivo after different types of sucrose challenges and with or without subsequent chewing of sugar-free gums. The ph was monitored using either the microelectrode method or intra-orally mounted electrodes. The outcome measures varied, but most studies reported a rise in the minimum plaque ph after a carbohydrate challenge when sugar-free gum was chewed in comparison to no gum, and/or a reduction in the area of the plaque ph curve below a fixed ph, such as resting ph, or a given value such as ph 5.5. The effects did not differ for gums with different types of polyols, but protection was greater if chewing was introduced soon after sugar intake. Similar results were obtained in healthy adults and children and adults with reduced saliva secretion capacity. Thus, there is a consistency among the studies that chewing sugar-free gum leads to rapid neutralisation of plaque ph in adults and children. One meta-analysis comprised 19 articles including six randomised controlled trials, nine controlled clinical trials and four cohort studies which investigated the efficacy of interventions using sugar-free chewing gums compared to no gum chewing. The studies lasted 24 to 40 months; the populations were all school aged children, representing different socio-economic status and countries. The polyols used were xylitol, xylitol-sorbitol blend, sorbitol and sorbitol-mannitol blend. The most common outcome was development of caries lesions. The outcome used in the meta-analysis was prevented fraction (PF). Pooled results revealed a PF of 58 % for the xylitol-containing gum, 52 % for the xylitol/sorbitol-containing gum, and 20 % for the sorbitol-containing gum. In addition, two out of three studies using a sorbitol-mannitol gum showed a reduction in the incidence of caries lesions. One study included in the meta-analysis used a xylitol gum, a sorbitol gum and a control gum without bulk sweeteners in a three year intervention. The study found that caries increments were significantly lower for all three gums, including the control gum, compared to the no gum group; indicating that a caries reduction occurs regardless of the presence of bulk sweetener in the sugar-free gum. A systematic review included eight trials on the effects of using sugar-free gum with sorbitol, with xylitol, and with a combination of sorbitol/xylitol. The use of chewing gum varied in frequency per 2

3 day and duration. Seven out of eight studies demonstrated significant caries reduction. Caries reduction appeared to be independent of polyol type, polyol composition and concentration and chewing regimes. The de- and remineralisation equilibrium of teeth is mainly driven by saliva and the main contributors are flow rate and concentrations of calcium, phosphate, and bicarbonate. At rest, low amounts of saliva are secreted, but stimulation by chewing may increase saliva flow more than 10-fold. When flow rate increases, saliva concentration of calcium, phosphate and bicarbonate also increases, and such increases favour remineralisation of tooth crystals. In weighing the evidence, the Panel took into account that many human studies of sugar-free chewing gum consumption were consistent in showing neutralisation of plaque acid, that almost all clinical trials on sugar-free chewing gum consumption showed a reduction in caries incidence, and that there was strong evidence supporting the biological plausibility for the effect. The Panel concludes that a cause and effect relationship has been established between the consumption of sugar-free chewing gum and plaque acid neutralisation and a reduction in incidence of caries. Plaque acid production may contribute to increased risk of caries. The Panel considers that, in order to obtain the claimed effect, 2-3 g of sugar-free chewing gum should be chewed for 20 minutes at least three times per day after meals. This quantity and pattern of use of chewing gum can easily be included within a balanced diet. There is a risk of osmotic diarrhoea at excessive intakes of polyols. 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. 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... 7 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 Glossary / Abbreviations

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, Articles 14 to 17 of that Regulation lay down provisions for the authorisation and subsequent inclusion of reduction of disease risk claims and claims referring to children s development and health in a Community list of permitted claims. According to Article 15 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 16/02/2010. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. During the check for completeness 6 of the application, the applicant was requested to provide missing information on 16/03/2010. The applicant provided the missing information on 22/04/2010. The scientific evaluation procedure started on 15/05/2010. During the meeting on 10/09/2010, the NDA Panel, after having evaluated the overall data submitted, adopted an opinion on the scientific substantiation of a health claim related to sugar-free chewing gum and neutralisation of plaque acids which reduces the risk of dental caries. 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 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: sugar-free chewing gum and neutralisation of plaque acids which reduces the risk of dental caries. EFSA DISCLAIMER The present opinion does not constitute, and cannot be construed as, an authorisation to the marketing of sugar-free chewing gum, a positive assessment of its safety, or a decision on whether sugar-free chewing gum is, or is not, classified as a foodstuff. It should be noted that such an assessment is not foreseen in the framework 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 In accordance with EFSA Scientific and Technical guidance for the Preparation and Presentation of the Application for Authorisation of a Health Claim 5

