RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.29 Acid based products
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Registration Checklist for Acidifiers
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 (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)
- 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 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.
- 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 In the event that these methods have not been peer-reviewed, additional information is required to validate the laboratory method as outlined in section 6.2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
- 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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