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.

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 / C.V. Agostoni, J.L. Bresson, S. Fairweather Tait, A. Flynn, I. Golly, H. Korhonen, P. Lagiou, M. Løvik, R. Marchelli, A. Martin, B. Moseley, M. Neuhäuser Berthold, H. Przyrembel, S. Salminen, Y. Sanz, S. Strain, S. Strobel, I. Tetens, D. Tomé, H. van Loveren, H. Verhagen. - In: EFSA JOURNAL. - ISSN 1831-4732. - 8:2(2010). [10.2903/j.efsa.2010.1470]

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

C.V. Agostoni
Primo
;
2010

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 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.
Microorganisms ; bacteria ; yeasts ; species ; strain ; characterisation ; scientific substantiation ; health claims
Settore MED/49 - Scienze Tecniche Dietetiche Applicate
2010
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/155668
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