What we heard report – Consultation on registration requirements for the acceptance of foreign decisions for livestock feed approvals in Canada

Introduction

We conducted a 60-day consultation on proposed new guidance for Feed approval or registration requirements for the acceptance of a foreign approval/authorization from February 7, 2023 to March 9, 2023. We are creating an alternate pathway to facilitate the pre-market evaluation process for the approval or registration of some feeds products which are already authorized by a foreign regulator. This new guidance clarifies which products are eligible and application requirements to submitting files under this pathway.

The purpose of the consultation was to gather comments and feedback on the proposed new guidance. We received a total of 8 comments from various stakeholders. All comments were carefully analyzed and, where applicable, used to revise and finalize the new guidance. A summary of the comments received during this consultation period is available below.

Background

We administer the National Feed Program, which includes a pre-market evaluation process for feeds that require approval or registration. For feeds that require pre-market evaluation, approval or registration must be obtained before they are manufactured in, sold in, or imported into Canada. The Feeds Regulations require an application to be submitted and for us to evaluate the information. The purpose of all feed evaluations is the same: to ensure that the feed ingredient is safe (in terms of animal health, human health via food residues and worker/bystander exposure and the environment) and effective for its intended purpose. The evaluation also ensures that the feed is accurately described in the Feeds Regulations and is labelled appropriately for its safe, effective use and for consumer protection. Following an evaluation, an ingredient approval decision is made and communicated to the applicant. The outcomes of an ingredient evaluation are described in RG-1 Regulatory Guidance outcomes of an ingredient assessment.

Cooperation and collaboration among regulatory agencies continue to be encouraged by many governments around the world. In the context of pre-market evaluation of livestock feeds, collaboration has the potential to benefit all involved participants, from the regulatory agency to the applicant submitting a product for evaluation. Recognition or acceptance of an evaluation, including recognition of foreign approvals, is an advanced form of collaboration in which an agency would recognise and accept the outcomes of another agency's evaluation of a specific product for the purposes of their own authorisation process of the same product.

When embarking on a path to recognizing foreign approvals, it is important that the foreign country's approval process is validated. The types of feed that require a pre-market evaluation vary between Canada and other jurisdictions and so do evaluation end-points and evaluation processes. 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. Some of these evaluations and feed approvals in a foreign jurisdiction may not cover the spectrum of evaluation end-points in terms of the feed being safe (in terms of animal health, human health via food residues and worker/bystander exposure and the environment) and effective for its intended purpose as mandated by the Canadian Feeds Act and regulations.

We conducted a validation process of 2 jurisdictions that we had a lot of familiarity with: the European Union (EU) and the United States (U.S.). To align with Canadian legislation, only a subset of feed ingredients meets the requirements for equivalency under these 2 jurisdictions. Following these findings, we created an alternate pathway to facilitate the pre-market evaluation process for the approval or registration of some feeds products which are already authorized by the United States Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA). This pathway was described in a new guidance document that clarifies which products are eligible and application requirements to submitting files under this pathway.

Who we heard from

During the consultation period, we received a total of 8 sets of comments and feedback.

Stakeholders were comprised of:

6 agricultural associations and organizations (industry associations and non-government organizations) from Canada as well as in the U.S.
2 companies

What we heard

There was overall support for the alternate pathway to facilitate the pre-market evaluation process for the approval or registration of some feeds already authorized by some foreign regulators.

Most of the comments were regarding the scope of the policy and submission requirements.

Stakeholder comments included:

suggestions that jurisdictions other than the U.S. and EU be considered in the future for this policy
expand the scope of the policy/pathway/process by considering the acceptance of favourable reviews from EFSA and the U.S. FDA, including generally recognized as safe (GRAS) notifications and ingredients recommended for inclusion in the Association of American Feed Control Officials (AAFCO) Official Publication
a request to include colour additive petitions (CAP) in the scope of the policy
a request for wider harmonization with the EU and the U.S. by including those ingredients that in Canada are classified as drugs and in the EU and U.S. have been accepted/approved as feeds or are being sold as feed or feed materials approved by the various EU countries
interest in including the viable microbials in the scope of the pathway/policy

