Current status: Closed
This consultation ran from October 25, 2024 to November 25, 2024.
About the consultation
The Canadian Food Inspection Agency (CFIA) was seeking comments on the following proposed new single ingredient feed (SIF) description for Bacillus licheniformis culture dehydrated.
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 (AFP) has completed a detailed evaluation of an application for the approval of Bacillus licheniformis culture dehydrated.
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 the CFIA's evaluation of available scientific data supports the safety and efficacy of Bacillus licheniformis culture dehydrated as a source of viable organisms for use as a component of gut modifier products for livestock species.
Proposed SIF description
The CFIA intends to add Bacillus licheniformis culture dehydrated under Subclass 6.19.2 (Gut modifier ingredients – Viable microorganisms) of Class 6 (Non-nutritive ingredients) in part 2 of the CFIT with the following description:
Bacillus licheniformis culture dehydrated
is the dried product composed of organic acid-producing Bacillus licheniformis and its growth medium, which are dried in such a manner as to preserve the viability of the Bacillus licheniformis bacteria. The culturing process of the microorganism shall be conducted in accordance with good manufacturing practices using a non-pathogenic strain of Bacillus licheniformis, which does not contain a novel trait. A microbial strain unique identifier shall be indicated on the label. It shall not contain other extraneous materials except in such amounts as may occur unavoidably during good manufacturing practices.
It shall be labelled with the following statement:
"This ingredient is approved as a source of viable organisms for use as a component of gut modifier products for livestock species."
It shall be labelled with a guarantee for the minimum number of colony forming units per gram.
An ingredient number will be assigned at the time this SIF is added to the CFIT.
Additional information
Bacillus licheniformis culture dehydrated will be placed into part 2 of the CFIT because it is a viable microbial strain (a source of viable microorganisms) and each source must be approved and registered.
This new SIF description is the result of the CFIA's project to update viable microorganism descriptions. As the CFIA continues to work on updating how viable microorganisms are named and described in the CFIT, species-level identification of these microorganisms is important. The CFIA will request that registrants with registered sources of viable microorganisms and applicants who are submitting new applications for viable microorganisms include data to support a species-level identification and confirm the intended purpose when they submit an application for SIF approval or renewal. This will allow the CFIA to accurately name and describe the viable microorganisms approved for use in livestock feed in Canada.
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 Bacillus licheniformis culture dehydrated.
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
The CFIA evaluators will review scientific questions or information for consideration in the evaluation. They will also evaluate non-scientific input and explore appropriate ways of addressing it.
Comments can be sent by email to the Animal Feed Program (AFP) at cfia.afp-paa.acia@inspection.gc.ca. Please use "Bacillus licheniformis culture dehydrated" in the subject line of the email. The CFIA was asking for comments and feedback by November 25, 30 days from the date of this posting.
Next steps
The CFIA will review all of the comments received. If no significant scientifically valid concerns are raised, the CFIA will finalize the approval of Bacillus licheniformis culture dehydrated and issue the approval to the applicant. If significant concerns are 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.
This 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