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

Revised: 2012-01-20

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

Next page: Subsection 3.22.1 | Previous page: Section 3.21