RG-1 Regulatory guidance:
Chapter 2 - Data requirements for single ingredient approval and feed registration
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2.1 Process to streamline approvals for category 1 feed registrations
- Requirements and checklist for streamlined approvals of category 1 feeds
- Appendix 1 – Label requirements for new and significant changes to standard mixed feeds listed in items 1-6 of schedule I table 3 of the Feeds Regulations, 1983
- Appendix 2 – Label requirements for simple mixtures and dilutions of single-ingredient feeds only containing ingredients listed in schedule IV part I classes 1 to 7.1
- 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
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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
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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
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2.7 Guidelines for the assessment of novel feeds: microbial sources
- 1 Introduction
- 2 Characterization of the microbial product
- 3 Inactivation of antimicrobials in feed
- 4 Animal and human safety
- 5 Environmental safety
- 6 Regulatory decision
- 7 New information requirements
- 8 Definitions
- Appendix I: Description of toxicity/infectivity/pathogenicity tests
- Appendix II: Molecular data checklists
- Appendix III: Vector description
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Figure 1: Example of a detailed map of a plasmid vector
(from APHIS petition #94-257-01p) - References
- 2.8 Guidance on bridging an application to data from publicly available literature and previously approved feed applications
- 2.9 Data flexibility for production performance endpoints and associated claims
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