Other feedback received:

encouraging us to be flexible with the enzyme naming conventions utilized in foreign approvals and documents, as these may vary from jurisdiction to jurisdiction
questions on how products with 1 or more ingredients that are not yet listed in the Schedules of the Feeds Regulations 1983 or are named differently will be considered under this policy
request to clarify the meaning of "generic product type" and to be included within the guidance document
clarification being sought on how changes to a product's approval status in a foreign jurisdiction (for example, amendment on the intended species) will impact that product's approval status in Canada under this policy
comment indicating in situations where end points are not completely covered; proposing that if needed, submissions for foreign evaluations may be supplemented with additional information to support the omitted end points/claims
conversely, others indicated that no additional data should be required, expressing that foreign submissions may be sufficient
respondents solicited clarification on the timeline to evaluate these applications and others requested to include a reasonable service standard for all these types of applications

Our response

The EU and the U.S. were chosen because their regulatory systems are similar and we have a good working relationship with officials in both jurisdictions. As each jurisdiction regulates ingredients for livestock feed a little differently, the need to exclude some ingredients from the process became clear. To be accepted within the scope of this policy, the product had to be considered a feed under the Feeds Act and regulations. In addition, to be eligible for this new pathway, the foreign authorization must be based on an evaluation that meets the Canadian endpoints for:

animal health
human health via food safety and worker/by-standard safety
environmental safety
fit for purpose

The viable microbials were not included in scope at present time to align with the EFSA acceptable products due to differences in product classification and approach for targeted antimicrobial activity assessment. We intend to re-evaluate the admissibility of these ingredients once further policy work is undertaken. We can re-evaluate the admissibility of these ingredients once our policy and procedures are changed for these feeds and information is published in guidance.

As for the question related to 1 or more ingredients that are not yet listed in the Schedules (now called the Canadian Feed Ingredients Table (CFIT)) or that are named differently, these ingredients will need to be compliant with Feeds Regulations. Ingredients must be listed and appropriately described in the CFIT before they are manufactured sold or imported into Canada. If a new ingredient or a modification to existing ingredient is identified via an application using this process, the current CFIT ingredient description pathway would apply (that is, consultation and decision regarding approval following the consultation). New text has been added to the policy document that clarifies the process following a decision to approve a feed under this process. In addition, clarifications have been added at the end of the document regarding a change in the foreign decision review such as adding a new species and how these files will be handed in the existing queue.

A comment was received regarding the acceptance of colour additives via the U.S.-FDA CAP process. These were not assessed as these evaluations are not performed by FDA's Centre for Veterinary Medicine. We will assess this process at a future date and if the process meets the policy, color additives from the CAP process will be added to the policy in appendix 1 of the guidance document later.

We received a comment to clarify what is intended by "generic product type" within the submission requirement section. Text has been added clarifying what was intended by this terminology.

Within the comments, there was a mention to supplement data in situations where the end-points are not completely covered. This would be time consuming for both the applicant and us to manage and the process could become lengthy due to the difficulty to determine which studies/information would be needed. For some end-points and some circumstances (for example, there are no documents from the regulatory jurisdiction documenting the review), the same original data may be needed for context to allow an officer to evaluate that end-point.

Regarding enzymes, we are currently undertaking a project to review all the ingredient descriptions associated with enzymes and new ingredients descriptions will be proposed via a public consultation. In developing the new ingredient descriptions for enzymes, we considered alignment with other jurisdictions in terms of naming.

Classification comments in terms of what is considered a feed and a veterinary drug in Canada as well as service standards were out of scope for this policy document. These aspects are addressed under other policy documents and other initiatives.

Next Steps

We would like to thank everyone who participated in the consultation process for contributing their time and sharing their views.

Based on the comments and feedback received from this consultation, amendments were made to the guidance on feed approval or registration requirements for the acceptance of a foreign approval/authorization. The updated guidance will be published on RG-1 Feed Registration Procedures and Labelling Standards web page.

Related information

Contact us

Animal Feed Program (AFP)
Canadian Food Inspection Agency
59 Camelot Dr
Ottawa ON K1A 0Y9
Email: cfia.afp-paa.acia@inspection.gc.ca

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