Current status: Open
Opened on March 21, 2025 and closes on May 21, 2025
About the consultation
We are seeking comments on the following 2 proposed new enzyme descriptions:
- phytase
- xylanase
We are also seeking comments on the following 9 proposed new terms (fermentation product types) for the Canadian Feed Ingredients Table (CFIT) glossary, which are associated with the proposed new enzyme descriptions:
- fermentation product liquid
- fermentation product condensed
- fermentation product dehydrated
- fermentation solubles liquid
- fermentation solubles condensed
- fermentation solubles dehydrated
- fermentation extract liquid
- fermentation extract condensed
- fermentation extract dehydrated
Background
The Feeds Regulations, 2024 require a proponent to submit a pre-market application for new feed ingredients or single ingredient feeds (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 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 consultation
SIFs listed and described in the CFIT are classified by purpose (the subclasses and classes in the CFIT refer to the purpose of the SIF). As we have transitioned from Schedules IV and V of the Feeds Regulations, 1983 to the CFIT of the Feeds Regulations, 2024, SIFs that were not classified with a clearly defined purpose or purposes were identified for review. This review process includes verifying SIF descriptions as well as reclassifying the SIFs according to their approved purposes in the CFIT. The reclassification process may involve organizing them by their respective subclasses to accurately reflect their intended purposes, if appropriate. For these SIFs under review, a SIF description may be modified, or a new description may be proposed.
We have begun a project to review SIF descriptions found in Subclass 6.21 (Fermentation products non-viable) of the CFIT. These SIFs are listed based on the production organism used to generate the SIF and the type of fermentation product produced (for example, Aspergillus niger fermentation product dehydrated). Although the SIFs in Subclass 6.21 are approved for the purpose of providing either non-nutritive substances (such as enzymes) or nutritive substances (such as nutrient metabolites), their specific purpose(s) is not specified, and the SIF name does not reflect the intended or active substance produced by the fermentation process. As such, we have identified SIFs in Subclass 6.21 (Fermentation products non-viable) that require a review to create descriptions reflective of their intended purpose.
For this consultation, we are specifically seeking comments on enzymes produced from fermentation processes with phytase or xylanase enzymatic activity, where the sources (production organisms) are currently listed in part 1 of the CFIT. Phytase and xylanase ingredients where the production organism is listed in part 2 will be addressed through a separate consultation process.
These proposed SIF descriptions will appear in Subclass 6.18 (Enzymes) of Class 6 (Non-nutritive ingredients) in part 1 of the CFIT. To support these proposed SIF descriptions, we are also proposing to add new terms to the CFIT glossary to define the different fermentation product types which are referred to in the proposed enzyme descriptions. We are planning to conduct future consultations to gather feedback on the remaining SIFs from fermentation processes, which will include other ingredients approved for different enzymatic activities (for example, amylase, glucanase).
Note that the existing fermentation product descriptions will not be removed from the CFIT at this time, and they will not be removed without further consultation. Both the enzyme-specific descriptions and the generic fermentation product descriptions will coexist in the CFIT to allow sufficient time for industry to update their labels.
Proposed definitions for fermentation product types as CFIT glossary terms
The CFIT contains a glossary for frequently used terms found in SIF descriptions. For the SIFs found in Subclass 6.21, the following 9 definitions for fermentation product types are being proposed that will complement the new proposed enzyme descriptions. Additional terms may be added to the glossary at a later date once other enzymes and other fermentation products have been reviewed.
- Fermentation product liquid
- is composed of the solids and solubles associated with the fermentation. It includes the medium in which the fermentation was conducted as well as fermentation substances and metabolites produced by the production organism. There is no separation or further extraction steps in the processing. This is the liquid form of the fermentation product, which has not undergone further processing to reduce the water content.
- Fermentation product condensed
- is composed of the solids and solubles associated with the fermentation. It includes the medium in which the fermentation was conducted as well as fermentation substances and metabolites produced by the production organism. There is no separation or further extraction steps in the processing. This is the condensed form of the fermentation product, which has undergone further processing to remove a considerable portion of the liquid.
- Fermentation product dehydrated
- is composed of the solids and solubles associated with the fermentation. It includes the medium in which the fermentation was conducted as well as fermentation substances and metabolites produced by the production organism. There is no separation or further extraction steps in the processing. This is the dried form of the fermentation product, resulting from the removal of the liquid portion from the fermentation product.
