EuroFIR eBASIS: application for health claims submissions and evaluations
1School of Food and Nutritional Sciences, University College Cork, Ireland. M.Kiely@ucc.ie
European Journal of Clinical Nutrition
|November 4, 2010
Summary
The EuroFIR eBASIS database, containing phytochemical data, shows significant overlap with submitted health claims. This resource aids regulators and claimants in evaluating plant-based bioactive compound health claims.
Area of Science:
- Food Science
- Nutritional Science
- Toxicology
Background:
- The European Food Information Resource (EuroFIR) established the eBASIS database for plant-derived bioactive compounds (phytochemicals).
- The European Food Safety Authority (EFSA) assesses health claims for scientific justification.
- This report evaluates the eBASIS database for its role in health claims preparation and evaluation.
Purpose of the Study:
- To evaluate the eBASIS biological effects database for its utility in health claims dossiers.
- To identify the overlap between the eBASIS database and health claims related to phytochemicals submitted to EFSA.
Main Methods:
- Compiled expert-evaluated data from human intervention studies on phytochemicals in the eBASIS database.
- Included data on 56 biomarkers, 144 bioactive compounds, and 17 compound classes.
- Compared eBASIS data with EFSA's health claims register (articles 13.1, 13.5, and 14).
Main Results:
- Significant overlap was found between eBASIS and EFSA health claims concerning plant-based bioactive compounds.
- 496 of 2157 plant-related article 13.1 claims, 6 of 7 article 13.5 claims, and 19 of 21 article 14 claims were included in eBASIS.
- The eBASIS database contains data on 144 bioactive compounds from 17 classes, derived from 445 studies.
Conclusions:
- The eBASIS database demonstrates extensive overlap with health claims for plant-based bioactive compounds.
- eBASIS serves as a valuable tool for regulators to verify health claims completeness.
- The database can assist claimants in compiling dossiers for functional foods and health claims.
Related Concept Videos
Bioequivalence studies: Biowaivers
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Health Information Technology and Healthcare Information System
Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
Clinically Relevant Drug Product Specifications: Methods of Establishment
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
Integrated Healthcare System
An integrated healthcare system (IHS) is a set of organizations that provides for or arranges to provide coordinated and continuous service to a defined population. The IHS takes responsibility for that particular population's health status and outcome, both clinically and fiscally. An integrated healthcare system is a well-organized, well-coordinated, and collaborative network. The integrated delivery system is a network that connects different healthcare providers to deliver organized,...
Methods of Documentation V: CBE
Charting by Exception, or CBE, is a method of documentation used in healthcare, particularly in nursing, that focuses on documenting only significant or abnormal findings rather than recording every detail. This approach aims to streamline the documentation process, improve efficiency, and ensure that healthcare providers can quickly identify deviations from normalcy in patient assessments.
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...
Healthcare Agencies II
There are various healthcare agencies in the United States—some of which are managed by religious institutions and others by different government branches.
Parish nursing is a growing specialty nursing profession that focuses on holistic healthcare, health promotion, and illness prevention. It blends professional nursing practice with a health ministry, focusing on health and healing within the context of a Christian community. Parish nurses serve as health educators, referral sources, and lay...
Parish nursing is a growing specialty nursing profession that focuses on holistic healthcare, health promotion, and illness prevention. It blends professional nursing practice with a health ministry, focusing on health and healing within the context of a Christian community. Parish nurses serve as health educators, referral sources, and lay...