6 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 17 of Regulation (EC) No 1924/

7 INFORMATION PROVIDED BY THE APPLICANT Applicant s name and address: Wrigley GmbH, Scientific & Regulatory Affairs EMEAI, Biberger Str. 18, D-82008, Unterhaching, Germany. Food/constituent as stated by the applicant According to the applicant, sugar-free chewing gum containing both bulk sweeteners (polyols) and high intensity sweeteners. All types of sugar-free chewing gum are composed of gum base, bulk sweeteners, high intensity sweeteners, other food additives (e.g. humectants, emulsifiers, colours and antioxidants) and flavours. Following the annex of EU Directive 94/35/EC 7 on sweeteners for use in foodstuffs, bulk sweeteners such as sorbitol, sorbitol syrup, mannitol, isomalt, maltitol, maltitol syrup, lactitol, xylitol and erythritol are permitted for use in sugar-free chewing gum at quantum satis. High intensity sweeteners such as acesulfame K, aspartame, cyclamic acid and its Na and Ca salts, saccharin and its Na, K and Ca salts, sucralose, thaumatin, neohesperidine DC and the salt of aspartame-acesulfame are permitted for use in sugar-free chewing gum with maximum levels specified in the annex of EU Directive 94/35/EC. Health relationship as claimed by the applicant According to the applicant, the consumption of sugar-free gum stimulates the flow of saliva, which increases the rate of clearance of sugars from the mouth, and also increases the concentration of bicarbonate buffers in saliva to raise plaque ph, helping to reverse the fall in ph which occurs after a carbohydrate challenge. Wording of the health claim as proposed by the applicant The applicant proposed the following wording for the health claim: Chewing of sugar-free chewing gum neutralises plaque acids which reduces the risk of dental caries. Specific conditions of use as proposed by the applicant The applicant recommends a pattern of regular use, with a base number of three daily occasions of chewing sugar-free chewing gum. ASSESSMENT 1. Characterisation of the food/constituent The food, which is the subject of the health claim, is sugar-free chewing gum containing both bulk sweeteners (polyols) and intensity sweeteners that are authorised for use in the EU. Sugar-free chewing gums are composed of gum base, bulk sweeteners (typically xylitol, sorbitol, and mannitol), high intensity sweeteners (such as acesulfame K, aspartame, cyclamic acid and its Na and Ca salts, and saccharin and its Na, K and Ca salts), and other food additives (e.g. humectants, emulsifiers, colours and antioxidants, waxes, flavours). Sugar-free gum refers to a gum which contains no more than 0.5 g of sugars per 100 g as per annex to Regulation (EC) No 1924/2006. The term sugars 7 European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs. OJ L 237, , p

