Chapter 3 - Specific Registration Information by Feed Type
3.22 Viable Microbials and Yeasts

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Regulation of Viable Microbial Strains, Viable Microbial Products, Viable Microbial Supplements (Diluted Viable Microbial Products), and Mixed Feeds containing Viable Microbial Products

This section of the RG-1 sets out the policy of the CFIA regarding viable microbial strains, viable microbial products (VMPs), viable microbial supplements, and mixed feeds containing VMPs that are manufactured or sold in Canada, or imported into Canada, as livestock feed.

This section is divided into three parts:

  • the introduction to Section 3.22 provides information regarding the CFIA and Health Canada's regulatory oversight of viable microbial products (VMPs) for oral administration to livestock, including an explanation of the regulatory classification of these products;
  • subsection 3.22.1 provides information regarding the CFIA's registration requirements for viable microbial strains; and
  • subsection 3.22.2 provides information regarding the CFIA's registration requirements for viable microbial products, viable microbial supplements (diluted VMPs) and mixed feeds containing VMPs.

Definitions

Viable microbial strain:
includes strains of viable yeast, viable fungi, and viable bacteria.
Viable microbial product (VMP):
viable microbial strain on a carrier.
Viable microbial supplement (diluted VMP):
dilutions of registered VMPs, e.g., a VMP on a carrier.
Mixed feeds containing VMPs:
nutritional feeds (premixes, supplements and complete feeds) claiming the presence of a VMP.
Embedded:
refers to the presence of a product used in the formulation of another product.

Classification of Viable Microbial Products

VMPs for voluntary oral administration to livestock species include both those mixed into livestock feed, and those delivered via the watering system. All VMPs for direct livestock consumption must be approved prior to their sale in Canada according to their classification as a livestock feed, a veterinary drug, or a veterinary biologic. VMPs are classified, along with other factors, on the basis of their intended purpose and label claims. The onus is on the company producing the product to determine, and support, the appropriate classification of its product in a satisfactory manner. The amount and type of substantiating data required for approval is directly related to the product's regulatory classification.

If applicants are uncertain as to the regulatory classification of their product, they may submit information on the product using the Information Template for Veterinary Product Classification Requests to the Veterinary Drugs Directorate (VDD) of Health Canada.

To obtain an electronic version of the template, please contact VDD. Requests for classification should include a cover letter, the completed template, and the related supporting documentation. All classification requests must be submitted in writing (mail, e-mail or facsimile) to VDD at the coordinates below:

Veterinary Drugs Directorate (VDD)
Health Canada
Holland Cross Complex
11 Holland Avenue, Suite 14
Postal Locator: 3000A
Ottawa ON  K1A 0K9

Telephone: 613-954-5687
Facsimile: 613-957-3861
E-mail: vetdrugs-medsvet@hc-sc.gc.ca

Upon review of this template, VDD will then consult with the Animal Feed Division (AFD) of the CFIA to agree on a classification decision. Drug status decisions will be made by the VDD; feed status decisions will be made by the AFD. The applicant will be notified in writing of the decision concerning the regulatory status of a product. For VMPs classified as veterinary drugs, VDD will provide information on the appropriate regulatory requirements and related guidance documents.

Veterinary Drugs

VMPs intended to be administered via forced oral administration, or in dosage forms consistent with forced oral administration (e.g., boluses, gavages or drenches) will be classified as veterinary drugs.

Products with indications for the following claims (along with other factors) may be considered veterinary drugs:

  • claims regarding improvements of production parameters beyond normal ranges (as defined in current National Research Council (NRC) or equivalent published literature, under normal conditions of animal husbandry);
  • statements that imply treatment, mitigation (i.e. reduction in incidence and severity) or prevention of a disease, disorder, abnormal physical state, or its symptoms;
  • any reference to intestinal flora; or
  • claims regarding restoration, correction or modification of organic function. Any stress-related claim will be evaluated on the basis of disease, disorder, abnormal physical state, or their symptoms resulting from stressful conditions.

Registration inquiries regarding drugs should be directed to the Veterinary Drugs Directorate (VDD) (see contact information above).

Veterinary Biologics

Products that imply, directly or indirectly, the diagnosis, treatment, mitigation or prevention of an infectious disease, mediated by an immune response or the modulation of an immune response, will be considered veterinary biologics. (See also Section 3.21, "Regulation of Veterinary Biologics in Livestock Feeds", for more information on veterinary biologics.) Registration inquiries regarding veterinary biologics should be directed to:

Canadian Centre for Veterinary Biologics
Animal Health Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa ON K1A 0Y9

Telephone: 613-773-7408
Facsimile: 613-773-7570

Livestock Feeds

Acceptable feed claim statements include improved appetite, weight gain, nutrient digestibility, feed efficiency, and other production parameters, to within normal ranges as defined in current National Research Council (NRC) or equivalent published literature, under normal conditions of animal husbandry. In the absence of NRC published values, the inclusion of a positive control group in an efficacy trial as a reference standard would be acceptable. Normal conditions of animal husbandry may include weaning, ration changes, vaccination, debeaking, dehorning, castration, shipping, shearing, etc.

Once a VMP has been determined to be a feed, then an application can be made to the Animal Feed Division of the CFIA for it to be evaluated for registration as a feed.

Products with Multiple Claims

Products with multiple claims will undergo a joint review by the regulatory groups involved, coordinated through the agency or department having authority over the principal claim. Products with multiple claims will be labelled with one approval number. The following hierarchy has been established to cover products with multiple claims: Veterinary biologic or Veterinary drug > Livestock feed (a product's status as a biologic or a drug takes precedence over its status as a feed). In other words, if the label claims for a VMP are such that it could be considered as both a veterinary biologic and a feed product, then it will be approved as a biologic, and a VMP that could be considered as both a veterinary drug and a feed will be approved as a drug. For the registration of veterinary biologics, a product licence is issued by the Terrestrial Animal Health Division of the CFIA, and an Establishment Licence Number must be shown on licensed veterinary biologics. A Drug Identification Number issued by HC must appear on any drug label. A Feed Registration Number must be indicated on feed labels.

