PMRA Guidance Document, Category C Application Guidance Document

Health Canada – Pest Management Regulatory Agency
18 September 2023

Table of contents

• Disclaimer
• 1.0 Purpose
• 2.0 Background
• 3.0 Qualification of a precedent product
• 4.0 Eligibility criteria for a Standard Category C application
• 5.0 Data protection
• 6.0 Ineligibility criteria of a Standard Category C application
• 7.0 Review timelines for Standard Category C applications
• 8.0 Preparation of a Standard Category C application
• 9.0 Glossary
• Appendix I – Overview of Standard Category C application types
• Appendix II – Questions

Disclaimer

This document does not constitute part of the Pest Control Products Act or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.

1.0 Purpose

This document provides guidance on the requirements for a Standard Category C application. It clarifies the review process for these types of submissions by the Pest Management Regulatory Agency (PMRA). This information supplements the document, Regulatory Note REG2003-01: Guidance on Selecting the Correct Category for Pest Control Product Submissions.

2.0 Background

A Standard Category C application is a submission without data requirements for new or amended registrations that require minor label or formulation reviews. Further requirements are described in the PMRA Guidance Document, Organizing and Formatting a Complete Submission for Pest Control Products. A minor amendment does not require data to support it, or a review of previously submitted data. Minor amendments must be based on a valid precedent; be editorial, or contain updates based on current practices.

A Standard Category C application must meet these criteria:

• The source of an active ingredient to formulate an end-use product or manufacturing concentrate must be currently registered in Canada.
• Amendments or new product registrations must be based on a currently registered precedent product.
• The information on formulants and formulant mixtures in the manufacture of pest control products must be acceptable to the PMRA; that is, complete information on the formulant or formulant mixture has been provided to the PMRA.
• Requests for waiver of data requirements cannot be considered under a Standard Category C application. Additionally, waivers are not to be included as part of the cover letter with the application.

The PMRA in their review of Standard Category C applications, aims to facilitate and provide more efficiency and a common understanding of the process by:

• Clarifying the requirements for acceptance of a Standard Category C application.
• Providing more information for Category C sub-types that require a PMRA review.

3.0 Qualification of a precedent product

An appropriate precedent product is required for several types of Standard Category C applications (for example, a similar product). Appendix I, Overview of Standard Category C application types, specifically indicates the types of applications that require the citation of a precedent product. The onus is on the applicant to provide a valid precedent that best supports their application.

3.1 Definition of a precedent product

A precedent product is a pest control product that is currently registered under the Pest Control Products Act in Canada.

3.2 Selecting a suitable precedent product

A suitable precedent product must meet these criteria:

• It must be equivalent or substantially similar to the proposed product. Differences may be acceptable if they are deemed to have no adverse implications for product quality or biological activity like safety, type or quantity of residue, or efficacy.
• A maximum of two precedents can be cited to support an application. The applicant must explain in their cover letter how the precedent product(s) supports the application.
• If two products are cited as an aggregate precedent to support label updates, or the labelling for a new product, the proposed label must clearly indicate which precedent supports the specified label information (the Comments function of the Track Changes feature in Microsoft Word is an excellent way to do this task).
• The PMRA will not consider a cited precedent product to be appropriate to support a Category C application if the cited precedent product was registered: 1) as a similar or identical product; 2) as a Master Copy/ Private Label; 3) through notification as a Repack/ Re-label product.
• A cited precedent product registered within the last 12 years is under data protection. Consequently, it will require a Letter of Access to Data from the registrant of the precedent product to be processed as a Standard Category C application. Refer to the regulatory directive listed in Section 5 for more guidance.
• Submissions for new adjuvants cannot be processed as a Standard Category C application. The formulation requires chemistry data and qualitative review to determine chemical equivalency to the cited precedent. Refer to the Regulatory Directive, DIR93-15: Registration Requirements for Adjuvant Products and guidance document, Value Guidelines for New Plant Protection Products and Label Amendments for more information.

In addition to the above criteria, there can be regulatory issues that the PMRA will consider in the validation of the cited precedent product. The onus is on the applicant to provide an appropriate precedent product that best supports their application.

