2717.pdf

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Scientific Opinion on the substantiation of health claims related to Saccharomyces cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms (ID 913, 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 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 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, Saccharomyces cerevisiae var. boulardii CNCM I-1079, is sufficiently characterised. The claimed effect, defence against pathogenic gastro-intestinal microorganisms, is a beneficial physiological effect. The proposed target population is the general population. The Panel notes that the evidence provided is not sufficient to establish that the strains Saccharomyces cerevisiae var. boulardii CNCM I-1079 and Saccharomyces cerevisiae var. boulardii Hansen CBS 5926, which were used in the studies provided, are identical, and considers that owing to the possibility that the effects are strain-specific, results obtained with one strain cannot be extrapolated to another strain. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of Saccharomyces cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms. © European Food Safety Authority, 2012
Słowa kluczowe: Saccharomyces cerevisiae var  
ID:    913  
Produkty: Saccharomyces cerevisiae var. boulardii CNCM I-1079  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Saccharomyces cerevisiae var. boulardii CNCM I-1079 (hereafter S. cerevisiae var. boulardii CNCM I-1079). 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.
Three references were also provided in the application related to the molecular techniques used for the identification and genetic typing of S. cerevisiae strains (Hennequin et al., 2001; Mallié et al., 2001; van der Aa Kühle and Jespersen, 2003), but none of them provided data on the strain that is the subject of the health claim, S. cerevisiae var. boulardii CNCM I-1079.
For S. cerevisiae var. boulardii CNCM I-1079, a culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) 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 production and quality controls (identity, purity, and biological and chemical safety) of the strain culture and the encapsulation process of S. cerevisiae var. boulardii CNCM I-1079 were provided.
The Panel considers that the food constituent, Saccharomyces cerevisiae var. boulardii CNCM I- 1079, 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, relates to defence against gastro-intestinal 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. Maintenance of defence against
pathogenic gastro-intestinal microorganisms may protect against gastro-intestinal infections and associated diarrhoea.
The Panel considers that defence against pathogenic gastro-intestinal microorganisms is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie obrony przed patogenami przewodu pokarmowego

The references provided included human studies which addressed the effect of S. cerevisiae var. boulardii on incidence of antibiotic-associated diarrhoea related to Clostridium difficile (Can et al., 2006; Lewis et al., 1998; McFarland et al., 1995; Surawicz et al., 1989); on Clostridium difficile recurrent diarrhoea (Surawicz et al., 2000); on antibiotic-associated diarrhoea related to candidiasis (Adam et al., 1977); on side-effects of Helicobacter pylori eradication therapy (Cindoruk et al., 2007; Cremonini et al., 2002; Duman et al., 2005); on traveller’s diarrhoea (Kirchhelle et al., 1996; Kollaritsch et al., 1989; Kollaritsch et al., 1993); on amoebiasis (Mansour-Ghanaei et al., 2003); on acute diarrhoea of unknown origin (Hochter et al., 1990); and four meta-analyses (D'Souza et al., 2002; McFarland, 2006, 2010; Szajewska and Mrukowicz, 2005). Animal studies, in vitro studies and a review paper were also provided. The Panel notes that the review submitted (Zanello et al., 2009) did not provide original data that can be used for the substantiation of the claim. The Panel also notes that in two animal studies (Girard et al., 2003; Sezer et al., 2009) models of diarrhoea of non-infectious origin were used, and that, therefore, they did not provide information that can be used for the scientific substantiation of a claim on defence against pathogens.
According to the application, the studies provided for the substantiation of the claim were conducted with the strain S. cerevisiae var. boulardii Hansen CBS 5926 from Biocodex, except for four studies in which the strain used was not specified. In two out of these four studies, the commercial brand name was mentioned (Perenterol®), which according to the application is manufactured by the owner of S. cerevisiae var. boulardii Hansen CBS 5926 (Kirchhelle et al., 1996; Kollaritsch et al., 1993), while the other two studies were conducted or sponsored by the company which owns S. cerevisiae var. boulardii Hansen CBS 5926 (Hochter et al., 1990; Surawicz et al., 2000).
In the application it was stated that “the strain S. cerevisiae var. boulardii CNCM I-1079 is genetically equivalent to S. boulardii CBS 5926 (also named S. cerevisiae var. boulardii Hansen CBS 5926 or ATCC 74012)” based on the genotypic analyses previously described in the characterisation section (RFLP analysis using a yeast DNA transposon probe for hybridisation and PFGE analysis) and submitted in the application.
The Panel notes that the evidence provided is not sufficient to establish that the strains S. cerevisiae var. boulardii CNCM I-1079 and S. cerevisiae var. boulardii Hansen CBS 5926 are identical, and that none of the studies provided for the scientific substantiation of the claim were conducted with the strain that is the subject of the claim (i.e. S. cerevisiae var. boulardii CNCM I-1079). The Panel considers that owing to the possibility that the effects are strain-specific, results obtained with one strain cannot be extrapolated to another strain.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Saccharomyces 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, Saccharomyces 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 gastro-intestinal pathogens. 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 Saccharomyces cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms.