Guide to the Canadian Federal Regulatory Requirements for Fertilizers and Supplements

3 - Registration Guide: Micronutrient Fertilizers

3.0 Registration Guide: Micronutrient Fertilizers
3.1 How do I obtain a new registration for my product?
3.2 What is the review process used by the Crop Inputs Division?
3.3 How do I re-register my product?
3.4 What if I want to change my product and/or the product label?
3.5 Can my registration be cancelled?
3.6 What are the labelling requirements for a micronutrient fertilizer?
3.7 What standards does my micronutrient fertilizer need to adhere to?
3.8 What are the import requirements for micronutrient fertilizers?
3.9 Contact Information
Appendix A: Fertilizer or Supplement Registration Application form
Appendix B: Declaration of Resident Canadian Agent
Appendix C: Efficacy and Safety Exemption Lists
Appendix D: Example Labels
Appendix E: Labelling Checklist

3.0 Registration Guide: Micronutrient Fertilizers

3.0.1 What is this section of the Guide about and who needs to read it?

This section of the Guide provides information on the regulatory requirements of micronutrient fertilizers that are sold in or imported into Canada. Anyone importing or selling a micronutrient fertilizer in Canada should read this guide.

NPK farm fertilizers containing micronutrients that have less than 24% combined NPK (chemical based), or less than 18% combined NPK (animal or vegetable based), require registration as a low analysis farm fertilizer. The regulatory requirements for these fertilizers are further discussed in the low analysis farm fertilizer section of the Guide. However, the efficacy requirements for micronutrient fertilizers in this chapter apply to any fertilizer that contains micronutrients.

3.0.2 What is a micronutrient fertilizer?

A micronutrient fertilizer is a fertilizer that contains the lesser plant nutrients: Boron (B), Chloride (Cl), Copper (Cu), Iron (Fe), Molybdenum (Mo), Manganese (Mn), or Zinc (Zn), and that does not contain Nitrogen (N), Phosphorus (P) or Potassium (K). Micronutrient fertilizers can also contain guarantees for Ca, Mg, and/or S.

3.0.3 How are micronutrient fertilizers regulated in Canada?

All micronutrient fertilizers sold or imported into Canada are subject to regulation and registration under the Fertilizers Act. As such, they must be safe when used as directed, efficacious for their intended purpose, and properly labelled.

Micronutrient fertilizers, imported into or sold in Canada, must obtain registration prior to the importation or sale of the product, and must maintain that registration by re-registering the product every 3 years.

3.1 How do I obtain a new registration for my product?

In order to import or sell a product that requires registration, an application for registration must first be reviewed and approved by the Crop Inputs Division in Ottawa. Details on what to submit are identified below. The review process is initiated by the Fertilizer Section upon receipt of a complete new registration (NR) submission package. Incomplete submission packages will be returned to the sender.

The submission package should be sent to the attention of the Client Services Administrator for the Crop Inputs Division by:

Mail:
59 Camelot Drive
Ottawa, ON
K1A 0Y9
Fax: 613-773-7163
E-mail: fertilizer@inspection.gc.ca

3.1.1 What do I need to submit for review?

The following is a list of the minimum amount of information that needs to be submitted in order for the new registration application to be reviewed. The Crop Inputs Division reserves the right to request additional information to accurately assess the safety and efficacy of the product based on the information that has been submitted.

Cover Letter explaining the intent of the submission

A copy of the proposed marketplace label

A completed Fertilizer and Supplement Registration Application Form:

Registration submission type (Specialty Fertilizer (Micronutrient) box is checked)
Brand of product (if any)
Name of product
The percent of nutrients in the Guaranteed Analysis section
Complete name and address of manufacturer and registrant
"Which name will appear on label- registrant or manufacturer" box is checked
Original signatures
Constituent Materials:
- Identification and description of all materials used in the production of the end product (include all formulants; dust control anticaking agents etc.)
- Proportion of the materials
- The source of the materials used Please note that the source information should include:
  - a) Country of origin;
  - b) Brief description of manufacturing process (i.e. by-product of another process, mining of materials, composting, synthesis etc.); and
  - c) Name of the distributor/supplier.
- If the above information is not directly available to the applicant, the distributor may submit it to the CFIA directly, and it will be protected as confidential business information. Please note that multiple potential sources for an ingredient can be submitted at the time of product registration. Any changes to the ingredients, their sources or the supplier(s) will require a major amendment to the product registration.
Other qualities:
- Physical characteristics (product formulation, e.g. granular, liquid)
- Description of the manufacturing / blending process
- Size guide number SGN (for blending products)

Registration Fee:

New Registration ($350.00 + HST)
Safety data review – if required ($500.00 + HST)
Efficacy data review – if required ($250.00 + HST)
The maximum fee payable for the consideration of an application = $1000.00 + HST

Designation of Signing Authority or written indication that signing authority is unchanged from previously provided information (see section 3.1.2)

Declaration of Canadian Agent Form (if residing outside of Canada) or written indication that Canadian Agent is unchanged from previously provided documentation (see section 3.1.3 and Appendix B).

Four (4) sets of analyses of the end-product for (Include method of analysis and sampling interval dates) for all guaranteed nutrients.

The required number of sample analyses for trace metals as listed in the table below. To demonstrate product safety the number of metals analyses required at the time of new registration or re-registration corresponds to the total number of batches/lots of product manufactured within a three (3) year interval preceding the submission of an application for a new or re-registration.

# of Batches/Lots* produced within a 3 year period	# of Sample analyses required (one analysis per individual batch)
1	1
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

The analyses must include the following eleven (11) elements: As, Cd, Cr, Co, Cu, Pb, Hg, Mo, Ni, Se and Zn. In addition to submitting the required results of analyses, the following validation studies are required when submitting 2 or more sets of analyses: % acceptable recovery, analytical range, limit of quantitation (LOQ), limit of detection (LOD) and % coefficient of variation (CV) repeatability. Each analysis report must bear the signature of the analyst and must be printed on laboratory letterhead. In addition, product samples must be taken either at regular time intervals or intervals that correspond to the actual batch manufacture in order to assess consistency in production.

Please also indicate the number of batches/lots produced within the three (3) year period preceding the file submission (used to determine the number of metal analyses required).

Safety and/or Efficacy Data (if product/ingredient/active is not on the efficacy or safety exemption list – see Appendix C).

3.1.2 What is meant by signing authority and why is it needed?

Before proceeding with the registration of a product(s), it necessary to provide the Crop Inputs Division with signing authority as outlined below. Signing authority is your means of telling Crop Inputs Division personnel who is authorized to sign the Fertilizer or Supplement Registration Application Form for your organization's submission. Signing authority is also used to inform Crop Inputs Division person who they can speak to with respect to your organization's submissions. If a person is not listed as having signing authority for your organization, Crop Inputs Division personnel will not divulge any information regarding the submission.

3.1.2.1 Corporations

A corporation may choose either of the following two methods to designate an individual(s) to sign applications for registration:

Supply the Crop Inputs Division with a copy of the letters of patent or certificate of incorporation together with a list of current Directors. If the person who will be signing fertilizer registrations is not a member of the Board of Directors, then a letter must be included from one of the directors authorizing this person to sign fertilizer registrations on behalf of the company.
Alternatively, we are also willing to accept a letter under the Corporate Seal of the Company, signed by the responsible officer, identifying the persons authorized to sign the applications for registration.

3.1.2.2 Partnerships and Sole Proprietorships

In the case of partnerships or sole proprietorships, evidence must be supplied that the firm name is registered under the appropriate provincial legislation. If the person who will be signing the application for registration is not one of the partners or the proprietor, then a letter must be included from one of the partners or the proprietor, authorizing this person to sign applications on behalf of the company.

3.1.3 What is meant by Resident Canadian Agent and why is it needed?

It is not mandatory that a registrant/applicant resides in Canada. However, for applicants residing outside Canada, a Resident Canadian Agent must also be designated, by filling out the form in Appendix B), who will co-sign registration/re-registration applications and to whom any notice or correspondence may be sent. 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 one Canadian Agent on file. If the applicant does not reside in Canada, the fertilizer or supplement is not eligible for registration unless the application is signed by the Resident Canadian Agent.

3.2 What is the review process used by the Crop Inputs Division?

3.2.1 Pre-Screening

All submissions are screened to determine whether the required information has been submitted. The pre-screening process is divided into two phases: 1) the completeness check and 2) the first response.

3.2.1.1 Completeness Check

During the completeness check the submission is reviewed to determine if a minimum amount of information has been submitted in order for an evaluator to initiate the review. The information required for a submission to be considered complete is outlined sections 3.1.1 (new registration), 3.3.1 (re-registration), 3.4.1 (minor amendment), 3.4.2 (major amendment). Any submissions that do not pass the "completeness" check will be returned to the applicant in their entirety, with a letter outlining the deficiencies.

3.2.1.2 First Response

The first response check is a further pre-screening step after the submission has entered the CFIA's Product Registration System (PRS). Any further outstanding information will be requested by an Evaluator to be submitted by the applicant within 30 days. If a response is not received by the stated deadline, the submission is immediately withdrawn and returned to the applicant. If the submission has no outstanding information requirements a letter will be sent indicating that the submission has been received and that there are no outstanding requirements at this time.

