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RG-1 Regulatory Guidance:
Chapter 1 – Administrative requirements for pre-market assessment and product registration of livestock feed

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1.1 Scope

This chapter of the RG-1 is intended to provide you with the information you will need to prepare and submit an application for pre-market assessment for ingredient approval/authorization and/or product registration.

Other chapters of the RG-1 provide more detailed information on requirements for the registration of specific types of feeds and feed ingredients.

1.2 The application process

1.2.1 Establishing a company file and signing authority

Applicants submitting a feed for pre-market assessment for the first time must submit information to enable the Animal Feed Program (AFP) to establish a company file containing a signing authority list. The list will contain the names of the persons who will be authorized to interact with the AFP in all aspects of the company's feed registration files (that is signing registration applications, discussing applications, submitting additional information, requesting updates on the status of files, transferring or deleting registrations, and generally corresponding with the AFP).

The AFP will only discuss files and correspond with the person(s) listed on the signing authority list. This policy is in place to protect confidential business information.

1.2.1.1 To establish signing authority

Corporations must supply a copy of the letters patent or certificate of incorporation, along with a list of the current Directors. A letter must be included from one of the proprietors, directors or partners, stating the name of the authorized representative(s) who will have signing authority for 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 AFP 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. The letter must simply state that "the following individuals (names) are authorized for signing authority for feed submissions/registrations for (company name)".

A person, already on file with the AFP 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 designations.

If no person from the original signing authority list remains to make changes to the list, a letter to re-establish signing authority as described above is required, with either the corporate seal of the company or the signature and stamp of a notary public.

1.2.2 Resident Canadian Agent

For applicants residing outside of Canada, a Resident Canadian Agent must also be designated, who will co-sign the Application for Feed Registration or Renewal (CFIA/ACIA 0009) and to whom any notice or correspondence may be sent. The 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. (Unless the Canadian Agent has also been named as a signing authority for the company, the AFP will not communicate with the Canadian Agent on matters related to confidential business information or the status of a submission.)

The Canadian Food Inspection Agency (CFIA) requires applicants who do not live in Canada to have a Canadian agent in the event that there are legal matters associated with the registration or approval of a feed A Canadian resident would be the contact to whom legal documents can be personally served; this is often difficult or impossible to do in jurisdictions outside Canada. It would then be the agent's responsibility to notify the applicant of legal issues.

Note that the requirement to have an agent for registered product(s) who physically lives in Canada applies to applicants of other commodities subject to pre-market assessment and/or registration by the CFIA, not just livestock feeds.

1.2.2.1 To establish a Resident Canadian Agent

The agent must fill out a Declaration of Resident Canadian Agent, Form II (CFIA/ACIA 1194), have it notarized and send the original form to the AFP. An individual with signing authority for the company must send a letter to the AFP stating the name of the Resident Canadian Agent. If the Resident Canadian Agent is also to have signing authority, this must be specified in the letter. The letter needs to have the original signature of the authorized representative writing the letter.

Resident Canadian Agents do not have full access to the company's files that are with the AFP unless they are also on the signing authority list as an authorized representative.

1.2.3 Changes to signing authority or Resident Canadian Agent

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

Since the CFIA requires original signatures, email correspondence is not acceptable for changes to the signing authority list, Canadian Agents, registrant name change, address change, registration transfers. All updates must be sent to:

Pre-market Application Submissions Office (PASO)
Attn: Animal Feed Program
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, ON K1A 0Y9
Canada

In general, there are no fees for changes to the signing authority list and/or Canadian Agents, unless this results in a change to the information that appears on your registered label. For example, if the name and/or address of the Canadian Agent appear on a label and the name or address is changed, an administrative amendment application package (including fees) will be required for each registration affected. See section 1.5 below for more information on submitting an administrative amendment.

Authorized signing authority representatives and/or Canadian Agents are not "assigned" to specific products for a company's files. They are identified by the company as having authority to interact with the AFP on behalf of the company in general. To facilitate communications, the AFP will correspond with the authorized individual that signed the application form for the submission in question, unless otherwise instructed at the time of application.

1.3 The application package

The regulatory (RG-1) guidance for feed registration procedures and labelling standards is divided into several chapters.

It is highly recommended that you refer to the guidance while you prepare your application. An organized, high quality submission greatly assists in timely evaluations of feeds, and reduces the potential for delays due to missing, incomplete or unclear information.

