T-4-111 - Registration of Micronutrient Fertilizers under the Fertilizers Act

September 2005

BACKGROUND

Micronutrient fertilizers must be registered under the Fertilizers Act prior to being sold in or imported into Canada. When seeking product registration an Applicant must provide the Fertilizer Section of the Canadian Food Inspection Agency (CFIA) with administrative and technical information on its product(s). This guideline has been developed to assist industry in the preparation of a request for product registration, by identifying the standards which micronutrient fertilizers must meet, and the documentation and data which must be provided in support of registration.

Once the information is received, the Fertilizer Section of the CFIA will conduct a preliminary review of the product and outline whether any further information is required.

STANDARDS

Products regulated under the authority of the Fertilizers Act must be efficacious for every purpose for which they are intended, they must be safe for use as intended (bearing in mind phytotoxicity, food safety, worker safety, and environmental safety) and they must be properly and accurately labelled.

One crucial aspect of micronutrient fertilizers is whether they meet their nutrient guarantee. We recognize that in formulating a product to meet a consistent, guaranteed nutrient level, test results used to confirm this level will generally show slightly more or slightly less nutrient than is guaranteed. Accordingly, a limited degree of variability is acceptable, and specific tolerance limits for this variability are set out in Schedule I of the Fertilizers Regulations. (These are primarily testing tolerances rather than manufacturing tolerances.)

Please note that the safety of micronutrient fertilizers is carefully considered at the time of registration. The safety review considers active ingredients, formulants and contaminants (in particular the heavy elements), and may address food safety, environmental safety, toxicity and worker protection. With regard to worker protection, it is necessary that labels carry precautionary statements which properly reflect protection against known hazards of the constituent materials.

The Fertilizers Regulations stipulates criteria required for the labelling of all fertilizers; if the fertilizer is sold in bulk and does not bear an actual label, the information normally required on the label must appear on the shipping bill or other documentation which accompanies the bulk shipment. The Regulations should be consulted for further guidance on product labelling.

Note: We would like to remind companies of their obligations under the Workplace Hazardous Materials Information System (WHMIS), which involve safety labels and Material Safety Data Sheets (MSDSs), appropriate cautionary statements, ingredient identification, etc.

REGISTRATION REQUIREMENTS

1.0 GENERAL

The following requirements apply to all products for which registration under the Fertilizers Act is requested.

2.0 MICRONUTRIENT-SPECIFIC

In addition to information on active ingredients and constituent materials as required on the Fertilizer and Supplement Registration Application, applicants seeking registration of micronutrient fertilizers must provide the following information:

Four (4) sets of analyses are required for all products. These analyses must be of four different representative samples of the end-product; these four samples must be collected over a period of two months, at intervals of approximately 2 weeks. Each sample analysed may be a composite sample representative of product generated over the two week interval.

ASSESSMENT

Once the above requirements for registration have been received, the CFIA will consider the efficacy, safety and labelling of the product. The applicant will be informed as to whether registration has been granted, additional information is required, modification of the product label is required, etc.

FOLLOW-UP MONITORING

Given the well-documented variability in nutrient and heavy element concentrations of several micronutrient fertilizers, it is necessary to monitor registered micronutrient fertilizers for continued compliance with the standards of the Fertilizers Act and Regulations. For this purpose, applications for re-registration are required to contain analyses of the guaranteed nutrients and the 11 heavy metals, mentioned in section 2.3, to the CFIA at 6 month intervals. Recommended criteria for sampling ans analysis are those identified under section 2.3 above. Should there be any deviation form these criteria, the applicant must seek approval for an alternate scheme form the Fertilizer Section of the CFIA, prior to sampling for the next re-registration period.

Following a request by the registrant, the CFIA may accept less than 4 set of the above analyses, based on information pertaining to historical analyses of the product, source materials, manufacturing processes, usage of industrial by-products, etc. Applicants should also recognize that this request can be denied at anytime by the CFIA. The two week interval and other criteria would remain necessary. Applicants' requests should therefor be timed accordingly.

To pursue registration of a micronutrient fertilizer, or for further information on the Fertilizers Act and Regulations or on the above data requirements, please contact the Fertilizer Section of the CFIA.

Canadian Food Inspection Agency
Plant Production Division
Fertilizer Section
2 Constellation Crescent
Ottawa, Ontario
K1A 0Y9
Canada
Telephone: 613-221-7519
Facsimile: 613-228-4552

This version replaces trade memorandum T-4-111 dated September 1997.