Share your thoughts: Proposed new livestock feed ingredient – Fumonisin esterase

Current status: Closed

This consultation ran from July 21, 2023 to August 21, 2023.

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About the consultation

The Canadian Food Inspection Agency (CFIA) is seeking comments on the following proposed new single ingredient feed (SIF) description for fumonisin esterase.

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 significantly from a conventional 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 label requirements. The CFIA will be transitioning to the Canadian Feed Ingredients Table (CFIT) that will be incorporated by reference into the Feeds Regulations, 2023 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 assessment

The CFIA's Animal Feed Program has completed a detailed assessment of an application for the approval of a new SIF: fumonisin esterase.

The assessment considered information related to:

the safety of feeding this SIF to livestock with respect to animal health
the safety of people who consume food derived from livestock that eat this SIF
the safety of workers/bystanders exposed to this SIF
environmental safety
an assessment of the fit-for-purpose and efficacy for this SIF, for the intended livestock species

The results of the CFIA's evaluation of available scientific data supports the safety and efficacy of fumonisin esterase and its intended purpose as a component of mycotoxin detoxifying agents in complete feeds for swine and poultry. Therefore, the CFIA recommends fumonisin esterase be approved as a new SIF and added to the Canadian Feed Ingredients Table (CFIT), accordingly.

Proposed SIF description

The CFIA intends to add fumonisin esterase to the CFIT under Subclass 6.23 (Mycotoxin detoxifying ingredients) of Class 6 (Non-nutritive ingredients) in part 2 of the CFIT with the following description:

Fumonisin esterase

is the enzyme preparation which has the activity to hydrolyze the tricarballylic acid side chains of fumonisins. This ingredient is produced from a fermentation process conducted in accordance with good manufacturing practices. This fermentation shall be conducted using a non-pathogenic strain of a microorganism, which does not contain a novel trait. The enzyme preparation may or may not contain residual growth media from the fermentation process.

The fermentation source (that is, production organism and fermentation type) of the enzyme preparation shall be indicated on the label.

This ingredient is approved for use as a component of mycotoxin detoxification agents for the degradation of fumonisins in complete feeds for poultry and swine.

If a carrier or facilitating agent 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 statements:

"This ingredient is free of antimicrobial activity and is not a source of viable microbial cells."

"This ingredient is approved for use as a component of mycotoxin detoxification agents for the degradation of fumonisins in complete feeds for poultry and swine."

Caution:

"Fumonisin esterase can only be used in complete feeds for poultry and swine that are considered safe for livestock consumption in accordance with the Canadian standards for mycotoxins and is not for use to remediate livestock feeds that do not comply with the Canadian standards for mycotoxins. (This caution statement is not required on complete feed labels.) / La fumonisine estérase ne peut être utilisée que dans les aliments complets pour la volaille et les porcs qui sont considérés comme sans danger pour la consommation d'animaux de ferme conformément aux normes canadiennes relatives aux mycotoxines et ne doit pas être utilisée pour remédier les aliments pour les animaux de ferme qui ne sont pas conformes aux normes canadiennes relatives aux mycotoxines. (Cet énoncé de précaution n'est pas requis sur les étiquettes des aliments complets.)"

It shall be labelled with guarantees for minimum fumonisin esterase activity, and maximum % moisture.

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

Additional information

Fumonisin esterase is approved as a mycotoxin detoxifying ingredient for use in livestock feeds in Canada by the CFIA. This SIF was placed into part 2 of the CFIT due to source specific data to demonstrate its intended purpose (mycotoxin detoxification activity) and the manufacturing process (from a fermentation process).

This SIF can only be used in complete feeds for swine or poultry that comply with the Canadian mycotoxin standards. To ensure proper use of this SIF and of future sources of mycotoxin detoxifying ingredients and any mixed feeds containing it, a caution statement was included in the SIF description and is to be applied to the SIF label and the label of any mixed feeds containing this SIF, other than complete feeds.

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 fumonisin esterase. Stakeholders are encouraged to share comments if there are:

concerns about the accuracy of SIF description
additional scientific data that should be considered before the SIF is approved

Scientific questions or information will be reviewed by the CFIA evaluators for consideration in the assessment. Non-scientific input will be evaluated and appropriate ways of addressing it will be explored.

Comments can be sent by email to the Animal Feed Program at cfia.afp-paa.acia@inspection.gc.ca. Please use "fumonisin esterase" in the subject line of the email. The CFIA is asking for comments and feedback by [August 21, 2023], 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 fumonisin esterase and issue the approval to the applicant. If there are significant concerns 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.

The SIF will be added to the CFIT at the next update, following publication of the Feeds Regulations, 2023.

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