欧洲纤维创新研究协会电子基础信息系统：保健声称提交与评估的应用。

EuroFIR eBASIS: application for health claims submissions and evaluations.

机构信息

School of Food and Nutritional Sciences, University College Cork, Ireland.

出版信息

Eur J Clin Nutr. 2010 Nov;64 Suppl 3:S101-7. doi: 10.1038/ejcn.2010.219.

DOI:10.1038/ejcn.2010.219

PMID:21045837

Abstract

BACKGROUND

The European Food Information Resource (EuroFIR) network has established the eBASIS (Bioactive Substances in Food Information System) online food composition and biological effects database for plant-derived bioactive compounds (phytochemicals). On the basis of submitted evidence, the European Food Safety Authority (EFSA) expert panel on Dietetic Products, Nutrition and Allergies assesses whether claims made under articles 13.1, 13.5 or 14 of the Regulation (EC) 1924/2006, which governs the use of nutrition and health claims on foods, are scientifically justified. This report evaluates the eBASIS biological effects database in the preparation and evaluation of health claims dossiers.

METHODS

The eBASIS biological effects database is a compilation of expert-evaluated data extracted from the literature, prioritizing human intervention studies to investigate health effects of phytochemicals. Currently included are >750 records from 445 studies providing data on 56 validated biomarkers, mainly relating to cardio-metabolic and bone health outcomes. The data cover 144 bioactive compounds from 17 compound classes. Using the EFSA Register of Questions and the database of general function health claims, we identified claims relating to phytochemicals made under articles 13.1, 13.5 and 14 and compared them with the eBASIS database to identify overlap between them.

RESULTS

The EFSA online health claims database contains 4240 submissions under article 13.1, of which 2157 pertain to plants or plant-based bioactive compounds; 496 of these relate to plants or bioactive compounds included in the eBASIS biological effects database. Out of the 18 current 13.5 'new function' claims on EFSA's register of questions, 7 are for plants or plant-based bioactive compounds, of which 6 are included in eBASIS. Of the 222 defined article 14 claims, 21 pertain to plants or plant-based bioactive compounds, of which 19 are in eBASIS.

CONCLUSIONS

There is extensive overlap between eBASIS and the submitted health claims that relate to plant-based bioactive compounds. EuroFIR eBASIS is a useful tool for regulators to independently check completeness of health claims applications relating to phytochemicals and is a potentially valuable resource to assist claimants in the compilation of dossiers on functional foods and health claims.

摘要

背景

欧洲食品信息资源（EuroFIR）网络建立了 eBASIS（食品中生物活性物质信息系统）在线食品成分和生物效应数据库，用于植物源性生物活性化合物（植物化学物质）。根据提交的证据，欧盟食品安全局（EFSA）营养产品、营养和过敏专家组评估根据法规（EC）1924/2006 第 13.1、13.5 或 14 条提出的声称是否具有科学依据，该法规管理食品营养和健康声称的使用。本报告评估了 eBASIS 生物效应数据库在准备和评估健康声称文件包方面的作用。

方法

eBASIS 生物效应数据库是从文献中提取的专家评估数据的汇编，优先考虑人类干预研究，以调查植物化学物质对健康的影响。目前包括来自 445 项研究的超过 750 条记录，提供了 56 个已验证生物标志物的数据，主要与心血管代谢和骨骼健康结果有关。该数据库涵盖了 17 个化合物类别中的 144 种生物活性化合物。使用 EFSA 问题登记册和一般功能健康声称数据库，我们确定了根据第 13.1、13.5 和 14 条提出的与植物化学物质有关的声称，并将其与 eBASIS 数据库进行了比较，以确定它们之间的重叠。

结果

EFSA 在线健康声称数据库包含 4240 条根据第 13.1 条提交的声明，其中 2157 条涉及植物或植物源性生物活性化合物；其中 496 条涉及 eBASIS 生物效应数据库中包含的植物或生物活性化合物。在 EFSA 问题登记册上的 18 项现行第 13.5 条“新功能”声称中，有 7 项涉及植物或植物源性生物活性化合物，其中 6 项涉及 eBASIS。在 222 项定义明确的第 14 条声称中，有 21 项涉及植物或植物源性生物活性化合物，其中 19 项在 eBASIS 中。