T-4-109 - Requirements for rhizobial inoculants and pre-inoculated seed under the Fertilizers Act

The Canadian Food Inspection Agency (CFIA) has introduced a streamlined registration process for fertilizers and supplements. Streamlined registration is reserved for products that have been deemed safe by the CFIA and have been shown to be effective based on foreign trial data or scientific literature.

October 2011

Introduction

1. Purpose

This document is intended to outline the safety, efficacy and labelling requirements specific to rhizobial inoculants and pre-inoculated seed under the Fertilizers Act and Regulations. Furthermore, these guidelines also provide direction as to conducting efficacy trials, generating laboratory data and describe the criteria and procedures for efficacy data evaluation.

2. Regulatory Authority

The Fertilizers Act and Regulations is the federal legislation governing the sale and importation of fertilizer and supplement products in Canada. Supplements are defined as; "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". Products containing viable microorganisms (such as rhizobia), if represented for the above uses, are considered supplements and are regulated by the Canadian Food Inspection Agency (CFIA) under the Fertilizers Act. The legislative authority of the Fertilizers Act governs the sale and importation of these products (including environmental release for experimental purposes), while their manufacture, proper use and safe disposal are controlled by provincial and municipal rules and regulations.

3. Prescribed Standards

Section 10.2 of Fertilizers Regulations contains specific standards for supplements consisting of rhizobia species (i.e. Rhizobium sp., Bradyrhizobium sp., Mesorhizobium sp. and Sinorhizobium sp.). Namely, products containing rhizobia represented for the seed treatment of legume crops (e.g. alfalfa, clover, birdsfoot trefoil, sainfoin, beans, peas and soybeans) must contain, per gram of product, a sufficient number of viable cells of the nodule-inducing species to deliver a specified number of viable cells per seed when used according to directions (Fertilizers Regulations, Section 10.2,(1)). These prescribed minima per seed vary between crop species depending on the seed size (see Table 1 below).

Table 1. Quality standards for inoculant supplements containing rhizobia (Fertilizers Regulations, Section 10.2.(1)).
Crop Seed Size No. of Seeds per kg Number of Viable Cells per Seed
Alfalfa, Clover, Birdsfoot Trefoil Small > 200,000 103
Sainfoin Medium 200,000 - 30,000 104
Beans, Peas, Soybeans Large < 30,000 105

In effect, rhizobial inoculants must not only meet the minimum number of viable cells as guaranteed on the label, but also contain enough cells so that when applied to seed at the recommended application rate, will meet or exceed the standards prescribed in Section 10.2(1) of the Fertilizers Regulations. By extension, pre-inoculated seeds of legume crops must also contain the prescribed minimum number of cells adhered to the seed as listed in the table above, in order to be in compliance (Fertilizers Regulations, Section 10.2.3).

For rhizobial inoculants intended to be applied in furrow for beans, peas, soybeans or seeds of similar size, the product must contain a sufficient number of viable cells per gram to deliver, at the recommended application rate, a minimum of 1011 viable cells per hectare (Fertilizers Regulations, Section 10.2.1.1).

Furthermore, rhizobia-containing supplements, as prescribed by the Regulations, must be applied at rates that do not interfere with the commonly used seeding rates for the given crop, and (including pre-inoculated seed) must not contain levels of contaminating microorganisms that would affect the viability or performance of the desired species (Fertilizers Regulations, Section 10.2.2(b) and 10.2.4(c)), or any other substance that would inhibit nodulation and nitrogen fixation of the active organism (Fertilizers Regulations, Section 10.2.4(b)).

Administrative Requirements

Administrative Requirements for a New Submission

  1. Cover Letter explaining the intent of the submission
  2. A copy of the proposed marketplace label
  3. A completed Fertilizer and Supplement Registration Application Form:
    • Registration submission type (Supplement box is checked)
    • Brand of product (if any)
    • Name of product
    • The number of viable cells of the active genus and, where known, the species, must be guaranteed as a minimum number per gram of product or per seed.
    • Complete name and address of manufacturer and registrant
    • "Which name will appear on label - registrant or manufacturer" box is checked
    • Original signatures
  4. Registration Fee:
    • New Registration ($350.00 + applicable HST)
    • Safety data review - if required ($500.00 + applicable HST)
    • Efficacy data review - if required ($250.00 + applicable HST)
    • The maximum fee payable for the consideration of an application = $1000.00 + applicable HST
  5. Designation of Signing Authority or written indication that signing authority is unchanged from previously provided information (Trade Memoranda T-4-95).
  6. Declaration of Canadian Agent Form (if residing outside of Canada) or written indication that Canadian Agent is unchanged from previously provided documentation.

