ID 1078 - Lactobacillus plantarum 299 (DSM 6595, 67B)

PL: Lactobacillus plantarum 299 (DSM 6595, 67B)
EN: Lactobacillus plantarum 299 (DSM 6595, 67B)
Pdf: Lactobacillus plantarum 299

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Lactobacillus plantarum 299 (DSM 6595, 67B) (hereafter L. plantarum (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, 1995; Molin et al., 1993, 2006; Nigatu et al., 2001).
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 at 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 “increase the amount of lactobacilli in the intestine/decrease the amount of enterobacteriaceae/inhibit pathogenic bacteria”. The Panel assumes that the target population is the general population.
The numbers/proportions of bacterial groups that would constitute a “healthy” intestinal 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 the amount of lactobacilli in the intestine is a beneficial physiological effect.
The Panel considers that decreasing potentially pathogenic intestinal microorganisms might be a beneficial physiological effect.
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3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Zmniejszenie ilość potencjalnie patogennych bakterii jelitowych

Five references were cited to substantiate the claim. These references were two human studies (Jacobsen et al., 1999; Johansson et al., 1993), two animal studies and one reference quoting an internal report that was not provided.
In a study by Johansson et al. (1993), in vivo colonisation of human intestinal mucosa by a mixture of 19 Lactobacillus strains (including L. plantarum 299) in fermented oatmeal soup and their effects on indigenous microbiota were investigated in 13 healthy adult volunteers. The soup mixture contained 18 other strains besides L. plantarum 299. The Panel considers that no conclusions can be drawn from a study with the afore-mentioned mixture for the scientific substantiation of the claim on L. plantarum 299 (DSM 6595, 67B) alone.
The study of Jacobsen et al. (1999) evaluated the ability of different lactobacillus strains to survive gastrointestinal transit by detection in faeces; L. plantarum 299, however, was not included in this part of the study. The same study also assessed different properties of L. plantarum 299 in vitro, including its acid and bile resistance, adhesion ability to Caco-2 cells and antimicrobial activity. Other studies focused on the effects of L. plantarum 299 on the intestinal barrier and microbiota in animal models of acute liver injury in Sprague-Dawley rats (Adawi et al., 1999) and on the impact of L. plantarum 299 on methotrexate-induced enterocolitis in rats (Mao et al., 1997). The Panel considers that while effects shown in animal and in vitro studies may be used as supportive evidence, human studies are required for the substantiation of a claim, and that evidence provided in animal and in vitro studies alone is not sufficient to predict the occurrence of an effect of L. plantarum 299 (DSM 6595, 67B) consumption on decreasing potentially pathogenic intestinal microorganisms in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum 299 (DSM 6595, 67B) and decreasing potentially pathogenic intestinal microorganisms.

Warunki i możliwe ograniczenia stosowania oświadczenia

At least 109 cfu/day