EFSA Journal (Jul 2012)
Scientific Opinion on the substantiation of a health claim related to <em>Saccharomyces cerevisiae</em> var. <em>boulardii</em> CNCM I-3799 and reducing gastro-intestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006
Abstract
<p>Following an application from Lesaffre International/Lesaffre Human Care, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to <em>Saccharomyces cerevisiae</em> var. <em>boulardii</em> CNCM I-3799 and reducing gastro-intestinal discomfort. The food constituent that is the subject of the health claim, <em>S. cerevisiae</em> var. <em>boulardii</em> CNCM I-3799, is sufficiently characterised. The claimed effect, reduction of gastro-intestinal discomfort, is a beneficial physiological effect. The target population proposed by the applicant is subjects from 18 to 74 years old with bowel discomfort. The Panel notes that none of the studies provided for the substantiation of the claim was conducted with the strain which is the subject of the claim (<em>S. cerevisiae </em>var<em>. boulardii </em>CNCM I-3799), except for two animal studies and one <em>in vitro</em> study. Upon an EFSA request, the applicant indicated that the rest of the studies provided were conducted with the strain produced by Biocodex Laboratories (<em>S. cerevisiae </em>var. <em>boulardii </em>HANSEN CBS 5926). The applicant also stated that the strain, which is the subject of the claim, <em>S. cerevisiae </em>var<em>. boulardii </em>CNCM I-3799, is equivalent to <em>S. cerevisiae </em>var<em>. boulardii </em>HANSEN CBS 5926, based on a comparative PCR inter-delta element analysis of both strains provided in the application. The Panel considered that the evidence provided was insufficient to establish that the strains <em>S. cerevisiae</em> var. <em>boulardii</em> CNCM I-3799 and HANSEN CBS 5926 are identical and, upon EFSA request for further information, additional evidence was not provided by the applicant. A cause and effect relationship cannot be established between the consumption of <em>S. cerevisiae</em> var. <em>boulardii</em> CNCM I-3799 and reducing gastro-intestinal discomfort.</p>
Keywords