List of CFIA Documents referenced in Section 3.22

Feeds Regulations, Schedule IV
Feeds Regulations, Schedule V

RG-1, Regulatory Guidance: Feed Registration Procedures and Labelling Standards

3.22.1 Registration Requirements for Viable Microbial Strains

Each viable microbial strain is required to undergo a mandatory pre-market assessment and registration prior to the registration of the Viable Microbial Product (VMP). These strains can fall in one of two categories:

1. Novel Microbial Feeds
2. Other Than Novel Microbial Feeds

The CFIA provides guidance to stakeholders on how to meet the requirements for the assessment process for microbial strains. Two documents (RG-1 Section 2.7, and RG-1 subsection 3.22.1) have been developed that outline the specific data requirements for the safety assessment of viable microbial strains. The following text explains how to determine which document to consult.

How to determine which guidance document applies to your strain (Section 2.7 or subsection 3.22.1)

Feed products vary widely in their individual characteristics, and the prescription of the same set of data requirements for all safety assessments would be impractical and onerous for applicants. Data requirements are tailored, instead, based on the nature of the specific product, including its history, use, and complexity. This allows applicants to concentrate on meeting those data requirements relevant for their particular product.

Novel Microbial Feeds

Any microorganism that is not currently listed in Part II of Schedule IV of the Feeds Regulations, or has a novel trait, is considered to be novel (see Appendix I below for definitions). In these cases, the draft document entitled Guidelines for the Safety Assessment of Novel Feeds: Microbial Sources (RG-1, Section 2.7) is to be used as a guide in preparing an application. The guidelines include criteria that will be considered in the assessment of safety and efficacy of a novel feed from microbial sources. They are not intended to explicitly define all of the data that could be required in the course of the assessment, however the list of requirements is more exhaustive than the requirements outlined in this subsection (3.22.1).

Other Than Novel Microbial Feeds

The present document, subsection 3.22.1, has been developed to guide applicants wishing to register individual microbial strains that do not contain a novel trait (see Appendix I below for definitions), and that belong to a genus already listed in Schedule IV, Part II. It is important to note that, under certain circumstances, a microbial species or strain may be considered novel even though its genus is listed in Schedule IV, Part II. This is usually because of a lack of familiarity with the particular species or strain, or because the species/strain could potentially cause foodborne disease and/or animal health issues. For these species or strains, a safety assessment is required, as per the draft Guidelines for the Assessment of Novel Feeds: Microbial Sources (Section 2.7).

Applicants seeking advice on determining which of the two guidance documents to follow in order to prepare a submission package can refer to Appendix II, or consult directly with the Animal Feed Division (AFD). Consultation with the AFD is highly recommended for any applicants experiencing difficulty in determining which approach to follow.

The following subsection outlines the requirements for the registration of viable microbial strains to be used in livestock feeds. For registration requirements for VMPs, please consult Registration of Viable Microbial Products (VMPs) and Mixed Feeds Containing VMPs (subsection 3.22.2), as well as Section 3.9, Forage Additives.

Submissions for registration of individual strains of microorganisms, other than those considered to be novel, must include the following:

Administrative Requirements

Standard registration requirements, including a completed and signed Application for Feed Registration or Renewal (CFIA/ACIA 0009) form; application fee as per Chapter 1, Application for Feed Registration and Ingredient Approval (Category 2); three (3) copies of the proposed product label; an accompanying cover letter; and signing authority/Canadian agent (if applicable), for each individual strain.

Labelling

A copy of the proposed label, which must include the following:

  • the ingredient name, in accordance with the ingredient definition in Part II of Schedule IV of the Feeds Regulations (e.g., Lactobacillus Culture Dehydrated);
  • the name of the organism (i.e., genus and species) including the strain identification number/code or the internal identification number used by the registrant (e.g., Lactococcus lactis LL 123);
  • any required statements pursuant to the ingredient description found in Part II of Schedule IV of the Feeds Regulations (e.g., product claim statement: "This product is for use only as a component of a silage additive to aid in the production of lactic acid or to lower the pH of the ensiled plant material or as a source of viable organisms in viable microbial products");
  • a guarantee for the activity of the microorganism (e.g., minimum 1 x 1012 CFU/g);
  • lot number;
  • date of manufacture;
  • expiration date (at least 12 months from the date of manufacture when stored under appropriate conditions);
  • recommended storage conditions in order to maintain activity until the expiration date;
  • cautionary and/or warning statements, if applicable (e.g., "This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling");
  • the name and address of the registrant;
  • the name and address of the manufacturer, if different from the registrant; and
  • the net amount (metric units).

The label is intended for CFIA use only.

Analytical Method

A sample from a recent lot, and a signed Certificate of Analysis showing the actual colony forming units or viable cells in that sample must be submitted. The assay method used for analysis must be provided, and must also be stated on the Certificate of Analysis. Refer to Section 6.2, Good Laboratory Practices Protocol for Feed Ingredient Approvals, for requirements concerning laboratory methodology.

Submit your sample, signed Certificate of Analysis and the laboratory methodology directly to the CFIA Laboratory at the following address:

Ottawa Laboratory (Carling)
Feed Bioanalysis and Microscopy Section
Canadian Food Inspection Agency
Building 22, Central Experimental Farm
960 Carling Avenue
Ottawa ON K1A 0C6

Please note that, along with submitting the sample, applicants will need to fill out the submission form in Appendix III below.

Scientific Data

  1. The purpose of the microbial strain in livestock feed.
  2. The history of the microorganism. If applicable, information on previous use in agriculture and/or other industries, as well as the origin or source and isolation method.
  3. The taxonomic identity of the strain, including genus, species, subspecies, strain and/or type, the origin of the strain (when, where and from which material it was isolated), and any identifying number or code used by the applicant, as well as any substantiated changes in nomenclature.
  4. The certificate from the depositary, if the strain has been deposited in a recognized culture collection, e.g., American Type Culture Collection (ATCC), Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH (DSMZ), National Collection of Food Bacteria (NCFB).
  5. An analytical report substantiating the identification and classification of the strain, including procedures for the isolation, quantification and identification (e.g., biotyping key, biochemical profile). Information on the methodologies used to analyse the viable counts of the strain, e.g., a copy of the AOAC International or other official method, is required. In the event that these methods have not been peer reviewed, additional information is required to validate the laboratory method as outlined in Section 6.2, Good Laboratory Practices Protocol for Feed Ingredient Approvals. The information submitted should allow the differentiation of the strain from other strains and closely related microorganisms.
  6. Information about any genetic manipulation of the strain. Please note that if the microbe is a novel feed (i.e., is not listed in Part II of Schedule IV, or is a genetically modified organism), the applicant will need to consult the Guidelines for the Assessment of Novel Feeds: Microbial Sources (Section 2.7).
  7. The identification data from three (3) recent manufacturing lots of the microorganism. (e.g., API strips).
  8. A detailed description of the manufacturing process including all downstream processing.
  9. The complete composition (ingredient list and levels) of the media on which the culture has been produced, and other processing aids from the initial inoculation to the downstream processing and manufacture, including the proportion or percentage of each ingredient of the downstream processing additives (e.g., cryoprotectants). Consideration for any potential contaminants which may be introduced either through the ingredients or the process should be identified here.