3.2.2 Review Streams

During the review stage, evaluators review the submission's information against the requirements of the Fertilizers Act and Regulations, and associated policies, with regards to efficacy, safety and labelling. All administrative requirements are also dealt with during the review. Depending on the submission type and the complexity of the submission, the file may be required to go through more than one type of assessment. The reviews are coordinated by the Program Design and Delivery Unit (PDDU) and files are directed to the proper stream based on the applicable requirements (e.g. toxicological safety, biological safety, efficacy data, etc.). Once the 1^st review is completed, deficiencies and outstanding information will be identified by an evaluator and a letter will be sent to the applicant detailing all of the outstanding issues. If a response is not received from the applicant by the stated deadline, the submission is immediately withdrawn and returned to the applicant at the applicant's expense, or disposed of through shredding of submitted materials. If the requested information is received by the CFIA at or before the stated deadline, the submission may undergo a 2^nd and/or 3^rd review in which the information is screened and assessed. Please note that the second review stage will begin as soon as the company has addressed any one of the terms listed in the review letter. Any subsequent information received will not be included in the second review, and will be not be reviewed until the third and final review is initiated. This helps to ensure that Service Delivery Standards are met. Therefore, all items should be addressed in one single, complete package. If the information provided is deemed complete, and meets all the CFIA's requirements, the product is registered. If the applicant has not addressed all of the issues in a sufficient manner within the three review time frames allotted, the file is closed and returned to the applicant at the applicant's expense, or disposed of through shredding of submitted materials.

3.3 How do I re-register my product?

In order to continue to import or sell a product that has been registered under the Fertilizers Act, the product registration must remain valid by re-registering the product every 3 years. To re-register and continue the sale or importation of a micronutrient fertilizer, an application for re-registration must first be reviewed and approved by the Fertilizer Section in Ottawa. Details on what to submit are identified below. The review process is initiated by the Fertilizer Section upon receipt of a complete re-registration (RR) submission package. Incomplete submission packages will be returned to the sender at the sender's expense.

The submission package can be sent to the attention of the Client Services Administrator for the Crop Inputs Division by:

Mail:
59 Camelot Drive
Ottawa, ON
K1A 0Y9
Fax: 613-773-7163
E-mail: fertilizer@inspection.gc.ca

3.3.1 What do I need to submit for review?

The following is a list of the minimum amount of information that needs to be submitted in order for the re-registration application to be reviewed. The Crop Inputs Division reserves the right to request additional information to accurately assess the safety and efficacy of the product based on the information that has been submitted.

Cover Letter explaining the intent of the submission

A copy of the proposed marketplace label

A completed Fertilizer and Supplement Registration Application Form:

Registration submission type (Specialty Fertilizer (Micronutrient) box is checked)
Brand of product (if any)
Name of product
The percent of nutrients in the Guaranteed Analysis section
Complete name and address of manufacturer and registrant
"Which name will appear on label- registrant or manufacturer" box is checked
Original signatures
Constituent Materials:
- Identification and description of all materials used in the production of the end product (include all formulants; dust control anticaking agents etc.)
- Proportion of the materials
- The source of the materials used
  Please note that the source information should include:
  - d) Country of origin;
  - e) Brief description of manufacturing process (i.e. by-product of another process, mining of materials, composting, synthesis etc.); and
  - f) Name of the distributor/supplier.
- If the above information is not directly available to the applicant, the distributor may submit it to the CFIA directly, and it will be protected as confidential business information. Please note that multiple potential sources for an ingredient can be submitted at the time of product registration. Any changes to the ingredients, their sources or the supplier(s) will require a major amendment to the product registration.
Other qualities:
- Physical characteristics (product formulation, e.g. granular, liquid)
- Description of the manufacturing / blending process
- Size guide number SGN (for blending products)

Registration Fee:

Re-Registration ($250.00 + HST)
Safety data review – if required ($500.00 + HST)
Efficacy data review – if required ($250.00 + HST)
The maximum fee payable for the consideration of an application = $1000.00 + HST

Designation of Signing Authority or written indication that signing authority is unchanged from previously provided information (see section 3.1.2)

Declaration of Canadian Agent Form (if residing outside of Canada) or written indication that Canadian Agent is unchanged from previously provided documentation (see section 3.1.3 and Appendix B).

Four (4) sets of analyses of the end-product for (Include method of analysis and sampling interval dates) for all guaranteed nutrients.

# of Batches/Lots* produced within a 3 year period	# of Sample analyses required (one analysis per individual batch)
1	1
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

Please also indicate the number of batches/lots produced within the three (3) year period preceding the file submission (used to determine the number of metal analyses required).

Safety and/or Efficacy Data (if product/ingredient/active is not on the efficacy or safety exemption list – see Appendix C).

3.4 What if I want to change my product and/or the product label?

Any changes to the label, chemical composition, ingredients or product formulation must be identified and submitted to the Fertilizer Section for review. The change(s) must be approved prior to its implementation to ensure continued product compliance. Amendments to a product registration can be made at the time of re-registration or between re-registrations. Amendments to a product registration are divided into two distinct categories: minor amendments and major amendments.

Minor amendments consist of changes to one or more of the following: the name or address of the registrant or manufacturer, the colour or format of the label, the product name or brand name, and the declaration of net contents. A fee of $50.00 + HST is charged for a minor amendment to a product registration, if the minor amendment is submitted between re-registration periods. If the amendment is submitted at the time of re-registration, there is no additional cost and the re-registration fee of $250.00 + HST is charged.

Major amendments are defined as any change(s) to the product registration other than the ones described above for a minor amendment. Major amendments can include, but are not limited to: changes to guarantees, substitution of constituent materials (that are not deemed equivalent – e.g. compost to Urea), addition of new ingredients to the product, changes to directions for use, etc. A major amendment includes a renewal of the product registration for up to a maximum of three years; therefore, the fee for a major amendment is $350.00 + HST.

3.4.1 What do I need to submit for a minor amendment review?

The following is a list of the minimum amount of information that needs to be submitted in order for the minor amendment application to be reviewed. The Crop Inputs Division reserves the right to request additional information to accurately assess the safety and efficacy of the product based on the information that has been submitted.

A cover letter explaining the intent of the submission and outlining the requested amendment.

A copy of the proposed marketplace product label (or its electronic version).

A "Fertilizer or Supplement Registration Application" form with original signatures, including:

Registration submission type (Specialty Fertilizer (Micronutrient) box is checked)
Brand of product (if any)
Name of product
Constituent Materials:
- Identification and description of all materials used in the production of the end product (include all formulants; dust control anticaking agents etc.)
- Proportion of the materials
- The source of the materials used
  Please note that the source information should include:
  - g) Country of origin;
  - h) Brief description of manufacturing process (i.e. by-product of another process, mining of materials, composting, synthesis etc.); and
  - i) Name of the distributor/supplier.
- If the above information is not directly available to the applicant, the distributor may submit it to the CFIA directly, and it will be protected as confidential business information. Please note that multiple potential sources for an ingredient can be submitted at the time of product registration. Any changes to the ingredients, their sources or the supplier(s) will require a major amendment to the product registration.
Other qualities (if not provided on registration form, give reference to location):
- Physical characteristics (product formulation, e.g. granular, liquid) of the end-product;
- Description of the manufacturing / blending process of the end-product.
The percent of nutrients in the "Guaranteed Analysis" section.
Complete name and address of manufacturer(s) (list all sites) and registrant.
"Which name will appear on label – registrant or manufacturer" box is checked.
Signature (electronic signatures are not permitted, but a scanned copy of the form with an original signature is acceptable) and date of signature of authorized representative (please also print names).
Signature of Canadian agent (if required) (please also print names).
Payment information.

Minor Amendment Fee (Canadian Dollars):

Minor amendment $50 + HST

Provide additional/new signing authority if required (see section 3.1.2).

Provide additional/new Canadian Agent if required (see section 3.1.3 and Appendix B).

Since minor amendments only include changes to the name or address of the registrant, the colour or format of the label, the product name, and the declaration of net contents, the constituent materials and the qualities of the product must remain the same as the currently registered product.

3.4.2 What do I need to submit for a major amendment review?

The following is a list of the minimum amount of information that needs to be submitted in order for the major amendment application to be opened. The Crop Inputs Division reserves the right to request additional information to accurately assess the safety and efficacy of the product based on the information that has been submitted.

A cover letter explaining the intent of the submission and outlining the requested amendment.

A copy of the proposed marketplace product label (or its electronic version).

A "Fertilizer or Supplement Registration Application" form with original signatures, including:

Registration submission type (Specialty Fertilizer (Micronutrient) box is checked)
Brand of product (if any)
Name of product
Constituent Materials:
- Identification and description of all materials used in the production of the end product (include all formulants; dust control anticaking agents etc.)
- Proportion of the materials
- The source of the materials used
  Please note that the source information should include:
  - j) Country of origin;
  - k) Brief description of manufacturing process (i.e. by-product of another process, mining of materials, composting, synthesis etc.); and
  - l) Name of the distributor/supplier.
- If the above information is not directly available to the applicant, the distributor may submit it to the CFIA directly, and it will be protected as confidential business information. Please note that multiple potential sources for an ingredient can be submitted at the time of product registration. Any changes to the ingredients, their sources or the supplier(s) will require a major amendment to the product registration.
Other qualities (if not provided on registration form, give reference to location):
- Physical characteristics (product formulation, e.g. granular, liquid) of the end-product;
- Description of the manufacturing / blending process of the end-product.
The percent of nutrients in the "Guaranteed Analysis" section.
Complete name and address of manufacturer(s) (list all sites) and registrant.
"Which name will appear on label – registrant or manufacturer" box is checked.
Signature and date of signature of authorized representative (please also print names).
Signature of Canadian agent (if required) (please also print names).
Payment information.

