RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.20 Rumen bypass feeds
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Registration Checklist for Rumen Bypass Feeds
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
- 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)
Product Composition
- 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
- 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
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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