Proposed guidance on how to determine when a plant-derived ingredient requires a feed pre-market assessment

On this page

• 1. Introduction
  • 1.1 Scope
  • 1.2 Regulatory authority
  • 1.3 National feed program
  • 1.4 Regulatory oversight of livestock feed ingredients
  • 1.5 Exemptions from the Feeds Act and Feeds Regulations
  • 1.6 Regulatory oversight of novel feed ingredients – important concepts for novelty determination
  • 1.7 Responsibilities under the Feeds Act and Feeds Regulations
  • 1.8 Basis for the proposed guidance
  • 1.9 Plant breeding practices that support feed safety
  • 1.10 Release of non-novel feed ingredients
• 2. Criteria to determine if a plant-derived ingredient would require a pre-market assessment
  • 2.1 Categories of plant-derived ingredients that would require a feed pre-market assessment in Canada
• 3. Rationale for criteria
  • 3.1 Ingredient that is not listed in schedule IV or V
  • 3.2 Ingredient that is listed in part II of schedule IV or V
  • 3.3 Ingredient that is listed in part I of schedules IV or V, however it does not meet the ingredient definition
  • 3.4 Ingredient that is listed in part I of schedules IV or V, however it contains a novel trait
    • 3.4.1 Ingredient from a plant containing foreign DNA
    • 3.4.2 A new nutrient is expressed in the plant
    • 3.4.3 The level of an endogenous nutrient is outside the documented range for that plant species
    • 3.4.4 The bioavailability of an endogenous nutrient is changed
    • 3.4.5 A new secondary metabolite is expressed in the plant or the level of an endogenous secondary metabolite is increased, impacting the safety or use of the ingredient
    • 3.4.6 The genetic modification to the plant alters an endogenous protein in a way that introduces or increases similarity with a known allergen or toxin relevant to animal or human health
    • 3.4.7 A new toxin, allergen or anti-nutrient is expressed in the plant, or the level of an endogenous toxin, allergen or anti-nutrient is increased beyond the documented range for that plant species
  • 3.5 Ingredient with a claim
• Appendix 1: Novelty determination work sheet for plant ingredients

1. Introduction

1.1 Scope

This new guidance clarifies what plant-derived feed ingredients require a pre-market assessment, as per the Feeds Act and Feeds Regulations, including how to make a novelty determination of ingredients derived through plant breeding destined to be used in livestock feeds. This guidance will supplement the existing "Guidelines for the assessment of novel feeds: Plant sources."

This guidance does not address the determination of whether a plant-derived product is a novel food (regulated under the Food and Drug Regulations) or a plant with a novel trait (PNT), subject to part V of the Seeds Regulations. Information on determining whether a plant is considered a novel food or a PNT is available in:

• Health Canada's Guidelines for the Safety Assessment of Novel Foods
• Canadian Food Inspection Agency's (CFIA) Directive 2009-09: Plants with novel traits regulated under part V of the Seeds Regulations: Guidelines for determining when to notify the CFIA

1.2 Regulatory authority

The manufacture, sale and import of livestock feeds are regulated in Canada under the Feeds Act and Feeds Regulations. All feeds must be safe, to livestock; to humans (via 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. Overall, safe feeds contribute to the production of healthy livestock and safe foods of animal origin for consumers.

Feed ingredients are listed and defined in schedules IV and V of the Feeds Regulations with appropriate guarantees, standards, and label requirements. All imported feeds must meet the same standards as domestic feeds.

1.3 National feed program

The Canadian Food Inspection Agency (CFIA) administers a national feed program which includes a pre-market assessment process for feeds that require an approval or registration. The purpose of all feed pre-market assessments is the same: to ensure that the feed ingredient is safe and effective for its intended purpose. The CFIA also verifies that the feed is labelled appropriately. The Feeds Regulations require a proponent to submit a pre-market application and the CFIA to evaluate this information in order to establish if the feed is safe and efficacious before it can be manufactured in, sold in, or imported into Canada.