Major amendment fee (Canadian Dollars):

Major amendment $350 + HST

Provide additional/new signing authority if required (see section 3.1.2).

Provide additional/new Canadian Agent if required (see section 3.1.3 and Appendix B).

Safety and/or Efficacy data (if there is a change to the ingredients, guarantees, or product application rates/directions; and the product/ingredient/active is not on the efficacy or safety exemption list) (see Appendix C).

Four (4) sets of analyses of the end-product for (Include method of analysis and sampling interval dates) for all guaranteed nutrients.

# of Batches/Lots* produced within a 3 year period	# of Sample analyses required (one analysis per individual batch)
1	1
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

Please also indicate the number of batches/lots produced within the three (3) year period preceding the file submission (used to determine the number of metal analyses required).

3.5 Can my registration be cancelled?

The certificate of registration may be cancelled at any time if there is reasonable certainty that there has been a violation of the Fertilizers Act and Regulations. The registrant will be advised by way of a notice, sent by registered mail. The registrant then has 30 days from the date of mailing to apply for an appeal.

3.6 What are the labelling requirements for a micronutrient fertilizer?

The Fertilizers Regulations specify what must be on the label of a micronutrient fertilizer in both general and specific terms. The following sub-sections, along with Appendices D and E, will aid in clarifying the labelling requirements of the Fertilizers Regulations, and outline any policies derived from the Fertilizers Regulations that are applicable to micronutrient fertilizers. In all cases the approved and registered product label must match the label being used in the marketplace.

3.6.1 General

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.

3.6.2 The main panel of the product label

The main panel of the label is considered to be the "principal display panel". This panel must display at least the product name, the product weight and the name and address of the registrant or the manufacturer.

3.6.3 Addresses

A complete address must include: company name, street address or P.O. Box, City, Province or State, Postal or Zip Code, and country if not in Canada. If an address stated on the label refers to the place of manufacture of the container, this must be clearly indicated (e.g., "bags manufactured by:"). If the product is packaged outside Canada, contains a Canadian address on the label, and is imported for resale in Canada, the words "imported by" or "imported for" must precede the Canadian address, unless the geographic origin of the pre-packaged product is also stated on the label.

3.6.4 Lettering, fonts, coloring, 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 coloring of the lettering of the information required to be on the label must contrast with the background of the label. All information must be printed in a font size that would be legible from a normal distance without the aid of magnifying devices.

3.6.5 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
514-873-6565
1-888-873-6202
Internet: www.oqlf.gouv.qc.ca

3.6.6 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. Accordingly, all units of measurement must be in the metric system. If the manufacturer wishes to use imperial units of measure, the imperial measurement must be enclosed in brackets following the metric equivalent, or in a separate column of a provided table. All conversions must be accurate.

3.6.7 Net Weight

All micronutrient fertilizers must be sold by weight. 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.

3.6.8 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.

3.6.9 Product Name

The name used for a product must not deceive or mislead the purchaser with respect to the composition or utility of the product. The names of micronutrient fertilizers can, but are not required to include, the guaranteed micronutrients (name or chemical symbol) and their amounts in the fertilizer. However, if one micronutrient is listed in the name then all guaranteed micronutrients must be listed. If a company chooses to include "chelated" in the product name, the micronutrient and amount chelated (percentage) must be in the name, so the purchaser is not misled to believe that the micronutrients within the product are 100% chelated. If all the guaranteed micronutrients are 100% chelated the word "chelated" can appear in the product name alone. To further describe the product, words may be included such as: "Liquid", or "Lawn (or Turf)". The product name may also incorporate the name of the crop on which the product is to be used, however, no names or designation of any type or types of soil are acceptable.

EXAMPLE: Eureka 5% Iron Fertilizer

3.6.10 Guaranteed Analysis

All micronutrient fertilizer labels must have a guaranteed analysis section. The inclusion of a guarantee for a substance is viewed as a claim regarding the activity of that substance. Therefore, only those substances that are known to be or have been shown to be effective may be guaranteed on a product label. Zero (0) guarantees and registered trademarks or statements are not acceptable and must not appear in the guaranteed analysis section.

Each nutrient should be identified on a separate line in the guaranteed analysis section and the elemental symbols and percent must be included. The guaranteed analysis should be described as the "Guaranteed Minimum Analysis" when the guarantees are principally for elements guaranteed on a minimum basis (i.e., calcium, magnesium, and sulphur). All nutrients are to be expressed as percent of individual plant nutrient in relation to the total product by weight. Sample labels are included in Appendix D to show examples of the format in which the guarantees should appear.

Micronutrients are to be guaranteed as an actual amount expressed in percent on an elemental basis. If calcium (Ca), magnesium (Mg) and sulphur (S) are to be guaranteed they must be guaranteed as a minimum amount expressed in percent on an elemental basis. If the micronutrient(s) and/or Ca, Mg, S, do not meet the minima found in Table 1 (below), reference to the nutrient may not appear on the label.

However, if the guarantees are for water soluble lesser nutrients in:

ready to use foliar fertilizers,
ready to use specialty liquid fertilizers labelled for daily use,
hydroponic or continuous liquid feed programs, or
potting soils;

the guarantees do not need to meet the minima outlined in Table I. These products must still be efficacious based on the recommended rate of application. In addition, no product can have nutrient guarantees below the CFIA laboratory's limit of quantification (detection limit) listed in Table I.

Table I: Minimum levels of lesser plant nutrients that may be guaranteed
ELEMENT	Minimum (%)	Limit of Quantification (%)
Calcium (Ca)	1.0000	0.0130
Magnesium (Mg)	0.5000	0.0030
Sulphur (S)	1.0000	0.0030
Boron (B)	0.0200	0.0002
Chloride (Cl)	0.1000	0.1000
Copper (Cu)	0.0500	0.0110
Iron (Fe)	0.1000	0.0020
Manganese (Mn)	0.0500	0.0010
Molybdenum (Mo)	0.0005	0.0005
Zinc (Zn)	0.0500	0.0020

Chelated micronutrients must be noted in the guaranteed analysis, and the amount of the chelating agent must be guaranteed on a minimum basis. If only part of the micronutrient is chelated, the degree of chelation must also be shown.

Tobacco fertilizers must include the minimum and maximum amounts of chloride expressed in per cent on the elemental basis.

3.6.11 Registration Number

The registration number of the micronutrient fertilizer must appear on the label, in the following manner or a similar manner:

Registration Number xxxxxxxB Fertilizers Act

Where "xxxxxxxB" 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 products at that time in that year (next 3 digits), and the suffix letter denoting the type of product (B = micronutrient fertilizer).

3.6.12 Directions for Use

Directions for use are required for micronutrient fertilizers. Recommendations for, or the promotion of, indiscriminate use of micronutrients are not acceptable. The directions for use section must include one of the following options:

a) Complete recommendations must be given. The recommendations must identify the crop, together with the recommended rate, timing of application and/or frequency of use, and the dilution if applicable;
b) If the product is intended only for use in blended/formulated fertilizers, a statement such as the following:
e.g. Only for Use in Blended Fertilizers; or
c) A statement indicating that the product is only to be used to treat micronutrient deficiencies, and the user should seek the advice of an agricultural representative or a professional agricultural consultant.

In all instances, 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. The Crop Inputs Division also recommends that all micronutrient fertilizers be labelled with a statement indicating that the user should seek the advice of an agricultural representative or a professional agricultural consultant.

When specific application rates are listed on the label, these rates combined with the guaranteed level of nutrient(s) and their solubility, must supply an efficacious amount of at least one the nutrient(s) that are guaranteed, in terms of meeting the nutritional needs of the crop. Alternatively, where specific label claims are made, these claims must be substantiated with efficacy data.

Although reference to soil types can not be made in a product name, reference can be made to the types of soils on which the product may be applied (e.g. Sandy soil) in an effort to better convey the conditions in which the product will be efficacious, or to differentiate application rates based on soil type.

In general, foliar application has proven to be an effective method of supplying micronutrients to deficient crops. Seed applications of fertilizer, however, do not necessarily supply a sufficient amount of nutrient to seedlings. Therefore, general recommendations for application of fertilizer to seed are unacceptable, unless data and/or a suitable scientific rationale to substantiate the effectiveness of the product for that use has been submitted to, and accepted by, the Crop Inputs Division. In addition, in instances where on seed use patterns are accepted, the product must be labelled such that the limited effectiveness of the product is clear. An example of this is a statement indicating that "the product is to be used in conjunction with a complete fertilizer program that relates to the fertility level of the soil."

3.6.13 Cautionary Statements

Micronutrient products containing B, Cu, Mn, Mo, and/or Zn, must have the following statement listed on the label:

"CAUTION: This fertilizer should be used only as recommended. It may prove harmful when misused."

