Last week, Health Canada issued an Interim Order that creates new registration processes for numerous types of UV and Ozone products. This new regulatory framework will include enclosed UV-C products such as CleanSlate UV.
We are encouraged by the steps Health Canada is taking. This move will better protect the buying public and will ensure the benefits of UV light technology are not undermined by improperly designed or marketed products.
The regulations and processes outlined by Health Canada are clear, reasonable, and will create an effective ‘minimum bar’ for new entrants without stifling innovation. We’re hopeful that other agencies, such as the US Environmental Protection Agency (EPA), will look at this framework and consider similar regulations.
Not familiar with Health Canada’s PMRA? Want to understand why this is important, and how it will impact customers? Read on.
Who Regulates UV Devices in Canada?
Health Canada regulates and outlines the safety and performance requirements that UV-based devices must meet. A division of Health Canada, the Pest Management Regulatory Agency (PMRA), regulates all pesticides and pest control products, including anything that claims to kill microorganisms (such as UV-C light).
For the past decade, most UV products have fallen into a regulatory gray zone.
The PMRA has had regulations that apply to UV products for some time. However, that regulation was typically too narrow (ie. UV-based tanning beds, water treatment) or adapted from chemical disinfectant regulations and therefore too broad. This led to very few UV products going through a formal registration process.
The changes announced last week are unique insofar as they are tailored to this product category, which is a positive development.
How has Health Canada Changed Regulations on UV Devices?
In 2018, the PMRA published a proposal PR02018-02 to exempt from registration, with conditions, “Germicidal UVC light-emitting devices where the lamps are shielded to prevent exposure to people during operation of the device.” The proposal was reviewed by key stakeholders and resulted in the release of the Notice of Intent.
On April 20, 2021,The Notice of Intent NOI2021-01: Interim Order (IO), along with the a Q&A was published to inform about Health Canada’s intention to register ultraviolet radiation-emitting devices under the Pest Control Products Act (PCPA) by next year. This also includes the amendment to grant exemption of registration of certain devices that meet specific conditions. Effective June 07, 2021, Health Canada has approved the Interim Order and is an immediate order under subsection 67.1 (1) of the PCPA.
Our team has been following these updates every step of the way. Our Chief Technology Officer, Manju Anand, is a committee member at the International Ultraviolet Association (IUVA) and has been involved in discussions with Health Canada on this subject. While there are still some clarifications needed from Health Canada, we’re pleased with the process to date.
Why Was This Necessary?
COVID-19 has spurred a lot of innovation in the infection control space, but it has also opened the door to many low-grade, improperly marketed products looking to capitalize on COVID fears.
Over the past year, our team has tracked over 100 new consumer UV light products. Some of these have been legitimate and well-designed. But the vast majority have been questionable in their efficacy, labelling and, most importantly, user safety.
For example, some products have advertised unsubstantiated claims as a UV sterilizer or are poorly designed to perform as an effective UV solution. Reputable retailers such as Costco and BestBuy have distributed products that, in all likelihood, will not meet the new criteria established by the PMRA.
Not only did this wave of products give the UV space a ‘bad rap’ in some circles, but they are running counter to the collective goal of reducing the spread of germs, by not properly outlining their capabilities and limitations.
What Does This Mean for UV Products Moving Forward?
There is a 30 day grace period for all UV-C products to comply with Health Canada regulations. After this, manufacturers and distributors have three options:
1. Stop selling and manufacturing/importing products.
2. Ensure a device is exempt from registration (meeting all the requirements laid out in the Interim Order) and declare the product as such;
3. Submit the device for registration and wait for approval.
These pathways are not mutually exclusive. For instance, a product could reasonably be exempt from registration (by only making supplementary sanitization claims) while pursuing a formal registration for ‘enhanced’ claims.
What Does This Mean for CleanSlate UV Customers?
Our priorities have always been user safety and scientific validation. The CleanSlate UV product meets and/or exceeds all the requirements set out by Health Canada, and we’ll be submitting a formal registration application in the coming days.
All of CleanSlate UV’s products currently in use are safe, and their deployment and use are consistent with the PMRA’s Interim Order.
We will continue manufacturing and selling CleanSlate UV devices to ensure that cell phones, tablets and other devices can be effectively sanitized without the use of harsh chemicals. We will make minor adjustments to product marketing claims to conform with the “exempt from registration” requirements while our application is being processed.
UV-C light has been gaining widespread acceptance in the infection control community for over a decade. Much of this is due to the pioneering work of full-room UVC companies like Tru-D and Xenex.
The mobile device UV space is only ~5 years old. CleanSlate UV is the global leader in professional device hygiene, with over 2000 installations and over 100 million devices sanitized. As a Canadian company, it’s encouraging to see Health Canada take a global leadership role in the clear and smart regulation of ‘next generation’ UV-C disinfection technologies.