Guide to submitting applications for registration under the Fertilizers Act
2. Application structure and layout
2.1 Tab 1: Administrative forms and fees
This section outlines the core administrative requirements for an application for registration.
2.1.1 - Cover letter
The applicant is required to state the intent of the application, thereby ensuring proper classification. The following must be indicated in the cover letter:
- Application type (for example new registration, re-registration, major amendment, minor amendment)
- Safety Assessment level (for example I, II or III) required (this will be subject to validation by the CFIA and the categorization may change following the pre-screening stage of the application)
- Reference to submission control number of an inquiry (for example 12345IQ) and/or previously granted registration number(s) relevant to the current application, if applicable
- Intended end-use of the product (for example agriculture, greenhouse, turf, residential lawn, home - indoor, seed inoculation, blending)
The electronic application platform does not support an applicant uploading a cover letter, however, there are data fields to collect all of the information identified above as being required in a cover letter. Any other additional information that the applicant might typically include in a cover letter can be provided to the CFIA through a "notes" field that can be found at the end of the online application. This notes field is provided so that an applicant can identify pertinent information that was not already submitted in the standard application fields.
2.1.2 - Confirm product details (Fertilizer or Supplement Registration Application form)
All sections of the Fertilizer or Supplement Registration Application – PDF form form must be completely and accurately filled out. For electronic applications the form has been replaced by a series of fillable fields. In both cases, the information provided must exactly match the label (or label text) that is submitted with the application. For paper-based applications, proponents may reference sections of their application package if there is insufficient room on the application form itself. The CFIA reserves the right to refuse a Fertilizer or Supplement Registration Application if the information provided is deemed incomplete. For guidance related to information requested on this form/fillable paper-based applications, please refer to the Guidelines to Completing the Fertilizer or Supplement Registration Application Form.
2.1.3 - Signing Authority, Delegated Representatives and Canadian Agents
Before proceeding with the registration of a product, it is necessary to provide the CFIA with signing authority as outlined in: T-4-95 - Signing Authority, Delegated Representatives and Canadian Agents. Signing authority is the means of informing the CFIA who they can correspond with regarding the application and for paper-based applications, who may sign the Fertilizer or Supplement Registration Application Form. The CFIA will not divulge any information regarding the application or discuss its status with any person(s) who does not have a valid signing authority. A corporation may also appoint a person to be a delegated representative. A delegated representative may correspond with the CFIA on matters relating to product registration, re-registration or approval, but may not sign application forms on behalf of the corporation.
It is not mandatory that a registrant/applicant reside in Canada. However, for applicants residing outside of Canada, a Resident Canadian Agent must be identified by name and address by filling out the prompted name and address fields in MyCFIA or by filling out the form. The Canadian Agent must co-sign all paper-based registration applications (including any re-registrations, amendments, etc.) and may be sent any related notice or correspondence as appropriate. A Canadian Agent must be a person, not a company, and this person must be a permanent resident of Canada. An applicant may have more than 1 Canadian Agent on file. Identification as the Canadian Agent does not automatically mean the person has a signing authority on the file and a separate statement (selection of the person in the signing authority field for electronic applications) is required to authorize the CFIA to communicate with the individual regarding the file.
2.1.4 - Registration Fee
In order for the CFIA to process a file, a registration fee is to be paid as per Part 5 of the CFIA's Fees notice.
- Fees described in the CFIA's Fees notice apply to applications made under the Fertilizers Act to:
- amend a registration; or
- assess the safety of a product
- In cases when the applicant requests a safety assessment only (no registration) the registration fee is not charged and the safety assessment fee is payable when the request is submitted.
In order to ensure consistency in the collection of fees and predictability for regulated parties, the safety fee is applied to all Level II and Level III safety assessments as defined in this guide.
|Product type||Registration fees||Safety fees|
|Major amendment (AM)||Check||1|
|Minor amendment (MA)||Check|
|New registration (NR) Level I||Check|
|New registration (NR) Level II||Check||Check|
|New registration (NR) Level III||Check||Check|
|New registration (NR) me-too||Check|
1. Safety fees are charged for a re-registration application or a major amendment only in cases where substantive changes to the product formulation are made, thereby triggering a safety assessment, which will be determined by a CFIA evaluator at 1st response.
