Re-evaluation Decision RVD2022-11, p-Menthane-3,8-diol and Its Associated End-use Products

Pest Management Regulatory Agency
11 August 2022
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2022-11E-PDF (PDF version)

Summary

To obtain a full copy of Re-evaluation Decision RVD2022-11, p-Menthane-3,8-diol and Its Associated End-use Products please contact our publications office.

Should you require further information please contact the Pest Management Information Service.

Table of contents

Re-evaluation decision for p-menthane-3,8-diol 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, published scientific 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.

p-Menthane-3,8-diol is a synthetic analogue of a compound derived from the lemon eucalyptus plant. Products containing p-menthane-3,8-diol are applied as personal insect repellents and repel mosquitoes, biting midges, blackflies and ticks following application. Currently registered products containing p-menthane-3,8-diol can be found in the Pesticide Product Information Database and in Appendix I.

The Proposed Re-evaluation Decision PRVD2021-14, p-Menthane-3,8-diol containing the evaluation of p-menthane-3,8-diol and proposed decision, underwent a 90 day consultation period ending on 20 March 2022. PRVD2021-14 proposed continued registration of all uses of p-methane-3,8-diol and associated end-use products registered for sale and use in Canada.

Health Canada received comments relating to the health assessment. Commenters are listed in Appendix II of the full version of RVD2022-11, p-Menthane-3,8-diol and Its Associated End-use Products. These comments are summarized in Appendix III of RVD2022-11 along with the responses by Health Canada. These comments did not result in revisions to the health assessment, but did result in changes to the cumulative assessment wording of the proposed re-evaluation decision as described in PRVD2021-14.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2021-14. There was no further information used in the re-evaluation decision. Therefore, the reference list of all information used in the proposed re-evaluation decision, set out in PRVD2021-14, represents the complete reference of information used in this final re-evaluation decision.

This document (RVD2022-11) presents the final re-evaluation decisionFootnote 1 for the re-evaluation of p-menthane-3,8-diol. All products containing p-menthane-3,8-diol that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for p-menthane-3,8-diol

Health Canada has completed the re-evaluation of p-menthane-3,8-diol. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing p-menthane-3,8-diol is acceptable. An evaluation of available scientific information found that the uses of p-menthane-3,8-diol products meet current standards for protection of human health and the environment and have acceptable value when used according to conditions of registration.

Other information

Any person may file a notice of objectionFootnote 2 regarding this decision on p-menthane-3,8-diol 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 Health Canada's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2021-14) are available for public inspection, upon application, in Health Canada's Reading Room. For more information, please contact Health Canada's Pest Management Information Service.

Appendix I Registered products containing p-menthane-3,8-diol in Canada

Table 1 Products containing p-menthanol-3,8-diol that do not require label amendments Footnote 1
Registration number Class Registrant Product name Formulation type Guarantee
27193 Technical S. C. Johnson and Son, Ltd. p-Menthane-3,8-diol Technical Dust or powder p-Menthane-3,8-diol 99 %
27194 Domestic S. C. Johnson and Son, Ltd. OFF! Botanicals Insect Repellent 1 Emulsifiable concentrate or emulsion p-Menthane-3,8-diol 10 %
29313 Domestic S. C. Johnson and Son, Ltd. OFF!®Familycare Botanicals Insect Repellent Lotion Emulsifiable concentrate or emulsion p-Menthane-3,8-diol 10 %
33948 Domestic S. C. Johnson and Son, Ltd. OFF!®Familycare®Botanicals®Insect Repellent Pump Spray Solution p-Menthane-3,8-diol 10 %
34004 Domestic S. C. Johnson and Son, Ltd. OFF!®Botanicals Insect Repellent Spritz Solution p-Menthane-3,8-diol 10 %
34008 Domestic S. C. Johnson and Son, Ltd. OFF!®Botanicals Insect Repellent Lotion Emulsifiable concentrate or emulsion p-Menthane-3,8-diol 10 %
Footnote 1

as of 28 April 2022, excluding discontinued products or products with a submission for discontinuation

Return to footnote 1 referrer

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