Feed approval and product registration guidance for the proposed Feeds Regulations, 2022

The information in this document is based on requirements set out in the proposed Feeds Regulations, 2022 (the "regulations"). The information is intended to help regulated parties understand the requirements within the regulations once they come into force. The proposed requirements are subject to change as the regulatory process advances through its various stages. In the interim, current laws applicable to livestock feed in Canada continue to apply.

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Introduction

The Feeds Act requires that feeds be approved or registered before they are manufactured, sold or imported into Canada.

The proposed Feeds Regulations, 2022 outline which feeds require approval or registration. It also sets out the requirements for obtaining approval or registration including the submission of applications, the information that must be supplied and the requirement that the information is assessed to ensure the feed is in compliance with the Feeds Act and regulations.

The process for approval or registration is largely unchanged from the current Feeds Regulations, 1983, with some updates to the information that is required to be submitted in support of an application. Single ingredient feeds (SIFs) will continue to require approval before they can be used in livestock feeds, however fewer mixed feeds will require registration under the proposed Feeds Regulations, 2022.

Purpose

This document is intended to help feed businesses understand the feed approval and registration requirements of the proposed Feeds Regulations, 2022.

What is included

This document provides details about the approval and registration requirements in the proposed Feeds Regulations, 2022. In addition, this document presents scenarios that feed stakeholders may face with respect to these requirements.

Approval versus registration

Under the proposed Feeds Regulations, 2022, there are some important differences between feed approval and feed registration that should be noted. These include the types of feeds that require approval compared to the types of feeds that require registration, differences in the final steps of the assessment and approval process, as well as the process that will be put in place for cancelling a feed approval compared to cancelling a feed registration.

Overview of the feed approval and registration requirements

Regulated parties will need to submit an application for the approval or registration of a feed. The Canadian Food Inspection Agency (CFIA) will then conduct an assessment to ensure the feed is safe for animals, humans and the environment, is effective for its intended purpose, and is labelled properly. Following the assessment, if the CFIA determines that the feed meets all of the requirements, the applicant will be informed that their feed is approved or registered and may now be manufactured, sold and/or imported into Canada. Approved SIFs will be listed in the new Canadian Feed Ingredients Table (CFIT). Registered feeds will be assigned a registration number, as is the practice under the current Feeds Regulations, 1983.

It is important to note that some SIFs may require both approval and registration, as described below.

Feeds that require approval

Feeds that will require approval under the proposed Feeds Regulations, 2022, whether manufactured domestically or imported, are the following:

  • feeds with a novel trait
  • SIFs that are not listed in the CFIT (formerly referred to as Schedules IV and V)
  • SIFs that are listed in the CFIT, with a purpose (as reflected in the class or subclass), composition, manufacturing process, intended livestock species or class of livestock or usage rate that is different from that described in that table
  • feeds intended for research or experimental purposes that are novel, imported or for which there is no safe disposal plan

Feeds that require registration

Feeds that will require registration under the proposed Feeds Regulations, 2022, whether manufactured domestically or imported, are the following:

  • SIFs listed in Part II of the CFIT (formerly referred to as Schedule IV and V)
  • mixed feeds administered in water
  • flavouring agents
  • medicated mineral feeds
  • medicated trace mineral salt feeds
  • mixed feeds containing a pest control product
  • specialty feeds that are not listed in the Tables of Permissible Claims for Feed Labels, or that do not meet the conditions set out in the table

In addition, if a feed that is otherwise exempt from registration meets any of the following criteria, it would then require registration if:

Imported feeds that do not require registration based on the criteria listed above would need to be registered if they are not imported by a licence holder. Additional information on imports and licensing are available in the Feed import and export guidance for the proposed Feeds Regulations, 2022 and Licensing guidance for the proposed Feeds Regulations, 2022.

