ID 785 - Polidekstroza

PL: Polidekstroza
EN: Polydextrose
Pdf: polydextrose

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is polydextrose.
Polydextrose is produced by the poly-condensation of glucose in the presence of sorbitol and citric acid under vacuum at high temperatures (Radosta et al., 1992). Polydextrose is highly branched, with a degree of polymerisation between 2 and 110 (on average approximately 12 glucose units), and with an average molecular weight of ~2,000 Daltons (Allingham, 1982; Murray, 1988). All possible linkages with the glycosidic carbon of glucose are present: α- and β-1,2; 1,3; 1,4; and 1,6; with the 1,6 linkage predominating (Auerbach et al., 2007). Polydextrose is highly soluble in water (80 g/100 g at 25°C) leading to a low viscosity solution (Allingham, 1982; Auerbach et al., 2007). Besides the polymer, polydextrose consists of small amounts of the starting materials glucose, sorbitol and citric acid, as well as levoglucosan and hydroxymethylfurfural formed by caramelisation during the poly- condensation process. Owing to the complex linkage distribution in the highly branched structure, it has been stated that polydextrose is resistant to gastric acid and mammalian gastro-intestinal enzymes (Auerbach et al., 2006). Polydextrose is used primarily in the food industry as a stabiliser, thickening agent, humectant and carrier (E1200).
The Panel considers that the food constituent, polydextrose, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effects.

2.3. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 785)

The claimed effect is “prebiotic/bifidogenic”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to increasing numbers of bacteria which are considered to be “beneficial”.
The numbers/proportions of bacterial groups that would constitute a “beneficial/healthy/good/or natural balance” of gastro-intestinal flora have not been established. Increasing the number of any group of microorganisms, including lactobacilli and/or bifidobacteria, is not in itself considered to be a beneficial physiological effect.
The Panel considers that the evidence provided does not establish that increasing numbers of gastro- intestinal microorganisms is a beneficial physiological effect.
The Panel considers that the claimed effect, in the context of decreasing potentially pathogenic gastro- intestinal microorganisms, might be a beneficial physiological effect.

3.2. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 785)

The references provided for the scientific substantiation of the claim included textbooks and general reviews which did not provide original data for the scientific substantiation of the claim. The majority of human, animal and in vitro studies were unrelated to the food constituent which is the subject of the health claim, and/or were unrelated to the claimed effect. Studies which were unrelated to the claimed effect included references on the energy value of polydextrose, and on the effects of polydextrose consumption on cyclo-oxygenase-2 gene expression in mucosa, on gastro-intestinal transit time and on breath hydrogen production. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Two human studies focused on the effects of polydextrose on faecal bifidobacteria and other microorganisms (e.g. lactobacilli, Bacteroidaceae, Bacteroides fragilis, Bacteroides vulgaris, Bacteroides intermedius, Eubacterium, Peptococcaeae, Veilonella, Megasphera, Enterobacteriaceae, streptococci, lecithinase-negative clostridia and yeasts) (Endo et al., 1991; Jie et al., 2000). The Panel notes that the microorganisms assessed in these studies are part of the commensal intestinal microbiota, and that the studies did not provide evidence for the characterisation of any of these groups as pathogens. In one human study, the effect of polydextrose on Clostridium perfringens was investigated (Endo et al., 1991), but no information was given about the pathogenicity of the bacterial strains studied.
The Panel notes that no human studies have been provided from which conclusions could be drawn for the scientific substantiation of the claim. The Panel considers that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of polydextrose consumption on decreasing potentially pathogenic gastro-intestinal microorganisms in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of polydextrose and decreasing potentially pathogenic gastro-intestinal microorganisms.

Warunki i możliwe ograniczenia stosowania oświadczenia

4g/ day