RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.2 Anion/cation balance feeds
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Registration Checklist for Anion/Cation Balance Feeds
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
- Guarantees for actual % chlorine and actual cation/anion balance expressed in mEq/kg
- Formula used to determine DCAB (Dietary Cation/Anion Balance)
- 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
- A minimum of 2 studies supporting the efficacy of the product to significantly reduce DCAB of the total diet (forage + concentrates) for typical dairy dry cow nutritional regimes must be submitted for evaluation.
- Calculations used to determine Dietary Cation/Anion Balance (DCAB)
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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