    Meat-derived ingredients (such as peptone, tryptone, beef extract, etc.) may be present in the media used for the production of the strain, either as a component of ready-made media (e.g., MRS), or as an individually added component in the production media. In order to minimize the risk of transmission of Transmissible Spongiform Encephalopathy (TSE) agents, material of ruminant origin must be sourced from a low-TSE-risk country. A signed statement must be submitted by registrants concerning the source of the meat-derived ingredients present in any of the media used, from the initial inoculation to the downstream processing. The country of origin of the animals from which these ingredients are derived must also be identified.

    Since a registrant may change suppliers at any time or the media supplier may change the source of their ingredients, it is the registrant's responsibility to monitor their suppliers to ensure that ingredients of ruminant origin present in the growth media comply with the above animal health requirements.

    Note: Importers of microorganisms used as livestock feeds must comply with all import requirements stipulated in the Health of Animals Act and Regulations. Applicants are advised to contact the Terrestrial Animal Health Division of the CFIA for information related to animal health. For such information, please contact:

    Import/ Export Section
    Terrestrial Animal Health Division
    Canadian Food Inspection Agency
    59 Camelot Drive
    Ottawa ON  K1A 0Y9

    Telephone: 613-773-2342
    Facsimile: 613-773-7571

  10. Information on any inherent antimicrobial activity expressed by the strain (if applicable).
  11. Information on the susceptibility of the strain to a range of antimicrobials. Susceptibility testing must be done using internationally recognised and standardized methods. Antimicrobial susceptibility testing should be determined for the following antimicrobials:
    Chemical class Antimicrobial
    ß-lactams Ampicillin
    Aminoglycosides Streptomycin
    Kanamycin/neomycin
    Gentamycin
    Chloramphenicols Chloramphenicol
    Tetracyclines Tetracycline
    Macrolides Erythromycin
    Streptogramins Quinupristin/dalfopristin
    Polypeptides Vancomycin
    Bacitracin
    Sulfonamides Sulfamethoxazole
    Fluoroquinolones Ciprofloxacin/enrofloxacin
    Oxazolidinones Linezolid
    Rifamycins Rifampicin

    Note 1: Where resistance to a particular antimicrobial is found, comments on the impact of this resistance with respect to human and animal health, as well as the environment, will be required.

    Note 2: Where the resistance profile of a strain to a particular antimicrobial raises concerns about potential transfer of the genetic resistance to other microorganisms, further information may be required from the applicant about the genetic basis and the likelihood of transfer of the resistance determinants.

  12. Where species of microorganisms used are taxonomically related to species that are pathogenic to humans or to animals, additional information may be required (e.g., Certificates of Analysis for toxins). For example, the genus Bacillus includes species approved for use in livestock feed, such as B. licheniformis and B. subtilis. The genus, however, contains known pathogenic species such as B. cereus, and other Bacillus species which may produce emetic and/or diarrhoeal toxins. Consequently, for any strain of Bacillus submitted for registration, experimental data must be provided to demonstrate that the strain does not produce any of the toxins associated with pathogenic Bacillus spp. The methods used to demonstrate the absence of toxin production must be scientifically valid and recognized. The data submitted must include the scientific reference to the assays, the experimental protocol and the results.
  13. A description of the quality control parameters used to monitor purity and identify of the strain from the master seed culture to the finished ingredient.

Required Certificates of Analysis

For each analytical requirement, please submit three (3) original Certificates of Analysis from three different lots of product. Only results of recent lots of product should be submitted, and they must be representative of the product submitted for registration.

Note: It is recommended to use the same manufacturing lots for identification, microbial counts and contaminant screening.

All Certificates of Analysis must be signed by the laboratory technician carrying out the test. The analytical methods used to conduct each analysis must be submitted. In the event that these methods have not been peer-reviewed, additional information is required to validate the laboratory method.

  1. Certificates of Analysis in support of label guarantees stating the actual colony forming units (CFU/g) or viable cells per gram (depending on the enumeration method).
  2. Certificates of Analysis for the screening of pathogens and other bacterial contaminants, including counts for the following:

    PseudomonasFootnote 7
    StaphylococcusFootnote 7
    E. coli, total coliformsFootnote 7
    SalmonellaFootnote 7
    Total plate count (or APC)Footnote 8
    Yeast and mold counts (with no Aspergillus flavus or Fusarium species detected)Footnote 8

  3. If metals are purposely supplemented in the media to result in a microbial product with enhanced levels of that metal, provide Certificates of Analysis for the metal in the final product.
  4. If heavy metals and/or chemical contaminants, either inherently present or introduced via the process, are anticipated (e.g., heavy metals from the media), Certificates of Analysis are required for these contaminants. Additional information for validating the laboratory method as outlined in Section 6.2, Good Laboratory Practices Protocol for Feed Ingredient Approvals.
  5. Certificates of Analysis are required to support the guaranteed shelf life of at least 12 months from the date of manufacture (i.e., a microbial count on the date of manufacture, and another count 12 months after the date of manufacture). The storage conditions used for the shelf life study should reflect the storage conditions recommended on the label.

Promotional Claims

If published literature or promotional material indicate that this strain could be considered a drug or a veterinary biologic as per its mode of action, registration applications will be closed and returned to the applicant. Applicants will then be advised, as applicable, to submit their application to the Veterinary Drug Directorate, Health Canada, or the Canadian Centre for Veterinary Biologics, CFIA (for more information, please refer to "Classification of Viable Microbial Products" at the beginning of section 3.22).

Safe Handling of Viable Microbial Strains and Viable Microbial Products

Microbial strains and products have the potential to cause dermal and respiratory irritation and/or sensitization. Registrants are therefore required to:

  • conduct dermal/respiratory sensitization/irritation studies; or
  • provide scientific rationale as to why this is not necessary; or
  • include the following statement on all microbial strain labels (i.e., individual cultures): "This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling.".

