2721.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to a combination of Propionibacterium freudenreichii SI 41 and Propionibacterium freudenreichii SI 26 and increasing numbers of gastro- intestinal microorganisms (ID 941, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 1 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a health claim pursuant to Article 13 of Regulation (EC) No 1924/2006 in the framework of further assessment related to a combination of Propionibacterium freudenreichii SI 41 and Propionibacterium freudenreichii SI 26 and increasing numbers of gastro-intestinal microorganisms. The food constituent that is the subject of the health claim, a combination of Propionibacterium freudenreichii SI 41 and Propionibacterium freudenreichii SI 26, is sufficiently characterised. The claimed effect proposed for further assessment is “beneficially affects the intestinal flora by increasing bifidobacteria”. The proposed target population is the general population. The evidence provided does not establish that the proposed claimed effect, increasing numbers of gastro-intestinal microorganisms, is a beneficial physiological effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of Propionibacterium freudenreichii SI 41 and Propionibacterium freudenreichii SI 26 and a beneficial physiological effect related to increasing numbers of gastro-intestinal microorganisms. © European Food Safety Authority, 2012
Słowa kluczowe: Propionibacterium freudenreichii   SI 26   SI 41   gastro-intestinal   health claims   microorganisms  
ID:    941  
Produkty: Propionibacterium freudenreichii SI 41, Propionibacterium freudenreichii SI 26  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is a combination of Propionibacterium freudenreichii SI 41 and Propionibacterium freudenreichii SI 26.
Propionibacterium freudenreichii SI41 (hereafter P. freudenreichii SI41) is also known as P. freudenreichii TL162. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided. Data on the identification and characterisation of P. freudenreichii SI41 at species and strain level using genotypic methods
(DNA-DNA hybridisation, 16S rRNA gene sequence analysis, species-specific PCR and PFGE) were provided in the application and accompanying references (Hervé et al., 2007; Jan et al., 2002). The Panel considers that Propionibacterium freudenreichii SI41 is sufficiently characterised.
Propionibacterium freudenreichii SI26 (hereafter P. freudenreichii SI26) is also known as P. freudenreichii TL166. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided. Data on the identification and characterisation of P. freudenreichii SI26 at species and strain level using genotypic methods (DNA- DNA hybridisation, 16S rRNA gene sequence analysis, species-specific PCR and PFGE) were provided in the application and the accompanying reference (Hervé et al., 2007). The Panel considers that Propionibacterium freudenreichii SI26 is sufficiently characterised.
The Panel considers that the food constituent, a combination of Propionibacterium freudenreichii SI41 and Propionibacterium freudenreichii SI26, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect, which is proposed for further assessment, is “beneficially affects the intestinal flora by increasing bifidobacteria”. The proposed target population is the general population.
The Panel notes that increasing the number of any groups of microorganisms, including lactobacilli and/or bifidobacteria, is not considered to be a beneficial physiological effect in itself, but needs to be linked to a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Zwiększenie ilości bakterii jelitowych

The references cited in relation to this claim included one human study, which addressed the effects of P. freudenreichii SI 41 and P. freudenreichii SI 26 on faecal propionibacteria and bifidobacteria concentrations, and on segmental colonic transit time (Bouglé et al., 1999), and two human studies on the effect of P. freudenreichii SI41 alone (and not the combination of the strains that is the subject of the claim) in different matrices (e.g. fermented milk, and classical or acid-resistant capsules) on, for example, propionibacterium populations in faeces, survival capacity/viability of the strain, or the metabolic activity of the strain in the gut (Hervé et al., 2007; Jan et al., 2002). The Panel considers that the evidence provided does not establish that increasing numbers of gastro- intestinal microorganisms is a beneficial physiological effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of Propionibacterium freudenreichii SI 41 and Propionibacterium freudenreichii SI 26 and a beneficial physiological effect related to increasing numbers of gastro- intestinal microorganisms.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, a combination of Propionibacterium freudenreichii SI 41 and Propionibacterium freudenreichii SI 26, which is the subject of the health claim, is sufficiently characterised.
The claimed effect proposed for further assessment is “beneficially affects the intestinal flora by increasing bifidobacteria”. The proposed target population is the general population. The evidence provided does not establish that increasing numbers of gastro- intestinal microorganisms is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of a combination of Propionibacterium freudenreichii SI 41 and Propionibacterium freudenreichii SI 26 and a beneficial physiological effect related to increasing numbers of gastro-intestinal microorganisms.