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T-3-20 - APPLICATION FOR FEED REGISTRATION AND INGREDIENT APPROVAL

September, 17, 2001

APPLICATION FOR FEED REGISTRATION AND INGREDIENT APPROVAL

1.0 INTRODUCTION

Under the authority of the Federal Feeds Act and Regulations, the Canadian Food Inspection Agency (CFIA) approves feed ingredients and registers feed products in order to verify that feeds meet

- standards for safety and usefulness,
and
- regulatory requirements for labelling,

prior to importation, manufacture or being offered for sale to livestock producers and other customers.

Evaluations are conducted by staff of the Feed Section.

The overall process of a feed registration is as follows:
the submission is screened in, logged in, reviewed, put on hold for additional information if required, and a notice of approval or rejection is sent to the registrant once the review is complete. Within three months of a product being registered, a final label must be submitted to the Feed Section for approval. The final label must include every change that the Evaluation Specialist has requested.

2.0 REGULATION OF LIVESTOCK FEEDS UNDER THE FEEDS ACT

2.1 Feeds Regulated under the Feeds Act and Regulations

Feeds for the following species of livestock are regulated under the Feeds Act and Regulations:

cattle, horses, sheep, goats, swine, poultry (chickens, turkeys, ducks, geese), fish, foxes, mink, and rabbits.

Feeds for other species are exempt from the Feeds Act and Regulations.

Only those feed ingredients that have been evaluated and approved by the Feed Section and listed in Schedule IV or V of the Feeds Regulations may be used in livestock feeds.

2.2 Feeds Requiring Registration

The following feeds must be registered prior to importation, manufacture or sale in Canada:

• all mixed feeds manufactured outside Canada;
• mineral feeds;
• converter feeds;
• micro-premixes;
• specialty feeds such as forage additives, viable microbial products, flavours, and mould inhibitors;
• milk replacers and any other substitutes for milk;
• fox feeds;
• single ingredient feeds listed in Part 2 of Schedule IV or V of the Feeds Regulations, e.g.: Mineral complexes, viable microbial cultures;
• complete feeds, supplements, and macro premixes, for all livestock, labeled with nutrient guarantee levels outside the ranges indicated in Table 4 (Schedule I) of the Feeds Regulations
.

2.3 Feeds Imported into Canada

For products with ingredients of United States origin, a USDA official export certificate or a notarized declaration that describes the shipment and indicates that it originated in the United States must be presented with the shipment at the port-of-entry to comply with the Canadian Health of Animals Regulations. In the case of a product containing ingredients from other countries, please contact the Animal Health and Production Division to receive a permit to import prior to submitting an application to the Feed Section. For more information on this permit, please contact the Import/Export Section of the Canadian Food Inspection Agency, at telephone number: 613-225-2342.

3.0 APPLICATION PROCESS

3.1 Signing Authority and Resident Agent Requirements

3.1.1 Signing Authority

Applicants seeking registration of feed(s) for the first time must submit information to enable the Feed Section to establish a company file containing a signing authority list. The list will contain the names of the persons who will be authorized to sign registration applications, discuss applications, and correspond with the Feed Section.

The Feed Section will only discuss files and correspond with the persons listed on the signing authority list.

To establish signing authority:

Corporations must supply a copy of the letters patent, or certificate of incorporation along with a list of current Directors. A letter must be included from one of the directors/partners/proprietor authorizing the person(s) to sign feed registrations.

In the case of partnerships or sole proprietorships, evidence that the firm name is registered under the appropriate provincial or state legislation, and a notarized letter designating the persons with signing authority must be supplied.

In place of the above information and letters, the Feed Section will accept a letter, on company letterhead, bearing the corporate seal or signature and stamp of a notary public, designating signing authority to the person(s) whom the company wishes to name.

A person, already on file with the Feed Section as having signing authority, may designate others to be added or deleted from the list, by submitting a letter, displaying their original signature. No copies or faxes will be accepted for any signing authority information.

3.1.2 Resident Canadian Agent

For applicants residing outside Canada, a Resident Canadian Agent must also be designated, who will co-sign registration/renewal applications and to whom any notice or correspondence may be sent. A Canadian Agent must be a person, not a company and this person must be a permanent resident of Canada. An applicant may have more than one Canadian Agent on file.

To establish a Resident Canadian Agent:

The agent must fill out a Declaration of Resident Canadian Agent, Form II (Form # CFIA 1194), have it notarized and sent to the Feed Section.  A copy of this form is available from the Feed Section or from our Area offices.

