RG-1 Regulatory Guidance:
Feed Registration Procedures and Labelling Standards
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Table of contents
- Introduction – Regulation of Livestock Feed in Canada
- Legal authorities
- Regulation of livestock feeds
- Single Ingredient Feeds (SIF)
- New ingredients requiring an assessment
- Existing ingredients requiring an assessment
- Outcomes of an ingredient assessment
- Classification of ingredients fed to livestock
- Other applicable legislative authorities for imported feed ingredients
- Requesting a copy of Schedules IV and V
- Mixed feed
- Standard vs specialty feed
- Pre-market assessment
- Product registration
- Feeds requiring registration: Do I need to register my product
- Research exemptions and authorizations
- Chapter 1 – Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed
- Chapter 2 – Data Requirements for Single Ingredient Approval and Feed Registration
- Chapter 3 – Specific Registration Information by Feed Type
- Chapter 4 – Labelling and Guarantees
- Chapter 5 – Research with Livestock Feeds
- Chapter 6 – Sampling and Laboratory Requirements
- Chapter 7 – Additional Information
- Chapter 8 – Pre-submission consultation procedures for livestock feed
Introduction – Regulation of Livestock Feed in Canada
The manufacture, sale and import of livestock feeds are regulated in Canada under the Feeds Act and Regulations administered by the Canadian Food Inspection Agency (CFIA). All feeds must be safe to livestock; to humans (by the potential transfer of residues into human food, that is, meat, milk and eggs, and via worker/bystander exposure); and to the environment.
Feeds must also be shown to be effective for their intended purpose. Approved feed ingredients are listed and defined in Schedules IV and V of the Feeds Regulations, with appropriate guarantees, standards and labelling requirements. All imported feeds must meet the same standards as domestic feeds.
Both industry and government share the responsibility for safe and effective feeds, and ultimately our food. The CFIA uses a number of tools, including consultation, publication of information (for example, the CFIA website), awareness campaigns, inspection activities and other initiatives to inform regulated parties of the requirements. Regulated parties must make themselves aware of the regulatory requirements with which they need to comply.
Under the authority of the Feeds Act and Regulations and the Health of Animals Act and Regulations, the CFIA administers a national feed program. There are two key components – mandatory pre-market assessment and the National Feed Inspection Program.
This document (the RG-1) is intended to help you determine whether your feed is subject to the requirements of the Feeds Act and Regulations, as well as to assist you in preparing and submitting an application for pre-market assessment for feed ingredient approval and/or feed product registration. Specific chapters of the RG-1 provide more detailed information on requirements for specific categories of feeds and feed ingredients.
The legislative authorities under which the CFIA regulates feeds include the following:
For the regulation of feeds and feed labelling:
- Feeds Act
- Feeds Regulations
- Health of Animals Act
- Health of Animals Regulations
- Organic Products Regulations
For the collection of fees:
Canadian Food Inspection Agency Fees Notice
Part XIV of the Health of Animals Regulations contains several regulatory measures associated with the production of animal food (feed containing an animal product or by-product) and the feeding of livestock. This includes a prohibition on feeding ("feed ban") of most proteins derived from ruminants (defined as "prohibited material") to ruminant animals, such as cattle, sheep, goats and deer. It also includes requirements for anyone who manufactures, imports, packages, stores, distributes, sells, or advertises for sale animal food for ruminants (and other animal species as specified in section 171.(1) of the Regulations) to keep records (for 10 years) that contain the lot number and any other information used to identify each lot of animal food.
Under the Canada Organic Regime, the Organic Products Regulations define specific requirements for products labelled as organic, including livestock feeds, or that bear the approved organic agricultural product legend (logo), and are sold inter-provincially or are imported.
Please note that other regulations, administered either by the CFIA or another department or agency of the Government of Canada, may also apply, depending on the type of feed or ingredient for example the Food and Drugs Act and Regulations and Pest Control Products Act and Regulations.
