ID 863 - 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different genotypic methods (Garrigues et al., 2005; Mayer et al., 2007; Ventura et al., 2001a; Yimin et al., 1999, unpublished).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 lactis Bb-12, although sequenced (Yimin et al., 1999, unpublished), was not publicly available at the time of the evaluation.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.

2.1. Odporność organizmu na patogeny (ID 863)

The claimed effect is “natural defence/immune system”. The Panel assumes that the target population is the general population.
From the clarifications and information provided by Member States, the Panel assumes that the claimed effect refers to “natural defence/immune defence by increasing phagocytic activity of blood granulocytes”, which could be interpreted as defence against pathogens by stimulating immunological responses.
The Panel considers that immune defence against pathogens is a beneficial physiological effect.

3.1. Odporność organizmu na patogeny (ID 863)

Among the references provided in relation to this claim were reviews, book chapters or nutrient intake recommendations that either did not contain any original data which could be used for the scientific substantiation of the claimed effect, or did not address the food constituent which is the subject of the claim. Some human studies were related to the effects of microorganisms other than Bifidobacterium animalis subsp. lactis Bb-12 or Bb-12 in combination with other strains or substances. A number of references addressed outcomes not related to the claimed effect, such as effects on constipation, non- pathogenic members of the microbiota, atopic eczema, strain survival, anti-mutagenic and anti- carcinogenic effects, blood lipids, strain adhesion properties, lactose intolerance, strain characterisation or short-chain fatty-acid production. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
A human intervention study addressed the effect of Bifidobacterium animalis ssp. lactis Bb-12 on incidence/episodes of diarrhoea in infants younger than 8 months (Chouraqui et al., 2004). The Panel considers that the intestinal microbiota in early childhood is different in terms of composition, diversity, stability and evolution, and that the evidence provided did not establish that these data from infants can be extrapolated to the general population.
Fukushima et al. (1998) studied the effect of a follow-on formula containing Bifidobacterium animalis subsp. lactis Bb-12 (200 mL of powdered cow's milk-based follow-on formula containing Bifidobacterium animalis ssp. lactis Bb-12, 109 CFU/day) in seven healthy Japanese children (15 to 31 months old) for 21 days. Faecal concentrations of total IgA and anti-poliovirus IgA were analysed during intake of the formula. The Panel notes that the small sample size of this study and that it was not controlled (lack of a control group), and considers that no conclusions can be drawn from this uncontrolled study for the scientific substantiation of the claimed effect.
Schiffrin et al. (1995; 1997) recruited healthy volunteers (n=28, mean age 36.9 years and age range 23-62 years). After three weeks during which volunteers received 120 mL of milk (three times per day) the volunteers were divided into two groups and given 120 mL fermented milk product supplemented with Lactobacillus acidophilus strain La1 (7x1010 CFU daily intake) or Bifidobacterium bifidum strain Bb-12 (now Bb-12) (1x1010 CFU daily intake), three times per day for three weeks. During the final six weeks volunteers received 120 mL of milk without the bacteria. Lymphocyte subpopulations and phagocytosis of Escherichia coli spp. ex vivo were measured. The Panel notes the lack of a placebo and the lack of blinding, that no information on outcomes related to pathogens was provided, and that evidence provided ex vivo is not sufficient to predict the occurrence of an effect in humans. The Panel considers that no conclusions can be drawn from this study 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 subsp. lactis Bb-12 consumption on immune defence against pathogens in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Bifidobacterium animalis ssp. lactis Bb-12 and immune defence against pathogens.

Warunki i możliwe ograniczenia stosowania oświadczenia

at least 109 cfu/day yoghurt daily consumption