Specialty feeds are a type of mixed feed that are now defined in the proposed Feeds Regulations, 2022. They are a mixed feed that does not provide any significant nutritional value, but is added to feed for a non-nutritional purpose (that is, has a purpose other than providing nutrients). These specialty feeds predominately contain SIFs listed in Class 6 (non-nutritive ingredients) of the CFIT.

Specialty feeds are used to improve or facilitate:

  • the preservation of a feed during storage or prior to feeding to livestock
  • the quality, flowability or pelleting of a feed
  • the ingredient dispersion or distribution in a feed
  • the ingestion, acceptability or digestion by livestock of a feed
  • the quality or availability of nutrients in a feed
  • the absorption of nutrients in a feed by livestock that have consumed it

Some examples of specialty feeds include anticaking agents, antioxidants, pelleting aids, mould inhibitors, forage additives, colouring agents, gut modifiers and fermentation products.

Specialty feeds will require registration unless the applicable claim on the label is listed in the Tables of Permissible Claims for Feed Labels (table 3: specialty feeds claims) and meets the conditions for the feed and label for that particular claim. As individual specialty feeds become better defined and understood it is expected that the claims for specialty feeds will be expanded and added into the Tables of Permissible Claims for Feed Labels, so that they no longer require registration.

All feeds, whether registered or not, must meet all regulatory requirements such as proper labelling, containing only approved SIFs as described in the CFIT, meeting any set standards, and being suitable for their intended purpose.

Information requirements

An application for approval or registration must be accompanied by supporting information outlined in sections 7(2) and 7(5) of the proposed Feeds Regulations, 2022. The required information in the proposed Feeds Regulations, 2022 is more specific than the satisfactory evidence section of the current Feeds Regulations, 1983. However, in most cases the proposed requirements align with the information that has been requested to support approval or registration in the past. More specific requirements are found in current regulatory guidance documents. These documents will be updated and supplemented with more details once the proposed Feeds Regulations, 2022 come into force.

Some of the information that must be supplied in the application package for SIFs and mixed feeds include:

  • the proposed feed label
  • a sample of the feed
  • a description of the feed, including a list of ingredients and intended purpose of the feed
  • the specifications of the feed, including appropriate guarantees
  • the identification and description of any contaminants found in the feed
  • a description of how the feed is manufactured
  • evidence to support the safety, efficacy, stability, label guarantees, and any claims for the feed
  • data to show whether there are potential changes to foods of animal origin (that is, meat, milk or eggs) when the feed is fed as intended

Feeds with a novel trait will also need to supply additional data to support the safety of the feed. This information is found in Section 7(3) of the proposed Feeds Regulations, 2022. This is the same information that is currently required for novel feeds with a novel trait under the Feeds Regulations, 1983, and includes:

  • the identification and characterization of the trait
  • the identification and characterization of the feed with a novel trait
  • a comparison of the characteristics of the feed with a novel trait to a feed without a novel trait
  • information to support the safety of the feed
  • the name of any other government that has been provided information about the feed with a novel trait and the purpose for which it was provided

For all applications for approval or registration, the CFIA may request additional information to support the application based on the evaluation.

Evaluation and decision

Once the application has been evaluated, a feed will be approved or registered if all of the required information was provided, a label was provided, and the feed was found to be in compliance with the Feeds Act and regulations. This includes the evaluation determining that the feed does not present a risk of harm to animal or human health or the environment. The feed must also meet all of the standards, be suitable for its intended purpose and be properly labelled. If a feed does not meet these criteria it will not be approved or registered. If a feed is not approved or registered, the applicant will be informed of the reasons for the refusal.

Approved feeds

For feeds that are approved, a written notice confirming the approval will be sent to the applicant. If the approved feed is a feed intended for research, the approval will indicate the conditions of the approval based on the proposed research.

If the approved feed is a SIF, the applicant will be notified and a draft ingredient description (either a description for a new ingredient or modification to existing one) will be posted for public consultation. Feedback received will be reviewed, and the final ingredient description will then be listed under the appropriate class within Part I or Part II of the CFIT.