2.2 Tab 2: Proposed marketplace label
Every person who packages, or causes to be packaged, a fertilizer or supplement, or who imports a packaged fertilizer or supplement, must ensure that the package is labelled in accordance with the Fertilizers Regulations. A copy of the product label, or all of the text that is proposed to appear on the product label, must be submitted with the application for registration. The CFIA will accept text-only versions of product labels during the initial review stages, but will not register the product without reviewing and approving the final marketplace label.
All information required by the regulations must be printed conspicuously, legibly and indelibly in both English and French.
A product label must:
- not include any incorrect or misleading information or symbol that could reasonably be expected to mislead a purchaser with respect to the identity of the product as a fertilizer or supplement, its safety, composition or directions for use
- be consistent with all information provided to the CFIA during the registration process
- clearly define any acronyms used; and
- use metric units of measurement. Equivalent imperial units are permitted to appear in addition to the metric (conversion must be accurate)
No changes may be made to the label, chemical composition or ingredients in a product that would impact its identity as a fertilizer or supplement, its safety, or its use, unless the registration is first amended accordingly.
A package containing a fertilizer or a supplement must be labelled with the following:
2.2.1 Product identity and description
- The name and address of the manufacturer or registrant or, if a fertilizer or supplement is not registered under the Fertilizer Regulations, the name and address of the person who packaged or caused the fertilizer or supplement to be packaged
- The name of the fertilizer or supplement. The name of a fertilizer that contains any major plant nutrient must include the grade designation that is stated as a hyphenated numerical series (the numerals must represent guarantees expressed in per cent for total nitrogen, available phosphoric acid and soluble potash listed in that order). Note: a fertilizer that is intended for daily feeding and that is not intended for further dilution is not required to have its grade as part of its name
- If the fertilizer or supplement is registered, its registration number
- If the fertilizer or supplement product is exempt from registration because it appears on the List of Primary Fertilizer and Supplement Materials (List of Materials), the Term (name) for each component, as it appears on the List of Materials, and any other information that is sufficient to demonstrate that the fertilizer or supplement is exempt
- the weight of the fertilizer or supplement (volume is also permitted)
- the lot number of the fertilizer or supplement; and
- in the case of a supplement in which the active ingredient may deteriorate, the date beyond which the supplement is not intended for use
2.2.2 Guaranteed analysis
The guaranteed analysis of a fertilizer or supplement must include, if applicable:
- the minimum amount of total nitrogen, available phosphoric acid and soluble potash, expressed in per cent
- the minimum amount of each secondary nutrient (calcium, magnesium or sulphur), expressed in per cent on an elemental basis
- the actual amount of each micronutrient (boron, chlorine, copper, iron, manganese, molybdenum or zinc), expressed in per cent on an elemental basis
- in the case of an untreated phosphatic fertilizer, the minimum amount of total phosphoric acid and the minimum amount of available phosphoric acid, expressed in per cent
- active microorganisms (except in the case of consortia) must each be listed by genus and species (and strain if available) along with the following information:
- number of viable cells per gram, or
- for each microorganism that is not a viable cell, another descriptor of the concentration of that microorganism on a per gram basis
- for microbial consortia: a descriptor of the concentration of viable microorganisms on a per gram basis;
- for active ingredient(s) intended to neutralize acidity:
- the amount of calcium and magnesium, if any, expressed in per cent on an elemental basis
- its neutralizing value, expressed in per cent of the acid neutralizing capacity of calcium carbonate, and
- the range of particle sizes of solid materials
- where an active ingredient is an acidifying material intended to increase the hydrogen ion concentration of a growing medium: its acidifying value, expressed in per cent of the basic neutralizing capacity of hydrochloric acid.
Other active ingredients
- organic matter: the amount expressed in per cent and the moisture content expressed in per cent; and
- any other active ingredient expressed in per cent.