- Fermentation solubles liquid
- consists of only the water-soluble materials derived from the fermentation process after separation of suspended solids. This is the liquid form of the fermentation solubles, which has not undergone further processing to reduce the water content.
- Fermentation solubles condensed
- consists of only the water-soluble materials derived from the fermentation process after separation of suspended solids. This is the condensed form of the fermentation solubles, which has undergone further processing to remove a considerable portion of the liquid.
- Fermentation solubles dehydrated
- consists of only the water-soluble materials derived from the fermentation process after separation of suspended solids. This is the dried form of the fermentation solubles, resulting from the removal of the liquid portion from the fermentation solubles.
- Fermentation extract liquid
- is the extract obtained from the water-soluble materials of the fermentation, processed through extraction, filtration, precipitation, or other separation methods to increase the purity of the desired substance(s). This is the liquid form of the fermentation extract, which has not undergone further processing to reduce the water content.
- Fermentation extract condensed
- is the extract obtained from the water-soluble materials of the fermentation, processed through extraction, filtration, precipitation, or other separation methods to increase the purity of the desired substance(s). This is the condensed form of the fermentation extract, which has undergone further processing to remove a considerable portion of the liquid.
- Fermentation extract dehydrated
- is the extract obtained from the water-soluble materials of the fermentation, processed through extraction, filtration, precipitation, or other separation methods to increase the purity of the desired substance(s). This is the dried form of the fermentation extract, resulting from the removal of the liquid portion from the fermentation extract.
Proposed SIF descriptions
We intend to add phytase and xylanase to part 1 of the CFIT under Subclass 6.18 (Enzymes) of Class 6 (Non-nutritive ingredients) with the following descriptions:
Phytase from ____________ (name of approved source as per the description)
is an enzyme which has the activity to hydrolyze phytate and increase the digestibility of phytin-bound phosphorus in complete feeds for poultry and swine. This enzyme 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 medium in which the microorganism is grown shall not be fortified with levels of substances, such as minerals and vitamins, above those required for optimal growth of the microorganism in the fermentation process. The enzyme preparation shall not contain other extraneous materials except in such amounts as may occur unavoidably during good manufacturing practices. The enzyme can only be obtained from an approved source of phytase as listed below.
The approved source of the phytase (that is, the approved species of the production organism) must be part of the name of the feed; for example, phytase from Aspergillus niger.
The following are approved sources of phytase:
- Aspergillus niger
- Aspergillus oryzae
- Bacillus subtilis
- Pseudomonas fluorescens
- Trichoderma longibrachiatum
The fermentation product type (for example, fermentation product dehydrated) of the enzyme preparation shall be indicated on the label and may follow the enzyme name (for example, phytase from Aspergillus niger fermentation product dehydrated). The fermentation product type does not need to be part of the name of the feed as long as the information appears on the label. In addition, the type of phytase may also be included on the label (for example, phytase (6-phytase) from Aspergillus niger fermentation product dehydrated).
The enzyme unit definition and the enzymatic assay conditions shall also be stated 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 as a source of phytase for use as a component of specialty feeds for swine and poultry."
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 phytase activity, and maximum percent moisture when the enzyme is presented in a dry form.
Xylanase from ____________ (name of approved source as per the description)
is an enzyme which has the activity to hydrolyze the polysaccharide xylan into simple monosaccharides and xylooligosaccharides in complete feeds for poultry and swine. The enzyme is produced from a fermentation process conducted in accordance with good manufacturing practices. This fermentation shall be conducted using non-pathogenic strain of a microorganism, which does not contain a novel trait. The medium in which the microorganism is grown shall not be fortified with levels of substances, such as minerals and vitamins, above those required for optimal growth of the microorganism in the fermentation process. The enzyme preparation shall not contain other extraneous materials except in such amounts as may occur unavoidably during good manufacturing practices. The enzyme can only be obtained from an approved source of xylanase as listed below.
The approved source of the xylanase (that is, the approved species of the production organism) must be part of the name of the feed; for example, xylanase from Bacillus subtilis.
