Submission Preparation Training - Guide to Submitting Applications for Registration under the Fertilizers Act

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Purpose

This training session will lead you through the steps required to complete a well-organized and complete submission package for registration of a fertilizer or supplement under the Fertilizers Act.

At the end of this session, you will be able to use this information as a checklist to assist you in preparing your submission.

1. Fertilizer Program Mandate

Regulated Products

Fertilizers and Supplements sold or imported into Canada are regulated under the authority of the federal Fertilizers Act administered by the Canadian Food Inspection Agency (CFIA).

Fertilizer:

any substance or mixture of substances containing nitrogen, phosphorus, potassium or other essential plant food, manufactured, sold or represented for use as a plant nutrient.

Supplement:

any substance or mixture of substances, other than a fertilizer, that is manufactured, sold or represented for use in the improvement of the physical condition of soils or to aid plant growth or crop yields.

Examples of Fertilizers and Supplements:

  • N, P, K fertilizers
  • Micronutrients
  • Lawn and garden products
  • Fertilizer-Pesticides
  • Chemical supplements
  • Microbial supplements
  • Composts
  • Waste-derived materials including biosolids

Program Objectives

To ensure that all regulated products imported into or sold in Canada are:

  1. Safe with respect to human, plant, animal health and the environment;
  2. Properly labelled to promote safe use.

NOTE: The CFIA no longer regulates product efficacy or quality - as such, performance claims and nutrient guarantees are not verified

Regulatory Landscape

  • Canadian Food Inspection Agency Act
  • Fertilizers Act and Regulations
  • Health of Animals Regulations (for Enhanced Feed Ban)
  • Canadian Environmental Protection Act (CEPA 99) Sch. II and IV
  • Pest Control Products Act

Key Program Activities

  1. Health and Safety

    Fertilizer Risk pathways:

    • Direct: Worker, handler, applicator, bystander
    • Indirect: Feed, grazing land; Food crop production (adsorption and absorption, plant uptake); Environment (soil, ground water, waterways)
  2. Market Access
    • Domestic: Registration and marketplace monitoring
    • Import Control: Registration requirements and import inspections
    • Exports: Authority to issue export certification was obtained through Agricultural Growth Act (Feb 2015) - This program is not in place yet.
  3. Consumer Protection
    • Label reviews: Adequate safety information including precautionary statements to protect the consumer.
    • Guaranteed analysis: Determines safe and sustainable product application (rate, frequency, target crop)
    • Product inspection: Marketplace monitoring of regulated products - label reviews, verification of registration, and sampling/testing for contaminants
  4. Other Activities
    • International Standard setting
    • Stakeholder engagement
    • OGD and FPT cooperation
    • Regulatory research and oversight

2. File Types

Research Authorizations (RA):

Purpose: Required prior to the environmental release of all novel supplements. RAs ensure the safe release of the supplement, prescribe confinement conditions, protective equipment, and crop disposal methods.

RS
Novel supplements that have not been previously assessed, are GM, or may present a risk/unknown to human health or the environment
RN
Poses negligible risk to plant, animal, human health and the environment, and non-genetically modified (GM)
RE
Renewals of past authorizations
RW
Request for waiver (confined trials i.e. growth chamber, greenhouse)

Applications for Registration:

Purpose: Required for some fertilizers and supplements prior to importation or sale.

New Registration: NR No Data & NR Data

Re-Registration: RR No Data & RR Data

Me-Too: NR-Me-Too

Amendments: MA (minor) & AM (major)

minor: name/address of registrant/manufacturer; product name/brand; colour/format of label

major: any other change

Example: Registration Number: 2015020A Fertilizers Act

A: Supplement; B: Micronutrient; C: Fertilizer -Pesticide; D: Farm Fertilizer

3. What Requires Registration

Fertilizers - Single Ingredients

This is an image to determine what single ingredients require registration. Description follows.
Description of flowchart – Registration requirements for single ingredient fertilizers

The flowchart shows when single ingredients require registration:

  • If the single ingredient is not in Schedule II and it is for farm use it must be registered.
  • If the single ingredient is not in Schedule II and it is for specialty use it is exempt.
  • If the single ingredient is in Schedule II it is exempt.

