Pesticide Device Regulation in Canada - Update
14 Jun 2022
Regulatory Amendment for UV-Emitting and Ozone-Generating Devices
On 08 June 2022, the Pest Management Regulatory Agency (PMRA) published the much-anticipated amendment to the Pest Control Products Regulations (PCPR) to better define how ultraviolet (UV) radiation-emitting devices and ozone-generating devices are regulated in Canada. Regulatory amendment SOR/2022-99 adds specific language about UV radiation‑emitting and ozone-generating devices to the PCPR and clarifies the requirements for pre-market approval of these devices before they can be manufactured, imported, sold, or distributed in Canada.
Under the amendment, ozone-generating devices must be registered in Canada prior to manufacture, import, sale, or distribution. The only exception is if the device is solely for the purpose of export from Canada, in which case the device can be manufactured, stored, transported, or imported for use in manufacturing.
UV Radiation-Emitting Devices
UV radiation-emitting devices must also be registered in Canada unless they meet the following exemption requirements:
- The device has proper electrical certification;
- The device's efficacy claims are limited to supplemental sanitization;
- There is no possibility of UV light exposure for users of the device; and
- The device does not generate any other harmful substance.
Devices that do not meet the UV light exposure requirement may still qualify for the exemption if they are intended for use in commercial or industrial premises, or in locations such as educational institutions and health care facilities. To meet the exemption under these circumstances, the device must be contained within a ventilation system or meet certain photobiological safety standards.
In addition to the devices themselves, UV lamps or other components that emit UV radiation qualify for the exemption if they are solely for use in an exempt device and make claims limited to supplemental sanitization.
Finally, UV radiation-emitting devices are also exempt from registration if they are solely for the purpose of export from Canada.
Registration Requirements for Pesticide Devices
In order to obtain pre-market approval for ozone-generating devices and for UV radiation-emitting devices that do not meet the exemption criteria, a registration application must be submitted to the PMRA that includes, but is not limited to, the following information:
- Labelling that complies with PMRA requirements;
- Certification for devices that contain electronic components;
- Exposure assessments including relevant safety assessment(s); and
- Efficacy support.
It is crucial that any pesticidal claims on the product labelling can be substantiated with product performance (efficacy) data produced using the product as described in the directions for use.
It is important to understand the registration requirements for pesticide devices, including which devices require pre-market approval prior to being manufactured, imported, sold, or distributed in Canada. Do you have questions about this topic, regulation of pesticides in Canada, the Pest Control Products Act (PCPA), or a related topic? Do you need assistance preparing a registration dossier for a pesticide or pesticide device? Contact our experts at Intertek. We're here to help!