Regulatory Proposal PRO2026-02, Revised environmental data requirements
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The online consultation is now closed.
Health Canada
Healthy Environments and Consumer Safety Branch
Pesticides Regulatory Directorate
29 June 2026
ISSN: 1925-122X (PDF version)
Catalogue number: H113-8/2026-2E-PDF (PDF version)
Summary
This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.
To obtain a full copy of Regulatory Proposal PRO2026-02, Revised Environmental Data Requirements please contact our publications office.
Should you require further information please contact the Pesticides Information Service.
Table of contents
- Document history
- 1.0 Introduction
- 2.0 Revised data requirements
- 3.0 Guidance for applicants
- 4.0 Next steps
Document history
| Update: | Update/Rationale: |
|---|---|
| 29 June 2026 | Response to comments received during PRO2016-01 and updated Regulatory Proposal (PRO2026-02) for consultation |
| 4 May 2016 | Initial publication for consultation (Regulatory Proposal PRO2016-01, Revised Environmental Data Requirements) |
1.0 Introduction
Health Canada is responsible for pesticide regulation in Canada. For all pest control products, Health Canada requires applicants to provide sufficient information to assess that risks to human health and the environment and the value of a product are acceptable.
The environmental information requirements for conventional pesticide registrations were established over 20 years ago in Regulatory Directive DIR2003-01, Organizing and Formatting a Complete Submission for Pest Control Products. Updates to the original requirements were consulted in 2016 (Regulatory Proposal PRO2016-01, Revised Environmental Data Requirements). Subsequently, in 2023, Health Canada published the environmental risk assessment guidance PMRA Guidance Document, Health Canada's Approach to Environmental Risk Assessment for Pest Control Products that details how the data requirements are used in Health Canada’s risk assessment process.
This Regulatory Proposal (Regulatory Proposal PRO2026-02, Revised Environmental Data Requirements) includes revisions to the environmental information requirements that reflects scientific and regulatory advancements since 2016, addresses public comments received on PRO2016-01 and presents updated guidance to assist applicants when preparing the environmental portion of the data package.
This Regulatory Proposal applies to conventional pesticides only. The registration of non-conventional products is discussed in Health Canada’s (2023) Guidance for the Registration of Non-Conventional Pest Control Products.
Revisions in the PRO2026-02 supersede the environmental information requirements outlined in DIR2003-01 and PRO2016-01.
2.0 Revised data requirements
The proposed revised environmental data requirements are presented in Appendix I of the full version of PRO2026-02. Appendices II, III, and IV of PRO2026-02 describe the circumstances under which certain environmental data are required for the various use-site categories.
Two aspects were considered when revising the environmental data requirements. First, the relevance and adequacy of each data requirement was examined considering current science. Second, their classification (required/conditionally required/not required/submit, when available) was updated within the different use-site categories. Main highlights include:
- Requirements that no longer reflect current risk assessment approaches, as per the PMRA Guidance Document, Health Canada's Approach to Environmental Risk Assessment for Pest Control Products, were eliminated, while some new requirements were introduced.
- When data are conditionally required (CR), additional guidance was provided to clarify the conditions under which data would be required.
- Where available, examples of acceptable environmental fate and ecotoxicity test guidelines have been added to the guidance.
Overall, the revisions continue to refine data requirements by eliminating studies that are rarely used while more clearly identifying studies that are required based on the use pattern and potential for environmental exposure. A summary of the revisions contained in the full version of PRO2026-02 are in Appendix V and the response to comments received on Regulatory Proposal PRO2016-01 are in Appendix VI.
The proposed revisions would not impact the ability to carry out Joint Reviews and collaborate with international regulatory partners. Where appropriate, care was taken in aligning with the data requirements of international pesticide regulatory programs.
3.0 Guidance for applicants
Applicants are encouraged to consult the Data Code (DACO) Tables in Appendix I of PRO2026-02 during the developmental phase of their product to understand the scope of the data required to support their registration. However, these data requirements are not intended to constitute a rigid list of data to be submitted in every case, but rather serve as a guide. Some of the required data may not be relevant in certain situations or may not be applicable to all uses within a given use-site category. Conversely, it may be appropriate to supplement the data package with data other than those required in the tables to address issues specific to the pesticide itself or to its use pattern. Applicants are therefore encouraged to request a pre-submission consultation to help determine what information is needed. It should also be noted that at any point during the assessment, as per Section 8 of the Pest Control Product Regulations, the submission of additional information may be required if the available information is inadequate or if uncertainties are identified during the risk assessment.
Where applicable, applicants are encouraged to submit data in a structured and easily accessible format – such as Microsoft Excel (.xls) or comma-separated values (.csv) – to support an associated study or data package. Where specified in the guidance below, standardized templates reflecting the preferred format may be available upon request from Pesticides Information Service.
Health Canada supports the principles of the reduction, refinement and replacement of animal testing. Alternative methods (such as in vitro or computer modelling) may be acceptable to fulfill the environmental information requirements if there is scientific justification demonstrating they provide information of equivalent quality and relevance as standard approaches. Reduction and refinement of standard methods for in vivo testing are also encouraged.
Before initiating any original testing or considering a waiver request, applicants are encouraged to request a pre-submission consultation on proposed protocols or waiver justifications, particularly when there are deviations from internationally recognized guidelines or standard approaches.
For additional information on the environmental risk assessment of pesticide products under the Pest Control Products Act, please refer to the Health Canada (2023) PMRA Guidance Document, Health Canada's Approach to Environmental Risk Assessment for Pest Control Products
4.0 Next steps
Upon publication of this regulatory proposal, the public, including the registrants and stakeholders, are encouraged to submit comments during the 30-day public consultation period.
Health Canada will accept written comments on the PRO2026-02 up to 30 days from the date of publication of the document. Comments on the proposed decision can be submitted during the consultation period to Health Canada through Pesticides Publications Section, or the Public Engagement Portal (Public Engagement Forms – Consultation Comment). For more information or if you have questions, contact the Pesticides Information Service.
Before making a final decision on the revised environmental data requirements, the comments received during the consultation period that are directly related to this regulatory proposal will be taken into consideration.