Regulating certain ultraviolet radiation-emitting and ozone-generating devices under the Pest Control Products Act: Devices subject to the Act
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Devices that apply
The Pest Control Products Act (PCPA) and the Pest Control Product Regulations (PCPR) govern UV radiation-emitting or ozone-generating devices imported, manufactured, represented, distributed, or used in homes, commercial settings and health care facilities to kill bacteria and viruses that are human pathogens.
The device may be an ozone-generating device or a UV radiation-emitting device that emits UVA, UVB or UVC wavelengths. Devices subject to regulation under the PCPA are those that are imported, manufactured, represented, distributed or used to:
- control, destroy or inactivate viruses, bacteria or other micro-organisms that are human pathogens (for example, E. coli, SARS-CoV-2, the virus that causes COVID-19) or
- reduce their levels on surfaces, on objects, in water or in air
Some examples are devices marketed for use in the home to kill bacteria and viruses:
- on surfaces and objects such as cell phones, keys and remote controls
- in water, such as humidifiers
- in the air in small- to large-sized rooms
Other examples are devices used in commercial or health care settings to kill bacteria and viruses on surfaces or in the air.
These devices require registration under the PCPA unless they meet certain criteria. If they meet these criteria, the device is considered authorized under the PCPA (see the following conditions for authorization).
Note that UV radiation-emitting devices that also generate or produce another substance, including ozone or hydroxyls, must be registered under the PCPA.
Conditions for authorization
Certain UV radiation-emitting devices are authorized, meaning they do not require registration if:
- they are certified by a product certification body accredited by the Standards Council of Canada as meeting the applicable Canadian electrical safety requirements
- recognized product certification bodies that are approved to provide certifications to the applicable standards include the Canadian Standards Association (CSA), Electrical Testing Laboratories (ETL) and Underwriters Laboratories Inc. (UL)
- the certification mark of the product certification body appears on the label
- no express or implied reference to prevention, treatment or mitigation of disease is made about the device
- any efficacy claim made about the device is only a claim of supplemental sanitization and does not replace the requirement for routine disinfection procedures
- examples of acceptable supplemental sanitization claims include:
- "This UV device helps reduce microorganisms on surfaces"
- "This UV device helps reduce bacteria on surfaces and objects"
- A supplemental sanitization claim cannot mention specific microorganisms or any quantifiable level of efficacy
- the device has at least one of the following:
- a locking mechanism during operation
- an automatic shut-off feature, if opened during operation
- for example, a magnetic clasp or zipper that immediately shuts off the UV lamp if opened during operation
- its ultraviolet lamp, or other UV emitting component, is fully shielded or enclosed in the device so that it prevents exposure to ultraviolet radiation
- examples of devices that do not meet this condition:
- handheld UV radiation-emitting devices with a clear plastic lens covering the UV lamp
- personal UV air sanitizers with slits on the sides that emit UV radiation
- devices with unshielded lamps intended for use in an empty room, that are equipped with motion sensors that turn the device off
- examples of devices that do not meet this condition:
- the device does not produce or generate any other substance that may be harmful to human health during operation
In addition to the conditions above, there are 2 options for devices to be authorized:
- for both options, the device be used in commercial or industrial premises or in institutional education or health care facilities and, as applicable:
- if the device itself is contained in a ventilation system in a manner that prevents exposure to UV radiation then it does not require its ultraviolet lamp to be fully shielded or enclosed in the device or
- if the ultraviolet lamp or UV component of the device is unshielded and the device does not have a locking or automatic shut-off mechanism, it must be either:
- certified as being in the "Exempt Group" classification by a product certification body per the International Electrotechnical Commission's standard 62471 or
- certified as being in an equivalent classification in a standard specified by Health Canada
The following information must appear on the display panels and in the operating manual.
