RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.17 Processing aids

Registration Checklist for Processing Aids to be Utilized in Livestock Feed Production

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name
• Product name reflecting purpose of the processing aid
• Directions for use for the processing aid for the intended process
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Net amount (metric measure)
• Date of Manufacture
• Expiration date
• Registration number (to be added)

Product Composition

• The ingredient formulation of the processing aid is required (Please note that such formulations are held in strict confidence)
• If the processing aid contains a polymer, the residual monomer concentration must be determined

Processing Conditions

• A schematic, or flow chart of the process, clearly indicating where the processing aid is to be applied in the process (e.g., rendering, meat processing) and quantities administered
• The stability of the processing aid during the process to include considerations of thermal stability
• The potential concentration of the processing aid, or its ingredients or breakdown products, present in the recovered solids (coagulated fat/protein mixture). Calculations must incorporate appropriate concentration factors
• If the processing aid is used as a flocculant in the treatment of wastewater a discussion on the partitioning of the flocculant should be provided, e.g., does the polymer/monomer constituents partition with the recovered solids or with the waste water?

Feed Ingredient Composition

• A description of how the recovered solids are to be used as a livestock feed ingredient, including types of feeds, inclusion rates, and intended species
• The final composition (list possible degradation products, if any) of the processing aid in the livestock feed ingredient

Quality Control Procedures

• Method of analysis for the processing aid, or its constituents and breakdown products in the feed ingredient
• Certificates of Analysis (for a minimum of 3 separate lots if applicable) of the processing aid, or its constituents and breakdown products, in the feed ingredient or in complete feeds

Safety Review

• Material Safety Data Sheet (MSDS) for the processing aid
• Appropriate toxicological studies for the processing aid and/or its constituents, including but not limited to, acute, sub-acute or chronic bioassays via the appropriate exposure route (oral), and bacterial mutagenicity and in vitro chromosome aberration studies. Toxicity results may be obtained from journals, toxicological data bases or registrant-funded toxicity studies. Results from toxicology studies using similar compounds may also be accepted, provided sufficient bridging data between compounds is established
• Toxicity must be considered for all species of intended use of the final feed ingredient

Note: Further information may be required after a review of the preliminary submission. Valid scientific rationale may be provided in place of data requirements.

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