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.

2.2. Ochrona skóry przed uszkodzeniami wywołanymi promieniami ultrafioletowymi (UV) (ID 900)

The claimed effect is “skin health”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to protection of the skin from UV-induced damage.
The Panel considers that protection of the skin from UV-induced damage 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.

3.2. Ochrona skóry przed uszkodzeniami wywołanymi promieniami ultrafioletowymi (UV) (ID 900)

Among the references provided in relation to the claim were unpublished reports, meeting abstracts or posters, which were either not accessible to the Panel or did not contain sufficient information for a full scientific evaluation. One animal study on the development of atopic dermatitis did not address outcomes related to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
In a double-blind, randomised, placebo-controlled human intervention study (Peguet-Navarro et al., 2008), 54 healthy male volunteers (aged 20 to 40 years) received daily oral supplementation with either L. johnsonii La1 (1x1010 CFU, n=27) or placebo (maltodextrin, n=27) for 66 days. Suction blister roofs and skin biopsies were taken from the right and left buttocks of each volunteer at baseline, and the UV minimal erythemal dose (MED) was determined. On day 56, the volunteers were exposed to 1.5 MED twice within 10 hrs on a 10x10 cm area on the right buttock from a 1,000 W xenon solar simulator, with an exposure spectrum according to the standards for determining sun protection factors. On days 1, 4 and 10 post-irradiation, suction blister roofs and biopsies were again collected from the right and left buttocks. Results were based on comparisons between exposed and un-exposed areas for each subject, and included immuno-histochemical analysis (scoring) of a number of cellular markers performed double-blind by a single examiner. In addition, epidermal cells (not further characterised) were isolated, and mixed epidermal cell-(allogenic) lymphocyte reactions were performed with lymphocytes from three unrelated allogeneic donors. The Panel notes that no functional studies on the immune response against foreign antigens were provided. The Panel further notes that in the statistical analysis only within-group comparisons were reported, with no statistical comparison between the two groups. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
One animal study on the effect of L. johnsonii on UV-induced immunosuppression was provided. The Panel considers that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of Lactobacillus johnsonii La1 consumption on protection of the skin from UV-induced damage in humans.
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 protection of the skin from UV-induced damage.