ID 866 - Bifidobacterium animalis ssp. lactis Bb-12

PL: Bifidobacterium animalis ssp. lactis Bb-12
EN: Bifidobacterium animalis ssp. lactis Bb-12
Pdf: Bifidobacterium animalis ssp. lactis Bb-12

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is Bifidobacterium animalis ssp. lactis Bb-12.
The species and strain identity and characteristics of Bifidobacterium animalis ssp. lactis Bb-12 (previously known as Bifidobacterium bifidum Bb-12, and also as Bifidobacterium lactis Bb-12, but subjected to reclassification) (Masco et al., 2004) have been determined using different genotypic methods (Garrigues et al., 2005; Mayer et al., 2007; Ventura et al., 2001a; Yimin et al., 1999, unpublished). It is important to point out that it may not be possible to differentiate commercially available Bifidobacterium animalis ssp. lactis strains from each other on the basis of traditional genetic methods (e.g. Pulsed Field Gel Electrophoresis) (Engel et al., 2003; Gueimonde et al., 2004), and that it may be necessary to use multi-locus sequencing or genome-wide approaches. The genome of Bifidobacterium animalis ssp. lactis Bb-12, although sequenced (Yimin et al., 1999, unpublished), was not publicly available at the time of the evaluation.
The deposit of the strain in the German culture collection DSMZ (Deutsche Sammlung von Mikroorganismen und Zellkulturen) under number DSM 15954 was reported in the literature (Kajander et al., 2008). In addition, several authors consider the Bifidobacterium animalis ssp. lactis Bb-12 strain to be also equal to the strain DSMZ 10140 (Ventura et al., 2001b). This view is due to the fact that, although the strain owner did not deposit the strain under the Bifidobacterium animalis ssp. lactis Bb-12 name, strain DSMZ 10140 was isolated from a yoghurt containing Bifidobacterium animalis ssp. lactis Bb-12 which was deposited by Meile et al. (1997).
The Panel considers that the food constituent, Bifidobacterium animalis ssp. lactis Bb-12, which is the subject of the health claims, is sufficiently characterised.

2.2. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 866)

The claimed effect is “intestinal flora; digestive system”. 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 the numbers of “beneficial” intestinal bacteria.
The numbers/proportions of bacterial groups which would constitute a “healthy, natural, good or beneficial” gastro-intestinal flora have not been established. Increasing the number of any group of microorganisms 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 866)

Most of the references provided addressed potential effects of foods/food constituents, including “probiotics” in general, or of foods/food constituents other than Bifidobacterium animalis ssp. lactis Bb-12 or Bb-12 in combination with other strains or substances and/or outcomes not related to decreasing potentially pathogenic gastro-intestinal microorganisms, such as atopic eczema or the survival of the strain in the gastro-intestinal tract. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Seven human intervention studies addressed outcomes related to the claimed effect (Alander et al., 2001; Fukushima et al., 1998; Matsumoto et al., 2000; Matsumoto et al., 2001; Murakami et al., 2006; Nishida et al., 2004; Uchida et al., 2005). Among these studies, one study was uncontrolled (Fukushima et al., 1998). The Panel considers that no conclusions can be drawn from this uncontrolled study for the scientific substantiation of the claimed effect.
In the remaining six human intervention studies, the effect of Bifidobacterium animalis ssp. lactis Bb-12 on different microorganism strains or groups was studied (through analysis of faecal samples by plate counting): bifidobacteria, lactic acid bacteria, Clostridium perfringens and coliforms (Alander et al., 2001; Matsumoto et al., 2001); bifidobacteria, lactobacilli, Bacteroidaceae, eubacteria, peptostreptococci, lecithinase positive clostridia, lecithinase negative clostridia, Veillonellae, Megasphaerae, Enterobacteriaceae, enterococci, stapphylococci, bacilli, yeast and moulds (Matsumoto et al., 2000); total anaerobes, bifidobacteria, lactobacilli, lecithinase positive clostridia, lecithinase negative clostridia, Bacteroidaceae, total aerobes, staphylococci, enterococci, Enterobacteriaceae and Clostridium perfringens (Murakami et al., 2006); total bacteria, total anaerobes, total aerobes, Bacteroidaceae, bifidobacteria, eubacteria, lecithinase positive clostridia, lecithinase negative clostridia, lactobacilli, streptococci and Enterobacteriaceae (Nishida et al., 2004); total bacteria, total anaerobes, total aerobes, Bacteroidaceae, bifidobacteria, eubacteria, Peptococcaceae, Veillonellae, lecithinase positive clostridia, lecithinase negative clostridia, lactobacilli, enterococci, Enterobacteriaceae and bacilli (Uchida et al., 2005). The only significant changes reported in the studies provided were related to bifidobacteria, Bacteroidaceae and Clostridium perfringens. The Panel notes that these microorganisms 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. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claimed effect.
The Panel notes that no human studies have been provided from which conclusions can be drawn for the scientific substantiation of the claimed effect. The Panel considers that human studies are required for the substantiation of a claim, and that evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of Bifidobacterium animalis ssp. lactis Bb-12 consumption on decreasing potentially pathogenic gastro-intestinal microorganisms.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Bifidobacterium animalis ssp. lactis Bb-12 and decreasing potentially pathogenic gastro-intestinal microorganisms.

Warunki i możliwe ograniczenia stosowania oświadczenia

at least 109 cfu/day