Regulation of livestock feeds
"Feed" is defined under section 2 of the Feeds Act as:
"… any substance or mixture of substances containing amino acids, anti-oxidants, carbohydrates, condiments, enzymes, fats, minerals, non-protein nitrogen products, proteins or vitamins, or pelletizing, colouring, foaming or flavouring agents and any other substance manufactured, sold or represented for use
- for consumption by livestock,
- for providing the nutritional requirements of livestock, or
- for the purpose of preventing or correcting nutritional disorders of livestock,
or any substance for use in any such substance or mixture of substances".
Feeds for the following species of livestock are currently regulated under the Feeds Act and Regulations: cattle, horses, sheep, goats, swine, poultry (chickens, turkeys, ducks, geese), fish, foxes, mink, and rabbits.
Feeds for other species are exempt from the Feeds Act and Regulations. However, they may still be subject to import or export requirements under other authorities administered by the CFIA.
Information on the importation of commodities regulated by the CFIA is available from the Automated Import Reference System (AIRS).
For further information relating to imports or exports of these products, please contact the Centre of Administration (CoA). The CoA is responsible for carrying out administrative tasks related to granting permissions (licenses, permits and registrations) for commercial operators and for travelers.
Products that are administered to livestock through either feed or water for therapeutic purposes may be considered as veterinary drugs, which are subject to the Foods and Drugs Act and Regulations administered by the Veterinary Drugs Directorate of Health Canada. More information on the classification of feeds and veterinary drugs is available in a guidance document posted on the Health Canada website.
Single Ingredient Feeds (SIF)
A "Single Ingredient Feed" is defined in the Feeds Regulations as "any substance or mixture of substances that is assessed or evaluated as being acceptable for use in feeds and that is described in an item of Schedule IV or V". Single ingredient feeds are typically referred to as "ingredients".
Schedule IV is divided into eight classes reflecting the definitions and approved purpose of the feed ingredient. The first seven ingredient classes are nutritional in nature including forages and roughages, silages, energy feeds, protein feeds, mineral products, and vitamins and yeast products. Class 8 lists miscellaneous ingredients reserved mainly for those ingredients with non-nutritive or technological roles in feeds. Schedule V is specifically for approved flavoring ingredients used in small quantities to flavor feeds including extracts, oils and chemicals.
Schedules IV and V are each further divided into Part I or Part II ingredients. Whether an ingredient is listed in either Part is based on whether the specific ingredient source poses safety or efficacy concerns and whether these concerns can be mitigated by restrictions within the definition (for example, use restrictions, warning or caution statements, maximum levels of contaminants), or significant variability exists to warrant a separate ingredient assessment for each source.
Part 1 of Schedules IV and V
Ingredients listed in Part I of Schedules IV and V have been evaluated for both safety and efficacy. These approved ingredients are listed in Schedule IV or V with appropriate definitions and conditions. They are exempt from registration and may be imported, sold and used freely in the manufacture of feeds in Canada, provided they conform to the ingredient definition as listed, are labeled as prescribed including required guarantees and meet standards identified in the regulations and further defined in regulatory guidance (for example, RG-8 Regulatory Guidance: Contaminants in Feed).
Part I ingredients may not have extra label guarantees or claims. Ingredients with extra label guarantees or claims that are not prescribed in the Feeds Regulations require pre-market assessment and approval.
Part II of Schedules IV and V
Ingredients in Part II Schedule IV and V are not exempt from registration. As 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. Each source of these ingredients must, therefore, be registered with information/data to support the safety and/or efficacy of the product.
Any ingredient that is not currently listed in, or that does not meet the definition provided in Schedule IV or V, must be approved by the CFIA prior to use for feeding livestock. Ingredients which are found to be unsafe or unsuitable, or where the information submitted is insufficient to substantiate safety and an intended feed purpose are not approved.
New ingredients requiring an assessment
Ingredients which 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 AFD does accept data that has been used to support ingredient approval in other jurisdictions.
Existing ingredients requiring an assessment
Any single ingredient feed that is listed in Schedule IV or V that 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
- it's safety
- the species or class of livestock intended to be fed and the usage rate, and
- its purpose as set out in the Schedules IV and V
requires a new safety and/or efficacy assessment(s)
Outcomes of an ingredient assessment
Following an assessment, a decision is made regarding the ingredient approval. The decision can fall into one of the following categories.