Note: If the active ingredient to be expressed in per cent, is present in a concentration of less than 0.001%, the guaranteed analysis may instead indicate its concentration, on a per gram basis, using another unit of measure.
2.2.3 Directions for use
For a fertilizer, the directions for use must include 1 of the following:
- complete recommendations, including the intended crop type, the rate, the frequency, and the timing of use or
- if the product is intended only for use in blended/formulated fertilizer, a statement such as "Only for Use in Blended Fertilizers" is included on the label or
- a statement indicating that the user should seek the advice of the county agricultural representative or a professional agricultural consultant
- Additionally, for all products that contain micronutrients intended to treat a specific nutrient deficiency, a statement must also appear on the label indicating that the product should be used on the basis of a soil and/or tissue analysis.
For a supplement, the complete directions for use are to appear on the product label and include: the intended plant/crop type, the rate, the frequency of application, and the timing of use. If applicable, dilution instructions
2.2.4 Precautionary statements
A statement setting out any precaution that is necessary to mitigate a risk of harm to human, animal or plant health or the environment (except pests) may be required on the label/package of any regulated fertilizer or supplement product. Table 1 and 2 outline precautionary statements that are required when certain ingredients are present in a fertilizer or supplement product. In addition to the statements below, additional product-specific precautionary statements may be required on a case-by-case basis depending on the ingredients in the product, the product's risk profile and its intended use pattern.
The CFIA requires that any hazard or precautionary statements and personal protective equipment requirements that appear on the safety data sheet be incorporated into the product labels. If these are contained within the WHIMS (Workplace Hazardous Materials Information System) box/portion of the label, they need not be duplicated elsewhere on the label. Additional precautionary statements and/or protective equipment requirements may be requested by the CFIA even if they do not appear on the safety data sheet.
|Active ingredient||Precautionary statement requirement|
|viable microorganisms||label may require cautionary statements and/or recommend personal protective equipment, in order to minimize dermal/respiratory sensitization/irritation potential.|
|supplemental metal (such as cobalt)||"Caution: This fertilizer contains (specify name of the supplemental metal) and should be used only as recommended. It may prove harmful when misused."|
|Boron, copper, iron, manganese, molybdenum or zinc||"Caution: This fertilizer contains (specify name of lesser plant nutrient) and should be used only as recommended. It may prove harmful when misused."|
|Boron content greater than or equal to 0.3% of the final product||"May damage fertility or the unborn child".|
|Fertilizer or supplement "is or contains"||Precautionary statement requirement|
|Priority allergens: peanuts, tree nuts, sesame seeds, milk, eggs, fish, crustaceans and molluscs, soy, wheat and triticale, sulphites and mustard.||"Caution: This product contains (list all allergens). Adverse reactions may occur in sensitive persons. If skin contact occurs, wash with soap and water. Wear dust mask and protective gloves. If allergic reaction occurs, seek medical attention".|
|Prohibited material as defined in subsection 162(1) of the Health of Animals Regulations||statements indicating that:
2.3 Tab 3: Product specification
All ingredients in the product (both active and inert) and their sources must be identified and listed under this tab. In addition, a detailed description of the manufacturing process preferably in the form of a flow chart is required together with all relevant quality control/assurance procedures used to ensure consistency in production and purity of the final product. This information is the minimum necessary for CFIA to conduct a preliminary assessment of the product and determine if additional information is required. It is intended for CFIA evaluators only and it is considered and treated as Confidential Business Information (CBI). CBI shall not be divulged or released without explicit authorization (in writing) of the registrant. If the registrant has or anticipates any difficulties in obtaining this information (due to its proprietary nature) it may be submitted by the distributor or manufacturer directly to the CFIA.
