The EFSA Journal (2008) 787, 1-9 Dairy and dental health Scientific substantiation of a health claim pursuant related to dairy products (milk and cheese) and dental health to Article 14 of Regulation (EC) No 1924/2006 1 Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Question No EFSA-Q-2008-112) Adopted on 12 August 2008 by written procedure PANEL MEMBERS Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Andreu Palou, Hildegard Przyrembel, Seppo Salminen, Sean (J.J) Strain, Stephan Strobel, Inge Tetens, Henk van den Berg, Hendrik van Loveren and Hans Verhagen. SUMMARY Following an application from National Dairy Council submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to dairy foods (milk and cheese) and dental health. The scope of the application was proposed to fall under a health claim referring to children s development and health. In the present application the food category dairy foods is defined as including milk and cheese. The Panel considers that the foods for which the claim is made (milk and cheese) are not sufficiently characterised, e.g. nutritional composition and its variability between products were not provided. The claimed effect promote dental health relates to reduction of dental caries development. Dental caries is a disease with a high prevalence in the EU, particularly in children. Dietary factors may influence the development of dental caries. The target population is children. Four observational, cross-sectional studies report either lower caries frequency in children with milk consumption compared to those who do not drink milk or significantly lower milk consumption in children with caries symptoms as compared to children without caries. No association between caries status and milk consumption has been found in two prospective cohort studies. No intervention studies were provided on the effect of milk on dental caries development in children. Studies in rodents indicate that cow s milk is noncariogenic and that 1 For citation purposes: Scientific Opinion of the Panel on Dietetic Products Nutrition and Allergies on a request from National Dairy Council on dairy and dental health. The EFSA Journal (2008) 787, 1-9 European Food Safety Authority, 2008
milk may have a mild protective effect against the cariogenic effect of sucrose. The Panel considers that the evidence provided is insufficient to establish a cause-effect relationship between consumption of milk and reduction of dental caries development in children. One intervention study investigated the effects of one 5-gram piece of hard cheese daily on caries increment measured as decayed missing and filled surfaces (DMFS) in children 7-9 years. At the end of the two-year intervention period, DMFS in the intervention group (0.65) was significantly lower than in the control group (2.4). The Panel considers that the significant weaknesses of this study limit its value as a source of data to substantiate a cause and effect relationship between the consumption of hard cheese and reduction of dental caries development in children. One prospective cohort study and one observational, cross-sectional study in children report a caries protective effect of hard cheeses and indicate a dose-response association. However, neither of these studies described the dietary pattern or other lifestyle factors in a comprehensive manner. One prospective cohort study finds no association between reported cheese consumption and caries development. The Panel considers that the evidence provided is insufficient to establish a cause-effect relationship between consumption of cheese and reduction of dental caries development in children. The Panel concludes that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of milk or cheese and dental health in children. Key words: Dairy products, milk, cheese, children, dental health, dental caries, disease, prevention, health promotion The EFSA Journal (2008) 787, 2-9
TABLE OF CONTENT Panel Members...1 Summary...1 Table of content...3 Background...4 Terms of reference...4 EFSA Disclaimer...4 Acknowledgements...5 1. Information provided by the applicant...6 1.1. Food/constituent as stated by the applicant...6 1.2. Health relationship as claimed by the applicant...6 1.3. Wording of the health claim as proposed by the applicant...6 1.4. Specific conditions for use as proposed by the applicant...6 2. Assessment...6 2.1. Characterisation of the food/constituent...6 2.2. Relevance of the claimed effect to human health...7 2.3. Scientific substantiation of the claimed effect...7 Conclusions...8 Documentation provided to EFSA...8 References...8 Glossary / Abbreviations...9 The EFSA Journal (2008) 787, 3-9
