RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.29 Acid based products
This page is part of the Guidance Document Repository (GDR).
Looking for related documents?
Search for related documents in the Guidance Document Repository
Registration Checklist for Acidifiers
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 (major 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)
- 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 are required to support the intended purpose of these products
- 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
- Scientific investigations show that the products when used as directed, significantly reduced the pH of feeds for each species/class for which they are intended. Where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the lowest inclusion rate.
- Studies show a significant difference (P<0.05) between the control and treated groups
- 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.
Lab Methods
- Original signed copies of Certificate of analysis for a minimum of 3 lots of these products supporting label guarantees for the primary acidifying ingredients.
- Information on the methodologies used to analyse the acid levels e.g. a copy of the AOAC International or other official method is required. In the event that these methods have not been peer-reviewed, additional information is required to validate the laboratory method as outlined in section 6.2
- Analytical methodology substantiating the guarantee(s) (e.g. novel guarantee or method) - provided for CFIA Laboratories
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.
- Date modified: