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

On this page

• Scope
• Process
• Submission requirements
• Summary of current jurisdiction evaluations

The following identifies the pre-market evaluation requirements for the approval or registration of livestock feeds based on the acceptance of foreign approvals or authorizations. 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 us for clarification at cfia.afp-paa.acia@inspection.gc.ca.

Scope

The types of feed that require a pre-market evaluation 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 evaluation and approval, and those that do not. Only a subset of feed ingredients aligns with the Canadian regulatory framework and meet the requirements for equivalency.

• Note: while this initiative focuses primarily on feed ingredients, in some situations, mixed feed products may also be considered if authorization was granted as such.

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

• ingredients/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
• ingredients/products that are not considered feeds in Canada, such as veterinary drugs, veterinary health products, or pest control products
  • this includes 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.
• ingredients/products derived using nanotechnology

Process

Feeds that are in scope and meet all criteria, as stated in Summary of current jurisdiction evaluations, 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 supply information that is described in this guidance. The pre-market evaluation process will consist of an audit of the approval or authorization information from the foreign jurisdiction rather than a comprehensive evaluation of all data typically submitted for a new feed.

Benefits of the process

This alternate pathway for feeds that have been approved in foreign jurisdictions should be beneficial to both industry and us. Applicants will be able to capitalize on application packages prepared for and submitted to foreign jurisdictions, resulting in less work for the applicant for the pre-market application of a new feed product in Canada. It is anticipated that the overall review of the application will be faster as we will be able to audit the information provided instead of performing a full pre-market assessment on a complete data package. This will simplify the process for new feed ingredients that have already been approved elsewhere, providing livestock producers with more options for feeds for their animals while maintaining the continued production of safe feed and foods in Canada. As mentioned in the scope, while this initiative focuses primarily on feed ingredients, in some situations, mixed feed products may also be considered if authorization was granted as such.

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 an ingredient/product 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.

The application package must include both administrative and technical requirements. As mentioned in the scope, while this initiative focuses primarily on feed ingredients, in some situations, mixed feed products may also be considered if authorization is granted as such. In such case, the applicant will need to apply for the registration or approval of the ingredient and the registration of the product.

Administrative requirements:

• submit the application package for registration or approval as per RG-1 Regulatory Guidance chapter 3.1 My CFIA online livestock feed applications

Technical requirements: upload the following items in My CFIA under the appropriate section during the application process:

• Canadian label in compliance with the Feeds Regulations labelling according to RG-12 Labelling of livestock feeds
• clear identification of the ingredient/product submitted
  • any validated identification, for example, Chemical Abstracts Service (CAS) number, strain identification of the fermentation production organism, internal ingredient/product tracking number, etc.
• proof of the approval or authorization by the recognized jurisdiction
  • direct linkage to the specific feed ingredient/product being submitted
    • for example, in the case of fermentation products, this would include the identification to the genus-species-strain level
    • broad approvals or authorizations for an entire category or type of ingredient/product may not be acceptable (for example, phytase vs phytase derived from a specific microbial strain)
• description of approved uses in the jurisdiction where this ingredient/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 evaluation, 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 evaluation opinion and decision provided by the recognized jurisdiction
    • if applicable, include any additional information that was applied to modify the final decision from the risk assessment, including any risk management or post-marketing changes
• method of analysis
  • provide the methods of analysis used to support the ingredient/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 our 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 the ingredient/product
  • a sample may be required of the ingredient/product
• for ingredients/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 evaluation 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, including:
    • a consideration of the metabolic fate of the ingredient/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 RG-1 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 ingredient/product), the applicant will be obligated to provide a copy of the complete submission package used in the foreign jurisdiction approval to us within 7 days. We will provide a letter to the applicant with instructions on how to submit the complete submission package to us. The final approval or registration will be provided after receipt of the information. This will allow us 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 ingredients/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, we may request additional information to support the evaluation. 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.

For applications that require a new ingredient description within the Canadian Feed Ingredients Table (CFIT) or a modification to an existing ingredient description, the current procedures for ingredient description consultation apply.

If we have granted approval or registration of a feed through this process and the approval in the foreign jurisdiction has expanded (for example, adding a new species), it is the responsibility of the applicant to submit a new application for evaluation if the applicant wishes to have it considered for amendment to their Canadian approval/registration.

In addition, it is the responsibility of a proponent to contact us if new information pertinent to the risk of harm to human or animal health or the environment becomes available. We will review this information and provide an opinion regarding the potential risk and or risk management options. In a situation where a foreign jurisdiction narrows, restricts or rescinds the approval of the feed in their respective jurisdiction, the applicant must notify us immediately.

We reserve the right to refuse any application based on its independent review process.

Summary of current jurisdiction evaluations