Proposed new livestock feed ingredients – Vitamins 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 2 proposed new single ingredient feed (SIF) descriptions:

  • riboflavin from fermentation process
  • vitamin B12 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 2 new SIFs: riboflavin from fermentation process and vitamin B12 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 riboflavin from fermentation process and vitamin B12 from fermentation process and their intended purpose as a supplemental source of riboflavin and vitamin B12, respectively, for livestock species.

Therefore, we recommend that riboflavin from fermentation process and vitamin B12 from fermentation process be approved as new SIFs and added to the CFIT, accordingly.

Proposed SIF descriptions

We intend to add riboflavin from fermentation process under subclass 5.4.1 (Vitamins from fermentation processes) of class 5 (Nutritional ingredients) in part 2 of the CFIT with the following description:

Riboflavin from fermentation process (or vitamin B2 from fermentation process)

is 7,8-dimethyl-10-[(2S,3S,4R)-2,3,4,5-tetrahydroxypentyl]benzo[g]pteridine-2,4-dione, generally expressed as C17H20N4O6, and having the CAS# 83-88-5. It is obtained from a fermentation process using a non-pathogenic strain of Bacillus subtilis or Ashbya gossypii (also known as Eremothecium gossypii), which does not contain a novel trait. 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 the product bears a name descriptive of the form (for example, crystalline), it shall correspond thereto and be indicated on the label.

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 milligrams of riboflavin per kilogram, and maximum percent moisture.

In addition, we intend to add vitamin B12 from fermentation process under subclass 5.4.1 (Vitamins from fermentation processes) of class 5 (Nutritional ingredients) in part 2 of the CFIT with the following description:

Vitamin B12 from fermentation process (or cyanocobalamin from fermentation process)

is cyanocobalamin, generally expressed as C63H88CoN14O14P, and having the CAS# 68-19-9. It is obtained from a fermentation process using a non-pathogenic strain of Ensifer adhaerans, which does not contain a novel trait. 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 the product bears a name descriptive of the form (for example, crystalline), it shall correspond thereto and be indicated on the label.

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 milligrams of vitamin B12 per kilogram, and maximum percent moisture.

Ingredient numbers will be assigned when these 2 SIFs are added to the CFIT.

Additional information

Since a chemically synthesized source of riboflavin (1-504-016 riboflavin) and a chemically synthesized source of vitamin B12 (1-504-020 vitamin B12 (or cyanocobalamin)) are already listed and described in the CFIT, we are proposing new descriptions for riboflavin and vitamin B12 that are produced from fermentation processes. This will differentiate the chemically synthesized sources of riboflavin and vitamin B12 found in the CFIT from the sources of riboflavin and vitamin B12 obtained from fermentation processes.

These SIFs will be placed into part 2 of the CFIT because of potential differences in the safety profile between sources, which must be evaluated. These differences between sources could arise from variations in purity, production organism characteristics, and manufacturing. Therefore, these SIFs will be placed in part 2 of the CFIT and all sources will need to undergo pre-market evaluation and obtain registration. The placement of these SIFs in part 2 of the CFIT is consistent with the placement of other vitamins from fermentation processes in part 2. The proposed descriptions indicate the production organisms used during the fermentation process, and include the standardized wording and required labelling statements for other SIFs produced from fermentation processes. These descriptions include 1 required labelling statement, and 1 worker safety statement for eye, skin and respiratory irritation and/or sensitization.

For the riboflavin from fermentation process description, the production organisms include the species Ashbya gossypii, which underwent taxonomic reclassification to Eremothecium gossypii. However, given that the former name Ashbya gossypii is still commonly used when referring to this species, both names appear in this description.

The evaluations that led to the creation of these 2 new SIF descriptions, riboflavin from fermentation process and vitamin B12 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 these 2 new SIF descriptions. However, given that the foreign decisions noted safety concerns that varied between sources, it was determined that each source should undergo evaluation and, therefore, these descriptions will be placed in part 2 of the CFIT. The pathway for consideration of ingredients under the policy Feed approval or registration requirements for the acceptance of a foreign approval/authorization is an option for proponents to have their ingredients evaluated.  

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 riboflavin from fermentation process and vitamin B12 from fermentation process.

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

These SIFs 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