Safety Requirements

Rhizobia are generally considered to be low hazard microorganisms with a well-established history of safe use. They are not known to be pathogenic to plants, animals or humans. Generally, rhizobia do not produce toxins, or by-products that are known to have negative effects on the environment or human health. Given optimum conditions for growth and survival, like most microorganisms, introduced rhizobia may establish themselves, proliferate, and persist in the environment. However, rhizobia are not known to be invasive, and do not pose a threat to biological diversity.

1. For Registration

A core safety data package is required for products that contain:

  1. Rhizobia (species of the genera Rhizobium, Bradyrhizobium, Mesorhizobium and Sinorhizobium), that are substantially equivalent/representative of the rhizobia group1; and
  2. are non-genetically modified; and
  3. are the only active microorganism in the product.

The core safety data package includes:

  1. Country of origin of the rhizobia
  2. Source(s) of the rhizobia (e.g., recognized culture collection, environmental/soil isolate)
  3. Microbial identification and taxonomic identification of the rhizobia
    • For rhizobial strains that are identical to those present in products already registered under the Fertilizers Act, and strains obtained from recognized culture collection - no additional information on the taxonomic identification of the organism is required. However, if the rhizobial strain is obtained from a culture collection, the accession number of the strain and its Certificate of Analysis must be provided.
    • For rhizobial isolated from a natural environment, taxonomic designation of the genus and species (and if possible strain) along with results of tests (morphological, biochemical or molecular) used to arrive at the taxonomic designation is required.
    • For further information on microbial identification, please refer to the guidance document entitled "Identification and taxonomic classification of microorganism(s) represented for use as supplements under the Fertilizers Act".
  4. A detailed description of the method of manufacture and blending process (if any)
  5. Quality assurance / Quality control (QA/QC) procedures to ensure consistency in production, purity of the final product and the absence of any potentially harmful contaminants in the final product
  6. Constituent Materials:
    1. Identification and description of all materials used in the production of the end product (include all media, carriers, adjuvants, formulants, dust control anticaking agents, etc.), with their associated Chemical Abstract Service Registry Number (CAS RN), if applicable;
    2. The source of all materials used;
    3. Proportion of all materials;
    4. Name of the distributor/supplier of all ingredients.
  7. Other product qualities, including physical characteristics (product formulation, e.g. granular, liquid)
  8. Material Safety Data Sheet (MSDS) for product and ingredients (if available)

If the above information is not directly available to the applicant, the manufacturer/distributor may submit it to the Fertilizer Section directly. This information will be protected as confidential business information and will not be shared with the applicant without the expressed consent of the manufacturer/distributor. Any changes to the ingredients, their sources or the supplier(s) may require a major amendment to the product registration.

1Certain species of Bradyrhizobium (for example, Bradyrhizobium elkanii) are reported to produce rhizobitoxine, which is phytotoxic to some legume species. Therefore, strains of Bradyrhizobium elkanii or other rhizobial strains that are known to produce phytotoxic levels of rhizobitoxine will require full safety data package as outlined below.

A full safety data package is required for products that contain:

  1. genetically-modified or deliberately modified rhizobia,
  2. other microorganism(s) in addition to rhizobia, or
  3. ingredient(s) that pose safety concerns.

Guidance on the safety standards and type of information required in a full safety data package to support a new registration of a rhizobia product can be found in one or more of the following Trade Memoranda:

2. For Research Trials

Product proponents who wish to to conduct research trials in Canada on novel supplements2 require a Research Authorization under the Fertilizers Act and Regulations prior to import into Canada or environmental release.

2all supplements (including rhizobial inoculants) that are not registered and not exempt from registration, or that contain a novel trait are considered to be novel supplements under the the Fertilizers Regulations.

All applicants wishing to conduct research trials are required to complete the Application for Research Authorization. Generally, non-genetically modified rhizobial inoculants fall into Category A of research authorizations which is a streamlined regulatory process for testing supplement products that pose negligible risk to plant, animal, human health and the environment. However, depending on the nature and properties of all ingredients in the novel supplement (as described on the application form), a Category B research authorization may be assigned to the trial, in which case a more detailed safety data package will be required to complete the safety assessment and issue a research authorization for the novel supplement.

For further guidance on the research authorization requirements, please consult Trade Memorandum, T-4-103 - Guidelines for Research Authorizations for Testing of Novel Supplements

NOTE: The Fertilizer Safety Office (FSO) reserves the right to require additional safety information, data, rationale or results of analysis to support the registration/approval of any product regulated under the Fertilizers Act and Regulations.