Renewal and/or Amendment of Registrations for Microorganisms

Strain registration certificates are issued for a three year period, renewable by March 31 of the third year after the registration date. All applications for renewal of a registered feed must be accompanied by:

  • the application fee (refer to Chapter 1 for fee amounts);
  • three (3) copies of the proposed label;
  • complete media formulation and any downstream additives; and
  • a signed statement from the registrant to the effect that no modifications were made to the manufacturing process or to the media composition since the strain was last registered or renewed.

Certificates of Analysis for three (3) recent lots substantiating identification of the strain, as well as guaranteed analysis, will be required at the time of renewal. Additional information may be requested if safety concerns emerge between the time of registration and renewal.

In the case of an amendment to a registration, applicants must submit a description of the amendment, any relevant supporting data, and administrative requirements.

Registration Checklists for Viable Microbial Strains

Below are two checklists, pertaining to viable microbial strains, which detail the information required for a submission for registration. Choose the relevant checklist based on the type of submission (new submission or renewal).

A completed checklist must be submitted to the Animal Feed Division (AFD) with each application for product registration. Please indicate the page number of your submission corresponding to each category in the checklist.

Note: Incomplete submissions will not be accepted by the AFD.

A) Applications for Registration for Viable Microbial Strains

  • For applications for registration for new sources of viable microbial strains found in Part II of Schedule IV of the Feeds Regulations.
Regulatory Status

Submission page # space

  • The strain and the viable microbial product containing the strain meets the criteria for classification as a feed (and not as a drug or veterinary biologic) according to the guidance provided in Section 3.22
  • Promotional claims (including internet and advertisement) consistent with stated purpose of the product
Administrative Registration Requirements

Submission page # space

  • Cover letter (detailing purpose of product, and any requested change(s) if product is already registered; please include the email address of the authorized representative)
  • One for Application for Feed Registration or Renewal (CFIA/ACIA 0009) form per product
  • Payment for a Category 2 feed (requiring safety or efficacy review) – cheque, money order, Visa, MasterCard or American Express
  • If a review of your ingredient has been performed previously by the AFD and the file was closed due to deficiencies identified, please enclose the return letter with the new application and detail in the cover letter how deficiencies were addressed
  • Supporting documentation for any changes in signing authority
  • If new Canadian Agent, a new Declaration of Resident Canadian Agent form
    For new companies:
  • Signing authority and/or corporate documents (requirement for all new companies)
  • Declaration of Resident Canadian Agent (CFIA/ACIA 1194) form (requirement for foreign companies only)
Proposed Label (3 copies)

Submission page # space

  • Brand name (optional)
  • Ingredient name
  • Name of organism including strain identification number/code
  • Product claim statement
  • Guaranteed analysis (active ingredients)
  • Lot number
  • Date of manufacture
  • Expiration date
  • Storage conditions
  • Caution and/or warning statements (if applicable)
  • Name and address of registrant
  • Name and address of manufacturer if different from registrant
  • Net amount (metric measure)
  • Registration number (to be added)
Data Requirements

Submission page # space

  • Statement indicating that the strain has not been genetically modified
  • Purpose of the microbial strain in livestock feed
  • History of the microorganism and isolation method
  • Taxonomic identity of the strain, including any substantiated changes in nomenclature
  • Certificates from the depositary
  • Analytical report substantiating the isolation, identification and classification of the strain
  • Identification data from three recent manufacturing lots of the micro-organism
Sample and Laboratory Method

Submission page # space

  • Sample from a recent lot with a corresponding Certificate of Analysis
  • Laboratory method used for the analysis indicated on the Certificate of Analysis
  • Submission form for Viable Microbial Strain samples has been filled out (Appendix III)
  • Sample, method and all accompanying documents have been submitted to the CFIA Ottawa Carling Laboratory
Product Manufacturing and Composition

Submission page # space

  • Description of the manufacturing and downstream processing of the organism, including quality control parameters
  • Complete composition of the media
Antimicrobial Susceptibility and Activity

Submission page # space

  • Information on the strain's susceptibility to antimicrobials
  • Information on the strain's antimicrobial activity
Certificates of Analysis

Submission page # space

  • Original, signed copies of Certificates of Analysis for a minimum of three different and recent lots of product supporting the label guarantees for the active ingredient
  • Original, signed Certificates of Analysis for screening of pathogens
  • Original, signed Certificates of Analysis for any other anticipated contaminants, as well as methods used to analyse for the contaminants
  • Original, signed Certificates of Analysis substantiating the guaranteed shelf life as stated on the label (i.e., one certificate on the date of manufacture and another certificate at the expiry date) for a minimum of three different and recent lots of product
Taxonomic Relationship with a Pathogenic Species

Submission page # space

  • If relationship with a pathogenic species has been determined, information provided to demonstrate that the strain does not produce any of the toxins associated with the taxonomically related pathogenic species
  • Methods used to demonstrate the absence of toxin production

Note: Further information may be required after the initial review of the submission by the AFD.

For applications for significant changes to registered viable microbial strains that are not brand name changes, please contact the AFD to obtain guidance on information requirements.

B) Applications for Renewal and/or Amendment of Registration

Regulatory Status

Submission page # space

  • The strain and the viable microbial product containing the strain continues to meet the criteria for classification as a feed (and not as a drug or veterinary biologic) according to the guidance provided in Section 3.22
  • Promotional claims (including internet and advertisement) continue to be consistent with stated purpose of the product
Administrative Registration Requirements

Submission page # space

  • Cover letter, stating any requested changes and including the email address of the authorized representative
  • One Application for Feed Registration or Renewal (CFIA/ACIA 0009) form per product
  • Payment of renewal fee – cheque, money order, Visa, MasterCard or American Express
  • Additional fees if modifications are made to the registration
  • Supporting documentation for any changes in signing authority
  • If new Canadian Agent, a new Declaration of Resident Canadian Agent form

    Note: Any proposed changes made to the approved product label will require an application for significant change or administrative amendment be made to the AFD. If an amendment is requested at the time of renewal, then two requests (renewal and amendment) are to be made on the same application form.
Product Label (as previously approved, 3 copies)

Submission page # space

  • If changes are made to label guarantees, Certificates of Analysis must be provided to support the changes.
Sample and Laboratory Method (if requested)

Submission page # space

  • Sample from a recent lot with a corresponding Certificate of Analysis
  • Laboratory method used for the analysis indicated on the Certificate of Analysis
  • Submission form for Viable Microbial Strain samples has been filled out (Appendix III)
  • Sample, method and all accompanying documents have been submitted to the CFIA Ottawa Carling Laboratory
Manufacturing process

Submission page # space

  • Signed statement that the manufacturing process, including processing additives used, has not altered from that submitted and approved by the AFD
    - or -
  • If manufacturing process has changed, the new process has been provided
Strain Identification

Submission page # space

  • Signed statement that the strain identity has not changed from that submitted for review and approved by the AFD
    - or -
  • If the strain has been reclassified (e.g., Streptococcus to Enterococcus), a signed statement describing the strain's new taxonomy

Appendix I

Definitions

Novel Feed: means a feed composed of, or derived from, a microorganism, plant or animal source that

  1. is not approved as livestock feed in Canada (i.e. is not listed in Schedule IV or V of the Feeds Regulations). These include non-traditional sources, such as Bacillus coagulans; feeds used or approved in other countries; and products approved for other uses in Canada; and/or
  2. contains a novel trait (see following definition).

