T-4-133 – Requesting a change to the List of Primary Fertilizer and Supplement Materials

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1. Purpose

The purpose of this document is to outline the process for requesting a change such as an addition, deletion or amendment, to a material term and/or definition as listed in the List of Primary Fertilizer and Supplement Materials.

2. Background

The list of materials is a document that is incorporated by reference into the Fertilizers Regulations, which means it can be updated by the Canadian Food Inspection Agency (CFIA) from time to time. The list contains the "terms" and "definitions" (including compositional criteria) of primary fertilizer and supplement materials that are exempt from registration and may be imported or sold in Canada without the CFIA's prior approval.

The list of materials is defined in the Fertilizers Regulations as:

The document entitled Primary Fertilizer and Supplement Materials prepared by the Agency and published on its website, as amended from time to time.

Products composed of these materials must meet all the prescribed safety and labelling standards and, as any other product regulated under the Fertilizers Act, are subject to marketplace monitoring and compliance verification conducted by the CFIA. The List of Materials is reserved for primary fertilizer and supplement materials only. Final commercial products or proprietary formulations are not eligible for inclusion on the List of Materials.

3. Process overview

3.1 Complete the screening form

To initiate the change request process, complete the screening form and submit it to the CFIA's Pre-market Application Submissions Office using "List of materials" in the email subject line.

Screening form for the List of Primary Fertilizer and Supplement Materials (PDF 162 kb)

Form description

Requester information

  • Name of the requester:
  • Affiliation/company:
  • Email address:
  • Telephone number:
  • Date of submission (yyyy-mm-dd):

Change request

Fields that do not apply should be left empty. All changes are required in both official languages.

Addition
  • New term
    • English:
    • French:
  • New definition
    • English:
    • French:
Deletion
  • Term to be deleted
    • English:
    • French:
  • Definition to be deleted
    • English:
    • French:
Amendments
  • Current term
    • English:
    • French:
  • Proposed changes to the current term. If no change is proposed, please indicate "no change proposed".
    • English:
    • French:
  • Current definition
    • English:
    • French:
  • Proposed changes to the current definition. If no change is proposed, please indicate "no change proposed".
    • English:
    • French:
  • Rationale for the proposed change:

To be completed by the CFIA

Material category
  • Category 1: Low risk, negligible safety concerns.
  • Category 2: Heterogeneous substances of unknown or variable composition, complex reaction products or extracts and materials containing viable microorganisms.
  • Category 3: Hazard and exposure potential present. Comprehensive risk assessment required.
Material exemption status
  • Exempt as a:
  • Not Exempt as a:
Decision

Eligible for addition in the List of Primary Fertilizer and Supplement Materials.

  • Yes
  • No

Reviewed by:
Name:
Position:
Signature:
Date:
Others consulted (if applicable):

3.2 Eligibility assessment

Once the CFIA receives the form, we will:

  • assess the eligibility of the request within 30 business days, and
  • provide you with a decision (eligible/ineligible for consideration) using the email address indicated in the "Requester information" section of the form

3.3 Submit the change request form

If your request is determined to be eligible, complete the change request form and send it to Pre-market Application Submissions Office using "List of materials" in the email subject line.

Change request form for the List of Primary Fertilizer and Supplement Materials (PDF 463 kb)

Form description

Section I – Applicant and change request details

Requester information
  • Name of the requester:
  • Affiliation/company:
  • Email address:
  • Telephone number:
  • Date of submission (yyyy-mm-dd):
Change request

Fields that do not apply should be left empty. All changes are required in both official languages.

Addition
  • New term
    • English:
    • French:
  • New definition
    • English:
    • French:
  • Rationale for the proposed change:
  • List of stakeholder groups that could be affected by/benefit from the change:
  • Potential impact on consumers, trade, regulated parties, and regulators:
Deletion
  • Term to be deleted
    • English:
    • French:
  • Definition to be deleted
    • English:
    • French:
  • Rationale for the proposed change:
  • List of stakeholder groups that could be affected by/benefit from the change:
  • Potential impact on consumers, trade, regulated parties, and regulators:
Amendments
  • Current term
    • English:
    • French:
  • Proposed changes to the current term. If no change is proposed, please indicate "no change proposed".
    • English:
    • French:
  • Current definition
    • English:
    • French:
  • Proposed changes to the current definition. If no change is proposed, please indicate "no change proposed".
    • English:
    • French:
  • Rationale for the proposed change:
  • List of stakeholder groups that could be affected by/benefit from the change:
  • Potential impact on consumers, trade, regulated parties, and regulators:

Section II – Information required for application prioritization

Champion information

A champion is an individual willing to support the material through the prioritization process.