Efficacy Requirements

The intent of this section is to detail efficacy requirements specific for rhizobial inoculants; as a result of wide acceptance of these products in the marketplace, and a well documented history of effective use efficacy requirements for rhizobial inoculants have been streamlined. Any additional efficacy requirements other than those specified below are outlined in Trade Memorandum T-4-108: Efficacy Data Requirements for Fertilizers and Supplements regulated under the Fertilizers Act. As such, product proponents seeking information on requirements regarding trial locations, representative crops, foreign data, bridging data, treatment structures, etc. should refer to T-4-108. As well, when rhizobial inoculant products contain, or are combined with, additional active ingredients (other than rhizobia), they are subject to the full efficacy requirements as outlined in T-4-108.

1. Minimum Number of Trials

A minimum of six efficacy trials are required to obtain national registration for a rhizobial inoculant, and a minimum of three trials are required for regional registration. Trials should be conducted over a minimum of two years to account for seasonal variability in environmental conditions such as soil moisture, humidity, precipitation, and soil and air temperature. However, if a company wishes to conduct all efficacy trials in a single year to support product efficacy, the product proponent must increase the number of trials to a minimum of eight trials in order to support a national registration, and four trials for regional registration. Additionally, in order to ensure that the product is subjected to a range of environmental conditions in the single year of testing, the product proponent must demonstrate that the trials are adequately spatially distributed within the production region(s).

Product efficacy will be assessed over the duration of the trials. At minimum, 60% of the trials, overall, must demonstrate a statistically significant benefit.

2. Planting Window and Seed Treatment Compatibility

2.1 Overview

The Fertilizers Regulations Section 10.2(1) requires that rhizobial inoculants when applied to legume seed according to label directions must deliver a specified number of viable cells. Table 1 of this document outlines the required numbers of viable cells for a given seed type. To determine the delivery to seed, the number of seeds per kg for the crop species and the product application rate is used; see sample calculation in example 3 below. For a listing of legume crop species and their associated number of seeds per kg please consult Appendix A.

Planting window is the period of time between inoculation and sowing during which the rhizobia remain viable on-seed. Therefore, it is important that the planting window is substantiated by scientific data to ensure that a sufficient number of rhizobia cells are viable when the seed is planted in order for the inoculant to produce the desired benefit. Further to this, seed treatment compatibility must be demonstrated when additional seed treatments (such as pesticides) are recommended for use along with a rhizobial inoculant in order to ensure that the viability of the rhizobia on seed is not compromised by the seed treatment. When rhizobial inoculant claim for compatibility with a specific seed treatment results in a change to the planting window, this information must communicated to the consumer.

As inoculant products contain viable microorganisms or other active ingredients subject to degradation or loss of viability over time. As such, these products must display an expiry date on their labels to indicate the date after which the product's performance can no longer be guaranteed. The shelf life is considered the period of time between the date of manufacture and the expiry date.

2.2 Laboratory Data

In order to support a planting window claim, data must be generated demonstrating the survival of rhizobia on seed for the duration of the proposed planting window. The planting window claim will also be evaluated through field trials (see Section 2.3). In order to demonstrate on-seed viability, seed must be inoculated with the final product formulation at the end of its proposed shelf life. Rhizobia are then recovered from seed at set time intervals, beginning with time 0. An appropriate methodology must be used to determine the on-seed survival of rhizobia (e.g., plate count enumeration, Most Probable Number (MPN) plant grow out test, etc.)

The on-seed survival data must be generated from a minimum of three independent batches or lots of inoculant (and extender where applicable, see Section F), at the end of the product's shelf life. Each sample of a batch or lot of inoculant should be applied as an independent treatment replicated a minimum of three times (i.e. 3 batches × 3 replicates).

When the Fertilizer Section evaluates the submitted on-seed survival laboratory data, we ensure that:

  1. the product is consistently formulated (should be within 1 log)
  2. the product's minimum guarantee is met at the end of its proposed shelf life
  3. the product's minimum guarantee will deliver an adequate number of viable cells per seed to meet the regulatory standard
  4. the amount of rhizobia on seed at the end of the proposed planting window will meet the regulatory standard for the corresponding seed size
  5. any pesticide or additional seed treatment compatibility is substantiated

The following examples of on-seed survival data will illustrate each of the items listed above. Please note, all of the examples shown are based on a product having a minimum guarantee of 1x1010 CFU/g, with an application rate of 5.65 g per kg of soybean seed. The examples provided below are designed only to assist applicants in providing the requisite data to the CFIA, and do not represent an actual product submission.

