SCIENTIFIC OPINION. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) 2, 3

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1 SCIENTIFIC OPINION Scientific Opinion on the substantiation of a health claim related to calcium-containing fruit juices and the reduction of tooth demineralisation 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 16 March 2011, replaces the earlier version published on 18 February ABSTRACT Following an application from FrieslandCampina submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of The Netherlands, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to acidic calcium-containing fruit juices and the reduction of tooth demineralisation. The scope of the application was proposed to fall under a health claim referring to reduction of disease risk. The Panel considers that the food, acidic calcium-containing fruit juices and comparative products, conventional fruit juices (not containing added calcium), are sufficiently characterised. The Panel considers that reducing tooth demineralisation resulting from erosive potential of a food is a beneficial physiological effect, provided that it is not accompanied by tooth demineralisation resulting from acid production in plaque through the fermentation of carbohydrates. A total of 37 pertinent studies were identified by the applicant, including observational studies, reviews, intervention studies on the erosive potential of fruit juices and other acidic drinks with and without added calcium in situ, in vitro studies on the erosive potential of acidic drinks with and without added calcium, and an animal study on the effect of calcium added to acidic drinks on dental erosion. The Panel notes that the potential of fruit juices with and without added calcium for demineralisation of dental enamel by acid production in plaque as a result of sugar fermentation was not assessed in any study. The Panel considers that the potential of fruit juices with and without added calcium for demineralisation of dental enamel, including the possible effects of both acids and sugars, has not been assessed appropriately. The Panel concludes that a cause and effect relationship has not been established between the consumption of acidic calcium-containing fruit juices in replacement of fruit juice without added calcium and the reduction of tooth demineralisation. European Food Safety Authority, 2011 KEY WORDS Calcium-containing fruit juices, tooth demineralisation, health claim. 1 On request from the Competent Authority of the Netherlands following an application by FrieslandCampina, Question No EFSA-Q , adopted on 28 January 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. 4 Where changes have been made to the opinion footnotes have been included to indicate the original text. Suggested citation: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to calcium-containing fruit juices and the reduction of tooth demineralisation pursuant to Article 14 of Regulation (EC) No 1924/ [8 pp.]. doi: /j.efsa Available online: European Food Safety Authority, 2011

2 SUMMARY Following an application from FrieslandCampina submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of The Netherlands, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to acidic calcium-containing fruit juices and reducing tooth demineralisation. The scope of the application was proposed to fall under a health claim referring to reduction of disease risk. The foods, which are the subject of the claim, are acidic calcium-containing fruit juices (orange, apple, mandarin, forest fruit and multi-fruit) with a ph <4.0 ( ) and containing calcium 200 mg/l and sugars g/100 ml. The comparative products for the claim are fruit juices without added calcium but with the same content of sugars. The Panel notes that these products are acidic (ph typically <4.0) and contain calcium at concentrations well below 200 mg/l 5 (e.g., ~10 mg/100 ml for orange juice). The Panel considers that the calcium-containing fruit juices, which are the subject of the health claim, and the proposed comparative products, conventional fruit juices (not containing added calcium), are sufficiently characterised in the context of the proposed claimed effect. The claimed effect relates to reduction of tooth demineralisation as a risk factor for tooth erosion. The target population is the general population. Demineralisation of tooth tissues can occur as a result of consumption of dietary acids in foods or beverages and frequent consumption can lead to dental erosion. Demineralisation of tooth tissues can also occur following acid production through the fermentation of carbohydrates by acid-producing bacteria in dental biofilms. The effect may be balanced by remineralisation when ph is neutralised and a state of calcium and phosphate supersaturation is achieved. If demineralisation is not balanced by remineralisation then net demineralisation of tooth tissues results which, if sustained, can lead to dental caries. Dental caries and dental erosion are diseases with a high prevalence in the EU. The Panel notes that the scientific assessment of the claim is based on a comparison of the effect of acidic calcium-containing fruit juices with conventional fruit juices (not containing added calcium), as proposed by the applicant. The Panel also notes that the foods which are the subject of the claim, i.e. the acidic calcium-containing fruit juices and the comparative fruit juices without added calcium, both contain sugars at about 9-11 g/100 ml. The Panel considers that reducing tooth demineralisation resulting from the erosive potential of a food is a beneficial physiological effect, provided that it is not accompanied by tooth demineralisation resulting from acid production in plaque through the fermentation of carbohydrates contained in the food. A total of 37 pertinent studies were identified by the applicant. These included 15 observational studies on the prevalence of dental erosion in children and adults in Europe and the association of fruit juice consumption with dental erosion, three reviews on mechanisms for dental erosion, six intervention studies (RCT) on the erosive potential of fruit juices and other acidic drinks with and without added calcium in situ, 12 in vitro studies on the erosive potential of fruit juices and other acidic drinks with and without added calcium, including one unpublished, confidential study, and one animal study on the effect of calcium added to acidic drinks on dental erosion in rats. The Panel notes that the potential of fruit juices with and without added calcium for demineralisation of dental enamel by acid production in plaque as a result of sugar fermentation was not assessed in any study. 5 The following change has been made to the opinion: 200 mg/100 ml has been replaced with 200 mg/l. 2

