Proposed new livestock feed ingredients – Viable Microorganisms: Closed consultation

Current status: Closed

This consultation ran from February 2, 2024 to March 4, 2024

About the consultation

The Canadian Food Inspection Agency (CFIA) was seeking comments on the following 15 proposed new viable microorganism descriptions:

• Limosilactobacillus reuteri culture dehydrated
• Bifidobacterium animalis culture dehydrated
• Bacillus velezensis culture dehydrated
• Acidipropionibacterium jensenii culture dehydrated
• Lactococcus lactis culture dehydrated
• Lacticaseibacillus paracasei culture dehydrated
• Lentilactobacillus buchneri culture dehydrated
• Pediococcus pentosaceus culture dehydrated
• Enterococcus lactis culture dehydrated
• Levilactobacillus brevis culture dehydrated
• Bacillus paralicheniformis culture dehydrated
• Bacillus subtilis culture dehydrated
• Streptococcus thermophilus culture dehydrated
• Lactobacillus acidophilus culture dehydrated
• Bacillus amyloliquefaciens culture dehydrated

Background

The Feeds Regulations require a proponent to submit a pre-market application for single ingredient feeds (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, 1983, 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 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

As the CFIA transitions from SIFs being listed and defined in Schedules IV and V to SIFs being listed, described and classified by purpose in the CFIT, we are reviewing the viable microorganisms descriptions. The CFIA has reviewed the following viable microorganism descriptions to ensure standardized species-specific descriptions for these viable microorganisms that accurately reflect their purpose(s). Since the CFIT describes and classifies each SIF with a clearly defined purpose or purposes, there is a need to reclassify these viable microorganisms according to their approved purpose(s) in the CFIT. Currently, 2 subclasses are applicable for viable microorganisms: Subclass 6.19.2 (Gut modifier ingredients – Viable microorganisms) and Subclass 6.20 (Forage additives). Note that no existing viable microorganism descriptions will be removed at this time.

The CFIA's Animal Feed Program has completed detailed evaluations of applications for the approval of 15 new viable microorganisms:

• Limosilactobacillus reuteri culture dehydrated
• Bifidobacterium animalis culture dehydrated
• Bacillus velezensis culture dehydrated
• Acidipropionibacterium jensenii culture dehydrated
• Lactococcus lactis culture dehydrated
• Lacticaseibacillus paracasei culture dehydrated
• Lentilactobacillus buchneri culture dehydrated
• Pediococcus pentosaceus culture dehydrated
• Enterococcus lactis culture dehydrated
• Levilactobacillus brevis culture dehydrated
• Bacillus paralicheniformis culture dehydrated
• Bacillus subtilis culture dehydrated
• Streptococcus thermophilus culture dehydrated
• Lactobacillus acidophilus culture dehydrated
• Bacillus amyloliquefaciens culture dehydrated

The evaluations considered information related to:

• the safety of feeding these SIFs to livestock with respect to animal health
• the safety of people who consume food 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 the CFIA's evaluation of available scientific data support the safety and efficacy of Limosilactobacillus reuteri culture dehydrated, Bifidobacterium animalis culture dehydrated, Bacillus velezensis culture dehydrated, Bacillus paralicheniformis culture dehydrated and Bacillus amyloliquefaciens culture dehydrated, and their intended purpose as a source of viable organisms for use as a component of gut modifier products for livestock species.

In addition, the results of the CFIA's evaluation of available scientific data support the safety and efficacy of Acidipropionibacterium jensenii culture dehydrated, Lactococcus lactis culture dehydrated, Lacticaseibacillus paracasei culture dehydrated, Lentilactobacillus buchneri culture dehydrated, Pediococcus pentosaceus culture dehydrated and Lactobacillus acidophilus culture dehydrated, and their intended purpose as a source of viable organisms for use as a component of forage additives to aid in the production of organic acids or to lower the pH of the ensiled plant materials.

