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RG-1 Regulatory guidance:
Chapter 2 - Data requirements for single ingredient approval and feed registration

2.1 Process to streamline approvals for category 1 feed registrations

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Purpose

The Canadian Food Inspection Agency (CFIA) and the feed industry continue to seek ways to streamline processes to help reduce the total time required to approve feed products requiring registration.

Background

Category 1 Feed Registrations are standard feeds that do not require safety or efficacy data review. These have relatively simple requirements and a straightforward approval process; however, they can take significant time to be evaluated due to the quality of submissions and subsequent interactions to ensure that information needed to evaluate the product is complete. This results in delays which affect all other registration submissions in the queue and contributes to a backlog.

Preliminary screening steps are currently built into the feed registration approval process so that when CFIA reviewers receive application packages, they are complete. These additional steps in the process can increase the overall time to register an application.

The streamlined process described in this document focuses on increasing the quality of registration submissions for Category 1 Feed Registrations to decrease the overall time it takes to review these products. Applications identified as streamlined will skip the preliminary technical screening, and proceed directly to the technical review to ensure the streamline requirements are met.

Benefits

Product eligibility

Products eligible for the streamlined process include:

The following product types are not eligible for the streamline process:

Requirements

The process is designed to meet the requirements of the Feeds Regulations, 1983. Eligible Category 1 feeds, must be labelled and contain the nutrient guarantees per Schedule I Table 3. Vitamin and mineral guarantees will be compared with minimums and maximums provided in Schedule I Table 4.

The requirements for the streamlined process have been organized into checklists found below:

Requirements and Checklist for Streamlined Approvals of Category 1 Feeds

Tools have been developed to assist the industry in demonstrating that requirements have been met and are available on the Animal Nutrition Association of Canada (ANAC) website at Streamline Approvals for Category 1 Feed Registrations

Note: applicants must self-identify that their application meets the requirements of the streamlined process. Identified applications that fail to provide all necessary information or that do not meet the requirements for the streamlined process, will be returned to the applicant and the applicant must begin a new registration application. Applications will not be placed on hold pending additional or revised information.

Process

The registration process would be as follows:

  1. registration package is completed and verified by the registrant against the requirements
  2. this includes verifying that every required element (as per CFIA's checklist) is complete, meets regulatory requirements, and is included in the package in the same order as proposed on the checklist
  3. registrant submits registration package to CFIA Premarket Application Submission Office (PASO), including the completed and signed checklist and cover letter indicating that this is a streamlined application
  4. the CFIA will review the file and either
    • issue a registration for applications that are complete and meet the requirements of the streamlined process
    • return the file if the application is incomplete
  5. the registration decision will then be sent to the applicant. Note the application fee will be retained by the CFIA

Note: this is a voluntary process. Products can still be submitted for registration without using the streamlined process, in which case traditional approval processes and timelines will apply. Before being submitted to CFIA for evaluation, ANAC Members can choose to have their registration packages pre-screened for completeness by ANAC – visit Streamline Approvals for Category 1 Feed Registrations.

Requirements and checklist for streamlined approvals of category 1 feeds

1. New and significant changes to standard mixed feeds listed in items 1-6 of Schedule I table 3 of the Feeds Regulations, 1983 - complete feeds (including milk replacers), supplements, macro-premixes, mineral feeds, micro-premixes, trace mineralized salts, or converter feeds

Requirements Page # or N/A CFIA Use

Completed application package is submitted in the same order as per this checklist and as per RG-1 Chapter 1 – Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed

  • Cover letter– indicating that this is a streamlined application
  • Application form
  • Application fee
  • Checklist

Label (3 copies) containing the information as per Section 26 of the Feeds Regulations, 1983 (see list in Appendix 1)

Note: for mixed feeds listed in items 1-6 of Schedule I Table 3, if label guarantees that are not indicated in Schedule I Table 3 appear on the label or if the label highlights the inclusion of another mixed feed, these feeds are not eligible for streamlined review

For example statements like – "Contains Moore's Mineral Complex" or "with Smith's Vitamin D".