Novel Trait: means a characteristic of the feed that

  1. has been intentionally selected, created or introduced into the feed through a specific genetic change, and
  2. based on valid scientific rationale, is not substantially equivalent in terms of its specific use and safety both for the environment and for human and animal health, to any characteristic of a similar feed that is set out in Schedule IV or V (Feeds Regulations).

With respect to novel feeds, novelty is the trigger for a mandatory pre-market assessment. Once a novel feed (including those containing a novel trait) has received authorization (i.e., it gets listed in Schedule IV or V or is determined to be substantially equivalent to an ingredient already listed in the Schedules), it is no longer considered to be novel.

Appendix II

Process for Determining Which Guidance Document (RG-1, Section 2.7, or RG-1, subsection 3.22.1) is to be Used in Preparation of a Microbial Submission

Q1: Is the microbial genusFootnote 9 listed in Schedule IV Part II of the Feeds Regulations?

A1: If no, then follow guidance in Section 2.7.
If yes, then go on to question 2.

Q2: Does the microorganism contain a novel trait (i.e., has been intentionally modified through a specific genetic change, or is not substantially equivalent to a similar strain)?

A2: If yes, then follow guidance in Section 2.7.
If no, then go on to question 3.

Q3: Is there history of use of similar strains in livestock feed (i.e., same genus and species) in Canada?

A3: If yes, then follow subsection 3.22.1 above.
If no then follow guidance in Section 2.7.

Consultation with the Animal Feed Division is highly recommended for any applicants experiencing difficulty in determining which approach to follow.

Appendix III

Submission Form for Viable Microbial Strains Samples

(Completed form must be submitted, with samples, to the CFIA Ottawa Carling Laboratory)

Sample submitted for:

  • Registration
  • Renewal1

Date sample submitted: space

Submitted by (registrant): space

Registrant address: space

Sample Information

Product name: space

Active Ingredient name: space

Sample amount: space

Guaranteed analysis: space

Shipping condition: space

Storage condition: space

1Registration number if renewal space

Checklist for submitting a sample to the CFIA:
  • Amount shipped (minimum 50g):
  • Product label:
  • Certificates of Analysis:
  • Method used for the analysis:

3.22.2 Registration Requirements for Viable Microbial Products (VMPs) and Mixed Feeds containing VMPs

This sub-section outlines the feed registration requirements for viable microbial products (VMPs) and mixed feeds containing VMPs in Canada. Viable microbials include viable yeast, viable fungi and viable bacteria. All individual microbial cultures (strains) that are to be used in the VMP formulation must be registered prior to being incorporated into the product. For information on registration requirements for individual microbial strains, please refer to subsection 3.22.1 Registration Requirements for Viable Microbial Strains (formerly T-3-159).

All VMPs that are classified as feeds (refer to "Classification of Viable Microbial Products" at the beginning of Section 3.22) are subject to the standards of the Feeds Regulations, and must be registered by the Animal Feed Division (AFD) of the CFIA. The following items are required as part of the submission for registration:

Administrative Requirements

Standard registration requirements, including a completed and signed Application for Feed Registration or Renewal (CFIA/ACIA 0009) form; application fee as per Chapter 1, Application for Feed Registration and Ingredient Approval (Category 2); three (3) copies of the proposed product label; an accompanying cover letter; and signing authority/Canadian agent (if applicable).

Labelling

Proposed labels for VMPs must include:

  • the product name, reflecting the purpose of the product and the intended species;
  • product claim statement(s);
  • a guarantee for minimum viable organisms, expressed in colony forming units (CFU) (for bacteria, yeast or fungi) or viable cells (yeasts only) per gram or kilogram;
  • a complete list of ingredients by generic name, as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds as needed;
  • directions for use to permit safe and effective use of the feed;
  • recommended storage conditions;
  • caution, warning and/or note statements as applicable (e.g., "Do Not Pellet");
  • an expiration date (at least six months from the date of manufacture when stored under appropriate conditions);
  • the net amount (metric units); and
  • the name and address of the registrant.

In order to ensure safe handling of VMPs, registrants are also required to include the following statement on all microbial product labels:

"This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling."

However, products manufactured using strains that have been demonstrated to be free of respiratory/dermal toxicity will not be required to bear this label statement (refer to "Safe Handling of VMPs" in subsection 3.22.1, Registration Requirements for Viable Microbial Strains.

Please note that brand names may be added to labels, even though this is not a regulatory requirement. If a brand name is present, however, the AFD may refuse to register a feed if, after evaluating the application for registration, it is determined that the brand name would tend to mislead a purchaser with respect to its composition or usefulness, or if the brand name would likely be confused with a brand already applied to a registered feed.

Product Description

The complete product formula, detailing each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations, and each concentration. The registration numbers for Part II ingredients (e.g. registered microbial strain) or mixed feeds must also be provided. Ingredient concentrations must not exceed maximums as per Schedules IV and V.

Scientific Data

Laboratory Methodology

As part of the product assessment, a CFIA laboratory will assess the method to be used to verify label guarantees, as provided by the company. The proposed method will be reviewed according to the protocol described in RG-1, Section 6.2, Good Laboratory Practices Protocol for Feed Ingredient Approvals.

