Special Review Decision SRD2025-02, Pydiflumetofen and its associated end-use products

Pest Management Regulatory Agency
11 December 2025
ISSN: 2561-6269 (PDF version)
Catalogue number: H113-17/2025-2E-PDF (PDF version)

Summary

Table of contents

• Special review decision for pydiflumetofen and associated end-use products
• Special review decision for pydiflumetofen
• Risk mitigation measures
• Implementation of the special review decision
• Next steps
• Other information
• Evaluation approach
• Appendix I  Registered products containing pydiflumetofen in Canada

Special review decision for pydiflumetofen and associated end-use products

Under the authority of the Pest Control Products Act, pesticides are regulated by Health Canada’s Pest Management Regulatory Agency (PMRA) on behalf of the Minister of Health. The Pest Control Products Act prescribes both the pre-market and post-market assessment (re-evaluations and special reviews) of pesticides to determine the acceptability or continued acceptability of human health and environmental risks, and acceptable value of a pesticide in Canada. Unlike a re-evaluation, a special review is triggered only under certain circumstances, as described in section 17 of the Pest Control Products Act, and the intent of a special review is to address specifically the identified aspect(s) of concern. The special review approach is described in the PMRA Guidance Document: Approach to Special Reviews of Pesticides. More details on the legislative framework are provided under the section of Legislative Framework of this document.

Health Canada evaluates the aspects of concern that prompted the special review in accordance with subsection 18(4) of the Pest Control Products Act. The internationally accepted science-based approach is used for the assessment of the aspect of concern, similar to all other scientific assessments (for example, new product registrations, re-evaluations). This step includes both risk assessment and risk management to address the concerns identified. Health Canada’s approach to risk and value assessment as well as risk management is outlined in the PMRA Guidance Document: Framework for Risk Assessment and Risk Management of Pest Control Products.^{Footnote 1}

Pursuant to subsection 17(1) of the Pest Control Products Act, Health Canada conducted a special review of all registered pest control products containing pydiflumetofen, based on a 28-day inhalation study in rat that was submitted under the incident reporting program (IRP). The identified aspect of concern is:

• Occupational inhalation exposure

To assess the aspect of concern, Health Canada considered the information that prompted the special review and other relevant information currently available, including existing assessments (PRD2018-06^{Footnote 2} and RD2020-10^{Footnote 3}).

Pydiflumetofen is a broad-spectrum fungicide currently registered as a foliar application, seed treatment or both, on various field food and feed crops, greenhouse food and non-food crops, outdoor ornamentals and turf for the control and suppression of certain diseases. All currently registered products containing pydiflumetofen have been considered in this special review. Currently registered pest control products containing pydiflumetofen are listed in Appendix I.

This document (Special Review Decision SRD2025-02, Special Review Decision of Pydiflumetofen and Its Associated End-use Products) presents the final regulatory decision^{Footnote 4} for the special review of pydiflumetofen. All pest control products containing pydiflumetofen that are registered in Canada are subject to this special review decision. Prior to finalizing this decision, Health Canada published the Proposed Special Review Decision PSRD2024-03, Proposed Special Review Decision for Pydiflumetofen and Its Associated End-use Products,^{Footnote 5} which underwent a 45-day public consultation period ending on 13 January 2025.

Comments and information directly related to the proposed special review decision, such as comments directed to the assessment of the aspect of concern were received during the public consultation period conducted in accordance with section 28 of the Pest Control Products Act. Commenters are listed in Appendix II of SRD2025-02 and comments are summarized in Appendix III of SRD2025-02 with the responses from Health Canada. These comments and information were considered but did not result in revisions to the risk assessment. Therefore, this decision is consistent with the proposed special review decision as described in PSRD2024-03.

A reference list of information used as the basis for the proposed special review decision is included in PSRD2024-03, and further information used in the special review decision is listed in Appendix V of SRD2025-02. Therefore, the complete reference list of all information used in this final special review decision includes both the information set out in PSRD2024-03 and the information set out in Appendix V of SRD2025-02.

