RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
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Registration Checklist for Antioxidants
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 (active ingredients)
- 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 the product
- Caution and/or warning statements (if applicable)
- Name and address of registrant
- Shelf life of product
- 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 reduce the rancidity or improve the preservation of nutrients susceptible to oxidation of the feed. 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 active antioxidant 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 In the event that these methods have not been peer-reviewed, additional information is required to validate the laboratory method as outlined in section 6.2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 Ottawa Laboratory (Carling)
- Original signed copies of Certificates of Analysis for a minimum of 3 lots of product to support product stability or shelf life.
- 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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