Current status: Closed
This consultation ran from September 18, 2025, to October 17, 2025
About the consultation
We were seeking comments on the following amended single ingredient feed (SIF) description for 25-hydroxyvitamin D3 monohydrate from fermentation process.
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. We evaluate 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. Our 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
Our Animal Feed Program (AFP) has completed a detailed evaluation of an application for the amendment of an existing SIF description: crystalline 25-hydroxyvitamin D3.
The SIF name will be changed from crystalline 25-hydroxyvitamin D3 to 25-hydroxyvitamin D3 monohydrate from fermentation process. The amended description will incorporate standardized wording and labelling statements for SIFs produced from fermentation processes, add another production organism and modify the description of the manufacturing process, to encompass all registered sources of this part 2 SIF.
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
- the fit-for-purpose and efficacy of this SIF for the intended livestock species
The results of our evaluation of available scientific data supports the safety and efficacy of 25-hydroxyvitamin D3 monohydrate from fermentation process and its intended purpose as a source of 25-hydroxyvitamin D3 in drinking water supplements and complete feeds for chickens and turkey and complete feeds for swine.
Therefore, we recommend that 25-hydroxyvitamin D3 monohydrate from fermentation process be approved and the amended SIF description replace the current SIF description in the CFIT, accordingly.
Amended SIF description
We intend to amend the existing SIF description for crystalline 25-hydroxyvitamin D3 under subclass 5.4.1 (Vitamins from fermentation processes) of class 5 (Nutritional ingredients) in part 2 of the CFIT. The SIF name will be changed from crystalline 25-hydroxyvitamin D3 to 25-hydroxyvitamin D3 monohydrate from fermentation process and the description amended to incorporate standardized wording and labelling statements for SIFs produced from fermentation processes, to add another production organism and simplify the manufacturing process to encompass all registered sources of this part 2 SIF.
The amended description is:
25-Hydroxyvitamin D3 monohydrate from fermentation process (or calcifediol monohydrate from fermentation process or 25-hydroxycholecalciferol monohydrate from fermentation process)
- is the monohydrate form of 25-hydroxyvitamin D3, generally expressed as C27H44O2·H2O and having the CAS# 63283-36-3. It is obtained from a manufacturing process that includes a fermentation process using a non-pathogenic strain of Saccharomyces cerevisiae or Pseudonocardia autotrophica that does not contain a novel trait. The manufacturing process may include further processing (for example, chemical transformation or purification) after fermentation. The manufacturing process shall be conducted in accordance with good manufacturing practices. It shall not contain other extraneous materials except in such amounts as may occur unavoidably during good manufacturing practices.
- If the product bears a name descriptive of the form (for example, crystalline), it shall correspond thereto and be indicated on the label.
- This ingredient is approved for use in supplements for drinking water and complete feeds for chickens and turkeys and in complete feeds for swine.
- It may be blended with suitable carriers listed in the Canadian Feed Ingredients Table to standardize the 25-hydroxyvitamin 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.
- If an antioxidant 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 labelled with the following statements:
- "One (1) milligram of 25-hydroxyvitamin D3 is equivalent to 40,000 International Units (IU) of vitamin D activity."
- "This ingredient is approved for use in supplements for drinking water and complete feeds for chickens and turkeys and in complete feeds for swine."
- "This ingredient is free of antimicrobial activity and is not a source of viable microbial cells."
- It shall be labelled with guarantees for minimum milligrams of 25-hydroxyvitamin D3 per kilogram and equivalent minimum International Units of vitamin D activity per kilogram.
Additional information
25-Hydroxyvitamin D3 monohydrate from fermentation process will remain in part 2 of the CFIT because there is no standardized analytical method to determine the vitamin D activity from 25-hydroxyvitamin D3 in livestock feeds and there is variability in the source and the manufacturing processes to produce the final SIF. This existing description was amended to simplify the manufacturing process to encompass the manufacturing process for all registered sources of this part 2 SIF, add another production organism (Pseudonocardia autotrophica) used during the fermentation process and better align with the wording in the new SIF descriptions that are produced from fermentation processes. Amendments to the existing description were required because we evaluated a new source that used a different production organism and different processing steps to manufacture the final SIF.
The amended description includes standardized wording and the required labelling statements for SIFs produced from fermentation processes. These changes provide better consistency between SIF descriptions for vitamins and amino acids from fermentation processes. This amended description includes 3 required labelling statements. A required labelling statement has been amended as the equivalency statement between milligrams and International Units (IU) for the vitamin activity should not be expressed as a ratio and therefore the "per kilogram" wording has been removed from that statement. In addition, this statement should state vitamin D activity and not vitamin D3 activity and as a result of this change, a required label guarantee has been modified.
The purpose of this SIF is a source of 25-hydroxyvitamin D3 and is only approved for use in drinking water supplements and complete feeds for chickens and turkeys and complete feeds for swine.
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 were welcomed from industry, governments, the public or other organizations or individuals.
Next steps
We will review all of the comments received. If no significant scientifically valid concerns are raised, we will finalize the approval of amended description for 25-hydroxyvitamin D3 monohydrate from fermentation process and issue the approval to the applicant. If significant concerns are raised, we 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 prepared.
This amended SIF description will be added to the CFIT at the next update.
Related information
Contact us
Animal Feed Program (AFP)
Canadian Food Inspection Agency
Email: cfia.afp-paa.acia@inspection.gc.ca