Example 1: A rhizobia product has a minimum guarantee of 1x1010 CFU/g and the following sets of analysis are submitted to support consistency of production:

The mean CFU/g taken from 3 lots of product and 3 replicates to support consistency of production.
Lot Number Replicate Number CFU/g Mean
Lot 1 Rep 1 2.00x1011 –
Lot 1 Rep 2 1.80x1011 1.59x1011
Lot 1 Rep 3 9.70x1010 –
Lot 2 Rep 1 1.20x1011 –
Lot 2 Rep 2 9.90x1010 1.06x1011
Lot 2 Rep 3 1.00x1011 –
Lot 3 Rep 1 1.10x1011 –
Lot 3 Rep 2 1.40x1011 1.13x1011
Lot 3 Rep 3 8.90x1010 –

The means of each of the three lots are never below the minimum guarantee and are consistently within a range of 1 log. Therefore, consistency in production has been demonstrated.

Example 2: A rhizobia product has a minimum guarantee of 1x1010 CFU/g and the following sets of analysis are submitted to support a shelf life of 6 months:

The mean CFU/g taken over time from 3 lots of product and 3 replicates to support the shelf life.
Lot Number Replicate Number Time 0 1 month 3 month 6 month
– – CFU/g CFU/g CFU/g CFU/g
Lot 1 Rep 1 2.00 x1011 1.80 x1011 1.00 x1011 8.20 x1010
Lot 1 Rep 2 1.80 x1011 1.50 x1011 9.50 x1010 9.00 x1010
Lot 1 Rep 3 9.70 x1010 9.20 x1010 8.40 x1010 9.00 x1010
Lot 1 Mean 1.59 x1011 1.41 x1011 9.30 x1010 8.73 x1010

(Although the above example has results from a single lot of product for the purposes of brevity, shelf life must be supported by results from 3 lots of product.)

At the end of the product shelf life (i.e. 6 months), the result is never below the minimum guarantee of the product. Therefore, the proposed shelf life of 6 months is supported.

Example 3: A rhizobia product has a minimum guarantee of 1x1010CFU/g, with an application rate of 5.65 g per kg of soybean seed.

According to the guarantee, the product should deliver a minimum of:

1x1010 CFU/g * 5.65 g * (1 kg of seed / 6667 soybean seeds per kg)
= 8.47x106 CFU/seed

The minimum delivery to seed exceeds the regulatory threshold set out in the Fertilizers Regulations, Section 10.2.(1), which is 105 viable cells per seed for large seeds such as soybean.

Example 4: A rhizobia product has a minimum guarantee of 1x1010 CFU/g, which corresponds to a minimum delivery on seed of 8.47x106 CFU/seed (as seen in the above example).

The following sets of analysis are generated to support a proposed planting window of 90 days:

The mean CFU/seed taken over time from 3 lots of product and 3 replicates to support the planting window.
Lot Number Replicate Number Time 0 1 day 5 days 30 days 90 days
– – CFU/seed CFU/seed CFU/seed CFU/seed CFU/seed
Lot 1 Rep 1 5.00x107 4.20 x107 4.00 x107 1.20 x107 9.80 x106
Lot 1 Rep 2 2.70 x107 2.00 x107 1.50 x107 8.90 x106 8.50 x106
Lot 1 Rep 3 3.20 x107 2.10 x107 2.00 x107 9.30 x106 9.00 x106
Lot 1 Mean 3.63 x107 2.77 x107 2.50 x107 1.01 x106 9.10 x106

(Although the above example has results from a single lot of product planting window must be supported by results from 3 lots of product.)

At the end of the planting window (i.e. 90 days), the mean result is never below the regulatory standard for Soybean sized seed (105) Therefore, the proposed planting window of 90 days is supported.

Example 5: Pesticide compatibility must be demonstrated with laboratory data showing that the inoculant survives on treated seed. The method of determining this is the same as described in the above Example 4), where the survival of rhizobia on seed must meet the regulatory standard at the end of the proposed planting window. Please note, laboratory data must be supplied for each of the seed-applied pesticide formulations that are claimed to be compatible with the rhizobia inoculant product, as well as, any multiple co-formulations.

2.3 Connecting Laboratory and Field Data

In order to ensure that the efficacy data generated through field trials is relevant and reflective of the efficacy of the final product formulation, the Fertilizer Section requires that the concentration of active ingredient used for field testing be no greater than the time 0 concentration for the shelf life / planting window as shown with the laboratory data.

2.4 Trial Data

When research trials are conducted to support registration of a new product or formulation, the trials must be conducted in a manner which adequately assesses any claims on the product label; this includes claims for planting window. Both field trial data and laboratory data are required to support planting window (on-seed viability) claims.