The Feed Section must be advised immediately of any changes to the signing authority or Canadian agent(s). Changes to signing authority must be completed by any of the above-mentioned methods.

3.2 The Application Package

Applicants seeking registration of livestock feeds, or feed ingredient approvals, must submit a complete application package. A complete, high quality submission is a prerequisite for the timely and successful evaluation of livestock feed products. Please ensure that the necessary forms are completed accurately and that all required information is included. Applicants may request confirmation of receipt of a dossier by means of email reply from the Feed Section.

The following items are essential in order for any application to be accepted for evaluation:

• Covering letter
• Application form
• Proposed product label (five copies)
  - All ingredients must be approved as per Schedules IV and V
  - Acceptable feed claims (no drug or veterinary biological claims should appear on the label)
• Supporting data (for Category 2 and 3 Feeds, only)
• Application fee

Any omissions will result in the return of the submission. Every submission is screened within 10 days of receipt and if any of the above-mentioned information is missing or incorrect, the Feed Section will return the complete submission package, including any fees sent, with a letter of explanation.

3.2.1 Covering Letter

For registration or approval of feeds or feed ingredients, it is important to include a covering letter clearly outlining the intent of the submission, including the intended purpose of the product.

3.2.2 Application Form

An application for feed registration or feed ingredient approval must be made using the APPLICATION FOR FEED REGISTRATION OR RENEWAL (Form # CFIA 0009).   A copy of this form is available from the Feed Section or from our Area offices (see Section 5.0 of this Memorandum for addresses). Use one application form per product. All points of manufacture of the feed must be listed on the form or in a note attached to the form.

The application form must be signed by a person having designated signing authority and if applicable, by the Resident Canadian Agent (Refer to Section 3.1 of this memorandum for establishment of Signing Authority and Canadian Agents).

3.2.3 Product Label

Feeds must be labeled in accordance with the Feeds Regulations (Sections 26-30) and associated Trade Memoranda. Each feed or feed ingredient to be approved, registered or amended must be accompanied by five (5) copies of the proposed label. Mixed feeds must contain only approved ingredients currently listed in Schedules IV and V of the Feeds Regulations. No drug or veterinary biologic claim may appear on a feed label. In the event that a feed or ingredient is approved, registered or amended, the applicant must submit five copies of the final label, incorporating all changes requested, within three months of the date of registration/approval.

3.2.4 Supporting Data/Satisfactory Evidence (for Category 2 and 3 Applications only)

In addition to the other requirements for feed registration or ingredient approval, the applicant must provide the Feed Section with satisfactory evidence (as defined in Section 8(2) of the Feeds Regulations and described further in various Trade Memoranda) to allow an evaluation of the safety and/or efficacy of the product in respect to livestock, humans and the environment.

Satisfactory evidence for Category 2 and 3 products includes a complete formulation of the product, listing the amount of each ingredient by the generic name as indicated in Schedules IV and V of the Feeds Regulations. If product efficacy is to be assessed, other evidence would include, for example, the results of statistically based scientific investigations conducted by qualified personnel under conditions similar to Canadian conditions. Submissions can include published peer reviewed journal articles, or alternatively, complete data packages including raw data and statistical analysis.

In cases where the evidence includes an evaluation of analytical methods, the evidence will be forwarded to the CFIA's Laboratories Directorate (LD) . The LD will conduct the laboratory method evaluation, separate from the Feed Section evaluation of the product.

Information requirements are product type specific. More details of the data requirements for specific types of applications are described in the various Feed Section Trade Memoranda, Registration checklists, and other guidelines. The complete list of Trade Memoranda are listed in T-3-0, "Index of Trade Memoranda", available from the Feed Section.

If the feed contains ingredients not currently listed in Schedules IV and V of the Feeds Regulations, an application for ingredient approval must be submitted for each of the unapproved ingredients, prior to submitting the application for the feed registration. Refer to Section 4.2 of this memorandum.

Any information deemed to be confidential by the submitting parties and marked accordingly will be kept in secured storage.

3.2.5 Application Fee

Enclose the appropriate application fee for the service requested. Refer to Section 4.0 of this Memorandum and the Fee Schedule (T-3-20, Supplement 1) which lists the fees for consideration of an application for ingredient approval and feed registration. Fees are payable in Canadian Funds, by VISA^TM or Mastercard^TM, American Express^TM or cheque (drawn from a Canadian bank) or money order payable to the Receiver General for Canada.

Note that the fees are not refundable, i.e., they are not contingent upon ingredient approval or feed registration.