Any micronutrient products containing prohibited material as defined by the Health of Animals Act (unless exempt) must bear the following warning statements:

feeding the product to cattle, sheep, deer or other ruminants is illegal and subject to fines or other punishment under the Health of Animals Act,
the product is not to be used on pasture land or other grazing areas for ruminants,
the product is not to be ingested, and
a person should wash his or her hands after the person uses the product.

These warning statements are required to be listed in both English and French, therefore the entire label must be in both English and French. These statements need not be worded exactly as they appear in the Fertilizers Regulations, as long as the intent of each statement is met.

All products containing/coated with a polymer are subject to safety and efficacy reviews, and must have the precautionary statements required by the Fertilizer Safety Office on the product label.

3.6.14 Ingredients List

Although not mandatory, materials used in the formulation of a product may be listed on the label under the heading "Ingredients" or "List of Ingredients". If one ingredient is listed on the label, all ingredients must be listed, and the list provided on the label must match the list provided on the Fertilizer or Supplement Registration Application form. Use of the phrase "Derived from" instead of "Ingredients" or "List of Ingredients" is not acceptable as it implies that the list provided is not complete.

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 Crop Inputs Division 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.

3.6.15 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. Below are examples of claims that are not allowed on a product label, or must be substantiated before appearing on a product label.

comparative 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
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.

If claims such as "certified" or "approved" appear on the label, the certifying body/entity that issued the certification or approval must be indicated on the label and a copy of the certificate must be provided with the registration application. Copies must also be provided upon request to customers.

3.6.16 Seller's

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 thereto. 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."

3.6.17 Lot Numbers

A lot number is defined in Supporting Section A of this Guide 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 micronutrient fertilizers are required to have a lot number listed on their label. The lot number must be printed on each package of a micronutrient fertilizer, or on the shipping bill if the micronutrient fertilizer is sold in bulk. The lot number must be legible and indelible, and should be preceded by a phrase "Lot number", "Batch number", or equivalent where possible. The lot number is necessary to facilitate product traceability and recall if required. Please note that micronutrient fertilizers 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.

3.6.18 Workplace Hazardous Material Information System (WHMIS)

The WHMIS is Canada's standard for hazard communication, and it requires the cautionary labelling of containers of hazardous materials, the provision of material safety data sheets (MSDSs) and worker education programs. The Hazardous Products Act prescribes the supplier/importer labelling and Material Safety Data Sheets (MSDS) requirements of the WHMIS. Section 12 of the Hazardous Products Act lists exemptions from these requirements for certain product categories such as food, pesticides and medical devices. Fertilizers and supplements are not included in any of these exemptions and thus, are subject to the WHMIS requirements legislated under the Hazardous Products Act. Furthermore, fertilizers and supplements are subject to the employer requirements set out by the federal, provincial and territorial (F/P/T) regulatory authorities responsible for occupational health and safety (OHS).

The Government of Canada has established administrative arrangements with F/P/T OHS regulators to conduct inspection for compliance with the WHMIS requirements of the Hazardous Products Act. However, Health Canada remains ultimately responsible for the administration of the Hazardous Products Act and it is the WHMIS program officials at Health Canada who set national regulatory, compliance and enforcement policies. The WHMIS Website was developed and is maintained by Health Canada's WHMIS program on behalf of all federal, provincial and territorial government WHMIS regulatory authorities. The site provides a single-window for national policies and information related to the administration of the WHMIS program in Canada.

The requirements for WHMIS labelling are not administered under the Fertilizers Act and Regulations. However, when the WHMIS label is used on a product subject to the Fertilizers Act, the information contained within the WHMIS label must not contravene the requirements of the Fertilizers Act and Regulations. The WHMIS legislation requires that WHMIS labels be in both English and French. The Fertilizers Act and Regulations requires that product labels be in English, or in French, or both English and French, in which case all of the information must be in both languages. Therefore, labels of products subject to the Fertilizers Act that have bilingual WHMIS labels must be entirely in both English and French.

Cautionary statements required by both the Fertilizers Act and WHMIS need only appear in the WHMIS section of the label. Label information required under the Fertilizers Act, but not required under the WHMIS, such as guaranteed analysis, registration numbers, etc., must be placed outside of the WHMIS hatched border. For products regulated under the Fertilizers Act, WHMIS labelling is required for micronutrient products, and any other product that can be used in the workplace. It is the responsibility of the supplier/importer to ensure that product labelling complies with both the Fertilizers Act and the WHMIS.

All information pertaining to WHMIS labelling, including MSDS requirements, classifications, exemptions and enforcement can be found in the WHMIS Reference Manual. The WHMIS Reference Manual provides a section-by-section description of the federal legislation which sets out the Canadian supplier and Canadian importer labelling and MSDS requirements. The manual, which includes a comprehensive index, is posted on the national WHMIS Web site.

or by contacting Health Canada at:

National WHMIS Office, Health Canada
MacDonald Building
123 Slater Street, AL 3504D
4th Floor
Ottawa, Ontario
K1A 0K9
Tel: 613-957-2342

3.6.19 Websites

Any company selling a product with a label containing a URL for a website must ensure that the information on the website concerning the product matches the information presented on the label, and that the information on the website does not contravene the Fertilizers Act and Regulations.

3.6.20 Labelling of Seed Coated with a Micronutrient Fertilizer

Seed to which a micronutrient fertilizer is applied must be labelled with the following information:

the name of the crop kind and kind of product (coated seed);
the grade of the seed;
the lot number of seed and fertilizer;
the percent by weight of seed and non-seed material;
the fertilizer grade of the coated seed product (grade must be based on the total weight of seed plus fertilizer);
the guaranteed analysis, where guarantees are expressed as a percentage of the total product weight (seed and fertilizer);
a statement indicating that the product is to be used in conjunction with a complete fertilizer program that relates to the fertility level of the soil;
the net weight of the seed and fertilizer; and
the name and address of the seller.

3.7 What standards does my micronutrient fertilizer need to adhere to?

3.7.1 Efficacy

As previously described, micronutrient fertilizers must be registered prior to importation into or sale in Canada. Products containing micronutrients, such as NPK fertilizers with a grade of 24% or more, or 18% or more for organic based products, may not require registration but are still regulated under the Fertilizers Act and Regulations. Generally, all fertilizers and supplements sold in Canada, and/or imported into Canada, must be safe, efficacious and properly labelled. Thus, efficacy assessments are a key element of the registration/approval process for products regulated under the Fertilizers Act.

The following efficacy data requirements apply not only to micronutrient fertilizers (i.e. requiring registration), but to all regulated products represented as containing micronutrients. The subsequent paragraphs focus on the: (1) efficacy data requirements for micronutrients and the related exemptions, (2) water solubility analysis for micronutrient fertilizers, (3) acceptable minimum number of trials when field or/and controlled environment trials are used in support of the efficacy of the product, (4) acceptable measurable parameters, and (5) soil analysis for the trial locations. Please note the requirements outlined in Trade Memorandum T-4-108: Efficacy data requirements for fertilizers and supplements regulated under the Fertilizers Act still apply, unless a specific requirement is addressed herein.

3.7.1.1 Micronutrient Efficacy Data Exemptions

The common forms of micronutrient fertilizers are inorganic and chelated. Under favorable climatic conditions, the effectiveness of a given micronutrient fertilizer in either form is related to its chemical and physical composition, as well as the application method used.

Based on a scientific literature review of micronutrient fertilizers in inorganic and chelated forms, the Crop Inputs Division has exempted the following micronutrient fertilizers from the submission of efficacy data to support their registration/approval:

micronutrient fertilizers (both soil and foliar-applied) represented as being chelated with ethylenediamine-tetraacetic acid disodium salt (EDTA), diethylenediamine-pentaacetic acid (DTPA), ethylenediamine-di-o-hydroxyphenylacetic (EDDHA) and N-(2-hydroxyethyl) ethylenediamine-N, N', and N'-triacetic acid trisodium salt (HEDTA);
soil-applied micronutrient fertilizers with greater than or equal to 40% water-solubility;
foliar-applied micronutrient fertilizers; and
- Historically, there has been no requirement to furnish the Crop Inputs Division with efficacy data for foliar-applied micronutrients, regardless of solubility. In the future, the Crop Inputs Division may revisit the issue of solubility of foliar-applied micronutrients, but at this time the current policy remains enacted; any micronutrient fertilizers represented solely for foliar application continue to be exempted from efficacy data requirements.
any micronutrient fertilizer labelled only for blending purposes with NPK fertilizers.

3.7.1.2 Water-Solubility Analyses

Submission of certificates of analysis showing nutrient water-solubility is required for all soil-applied micronutrient fertilizers. The Crop Inputs Division requires three (3) sets of water solubility analysis, for each claimed micronutrient, from three separate lots or batches of product. Analysis will be required for all soil-applied micronutrient product registrations or approvals, at re-registration, and whenever product formulation or constituent ingredients are amended.

Please note that Section 23 of the Fertilizers Regulations states, "Except as otherwise authorized by the Director, the methods of chemical analysis used to test a fertilizer or supplement shall be the latest methods published and approved by the Association of Official Analytical Chemists" (now referred to as the Association of Analytical Communities – AOAC). Please ensure that the methods used to generate the water solubility analysis are either approved by the Director of the Crop Inputs Division, or are published methods of the AOAC.

