Novel Feeds from Plant Sources
What are novel feeds from plant sources?
Novel feeds from plant sources include any plants and products/by-products derived there from that:
- are not approved as livestock feed in Canada (not listed in Schedule IV or V of the Feeds Regulations) e.g. papaya;
- and/or contain a novel trait e.g. herbicide tolerant soybean
A novel trait is an intentional genetic modification that results in a feed that is not substantially equivalent in terms of use and safety to an approved feed ingredient derived from plants of the same species set out in Schedule IV or V of the Feeds Regulations.
For those novel feeds containing a novel trait, it is the presence of a novel trait in a plant that triggers regulatory oversight, under the Feeds Regulations, not the method used to introduce the trait. Hence the plant rather than the process is subject to regulatory oversight. As such, novel feeds may be created by such methods as traditional breeding, mutagenesis, cell fusion, or recombinant DNA techniques. Substantive changes in agronomic, nutritional and compositional characteristic(s) of a plant that are outside the accepted range of variation for a given species, based on Canadian experience, would trigger regulation as a novel feed. In general, traditional breeding with approved germplasm in cultivation in Canada will not usually result in a novel feed.
About Schedule IV and Schedule V of the Feeds Regulations
Schedule IV and V of the Feeds Regulations list feed ingredients approved for use in livestock feed in Canada. Schedule IV comprises a range of ingredients such as forages and roughages, energy feeds, protein sources, vitamins, minerals, fermentation products and other miscellaneous products while Schedule V is restricted to flavouring ingredients. Each Schedule is divided into two parts:
Schedule IV part 1 and Schedule V part 1 list ingredients that do not require registration if they meet regulatory safety and labelling standards.
Schedule IV part 2 and Schedule V part 2 list ingredients that must be registered due to safety and/or efficacy concerns.
Safety assessment of novel feeds from plant sources
All novel feeds from plant sources must be assessed by the Animal Feed Division, CFIA, before they can be used as livestock feed in Canada. This assessment considers the safety of the feed to livestock, to humans via worker/by-stander exposure and consumption of animal products, and to the environment.
The Animal Feed Division conducts livestock feed safety assessments based on familiarity and substantial equivalence. Familiarity with the feed is knowledge of the characteristics of a plant species and experience with use as feed of that plant species in Canada, i.e. listed in Schedule IV or V. Substantial equivalence is based on the comparison of properties between the modified plant and an appropriate comparator. Taking into consideration both intended and unintended effects, similarities and differences between the modified plant and its counterpart are identified. Those aspects in the modified plant, which are determined to be equivalent to the counterpart are accepted and the safety assessment then focuses on the differences. The concept of substantial equivalence is endorsed by international groups such as OECD and FAO/WHO.
In the feed safety assessment, molecular, compositional, nutritional and toxicological data of the novel feed are compared to those of an appropriate counterpart. The identification and subsequent determination of levels of key nutrients, anti-nutrients and endogenous toxins and allergens is an important aspect of the determination of substantial equivalence. Applicants should refer to the "Guidelines for the Assessment of Novel Feeds: Plant Sources" for detailed guidance on data requirements. The OECD Consensus documents on individual crops may be of assistance as a reference to aid in the determination of the key elements to be examined.
Plant Biosafety Office, CFIA, authorizes the environmental release of a Plant with a Novel Trait (PNT) and Health Canada approves the use of a novel food. In the case of a PNT intended for environmental release, for use as a novel food and as a novel feed, approvals are required from all three regulatory bodies prior to environmental release or food or feed use. These approvals will be granted in a harmonized fashion to minimize the potential for unapproved products to enter the feed or food supplies or the Canadian environment.
Research with novel feeds from plant sources
Researchers in private, governmental or academic research establishments who intend to conduct research with novel feeds may require an authorization from the Animal Feed Division.
Reference Material - Applicants
- Application Form for Feed Registration or Renewal
- CFIA Detection and Identification Method Critera
- Guidelines for the Assessment of Novel Feeds: Plant Sources
- Pre-submission consultation procedures for novel foods and feeds derived from plants with novel traits
Status of PNTs and Novel Feeds in Canada
- Decision Documents - Determination of Environmental and Livestock Feed Safety
- Status of Regulated Plants with Novel Traits in Canada: Unconfined Environmental Release, Novel Livestock Feed Use, Variety Registration and Novel Food Use
- The Regulation of Plants with Novel Traits in Canada
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