  • Name of the champion:
  • Email address:
  • Telephone number:
Agronomic value

Agronomic value claims for a material must be supported by research data or peer-reviewed literature. All supporting documentation must be attached to this submission.

  • Describe the impacts of the material (direct or indirect) in terms of improving crop yield and quality, plant growth and development and/or benefits to soil health or fertility.
  • List all supporting documentation attached to your request (for example, AV-1 and AV-2), and provide a brief description of each.
    • Wherever possible, indicate whether data provided is peer-reviewed, whether trials have been conducted and specify who the data was generated by.
    • Specify if supporting data is available from other jurisdictions.
Sustainability value

Sustainability value claims for a material must be supported by research data or peer-reviewed literature. All supporting documentation must be attached to this submission.

  • Describe how the material supports / aligns with the development and application of fertilizers and supplements that benefit current and future generations without harmful impacts to humans or ecosystems.
  • Criteria taken into consideration for sustainability value are:
    • Equity and justice, with materials designed with engagement from potentially impacted communities to help avoid negative social impacts
    • Transparency, with health, safety, and environmental data disclosed and easier to access
    • Avoiding negative impacts on climate, biodiversity, and ecosystems by using renewable and non- toxic chemical building blocks and
    • Circularity, with materials designed to have a lifespan appropriate to their use that also enables safe reuse and non-toxic recycling
  • List all supporting documentation attached to your request (for example, SV-1 and SV-2), and provide a brief description of each.
    • Wherever possible please indicate whether data provided is peer-reviewed, whether trials have been conducted and specify who the data was generated by.
    • Specify if supporting data is available from other jurisdictions.
Market value

Market value claims for a material may be approximated via research or data, can be determined by letters of support, number of companies with the material registered and/or comparison of regulatory requirements in other countries (competitiveness). All supporting documentation must be attached to this submission.

  • Describe the market value of this material. Criteria taken into consideration for market value are:
    • market size in North America
    • market trends (historical vs potential market value)
    • number of proponents or companies interested in the material and
    • competitiveness with other jurisdictions
  • List all supporting documentation attached to your request (for example, MV-1, MV-2, etc.), and provide a brief description of each.

Section III – Safety rationale and data

Material description
  • Name of the material and Chemical Abstracts Service Registry Number (CAS/RN), if available and applicable:
  • Describe the source of the material (for example: chemical synthesis, harvested, fermentation), and include:
    • inputs
    • contaminants
    • residuals
    • reaction by-products, and
    • degradation products and their associated Chemical Abstracts Service Registry Number, if available
  • Describe the physical and chemical properties (for example: granular, liquid, pH)
Safety data and rationale

Consult the hazard assessment template (appendix 1) when filling out this section.

Safety data may not be available for all endpoints listed in the hazard assessment template. Provide as much data as possible.

The safety assessment for a new addition will assess all possible fertilizing or supplemental uses of the material. If the safety of the material cannot be substantiated, the request may be declined or additional data will be requested prior to approval of the material.

The safety rationale must be supported by research data or peer-reviewed literature. All supporting documentation must be attached to this submission.

  • Address potential:
    • human health hazards including (but not limited to) applicator, bystander, and food
    • ecological hazards including (but not limited to) aquatic, terrestrial, avian, soil, and plant
    • persistence and bioaccumulation of the ingredient including endpoints such as biodegradation, environmental half-life (soil, water, air), bioaccumulation factor, and bioconcentration factor
    • impacts on non-target organisms including (but not limited to) soil organisms, wildlife, birds, other plant species.
  • Risk assessments/information available from other jurisdictions
  • List all supporting documentation attached to your request (for example, SR-1 and SR-2), and provide a brief description of each.
    • Wherever possible please indicate whether data provided is peer-reviewed, whether trials have been conducted and specify who the data was generated by.
    • Specify if supporting data is available from other jurisdictions.
When the material is not a pure substance (no distinct CAS/RN number)