3.7.1.3 Efficacy Labelling

The Crop Inputs Division recommends that micronutrient water solubility be included in the Guaranteed Analysis of the marketplace label. Although not mandatory, when included in the Guaranteed Analysis, the water solubility should be represented as a minimum percentage value of the actual content of every claimed micronutrient. For example:

Zinc (Zn) (actual) 10%
40% water soluble

Additional labelling requirements for micronutrient fertilizers (including directions for use) can be found in Section 3.6.12.

3.7.1.4 Acceptable Minimum Number and Locations of Trials

Please note that T-4-108 provides the option of supporting product efficacy with a scientific rationale or field trials, or a combination of the two; please refer to T-4-108 for information concerning the requirements for a scientific rationale. Please note the requirements outlined in Trade Memorandum T-4-108: Efficacy data requirements for fertilizers and supplements regulated under the Fertilizers Act still apply, unless a specific requirement is addressed herein.

Where a product proponent wishes to support micronutrient product efficacy with field trials, the trials may be conducted in a controlled environment (e.g., growth chamber or greenhouse) and/or in field conditions over a single year. A minimum of 4 trials is required and a minimum of 60% of the trials must demonstrate a statistically significant positive response compared to an unfertilized control. A significance level of 5% is required for greenhouse trials.

When a micronutrient fertilizer is intended to be used for soil application, the soils used in the efficacy trials must be representative of those soil types in the region(s) were the product is intended to be used. Likewise, the climatic conditions in the environment where the trials are conducted should be similar to those in the region(s) where the product is intended to be used. Trials conducted outside Canada may be accepted with a rationale demonstrating that the climatic and soil conditions are comparable or equivalent to those found in the Canadian region(s) where the product is intended to be used.

3.7.1.5 Measurable parameters

As per T-4-108, efficacy is defined as the ability of a fertilizer or supplement to fulfill any label claims and to produce a desired or intended result based on the labelled guarantees and directions for use. Where the intended benefit of the micronutrient fertilizer is to treat an identified deficiency, and the product is labelled as such, crop yield should not be the only measurable parameter used to demonstrate the efficacy of the micronutrient fertilizer. Indeed, some studies showed increased micronutrient uptake without significant increase in crop yield. Therefore, tissue analysis for the micronutrients of interest is a relevant measurable parameter that can be used in order to show fertilizer efficacy for these products.

Most micronutrients are relatively immobile in planta. Therefore, analysis of older plant tissue (e.g., established leaves) may not show differences in nutrient concentration with the application of a micronutrient fertilizer. When tissue analysis is chosen to demonstrate fertilizer efficacy, new vegetative growth (i.e., actively growing tissue) should be used and compared to similar tissues from an unfertilized control to show uptake of the micronutrient of interest. Results of analysis showing the method of analysis used and plant tissue concentrations of the micronutrient of interest must be submitted to the Crop Inputs Division as part of the efficacy data package.

3.7.1.6 Soil Analysis

A number of variables relating to the soil, such as texture, moisture content, fertility, organic matter content and pH, may measurably influence the efficacy of a product, in the case of a soil treatment. Thus, these factors must be considered in selecting the sites of the tests, and should be documented. Therefore, soil analysis for the trial locations (both field and/or greenhouse/growth chamber), before application of the treatments, should be provided, which should include the soil zone and type, percent organic matter, soil pH, nutrient content (including the micronutrients of interest), and cation exchange capacity (CEC).

3.7.2 Safety

All micronutrient fertilizers regulated under the Fertilizers Act and Regulations must be safe with respect to human, plant, animal health and the environment. More specifically, the product must not contain:

any substances detrimental or seriously injurious to vegetation (except weeds), domestic animals, public health or the environment when used as directed;
any substance that would leave poisonous or harmful residues in plant tissues; or
Specified Risk Materials unless authorized by a permit issued under the Health of Animals regulations.

The Crop Inputs Division has established general safety standards that must be adhered to in order for micronutrient fertilizers to be deemed compliant with the Act and Regulations. These include standards for metals, microorganisms and organic contaminants.

3.7.2.1 Metal Standards

Standards for metals have been implemented due to the potential long-term adverse effects of metals in soils. Some metals are relatively toxic to plants, animals, and humans and have the potential to persist and accumulate in soils over time. The concentrations at which adverse effects occur are subject to a number of factors including the background levels of metals in the area, as well as factors that affect metal availability such as soil acidity, soil cation exchange capacity, organic matter content and soil structure.

The Crop Inputs Division's metal standards (Table II) are based on the maximum acceptable cumulative metal addition to soils over a 45 year period as opposed to a maximum acceptable concentration in the product per se. This approach is designed to limit the cumulative environmental load and thus long term impacts of product use. Furthermore, the 45 year time interval is used to ensure that repeated fertilizer application does not significantly impact/alter the background levels of metals in soil and lead to net deterioration of soil quality from generation to generation.

Some metals are also recognized micronutrients and may be applied in quantities that exceed the metal standards in an effort to correct for known soil micronutrient deficiency. In those instances, the micronutrient fertilizer must still meet all the prescribed labelling requirements (including guaranteed analysis) and analytical tolerances set out in the Fertilizers Regulations.

Table II: Maximum acceptable cumulative metal additions to soil (kg/ha/45 years)
METAL	CONCENTRATION (kg/ha/45 years)
Arsenic	15
Cadmium	4
Cobalt	30
Chromium	210
Copper	150
Lead	100
Mercury	1
Molybdenum	4
Nickel	36
Selenium	2.8
Zinc	370

The maximum acceptable level for a metal in a micronutrient fertilizer is calculated as follows:

[ ] maximum acceptable x = ([ ]x/(45 x Annual Product Application Rate)]) x 1,000,000

where: x = metal of concern

[ ]max acceptable x = maximum acceptable level for a metal in a micronutrient product in parts per million (ppm).

[ ]_x = the maximum acceptable cumulative metal additions to soil over 45 years for that metal being calculated from Table II.

45 years = representing an average period of time a person farms thus ensuring the land is returned to the next generation in the same condition as they received it.

Annual Product Application Rate – in units of kilograms per hectare (kg/ha) as indicated on the label.

Acceptable levels of other metals are considered on a case by case basis.

3.7.2.2 Contaminating Microorganisms

The contaminating microorganism standards currently used by the CFIA are based on indicator organisms: namely Salmonella and faecal coliforms. These organisms are used to verify the effectiveness of product processing and treatment, and serve as indicators of the potential presence of other contaminant microorganisms in the product. In order for a product to be deemed compliant it must test negative for Salmonella (non-detectable), and the Most Probable Number (MPN) of faecal coliforms must not exceed 1000 MPN per gram of product. The respective detection limits are: less than 1 cfu/25 gram for Salmonella and less than 2 cfu/gram for faecal coliforms.

Depending on the nature and source of the ingredients/materials used to manufacture the micronutrient fertilizer, the Fertilizer Safety Office may request analysis to demonstrate that the final product does not contain microorganisms at levels that are likely detrimental or seriously injurious to plants, animals and human health and environment. This analysis may be requested to support product registration or re-registration.

3.7.2.3 Organic Contaminant Standards

Currently, the only organic contaminant standard used by the Crop Inputs Division is for polychlorinated dibenzo-p-dioxins (dioxins) and polychlorinated dibenzofurans (furans). All other organic contaminants are considered on a case by case basis.

The standard for dioxins and furans is based on both a maximum cumulative application to soil and a maximum concentration in the final product. The maximum acceptable cumulative addition to soil is 5.355 mg TEQ/ha over a 45 year period (where TEQ = Toxic Equivalency Quotient); the maximum permissible dioxin and furan concentration in a product is 100 ng TEQ/kg product.

Depending on the nature and source of the ingredients/materials used to manufacture the micronutrient fertilizer, the Fertilizer Safety Office may request one (1) set of analysis for dioxins and furans to support product registration or re-registration for micronutrient fertilizers containing or made from waste materials.

3.7.2.4 Safety Data Requirements

Safety assessments in support of product registration and/or approval are conducted by the Fertilizer Safety Office largely on a case-by-case basis and the information required to complete the assessment varies depending on the product type, ingredients (both active and inert), their sources, degradation by-products, manufacturing process, use pattern and application rate. In general, products may require the submission of either 1) core safety data; 2) core safety data with results of analysis; or 3) a full safety data package.

3.7.2.4.1 Core Safety Data

Core safety data consists of the following:

Complete list of ingredients including their sources, CAS numbers (if available) and proportions. Please note that the source information should include:
- a. Country of origin;
- b. Brief description of production process (i.e. by-product of another process, mining of materials, composting, synthesis etc.); and
- c. Name of the distributor/supplier.
If the above information is not directly available to the applicant, the distributor may submit it to the CFIA directly, and it will be protected as confidential business information. Please note that multiple potential sources for an ingredient can be submitted at the time of product registration. Any changes to the ingredients, their sources or the supplier(s) will require a major amendment to the product registration.
Material Safety Data Sheet (MSDS) for ingredients and/or product (if available);
Method of manufacture of final product.

3.7.2.4.2 Core Safety Data and Results of Analysis

Core safety data and results of analysis consist of information outlined in section 3.7.2.4.1 along with the results of analysis depending on the product ingredients. The results of analysis must include:

# of Batches/Lots* produced within a 3 year period	# of Sample analyses required (one analysis per individual batch)
1	1
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

Please also indicate the number of batches/lots produced within the three (3) year period preceding the file submission (used to determine the number of metal analyses required).

and may also include one or more of the following, upon request:

Four sets of analyses for faecal coliform and Salmonella;
One set of analysis for dioxins and furans.

