ID 3025 - Lactobacillus fermentum ME-3

PL: Lactobacillus fermentum ME-3
EN: Lactic acid bacterium Lactobacillus fermentum ME-3
Pdf: Lactobacillus fermentum ME-3

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Lactobacillus fermentum ME-3.
No reference material was provided to support the identification/characterisation of the strain Lactobacillus fermentum ME-3. However, reference to L. fermentum ME-3 strain identification/characterisation by different phenotypic and genotypic methods was found in the literature (Kullisaar et al., 2002; Mikelsaar et al., 2003; Songisepp et al., 2005).
Reference to the deposit of the strain in the DSMZ (Deutsche Sammlung von Mikroorganismen und Zellkulturen) under number DSM 14241 was found in the literature (Mikelsaar et al., 2003; Songisepp et al., 2005). In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as patent deposits.
The Panel considers that the strain, Lactobacillus fermentum ME-3, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “A probiotic lactic acid bacterium Lactobacillus fermentum ME-3 helps to strengthen the organism's defence ability. ME-3 supports digestion by increasing in the intestine the total number of useful lactobacilli which ensure the break-down of nutrients into compounds that can be easily absorbed”. The Panel assumes that the target population is the general population.
From the clarifications provided by Member States, the Panel assumes that the claimed effect refers to “increasing in the intestine the total number of useful lactobacilli” and “suppressing harmful bacteria in gut”.
The numbers/proportions of bacterial groups that would constitute a “useful” intestinal microflora have not been established. Increasing the number of any groups of microorganisms, including lactobacilli, 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 intestinal microorganisms is a beneficial physiological effect.
The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Zmniejszenie ilość potencjalnie patogennych bakterii jelitowych

Only one reference was cited in relation to this claim, which was a conference report related to the effect of lactobacilli on eradication of Salmonella typhimurium in an animal model. The Panel considers that while effects shown in animal studies may be used as supportive evidence, human studies are required for the substantiation of a claim, and evidence provided in animal studies alone is not sufficient to predict the occurrence of an effect of Lactobacillus fermentum ME-3 consumption on decreasing potentially pathogenic gastro-intestinal microorganisms in humans.
No human studies were provided which addressed outcomes related to the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus fermentum ME-3 and decreasing potentially pathogenic gastro- intestinal microorganisms.

Warunki i możliwe ograniczenia stosowania oświadczenia

Bakterite sisaldus jogurtis 10e-6…10e-7 g/100 g. Juustus 0,097 g/100 g. Keefiris 10e-5 g/100 g. Kohukeses 0,009 g/ 100 g. Kohupiimas 0,0045 g/100 g.