BACKGROUND Regulation (EC) No 1924/2006 2 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 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 European Food Safety Authority (EFSA). Steps taken by EFSA: The application was received on 05/02/2008. The scope of the application was proposed to fall under a health claim referring to children s development and health. During the check for completeness 3 of the application, the applicant was requested to provide missing information on 03/03/2008. The applicant provided the missing information on 17/03/2008. The scientific evaluation procedure started on 15/04/2008. On 12 August 2008 the NDA Panel, after having evaluated the overall data submitted, adopted by written procedure an opinion on the scientific substantiation of a health claim related to dairy and dental health. TERMS OF REFERENCE EFSA will 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 is requested to issue a scientific opinion on the information provided by the applicant concerning a health claim related to: dairy (milk and cheese) and dental health. EFSA DISCLAIMER The present opinion does not constitute, and cannot be construed as, an authorisation to the marketing of dairy (milk and cheese), a positive assessment of its safety, nor a decision on whether dairy (milk and cheese) is, or is not, classified as a foodstuff. It should be noted that such an assessment or a decision are not foreseen in the framework of Regulation (EC) No 1924/2006. 2 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, 30.12.2006. Corrigendum OJ L 12, 18.1.2007, p. 3 18. 3 In accordance with EFSA Scientific and Technical guidance for the Preparation and Presentation of the Application for Authorisation of a Health Claim The EFSA Journal (2008) 787, 4-9
It should also be highlighted that the scope and the proposed wording of the claim as considered by the EFSA in this opinion may be subject to changes pending the outcome of the authorisation procedure foreseen in Articles 15 and 17 of Regulation (EC) No 1924/2006. ACKNOWLEDGEMENTS The European Food Safety Authority wishes to thank Ingegerd Johansson and the members of the Working Group for the preparation of this opinion: Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Hannu Korhonen, Ambroise Martin, Andreu Palou, Hildegard Przyrembel, Seppo Salminen, Sean (J.J.) Strain, Inge Tetens, Henk van den Berg, Hendrik van Loveren and Hans Verhagen. The EFSA Journal (2008) 787, 5-9
1. Information provided by the applicant Applicant s name and address: National Dairy Council, 28 Westland Square, Dublin 2, Ireland 1.1. Food/constituent as stated by the applicant Dairy products (milk & cheese) 1.2. Health relationship as claimed by the applicant The applicant states that dairy products are a staple food in a child s diet, and because of this, form a prominent and important shelf on the Department of Health & Children s Food Pyramid, and that one of the main reasons is because of their importance in the dental health of children. It is further stated that (i) promoting dental health through a combination of oral hygiene and good nutrition is important from an early age, (ii) dental caries and periodontal disease are common oral health diseases in children, (iii) both genetic and environmental factors contribute to dental caries and periodontal disease, and (iv) that risk of dental caries can be reduced by changing the oral environment (e.g. by dietary interventions). The applicant claims that many foods, including dairy products (milk and cheese), have been shown to be non-cariogenic and do not harm teeth. Some foods also have anti-cariogenic properties, protecting teeth from decay (referred to as cariostatic factors ). Milk and cheese demonstrate these qualities. They contain calcium, phosphate and casein protecting against demineralisation. Additionally, cheese is a strong gustatory stimulant to salivary flow which helps neutralise dental plaque acids, thus preventing dental caries development. Finally, the applicant claims, that finishing a meal with a piece of cheese helps counteract acids produced from carbohydrate foods eaten at the same meal. Several potential mechanisms (some described above) by which dairy foods such as cheese and milk may protect dental health are proposed. 1.3. Wording of the health claim as proposed by the applicant Dairy foods (milk & cheese) promote dental health in children. 1.4. Specific conditions for use as proposed by the applicant Nutrition information booklets intended for school use (primary and secondary). Worksheets, teacher s toolkits, information flyers and posters directed at children. Talk/presentations to teachers, parents and secondary school students. 2. Assessment 2.1. Characterisation of the food/constituent The health claim is made for dairy products (milk and cheese) which constitute a wide range of products of variable composition (McCance and Widdowson, 2002; Jensen, 1995). The Panel considers that the food products (milk and cheese), for which the claim is made, are not sufficiently characterised, e.g., nutritional composition and its variability between products were not provided. The EFSA Journal (2008) 787, 6-9
