Guide to the Canadian Federal Regulatory Requirements for Fertilizers and Supplements

1^st Edition - February 2010

Published by:
Crop Inputs Division
Plant Health and Biosecurity Directorate
Canadian Food Inspection Agency

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Table of Contents

1.0 The regulation of fertilizers and supplements in Canada, and the Canadian Food Inspection Agency's (CFIA) Role

• 1.0.1 What does the CFIA do?
• 1.0.2 What is the CFIA's mandate with respect to fertilizers and supplements?
• 1.0.3 What types of products are regulated under the Fertilizers Act and Regulations?
• 1.0.4 What aspects of fertilizer and supplement products are regulated?
• 1.0.5 What is a pre-market assessment?
• 1.0.6 What is involved in a product safety assessment?
• 1.0.7 What is involved in a product efficacy assessment?
• 1.0.8 How are labels verified?
• 1.0.9 In addition to pre-market assessments, what else does the CFIA do to ensure compliance?

1.1 What is the purpose of this Guide?

1.2 What is the scope of this Guide?

1.3 How do I know what section of the Guide to use?

2.0 Registration Guide: specialty Fertilizers and Pre-packaged Farm Fertilizers Containing a Pesticide

• 2.0.1 What is this section of the guide about and who needs to read it?
• 2.0.2 What is a customer formula fertilizer-pesticide
• 2.0.3 What is a Fertilizer-Pesticide Product?
• 2.0.4 How are Fertilizer-Pesticides regulated in Canada?

2.1 How do I obtain a new registration for my product?

• 2.1.1 What do I need to submit for review?
• 2.1.2 What is meant by signing authority and why is it needed?
  • 2.1.2.1 Corporations
  • 2.1.2.2 Partnerships and sole proprietorships
• 2.1.3 What is meant by resident Canadian Agent and why is it needed?

2.2 What is the review process used by the Crop Inputs Division?

• 2.2.1 Pre-Screening
  • 2.2.1.1 Completeness Check
  • 2.2.1.2 First Response
• 2.2.2 Review Streams

2.3 How do I re-register my product?

• 2.3.1 What do I need to submit for review?

2.4 What if I want to change my product and/or the product label?

• 2.4.1 What do I need to submit for a minor amendment review?
• 2.4.2 What do I need to submit for a major amendment review?

2.5 Can my registration be cancelled?

2.6 What are the labelling requirements for a fertilizer-pesticide?

• 2.6.1 General
• 2.6.2 The Compendium of Fertilizer-Use Pesticides
• 2.6.3 The main panel of the product label
• 2.6.4 Addresses
• 2.6.5 Lettering, fonts, colouring, and pictures
• 2.6.6 Languages
• 2.6.7 Units of Measure
• 2.6.8 Net weight
• 2.6.9 Brand Name
• 2.6.10 Product Name
• 2.6.11 Guaranteed Analysis
• 2.6.12 Registration number
• 2.6.13 Directions for Use
• 2.6.14 Cautionary statements
• 2.6.15 Ingredients List
• 2.6.16 Label claims
• 2.6.17 Slow and controlled release
• 2.6.18 Seller's guarantee
• 2.6.19 Lot numbers
• 2.6.20 Workplace Hazardous Material Information System (WHMIS)
• 2.6.21 Websites

2.7 What is the "Approved Brands List" for pesticides?

• 2.7.1 How do I get my pesticide product included in the Approved Brands list?
• 2.7.2 When and why is efficacy data required?
• 2.7.3 How do I demonstrate the efficacy of the fertilizer in the fertilizer-pesticide combination?

2.8 What standards does my fertilizer-pesticide product need to adhere to?

• 2.8.1 Efficacy
• 2.8.2 How do I demonstrate efficacy if required to?
• 2.8.3 Safety
  • 2.8.3.1 Metal Standards
  • 2.8.3.2 Contaminating Microorganismes
  • 2.8.3.3 Organic Contaminant Standards
  • 2.8.3.4 Safety Data Requirements
• 2.8.4 Guarantee tolerances

