Proposed amended livestock feed ingredient – L-Arginine 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 amended single ingredient feed (SIF) description for L-arginine 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 amendment of an existing SIF description: L-arginine.

The SIF name will be changed from L-arginine to L-arginine from fermentation process and the description amended to incorporate standardized wording and labelling statements for SIFs produced from fermentation processes.

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-arginine from fermentation process and its intended purpose as a supplemental source of L-arginine for livestock species.

Therefore, the CFIA recommends L-arginine from fermentation process be approved and the amended SIF description replace the current SIF description in the CFIT accordingly.

Amended SIF description

The CFIA intends to amend the existing SIF description for L-arginine under Subclass 5.1.1 (Amino acids from fermentation processes) of Class 5 (Nutritional ingredients) in part 1 of the CFIT. The SIF name will be changed to L-arginine from fermentation process and the description amended to incorporate standardized wording and labelling statements for SIFs produced from fermentation processes. The amended description is:

L-Arginine from fermentation process (or (S)-2-amino-5-guanidinopentanoic acid from fermentation process)

is the crystalline product containing a minimum of 80% (S)-2-amino-5-guanidinopentanoic acid, and having the CAS# 74-79-3. 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 18% 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-arginine, and maximum percent moisture.

Additional information

This existing description was amended to remove the strain specificity and better align with the wording in the new SIF description for L-threonine from fermentation process. The application for amendment used a different strain of Corynebacterium glutamicum to produce L-arginine. In addition, standardized wording and required labelling statements for SIFs produced from fermentation processes were included in the amended description. These changes provide better consistency between SIF descriptions for amino acids from fermentation processes. This amended 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 still as a supplemental source of the amino acid, L-arginine, for all livestock species.

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-arginine 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 amended

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-arginine 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-arginine 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 amended SIF description 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