4.0 Eligibility criteria for a Standard Category C application

The PMRA aims to clarify the requirements for different Standard Category C applications and the manner in which they are reviewed. The Standard Category C types are divided into four groups:

1. New registrations (that is, the issuance of a new Pest Control Product Registration Number)
2. Amendments to an existing registration
3. Mandatory amendments required by PMRA
4. Administrative changes

Appendix I provides an overview of Standard Category C application types, and highlights the expectations for each of these broad groups in terms of the label and the formulation of the proposed product. In addition, it is indicated whether a precedent product is required to support the application.

4.1 New registrations

The criteria for new registrations are described in the sections below.

4.1.1 Identical products

The new proposed product must meet these criteria to be considered identical to a registered precedent product:

• The source of the technical grade active ingredient(s) must be identical.
• The formulation must be identical.
• The uses must be the same as the cited precedent.

The above criteria apply solely to new end-use products and manufacturing concentrates.

New technical grade active ingredients must be manufactured in the same manufacturing plant as the precedent product (that is, they are a 100% re-pack of the precedent product). Additionally, the applicant must submit a Letter of Confirmation of source of supply from the registrant of the technical grade active ingredient (if different from the applicant).

4.1.2 Similar products

The new proposed product must meet these criteria to be considered similar to a registered precedent product:

• The technical grade active ingredient(s) must be registered by the PMRA.
• Technical grade active ingredients must be identical and be present at the same concentration (that is, within the standard certified limits, per the Guidance for completing the Statement of Product Specification Form (Form 6003)).
• Active ingredient(s) must be of the same chemical form (salt, acid, etc.).
• Formulation type (solution, emulsifiable concentrate, etc.) must be the same.
• Chemical and physical properties must be similar.
• Formulant(s) must be equivalent and at equivalent concentrations with the same functionality. Differences may be acceptable if they are deemed to have no adverse implications for product quality or biological activity like efficacy, safety, or type or quantity of residues.
• Label text may contain all, or a subset of, the use claims found on the cited precedent.

The above criteria apply solely to new end-use products and manufacturing concentrates. Category C applications to register a new technical grade active ingredient must always be identical to the precedent product.

4.2 Amendments to an existing registration

Standard Category C application amendments to an existing registration can consist of either a minor label change or a minor formulation change. A label or a formulation change requires the applicant to explain in the accompanying cover letter, the proposed change and why the change is necessary. In addition, the applicant must confirm that the proposed change(s) will not have an effect on either the chemical or biological aspects of the product. In the case of formulation amendments, the PMRA compares the proposed changes to the original formulation specifications to prevent a potential drift in product specifications. Label amendments require the applicant to provide a precedent as stated under Section 3.2 and Section 4.1.

Examples of an amendment are as follows:

• Amendment of the net content range
• Addition of a tank mix
• Addition of another use (for example, cooling towers, wheat/canola)
• Addition of a pest
• Addition of an alternate formulation

The maximum number of amendments allowed under one application is five (5). The example below presents allowable amendments that can be made under one application:

• Addition of one alternate formulation (amendment 1)
• Addition of two pests (amendments 2 and 3)
• Addition of one tank mix (amendment 4)
• Addition of one use (amendment 5)

Alternately, a Category C application could include:

• Addition of one pest (amendment 1)
• Addition of four tank mixes (amendments 2–5)

4.2.1 Minor label changes

Standard Category C label changes are limited to those supported by a precedent product, those that are editorial in nature, or those updated to meet current practices. Some examples of this type of application are described below.

4.2.1.1 Addition of a new pest and/or new site/host

The proposed product label for this type of application must be based on a precedent product and meet these criteria:

• The active ingredient(s) must be identical and registered by the PMRA.
• The rate of application must be the same.
• The formulant(s) must be the same or equivalent, and at the same or equivalent concentrations with the same functionality.
• The formulation type should be the same.
• There can be no expansion of the currently registered use pattern.
• The precedent product cannot be under data protection (unless a Letter of Access to Data has been provided from the registrant of the cited precedent).
• If it is a Minor Use that is being added or modified, additional criteria may apply.