- Feed is not approved for various reasons
- for example, the applicant has not provided sufficient information to substantiate safety and efficacy end-points, application is withdrawn
- Feed is approved with conditions
- Some conditions may be written in the approval letters (for example, herbicide tolerant corn where the approval is specific to the grain and not the forage) or ingredient definition (for example, only approved for specific animal species, contains a maximum inclusion rate, labelled with specific guarantees for safe usage, warning and caution statements)
- Feed is approved without conditions
For feed ingredients with a positive assessment outcome, the assessment also ensures that the feed is accurately categorized and defined in the Schedules, and that it is labelled appropriately for safe, effective use and for consumer protection. A decision regarding in which part of the Schedules (that is, Part I or II) to list the ingredient is decided at the end of the assessment process. The following decision outcomes can happen:
- creating a new ingredient definition
- modifying an existing ingredient definition, or
- a new definition is not warranted as the ingredient under review meets an existing ingredient definition as defined in Part I or II of Schedules IV or V
Classification of ingredients fed to livestock
In order for an ingredient to be assessed and authorized as a feed ingredient by the CFIA, it must first be classified as a feed. There are other substances that can be orally consumed by livestock which are not feed and are regulated differently. These include therapeutic (drug) products (regulated under the Food and Drugs Act), pest control products (Pest Control Products Act) and veterinary biologics (Health of Animals Act). This can lead to confusion, especially for foreign companies as products may be regulated differently in foreign jurisdictions.
Products such as coccidiostats and histomonostats are regulated as veterinary drugs in Canada, but are considered feed additives in the European Union (EU). Other types of products such as microbial products may have a different classification depending on the purpose or mode of action associated with them. Additionally, the use rate of an ingredient, the method of administration and types of claims associated with it can all have an impact on how the product is classified in Canada. Recognizing a need for a clear and transparent classification process for some ingredients and products intended for use in livestock species, the CFIA works collaboratively with Health Canada (HC) and, after extensive consultation, has developed guidance on veterinary drug and animal feeds classification in Canada. Please consult the Guidance Document on Classification of Veterinary Drugs and Animals Feeds.
This Guidance outlines the present approach to the classification of veterinary drugs and feeds, and provides interpretations and definitions. This guidance document is intended to assist proponents seeking to have new products assessed and authorized for marketing in Canada with determining what constitutes a veterinary drug or a feed and where to direct their applications accordingly. Since the initial posting, a working group from HC and the CFIA, in consultation with stakeholders, has added further clarification for the classification of ingredients and products. The working group also provides joint decisions on ingredients and products submitted for classification.
Other applicable legislative authorities for imported feed ingredients
It should be noted that although an ingredient may be listed within Schedule IV or V, other regulatory authorities respecting either animal or plant health, may prohibit or place additional conditions on the importation of livestock feed ingredients. Additional information on the importation of commodities regulated by the CFIA is available from the Automated Import Reference System (AIRS).
For further information relating to imports or exports of these products, please contact the Centre of Administration (CoA).
Requesting a copy of Schedules IV and V
To request a copy of the most recent version of Schedules IV and V, please send an e-mail with the subject line "Schedules IV and V" to the Animal Feed Division (AFD) at: firstname.lastname@example.org
Ingredients may be fed solely to livestock, however they are typically mixed together to manufacture various types of mixed feeds. A mixed feed is a feed that contains two or more single ingredient feeds. All mixed feeds must only be manufactured using ingredients that have been approved for use and listed in Schedules IV and V.
Standard vs specialty feed
Many mixed feeds (for example, premixes and supplements) may be used in the manufacture of complete feeds or rations; however, these are considered "standard feed". Some mixed feed may be dilutions of ingredients (on carriers) or combinations of miscellaneous ingredients (such as those listed in Class 8 of Part I and II of Schedule IV and of Schedule V) with the intent of acting as an additive or a providing a specific function. The AFD refers to these products as "specialty feed" and are similar to the "feed additive" terms used by the European Union. Examples of some "specialty feed" categories include:
- buffer feeds
- enzyme supplements
- flavouring agents
- mould inhibitors
- odour control agents
- pellet binders
- feed and animal product colouring/pigment agents
- viable microbial products and
- yeast cell wall products
- anti-caking agents
The Feeds Act and Regulations currently provide authority to the CFIA for pre-market assessment, which consists of two elements: assessment of new ingredients for approval/authorization, and product registration.