When your information is ready, you can submit a feed application via My CFIA based on the service request type as per the following steps below.

1.3.1 My CFIA online livestock feed applications

A service request must be submitted via My CFIA for each feed registration, feed ingredient approval, registration renewal, amendment to registration, research exemption or authorization, data review or request for an opinion for livestock feed.

Steps in the application process:

Step 1: Enroll as a user in My CFIA

If you are a first time My CFIA user, you will need to register and create a contact profile. You may then create a party profile with a business legal name which will be validated by the My CFIA Support Team.

To ensure a smooth transfer of your existing registrations into My CFIA, your legal business name and address must correspond to your existing company name and address established in your company file with the Animal Feed Program (AFP) and correspond to the legal business name and address submitted on the proof of business documents. The legal business name and address will appear on permissions as well as your approved documents such as labels.

When you enroll a party profile in My CFIA, the:

Service requests remain on hold until your party profile is validated. Once the CFIA validates the party profile, the profile authority can assign roles and authorities to individual contact profiles in My CFIA. The application evaluation process starts once your business profile is validated.

For more information about creating a My CFIA account, refer to Before you sign up for My CFIA.

Step 2: Submit an online application

To submit an online application:

Apply for feed approval or registration

To ensure that you select the right type of feed refer to the terms that are defined and described in the pop up captions available in My CFIA.

If you apply to amend an existing registration and the second digit of the registration number is 9 (X9XXXX), the type of feed is a single ingredient feed, all other registrations are mixed feeds.

Additional informational is available in the Introduction – Regulation of livestock feed in Canada to help you determine the right type of feed.

Apply for a research exemption or authorization permission to conduct research with livestock feeds in Canada
Apply for a feed data review or opinion

Step 3: Upload supporting documents

For each application, data must be submitted with your application via My CFIA. Upload supporting documents in My CFIA at the appropriate section during the application process:

Approval or registrations
Research feeds
Data review for incidental feed additives (IFAs)

1.3.2 Determining your submission type

The submission type and application fees are determined by the necessity to evaluate the safety and/or efficacy of the feed and if there is a new claim, logo or new guaranteed analysis that requires an evaluation by the CFIA.  The submission types are classified according to the category of feeds described below and will help you in determining the fees associated with your application, your submission type category (category 1, 2, or 3) and applicable fee amounts are determined according to the information provided in the My CFIA application.

Category 1: Feeds or ingredients requiring neither safety nor efficacy review

This type of submission involves an assessment of the feed's compliance with regulatory standards and labelling requirements as prescribed by the Feeds Regulations. This category includes mixed feeds with approved and/or registered ingredients as per Schedules IV and V as well as ingredients listed in Part 1 of Schedules IV and V of the Feeds Regulations.

Category 2: Feeds requiring safety or efficacy data review

This type of submission involves an assessment of safety (to livestock, workers, food and the environment) or efficacy of the feed. The assessment also verifies the feed's compliance with regulatory standards and labelling requirements as prescribed by the Feeds Regulations. This category applies to mixed feeds or ingredients requiring a safety or efficacy review. For mixed feeds that fall under this category, they must contain only approved or registered ingredients.

Category 3: Feeds or ingredients requiring safety and efficacy data review or the assessment of a claim

This type of submission involves an assessment of safety (to livestock, workers, food and the environment) and efficacy of a feed (for example, new purpose of the feed, a new claim, or new guaranteed analysis). The assessment also verifies the feed's compliance with regulatory standards and labelling requirements as prescribed by the Feeds Regulations.

1.3.3 Review your application and submit

During the application process in My CFIA, some information is provided and leads to the selection of a submission type which is identified on the final application screen "Review and submit". This is used to determine the applicable fees described under Part 4 of the CFIA Fees Notice for the consideration of an application for approval or registration and research applications. No applications fees are applied for data review applications.

Once your information is ready to be submitted, you can review your information on that screen and print the information for your records.

1.3.4 Preliminary screening

The preliminary screening is the first step of the application evaluation process. The purpose of this screening is to determine if your submission is complete and can be accepted for evaluation. The CFIA will notify you if your submission has been accepted for evaluation or rejected. It should be noted that acceptance of a submission is not a guarantee that the evaluation will result in the product being registered or approved.