2.3.1 - List of ingredients
220.127.116.11 - Input materials
For all materials used in the production of a registrable fertilizer or supplement, except microbial inocula described in section (18.104.22.168), the following information is required:
- Name of the material
- Chemical Abstracts Service number (CAS #, if available)
- Country of origin
- Source: for example . manufactured (for example dyes, chelators), harvested (for example seaweed, straw, yucca), mined (for example ores), by-product (for example baghouse/electrostatic dust, klinker, slag, electrolysis, ash), recycled organics Footnotes 1 (for example source separated organics, compost, biosolids, pulp and paper), synthesized (describe the chemical reaction and any residuals and reaction by-products)
- Manufacturing/purification processes of the ingredient, if applicable
- Concentration of the material in the final product
- Purpose of the material; and
- Safety data sheets which serve as basis for preliminary safety evaluation, identifying points (such as possible contaminants) which may need to be examined in greater detail. A safety data sheet should also provide a detailed explanation of precautions and protective measures. The Workplace Hazardous Materials Information System (WHMIS) provides criteria for developing a safety data sheet
Multiple sources of an ingredient may be identified at the time of product registration and used interchangeably during the manufacture of the product. Note: any changes to the ingredients, their sources or their supplier(s) or changes to the formulation after registration require a major amendment unless the CFIA first approves a submitted notification of source change.
22.214.171.124 – Microbial inocula
For products that contain naturally occurring viable microorganism(s) the following information is required:
- Purpose of the microbial strain in the supplement
- 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)
- Analytical results (including criteria and raw data) substantiating the taxonomic ID and classification
- 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
Strong and defensible taxonomic identification, preferably to the strain level, is important for the hazard characterization of the microorganism. The choice of methods for microbial identification is at the discretion of the applicant. However, the CFIA recommends that applicants adopt an integrated poly-phasic approach that includes phenotypic analysis (for example analysis of morphological traits or biochemical characteristics) along with molecular tools (for example DNA, RNA or protein based methods), to accurately identify the microorganism. The strengths and weaknesses of the various identification methods should be taken into consideration, such that the methods chosen complement each other to result in a conclusive and definitive identification of the microorganism, and allow for clear differentiation of the organism from any closely related pathogenic and/or toxigenic species and strains.
For a microbial consortium, defined as a complex community of microorganisms taken from a single natural environment whose composition is maintained without further manipulation, the following are required:
- f. A description of the source, which must be a single natural environment
- g. Processing details to support that composition is maintained without further manipulation
Where possible, identification of all individual species in a consortium should be provided. Where precise taxonomic designation is not possible, identification to the level of genus (and possibly family) can be used to describe the major constituents in a consortium. Where taxonomic groupings are identified, the consortium should be screened for hazardous species relevant to the product in question. Product-type and source-dependent indicators should be chosen by the proponent. For example, a product may be screened for species pathogenic to humans such as Salmonella sp., Listeria monocytogenes, Vibro sp., Campylobacter sp., Clostridia sp., Bacillus anthracis, Pseudomonas aeruginosa, Yersinia sp., Candida albicans, Aspergillus fumigatus, Faecal coliforms, Enterococci, Rotavirus, Norovirus and Ascaris lumbricoides. Please note that the Fertilizer Safety Section may request additional indicator screening at the time of review. Pathogenicity tests should be done on the final product formulation.
For additional information, please consult T-4-126 Identification and taxonomic classification of microorganism(s) represented for use as supplements under the Fertilizers Act.
For microorganisms modified by molecular biological techniques the following information is required:
- Flow diagram representing the genetic modification process including:
- the map of the construct inserted in the host
- location (chromosomal or plasmid)
- copy number
- cloning vector(s) used
- promoter sequences
- selectable marker genes including any antibiotic resistance genes
- Detailed description of the gene product(s), their properties and functions
- Description of the metabolic pathways altered by the insertion
- Unintended effects on gene expression (down-regulation or up-regulation of other genes)
- Stability of the inserted genetic material
- Horizontal gene transfer potential: capacity to transfer the genetic material between the organism and non-target species, the mechanisms of possible transfer (transformation, transduction or conjugation) and the elements involved (plasmids, bacteriophages, integrative conjugative elements, transposons, insertion sequences, integrons, gene cassettes and genomic islands)
- Procedures and tests to detect and quantify the modified microorganisms
- For endophytes, the potential presence of the microbe in the edible portion of the crop must be addressed
Substantiation of the purity of the inoculum is also required and includes:
- A description of the quality control parameters used to monitor, identity and purify the microorganism from the seed stock (primary inoculum), and the company name and address that keep the seed stock
- The manufacturing process and quality control parameters used to monitor the identity and purity of the final inoculum (used as an ingredient in the final product, generally mixed with inert ingredients); and
- Safety data sheet of the inoculum, if available
126.96.36.199 – Composition of the final product
The identity and relative proportions as weight/weight percentages (totalling 100%) must be provided for all ingredients present in the final product including all active and inert ingredients, contaminants, residuals, reaction by-products and degradation products.