Special review decision for pydiflumetofen

Health Canada has completed the special review for pydiflumetofen. Under the authority of the Pest Control Products Act, Health Canada has determined that the registration of products containing pydiflumetofen is required to be amended, in accordance with paragraph 21(2)(a) of the Pest Control Products Act. The assessments of the aspects of concern from this special review indicated that the risks to human health are acceptable for all uses of pydiflumetofen when used according to the amended conditions of registration, which includes new mitigation measures, as summarized in Risk mitigation measures and listed in Appendix IV of SRD2025-02.

Risk mitigation measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The required amendments, including any revised/updated label statements and/or mitigation measures, as a result of the special review of pydiflumetofen, are summarized below. Refer to Appendix IV of SRD2025-02 for details.

Human health

The following risk mitigation measures are required to address potential inhalation risks to workers in commercial facilities treating corn seed and workers using handheld equipment on agricultural crops:

• Commercial seed treatment of corn:
  • A filtering facepiece respirator (dust mask) is required during bagging, sewing, and stacking of treated seed.
  • A respirator is required during cleaning and repairing.
• Handheld application on agricultural crops:
  • Eye, head and respiratory protection are required when applying above waist-height, including overhead.

Other updates

The following label updates are required to correct errors relating to pre-harvest interval and application rate:

• For A20259 Fungicide (Registration Number 33020), correction to the pre-harvest interval from 3 days to 5 days.
• For Miravis Neo 300SE (Registration Number 33391), correction to the maximum product application rate from 1.5 L/ha to 0.75 L/ha.

Implementation of the special review decision

Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review provides information and general timelines regarding the implementation of post-market decisions, (for example, up to 24-month timeline for label amendments and up to 36-month phase-out timeline for cancelled registrations), and Information Note: Update on implementation of post-market decisions provides additional information on phase-out measures for post-market decisions that include cancellations. The post-market decision considers potential health and environmental risks regarding the use of the pest control product, and its value, when establishing the implementation timelines.

The health considerations for the implementation timeline for this final decision are outlined below.

Health considerations

When conducting human health risk assessments, risks from exposure to a pesticide are estimated by comparing potential exposures with the most relevant endpoint from toxicology studies, with standard protection factors incorporated to further protect human health, including the most sensitive population. These factors provide an inherent level of protection from exposures that could result in adverse effects to human health. Furthermore, Health Canada applies additional protection factors if warranted by the hazard profile of the pesticide or by the quality and completeness of the underlying data. When risks of concern are identified in the human health exposure scenarios, it does not necessarily mean that exposure will result in adverse effects, but mitigation measures to reduce potential risks would be required in order to support continued registration of the product/use.

Potential and relative health risks are thus considered acceptable during the general 2-year implementation period unless there is evidence from incident reports or other sources of real-world post-market surveillance data suggesting that there are adverse health effects occurring as a result of the use of the products according to the currently approved label/use conditions. Other considerations may include how widely the product is used, the populations potentially exposed to the product and/or other factors.

Taking into consideration these factors, the general 2-year implementation timeline for label amendments for pydiflumetofen is considered appropriate from a human health perspective.

Amendment timeframe 

Based on the above considerations, the required amendments (mitigation measures and label updates) for pest control products containing pydiflumetofen must be implemented within 24-months from the date of SRD2025-02.

Next steps

To comply with this decision, the required amendments (mitigation measures and label updates) must be implemented on all product labels no later than 24 months after the publication date of SRD2025-02. Accordingly, both registrants and retailers will have up to 24 months from the date of SRD2025-02 to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of this decision document to transition to using the newly amended labels, which will be available on the Public Registry.

Refer to Appendix I for details on specific products impacted by this decision.

Other information

Any person may file a notice of objection^{Footnote 6} regarding this decision on pydiflumetofen and its associated end-use products within 60 days from the date of publication of this Special Review Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides and pest management section of the Canada.ca website (Public Engagement Portal - Public Engagement Portal forms - Notice of Objection) or contact PMRA’s Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PSRD2024-03 and in Appendix V of SRD2025-02) are available for public inspection, upon application, in PMRA’s Reading Room. For more information, please contact PMRA’s Pest Management Information Service.

