Proposed new livestock feed ingredient – L-Threonine from fermentation process: Closed Consultation
Current status: Closed
This consultation ran from February 21, 2024 to March 22, 2024
About the consultation
The Canadian Food Inspection Agency (CFIA) was seeking comments on the following proposed new single ingredient feed (SIF) description for L-threonine from fermentation process.
Background
The Feeds Regulations require a proponent to submit a pre-market application for SIFs that are new, have been modified such that they differ from an approved SIF, or 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 currently listed and defined in Schedules IV and V of the Feeds Regulations, with appropriate guarantees, standards, and labelling requirements. The CFIA will be transitioning to the Canadian Feed Ingredients Table (CFIT) that will be incorporated by reference into the proposed Feeds Regulations, 2024 when they come into effect. In preparation for this new approach, the CFIA is consulting on new or amended SIFs so they can be added to the CFIT once it comes into effect. More information on this is available in the Notice to industry: Consultations on new or amended single ingredient feed descriptions.
About the evaluation
The CFIA's Animal Feed Program (AFP) has completed a detailed evaluation of an application for the approval of a new SIF: L-threonine from fermentation process.
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 L-threonine from fermentation process and its intended purpose as a supplemental source of L-threonine for livestock species.
Therefore, the CFIA recommends L-threonine from fermentation process be approved as a new SIF and added to the CFIT, accordingly.
Proposed SIF description
The CFIA intends to add L-threonine from fermentation process under Subclass 5.1.1 (Amino acids from fermentation processes) of Class 5 (Nutritional ingredients) in part 1 of the CFIT with the following description:
L-Threonine from fermentation process (or (2S,3R)-2-amino-3-hydroxybutanoic acid from fermentation process)
is the dried and concentrated product containing a minimum of 80% (2S,3R)-2-amino-3-hydroxybutanoic acid, and having the CAS# 72-19-5. It is obtained from a fermentation process using non-pathogenic strains of either Corynebacterium glutamicum or Escherichia coli K12, which do not contain a novel trait. It shall contain not more than 5% moisture. The fermentation 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 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 statement:
"This ingredient is free of antimicrobial activity and is not a source of viable microbial cells."
To address worker safety concerns, it shall be labelled with the following statement:
"This ingredient may cause eye, skin and respiratory irritation and/or sensitization. Appropriate protective equipment must be worn during handling. / Cet ingrédient peut causer une irritation des yeux, de la peau et des voies respiratoires et/ou une sensibilisation. Un appareil de protection approprié doit être porter lors de la manutention."
It shall be labelled with guarantees for minimum percent L-threonine, and maximum percent moisture.
An ingredient number will be assigned at the time the SIF is added to the CFIT.
Additional information
Since synthetically manufactured L-threonine (1-501-008) is already listed and described in part 1 of the CFIT, the CFIA is proposing a new description for L-threonine that is produced from a fermentation process. This will differentiate the 2 SIFs in the CFIT based on how they are manufactured.
The proposed new description for L-threonine from fermentation process requires that non-pathogenic microbes are used during the fermentation process, and includes the standardized wording and required labelling statements for SIFs produced from fermentation processes. This description includes 1 required labelling statement and a worker safety statement that are to be on the label of this SIF.
The purpose of this SIF is as a supplemental source of the amino acid, L-threonine, for all livestock species, similar to the synthetic source of L-threonine.
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 was seeking feedback on the proposed description for L-threonine from fermentation process.
Stakeholders were encouraged to share comments if there was:
- concerns about the accuracy of 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 "L-threonine from fermentation process" in the subject line of the email. The CFIA was asking for comments and feedback by March 22, 2024, 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 L-threonine from fermentation process 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, following publication of the proposed Feeds Regulations, 2024.
Related information
- Feeds Regulations
- Feeds Act
- Consultations on proposed regulatory and policy changes
- Notice to industry: Consultations on new or amended single ingredient feed descriptions
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
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