1.4 Regulatory oversight of livestock feed ingredients

The CFIA evaluates and regulates all feed ingredients, including novel feeds, in the same way. Any feed ingredient that is not already listed in schedule IV or V of the Feeds Regulations, or that has been modified in such a way that it is significantly different from a conventional ingredient listed in schedule IV or V, must undergo a pre-market assessment and approval before it can be manufactured in, sold in or imported into Canada as a feed ingredient.

Schedules IV and V of the Feeds Regulations are approved lists, with definitions and descriptions, of feed ingredients that can be fed to livestock according to the purpose or function of the ingredient in the diets of the various livestock species. The schedules are divided into 2 parts:

Part I feed ingredients in schedules IV and V:

• have been evaluated for both safety and efficacy
• are listed and defined in schedules IV and V with appropriate guarantees, standards, and label requirements
• are exempt from the registration requirement 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 labelled as prescribed including required guarantees, and
  • meet standards identified in the Feeds Regulations and further defined in regulatory guidance (for example, RG-8 Regulatory Guidance: Contaminants in Feed)
• must comply with the same standards (for example, contaminants, ingredient definitions) and labelling provisions as other feeds requiring registration and may not have extra label guarantees or claims
  • Feed ingredients with extra label guarantees or claims that are not prescribed in the Feeds Regulations or an ingredient that contains a novel trait require a pre-market assessment for approval and/or registration

Part II feed ingredients in schedules IV and V:

• are not exempt from the registration requirements of the Feeds Regulations as there may be inherent safety and/or efficacy variations associated with an individual source of the ingredient or introduced via the manufacturing process
• each source of these ingredients must be registered with information/data to support the safety and/or efficacy of the ingredient

Feed ingredients derived from plants that do not require a pre-market assessment are still regulated under the Feeds Act and Feeds Regulations if manufactured, sold or imported into Canada. These feeds must comply with the same standards (for example, contaminants, ingredient definitions) and labelling provisions as other feeds requiring a pre-market assessment.

In certain circumstances, it may be beneficial and of economic value for regulated parties to seek an approval for a modified plant ingredient that is not novel (for example, has lower toxin levels) as they may want to distinguish the new feed ingredients from their conventional counterparts (for example, meal and oil from canola quality Brassica napus verses non-canola quality Brassica napus). In such cases, the onus of seeking the approval may not be on the variety developer^{Footnote 1} but rather on other proponents such as the grain/ingredient manufacturers or industry associations.

1.5 Exemptions from the Feeds Act and Feeds Regulations

The Feeds Act does not apply to a feed that is manufactured by a livestock producer if it is not sold and has been incorporated into it any drug or other substance that presents a risk of harm to human or animal health or the environment.

With respect to novel feeds, the Feeds Regulations stipulate that no person shall release a novel feed unless the person has provided notification to the minister and has received approval from the minister.

1.6 Regulatory oversight of novel feed ingredients – important concepts for novelty determination

The Feeds Regulations require an applicant to submit a pre-market application and the CFIA to evaluate that the information in that application establishes that the feed is safe and efficacious before it can be manufactured in, sold in, or imported into Canada. The scope of the pre-market assessment process is delineated by the definitions of novel feed and novel trait in these regulations. When a feed is "novel", the regulations require pre-market notification and regulatory approval before manufacture in, sale in or import into Canada.

Novel feed is defined in the Feeds Regulations as:

• a feed, comprising an organism or organisms, or parts or products thereof, that
  1. (a) is not set out in schedule IV or V, or
  2. (b) has a novel trait
• novel trait, in respect of a feed, means a characteristic of the feed that
  1. (a) has been intentionally selected, created or introduced into the feed through a specific genetic change, and
  2. (b) based on valid scientific rationale, is not substantially equivalent, in terms of its specific use and safety both for the environment and for human and animal health, to any characteristic of a similar feed that is set out in schedule IV or V

Any ingredient derived from an organism that is not currently listed in, or that does not meet the definition provided in schedule IV or V is considered novel and must be approved by the CFIA prior to manufacture in, sale in or import into Canada. 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.