For additional information on the overall evaluation process, refer to the appropriate link below:

1.3.5 Application fees

Application fees are determined, based on the service requested and the submission type:

The CFIA fees are subject to an annual adjustment based on the Consumer Price Index (CPI). Please refer to CFIA's Fees Notice for updated fee amounts. Fees must be paid when the application and supporting documents are submitted and have been accepted to be logged in for evaluation.

CFIA will confirm the applicable fees and issue an invoice. To determine what method of payment is best for you, consult the guide How to complete a payment in My CFIA.

Fees are payable in Canadian Funds via My CFIA by Visa™, Mastercard™, American Express™ or by the on-account option.

If you do not have a valid CFIA account number and wish to apply for one, complete the form Application for Credit (CFIA/ACIA 0015) and email it to ARCentre@inspection.gc.ca.

Note that the fees are not refundable. The fees are for the consideration of your submission and not for the approval or registration of the feed.

1.4 The assessment process

Your submission will be assigned to one or more evaluators depending on the submission type and type of assessment that is required for your feed. Submissions are placed into the review queue based on the date they are received, and are assessed in the order in which they are received. After reviewing the submission, the evaluator(s) will determine whether the approval criteria have been met or if additional information is necessary in order to make the assessment decision.

In the event that additional information or clarification is needed by the evaluator(s), you will receive a deficiency letter putting your application on hold and advising you in writing what additional information or clarification is needed in order to proceed with the assessment. It should be noted that the hold period is not indefinite, and that you must provide all the requested information back to the evaluator within the time-lines identified in the deficiency letter.

1.4.1 Assessment outcomes

At the conclusion of the assessment process, the evaluator will advise you in writing of the outcome of the assessment. There are 3 possible outcomes of the assessment process: favourable, unfavourable and temporary registration.

1.4.2 Favourable assessment

If the assessment process allows for a positive conclusion, the evaluator will identify any label changes required in order to complete the assessment process. You will need to submit a final label to the Pre-market Application Submissions Office (PASO) within 90 days of the date of approval which includes all the changes requested by the evaluator. If accepted, this label is kept on file for post-market verification, as well as for comparison at renewal. The label that you provide must be a complete and accurate representation of the information that appears in the marketplace.

1.4.3 Unfavourable assessment (closed)

If the evaluation process cannot conclude on the safety or efficacy of your product, if you fail to address any deficiencies identified during the assessment, or if you miss the deadline for response without receiving an extension, the assessment will be considered to be complete and your submission will be closed. Your application form will be returned to you with a closing letter outlining the items that were not addressed, and what you must do should you wish to re-apply. The data submitted with your submission may be destroyed by shredding. If you wish to have the submission data returned to you, you will need to provide the PASO with a valid courier account in order to return the data. It should be noted that the fees associated with your application are assessed for the review, and not for a successful registration of the product.

1.4.4 Temporary registration

Upon concluding the assessment of a submission, the AFP may issue a temporary registration for a product that has demonstrated both safety and potential usefulness, but requires additional evidence in support of efficacy or validation of an analytical method. A temporary registration cannot be granted to a product that has not satisfied the regulatory requirements related to product safety, as stated in Section 9(5) of the Feeds Regulations.

It is important to note that it is not possible to submit an application requesting a temporary registration. The issuance of temporary registrations is an interim measure that allows companies to adequately comply with the conditions outlined in their approval letter. Only one temporary registration will be granted per product and the maximum duration for a temporary registration will be 3 years.

Products bearing a temporary registration number on the label will be identified by the letter "T" in front of the registration number. Normally no claims are permitted on product labels, as the desired claims and/or label guarantees remain to be substantiated.

To gain permanent registration status, you must submit the supporting information or data with a completed "Application for Feed Registration CFIA Form 0009" before the expiry of the temporary registration. The application fees are the same as those for a new application for registration for category 2 (new feed).

If the product has not been proven to be efficacious and the desired product claims have not been supported by acceptable scientific data by the end of the temporary period, and/or if other registration criteria have not been met as outlined in the approval letter granting temporary registration status, the temporary registration will expire and the product will not receive a full registration. Upon expiry of the temporary registration, the product will be considered non-compliant with Section 3 of the Feeds Act, and no longer permitted to be marketed or otherwise distributed within Canada.

1.4.5 Private labelled products

Private label registration is a process that 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 as they do not require any additional safety or efficacy evaluations.