Generally, all micronutrient fertilizers require core safety data and results of analysis.

3.7.2.4.3 Full Safety Data Package

Depending on the product type, guidance on the type of information required in a full safety data package can be found in one or more of the following Trade Memoranda:

Micronutrient fertilizers requiring a full safety data package include:

Polymer coated micronutrients with or without N, P, K fertilizers
Nano-encapsulated micronutrients with or without N, P, K fertilizers

NOTE: The 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.

3.7.3 Guarantee tolerances

When formulating a product to meet a consistent guaranteed amount of the active ingredient, analytical results used to confirm this level will generally show slightly more or slightly less active ingredient than is guaranteed. Accordingly, a limited degree of variability is acceptable, and specific tolerance limits for this variability are set out in Table III. These are analytical tolerances and not manufacturing tolerances. For some guarantees, both maximum and minimum levels have been established. The maximum levels have been established to prevent toxicity while minimum levels help to ensure efficacy.

Table III: Regulatory and administrative analytical tolerances for nutrient guarantees.
ACTIVE INGREDIENT	GUARANTEED AMOUNT	ALLOWED VARIABILIY (g = label guarantee)
Boron, Copper, Iron, Manganese, Molybdenum, Zinc	Under 1%	deficiency or excess = [g * 0.25]
Boron, Copper, Iron, Manganese, Molybdenum, Zinc	1% and over	deficiency or excess = [0.15 + (g * 0.10)] = max 1%
Calcium (Ca), Magnesium (Mg) and Sulphur (S)¹	Under 1%	deficiency = [g * 0.25]
Calcium (Ca), Magnesium (Mg) and Sulphur (S)¹	1% and over	deficiency = [0.15 + (g * 0.10)] = max 1%
Chloride	all amounts	minimum guarantee – deficiency = 0.2% maximum guarantee – excess = 0.2%

¹ – administrative tolerance.

Below are some sample calculations for determining the allowable tolerance around guarantees and the minimum/maximum allowable analytical result:

1) Guarantee of 4% Iron
Tolerance = [0.15 + (4 * 0.10)] = 0.55%
Minimum allowable analytical result = 3.45%
Maximum allowable analytical result = 4.55%

2) Guarantee of 0.5% Boron
Tolerance = [0.5 * 0.25] = 0.125%
Minimum allowable analytical result = 0.375%
Maximum allowable analytical result = 0.625%

3) Guarantee of 5% Chloride
Tolerance = [5 +/- 0.2]
Minimum allowable analytical result = 4.8%
Maximum allowable analytical result = 5.2%

3.8 What are the import requirements for micronutrient fertilizers?

Fertilizers that require registration in Canada prior to sale must also be registered prior to importation. However, there are two exceptions to this requirement:

Fertilizer materials that are imported for manufacturing purposes only and that require further treatment prior to sale are exempt from the provisions of the Fertilizers Act, as per section 3.(1)(d) of the Fertilizers Regulations, and
Fertilizers that are imported for direct application to soil by the importer and that are not offered for re-sale in Canada are exempt from the provisions of the Fertilizers Act, as per Section 3.(1)(f) of the Fertilizers Regulations.

To determine the import requirements for a particular product, please consult our Automated Import Reference System (AIRS).

For your reference, micronutrients are found under the Harmonized System (HS) code 382490, where

38 = Miscellaneous chemical products
24 = Prepared binders for foundry moulds or cores; chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included.
90 = Other

Under this HS code, micronutrients are further classified under the following Other Government Department (OGD) extensions:

6011 = Micronutrients
6015 = Mixtures of secondary plant nutrients and micronutrients

Import requirements under each OGD extension then depend on the End Use of the product.

3.9 Contact Information

If you have any questions about completing an application for registration for a micronutrient fertilizer please do not hesitate to contact the Crop Inputs Division.

Mail:
59 Camelot Drive
Ottawa, ON
K1A 0Y9
E-mail: fertilizer@inspection.gc.ca
Phone: 613-773-7189
Fax: 613-773-7163

Appendix A: Fertilizer or Supplement Registration Application form

CFIA/ACIA 3778 – PDF (642 kb)

Guidelines to Completing the Fertilizer or Supplement Registration Application

This document was created to assist registrants/applicants to thoroughly and accurately complete the Fertilizer or Supplement Registration Application Form. As a legal document, the form is required to be completed in its entirety. The Fertilizer Section of the Crop Inputs Division reserves the right to return a Fertilizer or Supplement Registration Application to the applicant if the form is deemed incomplete, or if the information provided does not exactly match the information stated on the accompanying label.

PRODUCT TYPE (mandatory)

Supplement Registration box must be selected if registering a substance or a 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. If supplement claims are made on the label, the product will be considered a registerable supplement. Registerable supplements can be chemical in nature (e.g. plant growth regulators, wetting agents) or microbial (contain viable microorganisms).

Specialty Fertilizer (Micronutrient) Registration box must be selected if registering a micronutrient fertilizer (containing boron (B), chloride (Cl), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and/or zinc (Zn) but not containing nitrogen (N), phosphorous (P) or potassium (K)).

Fertilizer-Pesticide Registration box must be selected if registering a fertilizer containing a pesticide listed in the Compendium of Fertilizer-Use Pesticides (CFUP).If pesticide or disease resistance claims are made on the label, and the pesticide is not listed in the CFUP, approval and/or registration from the Pest Management Regulatory Agency (PMRA) may be required.

Low Analysis Farm Fertilizer Registration box must be selected if registering a low analysis farm fertilizer (farm fertilizer with <24% NPK combined or with <18% NPK combined with at least 50% vegetable or animal origin and 25% water-insoluble nitrogen).

BRAND NAME (if applicable)

Brand refers to any distinctive mark or trade name, other than the name and grade required by the Fertilizer Regulations, that is applied by the manufacturer, registrant or vendor to distinguish the fertilizer or supplement from any other product. The brand must be identical to the brand name found on the marketplace label. If the brand name is bilingual on the label (appears differently in French and English), both the French and English wording must be included on the registration form.

NAME AND/OR GRADE (mandatory)

The name should be identical to the product name found on the marketplace label. If the product name is bilingual on the label (appears differently in French and English), both the French and English wording of the name must be included on the registration form.

The product name must include the following:

grade (for registerable products represented to contain any of the major nutrients N, P and/or K, e.g. 10-0-20). In the case of mixed fertilizers the numerals must be in whole numbers only, and
percentage and name of the micronutrient, pesticide or plant growth regulators guaranteed. The terms "with micronutrients", "micronutrient mix", etc. are also acceptable if two or more micronutrients are present.

CONSTITUENT MATERIALS (mandatory)

Include a complete list of ingredients used in the production of the end product including active and inert ingredients such as formulants and carriers. If registering a fertilizer-pesticide, all Pest Control Product (PCP) registration numbers must be included in this section. If an "Ingredients" section is found on the label, it must match the list of ingredients on the registration form.

OTHER QUALITIES (mandatory)

Include the physical characteristics of the product (e.g. liquid, granular, etc.) and a complete description of the manufacturing process. Reference may be made to attached documentation (e.g. MSDS, separate sheet with full method of manufacture, etc.) by including the text "see attached method of manufacture" or "refer to attached MSDS". If unchanged from previous re-registration, "refer to product file" is acceptable.

GUARANTEED ANALYSIS (mandatory)

Enter the percentage of each plant nutrient, pesticide and/or supplement active ingredient (if microbial, number per gram of product) found in the Guaranteed Analysis section of the product label. The minimum amount of organic matter, maximum moisture content and minimum amount of chelating agent must be included in this section, if applicable.

Note: For supplement products, the method of analysis for the active ingredient(s) must be included in the submission package.

NAME AND ADDRESS OF MANUFACTURER (mandatory)

A manufacturer is considered to be the company or individual who produces the final product. The manufacturers name and full postal address found on the registration form must be exactly the same as the name and address of the manufacturer found on the marketplace label (if applicable). Note that all manufacturing sites must be included. Therefore, reference can be made to attached documentation by including a statement such as "refer to attached list of manufacturing sites".

NAME AND ADDRESS OF APPLICANT (REGISTRANT) (mandatory)

An applicant (registrant) is a person who makes an application for registration or who has been issued a certificate of registration under the Fertilizers Act and Regulations. The applicant's name and full address found on the registration form must match the name and address of the applicant on the marketplace label (if applicable). If the name and address of the applicant is the same as the manufacturers name and address, it is acceptable to enter "same as manufacturer".

WHICH NAME WILL APPEAR ON THE LABEL? REGISTRANT MANUFACTURER (mandatory)

Check the registrant or manufacturer box to match what appears on the label. Please note that information that appears on the label of a registered product must be the same as the information on the certificate of registration.

SIGNATURE OF AUTHORIZED REPRESENTATIVE (mandatory)

Within this section, a clearly printed name and the accompanying signature of an authorized representative is necessary in order to proceed with the registration of a product. A corporation, partnership, sole proprietorship or individual must provide the Crop Inputs Division with a letter authorizing individuals to sign fertilizer registrations on behalf of the company.

