Scientific Opinion on the substantiation of health claims related to non characterised bacteria and yeasts pursuant to Article 13(1) of Regulation (EC) No 1924/2006
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Acknowledgment
The Panel wishes to thank for the preparation of this opinion: The members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. The members of the Claims Sub-Working Group on Gut/Immune: Miguel Gueimonde, Martinus Løvik, Bevan Moseley, Seppo Salminen, Yolanda Sanz, Stephan Strobel and Hendrik van Loveren.
Contact
nda@efsa.europa.eu
No abstract available
Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims related to microorganisms (bacteria and yeasts), for which the Panel considers that the data provided are not sufficient to demonstrate the characterisation of the microorganisms in question. The scientific substantiation is based on 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.
Correct identification of the bacterium’s and yeast’s species and strain is of critical importance, as the observed effects in the host are species and strain specific.
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. As indicated by the FAO/WHO (FAO/WHO, 2006), strains should also be deposited in an internationally recognised culture collection (with access number). 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.
Characterisation of bacteria - The Panel has decided to use the following criteria for characterisation of food constituents that are bacteria, which are the subject of health claims:
- Species identification by DNA-DNA hybridisation or 16S rRNA gene sequence analysis.
- Strain identification by DNA macrorestriction followed by pulsed-field gel electrophoresis (PFGE), randomly amplified polymorphic DNA analysis (RAPD), or other internationally accepted genetic typing molecular methods
Only when these two criteria were fulfilled, the bacterium was considered to be sufficiently characterised.
Characterisation of yeasts - The Panel has decided to use the following criteria for characterisation of food constituents that are yeasts, which are the subject of health claims:
- Species identification by restriction fragment length polymorphism analysis (RFLP) (e.g. RFLP of PCR products of the 5.8S rDNA internal transcribe spacer [ITS] region) or by sequencing analysis of DNA taxonomic markers (e.g. the D1 and D2 domains of 26S rDNA or ITS regions).
- Strains identification by chromosome length polymorphism analysis by PFGE, RAPDs, microsatellite DNA polymorphism analysis or other internationally accepted genetic typing molecular techniques
Only when these two criteria were fulfilled, the yeast was considered to be sufficiently characterised.
In the case of combination of several bacteria and/or yeasts, the Panel considers that if one microorganism used in the combination is not sufficiently characterised, the combination proposed is not sufficiently characterised.
Based on these criteria, the Panel considers that the bacteria and yeasts and combination thereof covered in this opinion, are not sufficiently characterised.
As the data available are insufficient to characterise the bacteria/yeasts/combination thereof addressed in this opinion, and that owing to the strain-specificity of the effects, the evidence obtained for one strain cannot be extrapolated to another, the Panel concludes that a cause and effect relationship has not been established between the consumption of the bacteria/yeasts/combination addressed in this opinion and their claimed effects.
Microorganisms, bacteria, yeasts, species, strain, characterisation, scientific substantiation, health claims