8 means all monosaccharides and disaccharides which are present in chewing gum, but the term excludes polyols (EU Directive 90/496/EEC 8 ). The detailed proportions of these ingredients vary between product formulations, but the general composition is the same (Rømer Rassing, 1996; Imfeld, 1999; Fritz, 2006). Typical proportions used for manufacturing sugar-free chewing sticks or pellets are described by the applicant. All ingredients are in accordance with applicable EU Food Legislation, and they can be adequately measured by chemical analytical methods. The Panel considers that the food, sugar-free chewing gum, which is the subject of the health claim, is sufficiently characterised. 2. Relevance of the claimed effect to human health The claimed effect is sugar-free chewing gum neutralises plaque acids which reduces the risk of dental caries. The target population is the general population. Acid production through the fermentation of carbohydrates by acid-producing bacteria in dental biofilms leads to demineralisation of tooth tissue hydroxyapatite crystals, and an altered biofilm ecology. Sustained demineralisation leads to dental caries, and the altered biofilm is characterised by increased numbers of acid producing bacteria. Neutralisation of ph re-creates a state of supersaturation of calcium and phosphate versus hydroxyapatite, and hence remineralisation of the crystals, and favours colonisation of less acid producing bacteria. This chain of events counteracts caries development. Chewing induces secretion of saliva with a higher content of bicarbonate (the main buffering component in saliva) than in unstimulated saliva. The Panel considers that plaque acid neutralisation might be a beneficial physiological effect in the context of reducing the risk of caries. 3. Scientific substantiation of the claimed effect The applicant performed a literature search in the following databases: BioMed Central, Cochrane Oral Health Reviews, Cochrane Library, Directory of Open Access Journals, and PubMed. The keywords chewing gum AND caries OR tooth decay and chewing gum AND caries risk were used to obtain publications regarding sugar-free chewing gum and dental caries. Publications related to remineralisation of tooth enamel were retrieved using the keywords chewing gum AND plaque ph OR plaque acid OR plaque acidity. The applicant identified a total of 47 publications which included 31 human intervention studies, one human observational study, one meta-analysis, one systematic review, eight other review publications, and five guidelines/consensus opinions. The Panel has already issued an opinion on sugar-free chewing gum and plaque acid neutralisation pursuant to Article 13(1) of Regulation (EC) No 1924/2006 (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009). The Panel concluded that a cause and effect relationship has been established between the consumption of sugar-free chewing gum and plaque acid neutralisation. A total of 18 studies, which reported on plaque acid neutralisation, were provided by the applicant. In these studies, ph was measured in tooth biofilms in vivo after different types of sucrose challenges (rinsing, meal, and snacks) and with or without subsequent chewing of sugar-free gums. The ph was monitored using either the microelectrode method (Shu et al., 2007; Dong et al., 2003; Gopinath et al., 8 Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs. OJ L 276, , p

