Proposed new and amended livestock feed ingredients – Amino acids from fermentation process: Closed consultation

Current status: Closed

This consultation ran from January 19, 2026, to February 19, 2026.

About the consultation

We were seeking comments on the following proposed new single ingredient feed (SIF) description:

  • L-isoleucine from fermentation process

In addition, we are seeking comments on the following amended SIF descriptions:

  • L-tryptophan from fermentation process
  • 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 applications for the approval of a new SIF: L-isoleucine from fermentation process. Our AFP has also completed detailed evaluations for the amendment of two existing SIF descriptions: L-tryptophan from fermentation process and L-lysine monohydrochloride from fermentation process.

The evaluations considered information related to:

  • the safety of feeding these SIFs to livestock with respect to animal health
  • the safety of foods derived from livestock that eat these SIFs
  • the safety of workers/bystanders exposed to these SIFs
  • environmental safety
  • the fit-for-purpose and efficacy of these SIFs for the intended livestock species

The results of our evaluations of available scientific data support the safety and efficacy of L-isoleucine from fermentation process, L-tryptophan from fermentation process and L-lysine monohydrochloride from fermentation process and their intended purpose as a supplemental source of L-isoleucine, L-tryptophan or L-lysine, respectively, for livestock species.

Therefore, we recommend that L-isoleucine from fermentation process be approved as a new SIF and added to the CFIT, accordingly.

Further, we recommend that the descriptions for L-tryptophan from fermentation process and L-lysine monohydrochloride from fermentation process be amended and the amended SIF descriptions replace the current SIF descriptions in the CFIT, accordingly.

Proposed SIF description

We intend to add L-isoleucine 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-Isoleucine from fermentation process (or (2S,3S)-2-amino-3-methylpentanoic acid from fermentation process)

is the crystalline product containing a minimum of 98% (2S,3S)-2-amino-3-methylpentanoic acid, and having the CAS# 73-32-5. 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 2% 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 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-isoleucine, and maximum percent moisture.

An ingredient number will be assigned at the time the SIF is added to the CFIT.

Amended SIF descriptions

We intend to amend the existing SIF description for L-tryptophan from fermentation process (1-501-023) under subclass 5.1.1 (Amino acids from fermentation processes) of class 5 (Nutritional ingredients) in part 1 of the CFIT. The amendments include adding another production organism (Escherichia coli) and adding a worker safety statement to the description.

The amended description is:

1-501-023 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 Escherichia coli or 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 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-tryptophan, and maximum percent moisture.

We also intend to amend the existing SIF description for L-lysine monohydrochloride from fermentation process (1-501-024) under subclass 5.1.1 (Amino acids from fermentation processes) of class 5 (Nutritional ingredients) in part 1 of the CFIT. The purity standard for this amino acid was revised as well as the specification for moisture content. In addition, another production organism (Escherichia coli) was included, and the worker safety statement was revised.

The amended description is:

1-501-024 L-Lysine monohydrochloride from fermentation process (or (2S)-2,6-diaminohexanoic acid hydrochloride from fermentation process)

is the crystalline product containing a minimum of 98% (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 Escherichia coli or Corynebacterium glutamicum, which does not contain a novel trait. It shall contain not more than 2% 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 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 monohydrochloride, minimum percent L-lysine, and maximum percent moisture.

Additional information

Since a chemically synthesized source of L-isoleucine (1-501-015 L-isoleucine) is already listed and described in part 1 of the CFIT, we are proposing a new description for L-isoleucine that is produced from a fermentation process. This will differentiate the chemically synthesized source of L-isoleucine found in the CFIT from the sources of L-isoleucine obtained from fermentation processes. The purpose of this SIF is as a supplemental source of the amino acid, L-isoleucine, for all livestock species, similar to the synthetic source of L-isoleucine.

The proposed new description for L-isoleucine from fermentation process will be placed into part 1 of the CFIT, aligning with the placement of other amino acids from fermentation processes.

The existing descriptions for L-tryptophan from fermentation process (1-501-023) and L-lysine monohydrochloride from fermentation process (1-501-024) found in subclass 5.1.1 (Amino acids from fermentation processes) of class 5 (Nutritional ingredients) in part 1 of the CFIT will remain in part 1. The addition of other production organisms (Escherichia coli strains) as approved sources and the change in the purity standard (minimum of 98%) do not change the decision to keep these amended descriptions in part 1 of the CFIT.

The description for L-tryptophan from fermentation process is being amended to allow the use of non-pathogenic Escherichia coli strains, which do not contain a novel trait, as the production organism. In addition, a worker safety statement was added to the amended description to address possible worker safety concerns associated with some sources of this SIF.

The description for L-lysine monohydrochloride from fermentation process is being amended to allow for a slightly lower purity of L-lysine monohydrochloride, slightly higher moisture content, and the use of non-pathogenic Escherichia coli strains, which do not contain a novel trait, as the production organism. In addition, revisions were made to the required worker safety statement.

These amendments increase the options of sources that could meet these amended descriptions and be considered approved. 

The evaluations that led to the creation of the new description for L-isoleucine from fermentation process and to the amendments to the existing descriptions for L-tryptophan from fermentation process and L-lysine monohydrochloride from fermentation process, included consideration of foreign approvals, through the use of the policy of Feed approval or registration requirements for the acceptance of a foreign approval/authorization. Authorizations and evaluation summaries from a trusted foreign jurisdiction contributed to the evaluations and supported the creation of the new SIF description and amendments to 2 existing SIF descriptions.

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.

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-isoleucine from fermentation process. In addition, if no significant scientifically valid concerns are raised, we will finalize the amended descriptions for L-tryptophan from fermentation process and L-lysine monohydrochloride from fermentation process.

If significant concerns are raised, we will evaluate the additional information.

L-Isoleucine from fermentation process will be added to the CFIT at the next update.

In addition, the amended descriptions for L-tryptophan from fermentation process and L-lysine monohydrochloride from fermentation process will be added to the CFIT at the next update.

Related information

Contact us

Animal Feed Program (AFP)
Canadian Food Inspection Agency
E-mail: cfia.afp-paa.acia@inspection.gc.ca