1233.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to fermented dairy products and decreasing potentially pathogenic intestinal microorganisms (ID 1376) 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 ssp  
ID:    1376  
Produkty: Fermentowane produkty mleczne  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Bifidobacterium Bb-12 and soluble fibre in fermented dairy products.
The bacterial strain, which is the subject of the health claim, is assumed to be Bifidobacterium animalis ssp. lactis Bb-12 (hereafter B. animalis ssp. lactis Bb-12). The strain B. animalis ssp. lactis Bb-12, previously known as B. lactis Bb-12, is subjected to reclassification (Masco et al., 2004). The species identity as well as the strain identity and characteristics have been determined using different genotypic methods (Yimin et al., unpublished; Garrigues et al., 2005; Mayer et al., 2007; Ventura et al., 2001a). It is important to point out that it may not be possible to differentiate 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. In this regard the genome of B. animalis ssp. lactis Bb-12 although sequenced (Yimin et al., unpublished) is not publicly available.
The deposit of the strain in the German culture collection DSMZ (Deutsche Sammlung von Mikroorganismen und Zellkulturen) under number DSM 15954 was reported in the literature (Kajander et al., 2008). In addition several authors consider the strain Bb-12 to be also equal to the strain DSMZ 10140 (Ventura et al., 2001b). This is owing to the fact that, although the strain owner did not deposit the strain under the Bb-12 name, strain DSMZ 10140 was isolated from a yoghurt containing Bb-12 and deposited by Meile et al. (1997).
The Panel considers that the strain Bifidobacterium animalis ssp. lactis Bb-12, which is the subject of the health claim, is sufficiently characterised.
There is a wide variety of soluble fibres. The Panel considers that the soluble fibre, which is the subject of the health claim, is not sufficiently characterised in the information provided.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “healthy digestion”. The Panel assumes that the target population is the general population.
“Healthy digestion” is not sufficiently defined. In the context of the proposed wording, the Panel assumes that the claimed effect relates to aspects of promoting the growth of “beneficial” bacteria and decreasing potentially pathogenic intestinal microorganisms.
The numbers/proportions of bacterial groups that would constitute a “beneficial” gut microbiota 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 promoting the growth of “beneficial” bacteria is beneficial to human health.
The Panel considers that decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.

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

Seventy-nine references were cited to substantiate the claimed effect.
Sixteen references were human studies where a Bifidobacterium strain alone or in combination with lactic acid bacteria (yoghurt or probiotic bacteria) were added into milk before fermentation or administered in form of capsules. In one study (Chouraqui et al., 2004), Bifidobacterium Bb-12 was the only bacterial strain added to an acidified infant formula but no soluble fibre was added. Three studies addressed the effect of Bifidobacterium Bb-12 added to yogurt (without soluble fibre) in subject with Helicobacter pylori infections (Wang et al. 2004; Sheu at al., 2002; Sheu et al. 2006). The Panel notes that these studies did not use the indicated conditions of use for the claimed effect applied (fermented dairy products containing 109 CFU B. animalis ssp. lactis Bb-12 and 6 grams soluble fibre).
The other references were not related to fermented dairy products or dealt with different outcomes, such as lactose intolerance, lactose maldigestion, low-lactose milk, oligofructose or inulin intake or “probiotic” containing capsules.
The Panel notes the references cited 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 ssp. lactis Bb-12 and soluble fibre in fermented dairy products and decreasing potentially pathogenic intestinal microorganisms.

Wnioski

On the basis of the data available, the Panel concludes that:
The food constituent that is the subject of the health claim is Bifidobacterium Bb-12 and soluble fibre in fermented dairy products. The strain Bifidobacterium animalis ssp. lactis Bb- 12 is sufficiently characterised. The soluble fibre is not sufficiently characterised.
The claimed effect is “healthy digestion”. 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 ssp. lactis Bb-12 and soluble fibre in fermented dairy products and decreasing potentially pathogenic intestinal microorganisms.