If the material is not a pure substance that is identified with a distinct CAS/RN number, you must also:

  • identify of any chemical contaminants and biological/microorganisms in the raw inputs used to produce the current/proposed material
  • characterize any microorganisms (in the case of microbial material), including:
    • taxonomic identification of the microorganism to the genus and species level; subspecies, and strain information may also be required depending on the nature of the microorganism)
    • relationship to known pathogens (for example phylogenetic trees)
    • origin of the microorganism (when, where and from which material it was isolated) if it is an environmental isolate; or the strain bank accession number and culture certificate if the strain has been deposited in a recognized culture collection, for example American Type Culture Collection (ATCC) or other
  • if any chemical contaminants and biologicals/microorganisms remain following manufacturing/treatment, determine the levels in soil based on maximum agronomically relevant application rates
  • compare soil concentrations of chemical or biological contaminants against existing standards

Section IV – Agronomic relevance

Describe the:

  • international alignment (where applicable)
  • consistency with well-established history of use and application patterns
  • exposure scenarios relevant to the material and its use. Consider all potential fertilizing or supplemental uses for the ingredient including maximum agronomically relevant application rates with various application methods (soil, foliar, aerial, backpack sprayer, and more)

Section V – To be filled by CFIA staff

  • Executive summary:
  • Conclusion:
  • References:

Appendix 1: Hazard assessment template

This section is to be used as a hazard assessment guide and template for additions to the list of materials.

  • Providing sufficient hazard data to substantiate the safety of the materials is required
  • Providing all listed endpoints may not be possible for the specific material and is not required.
  • When specific organism endpoints are not available, similar organisms can be used in their place.

This section includes a pre-screening framework which categorizes the material based off persistence & bioaccumulation, hazard, and exposure potential.

Change request summary
  • Proposed term
    • English:
    • French:
  • Proposed definition
    • English:
    • French:
  • Synonyms:
  • Structure:
  • Formula (including molecular weight in g/mol):
Physical, chemical and environmental properties
Modeling inputs
Exposure model inputs Unit Value Comments and references
Chemical class (Organic/Inorganic)
Organic carbon partitioning coefficient – Koc (mL/g)
Log octanol-water partitioning coefficient – Log Kow (unitless)
Henry's law constant at 25°C – H (unitless)
Henry's law constant at 25°C – H (atm-m3/mol)
Water solubility at 25°C (mg/L)
Diffusivity in air (cm2/s)
Diffusivity in water (cm2/s)
Vapour pressure at 25°C (atm)
Biodegradation adjustment factor (unitless)
Half-life – Unsaturated zone (days)
Half-life – Saturated zone (days)
Half-life (years)
Screening criteria
Criteria Screening criteria Value Comments and references
Persistence: Air ≥ 2 days
Persistence: Water ≥ 6 months
Persistence: Sediment ≥ 1 year
Bio-accumulation factor (BAF) >5000
Bio-concentration factor (BCF) >5000 or Log KOW > 5
Human: Oral exposure
Term/effect Screening criteria Value Comments and references
Acute LD50 ≤ 500 mg/kg bw
Sub-chronic LO(A)EL ≤ 90 mg/kg bw
and
NO(A)EL ≤ 30 mg/kg bw
Chronic LO(A)EL ≤ 30 mg/kg bw
and
NO(A)EL≤ 10 mg/kg bw
Developmental LO(A)EL ≤ 270 mg/kg bw
and
NO(A)EL ≤ 90 mg/kg bw
Reproductive LO(A)EL ≤ 30 mg/kg bw
and
NO(A)EL ≤ 10 mg/kg bw
Reference LO(A)EL ≤ 90 mg/kg bw
Human: Dermal exposure
Term/effect Screening criteria Value Comments and references
Acute LD50 ≤ 500 mg/kg bw
Sub-chronic LO(A)EL ≤ 90 mg/kg bw
and
NO(A)EL ≤ 30 mg/kg bw
Chronic LO(A)EL ≤ 30 mg/kg bw
and
NO(A)EL ≤ 10 mg/kg bw
Developmental LO(A)EL ≤ 270 mg/kg bw
and
NO(A)EL ≤ 90 mg/kg bw
Reproductive LO(A)EL ≤ 30 mg/kg bw
and
NO(A)EL ≤ 10 mg/kg bw
Reference n/a
Human: Inhalation exposure
Term/effect Screening criteria Value Comments and references
Acute LD50 ≤ 1500 mg/m3
Sub-chronic LO(A)EL ≤ 270 mg/m3
and
NO(A)EL ≤ 90 mg/m3
Chronic LO(A)EL ≤ 90 mg/m3
and
NO(A)EL ≤ 30 mg/m3
Developmental LO(A)EL ≤ 810 mg/m3
and
NO(A)EL ≤ 270 mg/m3
Reproductive LO(A)EL ≤ 90 mg/m3
and
NO(A)EL ≤ 30 mg/m3
Reference LO(A)EL ≤ 0.4mg/m3
Human: Carcinogenicity
Screening criteria Value Comments and references
Weight of evidence:
Group C/Class 3 or greater
Human: Genotoxicity
Screening criteria Value Comments and references
Weight of evidence:
Group C/Class 3 or greater
Human: Other
Screening criteria Value Comments and references
Terrestrial
Organism Screening criteria Compound value Comments and references
Mallard duck (Anas platyrhynchos)

