Current status: Open
Opened on April 19, 2025 and closes on May 19, 2025.
About the consultation
We are seeking comments on the following proposed new single ingredient feed (SIF) description for L-lysine monohydrochloride 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 approval of a new SIF: L-lysine monohydrochloride 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 our evaluation of available scientific data supports the safety and efficacy of L-lysine monohydrochloride from fermentation process and its intended purpose as a supplemental source of L-lysine for livestock species.
Therefore, we recommend that L-lysine monohydrochloride from fermentation process be approved as a new SIF and added to the CFIT, accordingly.
Proposed SIF description
We intend to add L-lysine monohydrochloride 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-Lysine monohydrochloride from fermentation process (or (2S)-2,6-diaminohexanoic acid hydrochloride from fermentation process)
is the crystalline product containing a minimum of 99% (2S)-2,6-diaminohexanoic acid hydrochloride (CAS# 657-27-2), with a maximum of 80% L-lysine (CAS# 56-87-1). 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."
To address worker safety concerns, it shall be labelled with the following statement:
"This ingredient may cause respiratory irritation and/or sensitization. Appropriate protective equipment must be worn during handling. / Cet ingrédient peut causer une irritation et/ou une sensibilisation des voies respiratoires. Un équipement de protection approprié doit être porté lors de la manipulation."
It shall be labelled with guarantees for minimum percent L-lysine monohydrochloride, minimum percent L-lysine, and maximum percent moisture.
An ingredient number will be assigned at the time the SIF is added to the CFIT.
Additional information
Since chemically synthesized sources of L-lysine (1-501-003 L-lysine, 1-501-016 L-Lysine monohydrochloride, 1-501-017 L-Lysine solution) are already listed and described in part 1 of the CFIT, we are proposing a new description for L-lysine monohydrochloride that is produced from a fermentation process. This will differentiate (based on how they are manufactured) the chemically synthesized sources of L-lysine found in the CFIT from the sources of L-lysine obtained from fermentation processes.
The proposed new description for L-lysine monohydrochloride 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, L-threonine from fermentation process, and L-tryptophan from fermentation process). This description includes 1 required labelling statement, and 1 worker safety statement for respiratory irritation and/or sensitization.
The purpose of this SIF is as a supplemental source of the amino acid, L-lysine, for all livestock species, similar to the synthetic sources of L-lysine.
Who is 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
We are seeking feedback on the proposed description for L-lysine monohydrochloride from fermentation process.
Stakeholders are encouraged to share comments if there are:
- concerns about the accuracy of the SIF description
- any scientific data that should be considered before the SIF is approved
Our 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 AFP at cfia.afp-paa.acia@inspection.gc.ca. Please use "L-lysine monohydrochloride from fermentation process" in the subject line of the email. We are asking for comments and feedback by May 19, 2025 30 days from the date of this posting.
Next steps
We will review all of the comments received. If no significant scientifically valid concerns are raised, we will finalize the approval of L-lysine monohydrochloride 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 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 Dr
Ottawa ON K1A 0Y9
Email: cfia.afp-paa.acia@inspection.gc.ca