2.2. Relevance of the claimed effect to human health Dairy and dental health The claimed effect promote dental health relates to reduction of dental caries development. Dental caries is a disease with a high prevalence in the EU, particularly in children, which causes pain, eating problems, and social stigma (Do and Spencer, 2007; Filstrup et al., 2003). Dietary factors may influence the development of dental caries. The Panel considers that reduction of dental caries is beneficial to children s health. 2.3. Scientific substantiation of the claimed effect The applicant performed a literature search on PubMed using as search terms babies, children, teenagers, adolescents, primary school-aged children, teeth, dental health, dentition, healthy teeth, dental erosion, cariogenic, cariostatic, tooth wear, tooth, milk, cheese, yogurt, dairy products, dairy foods, oral health. The search was limited to papers in English language and to children 0 to 18 years of age. No information was provided regarding limits for publication year or the dates on which the search was performed. Studies in adults and in vitro were excluded. The applicant states to have hand-searched for additional studies not identified through the review. The target population is children. The applicant identified four observational, cross-sectional studies that report either lower caries frequency in children with milk consumption compared to those who do not drink milk, or significantly lower milk consumption in children with caries symptoms as compared to children without caries (Zita et. al., 1959, Serra Majem et al., 1993; Petti et al., 1997; Petti et al., 2000). In one of these studies (Petti et al., 1997) conducted on a population of 6-11 year old non fluoride users with poor oral hygiene, a linearly decreasing risk (odds ratio) to develop caries was associated with increasing milk consumption (0 to 650 ml per day) only in those children with a high daily sucrose consumption frequency. Another study (Serra Majem et al., 1993) only found consumption of skimmed milk (and not of regular milk) to be higher in caries free children compared to those with caries. No association between caries status and milk consumption has been found in two prospective cohort studies (Ohlund et al., 2007; Marshall et al., 2003). No intervention studies were provided on the effect of milk on dental caries development in children. Studies in rodents indicate that cow s milk is non-cariogenic (Bowen et al., 1997; Bowen and Pearson, 1993) and that milk may have a mild protective effect against the cariogenic effect of sucrose when consumed simultaneously (Bowen and Pearson, 1993). The Panel considers that the evidence provided is insufficient to establish a cause and effect relationship between consumption of milk and reduction of dental caries in children. One intervention study (Gedalia et al., 1994), one prospective cohort study (Ohlund et al., 2007) and one observational, cross-sectional study (Petridou et al., 1996) were presented by the applicant to support a beneficial effect of hard cheese on dental caries in children. The two-year intervention study was conducted in school-children aged 7-9 years living in communal settlements in Jerusalem. The intervention group (all children from three settlements) was provided with one 5-gram piece of hard cheese (Edam type, 30% fat) daily after breakfast and asked to chew it for at least 1 minute before swallowing, whereas no cheese was provided to controls (all children from two settlements). All communities were supplied with drinking water containing 0.3 ppm fluoride and the children were receiving fluoride drops (dose not specified). Tooth brushings and rinsing were carried out with fluoridated preparations The EFSA Journal (2008) 787, 7-9