9 1997; Markovic et al., 1988; Abelson et al., 1990) or intra-orally mounted electrodes (Lee and Schachtele, 1992; Park 1990a, 1990b, 1993, 1995; Fröhlich et al., 1992; Maiwald et al., 1982; Jensen, 1986, 1988; Jensen and Wefel, 1989; Yankell and Emling, 1989) or unknown (Manning and Edgar, 1993; Dodds et al., 1991). These two methods, with appropriate standardisation, have been determined to be equivalent by an expert body (ADA, 1985). The outcome measures varied, but most studies reported a rise in the minimum plaque ph (min ph) after a carbohydrate challenge when sugar-free gum was chewed in comparison to no gum, and/or a reduction in the area of the plaque ph curve (AUC) below a fixed ph, such as resting ph, or a given value such as ph 5.5. Some studies reported ph curves only, with no numerical data. The 18 studies without exception demonstrated a rapid and sustained plaque acid neutralisation which occurred when sugar-free gum was chewed after an acid response to carbohydrate exposure. The effects did not differ for gums with different types of polyols, but protection was greater if chewing was introduced soon after sugar intake. Similar results were obtained in healthy adults (Shu et al., 2007; Dong et al., 2003; Abelson et al., 1990; Lee and Schachtele, 1992; Park 1990a, 1990b, 1993, 1995; Fröhlich et al., 1992; Maiwald et al., 1982; Jensen, 1986, 1988; Jensen and Wefel, 1989; Yankell and Emling, 1989; Manning and Edgar, 1993; Dodds et al., 1991) and children (Gopinath et al., 1997) and adults with reduced saliva secretion capacity (Markovic et al., 1988). Thus, there is a consistency among the studies that chewing sugar-free gum leads to rapid neutralisation of plaque ph in adults and children. As regards the effect of sugar-free chewing gum on the development of caries, the applicant provided one meta-analysis (19 articles) of six randomised controlled trials (RCT) (including four cluster RCT), nine controlled clinical trails (CCT), and four cohort studies which investigated the efficacy of interventions using sugar-free chewing gums compared to no gum chewing (Deshpande and Jadad, 2008). The studies lasted 24 to 40 months; the populations were all school aged children, representing different socio-economic status and countries. Four studies had several intervention arms, and in five studies the participants chewed the gums during school days only and in the remaining studies gums were chewed each day. The polyols used were xylitol (six studies), xylitol-sorbitol blend (five studies), sorbitol (five studies) and sorbitol-mannitol blend (three studies). Doses varied considerably between studies, with xylitol and sorbitol ranging from a low of approximately 2.9 g/day to a high of 10.7 g/day. Only a percentage range was reported in the studies in which a combination of sorbitol and mannitol was assessed. The most common outcome was development of caries lesions ( DMFS). The outcome used in the meta-analysis was prevented fraction [PF; PF=(X C -X E )/X C where X C is the mean increment in the control group and X E the mean increment in the test group]. Pooled results revealed a PF of 58 % for the xylitol-containing gum, 52 % for the xylitol/sorbitol-containing gum, and 20 % for the sorbitol-containing gum (95 % CI). In addition, two out of three studies using a sorbitol-mannitol gum showed a reduction in the incidence of caries lesions. The meta-analysis assessed the impact of total polyol load and did not control for the independent variables that could affect caries such as frequency of chewing, polyol per tablet or slab, and total duration of chewing. One study included in the above meta-analysis used a xylitol gum, a sorbitol gum and a control gum without bulk sweeteners in a three year intervention (Machiulskiene et al., 2001). The study found that caries increments were significantly lower for all three gums, including the control gum, compared to the no gum group, indicating that a caries reduction occurs regardless of the presence of bulk sweetener in the sugar-free gum. A systematic review by Mickenautsch et al. (2007) using more stringent exclusion criteria than Deshpande and Jadad (2008) included eight trials on the effects of using sugar-free gum with sorbitol (four trials), with xylitol (two trials), and with a combination of sorbitol/xylitol (two trials). The use of chewing gum varied in frequency per day (3-7 times) and duration (5-20 min). Seven out of eight studies demonstrated significant caries reduction. Caries reduction appeared to be independent of polyol type, polyol composition and concentration and chewing regimes. All of the 12 individual human studies provided by the applicant separately were already included in the above meta-analysis (Deshpande and Jadad, 2008) or the systematic review (Mickenautsch et al., 2007), respectively. 9

10 Dental caries is the dissolution of the calcium phosphate mineral crystals of tooth enamel and dentine by acids formed from dietary carbohydrates by bacteria in dental biofilms. The teeth are prevented from dissolving at neutral ph by an ionic supersaturation of calcium and phosphate in the surrounding crystal. After carbohydrate intake, the ph falls, and at a particular ph (the critical ph) the calcium and phosphate are no longer in sufficient concentrations to prevent crystal dissolution, and the tooth suffers demineralisation, the first phase of the caries process. When the ph rises again, the tooth can regain calcium and phosphate from plaque and saliva (remineralisation). This de- and remineralisation equilibrium is mainly driven by saliva and the main contributors are flow rate and calcium, phosphate, and bicarbonate concentrations (ten Cate et al., 2003). Chewing confers physiological stimulation on the secretory cells of the salivary glands via autonomic nerve signalling (Anderson et al, 1998; Wong, 2008). At rest, low amounts of saliva (mean 0.2 ml/min) are secreted, but chewing stimulation may increase saliva flow more than 10-fold. Elevated secretion is maintained even after extended stimulation. The main component of saliva is water which has rinsing and dilution effects. Saliva also contains an array of other components including calcium, phosphate, and buffering components (bicarbonate, phosphates and peptides) (Screebny, 2000; Wong, 2008). When flow rate increases, saliva concentration of calcium, phosphate and bicarbonate increases (Anderson et al, 1998; Wong, 2008) and such increases favour remineralisation of tooth crystals. In weighing the evidence, the Panel took into account that many human studies of sugar-free chewing gum consumption were consistent in showing neutralisation of plaque acid, that almost all clinical trials on sugar-free chewing gum consumption showed a reduction in caries incidence, and that there was strong evidence supporting the biological plausibility for the effect. The Panel concludes that a cause and effect relationship has been established between the consumption of sugar-free chewing gum and plaque acid neutralisation and a reduction in incidence of caries. Plaque acid production may contribute to increased risk of caries. 4. Panel s comments on the proposed wording The Panel considers that the following wording reflects the scientific evidence: Sugar-free chewing gum helps neutralise plaque acids. Plaque acids may increase the risk of dental caries. 5. Conditions and restrictions of use The Panel considers that, in order to obtain the claimed effect, 2-3 g of sugar-free chewing gum should be chewed for 20 minutes at least three times per day after meals. This quantity and pattern of use of chewing gum can easily be included within a balanced diet. Consumers suffering from phenylketonuria (PKU) are obliged to control phenylalanine intake. The labelling for sugar-free chewing gum containing aspartame, therefore, must include the statement contains a source of phenylalanine (EU Directive 94/54/EC 9 ). If excessive amounts of sugar-free chewing gum are consumed, laxative effects may occur owing to the content of bulk sweeteners (polyols). In order to ensure that consumers receive adequate information, the labelling for sugar-free chewing gum containing more than 10 % added polyols must include the advisory statement excessive consumption may produce laxative effects (EU Directive 9 Commission Directive 94/54/EC of 18 November 1994 concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Council Directive 79/112/EEC. OJ L 300, , p