The CFIA evaluates and regulates all feed ingredients in the same manner. Any feed ingredient that is new (that is, not already listed in Schedules IV and V of the Feeds Regulations), or has been modified such that it differs significantly from a conventional ingredient such as composition, manufacturing process, and/or use, is required to undergo a pre-market assessment and approval.
The purpose of all feed assessments is the same: to verify that the feed ingredient is safe (in terms of animal health, human health via food residues and worker/by-stander exposure, and the environment) and effective for its intended purpose prior to marketing.
A risk assessment framework is a key component of the safety and efficacy assessment. Following a positive assessment, the review also ensures that the feed is accurately defined in the Feeds Regulations so that they are labelled appropriately for safe and effective use and for consumer protection.
The specific requirements for a safety and efficacy assessment of a feed ingredient are dependent on the nature of the feed in question. Data requirements are tailored to familiarity, purpose and complexity of the product. The CFIA provides guidance to stakeholders on how to meet the data requirements for the assessment process through workshops, one-on-one consultations and the publication of guidance documents, including this document (RG -1, Regulatory Guidance: Feed Registration Procedures and Labelling Standards).
Once a new ingredient has been evaluated and found to be safe and effective as a feed, it is listed in either Part I or Part II of Schedule IV or V under the Class that corresponds to the purpose of the ingredient and risk. Part II SIFs are assigned a proprietary registration number.
Ingredients listed in Part I of either schedule are exempt from registration; provided that they meet the standards for composition described in the ingredient definition, meet the standards as defined, and are labelled appropriately. Ingredients with additional label guarantees, claims, or with languages other than English or French are, however, subject to registration. Ingredients that are listed in Part II of either schedule must be registered separately by the CFIA for each source. Each source of the ingredient that is listed in part II of Schedule IV or V must be registered by the CFIA.
Many complete feeds, supplements and macro premixes are exempt from registration provided that they comply with all standards and labelling requirements set out in the Feeds Regulations.
Specialty feeds, as described above, must be registered. Similarly to Schedule IV, Part II ingredients, the specific requirements for an efficacy and/or safety assessment for specialty feeds are dependent on the category in question, and guidance on how to meet the data requirements for the assessment process is provided in Chapter 3 of the RG-1.
Feeds requiring registration: Do I need to register my product
You will need to register your livestock feed if:
- you are importing a single ingredient feed into Canada, and it is not a single ingredient feed listed in Schedule IV, Part 1 of the Feeds Regulations
- you are importing into Canada a single ingredient feed listed in Schedule IV, Part 1, that has additional label guarantees or claims, or is labelled with languages other than English or French (see Chapter 4, section 4.11, for more information)
- you are manufacturing or importing a single ingredient feed listed in Part II of Schedule IV of the Feeds Regulations
- you are importing a mixed feed (a combination of two or more single feed ingredient feeds) for livestock into Canada; or
- you are manufacturing a feed in Canada that does not meet the criteria for exemption from registration as described in the Feeds Act and Regulations;
- you are manufacturing or importing a specialty feed, mineral feed, converter feeds, fox feed; milk replacer and any other milk substitutes
- You are manufacturing or importing complete feeds, supplements, and macro premixes, for all livestock, labelled with nutrient guarantee levels outside the ranges indicated in Table 4 (Schedule I) of the Feeds Regulations
If you are not certain whether your feed is subject to registration after reading this guidance document and the regulations, you may request a review of your feed label. Please send an email with the subject line "Label Review" a copy of the proposed label, and description of the product to the AFD at: email@example.com.
Research exemptions and authorizations
If a proponent wishes to conduct research on a feed that does not meet the regulatory requirements (that is, is not registered as prescribed, contains an approved ingredient that does not meet the purpose or description as listed in Schedules IV and V of the Feeds Regulations, or is an unapproved feed ingredient), they may need to submit an application for a Research Exemption or an Authorization of Novel Feed for Research Purposes to the AFD.
For more information, please consult Chapter 5 of the RG-1, Research with Livestock Feeds.
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