4.2.1.2 Addition of a tank mix partner

A tank mix is the simultaneous use of two or more registered pest control products in a single application. Standard Category C applications that request the addition of a tank mix are based entirely on precedent products according to these criteria:

• The tank mix is not specifically excluded or contraindicated on either tank mix partner label. Additionally, the proposed tank mix partner label does not contain a general statement that restricts tank mixtures to those solely appearing on its label.
• Each tank mix partner is registered for use in Canada on the crop of interest, including genetically modified crops.
• There is no expansion of the use pattern; both partners are registered on the same site.
• The application timings of all tank mix partners are compatible with crop and pest staging.
• Each tank mix partner is applied in accordance with its registered product label.
• The precedent product is not under data protection. If the proposed tank mix partner is owned by another registrant, the data supporting the tank mix partner might be protected under the Pest Control Products Regulations; therefore, a Letter of Access to Data will be required to support the application.
• Currently, the tank mix use is on one of the component product If this product is owned by another registrant, the data supporting the tank mix use may be protected under the Pest Control Products Regulations; again, a Letter of Access to Data will be required for support.
• The tank mix use is on the label of a product, where one of the tank mix partners has an identical or similar formulation with that of the proposed product. If said product, or the tank mix use is owned by another registrant, the data supporting the tank mix use may be protected under the Pest Control Products Regulations; a Letter of Access to Data will be required to support the application.

4.2.2 Minor formulation changes

Minor formulation changes refer to small amendments to the concentration(s) of the formulant(s), or the substitution of a similar formulant (with the same functionality) with another. Some examples of this type of application are described below.

4.2.2.1 Change in the identity or amount of formulants

The applicant's cover letter must outline all the proposed formulation amendments and provide assurances that both the chemical and biological aspects of the product will not be affected as a result of the amendment:

• The formulant(s) must be the same or equivalent and at the same or equivalent concentrations with the same functionality. Differences may be acceptable if they are deemed to have no adverse implications for product quality or biological activity like efficacy, safety, or type and quantity of residues.
• The formulant(s) must be on the most recent Formulants List; if not, then a Material Safety Data Sheet (MSDS) or Confidential Statement of Ingredients (CSI), must be provided to support the amendment.

4.2.2.2 Change to the guarantee

The guarantee of the active ingredient in the proposed amendment must remain within its certified limits as approved by the PMRA.

4.2.2.3 Addition of an alternate formulation

The applicant's cover letter must outline all of the proposed formulation amendments, and must provide assurances that both the chemical and biological aspects of the product will not be affected as a result of the amendment:

• The active ingredient(s) must be the same and registered by the PMRA.
• The active ingredient(s) must be the same concentration.
• The formulant(s) must be the same or equivalent, and at the same or equivalent concentrations with the same functionality. Differences may be acceptable if they are deemed to have no adverse implications for product quality or biological activity like efficacy, safety, or type and quantity of residues.
• The formulation type must be the same.
• The formulant(s) must be on the most recent Formulants List; if not, then an MSDS or CSI must be provided to support the amendment.

4.3 Mandatory amendments required by PMRA

These applications refer to label recommendations and/or formulation changes that are initiated by the PMRA following the development of a new policy, or as a result of a re-evaluation or special review decision.

Periodically, the PMRA publishes policy documents that require the registrant to amend their product. When submitting an application to comply with these policy documents, the cover letter must outline the policy document number. Unless otherwise stated in the policy document, no other changes can be made with this type of application.

In the case of a re-evaluation or special review decision, the application must reflect the label improvement or formulation change that is requested in the PMRA re-evaluation document. In addition, the changes proposed in the application must be limited to the re-evaluation decision (that is, no other changes to the product are to be made at this time). This restriction ensures more efficient processing of the application.

A copy of the PMRA letter must be included with the application.

4.4 Administrative changes

These Standard Category C applications include, but are not limited to, reinstatements, a change of source of registered active, and a request for Master/Initial Product status. Some examples of this type of application are described below.

4.4.1 Reinstatements

An applicant can submit a Standard Category C application for the reinstatement of an expired product registration if:

• The application is submitted within 12 months of the expired registration.^{Footnote *}
• There are no changes to the label and to the formulation; or in the case of a technical grade active ingredient, there is no change in the manufacturing site and specifications.
• The product contains a registered active ingredient.
• All appropriate and updated Letters of Confirmation of source of supply from the registrant of the technical grade active ingredient (if different from the applicant) are included.
• The product was not discontinued or cancelled as a result of a PMRA decision.

