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 L-tryptophan 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. 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 a new SIF: L-tryptophan 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-tryptophan from fermentation process and its intended purpose as a supplemental source of L-tryptophan for livestock species.
Therefore, the CFIA recommends L-tryptophan from fermentation process be approved as a new SIF and added to the CFIT, accordingly.
Proposed SIF description
The CFIA intends to add L-tryptophan 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-Tryptophan from fermentation process (or (2S)-2-amino-3-(1H-indol-3-yl) propanoic acid from fermentation process)
is the crystalline product containing a minimum of 98% (2S)-2-amino-3-(1H-indol-3-yl) propanoic acid, and having the CAS# 73-22-3. It is obtained from a fermentation process using a non-pathogenic strain of Corynebacterium glutamicum, which does not contain a novel trait. It shall contain not more than 1% 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 labelled with the following statement:
"This ingredient is free of antimicrobial activity and is not a source of viable microbial cells."
It shall be labelled with guarantees for minimum percent L-tryptophan, 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-tryptophan (1-501-009) is already listed and described in part 1 of the CFIT, the CFIA is proposing a new description for L-tryptophan 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-tryptophan from fermentation process requires that a non-pathogenic microbe is used during the fermentation process, and includes the standardized wording and required labelling statements for SIFs produced from fermentation processes (for example, L-arginine from fermentation process and L-threonine from fermentation process). This description includes 1 required labelling statement. The worker safety statement is not part of this description as data were provided to support that this SIF does not result in being an irritant to the skin and eyes, and does not result in skin sensitization.
The purpose of this SIF is as a supplemental source of the amino acid, L-tryptophan, for all livestock species, similar to the synthetic source of L-tryptophan.
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 L-tryptophan from fermentation process.
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 "L-tryptophan from fermentation process" in the subject line of the email. The CFIA was asking for comments and feedback by November 25, 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-tryptophan 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.
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