In order to demonstrate a planting window, the seed should be inoculated with the commercially formulated product (or product formulated in accordance with the manufacturing method to be used in commercial settings), stored as directed on the label, and planted at the end of the proposed planting window. A planting window tolerance (10% less than the proposed planting window, up to a maximum of 7 days) will be considered; giving the product proponents flexibility to account for any unfavourable environmental conditions at the time of conducting trials.

The following examples illustrate how this 10% tolerance will apply:

  1. For a 30 day planting window (supported by laboratory data), inoculated seed may be planted at any point after 27 days of inoculation (on-seed storage period).
  2. For a 90 day planting window (supported by laboratory data), inoculated seed may be planted at any point after 83 days of inoculation (on-seed storage period).

In situations where unforeseeable circumstances or weather conditions that are beyond the product proponent's control prevent trials from being conducted during the set tolerance period, exemptions may be considered by the Fertilizer Section on a case by case basis.

Please note: product proponents may wish to inoculate additional staggered lots of seed in order to gain flexibility when conducting trials to support the planting window claims. In the event of a weather delay, the additional seed lot(s) could serve as a contingency measure.

Efficacy data will be evaluated as described in T-4-108: Efficacy data requirements for fertilizers and supplements regulated under the Fertilizers Act, where a minimum 60% of trials, overall, must demonstrate a statistically significant benefit, evaluated at the 95% significance level (where 90% significance will be accepted with a rationale). In all instances, planting window supported by both field data and laboratory data will be accepted.

Labelling Requirements

As per the Fertilizers Regulations (Section 19.2), labels must not have any incorrect or misleading information or mark or brand or name that would tend to deceive or mislead a purchaser with respect to the composition or utility of the product. All information on the label must be supported by the information listed in the Fertilizer or Supplement Registration Application (CFIA/ACIA 3778) form.

1. The Main Panel of the Product Label

The main panel of the label must display at least the product name, the product net weight and the name and address (including: the street address or Postal Office Box, City, Province/State, Postal/ZIP Code, and if manufactured outside Canada, the country) of the registrant, the manufacturer or the person who packaged the product.

2. Lettering, Fonts, Colouring, and Pictures

All information on the label must be printed conspicuously, legibly and indelibly. To this end, information printed on the label that is not specifically required by the Fertilizers Regulations must not emphasize or obscure any information required to be printed on the label by the Fertilizer Regulations; and the colouring of the lettering of the information required to be on the label must contrast with the background of the label. All information must all be printed in a font size that would be legible from a normal distance without the aid of magnifying devices.

3. Languages

All information on the label must be printed in either English or French, or in both English and French. Information on additional language requirements in the province of Québec may be obtained from:

Office québécois de la langue française
125, rue Sherbrooke Ouest
Montréal Québec H2X 1X4
Canada
Telephone: 514-873-6565
Facsimile: 1-888-873-6202
Internet: www.oqlf.gouv.qc.ca

Please note that products containing prohibited material, as defined in the Health of Animals Regulations, must have certain warning statements listed on the label. These warning statements are required to be listed in both English and French, therefore the entire label must be in both English and French (Fertilizer Regulations, Sections 18.1 (j) and 19.1.2).

4. Units of Measure

Units of measurement shown on the label shall be expressed in accordance with the International System of Units (metric) as set out in Schedule I of the Weights and Measures Act. If the manufacturer wishes to use imperial units of measure, the imperial measurement must be enclosed in brackets following the metric equivalent, and all conversions must be accurate.

5. Net weight

All products must be sold by weight, and the net weight must be listed on the label. Dry formulated products must be described in grams (g), kilograms (kg) or tonnes (t). Liquid formulated products must be described in grams (g) or kilograms (kg), but the volume in millilitres (ml) or litres (L) may be included in addition to the weight.

6. Brand Name

If a brand name is listed on the application for registration, it must also appear on the product label. The brand is any distinctive mark or trade name other than a name or grade required by the Fertilizers Regulations, to distinguish a product from any other product. The brand name must not deceive or mislead the purchaser with respect to the composition or utility of the product.

7. Product Name

The product name must not deceive or mislead the purchaser with respect to the composition or intended use of the product.

8. Guaranteed Analysis

The number of viable cells of the active genus and, where known, the species, must be guaranteed as a minimum number per gram of product.

e.g. Guarantee: This inoculant contains a minimum of 200 million viable cells of Rhizobium meliloti per gram or 2x108

9. Registration number

The registration number of the inoculant product must appear on the label in the following manner:

Registration Number xxxxxxxA Fertilizers Act

Where "xxxxxxxA" denotes the number provided by the CFIA, after all registration requirements have been met. The registration number consists of three elements: the year in which the registration was initially granted (first four digits), the number of registered product in that year (next 3 digits), and the suffix letter denoting the type of product (A = supplement).

