Scientific Opinion on the substantiation of health claims related to
Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837) (ID 1010,
1011, 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 health claims pursuant to Article 13.1 of Regulation (EC) No 1924/2006
in the framework of further assessment related to Saccharomyces boulardii ATY-SB-101 and the following
claimed effects: "maintains and restores the natural flora" and "modulating both innate and adaptive host
immunity to respond against pathogen infection". The food constituent that is the subject of the claims,
Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837), is not sufficiently characterised. On the basis of
the data presented, the Panel concludes that a cause and effect relationship cannot be established between the
consumption of Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837) and the proposed claimed
effects.
© European Food Safety Authority, 2012
Słowa kluczowe:
ATY-SB-101
Saccharomyces boulardii
health claims
microorganisms
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837) related to the following claimed effects: "maintains and restores the natural flora" and "modulating both innate and adaptive host immunity to respond against pathogen infection".
A culture collection number from the Belgian Co-ordinated Collections of (Agro) Industrial Fungi and Yeast Collection (BCCM/MUCL) is provided (MUCL 53837). The BCCM/MUCL is an internationally recognised culture collection, which has the status of an International Depositary
Authority under the Budapest Treaty. In the MUCL, cultures can be deposited in a restricted-access collection for safe deposit or for patent purposes.
The identification of the strain ATY-SB-101, which is the subject of the claim, at species level (as S. cerevisiae) was based on phylogenetic analyses of rDNA sequences (the D1/D2 region and the 5.8S rDNA internal transcribe spacer [ITS] region) and the mitochondrial CytC gene sequence. The Panel notes that these analyses allow the identification of the strain ATY-SB-101 with the species S. cerevisiae but not the discrimination between S. cerevisiae and S. cerevisiae var. boulardii.
The characterisation of S. cerevisiae var. boulardii ATY-SB-101 at strain level was based on restriction analyses of two rDNA regions (ITS and 18S). The restriction analysis of the ITS region resulted in a unique DNA band, and that of the 18S rDNA in two bands. The Panel notes that comparative analysis of the DNA band profiles with those of a reference strain identified as S. cerevisiae var. boulardii, or references to publications showing the expected DNA profiles, were not provided, and therefore, it is not possible to conclude that the strain that is the subject of the claims (ATY-SB-101) can be identified as S. cerevisiae var boulardii.
Three references were provided in the application related to the use of phenotypic and genotypic techniques for the identification of S. cerevisiae strains (Fietto et al., 2004; van der Aa Kuhle and Jespersen, 2003; van der Aa Kuhle et al., 2005), but none of these included data related to the strain that is the subject of the health claims (ATY-SB-101).
The Panel considers that the food constituent, Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837), which is the subject of the health claims, is not sufficiently characterised.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837) and the proposed claimed effects.