Applications for registration of private labels must include:

As the formulation of the private label product must correspond exactly to the formulation originally approved for the parent product, any mandatory information present on the original label (for example list of ingredients, guaranteed analysis, directions for use, caution statements) must be present on the private label. If the private labelling company also manufactures the feed, the formulation is required and certificates of analysis may be requested.

1.5 Making changes to feed registrations

Registrants wishing to make a change to a feed registration at any time must first submit an application for an "amendment to registration" with the proposed changes to the AFP for approval using the Application for Feed Registration or Renewal (CFIA/ACIA 0009). Fees charged to registrants for an amendment to the existing terms of a registered product are based on whether the amendment is an "administrative amendment" or if it involves a "significant change", as defined in the Feeds Regulations.

1.5.1 Significant change

Significant change includes any change in:

  1. the brand of the feed
  2. the name of the feed
  3. the type or level of medicating ingredient in the feed
  4. 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
  5. 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
  6. the directions for the use of the feed; or
  7. the ingredients present in the feed, if it is a feed required to be labelled with the name of each ingredient as described in the Feeds Regulations (Section 26.(1)(j))

The submission type code 3260 is to be used on the application form for these types of changes. Please note that submission code 3260 is only applicable to the significant changes described in a., b. or c.

Any other significant change, including items d.-g. in the list above, is equivalent to a re-registration for that product type, and the application submitted must use the same submission code and pay the same fee as if it was a completely new application.

1.5.2 Administrative amendment

Any change to the terms of a feed registration not involving a "significant change" is regarded as an administrative amendment. Some examples would be: a company name change, a change of company address, or a registration transfer. The fee for an administrative amendment is $10.00 plus applicable taxes, as per Appendix A.

1.5.3 Amendment fees combined with renewal 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. For example:

Note: All fees are for each registration.

1.5.4 Registrant name and/or address change

If a registrant changes its name and/or address the following is required:

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

To ensure that files are kept up to date, the letter advising of the name and/or address change should be sent as soon as the change is known with a note saying that the actual amendment submission (with forms, labels and fees) will follow within X weeks. An acceptable time frame for sending the amendment submission would be 30-60 days.

A current listing of valid registrations may be requested at any time, but can only be provided to an authorized representative with signing authority. It can be requested by emailing the PASO at cfia.paso-bpdpm.acia@inspection.gc.ca.

A Resident Canadian Agent cannot request the list of valid registrations of a company unless he or she is also on the signing authority list for the company.

1.5.5 Changes to signing authority or resident canadian agent

The AFP must be advised immediately of any changes to the signing authority list or Canadian agent(s). In general, there are no fees for changes to the signing authority list and/or Canadian agents, unless if this results in a change to the information that appears on your registered label. For more information, please consult subsection 1.2.3 above.

1.5.6 Transfer of a registration

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

Any other changes (for example brand name, ingredients, nutrient levels) are considered significant changes and the applicable fees will differ, depending on the extent of the change.

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

If the change to the registration/label involves the company name or address and a significant change, both amendment fees are required (administrative and significant).

The transfer letter must list the products by registration number and by name and it needs to state that "the registration and all related data are to be transferred".

This type of amendment package needs to be sent in one complete submission.

Amendments to private labels
Applications for amendments to private label registrations will be evaluated on a case-by-case basis according to the following criteria:

1.5.7 Mandatory amendments

For mandatory registration amendments (that is amendments initiated by the AFP), the AFP will inform all holders of a registration for the type of product affected by the amendment, including private label registrants. Mandatory amendments must be made to both private labels and parent product labels. There will be no charge for such amendments.

In cases where an application is made for a private label for which the status of the original product registration would not satisfy new mandatory requirements (due to concerns with efficacy and/or safety data), the private label application will be refused until the original product meets all registration requirements. The holder of the original registration will be notified of the situation.

Minor mandatory amendments required by the AFP will be made to a private label product immediately upon registration or registration renewal, even though the label for the parent product may not yet comply with the new amendment. In these cases, the private label will be corrected before the original product label. Minor mandatory amendments to the original label will be made at the time of renewal or when an application for significant change is submitted to the AFP.

1.5.8 Voluntary amendments

When the original registrant is granted an amendment (for example revised guarantee, addition of a claim, changes in the formulation), the original registrant is responsible for notifying the private label registrant(s) of these amendments. In such cases, private label registrants are not obliged to update their registration to reflect the change(s) made to the original registration as long as the private label continues to comply with the Feeds Regulations. However, should the private labelling company choose to include the new information, an application package for a significant change must be submitted.