NAME, ADDRESS AND SIGNATURE OF RESIDENT AGENT IF APPLICANT IS NOT RESIDENT IN CANADA (if applicable)

It is not mandatory that a registrant/applicant resides in Canada. However, as stated in the Fertilizer Regulations, if the applicant does not reside in Canada, the fertilizer or supplement is not eligible for registration unless the application is signed by an agent of the applicant who is a permanent resident in Canada and to whom any notice or correspondence under the Act may be sent.

Appendix B: Declaration of Resident Canadian Agent

CFIA/ACIA 1194 – PDF (65 kb)

Appendix C: Efficacy and Safety Exemption Lists

Products that do NOT require Efficacy Data to support approval or registration

Fertilizers:

Soil-applied chemical N-P-K fertilizers that contain greater than 24% total N-P-K, and are not comprised of new slow or controlled release technology
Organic and organic based N-P-K fertilizers (e.g. processed waste) with greater than 18% total N-P-K
Lesser plant nutrients; Calcium (Ca), Magnesium (Mg) (=40% water soluble), and Sulphur (S)
Products that meet section a) of the definition of a Specialty Fertilizer (i.e. recommended for use only on household plants, urban gardens, lawns or golf courses or in nurseries or greenhouses), meet the nutritional needs of the crop, and are not comprised of new slow or controlled release technology
Fertilizer-pesticide combinations as found in the Fertilizer Pesticide Compendium
Non-chelated micronutrient fertilizers (with or without N-P-K) that are greater than 40% water soluble
Micronutrient fertilizers (with or without N-P-K) that are =40% water soluble and chelated with EDTA, EDDHA, DTPA or HEDTA

Supplements:

Products used only to correct soil acidity or alkalinity (e.g. liming materials)
Soil amendments represented to improve the condition of the soil by increasing organic matter (OM), if the OM is increased by at least 20 kg per 100m²
IBA within currently approved ranges (0.003 to 1%)

Products that REQUIRE Efficacy Data to support approval or registration

Fertilizers:

Foliar-applied N-P-K fertilizers
Low Analysis Farm Fertilizers (e.g. mixed ingredient chemical fertilizers containing less than 24% total N-P-K, or 18% total N-P-K if organic-based, represented for use on agricultural crops )
N-P-K fertilizers that contain phosphite/phosphoric acid
Micronutrient fertilizers (with or without NPK) with <40% water solubility
Micronutrient fertilizers chelated with something other than EDTA, EDDHA, DTPA or HEDTA, or that are claimed to be complexed
New slow or controlled release coatings for N-P-K fertilizers (e.g. polymers, urease inhibitors, etc.)
CFIA and PMRA-approved pesticides for use in fertilizer-pesticide combinations, but currently not found in the Fertilizer-Pesticide Compendium
Seed-applied nutrients (i.e. N-P-K, lesser nutrients and micronutrients)
Products represented as sources of plant nutrients and contain an element other than; N, P, K, Ca, Mg, S, B, Fe, Mn, Mo, Zn

Supplements:

Plant growth regulators (e.g. NAA, Kinetin), including Indole-3-Butyric acid (IBA) if not within the currently approved ranges
Signalling compounds (e.g. LCO's, Hesperetin, Naringenin)
Wetting agents and surfactants
Soil flocculants/stabilizers and water holding polymers (e.g. anionic polyacrylamides)
Any product containing micro-organisms (e.g. Rhizobia, Mycorrhizha, Penicillium sp.)
Inoculant extenders (products represented to improve inoculant on-seed survival)
Any product represented as a "bio-stimulant" (e.g. vitamins, enzymes)
Products represented to improve the physical condition of the soil other than fibrous organic matter.
Supplements sold only for the correction of soil acidity or alkalinity other than Ca, Mg, or S.

Products/ingredients that require the submission of core safety data to support approval or registration

Fertilizers:

NPK fertilizers without micronutrients
Lesser plant nutrients: Calcium (Ca), Magnesium (Mg), and Sulphur (S)
Fertilizer-Pesticide combinations as found in the Fertilizer Pesticide Compendium
Low analysis farm fertilizers

Supplements:

Indole-3-butyric acid (IBA) at a concentration not exceeding 1% of the product
Products used to correct soil acidity or alkalinity (e.g. liming materials)
Soil amendments represented to improve the condition of the soil by increasing organic matter (OM)
VAMs (Vesicular Arbuscular Myccorhizae) provided the species is substantially equivalent/representative of VAM group
Rhizobia (species of the genera Rhizobium, Bradyrhizobium, Mesorhizobium and Sinorhizobium), provided the species is substantially equivalent/representative of the rhizobia group
Bacillus subtilis provided the strain is representative of the species and does not produce any toxins
Please note that the presence of other active or inert ingredients in the product may trigger additional safety requirements. If any of the products listed above are made from or contain waste materials, they fall under the next section.

Products/ingredients that require the submission of core safety data AND results of analyses to support approval or registration

Non-chelated micronutrients
Micronutrients chelated with the following chelators: ethylenediamine-tetra-acetic acid disodium salt (EDTA), diethylenetriamine penta-acetic acid (DTPA), ethylenediamine-di-o-hydroxyphenylacetic acid (EDDHA), N-(2-hydroxyethyl) ethylenediamine-N, N', and N'-tri-acetic acid trisodium salt (HEDTA)
NPK fertilizers with micronutrients
All fertilizers and supplements containing waste derived materials (e.g. composts, processed sewage, pulp and paper sludges, etc.)

Products/ingredients that require the submission of a full safety data package AND may require results of analysis to support approval or registration

Fertilizers:

Fertilizers containing any of the supplements listed below
Micronutrients for foliar use
Micronutrients chelated with other chelators than those indicated above
NPK fertilizers (with or without micronutrients) containing/coated with polymers
Nano-materials and Nano-encapsulated fertilizers
Digestates and other products of microbial fermentation

Supplements:

Plant growth regulators other than IBA as described above (e.g. NAA, Kinetin)
Plant signalling compounds (e.g. LCO's, Hesperetin, Naringenin)
Wetting agents and surfactants
Water holding polymers and soil flocculants/stabilizers
Inoculant extenders (products represented to improve inoculant on-seed survival)
Any product represented as a "Bio-stimulant" (e.g. vitamins, enzymes)
Inoculants containing viable microorganisms other than VAM and Rhizobia
Microbial consortia products

NOTE: All fertilizers and supplements sold and imported into Canada must be safe with respect to human, animal, plant health and the environment. The product safety assessments performed by the Fertilizer Safety Office (FSO) are conducted on case-by-case basis and the information requirements may vary depending on the ingredients in the product (both active and inert), their sources, degradation by-products, manufacturing process, use pattern and application rate. To that effect, the 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

Appendix D: Example Labels

Label No. 1

Eureka Products
10% Mn

Guaranteed Analysis
Manganese (Mn) (actual) 10.0%

Registration Number 2001999B Fertilizers Act

DIRECTIONS FOR USE:
To be used in blending fertilizer for soil application.
Size Guide Number (SGN) 250.
Applications should be based on results of soil or leaf analysis.

PRECAUTIONS: KEEP OUT OF REACH OF CHILDREN. READ LABEL BEFORE USING. Harmful if swallowed. Avoid contact with eyes, skin and clothing. Avoid breathing spray mist. Store in its original container tightly closed and away from children and pets. Wear long-sleeved shirt, long pants, socks, shoes and chemical-resistant (e.g. rubber gloves). Rinse gloves before removal. Wash hands before eating, drinking, using tobacco or using the toilet. If fertilizer penetrates clothing, remove immediately; then wash thoroughly and put on clean clothing. Remove clothing and launder separately before reuse, and promptly and thoroughly wash hands and exposed skin with soap and water, then shower. Re-use gloves for fertilizer application only. Wash application equipment thoroughly after use.

IF IN EYES: Flush with plenty of water and get medical attention or contact poison control centre.

IF ON SKIN: Wash with soap and water.

IF SWALLOWED: Get medical attention or contact poison control centre.

NET WEIGHT: 20 kg (44 lb)

Manufactured By:
Eureka Inc.
26 John St., Winnipeg, MB R3S 4T5

Label No. 2 – Main Panel

Eureka Products
10% Iron Chelate

Registration Number 2001998B Fertilizers Act

NET WEIGHT: 25 kg

Eureka Inc.
29 John St.
Winnipeg, MB
R3S 4T5

Label No. 2 – Secondary Panel

Guaranteed Analysis
Iron (Fe) (actual) 4.0%
4.0% chelated Iron (Fe) (actual)
EDTA (chelating agent) (minimum) 21.0%

DIRECTIONS FOR USE: This product must only be used for corrections of iron deficiencies as determined by foliar or soil testing. Application rates are to be determined upon the advice of the county agricultural representative or a professional agricultural consultant.

Label No. 3

Eureka Products
10% Boron

Guaranteed Minimum Analysis
Calcium (Ca) 2.0%
Magnesium (Mg) 5.0%
Boron (B) (actual) 10.0%

DIRECTIONS FOR USE: This product should be applied based on the advice of a government agricultural representative or a professional agricultural consultant.

NOTICE: Seller's guarantee shall be limited to the terms set out on the label and subject thereto. 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.

