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Information Resource
Record information and status
Record ID
101221
Status
Published
Date of creation
2010-06-04 18:21 UTC (manoela.miranda@cbd.int)
Date of publication
2010-06-04 18:21 UTC (manoela.miranda@cbd.int)

General Information
Title
Guidelines for the Safety Assessment of Novel Foods
Author
Food Directorate Health Products and Food Branch, Health Canada
Language(s)
  • English
Publication date
2006-06
Subject
Summary, abstract or table of contents
Table of Contents

1. Introduction
1.1 Background
1.2 Purpose
1.3 Scope

2. Notification Procedure
2.1 Submission of a Novel Food Notification
2.2 Submission of a Safety Assessment Data Package
2.3 When to apply
2.4 Where to apply
2.5 Standard Operating Procedure

3. Other Regulatory Considerations
3.1 Environmental Impact
3.2 Plants with Novel Traits and Novel Feeds
3.3 Coordination of Regulatory Decisions for Novel Foods and
Novel Feeds derived from Plants with Novel Traits
3.4 New Information
3.5 Post-Market Monitoring

4. Information Requirements for Safety Assessment
4.1 Novel Foods Derived From Plants
4.1.1 Substance with No History of Safe Use
4.1.1.1 History of Use
4.1.1.2 Dietary Exposure
4.1.1.3 Nutritional Considerations
4.1.1.4 Toxicology Considerations
4.1.1.5 Allergenicity Considerations
4.1.1.6 Chemical Considerations

4.1.2 Novel Process
4.1.2.1 Details of Novel Process
4.1.2.2 Dietary exposure
4.1.2.3 History of Organism(s)
4.1.2.4 Nutritional Considerations
4.1.2.5 Toxicology Considerations
4.1.2.6 Allergenicity Considerations
4.1.2.7 Chemical Considerations

4.1.3 Genetic Modification
4.1.3.1 Characterization of Derived Line
4.1.3.2 Genetic Modification Considerations
4.1.3.3 History of Organism(s)
4.1.3.4 Dietary Exposure
4.1.3.5 Nutritional Considerations
4.1.3.6 Toxicology Considerations
4.1.3.7 Allergenicity Considerations
4.1.3.8 Chemical Considerations

4.2 Novel Foods Derived from Microorganisms
4.2.1 Substance with No Safe History of Use
4.2.1.1 History of Use
4.2.1.2 Dietary Exposure
4.2.1.3 Nutritional Considerations
4.2.1.4 Toxicology Considerations
4.2.1.5 Allergenicity Considerations
4.2.1.6 Chemical Considerations
4.2.1.7 Microbiological Considerations

4.2.2 Novel Process
4.2.2.1 Details of Novel Process
4.2.2.2 Dietary exposure
4.2.2.3 History of Organism(s)
4.2.2.4 Nutritional Considerations
4.2.2.5 Toxicology Considerations
4.2.2.6 Allergenicity Considerations
4.2.2.7 Chemical Considerations

4.2.3 Genetic Modification
4.2.3.1 Characterization of Derived Strain
4.2.3.2 Genetic Modification Considerations
4.2.3.3 History of Organism(s)
4.2.3.4 Dietary Exposure
4.2.3.5 Nutritional Considerations
4.2.3.6 Toxicology Considerations
4.2.3.7 Allergenicity Considerations
4.2.3.8 Chemical Considerations


Thematic areas
Additional Information
Type of resource
  • Article (journal / magazine / newspaper)
Publisher and its location
Health Canada