Re-evaluation Decision RVD2023-10, Capsaicin and Related Capsaicinoids and Its Associated End-use Products

Pest Management Regulatory Agency
30 March 2023
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2023-10E-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for capsaicin and related capsaicinoids and associated end-use products
• Re-evaluation decision for capsaicin and related capsaicinoids
• Risk mitigation measures
• Next steps
• Other information
• Appendix I Registered Products Containing Capsaicin and Related Capsaicinoids in Canada

Re-evaluation decision for capsaicin and related capsaicinoids and associated end-use products

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 health and environmental safety standards and continue to have value. The re-evaluation considers information from various sources such as data and information from pesticide manufacturers 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.

Capsaicin and related capsaicinoids (dihydrocapsaicin and nordihydrocapsaicin) are the essential oil extracts from pepper fruit, and the actives are always co-formulated. In Canada, capsaicin and related capsaicinoids are registered as animal repellents. They act as vertebrate repellents through irritation when they come into contact with skin or mucous membranes. Capsaicin and its related compounds are the only actives registered to repel bears. These are restricted class products formulated as pressurized spray to be used only by authorized customers. Similar products, at a lower concentration and smaller size, are also registered to deter aggressive dogs or coyotes in domestic settings. The actives, formulated as a suspension, are registered as commercial and domestic class products for use to protect trees and ornamentals from deer, rabbits and hares. Granular, dust and liquid domestic class products are also registered to deter dog, cat, raccoon, skunk, groundhog and squirrels to protect the residential areas or bird seeds.

Currently registered products containing capsaicin and related capsaicinoids can be found in the Pesticide Product Information Database and in Appendix I. The Proposed Re-evaluation Decision PRVD2022-14, Capsaicin and related capsaicinoids containing the evaluation of capsaicin and related capsaicinoids and proposed decision, underwent a 90-day consultation^{Footnote 1} period ending on 3 October 2022. PRVD2022-14 proposed continued registration of capsaicin and related capsaicinoids products in Canada, with the proposed updates to label directions and precautions to reflect the current labelling standards and improve clarity.

Health Canada received one comment relating to the value assessment. Commenters are listed in Appendix II of the full version of Re-evaluation Decision RVD2023-10, Capsaicin and Related Capsaicinoids and Its Associated End-use Products. The comment is summarized in Appendix III of RVD2023-10 along with the response by Health Canada. The comment did not result in revisions to the value assessment and did not result in changes to the proposed re-evaluation decision as described in PRVD2022-14. A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2022-14.

This document (RVD2023-10) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of capsaicin and related capsaicinoids, including the required label updates required to bring labels to current standards and improve clarity. All products containing capsaicin and related capsaicinoids that are registered in Canada are subject to re-evaluation decision.

Re-evaluation decision for capsaicin and related capsaicinoids

Health Canada has completed the re-evaluation of capsaicin and related capsaicinoids. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing capsaicin and related capsaicinoids is acceptable. Following a scientific review of the available information, Health Canada has determined that the health and environmental risks and the value of capsaicin and related capsaicinoids continue to be acceptable provided that the required mitigation measures are implemented. Label amendments, as summarized below and listed in Appendix IV of RVD2023-10, are required. No additional data are required at this time.

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 updated label statements as a result of the re-evaluation of capsaicin and related capsaicinoids, are summarized below. Refer to Appendix IV of RVD2023-10 for details.

Label improvements to meet current standards - Human health:

• Update to standard label statements (wording related to directions for use, first aid, and health precautions).

Label improvements to meet current standards - Environment:

• Updates to standard label statements (directions for use and disposal).

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 RVD2023-10. 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 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 3} regarding this decision on capsaicin and related capsaicinoids 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 section of the Canada.ca website (Request a Reconsideration of Decision) or contact PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2022-14) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact the Pest Management Information Service.

Appendix I Registered products containing capsaicin and related capsaicinoids in Canada