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What We Heard Report: Proposed new livestock feed ingredient - Sodium butyrate

Introduction

The Canadian Food Inspection Agency (CFIA) led a 30-day consultation on a new single ingredient feed (SIF) description for sodium butyrate from June 9, 2023 to July 9, 2023. The purpose of the consultation was to seek comments and feedback on the proposed addition of sodium butyrate to the Canadian Feed Ingredients Table (CFIT) under Subclass 6.19.3 (Gut modifier ingredients – Acids) of Class 6 (Non-nutritive ingredients) in part 1 of the CFIT.

A summary of the comments received during this consultation period are available below.

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.

The CFIA completed a detailed evaluation of an application seeking approval for the use of sodium butyrate as a component of gut modifier products in complete feeds for swine and poultry.

The evaluation considered information related to:

Following the evaluation, the CFIA consulted on the new description for sodium butyrate.

What we heard

The CFIA received a total of 5 sets of comments and feedback from stakeholders during the 30-day consultation period. The CFIA appreciates the feedback received on this consultation.

Comment: a respondent commented that the CFIA should not allow any product intended to fatten up animals for food.  Only allow healthy food for animals should be allowed.

CFIA response: sodium butyrate has been evaluated and found to be safe and efficacious for its intended purpose (component of gut modifier products) and its use in livestock feed in Canada.

Approved SIFs can have a nutritional purpose (for example, source of energy, source of protein, etc.) or they can provide a non-nutritional/technical function (for example, flavouring agent, anticaking agent, antioxidant, preservative, forage additive, etc.). If the information provided to the CFIA in support of the intended livestock feed purpose(s), nutritional or non-nutritional, supports that the SIF is safe and efficacious, it may be approved for use in livestock feed.

Comment: a respondent commented that they are against anything new to be fed to our livestock and they do not consider this SIF useful to our food supply.

CFIA response: as indicated in the previous response, the CFIA evaluates new SIFs to ensure they are safe and efficacious. These new SIFs provide additional options for livestock producers when feeding their animals. Gut modifiers work in the gastrointestinal (GI) tract of an animal. They achieve this by acting on the livestock feed itself while in the gut or by modifying the GI environment to provide a benefit to the animal and may be linked to a nutritional effect. These products can contribute to production and maintenance of healthy livestock.

Comment: another respondent suggested that sodium butyrate should be considered for ruminants and aquaculture (fish), given that there are extensive scientific literature for supporting the extension to other livestock species.

CFIA response: at this time, there will be no additional species added to the description, as this application only included data to support its use in swine and poultry. The CFIA evaluates new and amended SIFs based on the information supplied by the applicant. If a stakeholder would like a SIF approved for additional livestock species, they will need to submit an application to amend the SIF description. Refer to RG-1 Regulatory Guidance-Regulation of Livestock Feeds. The application must include data or information to support such amendments, including data to support any additional livestock species. It would follow the normal SIF approval process, including consultation.

Comment: a respondent questioned why only sodium butyrate is being described as a source of butyric acid and not other salts of butyric acid such as calcium butyrate. They indicated that there is published data available that any salt such as sodium and calcium will dissociate once ingested into butyric acid, and serve as a gut modifier. The respondent questioned whether it was possible to have 1 SIF description for both forms (that is, sodium and calcium butyrate) or if a separate description would be required for each salt of butyric acid.

CFIA response: the CFIA evaluates SIFs based on the information supplied in the application. Although butyric acid could possibly be sourced from sodium or calcium salts, this SIF description is approved based on the evaluation of the sodium salt of butyric acid. There will be no change to the SIF description at this time.  However, a stakeholder interested in feeding calcium butyrate may submit an application for approval of this ingredient as a new SIF and, if approved, a decision would be made at that time on whether a new SIF description is required or, if the calcium form could be added to this SIF description. Refer to RG-1 Regulatory Guidance-Regulation of Livestock Feeds.

Comment: a respondent also shared a complaint that sodium butyrate and calcium butyrate have been sold in Canada as flowing agents for the past 10 to15 years from Europe and China, without registration, while similar products were registered as acidifiers in Canada. The respondent noted that these companies selling imported sodium butyrate as flowing agents are the ones that would benefit from the new SIF description, given that the SIF will be approved in part 1 of the CFIT.

CFIA response: although sodium butyrate is listed in part 1, its approved use is as a component of a gut modifier product and not as a flowing agent. Since gut modifier products are specialty feeds requiring registration, this part 1 SIF can only be used to make a registered gut modifier product. Livestock feeds, including imported livestock feeds, must contain approved SIFs. If a stakeholder has a concern or a complaint about a product found in the marketplace or the SIFs that are used in a livestock feed formulation, they are encouraged to reach out to the CFIA to address the issue.

None of the respondents provided any comments on the actual SIF description. The comments and feedback received did not result in any changes to the SIF description.

Final SIF description

Following the CFIA's evaluation and determination of the safety and efficacy of this SIF, and since no significant concerns were raised during consultation, the CFIA has approved sodium butyrate with the following description:

Part 1
Class 6 – Non-nutritive ingredients
Subclass 6.19.3 (Gut modifier ingredients – Acids)

Sodium butyrate (or sodium butanoate)

is the sodium salt of butyric acid, generally expressed as CH3(CH2)2COONa, and having the Chemical Abstracts Service (CAS) number 156-54-7.

This ingredient is approved for use as a component of gut modifier products in an amount not to exceed 0.12% (1200 mg/kg) of the complete feed for swine and poultry.

It shall be labelled with the following statement:

"This ingredient is approved for use as a component of gut modifier products in an amount not to exceed 0.12% (1200 mg/kg) of the complete feed for swine and poultry."

It shall be labelled with a guarantee for minimum percent sodium butyrate.

This new description had been added to the CFIT.

Next steps

The CFIA would like to thank everyone who participated in the consultation process for contributing their time and sharing their views.

We are committed to reviewing any new scientific information on the safety of any SIF. Anyone who becomes aware of new scientific information respecting the safety of sodium butyrate is encouraged to contact the CFIA.

This new SIF (with the finalized description above) has been added to the CFIT to be included with the publication of the proposed Feeds Regulations, 2024.

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

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