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New regulations: Guide to submitting applications for registration under the Fertilizers Act
1. Introduction

This page is part of the Guidance Document Repository (GDR).

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1.1 Registrations under the Fertilizers Act

Fertilizers (essential plant nutrients) and supplements (products other than fertilizers that improve the physical condition of the soil or aid plant growth or crop yield) when imported into or sold in Canada are regulated under the authority of the federal Fertilizers Act and regulations administered by the Canadian Food Inspection Agency (CFIA). The Fertilizers Act and regulations require that all regulated products be safe with respect to human, animal and plant health and the environment and properly labelled to avoid misrepresentation in the marketplace. Some fertilizers and most supplements require mandatory pre-market assessment and registration prior to importation and sale in Canada. All registrations are valid for 60 months from the date of their issuance. Product proponents wishing to sell or import a registrable product after that date must apply to the CFIA to re-register and remain compliant beyond that time.

Furthermore, no changes to the label, chemical composition or ingredients in the product can be made if the change can reasonably be expected to affect its performance as a fertilizer or supplement, its safety or its use, unless the registration is amended accordingly (major or minor amendment). Alternatively, these changes can be made at the time of re-registration. Changes that will not affect product identity as a fertilizer or supplement, safety or use can be made without prior approval from the CFIA and they do not require notification. Contact the CFIA if you have any questions about whether or not changes you intend to make to your product(s) trigger a requirement to submit an amendment.

All products regulated under the Fertilizers Act and regulations are subject to marketplace monitoring which includes product inspections, sampling and testing as well as label verification. Non-compliant products may be subject to regulatory action including product detention (stop sale) and in cases of serious or repeated non-compliance, prosecution.

Truthful and accurate representation of products in the marketplace is key to consumer protection and prevention of fraud. Products that are supplements need to be represented as such and removal of claims and/or guarantees to avoid registration is not an appropriate corrective action.

1.2 Service Delivery Standards

The file review procedures and associated timeframes (Service Delivery Standards, SDS) for all registration related applications (new registrations, re-registrations, major and minor amendments) are described in Trade Memorandum T-4-122: Service Delivery Standards for Fertilizer and Supplement Registration. The service delivery standards include the actual CFIA review time and the queue time since all files are processed in the order they are received. The SDS vary by application type due to the nature and complexity of the assessment required and allow for up to 3 review cycles. Please note that unless there are deficiencies identified in the application, the file may not require all 3 reviews. Therefore, it is critically important that applicants invest the time and effort to familiarize themselves with the registration requirements before they submit an application to the CFIA.

When deficiencies in the application are identified at the first review stage, the applicants are required to respond to each question posed by the CFIA completely and with sufficient detail to address the deficiency. Partial responses and responses received past the specified timeframe are considered incomplete and the file will be closed. In addition, a file will be closed if an applicant discloses new information during the file review process about the product, its composition or manufacturing method, that warrants an additional review or assessment. If a product proponent still wishes to pursue registration, they would then have to submit a new application for CFIA's consideration and review.

1.3 Purpose of the guide

There are a number of documents available on the CFIA website that are intended to increase awareness and understanding of the regulatory requirements for fertilizer and supplements imported into and sold in Canada. The information requirements detailed in this document are specifically relevant to registrable products and designed to assist prospective registrants in preparing complete and well organized applications to facilitate the file review process and ultimately expedite time to market.

1.4 My CFIA: Electronic application platform

The CFIA now offers digital service delivery through the online platform My CFIA. My CFIA allows you to request, pay for and track the status of services online through a secure account that can be tailored to suit your business model. PASO (pre-market application submissions office) service requests for new fertilizer and supplement registration and research authorization applications are now available online. Guidance documents, videos and step-by-step walk-throughs for how to sign up for an account, manage an account and request services online can be found at My CFIA – User guidance.

1.5 Application format

Whether applications are electronic or paper-based, the information required to be submitted in support of an application is the same. All tabs required by product type and/or ingredient must be populated in their entirety. These include:

  1. Administrative forms and fees
  2. Marketplace label
  3. Product specification
  4. Results of analysis
  5. Safety rationale and supplemental data (as identified in Appendix 1).

Electronic applications

The system will prompt for information by providing a brief description of the requirement, appearing in the traditional tab order and organization, as fillable fields and document uploads. Please name uploaded files with the tab number and description of file contents. For example, Tab3_Manufacting_Process.pdf.

Paper-based applications (includes applications received by a method other than MyCFIA)

The information included in the registration package must be organized in form of sections (tabs) for ease of access and review by multiple CFIA evaluators (toxicologists, microbiologists, agronomists, etc.).

For all applications

It is not acceptable to omit a tab or bypass an upload prompt. If a tab is not relevant to the application, a brief written statement is required (for example "This product requires only core product information. As such, all required information has been submitted under Tabs 1, 2 and 3."), included in the file for paper- or uploaded for electronic-based applications respectively. In the electronic system, MyCFIA will not allow a user to advance to the next application requirement until all mandatory fields for the current requirement have been filled.

Applications may reference previous submissions by number, however, each application must be independent and complete, without requiring the CFIA to pull information from older applications. Re-registrations, amendments and me-too applications must contain all requisite information to facilitate and expedite file review. Incomplete applications will be closed.

1.6 Safety data requirements

To reduce burden on stakeholders and streamline the information required to support registration under the Fertilizers Act and regulations, the CFIA has implemented a tiered approach whereby the extent of the safety data requirements varies depending on the application type, nature of the product and its risk profile. All applications for registration require the submission of core product information (Safety assessment Level I), some also require results of analysis (Safety assessment Level II) to allow for verification of consistency in production or effectiveness of treatment as well as purity of the final product with respect to contaminant levels. Products with a higher or unknown risk profile necessitate a full safety assessment (Safety Assessment Level III), for which scientific rationales, supplemental safety data and/or additional results of analysis are required. The requisite assessment level (I, II or III) is determined based on the product ingredients (both active and inert) and their sources, potential residues, contaminants, and degradation by-products as well as the manufacturing process, use pattern and application rate and frequency. Table 1 shows the 3 Safety assessment levels and required information by Tab.

Table 1. Safety Assessment Levels and Information Requirements by Tab
Assessment Level Tab 1
(Administrative Requirements)
Tab 2
(Labelling Requirements)
Tab 3
(Product Specification)
Tab 4
(Results of Analysis )
Tab 5
(Safety Rationale and Supplemental Data)
I Check Check Check
II Check CheckCheck CheckCheck CheckCheck
III Check Check Check Check Table Note a Check

Table Note

Table Note a

Level III submissions may require some or all of the results of analysis

Return to table note a  referrer

A summary of information requirements for a variety of product ingredients can be found in Appendix 2.

Note: The CFIA reserves the right to require additional safety information, data, rationales or results of analysis to support the registration of any product regulated under the Fertilizers Act and regulations if and when additional safety concerns or questions have been identified during the review of the application.

In addition to familiarizing themselves with this guide, prospective registrants are encouraged to make use of the Inquiry (IQ) process to seek clarification and obtain guidance on the information requirements specific to their product, prior to submitting an application for registration. Additionally, product proponents may wish to request a Pre-Submission Consultation meeting with the CFIA, particularly in the early stages of product development, to obtain guidance, advice, and clarification on the regulatory requirements. The IQ and Pre-Submission Consultation processes can assist product proponents in generating appropriate data and information in support of product registration. Refer to Guidelines for Pre-submission Consultations for Fertilizer and Supplement Products Regulated Under the Fertilizers Act and Regulations for more details.

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