Supporting Pesticide Device Efficacy Claims in Canada
16 May 2023
Do you have the data to back up your product?
How are Pesticide Devices regulated in Canada currently?
In June 2022, Health Canada's Pest Management Regulatory Agency (PMRA) published an amendment to the Pest Control Products Regulations (PCPR) to better define how ultraviolet (UV)- and ozone-generating devices are regulated in Canada. A summary of the amendment is included in one of our previous blogs – see Pesticide Device Regulation in Canada – Update.
The PCPR outlines the requirements for manufacturers and distributors who wish to register a pesticide device in Canada. One of the registration requirements is to provide the PMRA with a complete dataset to address the value assessment requirements. You, as a manufacturer or distributor, essentially must prove that your device actually works in the way it is intended. While the guidelines clearly state the data requirements for a typical pesticide, the requirements are vague when it comes to pesticide devices.
How does this effect my device making antimicrobial claims?
The biggest take away is that the PMRA wants you to prove your device works the way your company claims it does. When the COVID-19 pandemic hit, a flurry of UV devices hit the market with claims that they were 99.9% effective against viruses, bacteria, and germs with no data to back up these statements. This was extremely misleading to consumers. When the PMRA recognized the prevalence of these misleading claims, they set out to provide a solution.
Prior to the June 2022 amendment to the PCPR, the existing regulations as they relate to devices were becoming a relic; they were out of date and difficult and time consuming to update. While the modernization of the PCPR can still be confusing for companies new to the regulatory world, registrants now have a clearer path forward and better definitions for pesticide devices that require registration versus those that do not.
How do I prove my marketing claims?
While specific guidelines to prove a product's performance have not yet been published for pesticide devices, the PMRA suggests reviewing the value guidelines for antimicrobial pesticides as a starting point. These guidelines outline the testing protocols and performance standards for typical antimicrobial products, which can be altered to suit the device being tested.
Things to keep in mind
The objective of efficacy studies is to confirm the level of microbial control under the proposed conditions of use for each device. The studies should address the level, duration, and consistency of control provided by the device being registered. Information that is available publicly—including scientific literature that supports the efficacy of UV lights, for example—can be included in the application package but is not sufficient on its own.
The use of internationally recognized test methods and protocols is preferred for efficacy claim substantiation, though adaptations of these methods are likely required to support efficacy for novel devices. When adapting the testing protocols and methods, it is important that the results are representative of real-world conditions.
What test method should I choose?
The particular test method adopted will depend on your label claims. Generally speaking, for a label to bear disinfection or sanitization claims, a minimum of a 3-log reduction of microbes is required (99.9% reduction). Testing on a single virus or bacterium would not be sufficient to support a general antiviral or antibacterial claim. The test results must also show that the product is effective at reducing microbes on the types of surfaces identified on the label (hard surfaces, soft surfaces, etc.). Typically, different models of a similar device would require separate registration, unless an acceptable rationale can be provided to the regulators, demonstrating that the models are identical voltage, current, function, etc.
Intertek is here to help!
It is important to understand the registration requirements for pesticide devices, including what type of testing is required, prior to applying for pre-market approval in Canada. Do you have questions about regulation of pesticide or pesticide devices in Canada, the Pest Control Products Act (PCPA), or a related topic? Do you need assistance determining which tests would be most appropriate for your product type, running those tests, or preparing a registration dossier for a pesticide or pesticide device? Contact our experts at Intertek. We're here to help!
References:
The Pest Control Products Act (S.C. 2002, c. 28)
https://laws-lois.justice.gc.ca/eng/acts/p-9.01/
Pest Control Product Regulations (SOR/2006-124)
Pest Control Products Regulations (justice.gc.ca)
Regulations Amending the Pest Control Products Regulations (Ultraviolet Radiation-emitting Devices and Ozone-generating Devices): SOR/2022-99
Value Guidelines for New Antimicrobial Pest Control Products and Label Amendments
Raquel Tranquada,
Associate III, Chemicals Group,
Intertek Assuris
Raquel Tranquada is a Senior Regulatory Associate in Intertek Assuris' Chemical Group. Her focus is supporting our North American biocide, pesticide, and fertilizer clients. By keeping a pulse on the regulatory changes in North America as well as her past experience with Hazard Communication, New Substance Notifications and placing studies with labs, Raquel is well positioned to assist clients with a full picture approach to biocide, pesticide, and fertilizer regulations in North America.