RG-1 Regulatory Guidance:
Chapter 5 - Research with Livestock Feeds
Section 2: Requirements for all applications
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For all applications, the applicant must submit all of the general information as outlined in this Section 2. Afterwards the applicant should proceed to Section 3 (for Feeds) or Section 4 (for Novel Feeds) for specific requirements.
Upon receipt of an application, the AFD will screen the application to confirm that the file contains all necessary information. Incomplete applications will be returned.
2.1 Administrative requirements
- a cover letter clearly identifying the responsible person(s), and describing the Research Feed, trial starting dates and purpose of the proposed research
- a completed Application Form for Feed Registration or Renewal CFIA/ACIA 0009 available in PDF format.
- the appropriate application fees as indicated on the first page of the application form
- a copy of the completed Checklist identifying the documents submitted to support the application with reference to where the information may be found in the application package. Where the information requirement is not applicable, this is to be indicated by (N/A) in the "Provided" column
Note: for research on multiple products during the same trial, a separate application is required for each product. However, one research protocol clearly identifying each of the products may be submitted with the package.
2.2 Information requirements
2.2.1 Characterization of the Research Feed
- name of the Research Feed (product name, brand name, purpose, target species, etc.)
- description of the Research Feed, including details related to the form of packaging (such as bulk, bag, etc.)
- complete list of ingredients and the product formulation
- detailed description of the manufacturing process
2.2.2 The location of, and information about, the research facility
- name and address of the location where the research will take place
- name of the person or body responsible for the research
- name and contact information (address, phone number, e-mail address and mailing address) of the person supervising the research
- description of the animal housing facilities and the access restrictions
2.2.3 Feed manufacturer
- name and address of the feed manufacturing facility that may be manufacturing the ingredient, or incorporating the ingredient into a mixed feed
- validated flushing and clean out procedures, if the Research Feed contains unapproved feed ingredients
2.2.4 Purpose and objectives of the proposed research
A detailed research protocol should include:
- objective of the research trial
- start date, end date, and duration of the research
- target species
- experimental design and the methods of statistical analysis
- treatments, replicates, number of animals per treatment, allocation of animals, etc.
- list of the variables to be measured, to include methods and frequency of measurements
- proposed (calculated) composition of the diet
2.2.5 Research protocols with a safe disposal option
- description of the method(s) to be used for the safe disposal of the livestock fed the Research Feed, and all animal products and by-products produced from the trial
- description of the method(s) to be used for the safe disposal of the leftover Research Feed once the study has been completed, with confirmation that the disposal facility is approved by animal or plant health conditions, where necessary
- address and contact information of the disposal facility
- description of the measures taken to prevent the release of the Research Feed in the processing facility and during transport, if the Research Feed will be processed in a location separate from the research facility
- description of the contingency plan to be followed to minimize any adverse effects of an accidental release of the Research Feed or the livestock fed the Research Feed and animal products/by-products thereof, if applicable
2.3 Safety data requirements
In addition to the administrative and information requirements outlined above, information and data demonstrating the safety of the Research Feed to livestock, humans, and the environment must be submitted.
For guidance on the safety data that may be required for both Feeds and Novel Feeds, please refer to the appropriate sections of RG-1, Chapter 2, Data Requirements for Single Ingredient Approval and Feed Registration.
Applications will be evaluated on a case-by-case basis, and the data requirements for the safety assessment may vary depending on the research material and the intended disposal methods at the end of the trial.
If the safety data available at the time of application is insufficient to assess the safety of Feeds and Novel Feeds and the purpose of the proposed research is to generate additional safety data, a Research Exemption or an Authorization of a Novel Feed for Research Purposes may be granted conditional on the safe disposal of the livestock, animal products and by-products, and any leftover Research Feed from the trial. The safe disposal condition may be revised upon submission of a new application for a safety assessment and review of the safety data generated during the research trial and any other data submitted by the applicant in support of the safety of the Research Feed. However, there is no guarantee that the review time for the new information, will coincide with marketability of the livestock and/or animal products produced from the trial.
Please note that entry into the food chain may also require approval by Health Canada (for example, for meat, milk, or eggs that are marketed as being "enriched" or "fortified" with nutrients at concentrations above what would normally be present). Applicants may contact the Submission Management and Information Unit of the Food Directorate, Health Canada by email at firstname.lastname@example.org to obtain additional information.
2.4 Imported feeds – Additional requirements
If the Research Feed is to be imported into Canada, the following information must be supplied for the importation of the product:
- total quantity of product to be imported, as determined by calculations reflective of the amount of feed required for the complete research trial
- means by which the product will enter the country (for example, courier, train, plane, etc.)
- approximate date of entry
- point of entry
Note that when more than one shipment of the Research Feed is required to complete the trial, the above information must be provided for each shipment. If the quantities and the dates of entry of the additional shipments are not included with the initial application, separate applications will be required for any future shipments.
Other regulatory authorities respecting either animal or plant health may prohibit or place additional conditions on the importation of livestock feed ingredients. Additional information on the importation of commodities regulated by the CFIA is available from the Automated Import Reference System (AIRS).
For Research Feeds imported into Canada containing animal products or by-products, the country of origin of the feed and the country of origin of the animal products and by-products must be identified, or the number of the Animal Health Import Permit provided. Please consult Import Policies - Animal Products and By-Products for more information on importing animals or animal products. Consult Import Procedures to learn more about feeds imported into Canada containing plant and plant products.
To request a permission to import a feed containing animal or animal by-products, contact the Centre of Administration for Permissions.
2.5 Other information
Any research trial authorized by the AFD may be subject to inspection by the CFIA to verify that all conditions placed on the research trials have been followed.
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