Novelty determination of plant-derived ingredients that are listed in part I of schedule IV or V is based on a comparison of the plant with the conventional plant already approved in the Canadian marketplace for livestock feed use^{Footnote 2}. Plant-derived ingredients are novel if they are not listed in schedule IV or V of the Feeds Regulations, and/or if they contain a novel trait. The Guidelines for the assessment of novel feeds: Plant sources describe the data requirements that must be addressed in a submission.

1.7 Responsibilities under the Feeds Act and Feeds Regulations

It is prohibited to sell, manufacture or import a feed that presents a risk of harm to human or animal health or the environment. It is the responsibility of proponents to be compliant with the Feeds Act and Feeds Regulations. Proponents are not required to notify the CFIA if they have determined that their plant-derived feed ingredient does not require a pre-market assessment under the Feeds Regulations. However, as administrators of the Feeds Act and Feeds Regulations, the CFIA must be satisfied with this determination and may ask the proponent to provide supporting scientific evidence. The CFIA will review this information and may request clarification or additional data before reaching a conclusion.

In addition, it is the responsibility of a proponent to contact the CFIA if new information pertinent to the risk of harm to human or animal health or the environment becomes available. The CFIA will review this information and provide an opinion regarding the potential risk.

The CFIA is available to provide regulatory opinions on a case-by-case basis. A proponent may request an opinion from the CFIA about whether a plant-derived feed ingredient would require a pre-market assessment. The CFIA will review the request and respond with a written opinion. More information about data review or requesting an opinion for livestock feed.

Proponents are encouraged to contact the CFIA in cases where they have questions or are unsure of their novelty determination. Interactions with the CFIA are especially beneficial for proponents who do not have experience with the Canadian feed regulatory system. For technical questions, email the CFIA's Animal Feed Program at: cfia.afp-paa.acia@inspection.gc.ca.

Any information provided to the CFIA is subject to the Access to Information Act and the Privacy Act and will be protected in accordance with these acts. Information submitted to the CFIA may be made available to the public in accordance with these acts.

1.8 Basis for the proposed guidance

Canada's regulatory oversight of plant products of biotechnology is based on the traits/characteristics of the product, regardless of how it was developed. To date, this has been interpreted in a way that has not taken account of whether the breeding method used to develop the plant is well characterized as safe.

Furthermore, technological advancements in plant biotechnology have created new tools of genetic modification (collectively referred to as gene editing^{Footnote 3} technologies) that enable plant developers to produce new plant varieties with precise and efficient targeted genetic modification. In particular, these tools have the ability to silence or alter the behaviour of endogenous plant genes. Over the past 25 years, the CFIA has assessed a large number (greater than 130) of novel feed ingredients derived from plants developed using plant breeding technologies, including mutagenesis and transgenic techniques.

Agricultural stakeholders have highlighted the need for greater clarity and predictability regarding which products of plant breeding, including those developed using gene editing technologies, would be considered a novel feed subject to pre-market assessment under the Feeds Act and Feeds Regulations. Making use of its past experience and the current scientific knowledge in plant breeding technologies, the CFIA is proposing to introduce supplementary guidance by clarifying and defining characteristics of a feed that could result in a novel feed ingredient as per the Feeds Regulations (described in section 2, Criteria to determine if a plant-derived ingredient would require a pre-market assessment).

1.9 Plant breeding practices that support feed safety

To ensure feed safety and compliance with the Feeds Act and Feeds Regulations, there is an expectation that plant developers rigorously analyze and understand their new plant varieties in relation to feed safety^{Footnote 4} during the breeding process prior to commercialization and throughout the commercial lifespan of the plant variety, including one that is developed using biotechnology. In-depth plant characterization is necessary to identify and mitigate against possible unintended hazards for feed safety in a plant as a result of an intentionally developed characteristic. These characterizations also provide assurance to the CFIA that any consequences of new characteristics are well-understood in relation to feed safety, including the potential risk of harm to human or animal health or the environment.

