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Scientific Opinion on the substantiation of health claims related to a combination of Lactobacillus rhamnosus CNCM I-1720, Lactobacillus helveticus CNCM I-1722, Bifidobacterium longum subsp. longum CNCM I-3470 and Saccharomyces cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms (ID 3017, further assessment) 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 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 rhamnosus CNCM I-1720, Lactobacillus helveticus CNCM I-1722, Bifidobacterium longum subsp. longum CNCM I-3470 and Saccharomyces cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms. The food constituent that is the subject of the health claim, a combination of L. rhamnosus CNCM I-1720, L. helveticus CNCM I-1722, B. longum subsp. longum CNCM I-3470 and S. cerevisiae var. boulardii CNCM I-1079, is sufficiently characterised. The claimed effect which is proposed for further assessment, defence against pathogenic gastro-intestinal microorganisms, is a beneficial physiological effect. The proposed target population is the general population. No human intervention studies which investigated the effect of a combination of L. rhamnosus CNCM I-1720, L. helveticus CNCM I-1722, B. longum subsp. longum CNCM I-3470 and S. cerevisiae var. boulardii CNCM I-1079 were provided. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of L. rhamnosus CNCM I-1720, L. helveticus CNCM I-1722, B. longum subsp. longum CNCM I-3470 and S. cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms. © European Food Safety Authority, 2012
Słowa kluczowe: Bifidobacterium longum CNCM I-3470   Lactobacillus helveticus CNCM I-1722   Lactobacillus rhamnosus CNCM I-1720   Saccharomyces cerevisiae var  
ID:    3017  
Produkty: Lactobacillus helveticus CNCM I-1722, Lactobacillus rhamnosus CNCM I-1720, Bifidobacterium longum CNCM I-3470, Saccharomyces cerevisiae boulardii  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is a combination of Lactobacillus rhamnosus CNCM I-1720, Lactobacillus helveticus CNCM I-1722, Bifidobacterium longum subsp. longum CNCM I-3470 and Saccharomyces cerevisiae var. boulardii CNCM I-1079.
The formulation, which is the subject of the claim, contains the bacterial strains in a ratio of 1:1:1 in the form of lyophilised powders with a total amount of bacteria per capsule of 5 x 109 CFU. The amount of S. cerevisiae var. boulardii is 125 mg (corresponding to 2.5 x109 CFU) per capsule.
The strain L. rhamnosus CNCM I-1720 is also known as L. rhamnosus R0011. A culture collection number from the French National Collection of Cultures of Microorganisms (CNCM I-1720) 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. rhamnosus CNCM I-1720 at species and strain level, by using both phenotypic (cell morphology, colony morphology, carbohydrate fermentation pattern, enzymatic activity profile) and genotypic (DNA-DNA hybridisation, 16S rRNA gene sequence analysis, 16S/23S intergenic spacer region sequence analysis, strain-specific PCR, RAPD, PFGE) methods, were provided in the application for further assessment and in the accompanying references (Roy and Ward, 2004; Verdu et al., 2008; Yeung et al., 2002). The Panel considers that L. rhamnosus CNCM I-1720 is sufficiently characterised.
The strain L. helveticus CNCM I-1722 is also known as L. helveticus R0052. A culture collection number from the CNCM, I-1722, was provided. 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) and genotypic (DNA-DNA hybridisation, 16S rRNA gene sequence analysis, 16S/23S intergenic spacer region sequence analysis, species-specific PCR, AFLP, MLST, RAPD, PFGE) methods, were provided in
the application for further assessment and in the accompanying references (Naser et al., 2006; Verdu et al., 2008). The Panel considers that L. helveticus CNCM I-1722 is sufficiently characterised.
The strain B. longum subsp. longum CNCM I-3470 is also known as B. longum R0175. A culture collection number from the CNCM, I-3470, was provided. Data on the identification and characterisation of B. longum subsp. longum CNCM I-3470 at species and strain level, by using both phenotypic (cell morphology, colony morphology, carbohydrate fermentation pattern, enzymatic activity profile, antimicrobials resistance pattern) 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 (Mattarelli et al., 2008). The Panel considers that B. longum subsp. longum CNCM I-3470 is sufficiently characterised.
For S. cerevisiae var. boulardii CNCM I-1079 a culture collection number from the CNCM, I-1079, was provided. Data on phenotypic (morphological and biochemical analyses) and genotypic (RFLP analysis using a yeast DNA transposon probe for hybridisation, and PFGE and PCR delta sequence analysis) characterisation of S. cerevisiae var. boulardii CNCM I-1079 were provided in the application for further assessment. The Panel considers that S. cerevisiae var. boulardii CNCM I-1079 is sufficiently characterised.
The Panel considers that the food constituent, a combination of L. rhamnosus CNCM I-1720, L. helveticus CNCM I-1722, B. longum subsp. longum CNCM I-3470 and S. cerevisiae var. boulardii CNCM I-1079, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect, which is proposed for further assessment, refers to “helps to fight against gastro-intestinal (GI) pathogens”. The proposed target population is the general population.
The presence of pathogenic micro-organisms in the gastro-intestinal tract (e.g. viruses and bacteria) may lead to the development of gastro-intestinal infections. Defence against pathogenic gastro-intestinal microorganisms may protect against the development of gastro-intestinal infections.
The Panel considers that defence against pathogenic gastro-intestinal microorganisms is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Obrona przeciwko chorobotwórczym patogenom w przewodzie pokarmowym

The references provided in relation to this claim included human intervention studies, meta-analyses, animal studies, in vitro studies, publications on characterisation aspects and one review paper.
The human, animal or in vitro studies provided investigated the effects of S. cerevisiae var. boulardii, the effects of individual bacterial strains or pairs of bacterial strains, which are part of the food constituent that is the subject of the claim, or combinations of microorganisms other than the combination of strains that is the subject of the claim.
No human intervention studies which investigated the effect of a combination of L. rhamnosus CNCM I-1720, L. helveticus CNCM I-1722, B. longum subsp. longum CNCM I-3470 and S.cerevisiae var. boulardii CNCM I-1079 were provided.
The Panel considers that, in the absence of evidence for an effect of the combination of L. rhamnosus CNCM I-1720, L. helveticus CNCM I-1722, B. longum subsp. longum CNCM I-3470 and S. cerevisiae var. boulardii CNCM I-1079 in humans, the studies on the effects of individual constituents provided cannot be used for substantiation of a claim on the combination. The Panel
considers that no conclusions can be drawn from the references provided on the individual strains 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. rhamnosus CNCM I-1720, L. helveticus CNCM I-1722, B. longum subsp. longum CNCM I-3470 and S. cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, a combination of L. rhamnosus CNCM I-1720, L. helveticus CNCM I-1722, B. longum subsp. longum CNCM I-3470 and S. cerevisiae var. boulardii CNCM I-1079, which is the subject of the health claim, is sufficiently characterised.
The claimed effect proposed for further assessment relates to defence against pathogenic gastro-intestinal microorganisms. The proposed target population is the general population. Defence against pathogenic gastro-intestinal microorganisms is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of a combination of L. rhamnosus CNCM I-1720, L. helveticus CNCM I-1722, B. longum subsp. longum CNCM I-3470 and S. cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms.