RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.21 Veterinary biologics

This page is part of the Guidance Document Repository (GDR).

Looking for related documents?
Search for related documents in the Guidance Document Repository

Regulation of Veterinary Biologics for use in Livestock Feeds

This section outlines the registration requirements for livestock feeds containing Veterinary Biologics (VB) that are licensed for use in livestock feeds.

Under the authority of the Health of Animals Act and Regulations, the Canadian Centre for Veterinary Biologics (CCVB) of the Canadian Food Inspection Agency (CFIA) is responsible for the licensing of all veterinary biologics, including those intended for use in livestock feed. The licensing process includes the evaluation of the manufacturing process, the efficacy and safety of the veterinary biologic, and the label indications for use. All veterinary biologics must be licensed by the CCVB prior to import, manufacture or sale in Canada. The CCVB works cooperatively with the Animal Feed Division (AFD) to regulate the use of veterinary biologics in livestock feeds (e.g. methodology, mixability, and labelling).

Livestock feeds containing a licensed VB manufactured, sold or imported in Canada are also considered to be veterinary biologics under the Health of Animals Act. The CCVB and AFD have agreed to regulate licensed biologics in livestock feeds as follows.

Registration Requirements for Livestock Feeds Containing a Licensed Veterinary Biologic

Livestock feeds containing a VB must be registered under the Feeds Act and Regulations. The following items are required as part of the submission package.

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); five copies of the proposed product label; an accompanying cover letter; and signing authority/Canadian agent (if applicable). General administrative information regarding the application for feed registration procedures, and the table of fees, can be found in Chapter 1.

Supplemental Information Requirements

Additionally, the following information and documentation are required with each application for registration:

detailed product formula in support of the approved level of inclusion; and
additional labelling information related to the licensed incorporated VB:
- the product name, reflecting the purpose of the product and the intended species (e.g., "Supplement with veterinary biologic for weaned piglets", "Veterinary biologic product for weaned piglets");
- label claim statement (as indicated for the licensed incorporated VB);
- list of ingredients, including the trade name (brand name) for the incorporated VB;
- guarantee for activity (if applicable);
- directions for use with regard to the mixing or feeding rate, intended species, or class of livestock, duration of feeding, reflecting the incorporated licensed VB;
- recommendations with respect to the optimum age for vaccination, repeat dose (booster) instructions, precautions, withdrawal period, and antidote for the incorporated licensed VB (if applicable);
- storage conditions reflecting those of the incorporated VB;
- an expiry date, reflecting that of the incorporated VB;
- a lot number or identification code; and
- the name and address of the facility that will manufacture the product.

Renewal of Registered Livestock Feeds Containing a Licensed VB

As with all registered products, feeds containing a licensed VB are registered for a 3-year period, renewable by March 31 of the third year after the registration date. All applications for registration renewal must be accompanied by a signed and completed application form; the appropriate fee; the complete product formulation; and five copies of the product label, as per Chapter 1.

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

Please note that the 3-year registration period does not supersede the CCVB requirement for annual renewal of licensing of the incorporated VB.

Amendment to a Registered Livestock Feed Containing a Licensed VB

Registrants wishing to make a change to the formula or label of a registered product at any time must first submit an application for an Amendment to Registration with the proposed changes to the AFD for approval. Any proposed changes to the brand or product name, product claim(s), directions for use or formulation and ingredients is considered a significant change to registration.

All applications for a significant change must be accompanied by the appropriate fee, five copies of the proposed label, and the product formulation.

Please refer to 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.

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

Please note that changes to the VB formulation (including manufacturing, claims, directions for use) will require approval by the CCVB first.

For information purposes, an updated list of approved veterinary biologics (with labelling information) for use in livestock feeds is attached. (See Annex 1).

All applications for the approval of a Veterinary Biologic should be addressed to:

National Manager
Canadian Centre for Veterinary Biologics
Animal Health Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9

Telephone No.: 613-773-7408
Fax No.: 613-773-7570

For further information about the regulation of veterinary biologics, please refer to the Canadian Centre for Veterinary Biologics page on the CFIA web site.

Annex 1

Veterinary Biologics Licenced for Use in Feeds

1. Approved Brand: HYPER-EGG-F-18

Manufactured by: Nutratech, A Division of J.H. Hare Associates Ltd.

Canadian Veterinary Biologics Establishment Licence Number: 58

Assigned Name: Escherichia coli polyclonal antibodies, chicken egg origin.

Approved Claim: For weaned piglets: As an aid in the prevention of diarrhea due to infection with enterotoxigenic Escherichia coli F-18.

Level of Veterinary Biologic: 2 - 4 kg per metric ton of feed.

Directions: To be fed to piglets during the 2-week period following weaning.

Caution: Product should be stored in a closed container in a dry place at 8-25°C (46-77°F).

2. Approved Brand: HYPER-EGG-K-88