The following three items must be submitted along with the application for registration:

  1. A laboratory method to verify label guarantees in terms of the viability of the microorganism (i.e., enumeration and identification) must be provided. For guarantees expressed in terms of viable cells per unit weight (yeast only), the method must discriminate between live and dead or heat stressed cells.
  2. Samples from three recent but different lots of the viable microbial product must be provided, which will be used to verify the method. Each sample must have a corresponding Certificate of Analysis signed by the company Quality Control Agent or the analyst that carried out the tests. The method used to analyse the samples must be the verification method provided to the CFIA and must be stated on the Certificate of Analysis. Samples must be accompanied by a completed "Submission Form for Viable Microbial Product Samples" (see Appendix I).
  3. A product label stating the minimum guaranteed activity: a guarantee for minimum viable organisms expressed in colony forming units (CFUs) for bacteria, yeast or fungi, or viable cells (yeasts only), per gram or kilogram.

Shelf Life Data

Data for three (3) recent and different lots are required to support the guaranteed shelf-life of at least six months from the date of manufacture (e.g., on the date of manufacture and at the expiry date). The storage conditions used for the shelf life study must reflect storage conditions recommended on the label.

Heat Stability/Pelleting Data

If the product is to be applied before the pelleting of feed, a complete and detailed description of the pelleting process (temperature, moisture, duration, etc.) is required, including original, signed Certificates of Analysis for three pre- and post-pelleting samples of the product which support the label guarantee. The data need to demonstrate that pelleting does not negatively affect the viability of the VMP. The pelleting conditions used in the pelleting study must reflect the conditions recommended on the label.

If Certificates of Analysis are not provided, one or more of the following statements will be required on the label:

"Do not pellet." or
"Apply post-pelleting." or
"Pelleting may negatively affect the effectiveness of this product."

Substantiation of Product Efficacy

All applications for registration of a VMP classified as a feed must be supported by satisfactory evidence to substantiate one or more feed claims for the product.

Scientific investigations presented in support of feed claims must be carried out by qualified research personnel, using suitable methods, designed to facilitate statistical analysis, analysed by appropriate statistical methods, and conducted under conditions similar to those which may be expected to occur in Canada. In cases where results of these studies have not been published in peer reviewed journals, copies of the raw data and printouts of statistical analysis are required for review by the AFD.

Studies to demonstrate efficacy of VMPs are to include at least two test groups: (1) Control Group - handled, not treated, and (2) Test Group - handled, and treated with the VMP. Handling refers to normal conditions of animal husbandry for that particular species, which may include weaning, ration changes, vaccination, debeaking, dehorning, castration, shipping, etc.

A minimum of three (3) efficacy studies in which the VMP is included in the ration at the recommended inclusion level and under label use conditions is required for each species on the label. These studies must substantiate the efficacy claim(s) that will be on the label for each species.

In cases where the label directions for use indicate a range of inclusion rates, the testing protocol must evaluate each individual inclusion rate.

In addition to the requirements outlined above, the efficacy studies must address the following:

  • All products designed for inclusion in broiler and turkey rations must be evaluated in rations which contain an approved coccidiostat at the recommended level.
  • Data must be submitted to demonstrate the efficacy of the product in all feed forms (e.g. mash, pellets, and pellets containing a pellet-binding agent) for which approval is required.
  • Studies must be conducted for an appropriate period of time consistent with the label claim desired. For claims concerning maintenance of productivity after a specific event, e.g., weaning, castration, etc., short term studies will be acceptable. Where the claim is more general in nature, the length of required studies must be longer, i.e., conducted up to market weight in meat-producing animals, or up to the start of the production phase in replacement animals.
  • The information submitted on efficacy trials must be as complete and descriptive as possible (i.e., containing a description of the actual product tested, and the protocol for experimental testing; for unpublished data, the complete set of raw data and computer printouts of statistical analysis).

Temporary Registrations

A temporary registration may be granted for VMPs for which all the basic registration requirements have been met, but for which the substantiating technical and/or scientific information submitted in support of product efficacy is partially lacking or incomplete.

Temporary registrations are issued for a limited period of time, up to a maximum of three (3) years, so as to allow companies the opportunity to complete tests and/or studies to determine the efficacy of their product as described above. If the efficacy data is not submitted prior to the expiry date, or if the efficacy data submitted is inadequate, the temporary registration number will not be renewed. Please note that the efficacy data must be submitted via a formal Application for Feed Registration as a "new" feed. The application fees for these types of changes are the same as those for a new application for registration for a Category 2 product (refer to RG-1, Chapter 1 for applicable fee amounts).

Products bearing a temporary registration number on the label will be identified by the letter "T" preceding the registration number. No claims will be allowed on product labels, as the desired claims and/or label guarantees will not yet have been substantiated by the applicant; however, the label will indicate any intended species for which efficacy data has been supplied and accepted.

Requirements for Renewal of Registration for VMPs

As with all registered feeds, VMPs that have been granted permanent registration status are registered for a 3-year period, renewable by March 31 of the third year after the registration date. All applications for renewal of a registered VMP must be accompanied by:

  • the application fee (refer to Chapter 1 for fee amounts);
  • three (3) copies of the proposed label; and
  • the product formulation, detailing the generic name as listed in Schedule IV or V of the Feeds Regulations, and the concentration of each. The registration numbers for Part II ingredients (e.g., registered microbial strain) or mixed feeds must also be indicated.

The renewal fee applies only in cases where no changes have been made to the product formula and label.

Requirements for Amendments (Significant Change) to a Registered VMP

Registrants wishing to make a change to the formula or label of a registered VMP at any time must first submit an application for an Amendment to Registration with the proposed changes to the AFD for approval. A significant change to the registration is considered as any proposed changes to any of the following:

  • brand or product name;
  • product claim statement(s);
  • label guarantee(s);
  • shelf life;
  • heat stability/pelleting statement;
  • directions for use including addition of new target species;
  • formulation;
  • list of ingredients on the label; or
  • manufacturing process.

The nature of the proposed changes will dictate the type of supporting information required. In general, any proposed change that will affect product efficacy will also require supplemental or new efficacy data (as outlined above). Examples include a proposed change or addition to the product claim, a change in the directions for use, or a change in the embedded viable microbial strains.

All applications for a significant change to a registered viable microbial product must be accompanied by the following:

  • application fee;
  • three (3) copies of the proposed label;
  • the product formulation, detailing the generic name as listed in Schedule IV or V of the Feeds Regulations and the concentration of each. The registration numbers for Part II ingredients (e.g., registered microbial strain) or mixed feeds must also be indicated, and
  • scientific data (e.g., lab method, shelf life, product efficacy, i.e. animal performance data (feeding trials), and heat stability/pelleting data for products to be pelleted) if applicable.