10. Directions for Use

Complete directions for use require rate of application, frequency of application, time of application and dilution (if applicable). They must also include the types of crops or soils on which the product is to be used. The requirement for directions for use does not apply to pre-inoculated seed.

11. Company information

The name and address of the registrant or manufacturer or packager must appear on the product label. If the label states a Canadian company name and address, but is manufactured or produced and labelled in a country other than Canada, the name and address must be preceded by the words "imported by" or "imported for" unless the geographic location of the pre-packaged product is stated on the label. Where any reference is made in respect of the place of manufacture of the label or container and not the place of manufacture of the product, the reference must be accompanied by an additional statement indicating that the place of manufacture refers only to the label or container. For example: "Bags made in the U.S.A.".

12. Seller's guarantee

A seller's guarantee states that the manufacturer is responsible for the recommended uses but not for the misuse of the product. The seller's guarantee is not required, but if present must not contain any information that would contravene the Fertilizers Act and Regulations, and any associated policies. The following is an example of a seller's guarantee: "NOTICE: Seller's guarantee shall be limited to the terms set out on the label and subject there to. The buyer assumes the risk to persons or property arising from the use or handling of this product and accepts the product on that condition."

13. Lot numbers

A lot number is defined in Supporting Section A of the Guide to the Canadian Federal Regulatory Requirements for Fertilizers and Supplements as: any combination of letters and/or numbers by which a fertilizer or supplement can be identified and traced. A lot number should be assigned to unique batches of product derived from a single production run, mining date/location, delivery date, packaging date, static pile, wind row, etc. Each lot or batch should be assigned on the belief that all product in the lot or batch is of similar chemical, biological, and physical characteristics. All supplements are required to have a lot number listed on their label. The lot number must be printed on each package of a supplement. The lot number must be legible and indelible, and should be preceded by the phrase "Lot number", "Batch number", or equivalent. The lot number is necessary to facilitate product traceability and recall if required. Please note that supplement products found to be in contravention of the Fertilizers Act and Regulations will be subject to enforcement action and that all product in Canada, with the same lot number, can be detained.

14. Websites

Many fertilizer and supplement manufacturers have developed websites for their products. If the website address is listed on the product label, all the information on the website must comply with the Fertilizers Act and Regulations and match the information listed on the product label.

15. Label claims

The Fertilizers Act and the Competition Act are the authorities under which the Canadian Food Inspection Agency and the Consumer Products Directorate of Industry Canada, respectively, may pursue enforcement and compliance actions against misleading claims. To protect the consumer from fraudulent claims, below are examples of claims that are not allowed on a product label, or must be substantiated before appearing on a product label:

  • extravagant or misleading advertising claims
    • words such as "greener", "healthier", "richer" or "better" imply comparison without actually indicating the basis of comparison. For this reason, they are unacceptable unless the basis for comparison is given
    • claims that products are "the best", "superior", "premium", or any words that denote these meanings are to be avoided, as they are likely to be false, exaggerated, misleading or deceptive
  • undefined acronyms
  • claims referencing product safety
    • environmentally safe, safe for children and pets, ecologically friendly - as all products must be safe with respect to plant, animal, human health and the environment such claims are not permitted as they would imply that other products may pose risks
  • unsubstantiated claims
    • specific claims such as "20% more yield", "$100 more return per hectare", "promotes germination" without supporting data
    • companies must be prepared to submit efficacy data to substantiate any claims or non-traditional uses of fertilizers to the Fertilizer Section for evaluation
  • claims for unidentified active ingredients
  • claims that discredit competing companies
  • claims such as certified or approved without mention of the certifying or approving agency/organization and without supplying a copy of the certificate or approval to the CFIA
  • the word "professional" is unacceptable unless sold only through distributors to the end user, and the main panel of the label must also bear the following statement: "For Professional Use Only"
  • graphics that imply a use pattern that has not been approved (e.g. food crop pictures when food use has not been approved); or unsubstantiated environmental benefits.

16. Ingredients

It is not necessary for constituent materials (includes all ingredients used to formulate the product) to be included on the label. However, if any of the constituent materials (other than those required to be identified in the guaranteed analysis section) are listed on the label, then all ingredients must be identified. All ingredients, or the method with which they are applied to the product, must respect the product formulation (i.e., granular or liquid). The use of the terminology "derived from" is not acceptable as it implies that not all the ingredients have been listed as required.