11 94/54/EC). Also, the use of chewing gum should be avoided in children less than three years of age owing to a high choking hazard in this age group. CONCLUSIONS On the basis of the data presented, the Panel concludes that: The food, sugar-free chewing gum, which is the subject of the health claim, is sufficiently characterised. The claimed effect is sugar-free chewing gum neutralises plaque acids which reduces the risk of dental caries. The target population is the general population. Plaque acid neutralisation might be a beneficial physiological effect in the context of reducing the risk of caries. A cause and effect relationship has been established between the consumption of sugar-free chewing gum and plaque acid neutralisation and a reduction in incidence of caries. Plaque acid production may contribute to increased risk of caries. The following wording reflects the scientific evidence: Sugar-free chewing gum helps neutralise plaque acids. Plaque acids may increase the risk of dental caries. In order to obtain the claimed effect, 2-3 g of sugar-free chewing gum should be chewed for 20 minutes at least three times per day after meals. This quantity and pattern of use of chewing gum can easily be included within a balanced diet. There is a risk of osmotic diarrhoea at excessive intakes of polyols. The use of chewing gum should be avoided in children less than three years of age owing to choking hazard. DOCUMENTATION PROVIDED TO EFSA Health claim application on sugar-free chewing gum and neutralisation of plaque acids which reduces the risk of dental caries pursuant to Article 14 of Regulation (EC) No 1924/2006 (Claim serial No: 0277_UK). February Submitted by Wrigley GmbH. REFERENCES Abelson DC, Barton J and Mandel ID, The effect of chewing sorbitol-sweetened Gum on salivary flow and cemental plaque ph in subjects with low salivary flow. Journal of Clinical Dentistry, 2, 3-5. ADA (American Dental Association), Scientific Consensus Conference on Methods for the Assessment of the Cariogenic Potential of Foods. University of Texas, Health Science Center, San Antonio. Anderson LC, Ekström J and Garrett JR, Glandular Mechanisms of Salivary Secretion. Frontiers of Oral Biology. Karger Publishers, Basel. Deshpande A and Jadad A, The impact of polyol-containing chewing gums on dental caries. A systemtic review of original randomized controlled trials and observational studies. Journal of the American Dental Association, 139, Dodds MWJ, Hsieh SC and Johnson DA, The effect of increased mastication by daily gumchewing on salivary gland output and dental plaque acidogenicity. Journal of Dental Research, 70,