4.4.2 Change to source of registered active in formulation

An applicant can change or add a source of registered active in the formulation of a registered product.

The application must meet these criteria:

• The active ingredient(s) must be the same and be registered by the PMRA.
• The active ingredient(s) must be present at the same concentration (that is, within the approved certified limits - per Guidance for completing the Statement of Product Specification Form (Form 6003).
• The active ingredient(s) must be of the same chemical form (salt, acid, etc.).
• A Letter of Confirmation of source of supply for each source of active ingredient must be included with the application if the source(s) is owned by a different registrant.

4.4.3 Upgrade to Master/Initial Product status

A Master Product status must be issued before the submission of an application to register a Master Copy product^{Footnote *} can be accepted for review. The granting of Master Product status can only be assigned to fully registered products that are not designated as technical grade active ingredients. The Master Copy products must be identical in formulation but may be formulated in a different plant from the Master Product. The label of the copy may contain all, or a subset of, the use claims and label text presently found on the Master Product label.

An Initial Product status must be issued before the submission of an application to register a Private Label^{Footnote *} can be accepted for review. The granting of Initial Product status can only be assigned to fully registered products that are not designated as manufacturing concentrates or technical grade active ingredients. Private Label products must be identical in formulation and be formulated on the same production line as the Initial Product. After a Private Label has been issued, no further amendments can be made to the Initial Product while the Private Label is still registered. This restriction applies to both labels and formulations.

The application to upgrade to Master/Initial Product status must be accompanied by Statement of Product Specification Form 6003; and, be accompanied by an appropriate and updated Letter of Confirmation of source of supply for each source of technical grade active ingredient in the product. It must also include both English and French labels.

5.0 Data protection

The data protection provisions of the Pest Control Products Regulations establish a legal framework by which an applicant or registrant may rely on data provided by other registrants. Refer to Regulatory Directive, DIR2010-04: Guidelines for Reliance on Proprietary Data Under the Pest Control Products Regulations and, Memo to Registrants – Data Protection Submission Review Process. These documents explain how the PMRA administers these regulations in the context of an application to register or amend a registration, and the expectations of each party. These regulations may be applicable to Standard Category C applications where the applicant and the registrant of the cited precedent product are different.

If the precedent product is supported by protected data (that is, compensable data) from a different registrant, the applicant will need to gain access to it through the data protection process unless:

1. The applicant has previously gained access to the data and has provided evidence of this, such as a Letter of Access to Data
2. The applicant has a Letter of Confirmation of source of supply from the registrant of the precedent product; or, is applying to register a master copy or private label.

6.0 Ineligibility criteria of a Standard Category C application

Before making a Standard Category C application, it is important to recognize the circumstances under which this type of application would not meet the eligibility criteria. Reasons for ineligibility include, but are not limited to:

• The new or amended product contains an active ingredient or source of active ingredient that is not currently registered in Canada. Guidance on these active ingredients is outlined in the Notice to Registrants: Pest Control Products Containing Active Ingredients or Sources of Active Ingredients that are Not Currently Registered in Canada (July 2004).
• The new or amended product is one of the following product types: anti-fouling paints, antisapstains, preservatives for millwork or joinery products, UV devices and preservatives for textiles or treated articles, and new adjuvants. Any and all formulation changes to these product types require a Category B application.
• The new or amended product contains a new formulant, defined as a “formulant not currently identified as being present in a registered Canadian pest control product”.
• The labelling of the new or amended product proposes differences in the precautionary statements in comparison to the precedent product. The precautionary symbols of the new or amended product must be the same as the precedent product, unless the change has been requested by the PMRA.
• The new or amended product proposes the substitution of a chemically dissimilar carrier/solvent for a product that is sprayed on crops, without a suitable precedent.
• The new or amended product proposes the addition of a bittering agent to a vertebrate-control bait product, without a suitable precedent.
• The new or amended product proposes the addition of a use that is not currently supported by any precedent product with the same active ingredient.

