1232.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to Bifidobacterium animalis Lafti B94 (CBS118.529) and decreasing potentially pathogenic intestinal microorganisms (ID 867) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Bifidobacterium animalis Lafti B94 (CBS118.529)   health claims   intestinal flora   potentially pathogenic microorganisms  
ID:    867  
Produkty: Bifidobacterium animalis Lafti B94 (CBS118.529)  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Bifidobacterium animalis Lafti B94 (CBS118.529) (hereafter B. animalis Lafti B94 (CBS118.529)). The strain B. animalis Lafti B94 was formerly known as B. lactis B94 and reclassified as subspecies of B. animalis (Masco et al., 2004). The species identity as well as the strain identity has been determined by phenotypic and genotypic methods (Crittenden et al., 2001; Mayer et al., 2007).
The Panel points out that it may not be possible to differentiate the commercially available B. animalis ssp. lactis strains from each other on the basis of traditional genetic methods (e.g. PFGE (Pulsed Field Gel Electrophoresis)) (Engel et al., 2003; Gueimonde et al., 2004.) and that it may be necessary to use multi-locus sequencing or genome-wide approaches.
The Panel notes that a culture collection number from the Centraalbureau voor Schimmelcultures (CBS) is given. The CBS is a non-public International Depositary Authority under the Budapest Treaty.
The Panel considers that the food constituent, Bifidobacterium animalis Lafti B94 (CBS118.529), which is the subject of the health claim is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “intestinal flora”. The Panel assumes that the target population is the general population.
“Intestinal flora” is not sufficiently defined. In the context of the proposed wording, the Panel assumes that the claimed effect refers to aspects of: “probiotic, enhance levels of beneficial microflora, support a balanced/beneficially affect intestinal microflora”.
The numbers/proportions of bacterial groups that would constitute a “beneficial/balanced intestinal flora” have not been established. Increasing the number of any groups of bacteria is not in itself considered as beneficial. The Panel considers that no evidence has been provided that aspects of the claimed effect, “probiotic” and “enhance levels of beneficial microflora”, are beneficial to human health.
The Panel considers that “support a balanced/beneficially affect intestinal microflora” in the context of decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.

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

Eleven references were cited to substantiate the claimed effect.
One human study addressed detection and quantification of the B94 strain in human faecal samples from a consumption study in 5 healthy volunteers aged between 25 and 50 years (Su et al., 2005). The Panel notes that this study did not address the relationship between the consumption of B. animalis Lafti B94 (CBS118.529) and the claimed effect.
The other references related to in vitro inhibition of Helicobacter pylori, animal studies investigating the effect of Lactobacillus casei and B. lactis B94 in a mouse model of Helicobacter pylori infection, and the effect of meat starter cultures on the ability of pathogens to colonise the gastrointestinal tract or infect the animals. The Panel notes that these studies provided little evidence to support the claimed effect in humans.
The remaining references include a workshop poster, reviews about probiotic research projects, and combination studies with prebiotics. The Panel notes that these references did not provide any scientific data that could be used to substantiate the claimed effect.
Overall, the references provided, including the human study, did not address the relationship between the consumption of B. animalis Lafti B94 (CBS118.529) and decreasing potentially pathogenic intestinal microorganisms and, therefore, did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Bifidobacterium animalis Lafti B94 (CBS118.529) and decreasing potentially pathogenic intestinal microorganisms.

Wnioski

On the basis of the data available, the Panel concludes that:
The food constituent, Bifidobacterium animalis Lafti B94 (CBS118.529), which is the subject of the health claim is sufficiently characterised.
The claimed effect is “intestinal flora”. The target population is assumed to be the general population. Decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.
A cause and effect relationship has not been established between the consumption of Bifidobacterium animalis Lafti B94 (CBS118.529) and decreasing potentially pathogenic intestinal microorganisms.