4.0 SUBMISSION CATEGORIES AND APPLICATION FEES

Fees charged to review the application for a feed or ingredient depend on the evaluation requirements, dictated by the category of the product, namely, whether the feed/ingredient is a standard, new, or novel product, as described in the following sections. The fee schedule (T-3-20 Supplement 1) lists the fees to be charged for the consideration of an application for the following types of submissions:

4.1 Category 1: Standard Feed or Standard Ingredient (Neither Safety nor Efficacy data review required)

4.2 Category 2: New Feed or New Ingredient (Safety OR Efficacy data review required)

The review of this type of submission involves a complete assessment of product safety (to livestock, workers, food and the environment), OR a review of data supporting the intended purpose of the product. An assessment of the product's compliance with regulatory standards and a review of the label for compliance with the Feeds Regulations are conducted. For a feed to fall under this category, it must contain only approved ingredients.

4.3 Category 3: Novel Feed or Novel Ingredient (Safety AND Efficacy data review required)

The review of a submission to register a novel feed or ingredient involves a complete assessment of product safety (to livestock, workers, food and the environment), a review of data supporting the intended purpose of the product, an assessment of the product's compliance with regulatory standards and a review of the label for compliance with the Feeds Regulations. Category 3 submissions are rare inasmuch as most safety evaluations will be done on the constituent ingredients as part of the ingredient review process.

4.4 Temporary Registration

Temporary registrations may be issued for products, for example forage additives, where the safety has been demonstrated, and potential usefulness of the feed has been demonstrated (ie experimental results that show trends but are not statistically proven), but additional evidence is required in order to permit full evaluation of efficacy (or analytical method). Temporary registrations are for a three year period (i.e. registration will not be renewed unless satisfactory evidence is provided).Temporary registrations are considered Category 2 (New Feed).

4.5 Research Exemptions

Research exemptions are issued by the CFIA for:

(1) the import of unapproved feeds or ingredients for research purposes, and
(2) release of novel feeds in Canada.

The review of a research exemption submission by the Feed Section involves an assessment of the information pertaining to the location of the research, identification of the qualified research personnel conducting the research, the ingredients in the feed to be tested, and the details of the experimental protocol, including disposal of any unused feed and the experimental animals. An application form, data and applicable fees must be submitted.

4.6 Registration Summary and Renewal of Registration

Registrations are granted for a three year period. The expiry date for registrations is March 31, three years after the date of registration. Note: this expiry date is applicable to registered feeds, ingredients, and those listed in Part II of Schedule IV of the Feeds Regulations. Failure to apply to renew the registration of a feed will automatically result in the expiry of the registration.

In the late autumn of each year, Registrants who own registrations that are due to expire the following March will receive a Registration Summary listing those registered products as well as instructions for renewal procedures.

When submitting an application for registration for renewal, the following must be included in the package:

• cover letter;
• one application form for each registration to be renewed;
• - the form must be completed and signed by an authorized representative (someone on the list of signing authority established for the company) and by the Resident Canadian Agent (if applicable)
• five copies of the current label;
• formula (if product is a Category 2 feed/ingredient, e.g.: flavouring agent, mould inhibitors, forage additives, acidifiers, etc.;)
• applicable fee (renewal fee is $40.00 + GST).

Note: Any amendment (significant or administrative) made to the registration, submitted at the time of renewal, should be stated in the cover letter and the applicable fee is the amendment fee plus the renewal fee. Refer to Section 4.7 of this memorandum and the Fee Schedule (T-3-20 Supplement 1) for a list of fees.

The process for evaluating a renewal application is very similar to a new registration. The file is screened in, logged in, reviewed, held pending receipt of additional information, if requested, then the notice of approval or rejection is sent to the registrant. Before approval is granted, a market ready final label must be submitted.

4.7 Fees for Amendments to Registered Feeds

Fees charged to registrants for an amendment to the existing terms of a registered product are based on whether the amendment involves a "significant change", as defined in the Feeds Regulations.

4.7.1 Significant Change

Significant change includes any change in:

(a) the brand of the feed*
(b) the name of the feed*
(c) the type or level of medicating ingredient in the feed*

* As per the Canadian Food Inspection Agency Fees Notice, the fee that is payable for items a-c above is $90 plus GST.

(d) the guaranteed level of a nutrient, unless the nutrient is listed in Table 4 of Schedule I for the species of livestock for which the feed is intended and both the former and revised guaranteed levels are within the limits set out in that Table for that nutrient,

(e) any statement, phrase or claim appearing on the label that relates to the purpose or function of the feed in general or to any medicating ingredient, nutrient or other ingredient present in the feed,

(f) the directions for the use of the feed, or

(g) the ingredients present in the feed, if it is a feed required to be labeled with the name of each ingredient as described in the Feeds Regulations (Section 26.(1)(j)).