The following points represent CFIA's understanding of plant developer practices and competencies relating to the full characterization of a new product of plant breeding, regardless of the methods used in its development and selection.

1. Plant developers are experts in the plant variety that they developed. For novelty determination, developers consider the feed ingredient(s) derived from the modified plant in comparison to approved feed ingredients listed in part I of schedules IV and V, in terms of use and safety for livestock feeds. This means that:
   • developers understand the typical range of important analytes that make up the nutrients, secondary metabolites, anti-nutrients, allergens and toxins of the plant variety they are developing or have developed
   • developers understand the intended characteristic(s) in their new plant variety and how it can influence the exposure of livestock, humans and the environment to nutrients, secondary metabolites, anti-nutrients, allergens and toxins of the plant-derived ingredient; and
   • developers are aware of expected end uses of their ingredients and how these end uses influence the exposure of livestock, humans and the environment to nutrients, secondary metabolites, anti-nutrients, allergens and toxins of the plant-derived feed
2. Plant developers are current in their knowledge of how the intended characteristic(s) may affect the expression of other characteristics, and how this may affect feed use and safety. For example, considerations may include how changes in a metabolic pathway could influence nutrient bioavailability, or lead to the accumulation of other metabolites that may have allergenic and/or toxic and/or anti-nutritional properties.
3. Plant developers consider whether there are possible impacts on feed safety and use linked to the new characteristics that they have or plan to introduce in the plant. In this sense, plant developers are considering hypotheses involving altering the levels of nutrients, secondary metabolites, anti-nutrients, allergens, and toxins.
4. Throughout the plant development process, any plants with characteristics that may negatively affect the safety and use of the feed derived from the modified plant are noted and discarded.
5. Following commercialization, plant developers carefully observe their plant varieties for characteristics that can negatively impact the safety and use of the feed derived from the modified plant in relation to the plant variety with which they are working. Any plants observed to possess characteristics that can negatively affect feed safety are discarded.

1.10 Release of non-novel feed ingredients

If a plant ingredient is not a novel feed, the Feeds Regulations do not require a pre-market assessment and approval before being manufactured, sold or imported into Canada. Feed ingredients derived from plants that do not require a pre-market assessment are still subject to regulation under the Feeds Act and Feeds Regulations. Furthermore, the plant-derived products must also comply with the requirements of other applicable legislation, including but not limited to the Food and Drugs Act, and the Seeds Act.

Even when a feed ingredient is not considered novel, the Government of Canada expects proponents to fully participate in available mechanisms that promote and support transparency. Regardless of the breeding method used, transparency regarding the technologies used to develop a plant line enables producers and consumers to benefit from the technologies and production systems that best meet their needs. These mechanisms can include:

• Best practices for introducing new plant lines to the marketplace, as established by industry and commodity associations
• Government-led databases of non-novel products, such as the Health Canada Transparency Initiative, and
• Industry-led seed databases and catalogues, such as the Canadian Variety Transparency Database

2. Criteria to determine if a plant-derived ingredient would require a pre-market assessment

Any feed ingredient that is new (for example, not already listed in schedule IV or V of the Feeds Regulations), or has been modified such that it differs significantly from a conventional ingredient, is required to undergo a pre-market assessment and approval.

For the Feeds Act and Feeds Regulations to apply, the ingredient derived from the plant needs to:

• meet the definition of a feed under the Feeds Act, and
• be represented for use by livestock species as defined in the Feeds Act and Feeds Regulations

Note that this guidance includes a worksheet (see appendix 1) to help facilitate how to determine if a plant ingredient requires a feed pre-market assessment.