The CFIT contains 7 different classes, each with a clearly defined purpose:

  • Classes 1 to 5 are nutritional-based SIFs such as roughages and forages, energy feeds, protein feeds, vitamins and minerals
  • Class 6 contains SIFs that are non-nutritional (and classified for a specific purpose) such as antioxidants, anticaking ingredients, colouring ingredients. They are added to livestock feeds to fulfill a specific non-nutritional purpose as per the class in the CFIT
  • Class 7 contains SIFs that have a specific purpose that does not align with classes 1 to 6

The CFIT will replace Schedules IV and V of the current Feeds Regulations, 1983. As a result, all SIFs from Schedules IV and V in current Feeds Regulations, 1983 will be transferred to the CFIT and grouped into new classes. In addition, both the English and French ingredient descriptions will be reviewed, standardized, and updated if necessary. A glossary has also been added to the CFIT to define terms and phrases commonly found in the ingredient descriptions.

If it is determined that a SIF presents a risk of harm to animal, human health or the environment, the SIF will either be removed from the CFIT or the approved ingredient description in the CFIT will be amended to address the risk. If a SIF is removed from the CFIT, it is no longer approved for use in livestock feeds in Canada.

Registered feeds

For feeds that are registered, a registration number will be assigned, and a registration certificate with an expiry date is issued to the registrant. Although the expiry date for registrations is no longer set out in the proposed Feeds Regulations, 2022, a policy and guidance regarding the expiry date for feed registrations will be developed in the future. This will provide flexibility to allow for longer registration periods, where appropriate.

Similar to the current regulations, the proposed Feeds Regulations, 2022 also outline a pathway to refuse registration, surrender an existing registration as well as the process for the cancellation of a registration.

Approval of feeds to be used for research or experimental purposes

A feed, other than a novel feed, that is manufactured in Canada and is to be used for research purposes (for example, research feeding trials) or for experimental purposes (for example, laboratory testing and analysis) is exempt from the Feeds Act and regulations. This exemption includes the feed approval process, and is only valid if the livestock fed the feed being used for research or experimental purposes are under the direct supervision of the research establishment, and any remaining feed, livestock and resulting livestock products are disposed of in a safe manner.

Feeds for research or experimental purposes that do not meet these criteria will require approval by the CFIA. This includes research feeds that are novel, those that are imported or situations where the remaining feed, the livestock that are fed the feed or livestock products (for example, meat, milk, eggs) may enter the feed or food chains.

The information that is required in an application for approval of a feed for research or experimental purposes is outlined in section 7(4) of the proposed Feeds Regulations, 2022.

Some of the information that must be supplied in the application package include:

  • a description of the feed, including a list of ingredients and the intended purpose of the feed
  • the species of livestock, number of livestock, and the amount of feed required to conduct the research
  • the research protocol
  • name and address of the research establishment
  • contact information of the person supervising the research
  • if the feed is imported, date of its importation and the Canadian port of entry
  • either a written plan for safe disposal of any remaining feed, livestock and livestock products or information to support a full safety assessment if the feed, livestock, or livestock products will enter the feed chain (including rendering) or food chain

The proposed Feeds Regulations, 2022 also includes a process for cancelling the approval of a feed intended for research or experimental purposes. This process is similar to the process used to cancel a registration.

It is important to note that feeds intended for research or experimental purposes that are approved by the CFIA do not have to meet some of the regulatory requirements, such as registration, licensing requirements, preventive control plan requirements, labelling and packaging as well as general and safety standards.

Transition to the new regulations

When the proposed Feeds Regulations, 2022 come into force there will be some feed types that currently require registration that will no longer be subject to the mandatory registration process. For these feeds, the CFIA will work with registrants to establish an approach to determine whether or not registrants would like to continue to have these feeds registered.

