ID 1077 -
Lactobacillus plantarum 299 (DSM 6595, 67B)
PL: Lactobacillus plantarum 299 (DSM 6595, 67B)
EN: Lactobacillus plantarum 299 (DSM 6595, 67B)
Pdf: Lactobacillus plantarum 299
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim is Lactobacillus plantarum 299 (DSM 6595, also as 67B) (hereafter L. plantarum 299 (DSM 6595)). The identification and characterisation of the strain Lactobacillus plantarum 299 (DSM 6595) by both phenotypic and genotypic methods are reported (Johansson et al., 1993; Johansson et al., 1995; Molin et al., 2006; Molin et al., 1993; Nigatu et al., 2001).
The Panel notes that the deposit of the strain in the DSMZ (Deutsche Sammlung von Mikroorganismen und Zellkulturen) as DSM 6595 is indicated. 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 food constituent, Lactobacillus plantarum 299 (DSM 6595, 67B), which is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
The claimed effect is “immune system”. The Panel assumes that the target population is the general population.
“Immune system” is not sufficiently defined and no more details were provided in the proposed wording.
The Panel considers that the claimed effect, “immune system”, has not been sufficiently defined.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Wpływ na układ odpornościowy
Twelve references were cited to substantiate the claimed effect. The references include four human intervention studies, a meta-analysis, one ex vivo, two in vitro and three animal studies and a reference related to a company internal report on Lactobacillus plantarum and intestinal mucins. With respect to the latter reference, the Panel considers that no scientific data was provided that could be used to substantiate the claimed effect.
Three intervention studies have been presented on the effects of Lactobacillus plantarum 299 (DSM 6595, 67B) on the incidence of bacterial infection in patients either suffering from server acute pancreatitis, or after liver transplantation or undergoing major abdominal surgery (Olah et al., 2002; Rayes et al., 2002a and 2000b). The meta-analysis of these intervention studies was presented on a poster (Alenfall et al., 2004). The Panel considers that the evidence provided does not establish that the results obtained from these studies with seriously ill patients can be extrapolated to the general population.
In the human intervention study by Johansson et al. (1993), different strains of lactobacilli were administered to healthy volunteers and reduction of pathogens in rectal mucosa was measured. It was not clear from the study whether the effect could be attributed to L. plantarum 299 (DSM 6595, 67B).
Studies on ex vivo IL-10 (interleukin 10) production by human mucosal cells induced by L. plantarum (Pathmakanthan et al., 2004), bacterial strain adherence to mucosal cells in vitro (Alderberth et al., 1996), in vitro antimicrobial activity (Jacobsen et al., 1999), reduced translocation of pathogens in rat models (Mao et al., 1997; Adawi et al., 1999), and reduced intestinal permeability in an animal model of biliary obstruction after enteral administration of L. plantarum species 299 (LP299) (White et al., 2006) were provided. The Panel notes that the evidence provided in the animal, in vitro and ex vivo studies does not predict the effect of L. plantarum 299 (DSM 6595, 67B) in humans.
Overall, the evidence provided did not establish that the results obtained in studies with seriously ill patients or from studies in animals, or conducted in vitro and ex vivo can be extrapolated to the general human population.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum 299 (DSM 6595, 67B) and “immune system”.
Warunki i możliwe ograniczenia stosowania oświadczenia
At least 109 cfu/day