1.6 Renewing feed registrations

Registrations are granted for a 3-year period. The expiry date for registrations is March 31, 3 years after the date of registration. For example, feeds that are registered in 2016 will have an expiry date of March 31, 2019. Please note that this expiry date is applicable to registered feeds and ingredients, and those products listed in Part II of Schedule IV of the Feeds Regulations. Failure to apply to renew the registration of a feed or ingredient will automatically result in the expiry of the registration. If your registration expires, you will need to submit an application for a new registration for your feed or ingredient.

If you have registrations that are due to expire the following March, you will receive a "registration summary" listing those registered products, as well as instructions for completing the applications for renewal. Additional information may be requested if safety and/or efficacy concerns emerge between the time of registration and the renewal due date. If there are specific requirements for the renewal of their registration, you will be advised what additional information will be required at the time of submission.

If your product/label has not changed since last approved, and a complete renewal application is posted (postmarked) before the March 31 deadline, you may continue to market your registered feed, unless you are advised otherwise.

To avoid having your registrations expire, a complete renewal package must be sent to the Pre-market Application Submissions Office (PASO) before March 31 of the year in which it expires. If your registration expires you may not import or sell your product until such time as it has been re-registered. Once re-registered, your product will be issued a new registration number.

Renewal packages posted after March 31 will be treated as new applications and will be subject to regular application fees. Applications for lapsed registrations will be placed in the existing submission queue for new submissions, where they will be reviewed on a first come, first served basis.

Due to the high volume of renewal applications that are received, acknowledgement of receipt will not be provided. If you wish to receive a record of delivery, it is suggested that you send your applications by courier or registered mail.

Any updates to your company's general information can be made directly on the "Company Information Sheet" included in your renewal package. To be accepted, the "Company Information Sheet" must contain either the corporate seal of the company, the seal of a notary public, or the original signature of someone currently listed as having signing authority.

If you wish to appoint a new Resident Canadian Agent, this individual must fill out, have notarized, and send a Declaration of Resident Canadian Agent, Form II (CFIA/ACIA 1194) to the AFP.

Incomplete renewal packages may be returned to the Registrant, without processing. This could result in the registration expiring. In order to assist you in preparing your renewal package, a checklist has been added as Appendix A at the end of this chapter.

Note: The renewal categorization and fee applies only in cases where no changes have been made to the product formula and label. Any amendment (significant or administrative) made to the registration, submitted at the time of renewal, should be stated in the cover letter, and you will need to include both the renewal fee and the applicable fee for the amendment.

The process for evaluating a renewal application is very similar to a new registration. The file is screened in, given a preliminary review, held pending receipt of additional information if requested by the evaluator, assessed, and then the notice of approval or rejection is sent to the registrant.

1.6.1 Renewal of registration for private label products

The following must be submitted with each application for registration renewal:

Note: If a parent product is issued a temporary registration, the private label product will only be granted temporary registration status. The expiry date for the private label product will be the same as that for the parent product. The granting of permanent registration status to a private label product that was previously given a temporary registration is contingent upon the parent product receiving permanent registration status. If the application for permanent registration is submitted at the time of renewal, the registration fee will be in addition to the renewal fee. If the application is submitted prior to the expiration of the temporary registration, the registration fee is the same as that for the consideration of a new category 2 feed.

1.7 Priority status and review of feed applications

Objective

This guidance aims to provide the criteria and the process by which feed applications may be prioritized for evaluation ahead of applications already in the queue.

About the process

As a regulatory agency, the Canadian Food Inspection Agency (CFIA) must maintain an impartial role in the pre-market assessment process of livestock feeds. Feed applications are reviewed in the order in which they are received. Moving a feed application forward in the queue at the request of the applicant would be an unfair practice that disadvantages other applicants who are also waiting to market their products. However, in certain unique circumstances, the CFIA may designate "priority status" to an application that meets strict criteria to undergo an evaluation ahead of other applications already in the queue. In this scenario, once an application has been submitted and successfully screened, it will become a priority and placed at the front of the queue for evaluation by the appropriate evaluation officer(s).

The priority status designation does not alter the scientific data requirements for approval or registration, including the required quality of evidence, nor does it shorten the time required for CFIA to conduct its evaluation. All existing regulatory requirements for livestock feeds, including all the assessment end-points, must continue to be met.

