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Scientific Opinion on the substantiation of a health claim related to a combination of Lactobacillus helveticus CNCM I-1722, Bifidobacterium longum subsp. infantis CNCM I-3424, Bifidobacterium bifidum CNCM I-3426 and fructo-oligosaccharides from sucrose and contribution to immune defence against pathogens (ID 3016, 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 (NDA) 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 Lactobacillus helveticus CNCM I-1722, Bifidobacterium longum subsp. infantis CNCM I-3424, Bifidobacterium bifidum CNCM I-3426 and fructo-oligosaccharides from sucrose and immune defence against pathogens. The food constituent that is the subject of the health claim, a combination of L. helveticus CNCM I-1722, B. longum subsp. infantis CNCM I-3424, B. bifidum CNCM I-3426 and fructo-oligosaccharides from sucrose, is sufficiently characterised. The claimed effect, contribution to immune defence against pathogens, is a beneficial physiological effect. The proposed target population is the general population. No human intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. On the basis of the data provided, the Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of L. helveticus CNCM I-1722, B. longum subsp. infantis CNCM I-3424, B. bifidum CNCM I-3426 and fructo-oligosaccharides from sucrose and contribution to immune defence against pathogens. © European Food Safety Authority, 2012
Słowa kluczowe: Bifidobacterium longum subsp   Lactobacillus helveticus CNCM I-1722  
ID:    3016  
Produkty: Symbiotyk: Lactobacillus helveticus CNCM I-1722, Bifidobacterium bifidum CNCM I-3426, Bifidobacterium infantis CNCM I-3424, fruktoligosacharydys z sacharozy  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is a combination of Lactobacillus helveticus CNCM I-1722, Bifidobacterium infantis CNCM I-3424 and Bifidobacterium bifidum CNCM I-3426 in the ratio of 6:2:2. The product also contains fructo-oligosaccharides (750 mg/sachet).
The strain L. helveticus CNCM I-1722 is also known as L. helveticus R0052. A culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM I-1722) was provided. The CNCM is a restricted-access non-public collection, which has the status of an International Depositary Authority under the Budapest Treaty. Data on the identification and characterisation of L. helveticus CNCM I-1722 at species and strain level, by using both phenotypic (cell morphology, colony morphology, carbohydrate fermentation pattern, enzymatic activity profile, PAGE) and genotypic (DNA-DNA hybridisation, 16S rRNA gene sequence analysis, 16S/23S intergenic spacer region sequence analysis, AFLP, MLST, RAPD, PFGE) methods, were provided in the application for further assessment and in the accompanying references (Naser et al., 2006). The Panel considers that the strain L. helveticus CNCM I-1722 is sufficiently characterised.
The strain B. infantis CNCM I-3424 is also known as B. infantis R0033. A culture collection number from the CNCM, I-3424, was provided. The species B. infantis has been reclassified as a subspecies of B. longum, i.e. B. longum subsp. infantis (Mattarelli et al., 2008). Data on the identification and characterisation of B. infantis CNCM I-3424 at species and strain level, by using both phenotypic (cell morphology, colony morphology, carbohydrate fermentation pattern, enzymatic activity profile) and genotypic (16S rRNA gene sequence analysis, elongation factor tuf gene sequence analysis, RAPD, PFGE) methods, were provided in the application for further assessment and in the accompanying references (Cazzola et al., 2010a). The Panel considers that the strain B. longum subsp. infantis CNCM I-3424 is sufficiently characterised.
The strain B. bifidum CNCM I-3426 is also known as B. bifidum R0071. A culture collection number from the CNCM, I-3426, was provided. Data on the identification and characterisation of B. bifidum CNCM I-3426 at species and strain level, by using both phenotypic (cell morphology, colony morphology, carbohydrate fermentation pattern, enzymatic activity profile) and genotypic (16S rRNA gene sequence analysis, elongation factor tuf gene sequence analysis, RAPD, PFGE) methods, were provided in the application for further assessment and in the accompanying references (Cazzola et al., 2010a). The Panel considers that the strain B. bifidum CNCM I-3426 is sufficiently characterised.