Fertilizers - Combination of Ingredients

This is an image to determine what combination of ingredients require registration. Description follows.
Description of flowchart – Registration requirements for combination ingredient fertilizers

The table below outlines when combination ingredients must be registered as shown in the flowchart image above

Ingredients Use Formula Nutrients Register or Exempt
Only N,P,or K;
Only Ca,Mg,or S;
NPK+Ca,Mg,S,B,Cl,Cu,Fe,Mn,Mn,Zn
Farm Use Not Customer formula Nutrients in Mineral form Exempt
Only N,P,or K;
Only Ca,Mg,or S;
NPK+Ca,Mg,S,B,Cl,Cu,Fe,Mn,Mn,Zn
Farm Use Not Customer formula Nutrients in non-mineral form Register
Only N,P,or K;
Only Ca,Mg,or S;
NPK+Ca,Mg,S,B,Cl,Cu,Fe,Mn,Mn,Zn
Farm Use Customer formula n/a Exempt
Only N,P,or K;
Only Ca,Mg,or S;
NPK+Ca,Mg,S,B,Cl,Cu,Fe,Mn,Mn,Zn
Specialty n/a n/a Exempt
Micronutrients n/a n/a n/a Register

Supplements

This is an image to determine what supplements require registration. Description follows.
Description of flowchart – Registration requirements for supplements

The flowchart shows when supplements require registration:

  • Schedule II, sold to adjust pH, and fibrous organic material are exempt.
  • Live organisms must be registered.
  • Seeds and potting soils that are treated with or contains a registered or exempt product are exempt.
  • Seeds and potting soils that are treated with or contains a product requiring registration but is not registered must be registered.

Fertilizer-Pesticides

This is an image to determine what fertilizer - pesticides require registration. Description follows.
Description of flowchart – Registration requirements for fertilizer-pesticides

The flowchart shows when fertilizer-pesticides require registration:

  • Customer Formula with registered pesticide is exempt.
  • Lawn and turf application is decoupled (disallowed).
  • Agricultural use must be registered.
  • Single ingredient with dual properties (corn gluten meal and ferrous sulphate) must be registered.

4. Information Requirements to Support Registration

Levels of safety assessment

Level I
products with well-established history of safe use and a negligible risk profile = core information only
Level II
products that may be contaminated with chemical or biological agents = core information + results of analysis
Level III
unknown or higher risk profile = core information + results of analysis + safety rationale and supplemental data

4.1 Administrative Forms and Fees (Level I, II and III)

This section outlines the five administrative requirements for an application for registration.

1. Include in the Cover Letter:

  • Type of submission (new, renewal, amendment)
  • Registration Levels (I, II, or III)
  • Reference to any applicable submission control number(s) or registration number(s)
  • Intended end-use of the product (e.g. agricultural, greenhouse, residential lawn, or indoor plant applications, further manufacturing etc.)

2. Application Form:

  • The application form is in Schedule III of the Fertilizers Regulations
  • Complete accurately and in its entirety.
  • Information on the application form must match the information on the label
  • The Fertilizer and Supplement Registration Application Form and the "Guidelines to Completing the Fertilizer or Supplement Registration Application Form" documents are available on the CFIA website.

3. Signing Authority:

To be authorized to sign an application form, you need to:

1) Provide a letter of patent or certificate of incorporation with a list of directors. The person who signs the form must be on the board of directors or on the certificate of incorporation.

If the person who will sign the registration form is not a member of the Board of Directors, then a letter is required from a member authorizing this person to sign on behalf of the company.

2) OR provide a letter signed by an individual with signing authority, identifying the persons authorized to sign the applications for registration.

A corporation may also appoint a person to be a delegated representative (may correspond with CFIA but may not sign the application form)

4. Resident Canadian Agent:

For applicants residing outside Canada, a resident Canadian Agent must be designated, by completing the form "Declaration of Resident Agent Form" found on the CFIA website.

  • The Canadian Agent must be a person,  not a company;
  • The Canadian Agent must be a permanent resident of Canada;
  • Any CFIA notice or correspondence may be sent to the Agent.

The declaration must be signed before a justice of the peace, etc.

Defined: any non-related person who is at or above the age of majority in the relevant province and who is of sound mind.

5. Registration Fees:

  • The registration fee must accompany the submission.
  • All fees, expect an application for registration and an application for re-registration, are subject to the Harmonized Sales Tax (13% HST).
  • The fee is payable to the "Receiver General for Canada".
  • We accept cheque, money order, or major credit card.
Registration Fees
Description Fee
New Registration $350
Renewal of Registration $250
Safety Data review $500
Minor Amendment $50
Amendment (other than minor) $350
Research review without safety assessment $250
Research review with safety assessment $500
Research program renewal $100

Submit required information either by email (ensure the word "fertilizer" is in the subject line) or by mail.