Criteria

Priority status may be granted to an application provided that it meets at least 1 of the following objectives:

Considerations in priority status requests

Alternative product availability will be considered when evaluating a priority status request. The decision for a priority status request will consider whether other types of feed products have been approved or registered for the same intended purpose, and the number of alternative products available in the market. In situations when there are considered to be a sufficient number of products available to meet demand, the priority status request will most likely be declined.

In a scenario when a priority status has been granted, approvals given by select foreign regulators (for example, European Food Safety Authority, United States Food and Drug Administration) for the same specified purpose may be considered in support of an application. Please consult the Animal Feed Program (AFP) for guidance on the use of foreign decisions for livestock feed approvals in Canada.

Process for requesting a priority status review

Step 1: contact the AFP via email to request a priority status that includes details relevant to the conditions stipulated above. The AFP will determine whether or not the request meets the criteria for priority status and will inform the applicant of its decision.

Step 2: if it is determined that your request meets the criteria for priority status, proceed to contact the AFP to set up a pre-submission consultation. Follow the process outlined in R G-1 Chapter 8 – Pre-submission consultation procedures for livestock feed. The outcome of the pre-submission consultation process will determine if the feed application continues to qualify for priority status.

Step 3: if during the pre-submission consultation process, your product is confirmed as being eligible for priority status, you will be asked to submit an application for approval and registration for the product via the following steps:

  1. apply via the online service My CFIA
  2. submit the application package as outlined in RG-1 Chapter 1.3
  3. select the permission type in My CFIA: Registration or approval
  4. in the online application name field, enter "Priority status for Product Name"
    • Please note that omitting "Priority status" from the application name may result in a longer evaluation process
  5. upload the label, the completed checklist when required, data requirements, and all other required information in the appropriate sections of the application
    • The application will undergo the standard process of preliminary screening, which serves to determine if the application is complete and can be accepted for evaluation
    • During the preliminary screening of an application for priority status, the AFP may request additional information as needed to clarify or confirm the eligibility of an application for priority status
    • The CFIA will inform the applicant of its final decision to accept or reject a request for priority status upon the completion of the preliminary screening step
      The final decision for priority status is made at this step

The applicant may request to change the status of the application to "priority" while the application is already in queue for technical review. To initiate the process, the applicant should promptly contact the AFP by email, referencing the case number of the application and providing a comprehensive explanation of the circumstances necessitating priority status. The CFIA will consider the request and may suggest organizing a pre-submission consultation to support this request.

Timeframes

Priority applications are subject to the same data requirements as non-priority applications and, therefore, require the same amount of time for evaluation. However, priority status applications receive priority in the queue.

For more information

If you have questions regarding this guidance or need assistance with requesting a priority status meeting through a pre-submission consultation, please contact the Animal Feed Program at cfia.afp-paa.acia@inspection.gc.ca.

1.8 Service standards and contact information

The Animal Feed Program will make every effort to respond to questions in a timely manner. In order to facilitate the submission process, applicants should read the available guidance and regulatory documents available on the website before contacting the AFP to ask their questions.

The AFP makes science- and evidence-based feed registration decisions using the information that applicants provide for assessment. For their part, applicants are expected to provide a complete submission of high quality.

If you submit an application that is accepted, your confirmation e-mail indicating that it was accepted will include an estimated time frame for the assessment. This estimate will be based on the current service delivery averages at the time of submission.

Due to the volume of submissions, applicants are advised not to request status updates prior to the end of the service delivery estimate provided. After this date, file status updates may be requested by sending an email to the PASO using the word feed and your file reference number in the subject line. Status update requests that do not include a reference number will not receive a response.

If you disagree with the outcome of an assessment, or if you have a complaint regarding the review of your submission, contact the AFP by email at: cfia.afp-paa.acia@inspection.gc.ca. You will be directed to speak with the evaluation manager. If you are not satisfied with the results of this discussion, you may contact the Director of the AFP. Following this, if your issue is still unresolved, you may file a complaint with the CFIA's Office of Complaints and Appeals.

1.8.1 Contact information

For questions of a technical nature related to the feed registration or ingredient approval process, please contact the AFP by email at: cfia.afp-paa.acia@inspection.gc.ca .

For questions related to the administrative process of submitting an application, or for file status updates (for submissions that have exceeded the estimated service delivery date), please contact the Pre-market Application Submissions Office.

