Proposed Re-evaluation Decision PRVD2018-10, Azadirachtin and Its Associated End-use Product
This consultation is now closed.
Pest Management Regulatory Agency
29 March 2018
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2018-10E-PDF (PDF version)
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Table of Contents
- Proposed Re-evaluation Decision
- Outcome of Science Evaluation
- Proposed Regulatory Decision for Azadirachtin
- International Context
- Next Steps
- Additional Scientific Information
Proposed Re-evaluation Decision
Under the authority of the Pest Control Products Act, all registered pesticides must be regularly re-evaluated by Health Canada’s Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental safety standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies to all re-evaluations.
Azadirachtin is a botanical insecticide extracted from seeds of the tropical neem tree (Azadirachta indica). Azadirachtin adversely affects insect hormones and also acts as a feeding deterrent. It is registered as a Commercial product.
This document (Proposed Re-evaluation Decision PRVD2018-10, Azadirachtin and Its Associated End-use Product) presents the proposed regulatory decision for the re-evaluation of azadirachtin as well as the science evaluation on which the proposed decision was based. All products containing azadirachtin registered in Canada are subject to this proposed re-evaluation decision. PRVD2018-10 is subject to a 90-day public consultation period, during which the public, including the pesticide manufacturers and stakeholders, may submit written comments and additional information to the PMRA Publications Section. The final re-evaluation decision will be published taking into consideration the comments and information received.
Outcome of Science Evaluation
Azadirachtin has value as a management tool to manage various insect pests of trees in forests, woodlots, urban and residential landscapes. Applied as a tree injection, it offers an alternative application method to foliar sprays and is important for insect pest management where there are limited, if any other active ingredients registered to control pests indicated on the label.
With respect to human health, azadirachtin is of low acute toxicity via the oral and dermal routes of exposure and slightly acutely toxic via the inhalation route. It is mildly irritating to the eyes and is a dermal sensitizer, but is not irritating to the skin. Under the current conditions of use, potential risk to human health from azadirachtin is not expected to be of concern.
Azadirachtin could enter the environment when used to control tree pests. However, when used according to the current label directions, azadirachtin is not expected to pose risks of concern to the environment.
Proposed Regulatory Decision for Azadirachtin
Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, products containing azadirachtin are being proposed for continued registration in Canada.
Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment that must be followed by law. As a result of the re-evaluation of azadirachtin, no further risk mitigation measures for product labels are being proposed.
Azadirachtin is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States, Australia, New Zealand and European Union Member States. As of 10 January 2018 no decision by an OECD member country to prohibit any uses of azadirachtin for health or environmental reasons has been identified.
The public including the registrants and stakeholders are encouraged to submit comments during the 90-day public consultation periodFootnote 1 upon publication of PRVD2018-10.
All comments received during the 90-day public consultation period will be taken into consideration in preparation of re-evaluation decision document.Footnote 2 The re-evaluation decision document will include the final re-evaluation decision, the reasons for it and a summary of comments received on the proposed re-evaluation decision with PMRA’s responses.
Additional Scientific Information
No additional data are required.
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