NET WEIGHT: 25 kg (55 lb)

Imported By:
Eureka Inc.
29 John St.
Winnipeg, MB
R3S 4T5

Label No. 4

Eureka Coated Seed
Variety "X" Rapeseed
Canada Certified No.2
Lot C2-01

Coating Ratio
67% Seed
33% Coating Material

Guaranteed Analysis
Boron (B) (actual) 0.2%
Zinc (Zn) (actual) 0.3%

This product is to be used in conjunction
with a complete fertilizer program
that relates to the fertility level of the soil.

Net Weight: 100 kg

Eureka
29 John St.
Winnipeg, MB
R3S 4T5

Appendix E: Labelling Checklist

Label Checklist – Micronutrients without NPK (containing B, Cl, Cu, Fe, Mn, Mo, and/or Zn) (containing no pesticides)

	Labelling – General Requirements:	Source
1	The registration number of the product	FzR 16.(1)(d), Guide 3.6.11
2	The brand of the fertilizer (if any) is printed on the product label	FzR: 16.(1)(b), Guide 3.6.8
3	The brand would not tend to deceive or mislead purchaser with respect to the composition or utility of the product	FzR: 19.(2)(b), Guide 3.6.8
4	The name of the fertilizer is printed on the product label	FzR: 16.(1)(c), 3.6.9
5	Product name is on the main/front panel of the fertilizer	FzR: 19.(1), Guide 3.6.2
6	The product name would not tend to deceive or mislead purchaser with respect to the composition or utility of the product	FzR: 19.(2)(b), Guide 3.6.9
7	If a micronutrient is referenced in the name, it is guaranteed.	FzR: 19.(2)(b), Guide 3.6.9
8	If the label guarantees more than one micronutrient, and the micronutrients are listed in the product name, all the guaranteed micronutrients are listed in the product name.	Guide 3.6.9
9	If the word chelated appears in the product name without a specific micronutrient, then all guaranteed micronutrients are 100% chelated.	Guide 3.6.9
10	The weight of the fertilizer is printed on the product label	FzR: 16.(1)(h), Guide 3.6.7
11	The product weight is on the main/front panel of the fertilizer	FzR: 19.(1), Guide 3.6.2
12	The product weight is in METRIC (equivalent imperial units may appear in addition to the metric)	FzR: 21.1(1)(a), Guide 3.6.6
13	The name of the person/company who manufactured the product or the registrant of the product is printed on the product label	FzR: 16.(1)(a), Guide 3.6.3
14	The name of the above person/company is on the main/front panel of the product label	FzR: 19.(1), Guide 3.6.2
15	The complete address of the manufacturer/packager includes: street address or P.O Box, City, Province/State, Postal/Zip Code, and, if manufactured outside Canada, the country	Guide Guide 3.6.3
16	The prescribed guaranteed analysis is printed on the product label	FzR: 16.(1)(e), Guide 3.6.10
17	Each nutrient is on a separate line.	Guide 3.6.10
18	There are no trademarks or statements found in the guaranteed analysis section.	Guide 3.6.10
19	The amount of each micronutrient expressed as a percentage on an elemental basis and guaranteed on an actual basis.	FzR: 15.(d), Guide 3.6.10
20	Guarantees are above the limit of quantification or minimums, depending on their use pattern, found in table 1 of this section of the Guide	FzR: 11.(3)(a), Guide 3.6.10 – Table I
21	The minimum amount of calcium, magnesium and sulphur expressed in percent on an elemental basis (if applicable).	FzR: 15.(c), Guide 3.6.10
22	Guarantees are above the limit of quantification or minimums, depending on their use pattern, found in table 1 of this section of the Guide	FzR: 11.(3)(a), Guide 3.6.10 – Table I
23	The minimum amount of each chelating agent (if applicable)	FzR: 11.(2), Guide 3.6.10
24	No "zero" guarantees	FzR: 11.(2), Guide 3.6.10
25	For Directions for Use, one of the following:	FzR: 16.(1)(f), Guide 3.6.12
26	(1) Complete recommendations, including the intended crop type, the rate, the frequency, and the timing of use (where the directions are consistent with provincial recommendations); OR	FzR: 16.(1)(f), Guide 3.6.12
27	(2) 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	FzR: 16.(1)(f), Guide 3.6.12
28	(3) A statement indicating that the user should seek the advice of the county agricultural representative or a professional agricultural consultant.	FzR: 16.(1)(f), Guide 3.6.12
29	In all instances, 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.	FzR: 16.(1)(f), Guide 3.6.12
30	The character, size, colour and placing of the printing on the label does not emphasize or obscure any part of the name, analysis or other information required to be on the label	FzR: 19.(3), Guide 3.6.4
31	The label does not have any incorrect or misleading information or mark	FzR: 19.(2)(a), Guide 3.6.14
32	If a website is on the label, the information and claims about the product must match. Otherwise, the website must be removed from the label	FzR: 19.(2)(a), Guide 3.6.19
33	The lot number of the fertilizer is on the label	FzR: 16.(1)(k), Guide 3.6.17
34	The product label is either (1) in English, (2) in French, or (3) in English and French	FzR: 19.(1.2), Guide 3.6.5
35	Ingredient List (not mandatory) – if one ingredient is listed on the label, all ingredients must be listed.	FzR: 19.(2)(a), Guide 3.6.14
36	Ingredients are under heading of "Ingredient List" (or similar), but not "Derived From"	FzR: 19.(2)(a), Guide 3.6.14

	Labelling – Efficacy Requirements:	Source
37	Product is efficacious for every purpose for which it is represented or sold	FzR: 11.(2), Guide 3.6.12 and 3.7
38	The minimum application rates supply enough nutrients to be considered efficacious for every purpose for which it is represented or sold (only applies if complete recommendations are included in the Directions for Use, including the intended crop type, the rate, the frequency, and the timing of use)	FzR: 11.(2), Guide 3.6.12 and 3.7
39	The application method of the product is considered to be efficacious by the Fertilizer Section	FzR: 11.(2)
40	Seed-application of micronutrients is not considered to be efficacious and its efficacy must be demonstrated to the Fertilizer Section	FzR: 11.(2)
41	Product is not chelated with something other than EDTA, EDDHA, DTPA or HEDTA, or claimed to be complexed.	FzR: 11.(2)
42	If a micronutrient is guaranteed on the label, at least 40% of it is water-soluble. If not, efficacy data is required.	FzR: 11.(2) Guide 3.7
43	For products with polymer-coated granules:	FzR: 10.3(2), Guide Appendix C
44	Polymer has been approved for use in fertilizers and supplements by the Fertilizer Section	FzR 10.3(2), Guide Appendix C

	Labelling – Safety Requirements:	Source
45	For products with polymer-coated granules:	FzA: 4., Guide Appendix C
46	Polymer has been approved for use in fertilizers and supplements by the Fertilizer Safety Office	FzR 10.3(2), Guide Appendix C
47	All necessary precautionary statements associated with the polymer are included on the product label	FzA 3.(c), Guide 3.6 and 3.6.13
48	Directions for use conform to the conditions established by the Crop Inputs Division	FzA 3.(c), Guide 3.6
49	where the fertilizer has intentionally incorporated in it or is represented to contain boron, copper, manganese, molybdenum or zinc or has a natural high content of one or more of these lesser plant nutrients, the following cautionary statement: "CAUTION: This fertilizer should be used only as recommended. It may prove harmful when misused."	FzR 16.(1)(i), Guide 3.6.13
50	If the product contains "prohibited material", the following precautionary statements are on the label:	FzR 16.(1)(j), Guide 3.6.13
51	feeding the product to cattle, sheep, deer or other ruminants is illegal and subject to fines or other punishment under the Health of Animals Act, the product is not to be used on pasture land or other grazing areas for ruminants, the product is not to be ingested, a person should wash his or her hands after the person uses the product.
52	il est interdit de nourrir les boeufs, moutons, cerfs et autres ruminants avec ce produit, et des amendes ou autres peines sont prévues à cet égard par la Loi sur la santé des animaux, il ne faut pas utiliser ce produit sur un pâturage ou autre espace vert utilisé par les ruminants. il ne faut pas ingérer ce produit. il faut se laver les mains après avoir utilisé ce produit.

**Please note that other labelling requirements may also apply, depending on the nature of the product.

Previous: Supporting Section A - Definitions | Table of Contents

Guide to the Canadian Federal Regulatory Requirements for Fertilizers and Supplements3 - Registration Guide: Micronutrient Fertilizers

Guidelines to Completing the Fertilizer or Supplement Registration Application

Products that do NOT require Efficacy Data to support approval or registration

Fertilizers:

Supplements:

Products that REQUIRE Efficacy Data to support approval or registration

Fertilizers:

Supplements:

Products/ingredients that require the submission of core safety data to support approval or registration

Fertilizers:

Supplements:

Products/ingredients that require the submission of core safety data AND results of analyses to support approval or registration

Products/ingredients that require the submission of a full safety data package AND may require results of analysis to support approval or registration

Fertilizers:

Supplements:

Label Checklist – Micronutrients without NPK (containing B, Cl, Cu, Fe, Mn, Mo, and/or Zn) (containing no pesticides)

Guide to the Canadian Federal Regulatory Requirements for Fertilizers and Supplements

3 - Registration Guide: Micronutrient Fertilizers