Current status: Open
Opened on July 22, 2026 and will close to the new input on August 24, 2026
About the consultation
We are seeking comments on the proposed new single ingredient feed (SIF) description for L-lysine solution 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 solution 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 and 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 support the safety and efficacy of L-lysine solution from fermentation process for its intended purpose as a source of L-lysine in livestock feeds.
Therefore, we recommend that L-lysine solution from fermentation process be approved as a new SIF and added to the CFIT.
Proposed SIF description
We intend to add L-lysine solution from fermentation process under subclass 5.1.1 (Amino acids from fermentation process) of class 5 (Nutritional ingredients) in part 1 of the CFIT with the following description:
L-Lysine solution from fermentation process (or liquid L-lysine from fermentation process or (2S)-2,6-diaminohexanoic acid solution from fermentation process)
is the liquid product containing a minimum of 50% (w/v) (2S)-2,6-diaminohexanoic acid (CAS# 56-87-1) in an aqueous solution. It is obtained from a fermentation process using a non-pathogenic strain of Corynebacterium glutamicum, which does not contain a novel trait, followed by purification and concentration steps. It shall contain not more than 50% moisture. Residual constituents originating from the fermentation process, which has been conducted in accordance with good manufacturing practices, may be present. 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 eye, skin and respiratory irritation and/or sensitization. Appropriate protective equipment must be worn during handling. / Cet ingrédient peut causer une irritation et/ou une sensibilisation des yeux, de la peau et 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, and maximum percent moisture.
An ingredient number will be assigned at the time this new SIF description is added to the CFIT.
Additional information
The proposed new description for L-lysine solution from fermentation process will be placed into part 1 of the CFIT, aligning with the placement of other amino acids from fermentation processes. L-lysine solution along with other sources of L-lysine (for example, 1-501-003 L-lysine, 1-501-016 L-lysine monohydrochloride, and 1-501-024 L-lysine monohydrochloride from fermentation process), have a history of safe use in Canada.
Since the chemically synthesized L-lysine solution (1-501-017 L-lysine solution) ingredient is already listed and described in part 1 of the CFIT, we are proposing a new description for L-lysine solution that is produced from a fermentation process. This will differentiate (based on how they are manufactured) the chemically synthesized L-lysine solution found in the CFIT from the L-lysine solution obtained from fermentation processes.
The proposed new description for L-lysine solution from fermentation process requires that a non-pathogenic production organism (in this case, a non-pathogenic strain of Corynebacterium glutamicum) is used for the fermentation process. The proposed new description also provides some details about the manufacturing process, which differs slightly from other amino acids produced from fermentation processes, and includes the standardized wording and required labelling statements for amino acids produced from fermentation processes (for example, 1-501-024 L-lysine monohydrochloride from fermentation process, 1-501-025 L-isoleucine from fermentation process). This description includes one required labelling statement, one worker safety statement for eye, skin and respiratory irritation and/or sensitization, and required label guarantees for minimum percent L-lysine and maximum percent moisture.
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 solution. Nutritionists formulating livestock feeds for various livestock species would adjust use rates as needed.
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 from industry, governments, the public or other organizations or individuals are welcome.
How to participate
We are seeking feedback on the proposed description for L-lysine solution 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 solution from fermentation process" in the subject line of the email. We are asking for comments and feedback by August 24, 2026, 30 days from the date of this posting.
Next steps
We will review all the comments received. If no significant scientifically valid concerns are raised, we will finalize the approval of L-lysine solution from fermentation process and issue the approval to the applicant.
If significant concerns are raised, we will evaluate the additional information.
This SIF 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