From the references provided, the Panel assumes that the fructo-oligosaccharides (FOS) are obtained from sucrose. They are prepared by enzymatic elongation of sucrose, and consist of a mixture of kestose (glucose-fructose-fructose, GF2), nystose (GF3) and fructosylnystose (GF4), with an average degree of polymerisation (DPav) of 3.6, and are sometimes referred to as short-chain fructo-oligosaccharides. FOS from sucrose differ from natural fructans by degree of polymerisation (DP) (only 10 % of native chicory inulin have a DP between 2 and 5) (Roberfroid, 2007), and differ from oligofructose prepared by inulin hydrolysis (DP from 2 to 7, DPav 4) by the presence of a glucose moiety.
The Panel considers that the food constituent, a combination of L. helveticus CNCM I-1722, B. longum subsp. infantis CNCM I-3424, B. bifidum CNCM I-3426 and fructo-oligosaccharides from sucrose, 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 “helps to stimulate the immune system and thereby decreases the risk of occurrence of common infectious diseases”. The proposed target population is the general population.
The Panel assumes that the claimed effect refers to contribution to immune defence against pathogens. The Panel considers that contribution to immune defence against pathogens is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Udział w obronie immunologicznej organizmu przeciwko patogenom

The references provided in relation to the claim included one human study, one meta-analysis of human studies, animal studies, in vitro studies and general review articles. Of these references, many were not related to the combination of food constituents which is the subject of the claim, or they addressed characterisation aspects of the microorganisms. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
One human intervention study (Cazzola et al., 2010b) and one animal study (Cazzola et al., 2010a) were carried out with the combination which is the subject of the health claim, consisting of L. helveticus CNCM I-1722, B. infantis CNCM I-3424 and B. bifidum CNCM I-3426 in the ratio of 6:2:2, with a total bacterial count ≥3 x 109 CFU and 750 mg FOS from sucrose.
In a multicentre, randomised, double-blind, placebo-controlled, parallel intervention study, Cazzola et al. (2010b) assessed the effect of consumption of the combination of bacterial strains and fructo-oligosaccharides, which is the subject of the claim, during a winter period (December – March) on the incidence of infections in 135 children (mean age 4.1±1.0 years) who had suffered from at least three episodes of ear, nose and throat infections, other respiratory tract infections or gastro-intestinal infections in the previous winter. The children were randomised in blocks of six to consume either the intervention (n=62) or the placebo (starch, n=73) for three months. All health problems of any type were recorded by parents in a diary. The primary outcome was the percentage of children who suffered from at least one health problem of any nature during the intervention period. Secondary outcomes comprised the percentages of children suffering from at least one health problem characterised by respiratory or gastro-intestinal symptoms, the percentage of children with at least one febrile episode, the number of reported health problems per included child, and the percentage of children with at least one health problem causing one or more days of school loss. The Panel notes that no information was provided on the diagnostic criteria and on the validity of diaries used to assess the incidence of infections, and that the evidence provided did not establish that the outcome measures used in this study were appropriate measures of infections in the study population. The Panel also notes that no information was provided in the publication about the use of rescue medication, which may have confounded the results and that different type of health problems were considered together. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
One animal study (Cazzola et al., 2010a) explored the mechanisms by which the combination of bacterial strains and fructo-oligosaccharides which is the subject of the claim could exert an effect on the response to infections by measuring serum levels of pro- and anti-inflammatory cytokines in a rat model. The Panel considers that in the absence of evidence for an effect on immune defence against pathogens in humans, evidence provided in this animal study cannot be used for the scientific substantiation of a claim on immune defence against pathogens.
The Panel notes that no human intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of L. helveticus CNCM I-1722, B. longum subsp. infantis CNCM I-3424, B. bifidum CNCM I-3426 and fructo-oligosaccharides from sucrose and contribution to immune defence against pathogens.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, a combination of L. helveticus CNCM I-1722, B. longum subsp. infantis CNCM I-3424, B. bifidum CNCM I-3426 and fructo-oligosaccharides from sucrose, which is the subject of the health claims, is sufficiently characterised.
The claimed effect proposed for further assessment is “helps to stimulate the immune system and thereby decreases the risk of occurrence of common infectious diseases”. The proposed target population is the general population. Contribution to immune defence against pathogens is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of a combination of L. helveticus CNCM I-1722, B. longum subsp. infantis CNCM I-3424, B. bifidum CNCM I-3426 and fructo-oligosaccharides from sucrose and contribution to immune defence against pathogens.