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Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from H.J. Heinz Supply Chain Europe B.V. submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to delive...

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Autores principales: Turck, Dominique, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Kearney, John, Knutsen, Helle Katrine, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Bresson, Jean‐Louis, Siani, Alfonso
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009160/
https://www.ncbi.nlm.nih.gov/pubmed/32626282
http://dx.doi.org/10.2903/j.efsa.2019.5656
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author Turck, Dominique
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Kearney, John
Knutsen, Helle Katrine
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Pelaez, Carmen
Pentieva, Kristina
Thies, Frank
Tsabouri, Sophia
Vinceti, Marco
Bresson, Jean‐Louis
Siani, Alfonso
author_facet Turck, Dominique
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Kearney, John
Knutsen, Helle Katrine
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Pelaez, Carmen
Pentieva, Kristina
Thies, Frank
Tsabouri, Sophia
Vinceti, Marco
Bresson, Jean‐Louis
Siani, Alfonso
collection PubMed
description Following an application from H.J. Heinz Supply Chain Europe B.V. submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Nutrimune and immune defence against pathogens in the gastrointestinal (GI) tract and upper respiratory tract (URT). The food Nutrimune (a pasteurised cow's skim milk fermented with Lactobacillus paracasei CBA L74) which is the subject of the health claim is sufficiently characterised. The Panel considers that immune defence against pathogens in GI tract and URT is a beneficial physiological effect. Two human intervention studies were submitted as being pertinent to the claim, which were evaluated by the Panel in the previous application. One human intervention study from which conclusions could be drawn showed an effect of Nutrimune on immune defence against pathogens in the GI tract and the URT. The post hoc re‐analysis of the two human studies combined does not address the methodological limitations of the second study raised in the previous opinion, i.e. that the study was not planned, designed, randomised and analysed as a multicentre study, and that the large disparity of subjects in the three centres was not duly justified. The results from one animal study could support an effect of Nutrimune on defence against pathogens in the GI tract. No evidence was provided for a plausible mechanism by which Nutrimune could exert the claimed effect in vivo in humans. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of Nutrimune and immune defence against pathogens in the GI tract and URT.
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spelling pubmed-70091602020-07-02 Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 Turck, Dominique Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Kearney, John Knutsen, Helle Katrine Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pelaez, Carmen Pentieva, Kristina Thies, Frank Tsabouri, Sophia Vinceti, Marco Bresson, Jean‐Louis Siani, Alfonso EFSA J Scientific Opinion Following an application from H.J. Heinz Supply Chain Europe B.V. submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Nutrimune and immune defence against pathogens in the gastrointestinal (GI) tract and upper respiratory tract (URT). The food Nutrimune (a pasteurised cow's skim milk fermented with Lactobacillus paracasei CBA L74) which is the subject of the health claim is sufficiently characterised. The Panel considers that immune defence against pathogens in GI tract and URT is a beneficial physiological effect. Two human intervention studies were submitted as being pertinent to the claim, which were evaluated by the Panel in the previous application. One human intervention study from which conclusions could be drawn showed an effect of Nutrimune on immune defence against pathogens in the GI tract and the URT. The post hoc re‐analysis of the two human studies combined does not address the methodological limitations of the second study raised in the previous opinion, i.e. that the study was not planned, designed, randomised and analysed as a multicentre study, and that the large disparity of subjects in the three centres was not duly justified. The results from one animal study could support an effect of Nutrimune on defence against pathogens in the GI tract. No evidence was provided for a plausible mechanism by which Nutrimune could exert the claimed effect in vivo in humans. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of Nutrimune and immune defence against pathogens in the GI tract and URT. John Wiley and Sons Inc. 2019-04-15 /pmc/articles/PMC7009160/ /pubmed/32626282 http://dx.doi.org/10.2903/j.efsa.2019.5656 Text en © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Turck, Dominique
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Kearney, John
Knutsen, Helle Katrine
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Pelaez, Carmen
Pentieva, Kristina
Thies, Frank
Tsabouri, Sophia
Vinceti, Marco
Bresson, Jean‐Louis
Siani, Alfonso
Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title_full Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title_fullStr Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title_full_unstemmed Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title_short Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title_sort nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to article 14 of regulation (ec) no 1924/2006
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009160/
https://www.ncbi.nlm.nih.gov/pubmed/32626282
http://dx.doi.org/10.2903/j.efsa.2019.5656
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