The fee that is payable for items d-g is the applicable fee for the consideration of an application for registration of that feed as set out in section 4.1, i.e. the same fee as if it was a new application.

4.7.2 Administrative Amendment

Any change to the terms of a feed registration NOT involving a "significant change" as defined in Section 4.7.1 is regarded as an administrative amendment. Some examples would be: a company name change, a change of company address or a registration transfer.

Examples of amendment fees:

Fees for administrative or significant changes at the time of renewal are of the sum of the renewal fee plus the applicable application fee.

e.g.: -if you change the brand name of your registration that is due for renewal, the fee would be: ($90.00 + $40.00 + GST)

-if you change an ingredient and your registration (flavouring agent) is due for renewal, the fee would be: ($285.00 + $40.00 + GST)

-if your company moves to another city and your registration is due for renewal, the fee would be: ($10.00 + $ 40.00 + GST)

All fees are per registration.

4.8 Registrant name and/or address change:

If a registrant changes it's name and/or address * the following is required:

• A letter from the registrant advising us that they are changing their name and/or address. The letter must be signed by an authorized representative currently on file in the Feed Section or the letter must bear the corporate seal of the company.
• An application form for each valid registration owned by the company. The forms must be filled out and signed.
• Five copies of each label, showing the new name and/or address of the registrant.
• Applicable fees for each registration. If the only change is the registrant's name and address, the fees are for administrative amendments only. Any other changes (brand name, ingredients, nutrient levels, etc.) are considered significant changes and the applicable fees will differ, depending on the change. Please refer to Section 4.5 of this memorandum for more information on fees charged. If the change is done at the time of renewal, the fee is in addition to the renewal fee.

* The following changes to an address only require a letter from the registrant: box number, suite number, street address, postal code. Application forms, new labels and fees are not required unless the change involves the city.

4.9 Transfer of a registration

A registration may be transferred from one registrant to another. The following is required:

• A letter from the current registrant advising us that they are transferring the registration(s) and all data associated with it/them. The letter must be signed by an authorized representative currently on file in the Feed Section or the letter must bear the corporate seal of the company.
• A letter from the new registrant advising us that they are taking over the registration(s). This letter must be signed by an authorized representative on file in the Feed Section. If this registrant does not already have a file opened with the Feed Section, they must establish signing authority as per Section 3.1 of this memorandum.
• An application form for each registration to be transferred. The form must be filled out and signed.
• Five copies of each label, showing the company name and address of  the new registrant.
• Applicable fees for each registration. If the only thing that changes is the registrant name and address, the fees are for administrative amendments only.

Any other changes (brand name, ingredients, nutrient levels, etc.) are considered significant changes and the applicable fees will differ, depending on the extent of the change. Please refer to Section 4.7 of this memorandum for more information on applicable fees.

If the transfer is done at the time of renewal, the fee is in addition to the renewal fee.

4.10 Service Standards:

(i) Timeliness:

For 90 percent or more of the applications received:

(a) Feed Section screens applications within ten days of receiving it;

(b) For products requiring a review of efficacy data, a preliminary review is conducted within 10 days of the screening date, and the results of the review are communicated to the applicant.

(c) Feed Section conducts efficacy, livestock, human and environmental safety reviews and responds to applicant within 90 days;

(d) The laboratory does a desk review of proposed method of analysis within 4 weeks of receiving it. If laboratory testing is required, it will be done within 12 weeks of receiving a suitable method and test samples depending on availability of specialized equipment.

(ii)Quality

(a) The Feeds Regulations are consistently interpreted and applied in registration/approval decisions;

(b) Information is openly exchanged between clients and evaluation specialists;

(c) Analytical methods are evaluated for specificity, selectivity, reliability and accuracy, using internationally standardized method validation procedures.

5.0 CONTACTS

Questions regarding this memorandum may be directed to :

Headquarters Office

Feed Section
Animal Health and Production Division
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario (Canada)
K1A 0Y9

Phone: 613-225-2342
Fax: 613-228-6614
Internet: http://www.inspection.gc.ca

Forms described in this T-memo are available from the Headquarters Office or the following Area Offices:

T-3-20 Supplement 1
September 17, 2001

• * Fees for consideration of an application are payable upon submission of the application and are not refundable for unsuccessful applications.  All fees listed are per registration.