On the primary display panel and in the manual:
- the intended use of the device
- the statement "KEEP OUT OF THE REACH OF CHILDREN" if the device is to be distributed mainly to the public for personal use in or around their homes
- the statement "READ THE LABEL AND ANY OPERATING MANUAL BEFORE USING" or "READ THE LABEL BEFORE USING", as appropriate
- the name, postal address, telephone number and email address of a contact person in Canada where public inquiries may be directed
On the secondary display panel and in the operating manual:
- under the heading "precautions", the following statements:
- "WARNING - UV radiation emitted from this device"
- "Unintended use of the device, or damage to the housing, may result in exposure to ultraviolet radiation"
- "Ultraviolet radiation may cause eye and skin irritation"
- "Avoid exposing eyes and skin to ultraviolet radiation"
- under the heading "DIRECTIONS FOR USE", the directions for using the device, including how to operate it and any limitations on its use
- if the UV device has a replaceable UV lamp or other UV-emitting component, also include instructions on the frequency of replacement and how the user may replace the component without being exposed to UV radiation
- the statement: "The use of this device is a supplement to and not a substitute for standard infection control practices to control transmission of infections; users must continue to follow all current infection control practices, including those practices related to cleaning and disinfection of environmental surfaces"
- devices that were authorized during the Interim Order may include the former statement for up to 6 months after the Interim Order expired: "The use of this device is a supplement to and not a substitute for standard infection control practices; users must continue to follow all current infection control practices, including those practices related to cleaning and disinfection of environmental surfaces"
- information that identifies any risks to health or to the environment associated with the handling, storage, display, distribution and disposal of the device or anything in connection with which the device is to be used, or its components, and instructions on procedures to reduce those risks
- if there is insufficient space on the secondary display panel to show all the required information above, the secondary display panel information (other than the precautionary statements) can be included in the operating manual.
The efficacy claims of an authorized UV radiation-emitting device would not be subject to a review. Thus, a supplemental sanitization claim cannot reference a threshold of efficacy or a specific pathogen name. Manufacturers wishing to make such claims would have to:
- apply to register the device
- provide supporting data to support the claimed threshold of efficacy against the specific pathogen
A UV radiation-emitting device, an ozone-generating device or a UV-emitting component that's manufactured or imported for manufacture in Canada solely for the purpose of export would be authorized if the exported product:
- the manufacturer of the exported product has signed an export certificate (PDF format) in front of a Commissioner of Oaths declaring that the product does not contravene any known requirements of the law of the countries to which it is shipped, consigned or about to be consigned
- the certificate must be kept for five years after the date of last shipment
- a new certificate must be prepared if the product or export destination changes.
- the certificate must be made available to the Minister upon request
- is exported in compliance with subsections 3.2(1) to (3) and (6) to (10) of the Pest Control Product Regulations
UV lamps, or other UV emitting components, that are subject to the Pest Control Products Act would be authorized under the following scenarios:
- the component is manufactured, represented or distributed solely for use in a UV device that meets the conditions for authorization, and labelled so that
- any claim of efficacy that is made regarding the device is made only in relation to supplemental sanitization
- no express or implied claim for the treatment, mitigation or prevention of disease is made regarding the device
- the component is evaluated as part of registration and labelled according to the conditions of the registration
Manufacturers, importers and distributors are responsible for determining if their device meets all authorization criteria. Those with questions on whether a product is subject to the PCPA can ask for a "subject to regulation" determination. This is a free service. Please email email@example.com.
Before submitting an application for registration, Health Canada's Pest Management Regulatory Agency (PMRA) recommends a pre-submission consultation. This is a free service. The PMRA provides written guidance to help prospective applicants complete and submit an application to register a new pest control product.
For a copy of the pre-submission consultation guidance (in both official languages) that outlines the regulatory requirements for UV radiation-emitting or ozone-generating devices:
- email firstname.lastname@example.org
- indicate either UV radiation-emitting device pre-submission guidance or ozone-generating device pre-submission guidance in the subject line
For UV radiation-emitting devices, the performance standard for reviewing an application for registration is 12 months.
No ozone-generating device has been registered to date for the purpose of controlling, reducing or destroying human pathogens. The performance standard for reviewing a major new use of a pest control product is 18 months.
A proposed registration decision is published for all major decisions, as defined under subsection 28(1) of the PCPA. There is a 45-day public consultation period before a registration is granted. Once Health Canada has registered one of these devices, any subsequent applications would be reviewed within the shorter 12-month timeline.
During the Interim Order period, the PMRA aimed to expedite the review of any UV radiation-emitting or ozone-generating device applications. As of December 2021, PMRA will only expedite applications for devices that are represented or used as a means to control or kill viruses, bacteria or other micro-organisms in the air, as well as any other type of air sanitizer application that the agency may receive. This position aligns with those taken by other Health Canada departments and the US Environmental Protection Agency.
The PMRA will only expedite a complete application containing all requirements. PMRA will put on hold applications that are incomplete and reject those that fail to submit the required information.
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