The input materials may be the same as the final product constituents providing there are no chemical reaction(s) or metabolic by-products generated during the manufacture/storage of the final product prior to sale and no growth of new microorganism(s) is taking place.
Final product safety data sheet should be provided with the application, if available.
2.3.2 – Method of manufacture
A description of the manufacturing process of the final product accompanied by a flowchart used as an overview of the process to determine if there is any potential for secondary reactions, formation of by-products and/or microbial contamination. This description must specify each production step, including point of feedstock incorporation and its proportion by weight and associated conditions, such as temperature, pressure, time, and processing equipment.
2.3.3 – Quality assurance and quality control procedures
In order to substantiate consistency in production and safety of the final product, proponents are required to provide the following details relating to Quality Assurance (QA) and Quality Control (QC) procedures used during manufacture process:
- Substantiation of the conformance of raw materials to specifications and standards (with analysis or accreditation when applicable)
- Indication of material(s) being tested (for example raw, intermediary or final product)
- Specification of analyses and sensitivity of test methods (limits of detection and/or limits of quantification)
- Identification of "pass" criteria
- Testing frequency (for example per batch or unit time) and point of sampling during production
- Monitoring of manufacturing conditions (for example time, pressure, moisture content); and
- Fate of noncompliant batches/lots (for example reprocessing, disposal)
2.3.4 – Physical characteristics of the final product
For example: granular, liquid, pH, colour, odor, size guide number (SGN).
2.4 Tab 4: Results of analysis
The results of analysis required in support of a registration vary depending on product type and the source of ingredients. Examples of ingredient-specific results of analysis that are required to be included in an application are provided in Appendix 2. The safety standards and limits for trace metals, dioxins and furans and indicator organisms (Salmonella and Faecal Coliform) used by the CFIA to assess product safety and efficiency of treatment or processing are outlined in Appendix 3. The upper tolerances around guarantees for fertilizers represented to contain micronutrients are also outlined in Appendix 3.
Product samples must be taken at intervals enabling assessment of the consistency in production (for example at regular time intervals, upon receipt of raw materials, per lot/batch, etc.). Applicants are required to indicate the number of batches produced annually. All results of analyses submitted to the CFIA must be printed on laboratory letterhead, bear the signature of the analyst, indicate sample preparation method(s),the test method(s) used together with limits of Quantitation (LOQ) and/or limits of detection (LOD).The results of analysis must also identify the body that certified/accredited the laboratory. To facilitate file review, results of analysis are to be accompanied by a table with all of the following column headings, identifying for each analysis and sample:
- name of product and/or constituent material (in full, no abbreviations)
- laboratory sample identification number
- manufacturing/sampling date; and
- type of analysis (for example metals/micronutrients, dioxins and furans, indicator organisms)
2.4.1 – Metals
To demonstrate compliance with the trace metals standards, proponents are required to provide results of analyses for the following 11 metals of concern: As, Cd, Co, Cu, Cr, Hg, Mo, Ni, Pb, Se, and Zn. The number of metal analyses that are required at the time of new registration or re-registration, corresponds to the total number of batches/lots of product manufactured within a 5 year interval preceding the submission of an application for a new or re-registration. This is depicted in Table 4. Analyses provided must be reflective of the batches manufactured over the 5 year period. For example, if 5 analyses are required, it is recommended to submit 1 analysis from each calendar year. Products generated by continuous process require 6 sets of analysis evenly spread over the 5 year interval preceding submission.