Pre-Market Application Submissions Office (PASO)
Canadian Food Inspection Agency

59 Camelot Drive
Ottawa, ON K1A 0Y9 Canada

Phone: 1-855-212-7695
Fax: 613-773-7115
Email: paso-bpdpm@inspection.gc.ca
Email: paso-bpdpm@canada.ca (January 2016)

4.2 Proposed Marketplace Label (Level I, II and III)

The following is required on product labels:

  • Name and address of manufacturer or registrant
  • Brand name (optional)
  • Name of fertilizer or supplement
  • Registration number
  • Guaranteed minimum analysis of active ingredients
  • Directions for use
  • Weight of fertilizer or supplement
  • Precautionary statements (MSDS)
  • Lot number
  • Expiry date, for supplements

Supplement Guaranteed Analysis:

  • Active ingredients expressed in percent (%);
  • Genus and species of active microorganism;
  • Minimum number of active viable cells per gram (i.e. cfu or spores /g).

Labeling requirements vary depending on the product type

4.3 Product Specification (Level I, II and III)

This section outlines four product description requirements necessary for product registration.

1. List of Ingredients

Identification, description, and purpose of all materials used in the production of the end-product, including:

  • Name and purpose of the material
  • Source of materials:
    • Manufacturer;
    • Country of Origin;
    • Origin of material (by-product of another process, mined, synthesized, harvested e.g. seaweed)
  • CAS #'s, if applicable
  • Concentration of materials in the final product
  • MSDS for ingredients and final product

For products that contain microorganisms:

Identification of the Microorganism

  • Purpose of the microbial strain
  • Relationship to known pathogens
  • Identification and taxonomic classification (genus, species, strain) with an analytical report substantiating the identification
  • Origin: when, where, environmental isolate or certificate from repository i.e. American Type Culture Collection (ATCC), Canadian Collection of Fungal Cultures (CCFC)

For products that contain GM microorganisms:

Additional Data includes:

  1. Flow diagram of the genetic modification
  2. Description of the gene product(s), function and properties
  3. Description of the metabolic pathways altered by the insertion
  4. Unintended effects on gene expression
  5. Stability of the inserted genetic material
  6. Horizontal gene transfer potential
  7. Procedures and tests to detect and quantify the modified microorganism

2. Method of Manufacture

  • Description of production/formulation/blending process
  • Description must specify each production step and associated conditions such as temperature, pressure, process time
  • Identify raw materials, and point of incorporation
  • Identify chemical reactions, and potential for reaction of by-products
  • A flow chart diagram

3. QA/QC Procedures

Provide Quality Assurance / Quality Control (QA/QC) procedures used during the manufacture of the product to ensure consistency in production, and purity of the final product. For example:

  • Indication of materials being tested (raw, intermediary or final product)
  • Testing frequency (per batch or unit time)
  • Monitoring manufacturing conditions (time, pressure, moisture content)
  • Point of sampling/monitoring during production
  • Substantiation of the conformance of raw materials to standards (with analysis or accreditation i.e. ISO)
  • Sensitivity of test methods; and identification of "pass" criteria

Purity of Inoculum

QA/QC used to monitor, identify, and purify the microorganism from the seed stock (primary inoculum); including company name/address that keeps the seed stock

QA/QC used to monitor the final inoculum (used as an ingredient in the final product)

QA/QC used to monitor the final product

4. Other Qualities

Physical characteristics of the final product (e.g. granular, liquid, particle size, colour and odour, density, melting point, boiling point, pH, solubility, size guide number etc.)

4.4 Results of analysis (Level II and III)

This section specifies the product-based results of analysis (RoA) that are required for product registration.

Results of Analysis (Level II and III)
Type Analysis
Metals:

Arsenic (As), Cadmium (Cd), Cobalt (Co), Copper (Cu), Chromium (Cr), Mercury (Hg), Molybdenum (Mo), Nickel (Ni), Lead (Pb), Selenium (Se), and Zinc (Zn).

The number of metals analyses corresponds to the total number of batches/lots of product manufactured within a three (3) year interval

Indicator Organisms:

Salmonella (must be absent / non-detectable).

Faecal coliform (levels must be below 1000 MPN per gram).

4 sets of analyses from 4 different lots/batches of the final product for Faecal coliforms and Salmonella.

