Current status: Closed
This consultation ran from August 22, 2024 to September 23, 2024.
About the consultation
The Canadian Food Inspection Agency (CFIA) was seeking comments on the following proposed new single ingredient feed (SIF) description for waxy-leaf nightshade leaf powder.
Background
The Feeds Regulations, 2024 require a proponent to submit a pre-market application for new feed ingredients or SIFs that have been modified such that they differ from an approved SIF, or SIFs that are for a new purpose. The CFIA evaluates the information in the application to establish that the SIF is safe, effective, and labelled correctly.
Approved SIFs are listed and described in the Canadian Feed Ingredients Table (CFIT), which is incorporated by reference (IBR) into the Feeds Regulations, 2024. The CFIA's Incorporation by Reference Policy requires that a consultation be conducted before changes to IBR documents are made. Refer to Documents incorporated by reference under the Feeds Regulations, 2024 for additional information.
About the evaluation
The CFIA's Animal Feed Program has completed a detailed evaluation of an application for the approval of a new SIF: waxy-leaf nightshade leaf powder.
The evaluation considered information related to:
- the safety of feeding this SIF to livestock with respect to animal health
- the safety of foods derived from livestock that eat this SIF
- the safety of workers/bystanders exposed to this SIF
- environmental safety
- an evaluation of the fit-for-purpose and efficacy of this SIF for the intended livestock species
The results of the CFIA's evaluation of available scientific data supports the safety and efficacy of waxy-leaf nightshade leaf powder for its intended purpose as a source of vitamin D activity in the total diet for broiler chickens.
Proposed SIF description
The CFIA intends to add waxy-leaf nightshade leaf powder under subclass 5.4.2 (Vitamins excluding those from fermentation processes) of class 5 (Nutritional ingredients) in part 2 of the CFIT with the following description:
Waxy-leaf nightshade leaf powder (or Solanum glaucophyllum leaf powder)
is the product that consists of waxy-leaf nightshade (Solanum glaucophyllum) leaves that have been dried by thermal means and finely ground under controlled conditions. It shall contain a minimum of 50 mg/kg of glycosylated 1,25-dihydroxyvitamin D3 (glycosylated 1,25-dihydroxycholecalciferol, G-1,25(OH)2D3), and it shall contain no more than 10 % moisture.
This ingredient is approved for use as a source of vitamin D activity in the total diet for broiler chickens.
It may be blended with suitable carriers listed in the Canadian Feed Ingredients Table to standardize the glycosylated 1,25-dihydroxyvitamin D3 concentration.
If a carrier is used, it must be approved for use in livestock feeds, it shall be used at the approved rate, and the common name or names shall be indicated on the label.
It shall be labeled with the following statements:
"1 milligram of glycosylated 1,25-dihydroxyvitamin D3 is equivalent to 11,000 International Units (IU) of vitamin D3 activity per kilogram."
"This ingredient is approved for use as a source of vitamin D activity in the total diet for broiler chickens."
It shall be labelled with guarantees for minimum milligrams of glycosylated 1,25-dihydroxyvitamin D3 per kilogram, equivalent minimum International Units of vitamin D3 activity per kilogram, and maximum percent moisture.
An ingredient number will be assigned at the time the SIF is added to the CFIT.
Additional information
Waxy-leaf nightshade leaf powder will be placed into part 2 of the CFIT due to the variability in the content of glycosylated 1,25-dihydroxyvitamin D3 in the leaves and the impact of the manufacturing processes on the content of glycosylated 1,25-dihydroxyvitamin D3. In addition, Solanum glaucophyllum belongs to the family Solanaceae and many species of this family of plants are known to produce secondary metabolites (for example, solanine) that may induce potential effects on the health of humans and animals.
This SIF shall contain a minimum of 50 mg/kg of glycosylated 1,25-dihydroxyvitamin D3 (glycosylated 1,25-dihydroxycholecalciferol, G-1,25(OH)2D3).
The purpose of this SIF is as a source of vitamin D activity in the total diet for broiler chickens.
This SIF will be imported as a dried, ground, and irradiated leaf powder.
Who was the focus of this consultation
Animal feed stakeholders, including:
- suppliers of feed ingredients
- commercial feed manufacturers
- feed importers, distributors and retailers
- industry associations
- other government departments
- international trading partners
- veterinarians
All comments are welcome from industry, governments, the public, or other organizations or individuals.
How to participate
The CFIA is seeking feedback on the proposed description for waxy-leaf nightshade leaf powder.
Stakeholders were encouraged to share comments if there was:
- concerns about the accuracy of the SIF description
- any scientific data that should be considered before the SIF is approved
Scientific questions or information will be reviewed by the CFIA evaluators for consideration in the evaluation. Non-scientific input will be evaluated and appropriate ways of addressing it will be explored.
Comments can be sent by email to the Animal Feed Program (AFP) at cfia.afp-paa.acia@inspection.gc.ca. Please use "waxy-leaf nightshade leaf powder" in the subject line of the email. The CFIA was asking for comments and feedback by September 23, 2024, 30 days from the date of this posting.
Next steps
The CFIA will review all of the comments received. If no valid scientific concerns are identified, the CFIA will finalize the approval for waxy-leaf nightshade leaf powder and issue the approval to the applicant. If there are significant concerns raised, the CFIA will evaluate the additional information and may, subject to the commenters consent, forward the comments to the applicant for their response. A what we heard report that summarizes the feedback received will be published.
The SIF will be added to the CFIT at the next update.
Related information
Contact us
Animal Feed Program (AFP)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Email: cfia.afp-paa.acia@inspection.gc.ca