3 In response to a request for clarification of the possible contribution to tooth demineralisation of sugar in the proposed foods, and, in particular, the extent to which consumption of fruit juices with and without added calcium might contribute to demineralisation of dental enamel by reducing plaque ph as a result of sugar fermentation, the applicant claimed that dental caries and dental erosion coincide only in a limited number of cases. However, the applicant did not provide any evidence to support this statement. The Panel considers that the potential of acidic fruit juices with and without added calcium for demineralisation of dental enamel, including the possible effects of both acids and sugars, has not been assessed appropriately. The Panel concludes that a cause and effect relationship has not been established between the consumption of acidic calcium-containing fruit juices in replacement of fruit juice without added calcium and the reduction of tooth demineralisation. 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... 7 Conclusions... 8 Documentation provided to EFSA... 8 References... 8 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, are authorised in accordance with this Regulation and are 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 this Regulation, an application for authorisation shall be submitted by the applicant to the national competent authority of a Member State, which 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 06/04/2009. The scope of the application was proposed to fall under a health claim referring to reduction of disease risk. The scientific evaluation procedure started on 15/04/2010. On 25/06/2010, the NDA Panel agreed on a list of questions which requests the applicant to provide additional particulars to accompany the application. The applicant submitted the responses to the NDA Panel s list of questions on 03/11/2010. During the meeting on 28/01/2011, the NDA Panel, after having evaluated the overall data submitted, adopted an opinion on the scientific substantiation of a health claim related to calcium-containing fruit juices and the 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 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 calcium-containing fruit juices and reducing tooth demineralisation. EFSA DISCLAIMER The present opinion does not constitute, and cannot be construed as, an authorisation to the marketing of calcium-containing fruit juices, a positive assessment of its safety, nor a decision on whether calcium-containing fruit juices 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 1924/2006. 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 17 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: FrieslandCampina, PO Box 25, 3900 NL Veenendaal, The Netherlands. Food/constituent as stated by the applicant According to the applicant, calcium salts added to fruit based drinks or juices with a ph of 4 or lower. Health relationship as claimed by the applicant According to the applicant, erosion of teeth occurs because during consumption of acidic foods like fruit juices or soft drinks, the acids from the food dissolve tooth minerals, mainly calcium and phosphate from the enamel or from the dentine. The ph value, and the calcium and phosphate content of a drink or foodstuff determine the degree of saturation with respect to the tooth mineral, which is the driving force of the dissolution. A low degree of undersaturation with respect to enamel or dentine leads to a very initial surface demineralization, which is followed by a local rise in ph and increased mineral content in the liquid surface layer adjacent to the tooth surface. This layer will then become saturated with respect to enamel (or dentine) and will not demineralise further. Two mechanisms play a role in the protective effect of calcium. By addition of calcium ions saturation conditions are reached earlier thus preventing further dissolution or erosion. In addition citrate, which is often present in drinks, has the capacity to bind calcium ions thereby removing calcium from the teeth. Therefore, citrate is considered to be highly erosive. Calcium added to the drink can bind to citrate, thereby reducing its capacity to extract calcium from the teeth. Wording of the health claim as proposed by the applicant The applicant proposed the following wordings for the health claim: Reduced risk for dental erosion, Mild for your teeth, Less erosive than fruit juices and drinks without added calcium. Specific conditions of use as proposed by the applicant According to the applicant, the claim is based on the addition of 200 mg calcium salts to one litre of fruit based drink or juice with ph <4. The target population for the intended health claim is the general population, both adults and children. ASSESSMENT 1. Characterisation of the food/constituent The foods/constituents originally proposed for the claim by the applicant were calcium salts added to fruit based drinks or juices with a ph of 4 or lower. Upon request for clarification, the applicant indicated that the foods which are the subject of the claim are calcium-containing fruit juices (orange, apple, mandarin, forest fruit and multi-fruit) with a ph <4.0 ( ) and containing calcium 200 mg/l and sugars g/100 ml. The comparative products for the claim are fruit juices without added calcium but with the same content of sugars. The Panel notes that these products are acidic (ph typically <4.0) and contain calcium at concentrations well below 200 mg/l 7 (e.g., ~10 mg/100 ml for orange juice). The Panel considers that the acidic calcium-containing fruit juices, which are the subject of the health claim, and the proposed comparative products, conventional fruit juices (not containing added calcium), are sufficiently characterised in the context of the proposed claimed effect. 7 The following change has been made to the opinion: 200 mg/100 ml has been replaced with 200 mg/l. 6