7.0 Review timelines for Standard Category C applications

The review time for a Standard Category C application is 37 days for screening and up to 240 days for evaluation which includes a label review, or 180 days for evaluation of formulation amendments only (as per PMRA Guidance Document: Management of Submissions Policy).

8.0 Preparation of a Standard Category C application

The Agency's ability to meet its commitment to review a Standard Category C application within the Management of Submissions Policy time frame will depend on the quality of the application. In addition, it depends on the completeness of the submitted information:

• Use current forms only (do not recycle old forms).
• Fill out the forms completely; make special note of contact information.
• If a Submission Contact is listed, make sure to include a Letter of Authorization of Representation that grants the PMRA permission to discuss submission details.
• Include a detailed cover letter; do not include any comments in the e-index.
• Use the most recently approved labels as the basis for the proposed amendments.
• Use one font style on proposed labels, without pictures or graphics.
• Provide all label components (container, booklet, water soluble bag, etc.).
• Check that the formulation type entered on the Statement of Product Specification Form (Form 6003) is accurate and matches the label.
• Check that all formulant trade names entered on the Statement of Product Specification Form (Form 6003) are accurate.
• Check that all manufacturing site names and addresses are accurate and complete.
• Remember to sign and date all forms.
• If it is unclear that the proposed application can be processed as a Standard Category C application, contact PMRA Info Serv to obtain more accurate guidance.
• Applicants are reminded to consult DIR2006-05: Requirements for Submitting Data Index, Documents and Forms for submitting documents in support of a Standard Category C application.

The required forms can be located on the Registrants and Applicants page on the Pesticides portion of the Canada.ca website:

• Form 6003: Statement of Product Specification Form
• Form 6005: Application for New or Amended Registration
• Form 6011: Fee Form
• Form 6023: Proposed New Uses and/or Uses to be Withdrawn from the Label

In addition, this documentation might be required:

• Letter of Authorization of Representation on proper letterhead and signed by the official with signing authority for each submission (valid only for that submission)
• Letter of Access to Data (when applicable) from the registrant of the precedent product
• Letter of Confirmation of source of supply (when applicable) on proper letterhead and signed by the official with signing authority

These documents apply to Standard Category C applications and should be consulted:

9.0 Glossary

9.1 Terms

Adjuvant

A product employed by the end user for in-tank mixing with a control product. Adjuvants whose intended use is to directly improve the efficacy or enhance the biological performance of the control product are registered under the authority of the Pest Control Products Act and Regulations.

End-use product(EP)

A product containing active ingredient(s) and usually formulant(s) that is labelled with instructions for direct pest control use or application.

Formulant

A formulant is any substance or group of substances other than the active ingredient that is intentionally added to a pest control product to improve its physical characteristics (for example, sprayability, solubility, spreadability and stability). Refer to DIR2006-02: Formulants Policy and Implementation Guidance Document.

Formulant mixture

A formulant mixture is a formulant composed of more than one substance.

Integrated system product (ISP)

May be used in manufacture of an end-use product or may itself be an end-use product; formed in a manufacturing process in which the integrated system product (a) contains an active ingredient that is not isolated due to physical limitations or uncertainty as to the specific active component(s); or (b) is purposely left as a mixture of components due to manufacturing or integrity considerations.

Label

Includes any written, printed or graphic matter (a) that is or is to be applied or attached to or included in, or that accompanies or is to accompany, a pest control product or a package; or (b) that belongs to a pest control product and is transmitted electronically, in accordance with the regulations.

Manufacturing Concentrate (MA)

A product containing a registered technical grade of active ingredient(s) and formulant(s) intended for further reformulating and/or repackaging into end-use products.

Technical Grade Active Ingredient(TGAI)

Contains the active ingredient and normally contains impurities that are by-products of the manufacturing process.

Appendix I – Overview of Standard Category C application types

Table 1 Standard Category C application types

Appendix II – Questions

Questions concerning these requirements should be directed to the PMRA through the Pest Management Information Service:

Telephone:
613-996-9231
1-800-267-6315 (Toll-free)

E-mail:
pmra.info-arla@hc-sc.gc.ca