Old regulations: Guide to Submitting Applications for Registration under the Fertilizers Act
1. Introduction

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 (FzA and FzR) administered by the Canadian Food Inspection Agency (CFIA). Pursuant to the Fertilizers Act and Regulations, all products must 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 36 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 renew their registration. Furthermore, no changes to the label, chemical composition or ingredients in the product can be made unless the registration is amended accordingly (major or minor amendment). Alternatively, these changes can be made at the time of re-registration. All products regulated under the Fertilizers Act and Regulations may be 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.

1.2 Service delivery standards for registration related submissions

To obtain registration, product proponents must submit an application to the CFIA - all applications must be directed to the Premarket Application Submissions Office (PASO). 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, the applicant's response time and the queue time since all files are processed in the order they are received. The SDS vary by submission type due to the nature and complexity of the assessment required and allow for up to three review cycles. Please note, that unless there are deficiencies identified in the submission, the file may not require all three reviews and the registration (for example new registration with data) may be issued within 245 days as opposed to 530 days if all three reviews are needed. 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 submission 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. A closed file does not advance to the next review stage and will be returned to the applicant or destroyed. The applicant would then have to re-submit a new package for CFIA's consideration and review. In addition, a file is closed if an applicant discloses substantively new information during the file review process about the product, its composition or manufacturing method, that warrant an additional review or assessment.

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 designed to assist prospective registrants in preparing complete and well organized submissions to facilitate the file review process and ultimately expedite time to market. This document is accompanied by a Submission Preparation Training that "walks" applicants through the file review process, to offer further guidance to prospective registrants.

1.4 Submission format

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.). 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). If the requisite information has already been submitted to the CFIA, the applicants must include a statement to that effect under the appropriate tab and, if applicable, reference all relevant submission control numbers (e.g. 12345IQ) or registration numbers (e.g. 1901001A) previously issued by the CFIA. In addition, bridging rationale substantiating why this information is pertinent to the current submission must also be provided.

While it is permissible for applicants to reference previously submitted information, single complete packages are preferred as they facilitate and expedite file review. It is not acceptable to omit a tab. If a tab or sub-tab is not relevant to the submission, a brief written statement is required (i.e. "This product requires only core product information. As such, all required information has been submitted under Tabs 1, 2 and 3."). Submissions without information or a brief statement under each tab are deemed incomplete and will be closed and returned to the applicant.

1.5 Safety data requirements

To reduce burden on stakeholders and streamline the information required to support registration under the Fertilizers Act and Regulations, the FSS has implemented a graduated approach whereby the extent of the safety data requirements varies depending on the submission 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 contamination 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 three Safety assessment levels and required information by Tab.

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 submission.

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 FSS, 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.