2.1 Categories of plant-derived ingredients that would require a feed pre-market assessment in Canada

The following 5 categories of plant-derived feed ingredients would require a pre-market assessment in order to determine their impact on feed safety and efficacy, including impacts on animal health, human health and the environment:

1. Ingredient that is not listed in schedule IV or V
2. Ingredient that is listed in part II of schedule IV or V
3. Ingredient that is listed in part I of schedules IV or V, however it does not meet the ingredient definition
4. Ingredient that is listed in part I of schedules IV or V, however it contains a novel trait:
   1. 4.1. Ingredient from a plant containing foreign DNA
   2. 4.2 A new nutrient is expressed in the plant
   3. 4.3. The level of an endogenous nutrient is outside the documented range for that plant species such that:
      1. 4.3.1 The level of the nutrient exceeds Maximum Nutrient Values; and/or
      2. 4.3.2 The use rate of the ingredient differs from that of the conventional ingredient
   4. 4.4. The bioavailability of an endogenous nutrient is changed such that:
      1. 4.4.1 The level of the nutrient exceeds the Maximum Nutrient Values; and/or
      2. 4.4.2 The use rate of the ingredient differs from that of the conventional ingredient
   5. 4.5 A new secondary metabolite is expressed in the plant or the level of an endogenous secondary metabolite is increased, impacting the safety or use of the ingredient
   6. 4.6 The genetic modification to the plant alters an endogenous protein in a way that introduces or increases similarity with a known allergen or toxin relevant to animal or human health
   7. 4.7 A new toxin, allergen or anti-nutrient is expressed in the plant, or the level of an endogenous toxin, allergen or anti-nutrient is increased beyond the documented range for that plant species
5. Ingredient with a claim^{Footnote 5}

3. Rationale for criteria

For the Feeds Act and Feeds Regulations to apply, the feed ingredient derived from the plant needs to:

• meet the definition of a feed under the Feeds Act
• be represented for use to livestock species as defined in the Feeds Act and Feeds Regulations

Meet the definition of a feed under the Feeds Act

In order for an ingredient to be assessed and approved as a feed ingredient by the CFIA, it must first be classified as a feed^{Footnote 6}. There are other plant-derived ingredients that can be orally consumed by livestock which are not feed and are regulated differently. These include veterinary drugs (regulated under the Food and Drugs Act), pest control products (Pest Control Products Act), and veterinary biologics (Health of Animals Act). The regulatory oversight of an ingredient will depend on its associated purpose or mode of action. Additionally, the use rate of an ingredient, the method of administration and the types of claims associated with it can all have an impact on how the ingredient is classified in Canada. However, ingredients consumed by livestock species are largely regulated as either veterinary drugs or livestock feeds. Recognizing a need for a clear and transparent classification process for some ingredients and products intended for use in livestock species, a guidance document on classification of veterinary drugs and livestock feeds has been developed to assist applicants in the classification.

Represented for use to livestock species as defined in the Feeds Act and Feeds Regulations

Although a primary plant ingredient may not be destined for consumption by livestock^{Footnote 7}, it is important for an applicant to consider the entire "life cycle" of plant ingredients derived from their modified plant as the Feeds Act and Feeds Regulations may apply to these ingredients. For example, feed ingredients can be recycled food products, which are materials that remain after, or are produced during, the processing, manufacture, preparation or sale of human food. Other examples include industrial applications such as ethanol production from corn, where by-products such as corn distillers' grains are routinely sold as livestock feeds. Any ingredient derived from a plant that is manufactured in, sold in or imported into Canada for livestock feeds is regulated under the Feeds Act and Feeds Regulations.

Plant-derived feed ingredients that would require a feed pre-market assessment

3.1 Ingredient that is not listed in schedule IV or V

Plant-derived ingredients not listed or described in schedules IV or V of the Feeds Regulations are novel feeds and require pre-market assessment and approval. It is important to consider all plant parts or ingredients manufactured (for example, meal, oil, extracts) from the plant that can be fed to livestock and verify if they are approved and listed in the schedules. For example, plant varieties that have new characteristics that result in a plant part or tissues (not currently used as feed ingredients) becoming suitable for feed use, are "novel feeds" and require pre-market assessment and approval.

3.2 Ingredient that is listed in part II of schedule IV or V

Part II of schedules IV and V lists ingredients for which there are safety and/or efficacy considerations associated with different sources. Each new source of any ingredient listed in part II of schedule IV or V requires a pre-market assessment for registration of the ingredient, regardless of whether it has been modified or not.

