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Vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on...

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Autores principales: Turck, Dominique, Bresson, Jean‐Louis, Burlingame, Barbara, Dean, Tara, Fairweather‐Tait, Susan, Heinonen, Marina, Hirsch‐Ernst, Karen Ildico, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Neuhäuser‐Berthold, Monika, Nowicka, Grażyna, Pentieva, Kristina, Sanz, Yolanda, Sjödin, Anders, Stern, Martin, Tomé, Daniel, Van Loveren, Henk, Vinceti, Marco, Willatts, Peter, Martin, Ambroise, Strain, John Joseph, Siani, Alfonso
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010181/
https://www.ncbi.nlm.nih.gov/pubmed/32625574
http://dx.doi.org/10.2903/j.efsa.2017.4914
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author Turck, Dominique
Bresson, Jean‐Louis
Burlingame, Barbara
Dean, Tara
Fairweather‐Tait, Susan
Heinonen, Marina
Hirsch‐Ernst, Karen Ildico
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Neuhäuser‐Berthold, Monika
Nowicka, Grażyna
Pentieva, Kristina
Sanz, Yolanda
Sjödin, Anders
Stern, Martin
Tomé, Daniel
Van Loveren, Henk
Vinceti, Marco
Willatts, Peter
Martin, Ambroise
Strain, John Joseph
Siani, Alfonso
author_facet Turck, Dominique
Bresson, Jean‐Louis
Burlingame, Barbara
Dean, Tara
Fairweather‐Tait, Susan
Heinonen, Marina
Hirsch‐Ernst, Karen Ildico
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Neuhäuser‐Berthold, Monika
Nowicka, Grażyna
Pentieva, Kristina
Sanz, Yolanda
Sjödin, Anders
Stern, Martin
Tomé, Daniel
Van Loveren, Henk
Vinceti, Marco
Willatts, Peter
Martin, Ambroise
Strain, John Joseph
Siani, Alfonso
collection PubMed
description Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood pressure. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is Vibigaba. The Panel considers that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is ‘contribution to the maintenance of normal blood pressure’. The Panel considers that maintenance of normal blood pressure is a beneficial physiological effect. The Panel notes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to the claim. The applicant did not reply to a specific request from EFSA to provide this information. The applicant identified one human intervention study as being pertinent to the claim. The Panel notes the important methodological limitations of the study (e.g. statistical methods used for data analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of normal blood pressure.
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spelling pubmed-70101812020-07-02 Vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Sjödin, Anders Stern, Martin Tomé, Daniel Van Loveren, Henk Vinceti, Marco Willatts, Peter Martin, Ambroise Strain, John Joseph Siani, Alfonso EFSA J Scientific Opinion Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood pressure. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is Vibigaba. The Panel considers that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is ‘contribution to the maintenance of normal blood pressure’. The Panel considers that maintenance of normal blood pressure is a beneficial physiological effect. The Panel notes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to the claim. The applicant did not reply to a specific request from EFSA to provide this information. The applicant identified one human intervention study as being pertinent to the claim. The Panel notes the important methodological limitations of the study (e.g. statistical methods used for data analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of normal blood pressure. John Wiley and Sons Inc. 2017-07-21 /pmc/articles/PMC7010181/ /pubmed/32625574 http://dx.doi.org/10.2903/j.efsa.2017.4914 Text en © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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
Bresson, Jean‐Louis
Burlingame, Barbara
Dean, Tara
Fairweather‐Tait, Susan
Heinonen, Marina
Hirsch‐Ernst, Karen Ildico
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Neuhäuser‐Berthold, Monika
Nowicka, Grażyna
Pentieva, Kristina
Sanz, Yolanda
Sjödin, Anders
Stern, Martin
Tomé, Daniel
Van Loveren, Henk
Vinceti, Marco
Willatts, Peter
Martin, Ambroise
Strain, John Joseph
Siani, Alfonso
Vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
title Vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
title_full Vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
title_fullStr Vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
title_full_unstemmed Vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
title_short Vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
title_sort vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to article 13(5) of regulation (ec) no 1924/2006
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010181/
https://www.ncbi.nlm.nih.gov/pubmed/32625574
http://dx.doi.org/10.2903/j.efsa.2017.4914
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