Appendix A: Checklist for renewals

To ensure a complete renewal package, all of the applicable items below must be included.

Checklist for renewals
Items must be included Provided
  • Cover letter
(Note: State any changes in the cover letter, if applicable)
  • Email address of the authorized representative
  • 1 application form (CFIA/ACIA 0009) per product registration submitted for renewal
  • Original signature of authorized representative on each application form
(Note: If a new person is signing the form(s), proper signing authority documents must be enclosed)
  • Original signature of Resident Canadian Agent on each application form, if applicable
(Note: If the Resident Canadian Agent is new, a new Declaration of Resident Canadian Agent, Form II (CFIA/ACIA 1194) must be enclosed)
  • 3 copies of each label submitted for renewal
(Note: The label must be the current label as used in the marketplace, or a facsimile thereof, and not a previously stamped label copy)
  • Confidential formula, if the product is a Category 2 feed (that is the second digit of your registration number is "8" (flavouring agent, mold inhibitor, horse treat, enzyme supplement, odour control agent, forage additive, etc.))
(Note: It must be supplied on a separate sheet of paper, and this information should not be within the contents of your cover letter)
  • The complete list of ingredients for all imported mixed feeds
(Note: If they are not listed on the approved label, they must be supplied on a separate sheet and not within the contents of your cover letter)
  • Applicable fees/per registration renewal
  • If modifications are being made to the existing registrations, additional fees will apply (See section 1.5 for additional information)

Appendix B: Registration checklist for standard mixed feeds

Standard Registration Requirements

space Completed application package per Chapter 1:

Proposed Label

Standard Registration Requirements

space Completed application package per Chapter 1:

Proposed Label

space Brand name (optional)
space Product name reflecting purpose of the product and the intended species
space Feed form if medicated and other than mash
space Medication, level and approved claim from Medicating Ingredient Brochure (MIB) (if applicable)
space Selenium statement located above guaranteed analysis (if applicable), "This feed contains added selenium at space mg/kg".
space Guaranteed analysis: required guarantees per Table 3 for the specific feed type
space The 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 or the statement: "A list of ingredients used in this feed may be obtained from the manufacturer or registrant".
space For first time applicants and all imported feeds: 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 is to be included with the submission (on a separate sheet or on a label).
space Directions for use to permit safe and effective use of feed
space Cautions (if selenium added): All species - "Directions for use must be carefully followed" Ruminants only - "Do not use in association with another feed containing supplemental selenium"
space Caution / Warnings (per MIB if applicable)
space Notes (if required by MIB)
space BSE statement if feed contains "prohibited material": "Feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animal Act."
space Name and address of registrant
space Net amount (metric measure)
space Registration number (to be added)
space Lot number (if applicable)

Other

space Data to support label guarantees that fall outside of Schedule I, Table 4

Note: Any feed claims (including Internet and advertising) must be supported by scientific evidence. Please see section 2.2, Registration Requirements for Specialty Product.

Further information may be required after a review of the preliminary submission.

Brand name (optional)

space Product name reflecting purpose of the product and the intended species
space Feed form if medicated and other than mash
space Medication, level and approved claim from Medicating Ingredient Brochure (MIB) (if applicable)
space Selenium statement located above guaranteed analysis (if applicable), "This feed contains added selenium at space mg/kg".
space Guaranteed analysis: required guarantees per Table 3 for the specific feed type
space The 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 or the statement: "A list of ingredients used in this feed may be obtained from the manufacturer or registrant".
space For first time applicants and all imported feeds: 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 is to be included with the submission (on a separate sheet or on a label).
space Directions for use to permit safe and effective use of feed
space Cautions (if selenium added): All species - "Directions for use must be carefully followed" Ruminants only - "Do not use in association with another feed containing supplemental selenium"
space Caution / Warnings (per MIB if applicable)
space Notes (if required by MIB)
space BSE statement if feed contains "prohibited material": "Feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animal Act."
space Name and address of registrant
space Net amount (metric measure)
space Registration number (to be added)
space Lot number (if applicable)

Other

space Data to support label guarantees that fall outside of Schedule I, Table 4

Note: Any feed claims (including Internet and advertising) must be supported by scientific evidence. Please see section 2.2, Registration Requirements for Specialty Product.

Further information may be required after a review of the preliminary submission.

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