3.3 Ingredient that is listed in part I of schedules IV or V, however it does not meet the ingredient definition

Feed ingredients that appear in part I of schedule IV or V of the Feeds Regulations but do not meet the definition as listed would require a pre-market assessment. It should be noted that all aspects of the ingredient definition must be met (that is, the purpose of the feed ingredient under the schedules, feed ingredient name and definition, including how it is manufactured, guaranteed analysis, labelling requirements, and species specified if applicable). For example:

• use rate
  • Certain feed ingredients have a prescribed use limit or a maximum inclusion rate outlined in their respective schedule IV or V definition
  • In addition, the definition may limit the use to specific livestock species or classes (for example, fish feed only)
  • If the use is different than what is prescribed in the schedules, a pre-market assessment is required
• purpose
  • Every ingredient used in livestock feeds has a specific purpose
  • In schedules IV and V, feed ingredients are classified into different classes based on their major functions, either for nutritional or non-nutritional purposes (for example, protein, energy, anti-caking, gut modifier)
  • In some cases, where the ingredient(s) derived from the plant is to be used for a function different or additional to what it is typically used for in livestock feeds, it would cause the derived feed to be considered a novel feed requiring pre-market assessment
• manufacturing
  • Feeds manufactured from processing techniques that differ from the processing techniques used for the conventional ingredient (for example, resulting in a change, addition, or removal of a feed processing technique) would require a pre-market assessment as new safety considerations may need to be considered
  • As examples, this could include the use of different extraction chemicals, lower processing temperatures, or no filtration steps

3.4 Ingredient that is listed in part I of schedules IV or V, however it contains a novel trait

This section describes plant-derived ingredients that, when compared to existing ingredients in part I of schedule IV and V, would require a pre-market assessment under the Feeds Regulations due to a novel trait. The section will focus on modifications in the plant that impact the safety and/or use of the feed, and will provide clarity for applicants to determine if their feed ingredient derived from the modified plant contains a novel trait and requires a pre-market assessment.

In this section, plant compositional changes are defined as changes to the levels of nutrients, anti-nutrients, allergens, toxins or secondary metabolites within a feed ingredient derived from plant breeding such that they fall outside the documented range typically found for that plant.

3.4.1 Ingredient from a plant containing foreign DNA

A pre-market assessment is required for feed ingredients derived from a plant that has been genetically modified such that the plant intended for commercialization contains foreign DNA^{Footnote 8}.

For gene-edited plants, DNA that encodes gene editing machinery (for example, Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Cas protein(s) and associated guide Ribonucleic acids (RNAs) is considered to be foreign DNA if present in the final plant ingredient.

3.4.2 A new nutrient is expressed in the plant

An ingredient that is listed in part I of schedule IV or V, but contains a compositional change such that a nutrient that was not previously present in the plant is now expressed, would be considered a novel feed and therefore require a pre-market assessment and approval.

A pre-market assessment would be required to evaluate the safety and efficacy of the new nutrient, its interactions with endogenous nutrients, and its effects on the target animal. The potential risk to human health (residue transfer to human food such as meat, milk and eggs) and the environment (excretion as a pollutant) would need to be assessed. The pre-market assessment would also evaluate whether the expression of the new nutrient impacts the use rate of the ingredient in livestock diets, or if the new nutrient alters the type or purpose of feeds derived from the plant.

3.4.3. The level of an endogenous nutrient is outside the documented range for that plant species

Certain nutrients such as minerals and vitamins are of particular concern in livestock nutrition as they may impact the health and safety of livestock, humans and the environment if in excess of the animal's tolerable limit. The excessive levels can be toxic to livestock or function as drugs and become residues in foods of animal origin.

The Animal Feed Program recognizes that variability of plant nutrient composition may exist naturally in plants due to variation in growing conditions. Hence, the use of documented ranges and Maximum Nutrient Values is recommended to identify ingredients that require a pre-market assessment.

