Feed approval or registration requirements for the acceptance of a foreign approval/authorization: Closed consultation

Current status: Closed

This document is part of the consultation on the use of foreign decisions for livestock feed approvals in Canada. This consultation ran from February 7, 2023 to March 9, 2023.

The Canadian Food Inspection Agency (CFIA) is seeking comments on proposed guidance on the feed approval or registration requirements for the acceptance of a foreign approval/authorization.

On this page

• Scope
• Process
• Submission requirements
• Appendix 1

The following identifies the pre-market assessment requirements for the approval or registration of livestock feeds based on the acceptance of foreign approvals or authorizations. In order to facilitate the pre-market application process, it is recommended that applicants read the information listed below prior to submitting an application. If questions remain, contact the CFIA for clarification at cfia.afp-paa.acia@inspection.gc.ca.

Scope

The scope of feeds included in this policy are livestock feed ingredients, with the following listed exclusions.

The types of feed that require a pre-market assessment vary between Canada and other jurisdictions. Based on the authorities in their supporting legislation, each jurisdiction may differ with respect to the animals for which they regulate feeds, the types of substances that are classified as feed and those that are considered medicinal, those that require pre-market assessment and approval, and those that do not. In order to align with Canadian legislation, only a subset of feed ingredients meet the requirements for equivalency.

The following exclusions will apply:

• products fed to animal species belonging to categories that do not meet the authority granted by the Feeds Act and regulations in Canada, such as companion animals
• products that are not considered feeds in Canada, such as veterinary drugs, veterinary health products, or pest control products
  This would include coccidiostats and histomonistats
• feed ingredients derived from plant and animal sources that have a novel trait, including those which have been genetically modified
• viable microbial strains, both unmodified and genetically modified
  Note: non-viable fermentation products remain in scope, for example, enzymes, amino acids, etc.
• products derived using nanotechnology

Process

Feeds that are in scope and meet all criteria, as stated in appendix 1, are eligible for consideration for recognition of their foreign approval or authorization. The applicant will need to submit an application for livestock feed approval or registration and will need to supply information that is described in this guidance. The pre-market assessment process will consist of the CFIA's audit of the approval or authorization information from the foreign jurisdiction rather than a comprehensive assessment of all data typically submitted for a new feed.

Submission requirements

All information must be supplied in English or French. A summary of the data which had been submitted to the original authorizing jurisdiction will be sufficient except in the case of item 4 below.

The following elements must be included in the application package:

• administrative requirements:
  submit the application package for registration or approval as per section 1.3.1 My CFIA online livestock feed applications of Regulatory Guidance (RG)-1 Chapter 1
• technical requirements: data must be submitted with your application via My CFIA.
  Upload the following items in My CFIA at the appropriate section during the application process.
  • Canadian label in compliance with the Feeds Regulations labelling according to chapter 4.0 General guidance on labelling of RG-1 Regulatory Guidance
  • clear identification of the product submitted
    • any validated identification, for example, Chemical Abstracts Service (CAS) number, strain identification of the fermentation production organism, internal product tracking number, etc
    • proof of the approval or authorization by the recognized jurisdiction
      • direct linkage to the specific feed product being submitted
        • note that generic product type approvals or authorizations may not be recognized
        • in the case of fermentation products, this would include the identification to the genus-species-strain level
    • description of approved uses in the jurisdiction where this product is approved (such as the intended purpose, species, direction for use) and any restrictions
    • defined purpose and claim as authorized by the original jurisdiction
    • copy of the label as proposed to the original jurisdiction
  • summary of the original submission package provided to the authorizing jurisdiction to complete the assessment, including:
    • copy of the table of contents from the original submission
    • brief summary of data supporting each of the endpoints
      • this includes animal health, human health (food safety and worker/bystander safety), environmental safety, fit for purpose/efficacy
      • the assessment opinion and decision provided by the recognized jurisdiction
      • if applicable, include any additional information that was applied in order to modify the final decision from the risk assessment, including any risk management or post-marketing options
  • method of analysis
    • provide the methods of analysis used to support the product with respect to its identification, characterization, specification, safety, shelf life, etc
      • sufficient detail is required to allow further verification of the method by the CFIA laboratory, if needed
        • helpful details may be found in RG-1 chapter 6.2 Good Laboratory Practices Protocol for Feed Ingredient Approvals or 6.3 Guidelines for the Evaluation of Methods to determine the Activity of Enzyme Ingredients used in Animal Feeds
    • 3 Certificates of Analysis from recent lots of product
    • product sample may be required
  • for products designed for the fortification of human food or for which residues may be transferred to foods of animal origin from the animal consumption of feeds, a joint food safety assessment with Health Canada may be required
    In these situations, the complete data package in support of consumer safety, rather than only the summary data, may be required. This could include:
    • a consideration of the metabolic fate of the product or metabolites
    • all metabolism and residue studies
      • in lab animals and target animal feeding trials
    • all tissue residue analytical results
    • methods of analysis used for the residue studies
    • human exposure analysis with a comparison to a maximum residue limit in food, if available

For additional information, refer to chapter 3.1 Guidance on data requirements to complete Sections 9, 10, 11 and 12 of the feed approval or registration application

Upon review of all information provided and a positive outcome (that is, pending approval or registration of the product), the applicant will be obligated to provide a copy of the complete submission package used in the foreign jurisdiction approval to the CFIA within 7 days. The CFIA will provide a letter to the applicant with instructions on how to submit the complete submission package to the agency. The final approval or registration will be provided after receipt of the information. This will allow the agency to readily respond to any potential risks and/or public health and safety emergencies as needed.

In some cases, it may not be possible to perfectly align the Canadian approval or registration to that of the foreign approval or authorization (for example, excluding a particular species on approval if they are not defined as livestock in Canada). The approval or registration will reflect products as described above in the scope section, which meets Canadian authorities and regulatory requirements, and any risk management requirements to meet Canadian conditions.

If outstanding questions remain, the CFIA may request additional information to support the assessment. Note that for any future changes to a feed that has been approved or registered through this process, such as adding a new species or new directions of use, the regular feed premarket application process will apply. This process is described at Livestock feed approval or registration: Overview.

The CFIA reserves the right to refuse any application based on its independent review process.

Approval or registration of a product through this pathway will obligate the applicant to immediately contact the CFIA if any new information leading to a change in risk or use of the product or restrictions is imposed by the original jurisdiction.

Appendix 1: Summary of current jurisdiction evaluations