Please refer to RG-1, Chapter 1 for additional information regarding significant changes to product registrations. The application fees for these types of changes are the same as those for a new application for registration for a Category 2 product (refer to Chapter 1 for applicable fee amounts).

It is recommended that the AFD be contacted in advance in order to determine what type of information and documentation will be required to be submitted with the proposed application for registration amendment.

Regulation of Diluted VMPs (Viable Microbial Supplements) and Mixed Feeds Containing and Highlighting VMPs

Registered VMPs that have been diluted with a suitable carrier(s) are considered supplements and are subject to registration. The "product name" for diluted VMPs shall be Viable Microbial Supplements for bacteria and fungi products, whereas for yeast products, the product name shall be Viable Yeast Supplements. Thus the term "Microbial Product" shall refer to the mother product, whereas the term "Microbial Supplement" shall refer to diluted formulations of the mother product.

Mixed feeds (i.e., supplements, premixes and complete feeds) containing registered VMPs are only exempt from registration if the following conditions are met:

  • there are no references to the presence of the VMP or viable microbial activity on the label, other than the listing of the brand name and registration number of the VMP in the list of ingredients; and
  • the mixed feed meets all other criteria for exemption from registration under the Feeds Regulations.

Note: All imported mixed feeds still require registration.

Mixed feeds (i.e., supplements, premixes and complete feeds) claiming or highlighting the presence of a VMP or viable microbial activity must be registered.

Viable microbial supplements, and mixed feeds highlighting the presence of VMPs, will require the following information as part of the submission package:

  • the product formulation, in order to verify the label guarantee for live cells/gram or CFU/gram;
  • fees for a specialty product, i.e. a Category 2 feed (refer to Chapter 1 for applicable fee amounts);
  • three (3) copies of the proposed label, in addition to the information required on standard labels (e.g., nutrient guarantees; see "Checklist for Standard Feeds");
  • the label claim statement (as indicated on the embedded registered VMP);
  • a list of ingredients, including the brand name and registration number for the embedded VMP;
  • a guarantee for live cells/gram or CFU/gram or kilogram;
  • directions for use, reflecting the inclusion rate on the embedded registered VMP;
  • storage conditions, reflecting those on the embedded registered VMP;
  • an expiry date, reflecting the date on the embedded registered VMP; and
  • any required/appropriate caution/note statements (e.g. "apply post pelleting," or "pelleting may reduce the effectiveness of this product").

Requirements for Renewal of Registration and Amendments (Significant Change) to Registered Viable Microbial Supplements and Mixed Feeds Containing VMPs

The same requirements as described for the renewal and amendments of a VMP apply, with the exception of the scientific data, as this pertains to the embedded VMP only.

Note: If the embedded registered VMP has been subject to a significant change that would require a modification to the mixed feed label (e.g., product claims, viable guarantee, directions for use, or stability information) and/or to the product formulation for the mixed feed (e.g., change in the viable microbial guarantee of the VMP), then the mixed feed containing that VMP will require re-formulation and an application for amendment of the registration for the significant change.

Registration Requirements for Private Label Products

The private label registration process has been put in place to allow companies to commercialize a product that is already registered by another company under a different brand name. Such applications are considered standard feeds and do not require any additional safety or efficacy evaluations. Note that if the private label product is manufactured by a different manufacturer from the original product manufacturer, then a product formula must be submitted by the applicant. For more information, please refer to Section 2.2, Registration Requirements for Specialty Products.

Promotional Claims

If published literature or promotional material describing the intent of a product submitted for registration or registration renewal indicates a drug or a veterinary biologic purpose for the VMP, the application will be closed and returned to the applicant. The applicant will be advised to submit their application to the VDD, Health Canada, or to the Canadian Centre for Veterinary Biologics, CFIA, as appropriate (refer to Classification of Viable Microbial Products at the beginning of Section 3.22 for contact addresses).

Registration Checklists for Viable Microbial Products (VMPs), Viable Microbial Supplements and Mixed Feeds Containing VMPs

Below are three checklists, pertaining to VMPs, viable microbial supplements or mixed feed claiming the presence of a VMP, and registration renewal of these products, which detail the information required for a submission for registration.

A completed checklist must be submitted to the Animal Feed Division (AFD) with each application for product registration. Please indicate the page number(s) of your submission corresponding to each category in the checklist.

Note: Incomplete submissions will not be accepted by the AFD.

A) Viable Microbial Products

  • For applications for registration of a registered viable microbial strain on carrier.
  • For applications for significant changes to registered VMPs that are not brand name changes.
  • For applications for significant changes to registered VMPs currently granted a temporary registration seeking permanent registration status.
Regulatory Status

Submission page # space

  • The VMP meets the criteria for classification as a feed (and not as a drug or veterinary biologic) according to the guidance provided in Section 3.22
  • Promotional claims (including internet and advertisement) consistent with stated purpose of the product
Administrative Registration Requirements

Submission page # space

  • Cover letter (detailing purpose of product, and any requested change(s) if product is already registered; please include the email address of the authorized representative)
  • One Application for Feed Registration or Renewal (CFIA/ACIA 0009) form per product
  • Payment for a Category 2 feed (requiring safety or efficacy) – cheque, money order, Visa, MasterCard or American Express
  • If a review of your VMP has been performed previously by the AFD and the file was closed due to deficiencies identified, please enclose the return letter with the new application and detail in the cover letter how deficiencies were addressed
  • Supporting documentation for any changes in signing authority
  • If new Canadian Agent, a new Declaration of Resident Canadian Agent form
    For new companies:
  • Signing authority and/or corporate documents (requirement for all new companies)
  • Declaration of Resident Canadian Agent (CFIA/ACIA 1194) form (requirement for foreign companies only)
Information on the Source of the
Strain(s)

Submission page # space

  • All viable microbial strains in the product have valid registration numbers
Proposed Label (3 copies)

Submission page # space

  • Brand name (optional)
  • Product name reflecting the purpose of the product and the intended species
  • Product claim statement
  • Guarantee for minimum viable organisms expressed in colony forming units (CFU) (for bacteria, yeast or fungi), or viable cells (yeasts only) per gram or kilogram
  • Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds as required
  • Directions for use to permit safe and effective use of the feed
  • Recommended storage conditions
  • Caution, warning and/or note statement(s) (if applicable)
  • Expiration date (at least 6 months from the date of manufacture when stored under appropriate conditions)
  • Name and address of registrant
  • Net amount (metric measure)
Formula