Applicants should consider the impact that the genetic modifications may have on compositional changes of a feed crop, so that the Maximum Nutrient Values are not exceeded for livestock. It is useful to consider the Maximum Nutrient Values tables in the Feeds Regulations and the Nutrient Requirements of Animals Collection^{Footnote 9} (NRAC) documents for the various species as reference sources.

An ingredient that is listed in part I of schedule IV or V, containing a compositional change such that the level of a nutrient for the plant is outside the documented range, may be considered a novel feed and require a pre-market assessment if the compositional change impacts the safety or use as described below (sections 3.4.3.1 and 3.4.3.2).

3.4.3.1 The level of the nutrient exceeds maximum nutrient values

In livestock feeding, certain minerals and vitamins are of particular concern at high intake levels. These nutrients may impact animal health (for example, they may be toxic or function by way of a therapeutic effect), human health (for example, residues may transfer to human food such as meat, milk and eggs), and the environment (for example, may be excreted as a pollutant).

If the modification results in increased levels of a nutrient of concern in the plant, such that the nutrient level in the total diet of the target livestock species/classes could be above the Maximum Nutrient Values, a pre-market assessment would be required.

List of nutrients with established Maximum Nutrient Values^{Footnote 10} in the total animal diet:

• Macro Minerals: Calcium (Ca), Phosphorous (P), Magnesium (Mg), Sodium (Na), Potassium (K) and Sulfur (S)
• Micro Minerals: Cobalt (Co), Copper (Cu), Iodine (I), Iron (Fe), Manganese (Mn), Selenium (Se) and Zinc (Zn)
• Vitamins: A, D and E

To determine nutrient levels in the total diet, the typical inclusion rate of the plant ingredient in feed for target species must be considered. The CFIA recommends plant developers consult Organisation for Economic Co-operation and Development (OECD) consensus documents^{Footnote 11}, Nutrient Requirements of Animals Collection (NRAC), published literature, or animal nutritionists that are familiar with formulating diets in Canada.

3.4.3.2 The use rate of the ingredient differs from that of the conventional ingredient

Unlike a more varied human diet, the composition of livestock diets is relatively consistent throughout animal's life span. Animal nutritionists consider the nutrient contribution of each ingredient to develop a balanced feed that meets the animal's nutritional requirements.

Modifications that result in altered nutrient concentrations in the plant may affect how the derived ingredient would be used in livestock feeds. If more or less of the ingredient is needed to meet the animal's nutritional requirements, compared to the typical inclusion rate of the conventional ingredient in the diet, a pre-market assessment would be required.

Note: modification may result in increased levels of nutrients that do not have the Maximum Nutrient Values indicated. Plant developers should evaluate whether the increase will affect the use rate of the ingredient in livestock diets. If the use rate is altered compared to the conventional ingredient, a pre-market assessment will be required.

3.4.4. The bioavailability of an endogenous nutrient is changed

An ingredient that is listed in part I of schedule IV or V, but contains a compositional change such that the nutrient bioavailability^{Footnote 12} is altered, impacting safety or use as described below (sections 3.4.4.1 and 3.4.4.2), will be considered a novel feed and require a pre-market assessment.

3.4.4.1 The level of the nutrient exceeds Maximum Nutrient Values

Modifications that result in increased bioavailability of nutrients in the plant may impact the safety of the derived ingredient. If nutrients are more available, they may be toxic to the animal, function with a therapeutic function, become residues in foods of animal origin, or be excreted into the environment.

If modification results in increased bioavailability of a nutrient of concern in the plant, such that the amount of nutrient available could reasonably be expected to be above the Maximum Nutrient Values, a pre-market assessment would be required.

To determine the impact of increased bioavailability on nutrient concentrations in the total animal diet, the typical inclusion rate of the plant ingredient in feed for target species must be considered. The CFIA recommends plant developers consult published literature or animal nutritionists that formulate diets in Canada.