The following are approved sources of xylanase:
- Aspergillus niger
- Aspergillus oryzae
- Bacillus subtilis
- Humicola insolens
- Penicillium funiculosum
- Trichoderma longibrachiatum
- Trichoderma viridae
The fermentation product type (for example, fermentation extract dehydrated) of the enzyme preparation shall be indicated on the label and may follow the enzyme name (for example, xylanase from Bacillus subtilis fermentation extract dehydrated). The fermentation product type does not need to be part of the name of the feed as long as the information appears on the label. In addition, the type of xylanase may also be included in the label (for example, xylanase (endo-xylanase) from Bacillus subtilis fermentation extract dehydrated).
The enzyme unit definition and the enzymatic assay conditions shall also be stated 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 as a source of xylanase for use as a component of specialty feeds for swine and poultry."
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 xylanase activity, and maximum percent moisture when the enzyme is presented in a dry form.
Ingredient numbers will be assigned when these 2 SIFs are added to the CFIT.
Additional information
As the proposed phytase and xylanase descriptions will serve as a template for future enzyme descriptions, we are asking that stakeholders carefully review the text and provide comments on the standardized wording and the format of these descriptions, as well as the approach for updating how enzymes are listed and described in the CFIT. We also ask that comments are provided for the 9 terms to be added to the CFIT glossary, as these describe fermentation product types. These definitions for the fermentation product types are important because the label for phytase or xylanase will need to include the approved production organism (genus and species) and the fermentation product type.
The descriptions for phytase and for xylanase are being proposed as part 1 SIFs. This will be similar to how many fermentation product SIFs appear in part 1 of the CFIT.
Approved sources of an enzyme are listed within the applicable enzyme description, and these are listed at the species level. If the production organism used to produce the enzyme contains a novel trait, even if the species is in the list of approved sources for that enzyme, the derived ingredient would be considered a novel feed that must undergo pre-market evaluation and obtain approval. The list of approved sources for phytase and xylanase are based on an internal review conducted by our evaluators to compile a list of previously evaluated and registered fermentation products non-viable.
See the Important concept of novel trait in the SIF description below for further details. Please refer to 2.7 Guidelines for the assessment for novel feeds: microbial sources for applicable data requirements for such an application.
The SIF name shall be in accordance with the SIF description. The SIF name listed in the CFIT includes a blank line that must be replaced by the name of the approved source of the production organism (genus and species). For example, if the SIF is a phytase that is derived from an Aspergillus niger fermentation product dehydrated, the name for that SIF would be "phytase from Aspergillus niger". This is the name that must be used on the SIF label and in the list of ingredients on a mixed feed label. The SIF label must include the fermentation product type (for example, fermentation product dehydrated) which can be included in the SIF name (for example, phytase from Aspergillus niger fermentation product dehydrated) or may appear elsewhere on the SIF label.
For detailed labelling requirements for livestock feeds, please refer to RG-12 Regulatory guidance: Labelling of livestock feeds.
For phytase or xylanase to be considered approved, all aspects of the SIF description must be met. Approval must be obtained prior to the SIF being sold, manufactured, or imported into Canada.
Important concept of novel trait in the SIF description
Novel feed and novel trait are defined in the Feeds Regulations, 2024 as follows:
novel feed means a feed that is an organism, a part of an organism or a product of an organism, or that consists of parts or products of an organism, and that
- is not listed in the CFIT; or
- has a novel trait
novel trait, in respect of a feed that is an organism, a part of an organism or a product of an organism, or that consists of parts or products of an organism, means a characteristic of the feed that
- has been intentionally selected, created or introduced into the feed through a specific genetic change; and
- based on valid scientific rationale, is not substantially equivalent, in terms of its specific use and safety for human or animal health or the environment, to any characteristic of a similar feed that is listed in the CFIT
Any ingredient derived from a microorganism that is not currently listed or does not meet the existing SIF description in the CFIT is considered novel. For enzymes produced using a production organism that contains a novel trait, even if the species is in the list of approved sources in the SIF description, the enzyme would be considered a novel feed and, therefore, a mandatory pre-market evaluation for approval or registration would be required. To meet the definition of novel trait, a specific genetic change in the production organism must have been intentionally selected, created or introduced. Common techniques used in biotechnology that result in novel traits include recombinant DNA (rDNA) techniques, genome editing, mutagenesis or the application of selective pressures.
