RG-1 Regulatory Guidance:
Chapter 2 - Data Requirements for Single Ingredient Approval and Feed Registration
2.3 Single Ingredient Feed Evaluation Requirements
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Single ingredient feed evaluation may require (but is not limited to):
- If applicable, standard registration requirements such as signing authority/resident agent, completed application form, registration fee.
Proposed label reflecting the purpose of the ingredient, and the standards, packaging and labelling requirements of the Feeds Act and Regulations.
- Ingredient Description
Precise description of the ingredient to assist in accurately describing the ingredient when listed in Schedule IV or V, (e.g. 4.2.3 Corn bran - outer coating of corn kernel with little or none of the starchy part of the germ).
- Complete details of the manufacturing process, if applicable, outlining the starting material, chemical and/or physical treatments and finished material, (e.g. 5.3.7 Corn gluten meal - dried residue from corn after the removal of the larger part of the starch and germ and the separation of the bran by the process employed in the wet milling manufacture of corn starch or syrup or by enzymatic treatment of the endosperm).
- Usefulness of the ingredient for the intended purpose (e.g. to assist in designating the class for Schedules IV and V).
- Background supportive information pertaining to listings in other publications if available (e.g. Association of American Feed Control Officials, National Feed Ingredients Association, Red Book, Code of Federal Regulations, Council of Europe, etc.).
- Scientific investigations presented in support of nutritional label claims must be: carried out by qualified research personnel; carried out using suitable methods; designed to facilitate statistical analysis; analysed by appropriate statistical methods; and conducted under conditions similar to those that may be expected to occur in Canada.
- Certificate of analysis and analytical methodology substantiating the guarantee in both the ingredient and mixed feed (e.g. novel guarantee or method).
- Quality control procedures demonstrating consistency if applicable.
- Specification sheet/analysis/contaminant content.
- Sample (if necessary).
- Safety Information (as necessary)
Scientific investigations concerning, but not limited to, chemical analyses and/or harmful residues and/or toxicological evaluation and/or animal feeding study and/or tissue residue analysis etc. presented in support must be: carried out by qualified research personnel; carried out using suitable methods; designed to facilitate statistical analysis; analysed by appropriate statistical methods; and conducted under conditions similar to those that may be expected to occur in Canada.
- Stability information if applicable.
- Suitable methodology for the detection of significant amounts of any ingredient, compound, substance, or organism intentionally incorporated into the feed or occurring as a contaminant.
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