twice daily (unsupervised). At the end of the two-year intervention period, caries increment measured as decayed missing and filled surfaces (DMFS) in the intervention group was significantly lower (0.65 DMFS) than in the control group (2.4 DMFS). The Panel notes a number of weaknesses in this study: no power calculations were reported to justify the size of the study sample, the randomisation of children into two groups is not sufficiently described, children given cheese were also given information on the possible benefit they could gain from consuming the cheese, background diet was not reported e.g. frequency of sugar consumption, use of fluoride drops, tooth brushings and rinsing were unsupervised and compliance was not reported. Although the authors state that the study was based on 179 schoolchildren, results are reported for 220 (84 in the intervention group and 136 in the control group). The Panel considers that the significant weaknesses of this study limit its value as a source of data to substantiate a cause and effect relationship between the consumption of hard cheese and reduction of dental caries in children. One prospective cohort study (Ohlund et al., 2007) and one observational, cross-sectional study (Petridou et al., 1996) in children with stratification by the level of intake report a caries protective effect of hard cheeses (types unspecified in all studies) and indicate a dose-response association. However, neither of these studies described the dietary pattern or other lifestyle factors in a comprehensive manner. One prospective cohort study finds no association between reported cheese consumption and caries development (Marshall et al., 2003). The Panel considers that the evidence provided is insufficient to establish a cause and effect relationship between consumption of cheese and dental health in children. CONCLUSIONS On the basis of the data presented, the Panel concludes that: The food category dairy (milk and cheese) subject of the health claim is not sufficiently characterised, e.g. nutritional composition and its variability between products were not provided. The claimed effect promote dental health relates to reduction of dental caries development which is considered beneficial to children s health. Dietary factors may influence the development of dental caries. A cause and effect relationship has not been established between the consumption of milk or cheese and dental health in children. DOCUMENTATION PROVIDED TO EFSA Health claim application on dairy foods and dental health pursuant to Article 14 of the Regulation (EC) No 1924/2006 (Claim serial No: 0032-IE). March 2008. Submitted by the National Dairy Council. REFERENCES Bowen WH, Pearson SK, 1993. Effect of milk on cariogenesis. Caries Res. 27, 461-466. Bowen WH, Pearson SK, VanWuyckhuyse BC, Tabak LA, 1991. Influence of milk, lactosereduced milk, and lactose on caries in desalivated rats. Caries Res. 25,283-286. Do LG, Spencer A, 2007. Oral health-related quality of life of children by dental caries and fluorosis experience. J. Public Health Dent. 67, 132-139. The EFSA Journal (2008) 787, 8-9
Filstrup SL, Briskie D, da Fonseca M, Lawrence L, Wandera A, Inglehart MR, 2003. Early childhood caries and quality of life: child and parent perspectives. Pediatr. Dent. 25, 431-440. Gedalia, I, Ben-Mosheh, S, Biton, J and Kogan D, 1994. Dental caries protection with hard cheese consumption. Am. J. Dentistr. 7, 331-332. Jensen RG, 1995. Handbook of milk composition. Academic Press, San Diego, USA. Källestål C, Fjelddahl A, 2007. A four-year cohort study of caries and its risk factors in adolescents with high and low risk at baseline. Swe. Dent. J. 31, 11-25. Marshall TA, Levy SM, Broffitt B, Warren JJ, Eichenberger-Gilmore JM, Burns TL, Stumbo PJ, 2003. Dental caries and beverage consumption in young children. Pediatrics. 112, e184-91. McCance RA and Widdowson EM, 2002. The composition of foods. Sixth Summary Edn. Cambridge: The Royal Society of chemistry. Ohlund I, Holgerson PL, Backman B, Lind T, Hernell O, Johansson I, 2007. Diet intake and caries prevalence in four-year-old children living in a low prevalence country. Caries. Res. 41, 26-33. Petridou E, Athanassouli T, Panagopoulos H, Revinthi K, 1996. Sociodemographic and dietary factors in relation to dental health among Greek adolescents. Community Dent. Oral Epidemiol. 24, 307-311. Petti S, Simonetti R, Simonetti D'Arca A, 1997. The effect of milk and sucrose consumption on caries in 6-to-11-year-old Italian schoolchildren. Eur. J. Epidemiol. 13, 659-64. Petti S, Cairella G, Tarsitani G., 2000. Rampant early childhood dental decay: an example from Italy. J. Public Health Dent. 60, 159-66. Serra Majem L, García Closas R, Ramón JM, Manau C, Cuenca E, Krasse B, 1993. Dietary habits and dental caries in a population of Spanish schoolchildren with low levels of caries experience. Caries Res. 27, 488-94. Zita AC, Mc Donald RE, Andrews AI, 1959. Dietary habits and dental caries experience in 200 children. J. Dent. Res. 38, 860-865. GLOSSARY / ABBREVIATIONS DMFS Decayed missing and filled surfaces The EFSA Journal (2008) 787, 9-9