Where results of requisite number of analyses are not available (for example because product is not yet being manufactured) please contact the Fertilizer Safety Section for guidance. These will be considered on a case-by-case basis.
|Number of batches/Lots produced within the 5 years preceding the application||Number of sample analyses required|
|2 to 4||2|
|5 to 9||3|
|10 to 16||4|
|17 to 25||5|
|26+ Schedule to be provided by stakeholder and approved by the CFIA||To be determined|
2.4.2 - Dioxins and furans
To demonstrate compliance with the CFIA Fertilizer Dioxin and Furan Standards, proponents must provide 1 set of TEQ dioxins and furans analyses (see Tables 6 and 7, Appendix 3). Note: Not all level II safety assessments require the submission of dioxin and furan analyses.
2.4.3 - Indicator organisms
Salmonella and Faecal coliforms are currently used by the CFIA as indicators of pathogen contamination and effectiveness of the treatment process. To demonstrate compliance with the CFIA requirements, proponents must provide 4 sets of result of analyses from 4 different lots/batches of the final product for Faecal coliform and Salmonella. Samples must be taken at intervals of at least 2 weeks for continuous or semi-continuous batches, or at intervals that correspond to the actual batch manufacture (see Table 8, Appendix 3).
2.4.4 – Upper tolerances for nutrient guarantees for fertilizers represented to contain micronutrients
To demonstrate compliance with the CFIA upper tolerances for fertilizers represented to contain micronutrients, proponents are required to provide results of analysis for guaranteed micronutrients (B, Cl, Cu, Fe, Mn, Mo, Zn) in addition to the results of analysis for the reportable metals (As, Cd, Cr, Co, Cu, Hg, Mo, Ni, Pb, Se, Zn). The analyses are required both at the time of registration and re-registration to ensure that the actual content of the nutrient in the product does not exceed the guarantee by an amount that is higher than the allowable tolerance (see Table 9, Appendix 3). The number of analyses required will be based on the number of batches produced as per the current policy - for details please refer to Table 4 above.
2.5 Tab 5: Safety rationale and supplemental data
Product safety assessments are conducted using the universal 4 step risk assessment framework that is also employed by other CFIA programs (for example plant, animal, food), sister government departments or Agencies (for example Health Canada, Environment Canada, Pesticide Regulatory Management Agency (PMRA)), and international counterparts (for example US Environmental Protection Agency (EPA)). The 4 steps of the framework consist of: hazard identification, dose-response assessment (hazard characterization), exposure assessment and risk characterization.
- Hazard identification is a determination of the adverse human health and environmental effects.
- Dose-response assessment is a quantification of the relationship between administered/received dose and biological response of an individual or population.
- Exposure assessment predicts the anticipated level of human and organism contact and/or uptake and environmental media concentrations that arise as a result of product use.
- Risk assessment is a deterministic or probabilistic estimate of the incidence of the adverse human and ecological effects on the basis of the hazard characterization and what is known about exposure; this is the basic risk assessment paradigm (Risk = hazard multiplied by exposure).
The safety endpoints detailed in this section are provided as guidance to substantiate the safety of a product with respect to human, plant, and animal health and the environment when the product is used as directed or applied in an amount that is not in excess of the amount that is necessary to achieve its intended purposes. Based on the assessment, additional information may be requested by the CFIA. The safety rationales and supplemental data are only required for level III full safety assessments and are determined based on the risk profile of the product. This Tab has been broken down into 3 sections: toxicological risk profile; microbial risk profile; and references and supplemental documentation. The CFIA strongly recommends that applicants seek assistance/advice from scientific professionals with expertise in human and environmental toxicology and/or microbiology to assist in preparing documentation required under this tab.
Where there are reasonable scientific grounds to believe that an information requirement identified in this tab is neither necessary, nor applicable to the safety assessment of a product/ingredient, a waiver from the information requirement or elements of it may be requested, and must be accompanied by a sound scientific rationale.
