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. 2017 Jul 21;15(7):e04913. doi: 10.2903/j.efsa.2017.4913. eCollection 2017 Jul.
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 cholesterol concentrations. 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 cholesterol levels'. The Panel considers that maintenance of normal blood cholesterol concentrations 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 cholesterol concentration.
洛特罗伊集团依据欧盟法规（EC）No 1924/2006第13(5)条，通过荷兰主管当局提交了一份关于健康声称授权的申请，欧洲食品安全局营养产品、营养与过敏专家组（NDA）被要求就与Vibigaba（发芽糙米）相关的健康声称及对维持正常血液胆固醇浓度的贡献提供科学依据的意见。该申请的范围拟属于基于新科学证据的健康声称。申请人提议作为健康声称主题的食品是Vibigaba。专家组认为发芽糙米Vibigaba具有充分的特征描述。申请人声称的效果是“有助于维持正常血液胆固醇水平”。专家组认为维持正常血液胆固醇浓度是一种有益的生理效应。专家组指出，申请人未进行全面的文献检索以确定可能与该声称相关的人体干预研究。申请人未回复欧洲食品安全局要求提供此信息的具体请求。申请人确定了一项与该声称相关的人体干预研究。专家组注意到该研究存在重要的方法学局限性（例如用于数据分析的统计方法不适用于研究设计），且关于该研究设计和实施所提供的信息不足以进行全面的科学评估。专家组认为无法从该研究得出关于该声称科学依据的结论。专家组得出结论，食用Vibigaba（发芽糙米）与维持正常血液胆固醇浓度之间尚未建立因果关系。