Dioxins and Furans: 1 set of analysis for the seventeen (17) most toxic congeners
Products/Ingredients Requiring RoA
Fertilizer or Supplement Compliance Analysis
Micronutrients Metals
Biochar Metals, Dioxins and furans
Humic and fulvic acids Metals
Seaweed Metals, indicator organisms
Cement Kiln dust Metals, Dioxins and furans
Compost and meals Metals, indicator organisms
Processed sewage including composts Metals, indicator organisms, dioxins and furans thereof, pulp and paper sludge
Wood ash Metals, dioxins and furans
Microorganisms Indicator organisms

Not a comprehensive list and source dependent

Please note:

  1. Samples must be taken at intervals enabling assessment of the consistency in production (e.g. regular time intervals, upon receipt of raw materials, per lot/batch, every 2 weeks for continuous or semi-continuous batches)
  2. Indicate the number of batches produced annually and the manufacturing date of each batch analyzed.
  3. RoA to be printed on lab letterhead, bear signature of the analyst, indicate sample preparation methods, method of analysis, and limits of detection

4.5 Safety Rationale and Supplemental Data (Level III)

1. Hazard Assessment

Identification and characterization of potential adverse effects on human, animal and plant health, and the environment

2. Exposure Assessment

Predicts the extent and duration of the exposure

3. Risk Assessment and Mitigation Measures

The risk assessment is based on the hazard, and what is known about exposure Risk = Hazard x Exposure

A) Toxicological Risk Profile

Toxicological Hazard Characterization

The applicant is responsible to identify all potential hazards associated with each ingredient in the product, including:

  1. Human Health Hazards:

    Acute (oral, dermal, inhalation); Subchronic (oral); Irritation (ocular, dermal); carcinogenicity; reproductive and developmental toxicity; endocrine disruption

  2. Environmental Hazards:

    Aquatic hazard profile (toxicity to vertebrates, invertebrates, benthic organisms, and algae)

    To assist in this characterization, all fields in Appendix 4 (in the supporting Guide) must be completed for all ingredients. 

Toxicological Exposure Assessment

The applicant is responsible to provide the exposure assessment for all ingredients and potential contaminants. Factors to consider include:

  • Routes of exposure: direct (applicator/user) and indirect (bystander, groundwater, contaminated soil contact, and food/feed consumption)
  • Intended use patterns (e.g., agricultural field use vs potting mixes; ornamental plant species vs food crops)
  • Application rate and frequency of application
  • Protective measures, such as personal protective equipment, re-entry restrictions, and post-harvest intervals
  • Must consider worst case exposure scenarios/studies

All fields in Appendix 5 (in the supporting Guide) for all constituent materials for which a high hazard level has been identified (Appendix 4) must be completed.

Toxicological Risk Assessment

The applicant is responsible to provide estimates of risk by combining the hazard characterization with exposure assessment.

The risk estimates derived by the applicant are subject to review and validation by the Fertilizer Safety Section (FSS) and additional information/ test data may be required in order to refine the exposure and hazard assessments and/or further mitigative measures may be imposed to facilitate safe use of the product.

Risk = Hazard x Exposure

B) Microbial Risk Profile

Microbial Hazard Assessment

The applicant is responsible to identify all potential hazards associated with the microorganism, including:

  1. Human, Animal and Plant Health Hazards:
    • Toxin production potential
    • Pathogenicity profiles
    • Allergenicity / Sensitization potential
  2. Environmental Hazards:
    • Effects on target and non-target species
    • Resistance to adverse environmental conditions (e.g., cold tolerance)
    • Resistance to selectable traits (antibiotic, heavy metal resistance)
    • Invasiveness

To assist in this characterization, all fields in Appendix 6 (in the supporting Guide) must be completed.

Microbial Exposure Assessment

The applicant is responsible to provide the exposure assessment of the microorganism.  Factors to consider include:

  • Natural occurrence (e.g. geographical distribution, hosts)
  • Physiological properties (e.g. growth parameters - temp, pH)
  • Description of the life cycle, including potential for dispersal
  • Product use pattern, and expected routes of exposure (e.g. dermal, inhalation, ingestion)

To assist in the exposure assessment, applicants must complete all fields in Appendix 7 (in the supporting Guide).

Microbial Risk Assessment

The risk assessment conclusion is based on the hazard and exposure. The FSS will review and validate the risk estimates derived by the applicant and additional safety data may be required.

Considerations for classification of microbial hazard severity and exposure levels are summarized in Appendix 8 of the guide, for your information.

Where appropriate, any preventative risk mitigation measures may be required.

Example of a Precautionary Statement:

"This product may contain fungi and/or bacteria and may cause adverse effects in individuals who are allergic to certain microorganisms including moulds and otherwise immunocompromised  individuals. Avoid exposure through inhalation or open wounds and eyes. Wear standard protective clothing and equipment during product handling and storage. Use this product in well ventilated areas"

Surrogate Data

In cases where information or elements of it are not available for a given ingredient, information pertaining to a similar substance or microorganism may be submitted (surrogate data).

