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RG-1 Regulatory Guidance:
Chapter 5 - Research with Livestock Feeds

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Section 1: Introduction

Livestock feeds and feed ingredients manufactured, sold or imported into Canada are subject to the Feeds Act and Regulations as administered by the Canadian Food Inspection Agency (CFIA). The submission of an application to the CFIA for feeds that are to be used in research trials in Canada may be required before the research trial begins for either a research exemption or research authorization, depending on the feed category.

The objective of this chapter is to clarify the regulatory requirements for the use of livestock feeds in research trials conducted in Canada and to provide guidance to applicants in order to:

For general information on the regulation of feed in Canada, the legal authorities, more complete definitions for feed and livestock, and feed types, please see the RG-1 Introduction – Regulation of Livestock Feed in Canada.

When an application is required, an approval/authorization from the AFD must be granted prior to beginning the research trial; and in the case of imported feed, prior to importation. The applicant must be a Canadian individual or company.

It is recommended that the research facility always consider the time necessary to obtain the appropriate approvals and authorizations well in advance of their intended trial start dates. This is especially important for research where a safety assessment is required.

Please note that the Agency has been experiencing an increasing volume of questions on research requirements for substances that are not considered "feed" as defined in the Feeds Act and Regulations. Substances fed to livestock species may fall under the jurisdiction of other legislation, as for example, therapeutic products, veterinary biologics, and pest control products. In particular, the guidance document on classification of veterinary drugs and livestock feeds, on the Health Canada website could be helpful for classifying products that fall within that grey-zone interface between drugs and feeds. A classification request as per the instructions in the guidance document may be submitted prior to the submission of an application for research.

If questions remain following the review of this guidance, researchers may contact the Animal Feed Division (AFD) by email to obtain an opinion at afd_daa@inspection.gc.ca

Step 1: Determine the category of the feed: Feed (other than a Novel Feed) or Novel Feed

The first step is to determine whether the feed to be used in the research trial is a Feed (other than a Novel Feed) or a Novel Feed. The following key terms and definitions are important for understanding this guidance, and are triggers for determining the appropriate pathway for completing an application for research.

For purposes of this document, Feeds that are not Novel Feeds will be denoted as simply "Feed". When a reference applies to both Feeds and Novel Feeds, the term "Research Feed" will be used.

Feed

A feed that belongs to this category includes:

Examples of Feeds could include an unregistered premix, a chelated mineral, a new source of zeolite, or a previously unapproved vitamin which is chemically-synthesized.

Research with this category of feed may require the submission of an application for a Research Exemption or a Research Exemption with a Safety Assessment.

Novel Feed

The category of Novel Feed comprises all feed composed of, or derived from, an organism or organisms that is not listed in Schedule IV or V, or has a novel trait. Unregistered sources of ingredients listed in Part 2 of the Schedules that meet this definition continue to be considered Novel Feeds.

Examples of Novel Feeds could include:

Research with the category of Novel Feed requires the submission of an application for an Authorization of a Novel Feed for Research Purposes.

Step 2: Determine if an application is required

Determine if any of the exemption criteria outlined below is applicable.

Exemption criteria:

If any of the above conditions apply, a submission for a research exemption or a research authorization is not required. It is important to note, however, that other regulatory obligations and/or oversight from other programs in the CFIA or other government departments may still apply to your research trial.

Imported products, deemed to be exempt as above, are subject to import requirements from the CFIA or other jurisdictions. General information is outlined in the Automated Import Reference System (AIRs)

Step 3: Determine the fate of all research materials

The next step is to determine the degree of containment or confinement of all materials used in or generated from the research trial. The data requirements for an application will depend on whether or not safe disposal conditions are met, as defined below.

Safe disposal means that the feed, livestock, and all animal products or by-products from the research trial do not enter into the food chain, the feed chain, or the environment. Note that rendering is not considered a safe disposal option, as rendered products may reenter the food chain through their use as feed.

Any disposal into the environment must be in accordance with federal, provincial and municipal environmental regulations.

For an imported Research Feed, any remaining feed and animal products from animals fed that feed may need to be incinerated prior to disposal in a landfill facility. If they are not incinerated, the remaining feed and animal products may be composted only in a suitable landfill or waste disposal facility once the conditions have been authorized.

Once Steps 1 to 3 have been completed, proceed to the application steps outlined below.

Section 2: Requirements for all applications

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 Animal Feed Division (AFD) will screen the application to confirm that the file contains all necessary information. Incomplete applications will be returned.

2.1 Administrative requirements

2.2 Information requirements

2.2.1 Characterization of the research feed

2.2.2 The location of, and information about, the research facility

2.2.3 Feed manufacturer

2.2.4 Purpose and objectives of the proposed research

A detailed research protocol should include:

2.2.5 Research protocols with a safe disposal option

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 smiu-ugdi@hc-sc.gc.ca 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:

Note that when more than 1 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 Canadian Food Inspection Agency (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.