Acute – LD50
>2000 mg/kg practically non-toxic
501 – 2000 mg/kg slightly toxic
51 – 500 mg/kg moderately toxic
10 – 50 mg/kg highly toxic
< 10 mg/kg very highly toxic

Sub-Chronic – LD50
>5000 mg/kg practically non-toxic
1001 – 5000 mg/kg slightly toxic
501 – 1000 mg/kg moderately toxic
50 – 500 mg/kg highly toxic
< 50 mg/kg very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Bobwhite quail (Colinus virginianus)

Acute – LD50
>2000 mg/kg practically non-toxic
501 – 2000 mg/kg slightly toxic
51 – 500 mg/kg moderately toxic
10 – 50 mg/kg highly toxic
< 10 mg/kg very highly toxic

Sub-Chronic – LD50
>5000 mg/kg practically non-toxic
1001 – 5000 mg/kg slightly toxic
501 – 1000 mg/kg moderately toxic
50 – 500 mg/kg highly toxic
< 50 mg/kg very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Rat (Rattus)

Acute – LD50
>2000 mg/kg practically non-toxic
501 – 2000 mg/kg slightly toxic
51 – 500 mg/kg moderately toxic
10 – 50 mg/kg highly toxic
< 10 mg/kg very highly toxic

Sub-Chronic – LD50
>5000 mg/kg practically non-toxic
1001 – 5000 mg/kg slightly toxic
501 – 1000 mg/kg moderately toxic
50 – 500 mg/kg highly toxic
< 50 mg/kg very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Mouse (Mus)

Acute – LD50
>2000 mg/kg practically non-toxic
501 – 2000 mg/kg slightly toxic
51 – 500 mg/kg moderately toxic
10 – 50 mg/kg highly toxic
< 10 mg/kg very highly toxic

Sub-Chronic – LD50
>5000 mg/kg practically non-toxic
1001 – 5000 mg/kg slightly toxic
501 – 1000 mg/kg moderately toxic
50 – 500 mg/kg highly toxic
< 50 mg/kg very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Organisms
Organism Screening criteria Compound value Comments and references
Honey bee (Apis) <2 µg/bee highly toxic
2-11 µg/bee moderately toxic
>11 µg/bee practically non-toxic
Earthworm (Eisenia foetida) Lowest EC50, NO(A)EL or
LO(A)EL
Plants
Organism Screening criteria Compound value Comments and references
Lettuce (Latuca sativa):
Germination and elongation		 Lowest EC50, NO(A)EL or
LO(A)EL
Green beans Seedling emergence (14-21 days)
and
Vegetative Vigor: EC25 and NO(A)EC:
emergence, height, dry weight, visual phytotoxicity
Spinach Seedling emergence (14-21 days)
and
Vegetative Vigor: EC25 and NO(A)EC:
emergence, height, dry weight, visual phytotoxicity
Radishes Seedling emergence (14-21 days)
and
Vegetative Vigor: EC25 and NO(A)EC:
emergence, height, dry weight, visual phytotoxicity
Corn, soybeans, root crop, tomato, cucumber, lettuce,
cabbage, oat, ryegrass, onion		 Seedling emergence (14-21 days)
and
Vegetative Vigor: EC25 and NO(A)EC:
emergence, height, dry weight, visual phytotoxicity
Endangered EC25 and NO(A)EC:
emergence, height, dry weight, visual phytotoxicity
Aquatic
Organism Screening criteria Compound value Comments and references
Rainbow trout (Oncorhynchus mykiss)

