The EFSA Journal (2008) 787, 1-9

European Food Safety Authority, 2008

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
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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
J ean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof, Hannu Korhonen, Pagona
Lagiou, Martinus Lvik, 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 childrens
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 cows 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

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The EFSA Journal (2008) 787, 2-9
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

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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

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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 childrens
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
childrens 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 J ournal of the European Union OJ L 404,
30.12.2006. Corrigendum OJ L 12, 18.1.2007, p. 318.
3
In accordance with EFSA Scientific and Technical guidance for the Preparation and Presentation of the Application for
Authorisation of a Health Claim

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The EFSA Journal (2008) 787, 5-9
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 J ohansson and the members of
the Working Group for the preparation of this opinion: J ean-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.


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1. Information provided by the applicant
Applicants 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 childs diet, and because of this,
form a prominent and important shelf on the Department of Health & Childrens 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,
teachers 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; J ensen, 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.


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2.2. Relevance of the claimed effect to human 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 childrens 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 cows 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 J erusalem. 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

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The EFSA Journal (2008) 787, 8-9
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 childrens 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, lactose-
reduced 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.

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The EFSA Journal (2008) 787, 9-9
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.
J ensen RG, 1995. Handbook of milk composition. Academic Press, San Diego, USA.
Kllestl 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 J J , Eichenberger-Gilmore J M, 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, J ohansson 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, Garca Closas R, Ramn J M, 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