RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.20 Rumen bypass feeds

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
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)
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 the Feeds 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 may not be required if the product contains predominantly recognized sources of bypass protein/fat ingredients
If the product is intended a a source of bypass nutrients other than recognized proteins/fats, scientific studies are required
Studies carried out by qualified personnel
Suitable methods used in studies
Studies designed to facilitate statistical analysis
Data analysed by appropriate statistical methods
Studies conducted under conditions similar to those that may be expected to occur in Canada
Results showing a significant increase in a related parameter in the blood or plasma of treated animals, e.g., significant increase in plasma amino acids for bypass amino acids
Studies show a significant difference (P<0.05) between the control and treated groups
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.