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Brook trout (Salvelinaus fontinalis)

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Fathead minnow (Pimephales promelas)

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Daphnids (Daphnia sp.)
(Ceri daphnia dubia)

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Green algae (Selenastrum capricornutum)

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Freshwater sediment
Organism Screening criteria Compound value Comments and References
Amphipod (Hyallela azteca) Chronic
Lowest NO(A)EL or LO(A)EL
Midge larvae (Chironomus tentans)
(Chironomus riparius)		 Chronic
Lowest NO(A)EL or LO(A)EL
Marine/Estuarine
Organism Screening criteria Compound value Comments and References
Bivale mollusks

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Silverside (Menidia beryllina)

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Sheepshead minnow (Cyprinodon variegates)

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Mysid (Mysidopsis bahia)

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Algae (Champia parvula)

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Sea urchin (Arbacia punctulata)

Acute
Lowest EC50 or LC50
>10 to 100 ppm slightly toxic
>1 to 10 ppm moderately toxic
0.1 to 1.0 ppm highly toxic
< 0.1 ppm very highly toxic

Chronic
Lowest NO(A)EL or LO(A)EL
Microbial
Organism Screening criteria Value Comments and references

Other

  • Hazard or safety concerns (for example, indirect toxicity, promotes pathogen growth and more):
  • Potential contaminants:
  • Exposure scenarios and use patterns:
  • Comments:

Safety pre-screening framework

Category result
  • Persistence and bioaccumulation
    • Yes
    • No
  • Hazard
    • Yes
    • No
  • Exposure potential
    • Yes
    • No

Categorization criteria

Identify the category that applies to the material

Applicable Category Category Persistence and bioaccumulation Hazard Exposure potential Action required
1 Yes / No No No None
1 Yes / No Yes No None
1 Yes / No No Yes None
2 UVCB / Uncertain UVCB / Uncertain UVCB / Uncertain Further investigation to determine if risk assessment required
3 Yes / No Yes Yes In-depth risk assessment required
3 Yes / No Carcinogenicity / Genotoxicity Yes / No In-depth risk assessment required

3.4 How your request will be reviewed

The CFIA shares all change request forms with the List of Material Steering Committee. The committee periodically assesses the information in Section II of the applications to assign a priority score for each change request. The prioritization score determines when the CFIA will begin its review but does not otherwise affect the safety assessment that the CFIA will conduct on the material.

The prioritization criteria were designed and tested by the committee. They consider:

  • the availability of a champion
  • the expected complexity of the safety review (time required to review)
  • the material's existing exemption from registration status (due to other exemptions within the Regulations)
  • agronomic value
  • sustainability value
  • market value, and
  • the quality of supporting research and data that are included in the application package

Importantly, the information submitted to support a change request is not treated as Confidential Business Information. Applications should be based on publicly available literature and scientific data. Confidential data collected or developed by the applicant may be used in support of an application, but in submitting that information, the applicant waives confidentiality and agrees to the information being made public. Once submitted, any data provided in support of the application may be shared or distributed by the CFIA, or the List of Materials Steering Committee, to other interested parties without written consent from the change proponent.

The List of Materials will be updated periodically to incorporate successful change requests. The resulting exemptions from pre-market registration will be available to all materials that meet the new designated terms and definitions (including the associated compositional criteria) and may be used by any party interested in marketing a product containing the materials.

4. Timelines

There are no service delivery standards associated with the review of change requests. When a screening form is submitted, the CFIA provides a decision of eligible/ineligible for consideration within 30 business days of receipt of the request.

The timelines for assessment of the full application depend on prioritization and nature of the request. At any stage, if deficiencies or data gaps are identified, the CFIA will contact the requester to address the deficiency. It is important that requesters respond quickly and comprehensively to prevent delays.

5. Fees

There are currently no fees in the CFIA fees notice applicable to this service, and so the List of Materials Change Request process is provided free of charge.

6. Contact information

Fertilizer Safety Section
Canadian Food Inspection Agency
Email: cfia.paso-bpdpm.acia@inspection.gc.ca

Date modified: