sugar free chewing gum article 14

EFSA Journal 2010;8(10):1776

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 1924/2006. EFSA Journal 2010;8(10):1776. [14 pp.].

doi:10.2903/j.efsa.2010.1776. Available online: www.efsa.europa.eu/efsajournal.htm

1 © European Food Safety Authority, 2010

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 1924/20061

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

European Food Safety Authority (EFSA), Parma, Italy

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-2010-00118, adopted on 10 September 2010.

2 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: [email protected]

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.

mailto:[email protected]

Sugar-free chewing gum and neutralisation of plaque acids

2 EFSA Journal 2010;8(10):1776

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


3 EFSA Journal 2010;8(10):1776

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.


4 EFSA Journal 2010;8(10):1776

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 ............................................................................................................................................... 7 1. Characterisation of the food/constituent ......................................................................................... 7 2. Relevance of the claimed effect to human health ............................................................................ 8 3. Scientific substantiation of the claimed effect ................................................................................ 8 4. Panel’s comments on the proposed wording ................................................................................. 10 5. Conditions and restrictions of use ................................................................................................. 10 Conclusions ............................................................................................................................................ 11 Documentation provided to EFSA ......................................................................................................... 11 References .............................................................................................................................................. 11 Glossary / Abbreviations ........................................................................................................................ 14


5 EFSA Journal 2010;8(10):1776

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION

Regulation (EC) No 1924/20064 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 completeness5 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 1924/2006.

4 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.

5 In accordance with EFSA “Scientific and Technical guidance for the Preparation and Presentation of the Application for

Authorisation of a Health Claim”


6 EFSA Journal 2010;8(10):1776

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 1924/2006.


7 EFSA Journal 2010;8(10):1776

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/EC6 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”

6 European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs. OJ L 237,

10.9.1994, p. 3–12.


8 EFSA Journal 2010;8(10):1776

means all monosaccharides and disaccharides which are present in chewing gum, but the term

excludes polyols (EU Directive 90/496/EEC7).

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.,

7 Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs. OJ L 276, 6.10.1990, p. 40–44.


9 EFSA Journal 2010;8(10):1776

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=(XC-XE)/XC where XC is the

mean increment in the control group and XE 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.


10 EFSA Journal 2010;8(10):1776

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/EC8).

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

8 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, 23.11.1994, p. 14–15.


11 EFSA Journal 2010;8(10):1776

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 2010. Submitted by Wrigley GmbH.

REFERENCES

Abelson DC, Barton J and Mandel ID, 1990. 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), 1985. 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, 1998. Glandular Mechanisms of Salivary Secretion.

Frontiers of Oral Biology. Karger Publishers, Basel.

Deshpande A and Jadad A, 2008. 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, 1602-1614.

Dodds MWJ, Hsieh SC and Johnson DA, 1991. The effect of increased mastication by daily gum-

chewing on salivary gland output and dental plaque acidogenicity. Journal of Dental Research, 70,

1471-1478.


12 EFSA Journal 2010;8(10):1776

Dong Y, Pan Y, Wang D and Cao C, 2003. 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), 2009. 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, 2006. Formulation and production of chewing and bubble gum. Kennedy´s publications ltd,

London.

Fröhlich S, Maiwald HJ and Flowedew G, 1992. Effect of gum chewing on the pH of dental plaque.

Journal of Clinical Dentistry, 3, 75-78.

Gopinath VK, Tandon S and Shirwaikar A, 1997. The effect of chewing gums on acidogenicity of

plaque after a sucrose challenge. Journal of Clinical Pediatric Dentistry, 22, 77-81.

Imfeld T, 1999. Chewing gum-facts and fiction: a review of gum-chewing and oral health. Criticial

Reviews in Oral Biology and Medicine, 10, 405-419.

Jensen ME, 1986. Responses of interproximal plaque pH to snack foods and effect of chewing

sorbitol- containing gum. The Journal of the American Dental Association, 113, 262-266.

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GLOSSARY / ABBREVIATIONS

AUC Area under the curve

CCT Controlled clinical trial

DMFS Decayed missing filled surfaces

PF Prevented fraction

PKU Phenylketonuria

RCT Randomised controlled trial

sugar free chewing gum article 14

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