Regulatory Decision Document: p-Menthane-3,8-diol

29 November 2002
ISBN: 0-662-33188-5
Cat. No. H113-6/2002-4E
(RDD2002-04)

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The active ingredient, p-menthane-3,8-diol, and the associated end-use product, OFF! Botanicals Lotion Insect Repellent 1, containing p-menthane-3,8-diol, for use as a personal insect repellent against mosquitoes and black flies, are eligible for full registration under Section 13 of the Pest Control Products (PCP) Regulations.

These products were proposed for registration in Proposed Regulatory Decision Document PRDD2002-02 p-Menthane-3,8-diol. This Regulatory Decision Document outlines this stage of the Pest Management Regulatory Agency's regulatory decision-making process concerning the use of active ingredient, p-menthane-3,8-diol, and the associated end-use product, OFF! Botanicals Lotion Insect Repellent 1, containing p-menthane-3,8-diol, for use as a personal insect repellent against mosquitoes and black flies.

1.0 Introduction

This Regulatory Decision Document outlines the Pest Management Regulatory Agency's (PMRA) regulatory decision-making process concerning the use of active ingredient, p-menthane-3,8-diol, and the associated end-use product, OFF! Botanicals Lotion Insect Repellent 1, containing p-menthane-3,8-diol, for use as a personal insect repellent against mosquitoes and black flies.

2.0 Background

The PMRA carried out an assessment of available information in accordance with Section 9 of the Pest Control Products (PCP) Regulations. The assessment found that there was sufficient information, pursuant to Section 18(b), to allow a determination of the safety, merit and value of p-menthane-3,8-diol, and the associated end-use product, OFF! Botanicals Lotion Insect Repellent 1, containing p-menthane-3,8-diol, developed by S. C. Johnson Canada Inc. The PMRA concluded that the use of OFF! Botanicals Lotion Insect Repellent 1 in accordance with the label accompanying the product has merit and value consistent with Section 18(c) of the PCP Regulations and does not entail an unacceptable risk of harm under Section 18(d).

These products were proposed for registration in Proposed Regulatory Decision Document PRDD2002-02. One comment was received by the PMRA concerning PRDD2002-02 and is addressed in Appendix I.

3.0 Regulatory decision

Based on the considerations outlined above, p-menthane-3,8-diol, and the associated enduse product, OFF! Botanicals Lotion Insect Repellent 1, for use as a personal insect repellent against mosquitoes and black flies, are eligible for full registration, pursuant to Section 13 of the PCP Regulations.