For eligible feed types, applicants who have applications for feed registration that are in the registration file queue but have not yet been completed at the time of the new regulations coming into force, will be given the opportunity to either continue with the registration process or voluntarily withdraw their application. Note that applications that were submitted under the current Feeds Regulations, 1983, will be assessed under those regulations. This means that no new or additional information that would be otherwise required under the proposed Feeds Regulations, 2022 needs to be provided.

Any feed that is already registered at the time the proposed Feeds Regulations, 2022 come into force will be considered registered under the new regulations. The registration number and expiry date for that registration will remain unchanged.

Additional information on the transitional and coming into force provisions can be found in the Guide to timelines for complying with the Feeds Regulations, 2022.

Benefits

The updated approval and registration requirements and processes will provide the following benefits:

  • clear information about what must be included in an application for feed approval or registration
  • a more transparent feed assessment and approval process
  • a decrease in the number of mixed feed types that will require mandatory product registration as compared to the current Feeds Regulations, 1983.

Feed approval and registration scenarios

In this section, some common scenarios are presented to help regulated parties comply with feed approval and registration requirements for livestock feeds.

Example 1: A feed establishment manufactures a mixed feed in Canada that contains all Part I SIFs

The mixed feed would not be considered a specialty feed based on the ingredients and its purpose. The feed label is in English and French only, there are no label claims, it only contains mandatory and permitted optional guarantees for that particular mixed feed type, and meets all labelling requirements.

  • This mixed feed would not require registration
  • If the mixed feed was manufactured outside of Canada (under the same conditions as presented in the scenario above) and then imported into Canada, registration is required unless the mixed feed is being imported by a licence holder
    • Imported feeds for sale either require registration or must be imported by a licence holder

Example 2: A feed establishment manufactures a medicated mineral feed in Canada

The feed label is in English and French only, there are no label claims, and it meets all labelling requirements.

  • This medicated mineral feed must be registered
  • Medicated mineral feeds are one of the mixed feed types that will continue to require registration, whether the medicated mineral feed is imported into Canada for sale or manufactured in Canada

Example 3: A feed establishment wants to import a medicated mineral feed

The feed label is in English and French only, there are no label claims, and meets all labelling requirements. The feed establishment has a licence.

  • This medicated mineral feed must be registered
  • Medicated mineral feeds are one of the mixed feed types that will continue to require registration, even if it is imported by a licence holder
    • Medicated mineral feeds will require registration if they are imported for sale, imported for their own personal use, imported for sale by a licence holder or are manufactured in Canada

Example 4: A feed establishment manufactures a complete feed in Canada containing a registered flavouring agent

The complete feed label is in English and French only, there are no label claims, and meets all labelling requirements.

  • This complete feed does not need to be registered
    • A complete feed is defined as a mixed feed that, when used for the type of livestock and for the purposes stated on the label, provides all of the nutrients necessary for the maintenance of life or for promoting production, except water and, in the case of ruminants and horses, roughage
  • A complete feed manufactured in Canada that contains a registered flavouring agent would not require registration
    • If the complete feed containing the registered flavouring agent was imported for sale into Canada, it would require registration unless it is imported by a licence holder

Example 5: A feed establishment manufactures a Part I SIF in Canada

The feed label is in English and French only, there are no label claims, and meets all labelling requirements, but does not meet the ingredient description (such as intended livestock species, maximum inclusion rate, intended purpose, compositional or safety standards or manufacturing process), as described in the CFIT.

  • This new Part I SIF needs approval
  • Approval is required whether the Part I SIF is imported for sale or manufactured in Canada, as it does not meet the existing ingredient description in the CFIT

Example 6: A feed establishment manufactures a Part I SIF in Canada

The feed label is in English and French only, there are no label claims, and meets all labelling requirements, but the label has an extra guarantee that is not found in the ingredient description as described in the CFIT.