Approved source is missing from the list of approved sources
If you have previously received approval from the Animal Feed Program (AFP) for your fermentation product non-viable that is a source of phytase or xylanase, but you do not see the species of the production organism in the list of approved sources in the applicable proposed SIF description, please notify us by sending an email to the AFP at cfia.afp-paa.acia@inspection.gc.ca during the consultation period. We ask that you submit information from the approval documents, such as the registration number and approved label, so that we can substantiate the approval. We will then confirm its approval in our records and, if it is an approved source, we will add it to the list of approved sources. Sources that have not undergone pre-market evaluation and have not obtained approval from the AFP will not be added to the list of approved sources.
If a phytase or xylanase is not from an approved source as listed in the applicable SIF description, it would not meet the SIF description and would not be considered approved. Proponents seeking to have a new source approved would have to submit an application for feed approval that addresses the data requirements set out in 2.7 Guidelines for the assessment for novel feeds: microbial sources . If the outcome of the pre-market evaluation is positive, then we will conduct a public consultation for the addition of that new source to the list of approved sources in the SIF description of the CFIT.
Impacts on mixed feeds and updating the process
An enzyme SIF on carrier(s) (currently called an enzyme supplement) is classified as a mixed feed and considered a specialty feed. Under the Feeds Regulations, 2024, specialty feeds require registration unless they are exempt because they are using an approved claim that is listed in table 3 (Specialty feeds claims) of the Tables of Permissible Claims for Feed Labels and the specialty feed meets the conditions for the feed and the label for that approved claim. Currently, there is 1 enzyme-related claim for phytase products found in item 5 of table 3 of the Tables of Permissible Claims for Feed Labels.
Once this consultation for the proposed new enzyme descriptions for phytase and xylanase has closed, we will consult on proposed changes to the Tables of Permissible Claims for Feed Labels. The proposed updates will include amending the existing phytase product claim and adding new enzyme-related claims in table 3 of the Tables of Permissible Claims for Feed Labels to reflect the new enzyme descriptions. The proposed updates will result in some of the enzyme products (for example, phytase and xylanase) being exempt from registration if all conditions for these claims have been met. Any changes to the Tables of Permissible Claims for Feed Labels will be consulted on before any updates are made to this IBR document.
Note that we will be adjusting the terminology from "enzyme supplement" to "enzyme-bearing products", as the term 'supplement' in the Feeds Regulations, 2024 is specifically defined for nutritional livestock feeds.
Updating existing registered mixed feeds that have an enzyme single ingredient feed
If registered mixed feeds include the list of ingredients on the label, the label will need to be updated to reflect the change in the approved SIF name(s) of the embedded enzyme(s). To facilitate the changes, the AFP will be requiring updates to the label as part of the renewal application for mixed feeds that require registration. When submitting your renewal application for the registered mixed feed, please update the list of ingredients on the label to reflect the new SIF name(s) as listed in the CFIT for the embedded enzymes (for example, phytase, xylanase). In your application in My CFIA, please indicate that the changes made to the label reflect the updated SIF name(s) and is not the result of a change in the formulation. As these updates are being initiated by the AFP and the changes to the labels are solely to reflect the updated SIF name(s) of the embedded enzyme(s), we will not be charging an additional fee for this amendment.
Who is 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
We are inviting feedback on the proposed new descriptions for phytase and xylanase, as well as the definitions for the fermentation product types.
Stakeholders are encouraged to share comments if there are:
- any concerns about the accuracy of the SIF descriptions
- any concerns about the accuracy of the fermentation product type definitions
- any microbial fermentation sources that have previously been approved but are missing from the list of approved sources for phytase and xylanase
- any scientific information that should be considered before these SIFs are approved
This feedback will be valuable in ensuring the accuracy and completeness of the proposed reclassifications and descriptions.
Comments can be sent by email to the Animal Feed Program (AFP) at cfia.afp-paa.acia@inspection.gc.ca. Please use "phytase and xylanase" in the subject line of the email. We are asking for comments and feedback by May 21, 2025, which is 60 days from the date of this posting.
Next steps
We will review all the comments received. If no significant scientifically valid concerns are raised, we will finalize the reclassification and proposed descriptions for phytase and xylanase, and the defined terms for fermentation product types to be added to the glossary in the CFIT. If significant concerns are raised, we will evaluate the additional information. A "what we heard" report that summarizes the feedback received will be published.
These SIFs (phytase and xylanase) will be added to the CFIT at the next update. In addition, the definitions for the various fermentation product types will be added to the CFIT glossary at the next update.
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