Submission page # space

  • Formulation/percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds
  • Formulation/ingredients - level of ingredients not to exceed maximums as per Schedules IV and V
  • All microbial cultures (strains) listed in the formula have valid registration number(s)
Sample and Laboratory Method

Submission page # space

  • Samples from three recent lots of product, with corresponding Certificates of Analysis, have been sent directly to the CFIA Ottawa Carling Laboratory
  • Laboratory method used for the analyses indicated on the Certificates of Analysis
  • Submission Form for Viable Microbial Product Samples has been filled out (Appendix I)
  • Method and all accompanying documents have been sent to the Animal Feed Division
Certificates of Analysis

Submission page # space

  • Original, signed copies of Certificates of Analysis for a minimum of three different and recent lots of product supporting the label guarantees for the active ingredients
  • Original, signed Certificates of Analysis substantiating the guaranteed shelf life as stated on the label (i.e., the date of manufacture and at the expiry date) for a minimum of three different and recent lots of product
  • Original, signed Certificates of Analysis to support pelleting application
Feeding Trials

Submission page # space

  • Minimum of three (3) feeding trials per intended livestock species
  • Feeding trials conducted as per guidance on Substantiation of Product Efficacy in subsection 3.22.2 above
Dermal and Respiratory Irritation and/or Sensitivity

Submission page # space

  • Dermal/respiratory sensitization/irritation studies or provide scientific rationale as to why these are not necessary
    - or -
  • Required statement included on the label as follows: "This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling."

Note: Further information may be required after the initial review of the submission by the AFD.

B) Diluted VMPs (Viable Microbial Supplements) and Mixed Feeds Containing VMPs

  • For applications for registration for viable microbial supplements (i.e., diluted VMPs).
  • For applications for registration for mixed feeds (e.g., complete feeds, premixes, supplements) that claim the presence of a VMP on the product label (i.e., either in the brand name, in the product name, or through the addition of a label guarantee for the viable microbial).
  • For applications for significant changes to viable microbial supplements and mixed feeds containing VMPs that are not brand name changes.
Regulatory Status

Submission page # space

  • Promotional claims (including internet and advertisement) continue to be consistent with stated purpose of the product
Administrative Registration Requirements

Submission page # space

  • Cover letter (detailing purpose of product, and any requested change(s) if product is already registered; please include the email address of the authorized representative)
  • One Application for Feed Registration or Renewal (CFIA/ACIA 0009) form per product
  • Payment for a Category 3 feed (requiring safety and efficacy) – cheque, money order, Visa, MasterCard or American Express
  • If a review of your VMP has been performed previously by the AFD and the file was closed due to deficiencies identified, please enclose the return letter with the new application and detail in the cover letter how deficiencies were addressed
  • Supporting documentation for any changes in signing authority
  • If new Canadian Agent, a new Declaration of Resident Canadian Agent form
    For new companies:
  • Signing authority and/or corporate documents (requirement for all new companies)
  • Declaration of Resident Canadian Agent (CFIA/ACIA 1194) form (requirement for foreign companies only)
Information on the Source of the embedded VMPs

Submission page # space

  • All VMPs in the product have valid registration numbers
Proposed Label (3 copies)

Submission page # space

  • Brand name (optional)
  • Product name reflecting the purpose of the product and the intended species
  • Product claim statement
  • Guarantee for minimum viable organisms expressed in colony forming units (CFU) (for bacteria, yeast or fungi), or viable cells (yeasts only) per gram or kg
  • Nutrient guarantees (if applicable; mixed feeds)
  • Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds as required
  • Directions for use to permit safe and effective use of the feed
  • Recommended storage conditions
  • Caution, warning, and/or note statements (e.g. "Do Not Pellet")
  • Expiration date (at least 6 months from the date of manufacture when stored under appropriate conditions)
  • Name and address of registrant
  • Net amount (metric measure)
Formula

Submission page # space

  • Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds
  • Formulation / Ingredients – level of ingredients not to exceed maximums as per Schedules IV and V.

Note: Further information may be required after the initial review of the submission by the AFD.

C) Applications for Renewal of Registration

Regulatory Status

Submission page # space

  • Promotional claims (including internet and advertisement) consistent with stated purpose of the product
Administrative Registration Requirements

Submission page # space

  • Cover letter, stating any requested changes and including the email address of the authorized representative
  • One Application for Feed Registration or Renewal (CFIA/ACIA 0009) form per product
  • Payment of renewal fee – cheque, money order, Visa, MasterCard or American Express
  • Additional fees if modifications are made to the registration
  • Supporting documentation for any changes in signing authority
  • If new Canadian Agent, a new Declaration of Resident Canadian Agent form
Product Label (as previously approved, 3 copies)

Submission page # space

Note: Any proposed changes made to the approved product label require, in addition to the renewal application, an application for significant change or administrative amendment (these two requests are to be made on the same application form). This will necessitate payment of the fee for the evaluation of the revised product label in addition to the renewal fees.

  • If changes are made to label guarantees, Certificates of Analysis provided to support the changes (not required for diluted VMPs and mixed feeds)
Formula (as previously approved)

Submission page # space

Note: Any proposed changes made to the approved product formulation will require that in addition to the renewal application, an application for significant change (these two requests are to be made on the same application form). This will necessitate payment of the fee for the evaluation of the revised product formulation in addition to the renewal fees.

  • If changes are requested, the revised formulation/percentage composition listing the amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds, provided to support the changes
Laboratory Method

Submission page # space

  • Signed statement that the analytical method used to verify label guarantees has not changed from that submitted for review and previously approved by the AFD (not required for diluted VMPs and mixed feeds)
    - or -
  • If the method has changed, the revised method has been provided, with three recent samples and three corresponding Certificates of Analysis

Appendix I

Submission Form for Viable Microbial Product Samples

(Completed form must be submitted, with samples, to the CFIA Ottawa Carling Laboratory)

Sample submitted for:

  • Registration
  • Renewal1

Date sample submitted: space

Submitted by (registrant): space

Registrant address: space

Sample Information

Product name: space

Active Ingredient name(s): space

Sample amount: space

Guaranteed analysis: space

Shipping condition: space

Storage condition: space

1Registration number if renewal space

Checklist for submitting a sample to the CFIA:
  • Amount shipped (minimum 50g/active ingredient):
  • Product label:
  • Certificates of Analysis:
  • Method used for the analysis:
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