Chapter 1 - Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed
1.3 The Application Package
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The RG-1 guidance document is divided into several Chapters. Chapter 2 describes the type of information you may need to provide if you are submitting an application for a feed or ingredient that requires safety and/or efficacy data. Chapter 3 provides product-specific guidance in terms of preparing a submission, and Chapter 4 provides guidance on labelling requirements. It is highly recommended that you refer to these documents while you are preparing your submission. An organized, high quality submission greatly assists in timely evaluations of products, and reduces the potential for delays caused due to missing, incomplete or unclear information.
In addition to the company file information, signing authority, and Resident Canadian Agent information (for new applications), the following items are essential in order for any application to be accepted for evaluation:
- Cover letter: Your cover letter should provide a brief description of the items you are submitting, and where they can be found in the submission package. If you have a preferred method to be contacted (e.g. an email or mailing address to receive correspondence), this information should be included in the cover letter. Do not include confidential information such as product formulations or credit card information.
- Application Form: Be sure to include one completed application form for each product you are submitting for registration. See below for details about completing the form.
- Product Labels: Provide three (3) copies of your proposed product label. Text versions are acceptable for the initial assessment. You do not have to submit a professionally designed label, but the information you provide must represent all the information that you wish to have on the label that will appear in the marketplace. Your proposed labels should be printed on standard letter-size paper; multiple pages are acceptable if needed to provide all the labelling information. Please note that labels must be submitted in a paper format, as electronic copies are not accepted. Labels must be legible. If the font or contrast is such that the information is not legible, your submission may be returned to you. Do not send bags, totes, buckets etc. Additional guidance on the labelling of livestock feeds may be found in Chapter 4 of the RG-1.
- List of ingredients: Only ingredients that have been approved and listed in Schedule IV or V of the Feeds Regulations may be used in the manufacture of livestock feeds. Please include the complete list of ingredients used in the feed. If the feed contains ingredients that are listed in Part II of the Schedules, you will also need to include the registration number of these ingredients.
- Supporting Data: Depending on the type of product you are submitting for registration, you will need to provide data in support of your application. Please review Chapters 2 and 3 of the RG-1 for details on what may be required for your product.
- Application fees: Fees must be included, corresponding to the product submission type.
1.3.1 Completing the Application Form
An application for feed registration or feed ingredient approval must be made using the Application for Feed Registration or Renewal (CFIA/ACIA 0009) - PDF (98 kb). The instructions for completing the form are included with the application form. One application form must be completed for each feed submitted for registration.
If you are making an amendment at the time of renewal, the fees are additive, and you will need to enter the individual submission codes on separate lines in this field (for example, renewal on the first line, and administrative amendment on the second line).
The application form must be signed by a person having designated signing authority and, if applicable (i.e. if the applicant resides outside of Canada), by the Resident Canadian Agent.
Note: We are unable to accept applications electronically at this time. If you are sending a copy of your application by e-mail in order to get guidance on completing the form, do not include your credit card information.
The company name and address filled out on the application form and on the labels, must be exactly as established with the company file.
If the company has a different mailing address than the official registrant address, the AFD must be notified by a letter, signed by an authorized representative. The letter must clearly state both addresses (registrant and mailing). The registrant's address is the one that must appear on the application forms and labels.
It is the policy of the AFD to send all correspondence to the registration address; therefore, the mailing address (if different) must be noted in the cover letter of each new application package, to ensure correspondence is sent to the appropriate destination.
1.3.2 Determining your Submission Type
Fees charged to review an application for a feed or ingredient depend on the assessment requirements, which are 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.
Category 1: Standard Feed or Ingredient (Neither Safety nor Efficacy data review required)
The review of this type of submission involves an assessment of the feed or ingredient's compliance with regulatory standards and a review of the label for compliance with the Feeds Regulations. This category includes feeds for which all ingredients are approved. For example, a supplement supplying approved nutrients at concentrations in accordance with Table 4 of the Feeds Regulations.
Examples of a Category 1 Feed: pig starter, calf milk replacer, dairy premix.
Examples of a Category 1 Ingredient: any ingredient listed in Part I of Schedules IV and V of the Feeds Regulations (voluntary registration).
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. This category applies to mixed feeds or ingredients that are new. New Feeds that fall under this category must contain only approved ingredients.
Examples of a Category 2 Feed: forage additives, mould inhibitors, flavouring agents, pellet binders, antioxidants, anticaking agents, complete feeds or supplements with guaranteed analysis outside Table 4.
Examples of a Category 2 Ingredient: flavouring ingredient, single viable microbial strain, viable yeast, and ingredients listed in Part II of Schedules IV or V of the Feeds Regulations.
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 for mixed feeds are uncommon; this is most often used as a category for the review of ingredients.
Examples of a Category 3 Ingredient: genetically-modified plants, ingredients not listed in Schedules IV and V of the Feeds Regulations or new nutrient sources.
1.3.3 Application Fees
Enclose the appropriate application fee, based on the service requested and the submission type. Refer to Appendix A at the end of this chapter for a list of the fees for applications for ingredient approval and feed registration. Fees are payable in Canadian Funds, by Visa™, Mastercard™, American Express™, or by 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.
1.3.4 Sending your Completed Application
Once you have completed your application form, and included all the information necessary for your submission, you will send this information to:
Pre-Market Application Submissions Office
Attn: Animal Feed Division
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, ON K1A 0Y9
Your application form and your designation of signing authority and Canadian Agent form (if applicable) must be original documents signed in ink. Data submissions must be submitted as paper copy. In addition to the paper copy data submission package, it is highly recommended to provide an electronic copy of the data alongside the submission package.
When submitting applications for products that will require a safety and efficacy assessment, it is recommended that two copies of the data are provided in the electronic form (USB or CD).
We are unable to accept applications via e-mail, as Government of Canada policy does not permit us to receive credit card information in this manner. Note that any e-mails containing this information will be deleted and emptied from the recipient's mailbox; therefore you will not receive a response.
1.3.5 Preliminary Screening
Upon receipt of your application, the CFIA performs preliminary screening of the materials, to determine if all necessary elements are present (i.e. signing authority, company information, application form, fees and supporting data).
Based on the preliminary screening, you will be advised if your submission has been accepted for review or rejected. Depending on the volume and quality of the applications, this may take upwards of 10-20 working days. It should be noted that acceptance of a submission is not a guarantee that the submission will be approved.
Submissions can be screened-out for multiple reasons (e.g., the product is not considered a feed, the application form is not signed or insufficient data has been provided). Incomplete submissions will be screened-out. If your submission is screened-out, you will receive a return letter explaining why the submission was not accepted. If your product is considered to be a feed, you will be advised what items must be addressed in order to have your application accepted. Rejected submissions may be destroyed by shredding. Should you wish to have your submission returned to you in the event of it being screened-out, you will need to provide a courier account number with your application, and request to have information returned to you in the event of rejection.
If your submission is accepted, you will receive a confirmation e-mail indicating that it was accepted. This e-mail will also include your file reference number and an estimated time frame for review. This estimate is based on the current service delivery averages at the time of submission.
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