7 2. Relevance of the claimed effect to human health Calcium-containing fruit juices and the reduction of tooth demineralisation The claimed effect originally proposed by the applicant was reduced risk for dental erosion. Upon request for clarification, the applicant indicated that the claimed effect referred to reduction of tooth demineralisation as a risk factor for tooth erosion. The target population proposed by the applicant is the general population. Demineralisation of tooth tissues can occur as a result of consumption of dietary acids in foods or beverages and frequent consumption can lead to dental erosion. Demineralisation of tooth tissues can also occur following acid production through the fermentation of carbohydrates by acid-producing bacteria in dental biofilms. The effect may be balanced by remineralisation when ph is neutralised and a state of calcium and phosphate supersaturation is achieved. If demineralisation is not balanced by remineralisation then net demineralisation of tooth tissues results which, if sustained, can lead to dental caries. Dental caries and dental erosion are diseases with a high prevalence in the EU. The Panel notes that the scientific assessment of the claim is based on a comparison of the effect of calcium-containing fruit juices with conventional fruit juices (not containing added calcium), as proposed by the applicant. The Panel also notes that the foods which are the subject of the claim, i.e. the calcium-containing fruit juices and the comparative fruit juices without added calcium, both contain sugars at about 9-11 g/100 ml. The Panel considers that reducing tooth demineralisation resulting from the erosive potential of a food is a beneficial physiological effect, provided that it is not accompanied by tooth demineralisation resulting from acid production in plaque through the fermentation of carbohydrates contained in the food. 3. Scientific substantiation of the claimed effect The applicant performed a literature search in PubMed. The search strategy, including keywords, inclusion and exclusion criteria was presented. Inclusion criteria comprised interventions by adding calcium to beverages and measuring their effect on dental erosion (in vivo and in vitro), intervention studies on the relation between calcium concentration in drinks and dental erosion, in vitro studies on the effect of fruit-based drinks on dental erosion, observational studies on the prevalence of dental erosion in EU countries, within the last ten years. References describing interventions/in vitro research by adding a combination of calcium with other ingredients to beverages, in vitro studies on the effect of one single drink on dental erosion and observational human studies on the prevalence of dental erosion in non-eu countries were excluded. A list of 660 excluded references was attached. A total of 37 pertinent studies were identified by the applicant. These included 15 observational studies on the prevalence of dental erosion in children and adults in Europe and the association of fruit juice consumption with dental erosion, three reviews on mechanisms for dental erosion, six intervention studies (RCT) on the erosive potential of fruit juices and other acidic drinks with and without added calcium in situ, 12 in vitro studies on the erosive potential of fruit juices and other acidic drinks with and without added calcium, including one unpublished, confidential study (van Loveren et al., 2009), and one animal study on the effect of calcium added to acidic drinks on dental erosion in rats. The Panel notes that the potential of fruit juices with and without added calcium for demineralisation of dental enamel by acid production in plaque as a result of sugar fermentation was not assessed in any study. In response to a request for clarification of the possible contribution to tooth demineralisation of sugar in the proposed foods, and, in particular, the extent to which consumption of fruit juices with and without added calcium might contribute to demineralisation of dental enamel by reducing plaque ph as a result of sugar fermentation, the applicant claimed that dental caries and dental erosion coincide 7

8 only in a limited number of cases. However, the applicant did not provide any evidence to support this statement. The Panel considers that the potential of acidic fruit juices with and without added calcium for demineralisation of dental enamel, including the possible effects of both acids and sugars, has not been assessed appropriately. The Panel concludes that a cause and effect relationship has not been established between consumption of acidic calcium-containing fruit juices in replacement of fruit juice without added calcium and the reduction of tooth demineralisation. CONCLUSIONS On the basis of the data presented, the Panel concludes that: The food, acidic calcium-containing fruit juices, which is the subject of the health claim, and the proposed comparative products, conventional fruit juices (not containing added calcium), are sufficiently characterised in the context of the proposed claimed effect. The claimed effect is reduction of tooth demineralisation as a risk factor for tooth erosion when compared to conventional fruit juices (not containing added calcium). The target population is the general population. The Panel considers that reducing tooth demineralisation resulting from the erosive potential of a food is a beneficial physiological effect, provided that it is not accompanied by tooth demineralisation resulting from acid production in plaque through the fermentation of carbohydrates. A cause and effect relationship has not been established between consumption of acidic calcium-containing fruit juices in replacement of fruit juice without added calcium and the reduction of tooth demineralisation. DOCUMENTATION PROVIDED TO EFSA Health claim application on calcium-containing fruit juices and reducing tooth demineralisation pursuant to Article 14 of Regulation (EC) No 1924/2006 (Claim serial No: 0248_NL). April Submitted by FrieslandCampina. REFERENCES Van Loveren C, Buijs M, Kleverlaan CJ, The addition of small amounts of calcium lactate to fruit juices reduces the risk of dental erosion (confidential, unpublished). GLOSSARY / ABBREVIATIONS EU European Union RCT randomised controlled trial 8

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