6. Registration Processes
- 10 Mins to read
- DarkLight
6. Registration Processes
- 10 Mins to read
- DarkLight
Article summary
Did you find this summary helpful?
Thank you for your feedback
Animal Feed
Canada
This section provides information on any product notification or registration and manufacturing site registration processes.
6.1 Product Notification
(A) Ingredient/Raw Material
No product notification. Only product registration is required.
(B) General Feed
No product notification. Only product registration is required.
(B) Category
The category of “Mixed Livestock Feed” should comply with the requirements in Section 6.1 on “General Feed” above.
(B) Product
A “Mixed Livestock Feed - Supplement" product should comply with the requirements in Section 6.1 on “General Feed” above.
6.2 Product Registration
(A) Ingredient/Raw Material [1-3]
1a. Ingredients that are not listed in Schedule IV or V require a full safety and efficacy assessment. If an ingredient is already used in another country, a full assessment is still required; however, the AFP (Animal Feed Program) does accept data that has been used to support ingredient approval in other jurisdictions.
1b. Any single ingredient feed that is listed in Schedule IV or V requires a new safety and/or efficacy assessment if it is different in terms of:
- Its composition, structure, nutritional quality, or physiological effects
- The process by which it is manufactured
- The manner in which it is metabolized in the body of the livestock intended to be fed
- Its safety
- The species or class of livestock intended to be fed and the usage rate
- Its purpose as set out in Schedules IV and V
1c. Ingredient for which there may be inherent safety and/or efficacy variations associated with an individual source of the ingredient, or introduced via the manufacturing process, a pre-market assessment is required.
2. The authority that handles these assessments is:
- AFP (Animal Feed Program) if the ingredient meets the definition provided in Schedule IV or V but is not on it and requires a full safety and efficacy assessment.
- CFIA (Canadian Food Inspection Agency) if the ingredient is not currently listed in part II of Schedule IV or V (or that does not meet the definition provided in Schedule IV or V (1b)).
Assessing a new ingredient is a complex process. Please refer to the links in references [1-3].
For a "Mixed Livestock Feed - Supplement" product, when raw materials are in Schedule IV and V, registration is not required if the materials are made from non-novel sources. For novel traits in organisms (plant and microorganisms), the details of the application package are provided in the Guidelines for the Safety Assessment of Novel Foods and require data on the following [4], as applicable:
- History of use
- Dietary exposure
- Detail of novel process
- History of organism(s)
- Characterization of derived line/strain
- Genetic modification considerations
- Nutritional considerations
- Toxicology considerations
- Allergenicity considerations
- Chemical considerations
- Microbiological considerations
Ingredients that are imported for subsequent production will need to follow a similar process and provide the necessary documents for registration as listed under "(B) General Feed" below.
Depending on the trait, the registration process can take from 2 to as long as 10 years.
GMO registration [4,5]
Any novel trait that has not yet been reviewed by Health Canada or CFIA needs to be assessed by Health Canada (and/or CFIA if the new trait is used exclusively for animal feed). If positive, the process will lead to obtaining a novel food/novel trait "Letter of No Objection".
Canada has a positive list of "novel" foods that is a searchable database [4].
The main steps in the safety assessment are:
- A manufacturer, importer, or developer submits detailed information to Health Canada. They outline exactly how the product was developed.
- If the data provided is not complete, Health Canada scientists will ask the developer for more information and scientific data. Some products that do not meet Health Canada's strict criteria either have their submission closed by Health Canada, or withdrawn voluntarily by the manufacturer before a safety assessment is completed.
- Health Canada scientists may supplement the information submitted by the manufacturer with relevant published data from the larger scientific community.
- Health Canada scientists assess all the information available. The reviews take into consideration all the available evidence before making a final decision about the health and safety of a new GM food. [5]
(B) General Feed [6]
No registration is required for feed made in Canada from the ingredients listed in Schedules IV and V.
For IMPORTED feed, registration is required and whoever registers the feed, whether importer or manufacturer must have a Canadian address OR a Resident Agent identified to act on their behalf to register the product. The Canadian Food Inspection Agency (CFIA) is the authority for approval of registration.
Various conditions apply depending on the type of feed. Once registered, the feed is assigned a registration number. The registration process also includes the assessment and approval of the product label to be used in the Canadian marketplace. The registration number is required on any product labeling and import documentation as verification that the product has been registered as prescribed.
Registrations are granted for a 3-year period. The expiry date for registrations is March 31, 3 years after the date of registration. For example, feeds that are registered in 2016 will have an expiry date of March 31, 2019. Please note that this expiry date is applicable to registered feeds and ingredients, and those products listed in Part II of Schedule IV of the Feeds Regulations. Failure to apply to renew the registration of a feed or ingredient will automatically result in the expiry of the registration. If your registration expires, you will need to submit an application for a new registration for your feed or ingredient.
To avoid having your registrations expire, a complete renewal package must be sent to the Pre-market Application Submissions Office (PASO) before March 31 of the year in which it expires. If your registration expires, you may not import or sell your product until such time as it has been re-registered. Once re-registered, your product will be issued a new registration number.
Note: The renewal categorization and fee apply only in cases where no changes have been made to the product formula and label. Any amendment (significant or administrative) made to the registration, submitted at the time of renewal, should be stated in the cover letter, and you will need to include both the renewal fee and the applicable fee for the amendment.
The process for evaluating a renewal application is very similar to a new registration. The file is screened in, given a preliminary review, held pending receipt of additional information if requested by the evaluator, assessed, and then the notice of approval or rejection is sent to the registrant.
