Re-evaluation Decision RVD2025-07, Fatty acid cluster and its associated end-use products

• Pest Management Regulatory Agency
• 14 November 2025
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2025-7E-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for fatty acid cluster and associated end-use products
• Re-evaluation decision for fatty acid cluster
• Risk mitigation measures
• Implementation of the re-evaluation decision
• Next steps
• Other information
• Risk management
• Appendix I Registered products containing Fatty Acid Cluster in Canada

Re-evaluation decision for fatty acid cluster and associated end-use products

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they meet current health and environmental standards and have value. The re-evaluation considers data and information from pesticide manufacturers, incident reports and other regulatory agencies, as well as comments received during public consultations. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Potassium salts of fatty acid products are insecticides or herbicides registered for both commercial and/or domestic applications on: greenhouse, indoor and outdoor ornamentals; greenhouse vegetables, herbs and spices; cannabis grown indoors in greenhouses or other enclosed structures; outdoor fruits, vegetables and certain nuts; turf and lawns; outdoor use on structures; outdoor areas; and seed production for several crops.

Products of triethanolamine salts of fatty acids are insecticides registered for commercial and/or domestic uses on: greenhouse, indoor and outdoor ornamentals; and outdoor fruits and vegetables.

Products of fatty acids are herbicides registered for both commercial and/or domestic uses to control several species of weeds around commercial and domestic buildings, around greenhouses, several outdoor areas, and around plants and gardens.

Finally, products of ammonium salt of fatty acid are herbicides registered for both commercial and/or domestic uses to manage weed species and liverworts around: greenhouse crops; interiorscapes; outdoor food crops; commercial cannabis and industrial hemp grown indoors in greenhouses or other enclosed structures; commercial cannabis grown outdoors and industrial hemp grown outdoors; outdoor areas and on and around structures, patios and walkways; and outdoor turf and gardens.

Currently registered products containing active ingredients in the fatty acid cluster can be found in the Pesticide Product Information Database and in Appendix I. The Proposed Re-evaluation Decision PRVD2025-05, Fatty Acid Cluster and Its Associated End-use Products^{Footnote 1} containing the evaluation of potassium salts of fatty acid, triethanolamine salts of fatty acids, fatty acids and ammonium salt of fatty acid and proposed decision, underwent a 90 day consultation period ending on 5 June 2025. PRVD2025-05 proposed continued registration of all uses with updated label amendments such as updated precaution statements and storage directions.

Health Canada received two comments relating to the proposed label amendments. The commenters are listed in Appendix II of the full version of Re-evaluation Decision RVD2025-07, Fatty Acid cluster and Its associated end-use product. The comments are summarized in Appendix III of RVD2025-07 along with the responses by Health Canada. The comments resulted in revisions to the proposed label amendments, and did not result in changes to the proposed re-evaluation decision as described in PRVD2025-05.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2025-05; no further information was used in the final re-evaluation decision. Therefore, the complete reference list of all information used in this final re-evaluation decision is set out in PRVD2025-05.

This document (RVD2025-07) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of fatty acids cluster, including the required amendments (risk mitigation measures) to protect human health and the environment, as well as label amendments required to bring labels to current standards. All products containing potassium salts of fatty acid, triethanolamine salts of fatty acids, fatty acids and ammonium salt of fatty acid that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for fatty acid cluster

Health Canada has completed the re-evaluation of fatty acid cluster (fatty acids, potassium salts of fatty acids, triethanolamine salts of fatty acids, and ammonium salt of fatty acid). Under the authority of the Pest Control Products Act, Health Canada has completed all required evaluations and consultations and has determined that the registration of products containing fatty acid cluster active ingredients are required to be amended, in accordance with paragraph 21(2)(a) of the Pest Control Products Act. An evaluation of available scientific information respecting the health and environmental risks and value of active ingredients in the fatty acid cluster found that all uses of fatty acid cluster products meet current standards for protection of human health and the environment and have acceptable value when used according to the amended conditions of registration which includes new mitigation measures. Label amendments, as summarized below and listed in Appendix IV of RVD2025-07, are required.

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 updated label statements and/or mitigation measures, as a result of the re-evaluation of fatty acid cluster, are summarized below. Refer to Appendix IV of RVD2025-07 for details.

Human health

• Clarify use directions labels according to use pattern, update restricted-entry interval (REI), personal protective equipment (PPE) and first-aid statements.
• Add of precautionary statements for people and pets.

Environment

To protect the environment, the following risk-reduction measures are required:

• Label amendments to meet current standards: update environmental precaution, runoff, disposal and storage statements.

Implementation of the re-evaluation 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.

Amendment timeframe

The implementation timeline of 24 months for the required label amendments for pest control products containing active ingredients in the fatty acid cluster is considered acceptable. These required amendments must be implemented within 24 months after the publication date of RVD2025-07.

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

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 RVD2025-07. Accordingly, both registrants and retailers will have up to 24 months from the date of this decision document 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 RVD2025-07 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 3} regarding this decision on fatty acid cluster and its associated end-use products within 60 days from the date of publication of this Re-evaluation 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 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 PRVD2025-05) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact Health Canada's Pest Management Information Service.

Risk management

The outcomes of the assessments of risks to human health and the environment, and the assessment of value, form the basis for identifying risk management strategies. These include appropriate risk mitigation measures and are a key part of decision-making on whether health and environmental risks are acceptable. The development of risk management strategies take place within the context of the pesticide's conditions of registration. Conditions can relate to, among other things, the specific use (for example, application rates, timing, frequency and method of application), personal protective equipment, pre-harvest intervals, restricted-entry intervals, buffer zones, spray drift and runoff mitigation measures, handling, manufacture, storage or distribution of a pesticide. If feasible conditions of use that have acceptable risk and value cannot be identified, the pesticide use will not be eligible for registration.

The selected risk management strategy is then implemented as part of the re-evaluation decision. The pesticide registration conditions include legally-binding use directions on the label. Any use in contravention of the label or other specified conditions is illegal under the Pest Control Products Act. Implementation of post-market decisions follow the framework articulated in the Policy on Cancellations and Amendments Following Re-evaluation and Special Review.^{Footnote 4}

Following a decision, continuous oversight activities such as post-market review, monitoring and surveillance, including incident reporting, all play an essential role to help ensure the continued acceptability of risks and value of registered pesticides.

Appendix I Registered products containing Fatty Acid Cluster in Canada