Permission for the inclusion of partial ingredient listings on the product label may be granted but is contingent on the product proponent demonstrating that the listing is a method for communicating hazard warnings, and that the specific ingredients listed exceed international notification thresholds but are still within a safe level when the product is used as directed. Further, the inclusion of the ingredients cannot convey marketing advantage or benefits of the product beyond what is already attributable to the guaranteed active ingredients and other label claims. The Fertilizer Section will review the information provided by the product proponent on a case-by-case basis to verify the hazard statements and determine whether the inclusion of the partial listing of ingredients is warranted. Please contact the Fertilizer Safety Office for further information if required.

17. Expiry Date

Products containing viable microorganisms or other active ingredients subject to degradation or loss of viability over time must have an expiry date on their labels which indicates the date after which the product's performance can no longer be guaranteed.

18. Cautionary Statements

Depending on the composition and intended use of the product, precautionary statements deemed appropriate to protect humans, animals, plants, and the environment should be included on the label.

For example, rhizobial inoculant products that contain non-sterile peat or clay carriers may contain microorganisms which may pose potential health concerns. Therefore, for non-sterile peat based products, registrants are required to include precautionary statements protecting users from potential hazards. The Fertilizer Safety Office recommends the following precautionary statements:

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

The statements listed above are currently required for all new registrations.

Please note that the cautionary statements do not have to be used verbatim as long as the intent of the statements is adequately reflected and conveyed to the user. The precautionary statements will be reviewed on a case-by-case basis and must be approved by the FSO before the product is granted registration, re-registration and/or approval.

19. Planting Window Statement

When a rhizobia product claims a specific planting window, the label must contain a statement similar to:

"This product will deliver a minimum of 10x CFU per seed at the end of the recommended planting window when applied at the recommended rates and properly handled and stored."

The claimed amount of CFU per seed must be supported by laboratory data (Section 2.2) and may not be below the standards as described in the Fertilizer Regulations (Section 10.2 (1)). It is recommended this statement also appear on seed tags for pre-inoculated seed.

20. Pre-inoculated seed

The above labelling requirements are required for legume seed pre-inoculated with rhizobia with the following exceptions:

Pre-inoculated seed is not required to include Directions for Use OR a Guaranteed Analysis on the seed tag if the following statement is included:

"This product is treated with (species name or genus of the active microorganism) inoculum."

Please note that pre-inoculated seed is not required to be registered if the inoculant used to treat the seed is registered. Rhizobial inoculants must be registered prior to application on seed. In addition, the inoculant registration number must also be displayed on the seed tag of pre-inoculated seed.

Inoculant Extenders

1. Background

Legume inoculant extenders are typically applied to seed at the time of inoculation. These products usually claim to extend the on-seed survival of rhizobia past the recommended planting window. Inoculant extenders when sold alone do NOT fall under the purview of the Fertilizers Act. However, once the extender is applied to seed for sale, the resulting pre-inoculated seed is regulated under the Fertilizers Act (Section 3.1(d)). The inoculated seed with the extender MUST meet the prescribed safety, efficacy and labelling requirements.

Specifically, Section 10.2(5) of the Fertilizers Regulations states:

"Where a supplement consists of coated pre-inoculated seed, that is, a seed to which inoculum is adhered and that is coated with a material for the purpose of protecting the viability of bacteria contained in the inoculum, the person who packed the product shall provide the President of the Agency with results of scientific investigations respecting the effectiveness of the product for its intended purposes including the minimum number of viable cells of intended Rhizobium species per seed."

As such, requirements apply to individuals/establishments that pack the pre-inoculated seed for sale; however, manufacturers of extender products may submit the required data/information directly to the Fertilizer Section to facilitate the sale of pre-inoculated seed treated with an extender in the marketplace. These requirements are not intended as an additional burden to manufacturers of co-products (inoculant + extender in same product package), as the efficacy of both the inoculant and extender should be assessed during the initial product registration process.

2. Administrative Requirements

The following information is required by the Fertilizer Section in order to constitute a complete submission package for the review of an inoculant extender product:

  • Cover letter outlining the purpose of the submission
  • Copy of the extender product label (this should include; rates of application, formulations of inoculant to be used with, claims concerning extended planting window, etc.)
  • Designation of Signing Authority and Incorporation Papers

3. Efficacy Requirements

The effectiveness of the extender product must be demonstrated with scientifically valid data. The data submitted must support both the extended survival of the rhizobia on seed (see above Section D-2 Planting Window and Pesticide Compatibility, for more information) AND show that the extender has no adverse effect on the field performance of the pre-inoculated seed.

When extender products are intended to be packaged along with inoculants (e.g. co-products), field trials should be conducted in accordance with the requirements outlined above in Section D of this document. Additionally, the experimental design for co-products (inoculant + extenders) requires at least three treatments; an untreated control, the inoculant alone (tested at the end of the recommended planting window) and the inoculant + extender (tested at the end of the recommended extended planting window for the inoculant + extender combination). Under this experimental design, the efficacy of the inoculant as well as the extender are tested.