2.9 What are the Import Requirements for fertilizer-pesticides?

2.10 Contact Information

Appendix A: Fertilizer or supplement registration application form

Appendix B: Declaration of resident Canadian Agent

Appendix C: Efficacy and safety exemption lists

Appendix D: Example labels

• Granular Fertilizer-Pesticide - Main Panel
• Granular Fertilizer-Pesticide - Secondary Panel
• Granular Fertilizer-Pesticide with Micronutrients - Main Panel
• Granular Fertilizer-Pesticide with Micronutrients - Secondary Panel
• Liquid Fertilizer-Pesticide with a Chelated Micronutrient - Main Panel
• Liquid Fertilizer-Pesticide with a Chelated Micronutrient - Secondary Panel
• Granular Fertilizer-Pesticide with Slow Release Nitrogen - Main Panel
• Granular Fertilizer-Pesticide with Slow Release Nitrogen - Secondary Panel

Appendix E: Labelling checklist

Supporting Section A - Definitions

3.0 Registration Guide: Micronutrient Fertilizers

• 3.0.1 What is this Section of the Guide About and Who Needs to Read it?
• 3.0.2 What is a Micronutrient Fertilizer?
• 3.0.3 How are Micronutrient Fertilizers Regulated in Canada?

3.1 How do I Obtain a New Registration for My Product?

• 3.1.1 What do I need to Submit for Review?
• 3.1.2 What is Meant by Signing Authority and Why is it Needed?
  • 3.1.2.1 Corporations
  • 3.1.2.2 Partnerships and Sole Proprietorships
• 3.1.3 What is Meant by Resident Canadian Agent and Why is it Needed?

3.2 What is the Review Process Used by the Crop Inputs Division?

• 3.2.1 Pre-Screening
  • 3.2.1.1 Completeness Check
  • 3.2.1.2 First Response
• 3.2.2 Review Streams

3.3 How Do I Re-register My Product?

• 3.3.1 What do I Need to Submit for Review?

3.4 What if I Want to Change My Product and/or the Product Label?

• 3.4.1 What Do I Need to Submit for a Minor Amendment Review?
• 3.4.2 What do I Need to Submit for a Major Amendment Review?

3.5 Can My Registration Be Cancelled?

3.6 What are the Labelling Requirements for a Micronutrient Fertilizer?

• 3.6.1 General
• 3.6.2 The Main Panel of the Product Label
• 3.6.3 Addresses
• 3.6.4 Lettering, Coloring, and Pictures
• 3.6.5 Languages
• 3.6.6 Units of Measure
• 3.6.7 Net Weight
• 3.6.8 Brand Name
• 3.6.9 Product Name
• 3.6.10 Guaranteed Analysis
• 3.6.11 Registration Number
• 3.6.12 Directions for Use
• 3.6.13 Cautionary Statements
• 3.6.14 Ingredients List
• 3.6.15 Label Claims
• 3.6.16 Seller's Guarantee
• 3.6.17 Lot Numbers
• 3.6.18 Workplace Hazardous Material Information System (WHMIS)
• 3.6.19 Websites
• 3.6.20 Labelling of Seed Coated With a Micronutrient Fertilizer

3.7 What Standards Does My Micronutrient Fertilizer Need to Adhere to?

• 3.7.1 Efficacy
  • 3.7.1.1 Micronutrient Efficacy Data Exemptions
  • 3.7.1.2 Water-Solubility Analyses
  • 3.7.1.3 Efficacy Labelling
  • 3.7.1.4 Acceptable Minimum Number and Locations of Trials
  • 3.7.1.5 Measurable parameters
  • 3.7.1.6 Soil Analysis
• 3.7.2 Safety
  • 3.7.2.1 Metal Standards
  • 3.7.2.2 Contaminating Microorganisms
  • 3.7.2.3 Organic Contaminant Standards
  • 3.7.2.4 Safety Data Requirements
    • 3.7.2.4.1 Core Safety Data
    • 3.7.2.4.2 Core Safety Data and Results of Analysis
    • 3.7.2.4.3 Full Safety Data Package
• 3.7.3 Guarantee Tolerances

3.8 What are the Import Requirements for Micronutrient Fertilizers?

3.9 Contact Information

Appendix A: Fertilizer for Supplement Registration Application Form

Appendix B: Declaration of Resident Canadian Agent

Appendix C: Efficacy and Safety Exemption Lists

Appendix D: Example Labels

• Label No. 1
• Label No. 2 - Main Panel
• Label No. 2 - Secondary Panel
• Label No. 3
• Label No. 4

Appendix E: Labelling Checklist

Next Page: Supporting Section A - Definitions