Chapter 3 - Specific Registration Information by Feed Type
3.16 Pellet Binders

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Registration Checklist for Pellet Binders

Administrative Registration Requirements

  • Completed application package per Chapter 1

Proposed Label

  • Brand name (optional)
  • Product name reflecting purpose of the product and the intended species
  • Product claim statement
  • Guaranteed analysis (active ingredient(s))
  • 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
  • Directions for use to permit safe and effective use of feed
  • Caution and/or warning statements (if applicable)
  • Required statement: "Consult the Compendium of Medicating Ingredients Brochures for acceptable drug compatibility with this product"
  • Name and address of registrant
  • Net amount (metric measure)
  • Registration number (to be added)

Product Composition

  • Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of Feed Regulations including registration numbers for Part II ingredients or mixed feeds
  • Formulation / Ingredients - verify level of ingredients does not exceed maximums per Schedules IV and V

Scientific Studies

  • Scientific studies are required to support the intended purpose of the product and must be provided for our review
  • Studies carried out by qualified personnel
  • Suitable methods used in studies
  • Studies designed to facilitate statistical analysis. The research design must include at least 3 replicates of each treatment involved, including the control.
  • Data analysed by appropriate statistical methods
  • Studies conducted under conditions similar to those that may be expected to occur in Canada
  • Scientific investigations show that the product, when used as directed, significantly (P<0.05) improves pellet durability in a specific feed for a specific class of livestock
  • When the pellet binder is intended for use in a variety of feeds and/or for various classes of livestock, scientific investigations must show significant differences (P<0.05) between the control and treated groups, for each of the specific feeds and/or livestock groups where the product is intended for use
  • Where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the lowest inclusion rate
  • Where results of these studies have not been published in a refereed journal, copies of the raw data and printouts of statistical analysis are required for our review

Sample

  • Provided (if necessary to validate lab methodology)

Promotional Claims (including Internet and Advertising)

  • Consistent with stated purpose of product

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

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