  • This Part I SIF must be registered
  • This Part I SIF manufactured in Canada must be registered due to the fact that the additional label guarantee is not required by the ingredient description as stated in the CFIT
    • Therefore, it does not meet the exemption from registration criteria for this type of feed
  • If this Part I SIF with the extra label guarantee was imported into Canada, it would also require registration

Example 7: A feed establishment wants to import a Part I SIF for sale

The label is in English and French only, there are no label claims, and it meets all labelling requirements.

  • This imported Part I SIF needs to either be registered or imported by a licence holder
  • If the Part I SIF is imported by a licence holder, it does not need to be registered
    • However, if it is imported by someone who is not a licence holder, it would require registration

Example 8: A feed establishment wants to import a Part II SIF for sale

The label is in English and French only, there are no label claims, and meets all labelling requirements. The SIF meets the ingredient description in the CFIT. The feed establishment has a licence.

  • This imported Part II SIF must be registered even if the importer is a licence holder
  • Part II SIFs are one of the feed types that require registration, whether they are imported for sale, imported for their own personal use, imported for sale by a licence holder or are manufactured in Canada

Example 9: A livestock producer wants to import a Part I SIF for their own personal use (that is, not for commercial use)

The label is in English and French only, there are no label claims, and it meets all labelling requirements.

  • This imported Part I SIF must be registered
  • The livestock producer would need to register this Part I SIF before it could be imported for their own personal use
    • Feeds that are imported and are not intended for sale must be registered before being imported

Example 10: A livestock producer wants to import a Part II SIF for their own personal use (that is, not for commercial use)

The label is in English and French only, there are no label claims, and meets all labelling requirements.

  • This imported Part II SIF must be registered
  • Part II SIFs are one of the feed types that require registration, whether it is being imported for sale, imported for their own personal use or is manufactured in Canada

Example 11: A feed establishment manufactures a specialty feed in Canada

The specialty feed label is in English and French only, meets the claims and conditions as set out in the Tables of Permissible Claims for Feed Labels, only contains mandatory and permitted optional guarantees for that particular specialty feed, and meets all other labelling requirements.

  • This specialty feed does not need to be registered
  • This specialty feed is exempt from registration as long as it meets the conditions for the claim (as they relate to feed type and additional labelling requirements) as set out in the Tables of Permissible Claims for Feed Labels

Example 12: A feed establishment imports a specialty feed into Canada

The specialty feed label is in English and French only, meets the claims and conditions as set out in the Tables of Permissible Claims for Feed Labels, only contains mandatory and permitted optional guarantees for that particular specialty feed, and meets all other labelling requirements. The feed establishment has a licence.

  • This imported specialty feed does not need to be registered
  • This imported specialty feed would not require registration as long as the specialty feed meets the conditions for the claim (feed type and labelling requirements) as set out in the Tables of Permissible Claims for Feed Labels, and is being imported by a licence holder
    • Imported feeds for sale either require registration or must be imported by a licence holder

Example 13: A feed establishment manufactures a specialty feed in Canada

The specialty feed label is in English and French only, only contains mandatory and permitted optional guarantees for that particular specialty feed, but the claim on the label is not set out in the Tables of Permissible Claims for Feed Labels.

  • This specialty feed must be registered
  • This specialty feed requires registration because the label bears a claim that is not found in the Tables of Permissible Claims for Feed Labels, and therefore would not be exempt from registration

Example 14: A feed establishment imports a specialty feed into Canada

The specialty feed label is in English and French only, only contains mandatory and optional guarantees for that particular specialty feed, but the claim on the label is not set out in the tables of permissible claims for feed labels. The feed establishment has a licence.

  • This imported specialty feed must be registered
  • Even though the feed establishment has a licence, registration is required because the claim on the label for the imported specialty feed does not appear in the Tables of Permissible Claims for Feed Labels
    • For this reason, this imported specialty feed cannot be exempt from registration
      • In fact, it does not matter whether this specialty feed is imported for sale, imported for own personal use, imported for sale by a licence holder or manufactured within Canada, it will require registration
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