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

Dominique Turck, EFSA NDA Panel

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Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of the Netherlands, the EFSA Panelon 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 maintenance of long-term normal blood glucose concentration. 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 Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is contribution to the maintenance of normal glycated haemoglobin level'. The Panelconsiders that maintenance of long-term normal blood glucose concentration is a beneficial physiological effect. The Panelnotes 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 Panelnotes 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 Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration.
Originalspråkengelska
Artikelnummer4916
TidskriftEFSA Journal
Volym15
Utgåva7
Antal sidor9
ISSN2314-9396
DOI
StatusPublicerad - 21 jul 2017
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title = "Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006",
abstract = "Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of the Netherlands, the EFSA Panelon 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 maintenance of long-term normal blood glucose concentration. 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 Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is contribution to the maintenance of normal glycated haemoglobin level'. The Panelconsiders that maintenance of long-term normal blood glucose concentration is a beneficial physiological effect. The Panelnotes 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 Panelnotes 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 Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration.",
keywords = "416 Food Science, germinated brown rice , Vibigaba , blood glucose , HbA1c , health claim",
author = "Heinonen, {Irma Marina} and Dominique Turck and {EFSA NDA Panel}",
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Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. / Turck, Dominique; EFSA NDA Panel.

I: EFSA Journal, Vol. 15, Nr. 7, 4916, 21.07.2017.

Forskningsoutput: TidskriftsbidragArtikelVetenskaplig

TY - JOUR

T1 - Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

AU - Heinonen, Irma Marina

AU - Turck, Dominique

AU - EFSA NDA Panel

PY - 2017/7/21

Y1 - 2017/7/21

N2 - Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of the Netherlands, the EFSA Panelon 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 maintenance of long-term normal blood glucose concentration. 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 Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is contribution to the maintenance of normal glycated haemoglobin level'. The Panelconsiders that maintenance of long-term normal blood glucose concentration is a beneficial physiological effect. The Panelnotes 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 Panelnotes 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 Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration.

AB - Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of the Netherlands, the EFSA Panelon 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 maintenance of long-term normal blood glucose concentration. 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 Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is contribution to the maintenance of normal glycated haemoglobin level'. The Panelconsiders that maintenance of long-term normal blood glucose concentration is a beneficial physiological effect. The Panelnotes 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 Panelnotes 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 Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration.

KW - 416 Food Science

KW - germinated brown rice

KW - Vibigaba

KW - blood glucose

KW - HbA1c

KW - health claim

U2 - 10.2903/j.efsa.2017.4916

DO - 10.2903/j.efsa.2017.4916

M3 - Article

VL - 15

JO - EFSA Journal

JF - EFSA Journal

SN - 2314-9396

IS - 7

M1 - 4916

ER -