ID 913 -
Saccharomyces cerevisiae var. boulardii CNCM I-1079
PL: Saccharomyces cerevisiae var. boulardii CNCM I-1079
EN: Sacharomyces cerevisiae var boulardii
Pdf: Saccharomyces cerevisiae var. boulardii CNCM I-1079
1. Charakterystyka żywności / składnika
Introduction on the process used for characterisation of food constituents that are microorganisms: Microorganisms or microbes (e.g. bacteria) are living organisms, and can change over time depending on culture conditions. Correct identification of the microorganism‟s species and strain is of critical importance, as the observed effects are species and strain specific. The appropriate classification, identification and nomenclature of microorganisms constitute the starting point for the assessment of microbial properties. Classification assigns an organism to a known taxonomic group according to its similarity to that group. This allows the prediction of the properties of the microorganism on the basis of what is already known about the taxa. A reliable identification confirms the identity of the strain(s) used in a given process and requires the use of appropriate methods. Traditional phenotypic identification of bacteria is not always reliable since certain species cannot be distinguished by these methods. Molecular techniques have emerged in recent years as a replacement or complement to traditional phenotypic tests. DNA-DNA hybridization has become the generally accepted standard for determination of bacterial species identification. However this technique is difficult to perform and requires an expertise not normally present in the food industry. For these reasons phylogenetically based approaches such as sequence analysis of the 16S rRNA gene has proven to be a useful tool for bacterial identification. The EU-funded PROSAFE project concluded that biochemical tests should not be used as a stand-alone approach for identification of bacterial cultures (Vankerckhoven et al., 2008). The use of 16S rRNA gene sequence analysis was considered the best tool for routine species identification. Moreover, the use of sequence-based methods, such as 16S rRNA gene sequencing, was encouraged given their high reproducibility and data exchangeability (Vankerckhoven et al., 2008). The FAO/WHO expert group (FAO, 2006) recommends that phenotypic tests should be done first, followed by genetic identification, using methods such as DNA-DNA hybridization or 16S rRNA sequence analysis. Nevertheless, it is important to underline that in some cases 16S rRNA sequencing has a limited resolution and it may not be enough for discrimination of closely related species (Felis and Dellaglio, 2007; Vankerckhoven et al., 2008) being necessary to use other methods.
For the strain identification (characterisation of the strain by genetic typing), the FAO/WHO working group also recommended that strain typing has to be performed with a reproducible genetic method or using a unique phenotypic trait (FAO, 2006). DNA macrorestriction followed by Pulsed Field Gel Electrophoresis (PFGE) is considered as the generally accepted standard (FAO, 2006) and it has been extensively used for differentiating commercial microorganism strains. Other discriminatory molecular methods, such as Randomly Amplified Polymorphic DNA (RAPD) or Amplified rDNA restriction analysis (ARDRA) among others, are also available for strain characterisation. Hence, species identification and sufficient characterisation (genetic typing) at strain level by using internationally accepted molecular methods is needed. In addition, strains should be named according to the International Code of Nomenclature. Although there is no direct requirement on deposition of the particular strain in an internationally recognised culture collection, the FAO/WHO (FAO, 2006) recommends that strains should also be deposited in an internationally recognised culture collection (with access number). These will assure the tracking and access of scientists and regulatory authorities to the strain and related information in case it is needed. In the context of the Regulation (EC) nº 1924/2006, the purposes of characterisation are to confirm the identity of the food/constituent that is the subject of the health claim, and to establish that the studies provided for substantiation of the health claim were performed with the food/constituent in respect of which the health claim is made. Although not required for substantiation of a claim, characterisation should also be sufficient to allow control authorities to verify that the food/constituent which bears a health claim is the same one that was the subject of a community authorisation. The Panel has decided to use the following criteria for characterisation of food constituents that are microorganisms, which are the subject of health claims:
Species identification by DNA-DNA hybridization or 16S rRNA sequence analysis.
Strain identification by DNA macrorestriction followed by PFGE, RAPD, ARDRA or other internationally accepted genetic typing molecular methods.
Only when these two criteria were fulfilled, the microorganism was considered to be sufficiently characterised. In case of combination of several microorganisms, the Panel considers that if one microorganism used in the combination is not sufficiently characterised, the combination proposed is not sufficiently characterised. The characterisation of food constituents that are microorganisms, which are the subject of health claims pursuant to Article 13 of the Regulation (EC) nº 1924/2006, is based on evaluation of available references up to 31 December 2008, including the following:
The information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders;
Generally available data obtained by searching PubMed and Web of Science databases by using the strain name as search term.
1.21. Characterisation of “Saccharomyces cerevisiae var boulardii” (ID 913)
The food constituent that is the subject of the health claim is Saccharomyces cerevisiae var boulardii. No strain identification or name is provided. The Panel considers that Saccharomyces cerevisiae var boulardii, which is the subject of the health claim ID 913, is not 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.
Warunki i możliwe ograniczenia stosowania oświadczenia
at least 4x109 cfu/ day