This scientific output, published on 16 March 2011, replaces the earlier version published on 18 February 2011
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 (3.6-3.9) and containing calcium ≥200 mg/l and sugars 9.2-11.4 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 (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.
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.