Submission Completeness Checklist for Fertilizer or Supplement Registration Applications: Major Amendment

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A complete submission package must include all the information requirements as indicated below and must be organized in the form of sections or tabs as per the Guide to Submitting Applications for Registration Under the Fertilizers Act.

Mandatory List of Tabs and Sub-Tabs

Tab 1: Administrative Forms and Fees (Required for Safety Assessment Levels I, II, and III)

Tab 2: Marketplace Label (Required for Safety Assessment Levels I, II, and III)

  • Proposed Market Place Label

Tab 3: Product Specification (Required for Safety Assessment Levels I, II, and III)

  • List of Ingredients: Input MaterialsFootnote 1 (preferably in table-format; always include Name of the material, CAS# (if available), Manufacturer, Country of origin, Source, Manufacturing/purification processes, Concentration in the final product, Purpose, and (M)SDS)
  • List of Ingredients: Microbial Inocula, when product contains viable microorganism (always include purpose of the microroganism; its taxonomic identification to the strain level if possible; analytical results; relationship to known pathogens; strain bank accession number or environmental isolate's origin/proof of purity)Footnote 1
  • List of Ingredients: Composition of the Final ProductFootnote 1 (preferably in table-format; always include Identity of the ingredient, Relative proportion as w/w percentage of the final product, and (M)SDS)
  • Method of ManufactureFootnote 1
  • Quality Assurance and Quality Control ProceduresFootnote 1
  • Physical CharacteristicsFootnote 1

Tab 4: Results of Analysis (Required for Safety Assessment Levels II and III)

  • Total number of batches/lots produced within a 3 year period (if applicable)
  • Sets of Metal Analyses as required
  • One (1) set of Dioxins and Furans (if applicable; required with new product application only)Footnote 1
  • Four (4) sets of Indicator Organisms (if applicable)

Tab 5: Safety Rationale and Supplemental Data (Required for Safety Assessment Level III)

  • Toxicological Risk Profile (Hazard, Exposure, Risk Assessment)Footnote 1
  • Microbial Risk Profile (Hazard, Exposure, Risk Assessment)Footnote 1
  • References and Supplemental DocumentationFootnote 1

Please note that requirements vary depending on the product type. (Consult Appendix 2 of the guide in order to determine which Tabs are required for each product.)

The Fertilizer Safety Section reserves the right to require additional information, data, fees, rationale or results of analysis to support the registration of any product regulated under the Fertilizers Act and Regulations.

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