Section 3: Feeds – research exemption or research exemption with a safety assessment

Section 3 of the Feeds Regulations permits the exemption from registration of feed, other than a novel feed, from the operations of the Act for experimental purposes, provided that certain conditions are met.

Individuals or companies who intend to conduct research with feeds will fall into one of the following three categories:

  1. the feed is manufactured in Canada for research purposes and the research facility accepts full responsibility for safe disposal – No application is required
  2. the feed is imported into Canada and the research facility accepts full responsibility for safe disposal – Application for a Research Exemption is required
  3. the feed is imported or manufactured in Canada and there is no safe disposal plan – Application for a Research Exemption with a Safety Assessment is required

Where the research protocol does not include safe disposal, or the applicant seeks approval for the feed and/or livestock and/or resulting animal products or by-products to enter the food or feed chain or the environment, a submission requesting a safety review of the feed is required and an evaluation will be conducted by the AFD.

Notice of decision

Upon completion of the application, a letter will be provided to the Canadian applicant which:

If the feed is imported and the application is approved, the Canadian applicant will receive an additional letter allowing the importation of the feed. This letter must accompany the shipment into Canada.

Section 4: Novel feeds – authorization of a novel feed for research purposes

Facilities conducting research with a novel feed either imported or manufactured in Canada must apply for an Authorization of a Novel Feed for Research Purposes prior to the initiation of the research trial at a facility.

A safety assessment is conducted for all novel feeds used in research. The extent of the assessment is dependent on the degree of the containment or confinement of the research materials (all livestock, animal products and by-products, and/or remaining feed) that could enter the food or feed chain or the environment. If the research is conducted in a contained facility, as defined below, and not imported, minimal requirements may apply. However, an application is still required.

Contained: the use and handling of the novel feed or ingredient is managed in a manner that prevents its release, and includes any feed, remaining feed, and animal products and by-products, including excreta from the livestock consuming the feed.

Notice of decision

Upon completion of the application, a letter will be provided to the Canadian applicant which:

If the Novel Feed is imported and the application is approved, the Canadian applicant will receive a second letter allowing the importation of the Novel Feed. This letter must accompany the shipment into Canada.

Section 5: Notification of change – post-approval or -authorization

The applicant is required to notify the AFD should they plan to make any modifications or changes to the research feeding trial(s), the livestock used in the trial, or the Research Feed, other than what has already been provided to the AFD in the application package. The applicant can notify the AFD either by email or letter, and must clearly state the planned changes. The notification is required to ensure that any changes to the research from the original information reviewed will not result in any safety concerns and/or non-compliance. The AFD will review the proposed changes and provide direction on what steps or procedures will be required. For example, it is common for the start and end dates of a trial to change, and these may be recognized by a simple response to the applicant. The changes made to the original decision will be kept on file for future reference.

Any major changes to the protocol, livestock species, containment, addition of other Research Feeds, etc., would necessitate the submission of a new application.

Section 6: Checklist

Printable checklist - PDF (82 kb)

Submission Checklist for research with livestock feeds

Below is a checklist, pertaining to research with livestock feeds, which detail the information required for the submission of an application for feed exemption or authorization intended for research.

Note: A completed checklist must be submitted to the Animal Feed Division (AFD) with each application for research feed exemption or authorization.

Please indicate the submission page number corresponding to each item in the checklist.

Submissions received without the completed checklists will be returned.

Additional guidance

With your submission package, you must include one cover letter with the following information (mandatory):

You must complete one Application for Feed Registration and Renewal Form per product:

Total application fees (cheque, money order, Visa, MasterCard, or American Express payable in Canadian Funds):

Research Applications:

For all research feeds, you must include: Characterization of the research feed
Page number or N/A
name of the research feed (product name, brand name, purpose, target species, etc.)
description of the research feed, including details related to form of packaging (i.e., bulk, bag, etc.)
complete list of ingredients and the product formulation
detailed description of the manufacturing process
For all research feeds, you must include: Location of, and information about, the research facility
Page number or N/A
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
For all research feeds, you must include: Feed manufacturer
Page number or N/A
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 cleanout procedures, if the research feed contains unapproved ingredients
For all research feeds, you must include: A detailed research protocol
Page number or N/A
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
For research protocols with a safe disposal option, you must include
Page number or N/A
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 feed and animal products/by-products thereof, if applicable
Safety data requirements
Page number or N/A
Provide information and data demonstrating the safety of the Research Feed to livestock, humans, and the environment in sufficient details to assess the safety of the Research Feed (Feeds and Novel Feeds) for the purpose of the proposed research.
If the safety data is not required, clearly explain why.
If the Research Feed is to be imported into Canada, you must include
Page number or N/A
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 (e.g., courier, train, plane, etc.)
approximate date of entry
point of entry
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