The results of the CFIA's evaluation of the available scientific data also support the safety and efficacy of Enterococcus lactis culture dehydrated, Levilactobacillus brevis culture dehydrated, Bacillus subtilis culture dehydrated and Streptococcus thermophilus culture dehydrated for 2 purposes; as a source of viable organisms for use as a component of gut modifier products for livestock species, and as a source of viable organisms for use as a component of forage additives to aid in the production of organic acids or to lower the pH of the ensiled plant materials. The CFIA recommends Enterococcus lactis culture dehydrated, Levilactobacillus brevis culture dehydrated, Bacillus subtilis culture dehydrated and Streptococcus thermophilus culture dehydrated be approved as new multiple-purpose SIFs and added to 2 different subclasses of the CFIT.

Therefore, the CFIA recommends these 15 viable microorganisms be approved as new SIFs and added to the CFIT accordingly.

Proposed SIF descriptions

The CFIA intends to add the following 9 viable microorganisms to the CFIT under Subclass 6.19.2 (Gut modifier ingredients – Viable microorganisms) of Class 6 (Non-nutritive ingredients) in part 2 of the CFIT with the following descriptions:

The CFIA also intends to add the following 10 viable microorganisms to the CFIT under Subclass 6.20 (Forage additives) of Class 6 (Non-nutritive ingredients) in part 2 of the CFIT with the following descriptions:

Ingredient numbers will be assigned when these SIFs are added to the CFIT. Note that a different ingredient number would be assigned for each approved purpose for Enterococcus lactis culture dehydrated, Levilactobacillus brevis culture dehydrated, Bacillus subtilis culture dehydrated, and Streptococcus thermophilus culture dehydrated.

Additional information

These 15 new viable microorganisms will be placed into part 2 of the CFIT because they are viable microbial strains (a source of viable microorganisms), and each source must be approved and registered. These SIFs are approved either as a component of gut modifier products or as a component of forage additives to aid in the production of organic acids or to lower the pH of the ensiled plant materials. In the case of Enterococcus lactis culture dehydrated, Levilactobacillus brevis culture dehydrated, Bacillus subtilis culture dehydrated and Streptococcus thermophilus culture dehydrated, they are approved for both purposes.

As mentioned above, these 15 new descriptions are the result of the CFIA's project to update viable microorganism descriptions. In addition, some species have been reclassified into new genera due to taxonomic changes. These reclassifications are possible because of newer tools (for example, whole genome sequencing and bioinformatics) for comparing microbial genomes that are more sensitive to differences between species compared to traditional microbiological methods. Since there have been taxonomy changes, the CFIA is revising SIF names for the microorganisms by including the correct genus and species. The change in the naming of these viable microorganisms will improve transparency as species of the same genus are known to differ in terms of characteristics, environmental niches, metabolic properties and even toxicity (for example, Bacillus cereus vs. Bacillus subtilis).

As the CFIA continues to work on updating how viable microorganisms are named and described in the CFIT, species-level identification of these microorganisms is important. The CFIA will request that registrants with registered sources of viable microorganisms and applicants who are submitting new applications for viable microorganisms include data to support a species-level identification and confirm the intended purpose when they submit an application for SIF approval or renewal. This will allow the CFIA to accurately name and describe the viable microorganisms approved for use in livestock feed in Canada.

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 new descriptions for 15 viable microorganisms. Stakeholders were encouraged to share comments if there was:

• concerns about the accuracy of SIF descriptions
• additional scientific data that should be considered before these SIFs are approved

The CFIA's evaluators will review any scientific questions or information that are provided for consideration in the evaluation. 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 (AFP) at cfia.afp-paa.acia@inspection.gc.ca. Please use "Viable microorganisms" in the subject line of the email. The CFIA was asking for comments and feedback by March 4, 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 these viable microorganism descriptions and issue the approval to the applicants. If significant concerns are raised, the CFIA will evaluate the additional information and may, subject to the commenters' consent, forward the comments to the applicants for their response. A what we heard report that summarizes the feedback received will be published.

These SIFs (15 viable microorganisms) will be added to the CFIT at the next update, following the 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
E-mail: cfia.afp-paa.acia@inspection.gc.ca