ID 896 -
Lactobacillus johnsonii NCC 533 (La1) (CNCM I-1225)
PL: Lactobacillus johnsonii NCC 533 (La1) (CNCM I-1225)
EN: Lactobacillus johnsonii NCC 533 (La1) (Pasteur culture collection CNCM I-1225)
Pdf: Lactobacillus johnsonii NCC 533
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is “Lactobacillus johnsonii NCC 533 (La1) (CNCM I-1225)”, (hereafter L. johnsonii NCC 533 or L. johnsonii La1).
The identification/characterisation of the strain L. johnsonii NCC 533 has not been included in the studies provided but different studies on phenotypic and genotypic identification/characterisation can be found in the literature (Berger et al., 2007; Ventura et al., 2004). In addition, the genome sequence of L. johnsonii NCC 533 is publicly available at the NCBI database (accession NC_005362) (Pridmore et al., 2004). A culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) was also provided. The strain Lactobacillus acidophilus La1 has been re-classified as L. johnsonii La1.
The Panel considers that the food constituent, Lactobacillus johnsonii NCC 533 (La1) (CNCM I-1225), which is the subject of the health claims, is sufficiently characterised.
2.1. Wzmocnienie odpowiedzi immunologicznej przeciw patogenom przewodu pokarmowego (ID 896)
The claimed effect is “natural defence/immune system”. The Panel assumes that the target population is the general population.
In the context of the clarifications from Member States and the references provided, the Panel assumes that the claimed effect refers to improving immune defence against pathogenic gastro-intestinal microorganisms.
The Panel considers that improving immune defence against pathogenic gastro-intestinal microorganisms is a beneficial physiological effect.
3.1. Wzmocnienie odpowiedzi immunologicznej przeciw patogenom przewodu pokarmowego (ID 896)
Among the references provided in relation to the claim, six citations were incomplete and the corresponding references could not be retrieved, the full texts of four references were not accessible to the Panel after every reasonable effort was made to retrieve them, three review papers did not provide original data, one reference was in Japanese and no translation into an EU language was available to the Panel, one human study did not address outcomes related to the claimed effect, three human studies addressed the effects of different combinations of food constituents and did not allow conclusions to be drawn on the effects of L. johnsonii La1 alone (e.g. L. johnsonii La1 plus S. thermophilus without controlling for the effect of S. thermophilus alone), and one human study used an administration route (i.e. via naso-gastric tube) which is not relevant for the substantiation of a claim on a food for oral consumption. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The remaining references included six human studies, 11 animal studies and 26 in vitro studies.
In a randomised, double-blind, placebo-controlled cross-over study (Yamano et al., 2006), 22 young healthy Japanese women (aged 20-22 years) received either 120 mL of fermented milk with L. johnsonii La1 (NCC 533) (1x109 CFU/day) and Streptococcus thermophilus (1x108 CFU/day) or the same amount of fermented (placebo) milk with S. thermophilus (1x108 CFU/day) only, for 21 days each with a wash-out period of 29 days in between. The effect of L. johnsonii La1 (NCC 533) on the intestinal microbiota (15 microorganisms or groups thereof) was investigated, including the appearance rate and numbers of lecithinase-positive Clostridium in the faeces. The Panel notes that the high number of primary outcomes tested was not taken into account in the statistical analysis, and that the number of lecithinase-positive Clostridium carriers was low. Therefore, it cannot be excluded that the borderline statistical significance of the difference in the number of lecithinase-positive Clostridium reported between the intervention and placebo groups is a chance finding. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
Brunser (2000) reported on a partially randomised and blinded study on anti-polio secretory IgA in saliva after oral polio vaccination in groups of infants (116 were enrolled) between four and six months old, in which the primary outcome was the safety of the formula and the secondary outcomes included the immune response to oral polio vaccination (IgA in saliva) and faecal bacterial composition. In another study, Brunser et al. (2006) evaluated the effect of L. johnsonii La1 on faecal bacterial counts in 90 infants (around 3.5 months of age). The Panel notes that the immune system in early childhood is still developing, and that the microbiota is different in composition, diversity, stability and evolution from that of adults. The Panel considers that the evidence provided does not establish that data from these study populations can be extrapolated to the general population.
In a double-blind, placebo-controlled study by Donnet-Hughes et al. (1999), a total of 42 volunteers were randomised to receive S. thermophilus only, S. thermophilus with 109 CFU L. johnsonii La1, or S. thermophilus with 108 CFU L. johnsonii La1 daily for three weeks after a 3-week run-in phase in which all volunteers received milk. Outcome measures included phagocytic activity and leukocyte oxidative burst. Two other human intervention studies with a parallel-group design (Schiffrin et al., 1995; 1997) in which individuals were given fermented milk with L. acidophilus La1 (re-classified as L. johnsonii La1) (7x1010 CFU/day) or Bifidobacterium bifidum strain Bb-12 (currently B. animalis, 1x1010 CFU/day) for three weeks were provided. Outcome measures were lymphocyte subsets and leukocyte phagocytic activity. In these studies, only within-group (and not between-group) comparisons were reported for the outcome measures. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
Eleven animal studies on the effects of L. johnsonii La1 on the development and function of the immune system in gnotobiotic mice, as well as on oral tolerance, antibody production, and other parameters of immune function in mice were cited. None of the studies addressed outcomes directly related to pathogens. The in vitro studies dealt with the proliferative and cytokine responses of various immune and epithelial cell types, cellular interactions, bacterial adhesion to epithelial cells and production of bacteriocins. The Panel considers that evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of L. johnsonii La1 consumption on improving immune defence against pathogens in humans.
The Panel notes that no human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus johnsonii NCC 533 (La1) (CNCM I-1225) and improving immune defence against pathogenic gastro-intestinal microorganisms.
Warunki i możliwe ograniczenia stosowania oświadczenia
at least 109 cfu/day
Fermented milk and spray-dried