ID 3004 - 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.

2.1. Poprawa regularności pracy jelit (ID 3004)

The claimed effect is “bowel regularity”. 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 improvement of bowel regularity.
The Panel considers that improvement of bowel regularity may be a beneficial physiological effect.

3.1. Poprawa regularności pracy jelit (ID 3004)

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 one publication in Japanese of which no English translation was available to the Panel. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Five human intervention studies were cited in the consolidated list, all of which were included in an internal report (Cantox Health Sciences International, 2009, unpublished) which was also provided.
In a human intervention study (Ogata et al., 1999), 250 mL of a test yoghurt supplemented with Bifidobacterium longum BB536 (2×107 viable BB536 cells per mL, 5x109 cells per day, containing also Streptococcus thermophilus STH450 and Lactobacillus delbrueckii subsp. bulgaricus LBU108) or a control yoghurt (with the same bacterial cultures but without Bifidobacterium longum BB536) were administered daily for two weeks to six healthy volunteers. The effects on faecal microbiota, faecal putrefactive substances, faecal enzymatic activities and faecal properties were examined. The Panel notes that the study did not address outcomes related to the improvement of bowel regularity.
In another study by the same group (Ogata et al., 1997), the effect of Bifidobacterium longum BB536 administered in 200 mL of milk per day for three weeks (2 x109 CFU/day) to adult volunteers was studied in a sequential design. Defecation frequency and faecal characteristics were investigated in 40 women suffering from constipation. Milk without Bifidobacterium longum BB536 was used as placebo. The Panel notes that the intervention order was not randomised, that the study design did not allow the exclusion of a time effect, that no information on blinding was provided, and that the statistical evaluation did not correct for multiple repeated measures. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
In another study, adult volunteers were administered a test yoghurt containing Bifidobacterium longum BB536 (100 g of yoghurt, >2x107 viable BB536 cells per mL, containing also Streptococcus thermophilus STH450 and Lactobacillus delbrueckii subsp. bulgaricus LBU108) or a control yoghurt (containing Streptococcus thermophilus STH450 and Lactobacillus delbrueckii subsp. bulgaricus LBU108), and their effects on faecal microbiota, ammonia concentrations, faecal characteristics (colour, consistency) and defecation frequency were examined (Yaeshima et al., 1997). Eleven women were assigned as subjects to test the effects of Bifidobacterium longum BB536 on the intestinal environment, and 39 women were assigned as subjects to test the effects on faecal characteristics and defecation frequency. After a two-week run-in period, in which the subjects consumed control yoghurt, the subjects consumed 100 g of Bifidobacterium longum BB536 yoghurt per day for the subsequent test period, which was two weeks for testing effects on the intestinal microbiota, and three weeks for testing effects on faecal characteristics and defecation frequency. The Panel notes that the intervention order was not randomised, that the study design did not allow the exclusion of a time effect, that no information on blinding was provided, and that the statistical evaluation did not correct for multiple repeated measures. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
The same group (Yaeshima et al., 2001) analysed the defecation frequency and faecal characteristics in 43 healthy female volunteers with constipation. A daily dose of 180 mL of a non-fermented milk (1×107 CFU/mL of Lactobacillus gasseri, >1.2×107 CFU/mL of Bifidobacterium longum BB536, and fortified with 376 mg calcium per bottle (180 mL)) was administered for two weeks. The effects on defecation frequency and faecal characteristics were examined and compared with the effects of placebo non-fermented milk. The placebo milk contained Lactobacillus gasseri, and was also fortified with calcium. The total study duration was eight weeks divided into four consecutive periods: milk- free period 1 (1st and 2nd week), Bifidobacterium longum BB536 milk administration period (3rd and 4th week), milk-free period 2 (5th and 6th week), and placebo milk administration period (7th and 8th week). Defecation frequency and number of days without defecation were reported. The Panel notes that the intervention order was not randomised, that the study design did not allow the exclusion of a time effect, that no information on blinding was provided, and that the statistical evaluation did not correct for multiple repeated measures. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
A sweet yoghurt containing Bifidobacterium longum BB536 was administered to 41 healthy women volunteers (Yaeshima et al., 1998), and the effects on defecation frequency and faecal characteristics were examined. The study duration was eight weeks, which was divided into four consecutive periods: yoghurt-free period 1 (1st and 2nd week), Bifidobacterium longum BB536 yoghurt (100 g per day, 2x107 CFU/g) administration period (3rd and 4th week), yoghurt-free period 2 (5th and 6th week), and placebo standard sweet yoghurt administration period (7th and 8th week). Changes in defecation frequency were investigated. The Panel notes that the intervention order was not randomised, and that the study design did not allow for the possibility of a time effect. Furthermore, the study was not blinded and the statistical evaluation did not correct for multiple repeated measures. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between consumption of Bifidobacterium longum BB536 and improvement of bowel regularity.

Warunki i możliwe ograniczenia stosowania oświadczenia

The effective dose required for bowel regularity is approximately 2 X 109 to 2 X 1010 CFU per day. To carry the proposed Article 13 claim, a product should contain at least 1 X 109 CFU per 100 g serving. Products containing this minimum effective dose of BB536 should be consumed for a minimum of 1 week for claimed effects to be apparent. As BB536 does not permanently colonize the gut, continued intake of products containing BB536 is desirable.