1.1. Zdrowy i zrównoważony układ pokarmowy (ID 1371, 4228)

The claimed effects are “intestinal flora”, “digestive health” and “ingestion of cheese containing probiotic culture Lb. paracasei NFBC 338 positively influences the healthy balance of the gut microflora”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effects refer to maintenance of, or contribution to, a healthy and balanced digestive system, which is not sufficiently defined.
The Panel notes that the references provided were either not related to the food(s)/food constituent(s) evaluated in this opinion or were related to general review articles/reports, publications in the category of guidelines/authoritative reports, conference abstracts and quality/processing technology of the food, and that it is not possible to establish which effect is the target of the claim.
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The Panel considers that the claimed effects are general and non-specific and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.2. Zwiększenie ilości mikroorganizmów w przewodzie pokarmowym (ID 864, 1371, 3073, 4228)

The claimed effects are “gut health”, “intestinal flora”, “digestive health” and “ingestion of cheese containing probiotic culture Lb. paracasei NFBC 338 positively influences the healthy balance of the gut microflora”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effects refer to an increase in the number of “good” bacteria that are considered to be beneficial.
The numbers/proportions of bacterial groups that would constitute a “good, balanced, healthy or beneficial intestinal/colon flora” have not been established. Increasing the number of any groups 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 concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this opinion and a beneficial physiological effect related to increasing numbers of gastro-intestinal microorganisms.

1.3. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 864, 1371, 3073, 4228)

The claimed effects are “gut health”, “intestinal flora”, “digestive health” and “ingestion of cheese containing probiotic culture Lb. paracasei NFBC 338 positively influences the healthy balance of the gut microflora”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effects refer to changes in the number of gastro-intestinal microorganisms.
The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.

2.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 864, 1371, 3073, 4228)

Most of the references provided addressed potential effects of food(s)/food constituent(s) in general, or of food(s)/food constituent(s) other than those for which the specific claims are proposed, and/or claimed effects other than decreasing potentially pathogenic gastro-intestinal microorganisms. These comprise review articles; general reports and publications in the category of guidelines/authoritative reports; internal reports and technical documents about a food constituent; conference abstracts and references not related to the food(s)/food constituent(s) addressed in this opinion or related to combination with other constituents; and also references that addressed the physiological effects of the food(s)/food constituent(s) in rats (e.g. faecal counts of Lactobacillus and Bifidobacterium, acetate and total short-chain fatty acids, concentrations of primary bile acids, cholesterol and cholesterol metabolites). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Some of the references provided addressed other aspects of the food(s)/food constituent(s), including the detection/analysis or quality/processing technology of the food constituents, the pharmacokinetics of the food constituents, anti-DNA damaging potential, antiradical/antioxidant/anti-mutagenic
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properties, and enzymatic and polymerase chain reaction activity. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
For one claim addressed in this opinion (ID 4228), none of the references cited were related to the food constituent that is the subject of the claim and/or the claimed effect. The Panel notes that the references cited provided no data that could be used for the scientific substantiation of the claimed effect.
One human intervention study investigated the effects of the food(s)/food constituent(s) on several markers, e.g. faecal levels of total bifidobacteria and B. lactis; microbial activity as determined by measuring short-chain fatty acids (acetic, butyric and propionic acids) and branched-chain fatty acids (valeric, iso-butyric, 2-methyl butyric and iso-valeric acids); and immune markers (IgA and tumour necrosis factor (TNF)-α) (Ouwehand et al., 2006). The Panel notes that the changes in these markers do not predict effects on gastro-intestinal pathogens in humans. Furthermore, this study did not address the effect on pathogens as outcomes.
No human studies that investigated the effects of the food(s)/food constituent(s) on outcomes related to decreasing potentially pathogenic gastro-intestinal microorganisms have been provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this opinion and decreasing potentially pathogenic gastro-intestinal microorganisms.