RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.16 Pellet binders
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Registration Checklist for Pellet Binders
Administrative Registration Requirements
- Completed application package per Chapter 1
- 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)
- 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 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
- 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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