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.

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.

2.3. Naturalne funkcje układu odpornościowego (ID 924)

The claimed effect is “natural immune function”. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were given in the proposed wording or clarifications provided by Member States. Given the multiple roles of the immune system, the specific aspect of immune function that is the subject of the claim needs to be specified, but has not been indicated in the information provided.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

2.4. Zmniejszenie dolegliwości związanych z chorobami zapalnymi jelit (ID 1469)

The claimed effect is “natural immune function”.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to the reduction of symptoms of inflammatory bowel conditions.
The Panel notes that inflammatory bowel conditions are associated with Crohn's disease or ulcerative colitis, and that the target population for the claim is patients with Crohn's disease or ulcerative colitis.
The Panel considers that the claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

2.5. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 3089)

The claimed effect is “maintain normal cholesterol”. The Panel assumes that the target population is the general population.
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries. Elevated LDL-cholesterol, by convention >160 mg/dL (>4.1 mmol/L), may compromise the normal structure and function of the arteries.
The Panel considers that maintenance of normal blood LDL-cholesterol concentrations 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.

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.

3.3. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 3089)

None of the references provided for the scientific substantiation of the claim addressed the strain Bifidobacterium animalis ssp. lactis Bb-12, which is the subject of the claim. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Bifidobacterium animalis ssp. lactis Bb-12 and maintenance of normal blood LDL- cholesterol concentrations.