Proposed Maximum Residue Limit PMRL2025-27, Spidoxamat

Table of contents

Purpose of consultation

Maximum Residue Limits (MRLs)Footnote 1 are being proposed for the pesticide spidoxamat as part of the following applications for Canadian use under submission numbers 2022-5345, 2022-5346, 2022-5458, 2022-5459; and submission number 2022-5460 for imported commodities.

Under the authority of the Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) is proposing acceptability of the uses requested under the above-noted applications to register the technical grade spidoxamat and the end-use products Velancor, Plenexos Smart, Plenexos Care for new uses on pistachios, pome fruits (crop group 11-09), stone fruits (crop group 12-09), small fruits vine climbing, except fuzzy kiwifruit (crop subgroup 13-07F), and tree nuts (except almonds and pistachios) in Canada, to control or suppress various insects as soil and foliar applications (please refer to Table 1).

The evaluation of these spidoxamat applications indicated that the end-use products have value, and the human health and environmental risks associated with their proposed uses are acceptable. Details regarding these applications can be found in Proposed Registration Decision PRD2025-15, Spidoxamat, Velancor, Plenexos Smart, Plenexos Care, posted to the Pesticides and pest management portion of the Canada.ca website on 18 November 2025. Dietary risks from the consumption of foods listed in Table 1 were shown to be acceptable when spidoxamat is used according to the supported label directions. Therefore, foods containing residues resulting from these uses are safe to eat, and MRLs are being proposed as a result of this assessment.

In addition, Health Canada is proposing acceptability of the request to specify an MRL for spidoxamat on imported citrus fruits (crop group 10, revised), in order to permit the import and sale of food that could contain such residues. Health Canada has determined the quantity of residues that may remain in or on the imported commodities when spidoxamat is used according to the label directions of the exporting country, and that such residues will not be a concern to human health. Details regarding the proposed MRL on imported commodities can also be found in PRD2025-15.

Dietary health assessment

In assessing the risk of a pesticide, Health Canada combines information on pesticide toxicity with information on the degree and duration of dietary exposure to the pesticide residue from food. The risk assessment process involves four distinct steps:

  1. Identifying the toxicology hazards posed by the pesticide;
  2. Determining the "acceptable dietary level" for Canadians (including all vulnerable populations), which is protective of adverse health effects;
  3. Estimating human dietary exposure to the pesticide from all applicable sources (domestic and imported commodities); and
  4. Characterizing health risk by comparing the estimated human dietary exposure to the acceptable dietary level.

Before registering a pesticide for food use in Canada, Health Canada must determine the quantity of residues that could remain in or on the food when the pesticide is used according to label directions and that such residues will not be a concern to human health (step 3 and step 4). If estimated human exposure is less than or equal to the acceptable level (developed in step 2), Health Canada concludes that consuming residues resulting from use according to approved label directions is not a health concern. The proposed MRL is then subject to consultation to legally specify it as an MRL. An MRL applies to the identified raw agricultural food commodity, as well as to any processed food product that contains it, except for certain instances where different MRLs are specified for the raw agricultural commodity and its processed product(s).

Consultation on the proposed MRLs for spidoxamat is being conducted via this document and PRD2025-15. Health Canada invites the public to submit written comments on the proposed MRLs for spidoxamat in accordance with the process outlined in the How to get involved Section of this document, and with the process outlined in PRD2025-15.

To comply with Canada's international trade obligations, consultation on the proposed MRLs is also being conducted internationally by notifying the World Trade Organization, as coordinated by Canada's Notification Authority and Enquiry Point.

Proposed MRLs

The proposed MRLs for spidoxamat are summarized in Table 1.

Table 1 Proposed maximum residue limits for spidoxamat
Common name Residue definition MRL
(ppm)Table 1 Footnote 1
Food commodity
Spidoxamat 11-(4-chloro-2,6-dimethylphenyl)-12-hydroxy-1,4-dioxa-9-azadispiro[4.2.4.2]tetradec-11-en-10-one 1.5 Stone fruits (crop group 12-09)
1.0 Small fruits vine climbing, except fuzzy kiwifruit (crop subgroup 13-07F)
0.9 Citrus fruits (crop group 10) (revised); pistachios
0.3 Pome fruits (crop group 11-09)
0.01 Tree nuts (crop group 14-11, except almond and pistachio)

The commodities included in the listed crop groups/subgroups can be found on the Residue Chemistry Crop Groups webpage in the Pesticides and pest management section of Canada.ca.

MRLs established in Canada may be found using the Maximum Residue Limit Database on the Maximum residue limits, human health, and food safety webpage. The database allows users to search for established MRLs, regulated under the Pest Control Products Act, both for pesticides or for food commodities.

International situation and trade implications

Spidoxamat is a new active ingredient that is concurrently being registered in Canada and the United States (U.S.). As reported in Table 2, the MRLs proposed for spidoxamat in Canada are the same as corresponding tolerances to be promulgated in the U.S. Once established, the U.S. tolerances for spidoxamat will be listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide.

Currently, there are no Codex MRLsFootnote 2 listed for spidoxamat in or on any commodity on the Codex Alimentarius Pesticide Index webpage.

Table 2 Comparison of proposed Canadian MRLs, U.S. tolerances and Codex MRLs
Food commodity Proposed Canadian MRL
(ppm)
Proposed U.S. tolerance
(ppm)
Established Codex MRL
(ppm)
Stone fruits (crop group 12-09) 1.5 1.5 (Stone fruits, crop group 12-12) Not established
Small fruits vine climbing, except fuzzy kiwifruit (crop subgroup 13-07F) 1.0 1.0 (Small fruits vine climbing, except fuzzy kiwifruit, crop subgroup 13-07F) Not established
Citrus fruits (revised) (crop group 10) 0.9 0.9 (Citrus fruits, crop group 10-10) Not established
Pistachios 0.9 0.9 Not established
Pome fruits (crop group 11-09) 0.3 0.3 (Pome fruits, crop group 11-10) Not established
Tree nuts (except almond and pistachio) (crop group 14-11) 0.01 0.01 (Tree nuts, crop group 14-12, except almond and pistachio) Not established

ppm = parts per million

How to get involved

Health Canada invites the public to submit written comments on the proposed MRLs for spidoxamat up to 75 days from the date of publication of this document (by 1 February 2025). Please forward your comments to the Pest Management Regulatory Agency Publications Section. Health Canada will consider all comments received and a science-based approach will be applied in making a final decision on the proposed MRLs. Comments received will be addressed in a response to comments document found in Pesticides and pest management consultations. The established MRLs will be legally in effect as of the date that they are entered into the Maximum Residue Limit Database.

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2025-11-18