Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms (DRAFT)

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Introduction | Guidelines | Part 1 | Part 2 | Part 3 | Appendix 1 | Appendix 2 | Appendix 3

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Table of Contents

1. Introduction
1.1 Background
1.2 Purpose of Guidelines
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 Harmonization of Regulatory Approvals for Novel Foods and Novel Feeds derived from Plants with Novel Traits
3.4 Post-Market Information

4. Information Requirements for Safety Assessment
4.1 Novel Foods Derived From Plants

4.2 Novel Foods Derived from Microorganisms

Appendix A: Nutrition Considerations - Key micronutrients (vitamins and minerals)