12 Dong Y, Pan Y, Wang D and Cao C, Effect of sugarless chewing gum on dental plaque ph in situ after the mouth is rinsed with sucrose solution. China Stomatology Journal, 38. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Scientific Opinion on the substantiation of health claims related to sugar-free chewing gum and dental and oral health, including gum and tooth protection and strength (ID 1149), plaque acid neutralisation (ID 1150), maintenance of tooth mineralisation (ID 1151), reduction of oral dryness (ID 1240), and maintenance of the normal body weight (ID 1152) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal, 7(9):1271, 20 pp. Fritz D, Formulation and production of chewing and bubble gum. Kennedy s publications ltd, London. Fröhlich S, Maiwald HJ and Flowedew G, Effect of gum chewing on the ph of dental plaque. Journal of Clinical Dentistry, 3, Gopinath VK, Tandon S and Shirwaikar A, The effect of chewing gums on acidogenicity of plaque after a sucrose challenge. Journal of Clinical Pediatric Dentistry, 22, Imfeld T, Chewing gum-facts and fiction: a review of gum-chewing and oral health. Criticial Reviews in Oral Biology and Medicine, 10, Jensen ME, Responses of interproximal plaque ph to snack foods and effect of chewing sorbitol- containing gum. The Journal of the American Dental Association, 113, Jensen, ME, Effects of chewing sorbitol gum on salivary and interproximal plaque ph. Journal of Clinical Dentistry, 1, Jensen ME and Wefel, JS, Human plaque ph responses to meals and the effects of chewing gum. British Dental Journal, 167, Lee IK and Schachtele CF, Effect of gum chewing following food ingestion on the ph of interproximal dental plaque. Quintessence International, 23, Machiulskiene V, Nyvad B and Baelum V, Caries-preventive effect of sugar-substituted chewing gum. Community Dentistry and Oral Epidemiology, 29, Maiwald HJ, Banoczy S, Tietze W, Toth Z and Vegh A, Effect of sugared and sugar-free chewing gum on plaque ph. Zahn, Mund und Kieferheilkunde, 70, Manning RH and Edgar WM, ph changes in plaque after eating snacks and meals, and their modification by chewing sugared or sugar-free gum. British Dental Journal, 174, Markovic N, Abelson DH and Mandel ID, Sorbitol gum in xerostomics the effects on dental plaque and salivary flow rates. Gerodontology, 7, Mickenautsch S, Leal S C, Yengopal V, Bezerra A C and Cruvinel V, Sugar-free chewing gum and dental caries a systematic review. Journal of Applied Oral Science, 15, Park KK, Schemehorn BR, Bolton JW and Stookey GK, 1990a. Effect of sorbitol gum chewing on plaque ph response after ingesting snacks containing predominantly sucrose or starch. American Journal of Dentistry, 3, Park KK, Schemehorn BR, Bolton JW and Stookey GK, 1990b. The impact of chewing sugarless gum on the acidogenicity of fast-food meals. American Journal of Dentistry, 3, Park KK, Schemehorn BR and Stookey GK, Effect of time and duration of sorbitol gum chewing on plaque acidogenicity. Pediatric Dentistry, 15, Park KK, Hernandez D, Schemehorn BR, Katz BP, Stookey GK, Sanders PG and Butchko HH, Effect of chewing gums on plaque ph after a sucrose challenge. ASDC Journal of Dentistry for Children, 62,

13 Rømer Rassing M, Specialized oral mucosal drug delivery systems: chewing gum. In: Oral mucosal drug delivery, Eds Rathbone MJ, Marcel Dekker, Inc, New York. Screebny LM, Saliva in health and disease: an appraisal and update. International Dental Journal, 50, Shu CB, Tao DY, Wang S and Feng XP, Effect of two kinds of chewing gums on dental plaque ph. Shanghai Journal of Stomatology, 16, ten Cate JM, Larsen MJ, Pearce ELF and Fejerskov O, In: Dental caries. The disease and its clinical management. Eds Fejerskov O and Kidd E. Blackwell Munksgaard. Copenhagen, Denmark. Wong D, Salivary diagnostics. Wiley-Blackwell, 320 pp. Yankell SL and Emling RC, Clinical study to evaluate the effects of three marketed sugarless chewing gum products on plaque ph, pca, and swallowing Rates. Journal of Clinical Dentistry, 1,

14 GLOSSARY / ABBREVIATIONS AUC Area under the curve CCT DMFS PF PKU RCT Controlled clinical trial Decayed missing filled surfaces Prevented fraction Phenylketonuria Randomised controlled trial 14