3.4.4.2 The use rate of the ingredient differs from that of the conventional ingredient

Modifications that result in altered nutrient bioavailability may affect how the derived ingredient would be used in livestock feeds. If more or less of the ingredient is needed to meet the animal's nutritional requirements, compared to the typical use rate, a pre-market assessment would be required.

Note: genetic modification may result in decreased bioavailability of nutrients in the plant, below the documented range for the conventional ingredient. Plant developers should evaluate whether the decrease would affect the rate of inclusion of the ingredient in livestock diets. If use rate would reasonably be expected to differ from that of the conventional ingredient, a pre-market assessment would be required.

3.4.5 A new secondary metabolite is expressed in the plant or the level of an endogenous secondary metabolite is increased, impacting the safety or use of the ingredient

Numerous plant secondary metabolites, such as alkaloids, anthocyanins, flavonoids, quinones, lignans, sterols, carotenoids, cannabinoids and terpenoids have found commercial applications as drugs, dyes, flavours, fragrances and even insecticides. However, for the major agricultural crops, many of these compounds are considered nutrients, anti-nutrients or toxins and are therefore captured in other sections of this document.

Plant developers should consider whether a new secondary metabolite is expressed or an existing secondary metabolite is increased in their plant variety as follows:

• new metabolite: if a new secondary metabolite is expressed in the modified plant (for example, introduced via a cross with a wild relative), the derived ingredients would require a pre-market safety assessment

• endogenous metabolite: an increase in the level of an endogenous secondary metabolite could potentially impact feed safety or the use of the ingredient in livestock feeds

  In this case a pre-market safety assessment would be required

Note: when a new secondary metabolite is expressed or the level of an endogenous secondary metabolite is increased, impacting its purpose (for example, therapeutic, pesticidal), the regulatory status of the plant may be impacted requiring it to meet the requirements of other Canadian legislation.

3.4.6. The genetic modification to the plant alters an endogenous protein in a way that introduces or increases similarity with a known allergen or toxin relevant to animal or human health

Toxins and allergens are potentially harmful components in feeds that may impact animal or human health or the environment. In situations where an endogenous protein is altered and now has significant similarity^{Footnote 13} to a known toxin or allergen relevant to animal or human health, or the environment, the impacts need to be assessed, and a pre-market assessment would be required.

3.4.7 A new toxin, allergen or anti-nutrient is expressed in the plant, or the level of an endogenous toxin, allergen or anti-nutrient is increased beyond the documented range for that plant species

Allergens, toxins and anti-nutrients are potentially harmful components in feeds derived from plants that may impact animal health and reduce the utilization of nutrients by livestock. As such, these components can negatively impact feed safety and limit the use of the plant-derived ingredient in feed. Most toxins, allergens and anti-nutrients are usually reduced through plant breeding or processing the feed before feeding to livestock.

In situations where a new toxin, allergen or anti-nutrient is expressed in the modified plant, the derived ingredient would require a pre-market assessment. The safety of the new toxin, allergen or anti-nutrient would be considered in the assessment.

In situations where the levels of endogenous toxins, allergens and anti-nutrients in a plant are above the documented range, the feed ingredients derived from such plants would also require a pre-market assessment.

3.5 Ingredient with a claim

A feed claim is not permitted on the feed label unless the feed has been approved or registered. If an applicant wishes to market a feed differently than for the purpose for which it is approved or how it is described in schedule IV or V, the applicant will need to submit an application for the ingredient(s) for pre-market assessment and approval.

Appendix 1: Novelty determination work sheet for plant ingredients

The questions found in the worksheet will need to be answered for all potential feed ingredients derived from the plant. For reference, see section 3 "Rationale for criteria" of this guidance.

A. The following questions are related to regulatory definitions found in the Feeds Act and Feeds Regulations

B. The following questions are related to schedules IV and V of the Feeds Regulations

C. The following questions are related to whether the feed ingredient contains a novel trait

Note: a plant-derived ingredient will no longer meet the ingredient definition in schedule IV or V when the answer to any of the questions listed below is yes.

Section D: Questions related to claims