Chapter 2 - Data Requirements for Single Ingredient Approval and Feed Registration

Complete chapter

Table of Contents

• 2.1 Registration Checklist for Standard Mixed Feeds
• 2.2 Registration Requirements for Specialty Products
• 2.3 Single Ingredient Feed Evaluation Requirements
• 2.4 Generic Data Requirements for Safety Evaluations of Single Ingredients
• 2.5 Data Requirements for Product Safety Evaluations: Explanatory Notes
  • 1.0 Identification and Use of the Product
  • 2.0 Chemical Components including Contaminants and Impurities
  • 3.0 Method(s) of Analysis, Recovery, and Detection Limit Data for the Analyses
  • 4.0 Physicochemical Data
  • 5.0 Mammalian Toxicological Data
  • 6.0 Suggested Maximum Residue Limit (MRL) or Tolerance
  • 7.0 Human Exposure Data and Exposure Estimation
  • 8.0 Livestock Metabolic Fate and Residue Studies
  • 9.0 Environmental Fate and Effects
• 2.6 Guidelines for the Assessment of Novel Feeds: Plant Sources
  • 1.0 Introduction
  • 2.0 Characterization of the Plant Source
  • 3.0 Nutritional Data
  • 4.0 Dietary Exposure
  • 5.0 Toxicology Data
  • 6.0 Allergenicity Data
  • 7.0 Laboratory Animal/Livestock Feeding Trials
  • 8.0 Evaluation of Environmental Safety
  • 9.0 Method of Detection and Identification Requirements
  • 10.0 Regulatory Decision
  • 11.0 Posting of Decision
  • 12.0 New Information Requirements
  • 13.0 Definitions
  • 14.0 References
  • Appendix I: Molecular Characterization Requirements for Feeds with Novel Traits Derived from Plants Developed using Recombinant DNA Techniques
  • Appendix II: Novelty Determination Guidance
• 2.7 Guidelines for the Assessment of Novel Feeds: Microbial Sources