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Scientific Opinion on the substantiation of health claims related to fructo-oligosaccharides (FOS) and decreasing potentially pathogenic gastro-intestinal microorganisms (ID 781) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Fructo-oligosaccharides (FOS)   gastro-intestinal microorganisms   health claims  
ID:    781  
Produkty: Fruktooligosacharydy  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is fructo-oligosaccharides (FOS).
FOS constitute a class of saccharide oligomers consisting of short chains of fructose molecules. FOS are manufactured by enzymatic or chemical degradation of inulin, or by enzymatic elongation of sucrose. Different types of FOS mixtures are available on the market.
This opinion refers to FOS from both inulin and sucrose.
The Panel considers that the food constituent, fructo-oligosaccharides, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is ―beneficial effect on intestinal microflora, gut integrity, digestion‖. 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 in the gut which are considered to be ―beneficial‖.
The numbers/proportions of bacterial groups which would constitute a ―healthy balanced‖ gastro-intestinal flora have not been established. Increasing the number of any group of microorganisms in the gut, 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. Naukowe uzasadnienia wpływu na zdrowie człowieka - Zmniejszenie ilości potencjalnie patogennych mikroorganizmów w przewodzie pokarmowym

Among the references provided in relation to this claim were textbooks and narrative reviews which did not provide original data for the scientific substantiation of the claim.
Some of the human studies provided used food constituents other than FOS, or reported on health outcomes (e.g. beta-glucuronidase and reductase activity, faecal wet and dry weight, colonic crypt cell proliferation, and blood lipids) unrelated to the claimed effect. One conference report was not available to the Panel after every reasonable effort had been made to retrieve it. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
A number of human intervention studies focused on the effects of FOS on faecal bifidobacteria (Bouhnik et al., 1996; Bouhnik et al., 1999; Bouhnik et al., 2004; Kruse et al., 1999), or bifidobacteria together with other bacteria groups (e.g. lactobacilli, enterobacteria, Bacteroides, clostridia, fusobacteria, coliforms, Gram-positive cocci, Bacteroides-Prevotella group, Clostridium perfringens- Clostridium histolyticum group, total anaerobes, and total aerobes) (Bouhnik et al., 2006; Bouhnik et al., 2007; Gibson et al., 1995; Kleessen et al., 1997; Rao, 2001; Tuohy et al., 2001). The Panel notes that the bacterial groups analysed in these studies are part of the commensal intestinal microbiota, and that no evidence was provided for the characterisation of any of these bacterial groups as pathogens. In four human studies the effects of FOS on Clostridium perfringens were investigated (Menne et al., 2000; Mitsuoka et al., 1986; Mitsuoka et al., 1987; Tokunaga et al., 1993) but no information was provided about the pathogenicity of the bacterial strains studied. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Human studies addressing outcomes such as faecal pH and short-chain fatty acid concentrations in faeces may provide information on the mechanisms by which the food constituent could exert the claimed effect, but are not sufficient per se to predict an effect of FOS on decreasing potentially pathogenic gastro-intestinal microorganisms.
The Panel notes that no human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided.
The Panel considers that evidence provided in in vitro studies is not sufficient to predict the occurrence of an effect of FOS consumption on potentially pathogenic gastro-intestinal microorganisms in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of fructo-oligosaccharides and decreasing potentially pathogenic gastro-intestinal microorganisms.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, fructo-oligosaccharides, which is the subject of the claim, is sufficiently characterised in relation to the claimed effect.
The claimed effect is ―beneficial effect on intestinal microflora, gut integrity, digestion‖. The target population is assumed to be the general population. Decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of fructo-oligosaccharides and decreasing potentially pathogenic gastro-intestinal microorganisms.