For "stand alone" extender products, the efficacy of an extender product must be demonstrated for each of the inoculant formulations (species of the rhizobia inoculant and carrier material) that are intended to be used or claimed to be compatible with the extender product. The trial design requires a minimum two treatments; the inoculant alone (tested at the end of the recommended planting window) and the inoculant + extender (tested at the end of the recommended extended planting window for the inoculant + extender combination).

Efficacy evaluation of the extender product must be supported by appropriate statistical analysis. The analysis MUST demonstrate no significant negative effect of the extender on inoculant performance at the end of the extended planting window.

4. Safety Requirements

In accordance with the Fertilizers Act and Regulations, all fertilizers and supplements must be safe, efficacious, and properly-labelled. For inoculated seeds treated with extenders, the applicant is required to submit a scientifically-based, properly-referenced rationale that attests to the safety of the extender product (and its ingredients) to humans (workers and bystanders), terrestrial and aquatic organisms (including the target plants) and the environment when the product is used according to directions. For guidance on the type of information that is required for establishing product safety, please consult Trade Memorandum T-4-113: Guidelines to Safety Assessments of Fertilizers and Supplements and to Information to be Submitted in Demonstrating Product Safety, and its supplement, T-4-113 (Supplement 1): Data Requirements for Product Safety Evaluations: Explanatory Notes.

In addition to the scientifically-based, properly-referenced rationale, all of the following information must be submitted:

  • identification of all the ingredients in the extender, including the CAS RN (Chemical Abstract Service Registry Number) or other registry number/identifier for each ingredient;
  • identification of any potential contaminants (chemical or microbial) that may be present in the product or its ingredients;
  • the concentration of each ingredient in the final product;
  • a detailed description of the manufacturing process and blending process (if applicable) including QA/QC procedures;
  • the citation for every reference that is used to support the safety of the product (please provide copies of any cited references) and
  • MSDS of the products or ingredients (if available)

Please note that the FSO reserves the right to request additional information to assess the safety of the product. Also note that if the extender is manufactured in Canada and includes a preservative as one of its ingredients, the preservative must be registered for such use under the Pest Control Products Act (PCPA) through the Pest Management Regulatory Agency (PMRA).

Once the safety of the product has been reviewed, the appropriate precautionary statements for the product label will be established.

Appendix A: Number of Seed per kg

Scientific and Common Name Number of Seeds per kg3
Arachis hypogaea L. peanut 2,205
Astragalus cicer L. cicer milkvetch 286,650
Cicer arietinum L. –
Chickpea (Desi) 4,098
Chickpea (Kabuli) 2,719
Securigera varia (L.) Lassen crownvetch 242,550
Glycine max (L.) Merr. soybean 6,667
Lathyrus sativus L. chickling vetch, grass pea –
Lens culinaris Medik. lentil 19,845
Lotus corniculatus bird's foot trefoil 826,875
Lupinus angustifolius L. (blue lupin(e)) 6,978
Lupinus albus (white lupin(e)) 2,951
Lupinus luteus (yellow lupin(e)) 7,930
Medicago sativa L. alfalfa 441,000
Melilotus albus Medik. white sweet clover 573,340
Melilotus officinalis (L.) Lam yellow sweet clover 573,300
Onobrychis viciifolia Scop. sainfoin 66,150
Phaseolus vulgaris L. common beans 2,481
Pisum sativum L. field or garden peas 4,310
Mucuna pruriens (L.) DC. var. utilis (Wall. ex Wight) Baker ex Burck velvetbeans 2,205
Trifolium hybridum L. alsike clover 1,543,500
Trifolium incarnatum L. crimson clover 308,700
Trifolium pratense L. red clover 606,375
Trifolium repens L. white clover, ladino clover 1,764,000
Vicia sativa L. subsp. sativa common vetch 15,435
Vicia villosa Roth. subsp. villosa hairy vetch 44,100
Vicia faba L. var. faba Faba bean 2,326
Vicia faba L. var. faba broadbean 1,103

3To comply with the table under Section 10.2 C(ii) in Fertilizers Regulations, seed size greater than 200,000 seeds/kg = small; 30,000 - 200,000 seeds/kg = intermediate; and less than 30,000 seeds/kg = large.

Canadian Food Inspection Agency
Plant Health and Biosecurity Directorate
Crop Inputs Division
Fertilizer Section
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Canada
Telephone: 613-773-7189
Facsimile: 613-773-7163