ID 3005 - Bifidobacterium longum BB536

PL: Bifidobacterium longum BB536
EN: Morinaga Bifidobacterium longum BB536
Pdf: Bifidobacterium longum BB536

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is Bifidobacterium longum BB536.
No references were provided to support the identification and characterisation of this strain. However, reference to the identification and characterisation of Bifidobacterium longum BB536 by different genotypic methods was found in the literature (Mayer et al., 2007).
No indication of the deposit of the strain in an internationally recognised culture collection was found.
The Panel considers that Bifidobacterium longum BB536, which is the subject of the health claims, is sufficiently characterised.

2.3. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 3005)

The claimed effect is “healthy balance of intestinal bacteria”. 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 suppressing the growth of harmful gastro-intestinal bacteria.
The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.

3.3. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 3005)

The references provided for the scientific substantiation of the claim included a review article and a publication from an authoritative body, which did not contain any primary data which could be used for the scientific substantiation of the claimed effect, and a paper on the isolation/identification of bifidobacteria which is not related to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Seven studies assessed the relationship between dietary intakes of Bifidobacterium longum BB536 and gastro-intestinal microbiota (Ballongue et al., 1993; Odamaki et al., 2007a; 2007b; Ogata et al., 1997; 1999; Tomoda et al., 1991; Yaeshima et al., 1997), all of which were included in an internal report (Cantox Health Sciences International, 2009, unpublished) which was also provided. Faecal levels of the Bacteroides group and Clostridium perfringens were measured in a number of early human intervention studies using traditional culture methods. Several different groups of Bacteroides and clostridia have been analysed, but consistent comparisons are not possible between the reports because of the use of different methodologies. The Panel notes that Bacteroides and clostridia represent a large group of bacteria that are part of the commensal intestinal microbiota, and that the studies did not provide evidence for their characterisation as pathogens. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claimed effect.
One in vitro study investigated the effect of Bifidobacterium longum BB536 on intestinal pathogens in co-cultivation experiments (Araya-Kojima et al., 1995), and one animal study examined the resistance of Bifidobacterium-monoassociated mice to Escherichia coli challenge (Yamazaki et al., 1982). The Panel considers that evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of Bifidobacterium longum BB536 consumption on the reduction of potentially pathogenic gastro-intestinal microorganisms in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Bifidobacterium longum BB536 and decreasing potentially pathogenic gastro- intestinal microorganisms.

Warunki i możliwe ograniczenia stosowania oświadczenia

The effective dose required to maintain a healthy balance of intestinal flora is estimated to be between 1 X 108 and 1 X 1011 CFU per day. To carry the proposed Article 13 claim, a product should contain at least 1 X 108 CFU per 100 g serving. Products containing this minimum effective dose of BB536 should be consumed for a minimum of 2 weeks for claimed effects to be apparent. As BB536 does not permanently colonize the gut, continued intake of products containing BB536 is desirable.