This requires a rationale demonstrating similarity between the substances of interest and its surrogate including all relevant characteristics (physical, chemical, or toxicological).

Surrogate data for microorganisms must be substantiated by a comparison of the organism under review and its surrogate with respect to pathogenicity, toxigenicity and its  behaviour in the environment (persistence, life cycle, invasiveness etc.)

List of Products Requiring a Safety Rationale and Supplemental Data (Level III assessment)

  • Polymeric soil stabilizers and wetting agents
  • Registerable supplement(s)
  • Nano-encapsulated fertilizers and nano-materials
  • Plant growth regulators (other than IBA)
  • Inoculant extenders sold with an inoculant
  • Viable microorganisms
  • Metabolites of organisms
  • Plant signalling compounds (e.g. LCOs, Hesperetin, Naringenin)

Note: this is not a comprehensive list

5. Submission Layout

This image represents the mandatory format for submitting an application for registration under the Fertilizers Act. Description follows.
Description of image – Submission Layout

This image represents the mandatory format for submitting an application for registration under the Fertilizers Act.

This image includes a structured list of tabs and sub-tabs to assist applicants in preparing well organized submissions. The entitled tabs and sub-tabs include:

  • Administrative Forms and Fees
    • Cover Letter
    • Application Form
    • Signing Authority
    • Fees
  • Marketplace Label
  • Product Specifications
    • List of ingredients
    • Manufacturing Process
    • Quality Assurance/Control
    • Product Qualities
  • Results of Analysis
  • Safety Rationale and Supplemental Data
    • Hazard Characterization
    • Risk Assessment
    • References/Data

Safety Assessment Level I: Complete Tabs 1-3
Safety Assessment Level II: Complete Tabs 1-4
Safety Assessment Level III: Complete Tabs 1-5

6. File Review Stages and Service Delivery Standards

Review Stages

This image represents the review stages your file may go through. Description follows.
Description of flowchart – Review Stages

This flowchart shows the review stages your file may go through.

The first step is pre-screen (PASO). After the pre-screen (PASO) there are two possible options:

  1. Close and refund; or
  2. First response and completeness Check

After the completeness check there are two possible options:

  1. Close; or
  2. Conduct a first review: (admin check; label review; safety assessment), second review (confirm and review requested info), and third review (confirm and review requested info)

After the third review the file will be registered or closed

Service Delivery Standards (T-4-122)
Type Pre-Screen ART 1st Review ART 2nd Review ART 3rd Review Total
Me-too 45 30 20 N/A 95
Minor Amendment 45 30 20 30 10 N/A 135
RR-no data 45 30 120 90 60 N/A 345
NR-no data 45 30 150 90 90 30 30 465
NR-data 45 30 200 90 90 30 45 530
RR-data 45 30 200 90 90 30 45 530
Major Amendment 45 30 200 90 90 30 45 530

ART: Applicant response time; Pre-screen includes first response; time is in working days

Note: NR-data could be issued within 245 days instead of 530 days, if there are no deficiencies

7. Do's and Don'ts of Submission Packages

Do's

  1. Familiarize yourself with the registration requirements PRIOR to submitting an application
  2. Structure your submission in accordance with the Tab format
  3. Make sure all documentation is in place and accurate (application form that matches the label, signing authority etc.)
  4. Use scientific literature or experimental data to support your safety rationales
  5. Use accredited laboratories to conduct the analysis
  6. List references used
  7. Respond to CFIA questions fully and within the specified time frame and provide as much detail as possible
  8. Consult and obtain advice from scientific professionals (e.g., toxicologists, microbiologists)

Don'ts

  1. Apply for registration before researching the regulatory requirements
  2. Submit documentation for registration piecemeal, in no particular order or structure
  3. Submit an application form that is partially filled out or does not align with information on the label
  4. Use anecdotal evidence; testimonials or personal experience (i.e. using it on my lawn) in support of your product safety
  5. Fail to conduct appropriate analysis or implement appropriate QA/QC procedures to substantiate consistency in production and purity of the final product
  6. Use poor quality input materials
  7. Respond to some but not all CFIA questions, provide partial answers with no detail and with a delay
  8. Attempt to address technical questions without having the expertise in house

8. Reference Materials

These are the references available for more information on the file submission process:

All reference material is available through the CFIA website: www.inspection.gc.ca

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