Evaluation approach

Legislative framework

The Minister of Health’s primary objective under the Pest Control Products Act (or the Act) subsection 4(1) is to prevent unacceptable risks to individuals and the environment from the use of pest control products.

As noted in the preamble of the Act, it is in the national interest that the attainment of the objectives of the federal regulatory system continue to be pursued through a scientifically-based national registration system that addresses risks to human health, the environment and value both before and after registration and applies to the regulation of pest control products throughout Canada; and that pest control products with acceptable risk and value be registered for use only if it is shown that their use would be efficacious and if conditions of registration can be established to prevent unacceptable risks to human health and the environment.

For the purposes of the Act, the health or environmental risks of a pest control product are acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from exposure to or use of the product, taking into account its conditions of registration as per subsection 2(2) of the Pest Control Products Act.

Risk for the human health and environment, and value are defined under the Act subsection 2(1) as follows:

Health risk, in respect of a pest control product, means the possibility of harm to human health resulting from exposure to or use of the product, taking into account its conditions or proposed conditions of registration. 

Environmental risk, in respect of a pest control product, means the possibility of harm to the environment, including its biological diversity, resulting from exposure to or use of the product, taking into account its conditions or proposed conditions of registration

Value, in respect of a pest control product, means the product’s actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product’s (a) efficacy; (b) effect on host organisms in connection with which it is intended to be used; and (c) health, safety and environmental benefits and social and economic impact.

When evaluating the health and environmental risks of a pesticide and determining whether those risks are acceptable, subsection 19(2) of the Pest Control Products Act requires Health Canada to apply a scientifically-based approach. The science-based approach to assessing pesticides considers both the toxicity and the level of exposure of a pesticide in order to fully characterize risk. Health Canada’s approach to risk and value assessment is outlined in PMRA Guidance Document: A Framework for Risk Assessment and Risk Management of Pest Control Products.

Appendix I Registered products containing pydiflumetofen in Canada

Table 1 Registered pydiflumetofen products in Canada requiring label amendments^{Table 1 Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation type	Active Ingredient (g/L, %)
33017	Technical	Syngenta Canada Inc.	Pydiflumetofen Technical	Solid	98.7
33018	Commercial	Syngenta Canada Inc.	A19649 Fungicide	Suspension	200
33019	Commercial	Syngenta Canada Inc.	Posterity Fungicide	Suspension	200
33020	Commercial	Syngenta Canada Inc.	A20259 Fungicide	Suspension	75
33021	Commercial	Syngenta Canada Inc.	A20560 Fungicide	Suspension	150
33022	Commercial	Syngenta Canada Inc.	A21461 Fungicide	Suspension	75
33206	Commercial	Syngenta Canada Inc.	Miravis Duo Fungicide	Suspension	75
33207	Commercial	Syngenta Canada Inc.	Miravis Prime Fungicide	Suspension	150
33213	Commercial	Syngenta Canada Inc.	Miravis Bold Fungicide	Suspension	200
33391	Commercial	Syngenta Canada Inc.	Miravis Neo 300SE	Suspension	75
33572	Commercial	Syngenta Canada Inc.	A21573 Fungicide	Suspension	150
33573	Commercial	Syngenta Canada Inc.	Miravis Ace Fungicide	Suspension	150
33643	Commercial	Syngenta Canada Inc.	Saltro	Suspension	500
33798	Commercial	Syngenta Canada Inc.	A22070 Fungicide	Suspension	10.2
34323	Commercial	Syngenta Canada Inc.	Miravis Era A	Suspension	200
34613	Commercial	Syngenta Canada Inc.	Trebuset	Suspension	500
34616	Commercial	Syngenta Canada Inc.	A23089 Fungicide	Suspension	75
34775	Commercial	Syngenta Canada Inc.	A20808 Fungicide	Suspension	100
34841	Commercial	Syngenta Canada Inc.	Miravis Star Fungicide	Suspension	100
Table 1 Footnote 1 as of 16 September 2025, excluding discontinued products or products with a submission for discontinuation Table 1 Return to footnote 1 referrer

Footnotes