Claims that are part of the Permissible claims policy for livestock feed are allowed

For complete feeds:

calculations showing that the nutrients requiring labelling guarantees as per Schedule I Table 3 meet or exceed the Schedule I Table 4 minimums and do not exceed the maximums

For mixed feeds other than complete feeds:

  • calculations showing that the nutrients requiring labelling guarantees as per Schedule I Table 3, when fed according to the directions for use, provide at least 10% of the Schedule I Table 4 nutrient minimum and do not exceed the nutrient maximums
  • if a nutrient does not provide at least 10% of the minimum value in Schedule I Table 4, the nutrient should not appear as a guarantee on the label.
  • a calculation must still be included to demonstrate the rationale for excluding the guarantee

For medicated feeds:

calculations showing that the level of medication supplied is in accordance with the Compendium of Medicating Ingredient Brochure (CMIB) directions for use associated with the appropriate claim

Note: imported medicated feeds are not eligible for streamlined review

For new feed applications and all imported feeds:

  • a complete list of ingredients identified by their generic name and item number as listed in the Administrative Schedule IV or V of the Feeds Regulations, 1983, including Canadian Feed Registration Numbers for Part II ingredients or registered mixed feeds, must be included with the submission (on a separate sheet or on the label)
  • the complete list of ingredients should include all of the ingredients used in any premix or supplement used to make the category 1 feed (for example, an in-house premix)
  • if that premix or supplement is registered, the list of its ingredients is not required, only the registration number and a copy of the label
  • provide a copy of the label of any other registered feeds included in your mixed feed
  • the list of ingredients is not required if the streamlined application is for a renewal or an amendment to an already registered feed.

2. Simple mixtures and dilutions of single ingredient feeds only containing ingredients listed in schedule IV part I classes 1 to 7

Products admissible for streamlined approvals are:

  • intended to facilitate the addition of ingredients typically included in small quantities to livestock feeds if added alone, like vitamins and minerals
  • simple mixtures of feed ingredients like grains, cereals, and/or meals that provide protein and energy (carbohydrate and fats), that is, macronutrients
Requirements Page # or N/A CFIA Use

Completed application package is submitted in the same order as per this checklist and as per RG-1 Chapter 1 – Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed

  • Cover letter– indicating that this is a streamlined application
  • Application form
  • Application fee
  • Checklist

Label (3 copies) containing the information as per section 26 of the regulations (see list in Appendix 2)

Note: for simple mixtures and dilutions of single-ingredient feeds from Schedule IV part I Classes 1-7, only label guarantees indicated in the individual single-ingredient feed definitions should be present on the label

  • some single ingredient feeds allow for identifying the names of pelleting aids, mould inhibitors, anticaking or flow agents used in their manufacture
  • the names of these may be transferred to the label of these simple mixtures or dilutions of single-ingredient feeds
  • if they are registered, provide a copy of the label of any registered feeds included in your simple mixture
Calculations
  • calculations showing the amalgamation of guarantees being transposed from the single ingredient feeds

Appendix 1 – Label requirements for new and significant changes to standard mixed feeds listed in items 1-6 of schedule I table 3 of the Feeds Regulations, 1983

Proposed label

  • Brand name (optional)
  • Feed name/Product name reflecting the purpose of the product and the intended species
  • Feed form if medicated and other than mash
  • Medication, level and approved claim from Compendium of Medicating Ingredient Brochure (CMIB) (if applicable)
  • Selenium statement located above guaranteed analysis (if applicable), "This feed contains added selenium at spacemg/kg"
  • Guaranteed analysis: required guarantees per Table 3 for the specific feed type
  • The complete list of ingredients identified by generic name as listed in Schedule IV or V of the Feeds Regulations, 1983, 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"
  • Directions for use to permit safe and effective use of the feed
  • 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"
  • Caution / Warnings (per CMIB if applicable)
  • Notes (if required by CMIB)
  • Bovine spongiform encephalopathy (BSE) statement if the 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."
  • Name and address of the registrant
  • For imported feeds: country of origin or “Imported by or Imported for” followed by the Canadian person or company name and address for whom the feed was manufactured or produced for resale
  • Net amount (weight or volume - metric measure required – other units optional)
  • Registration number (to be added once the feed is registered)
  • Lot number (if applicable)

Appendix 2 – Label requirements for simple mixtures and dilutions of single-ingredient feeds only containing ingredients listed in schedule IV part I classes 1 to 7

Proposed label

  • Brand name (optional)
  • Feed name/Product name reflecting the purpose of the product and the intended species
  • Guaranteed analysis: amalgamated guarantees as per Schedule IV ingredient definitions directly related to the individual single ingredient feeds contained within the product
  • The complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, 1983
  • Directions for use to permit safe and effective use of the feed
  • 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"
  • Labelling statements as per Schedule IV ingredient definitions directly related to the individual single ingredient feeds contained within the product
  • BSE statement if the 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."
  • Name and address of the registrant
  • For imported feeds: country of origin or “Imported by or Imported for” followed by the Canadian person or company name and address for whom the feed was manufactured or produced for resale
  • Net amount (weight or volume - metric measure required – other units optional)
  • Registration number (to be added once the feed is registered)
  • Lot number (if applicable)
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