RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.16 Pellet binders

This page is part of the Guidance Document Repository (GDR).

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

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