2.5.1 - Toxicological risk profile
188.8.131.52 - Toxicological hazard characterization
For products or ingredients that do not have a well-established history of safe use in fertilizers or supplements, the hazard characterization table in Appendix 4 must be populated. If elements identified in the table are either not applicable or relevant to an ingredient, please provide a literature-supported scientific rationale explaining this determination.
Toxicological hazard characterization may be based on information found in published peer-reviewed scientific literature, international regulatory databases, in vitro and in vivo toxicity testing/studies and/or, in the absence of experimental data, modelling. Information pertaining to a similar substance may be submitted (surrogate data). Using surrogate data requires a rationale demonstrating similarity between substances for all relevant characteristics (physical, chemical, or toxicological). Appendix 10 provides a list of useful information resources to aid in the hazard determination.
If other hazard endpoints (for example allergenicity), route-specific hazards (for example pulmonary carcinogenicity with chronic inhalation exposure) or species-specific hazards (for example avian toxicity) are known to the applicant, it is their responsibility to identify them. Additional information may be required by the CFIA depending on risks identified.
High hazard ingredients
An ingredient is considered high hazard if it meets 1 of more of the following criteria (Hazard criteria identified in Appendix 4):
- high acute toxicity (LD50 ≤ 500 mg/kg, ≤ 1 500 mg/m3)
- subchronic toxicity (NO(A)EL ≤ 30 mg/kg bw/d; LO(A)EL ≤ 90 mg/kg bw/d)
- or chronic toxicity (NO(A)EL ≤ 10 mg/kg bw/d; LO(A)EL ≤ 30 mg/kg bw/d)
- exhibits carcinogenicity, clastogenicity, mutagenicity, reproductive or developmental toxicity, teratogenicity or endocrine disruption (a positive result)
- or is of high acute aquatic toxicity (lowest EC50/LC50 < 0.1ppm)
If any of these criteria are met, a toxicological exposure and risk assessment must be conducted (as detailed in sub-tabs 184.108.40.206 and 220.127.116.11).
Ingredients that do not meet any of the hazard criteria
These ingredients do not require an exposure assessment or risk assessment and completion of sub-tab 18.104.22.168 and 22.214.171.124 is not mandatory.
126.96.36.199 - Toxicological exposure assessment
Applicants must populate all fields of the table found in Appendix 5 for all constituent materials (active and inert), residuals, contaminants and degradation products for which a high hazard level has been identified, as per the endpoint-specific Hazard Criteria found in Appendix 4. Both direct routes of exposure (occupational mixer, loader, applicator/user) and indirect routes of exposure (by-stander, groundwater, food or feed crop residue, contaminated soil contact and consumption) must be addressed. The choice of appropriate or relevant routes of exposure is based on the intended use pattern of the product (for example agricultural field use vs. potting mixes; ornamental plant species vs. food crops), frequency and rates of application as well as the physicochemical properties of the product and its constituents. These are important factors in determining human, animal, non-target plant and environmental exposure scenarios and must be identified in Appendix 5. Applicants must consider worst-case exposure scenarios. Label statements intended to limit exposures such as recommendations for protective equipment to be used, safe handling and disposal procedures, precautionary statements and use pattern restrictions (for example do not use on food crops or grazing lands) as well as post-entry intervals (if applicable) should be integrated in the estimates of human and environmental exposure. The CFIA considers the custom-applicator scenario as the worst-case frequency of occupational exposure.
188.8.131.52 - Toxicological risk assessment
Applicants must generate estimates of risk (to be populated in Appendix 5) by combining the hazard and exposure assessments for each high hazard ingredient under all relevant exposure scenarios characterized in sub–tab 184.108.40.206. The CFIA will review and validate the risk estimate(s) derived by the applicant. Additional information/test data may be required in order to refine the exposure and hazard assessments and/or require mitigation measures such as protective equipment to be used, safe handling and disposal procedures, precautionary statements, use pattern restrictions (for example food vs. non-food crop) and any post-entry intervals, if applicable to facilitate safe use of the product.