(B) Category [6,7]
No registration is required for mixed feed/supplements made in Canada from the ingredients listed in Schedules IV and V. All imported mixed livestock feeds must be registered and must be manufactured using only those ingredients that have been approved for use in livestock feeds in Canada and listed in Schedules IV and V (under Ingredient/Raw Material Section 6.2) prior to being imported into Canada. The Canadian Food Inspection Agency is the authority for approval of registration.
In the case where a mixed feed contains an unapproved ingredient, that ingredient must first undergo the feed ingredient approval process with the CFIA prior to the mixed feed being eligible for registration. Furthermore, any changes to the product formulation of an already registered feed would be considered a significant change requiring re-registration prior to import and sale in Canada.
Once registered, the feed is assigned a registration number. The registration process also includes the assessment and approval of the product label to be used in the Canadian marketplace. The registration number is required on any product labeling and import documentation as verification that the product has been registered as prescribed.
In addition to the feed ingredient approval process (if applicable), mixed feeds may be imported into Canada as long as the following criteria are fully met:
- The mixed feed has been registered by the CFIA and is labeled appropriately (using the approved product label)
- The registration number is clearly indicated on the product label and on the applicable import declarations
- Conform to the applicable safety standards outlined in Section 19 of the Feeds Regulations and RG-8 Regulatory Guidance: Contaminants in Feed
- Conform to any additional import conditions related to other acts and regulations, if applicable (for example, permit(s) to import; export certificates from the country of origin)
Some of the information that must be supplied in the application package for mixed feeds include [8,9]:
- Proposed feed label
- Sample of the feed
- Description of the feed, including a list of ingredients and the intended purpose of the feed
- Specifications of the feed, including appropriate guarantees
- 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
For feeds that are registered, a registration number will be assigned, and a registration certificate with an expiry date will be issued to the registrant.
Estimated cost: Mixed feed registration required for imported feeds - CFIA Fees - $100 - 475 CDN depending on the level of review [10].
(B) Product
A “Mixed Livestock Feed - Supplement” product should comply with the product registration requirements under “Ingredients", "General Feed”, and "Category" in Section 6.2 above.
6.3 Other Notes or Requirements
Product Notification
Not applicable.
Product Registration
(A) Ingredient/Raw Material
None.
(B) Product
Note on product registration/approval:
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
- Single-ingredient feeds that are not listed in Schedules IV and V
- Single-ingredient feeds that are listed in Schedules IV and V 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
- Flavoring 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:
- It bears a label with information in languages other than English or French.
- It bears a label claim that is not listed in the Tables of Permissible Claims for Feed Labels, or in the ingredient definition for Single ingredient feeds.
- It bears a label guarantee that is not listed in the Tables of Nutrient Guarantees and Conditions for Feed Labels or in the ingredient definition for a particular SIF.
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 license holder.
All imported mixed feeds can be registered by the manufacturer (which is a more efficient way to do this so that any importers can use the manufacturer's registration number to import the product) OR each Importer that imports the product can register the feed prior to importing it. Since there is often confidential information that the manufacturer may not wish to share with importers, it is usually the manufacturer that registers the feed.
Note: Whoever registers the feed, whether importer or manufacturer, they must have a Canadian address OR a Resident Agent is identified to act on their behalf and to whom any notice or correspondence may be sent. Legal fees are about $700 Cdn as a one-time setup. Consultant support for the registration process - $1500 - $3000 - recommended.
For importers to register the feed, they must be licensed and have a Canadian address.
6.4 Manufacturing Site Registration
General Feed
There is no registration required for the manufacturing site, but the site must demonstrate GMPs. [12]
Category
The category of “Mixed Livestock Feed” should comply with the manufacturing site registration requirements under the “General Feed” Section 6.4 above.
Product
A “Mixed Livestock Feed - Supplement” product should comply with the manufacturing site registration requirements under the “General Feed” Section 6.4 above.
6.4.1 Standard/Rules for Manufacturing Site
General Feed
GMPs (HACCP PCPs) [12].
Category
The category of “Mixed Livestock Feed” should comply with the standards/rules outlined in the “General Feed” Section 6.4.1 above.
Product
A “Mixed Livestock Feed - Supplement” product should comply with the standards/rules outlined in the “General Feed” Section 6.4.1 above.
6.4.2 Other Notes or Requirements for Manufacturing Site Registration
None.
6.5 References
1. RG-1 Regulatory Guidance: Chapter 1 – Administrative requirements for pre-market assessment and product registration of livestock feed
2. RG-1 Regulatory Guidance: Chapter 1 – Administrative requirements for pre-market assessment and product registration of livestock feed 1.3 The application package
3. RG-1 Regulatory Guidance: Feed Registration Procedures and Labelling Standards
4. Guidelines for the Safety Assessment of Novel Foods
5. Completed safety assessments of novel foods including genetically modified (GM) foods
6. RG-10 Regulatory Guidance Importing livestock feeds (mixed feeds and single ingredient feeds) into Canada
7. Licensing guidance for the proposed Feeds Regulations, 2022
8. Chapter 1 – Administrative requirements for pre-market assessment and product registration of livestock feed 1.3 The application package
9. Feed approval and product registration guidance for the proposed Feeds Regulations, 2022
10. CFIA Fees Notice
11. Chapter 1 – Administrative requirements for pre-market assessment and product registration of livestock feed 1.3 The application package
12. Feed import and export guidance for the proposed Feeds Regulations, 2022
Was this article helpful?