植物和微生物来源新型食品的安全性评价指南(Safety Assessment of Novel Foods Derived from Plants and Microorganisms)

　　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

　　4.1.1 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

　　Appendix A: Nutrition Considerations - Key micronutrients （vitamins and minerals）
      
        具体内容见附件：   植物和微生物来源的新型食品安全性评价指南.pdf