2.5.2 - Microbial risk profile
220.127.116.11 - Microbial hazard assessment
A hazard assessment characterizes the microorganism and identifies the potential adverse effects (for example, pathogenicity/toxicity, sensitization, toxigenicity and antimicrobial resistance priority status) towards humans, animals and plants, and the environment. The hazards may be posed by the microorganism itself, its metabolites/toxins or its genetic material.
Source of hazard information include test data, a review of case reports and analytical studies from scientific literature, and research investigations (completed or ongoing). Hazard information considered in the assessment may be for the specific microorganism being assessed, or a suitable surrogate, if there is insufficient information on the specific microorganism and the choice of surrogate is supported by a sound scientific rationale. Factors affecting the severity (degree) of hazard may be strain specific and therefore the assessment must address the factors known or suspected to be produced by the strain, as well as those known or suspected to be produced by other strains of the species (or genus). The severity of hazard may also be affected by the life stage of the organism. For this reason, all stages of the life cycle of the microorganism and their potential effects must be considered.
Ideally, test/study data are used to evaluate the potential adverse effects of the specific microorganism being assessed. Testing typically starts with a maximum hazard dose (maximum label dose/rate). If adverse effects are reported at this dose, a range of lesser doses may be used to establish a dose-response relationship, and ideally to identify an appropriate statistical endpoint, such as median infective, effective or lethal dose or concentration (ID50/IC50, ED50/EC50, LD50/LC50) (Environment Canada, EPS 1/RM/46, March 2005). Recommended methodology for testing the pathogenicity/toxicity of microorganisms on human, animals and plants are available in the "Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms" (Environment Canada, Report EPS 1/RM/44, March 2004). Appendix 11 describes the documents referenced in this section and additional useful information resources. A study report should be prepared for each study. The OECD's Principles of Good Laboratory Practice (GLP) include guidance on reporting study results (OECD; 1998a). The extent of compliance with OECD's Principles of Good Laboratory Practice should be indicated.
Appendix 6 highlights the data required for microbial hazard characterization. We recommend that the applicant uses Appendix 6 as a checklist to assist in providing all relevant information that is required. The information presented should be referenced, and a copy of each referenced publication/documentation or analytical/study report must be included in the application.
18.104.22.168 - Microbial exposure assessment
An exposure assessment identifies the mechanisms by which a microorganism is introduced into a receiving environment, considers its environmental expression and fate, and estimates the likelihood, magnitude, frequency, duration, and/or extent of human and environmental exposure. Exposure to the microorganism may be direct (for example, through contact with the product) or indirect. Indirect exposure assessment considers how the microorganism is released into the environment through known, proposed or predicted uses, and the environmental fate of the microorganism, its genetic material, toxins and metabolites.
Information considered in the exposure assessment may be for the specific microorganism being assessed, or a suitable surrogate, if there is insufficient information on the specific microorganism and the choice of surrogate is supported by a sound scientific rationale.
Appendix 7 highlights the factors that need to be addressed in order to characterize the exposure to the microorganism. We recommend that the applicant uses Appendix 7 as a checklist to assist in providing all relevant information that is required.
22.214.171.124 - Microbial risk assessment
The risk assessment conclusion is based on the hazard, and on what is known about the exposure. Considerations for classification of microbial hazard severity and exposure level are summarized in Appendix 8. Where appropriate, any preventative risk mitigation measures such as protective equipment to be used, safe handling and disposal procedures, precautionary statements and use pattern restrictions (for example do not use on food crops or grazing lands) as well as post-entry intervals maybe required to minimize worker and environmental exposures.
2.5.3 - References and supplemental documentation
All published information used to fulfill the requirements under Tab 5 must be cited in-text (author/source, year) and also provided in a list of references under this sub-tab. Each document must be properly referenced (authors, document name, source, date and page numbers).
Also, copies of all published information referenced under Tab 5 and analytical results used or mentioned in Tab 4 and Tab 5 must be provided under this sub-tab. All models or modelling software employed in support of the safety rationale must be cited in-text (model, version) and must also be provided in the list of references under this tab.
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