Scientific Opinion on the substantiation of health claims related to
Lactobacillus plantarum BFE 1685 and decreasing potentially pathogenic
intestinal microorganisms (ID 992) pursuant to Article 13(1) of
Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Lactobacillus plantarum BFE 1685
health claims
intestinal flora
potentially pathogenic microorganisms
1. Charakterystyka żywności / składnika
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Zmniejszenie ilość potencjalnie patogennych bakterii jelitowych
The food constituent that is the subject of the health claim is Lactobacillus plantarum BFE 1685. The strain Lactobacillus plantarum BFE 1685 identity/characteristics have been determined using phenotypic and genotypic methods (Vizoso Pinto et al., 2006).
The Panel notes that no indication of the deposition of the strain in an internationally recognised culture collection was reported.
The Panel considers that the food constituent, Lactobacillus plantarum BFE 1685, which is the subject of the health claim is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
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Zmniejszenie ilość potencjalnie patogennych bakterii jelitowych
The claimed effect is “digestive health/intestinal flora”. The Panel assumes that the target population is the general population.
“Digestive health/intestinal flora” is not sufficiently defined. In the context of the proposed wording, the Panel assumes that the claimed effect refers to aspects of: “maintaining/restoring the balance of intestinal flora”.
The numbers/proportions of bacterial groups that would constitute a “balanced intestinal flora” have not been established. Increasing or decreasing the number of any groups of bacteria is not in itself considered to be beneficial. The Panel considers that no evidence has been provided that aspects of
the claimed effect “maintaining/restoring the balance of intestinal flora” are beneficial to human health.
The Panel considers that “maintaining/restoring the balance of intestinal flora” in the context of decreasing potentially pathogenic intestinal microorganisms might be a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Zmniejszenie ilość potencjalnie patogennych bakterii jelitowych
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Zmniejszenie ilość potencjalnie patogennych bakterii jelitowych
A total of six references were cited to substantiate the claimed effect.
In four of the studies provided, the strain Lactobacillus plantarum BFE 1685 was not included among the studied strains. The Panel considers that the evidence obtained for one strain cannot be extrapolated to another, owing to the strain-specificity of the effects.
Two in vitro studies provided report data on identification and characterisation of the strains, their resistance to gastrointestinal conditions, antibiotics resistance, antimicrobial potential (Vizoso Pinto et al., 2006), and adhesion properties of the bacterial strains, competitive exclusion of pathogens and induction of cytokine production using a epithelial cell line (Vizoso Pinto et al., 2007). The Panel considers that the evidence provided in in vitro studies is not sufficient to predict the occurrence of an effect of Lactobacillus plantarum BFE 1685 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 BFE 1685 and decreasing potentially pathogenic intestinal microorganisms.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food/constituent, Lactobacillus plantarum BFE 1685, which is the subject of the health claim is sufficiently characterised.
The claimed effect is “digestive health/intestinal flora”. The target population is assumed to be the general population. “Maintaining/restoring the balance of intestinal flora” in the context of decreasing potentially pathogenic intestinal microorganisms might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of Lactobacillus plantarum BFE 1685 and decreasing potentially pathogenic intestinal microorganisms.
