RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.1 Guidance on data requirements to complete Sections 9, 10, 11 and 12 of the feed approval or registration application

Existing regulatory guidance documents are found on the Canadian Food Inspection Agency (CFIA) website for the approval or registration of various feed types. These outline the data requirements needed to complete Sections 9, 10, 11 and 12 of your feed approval or registration application.

• Section 9 Guidance on data requirements to establish the identification, the characterization and conditions of use of the feed, and methods of analysis of the feed
• Section 10 Guidance on data requirements to establish the safety of the livestock feed
• Section 11 Guidance on data requirements to establish the efficacy of the livestock feed
• Section 12 Novel Feed from animal or plant sources with a novel trait

Other references may offer additional support in completing these sections and can be found on external websites such as:

• International Cooperation for Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF)
• Organisation for Economic Co-operation and Development (OECD)

Section 9 Guidance on data requirements to establish the identification, the characterization and conditions of use of the feed, and methods of analysis of the feed

• CFIA – Chapter 2.3 Single Ingredient Feed Evaluation Requirements
• ICCF – Guidance Document #04 Manufacturing Process and Specification – PDF (788 kb)
• CFIA – Chapter 2.7 Guidelines for the assessment of novel feeds: microbial sources
• CFIA – Chapter 6 – Sampling and Laboratory Requirements
• ICCF – Guidance Document #01 Stability Testing of Feed ingredients – PDF (471 kb)
• ICCF – Guidance Document #03 Homogeneity Testing of Feed Ingredients – PDF (535 kb)

Section 10 Guidance on data requirements to establish the safety of the livestock feed

• CFIA – Chapter 2.3 Single Ingredient Feed Evaluation Requirements
• CFIA – Chapter 2.4 Generic Data Requirements for Safety Evaluations of Single Ingredients
• CFIA – Chapter 2.7 Guidelines for the assessment of novel feeds: microbial sources
• CFIA – Chapter 2.8 Guidance on bridging an application to data from publicly available literature and previously approved feed applications
• ICCF – Guidance Document #05 Genotoxicity Testing – PDF (600 kb)
• ICCF – Guidance Document #02 – Sub-Chronic Oral Toxicity Testing in Laboratory Animals – PDF (608 kb)

Section 11 Guidance on data requirements to establish the efficacy of the livestock feed

• CFIA – Chapter 2 item 5 2.2 Registration Requirements for Specialty Products
• CFIA – Chapter 2.8 Guidance on bridging an application to data from publicly available literature and previously approved feed applications
• CFIA – Chapter 2.9 Data flexibility for production performance endpoints and associated claims
• EFSA – EFSA Guidance on the assessment of the efficacy of feed additives. Note: the CFIA is in the process of developing guidance for the efficacy data requirements of livestock feeds. In the interim, EFSA guidance can offer support to assist applicants in their application process.

Section 12 Novel Feed from animal or plant sources with a novel trait

• CFIA – Chapter 2.6 Guidelines for the assessment of novel feeds: Plant sources
• OECD – Organisation for Economic Co-operation and Development – consensus documents

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