Notice to industry: Regulatory requirements for UV light-emitting products with COVID-19 claims

Date published: August 5th, 2021

The COVID-19 pandemic has seen increased interest in the use of ultraviolet (UV) light-emitting products for decontamination. Some products claim to protect against COVID-19 or prevent its transmission by using UV radiation to eliminate the SARS-CoV-2 virus. These products are used to disinfect rooms, environmental surfaces and household items such as keys and wallets.

This notice is intended to inform industry of the regulatory classification of UV light-emitting decontamination products making COVID-19 claims. Health Canada also wishes to provide information on the applicable pathways for market authorization.

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About UV light

UV light-emitting products are typically sold as lamps, wands and small or large chambers. They make various claims related to decontamination and are sold and represented using terms such as disinfection, sterilization, sanitization, decontamination and cleaning. In addition to disinfecting hard surfaces, UV light has been used for many years to decontaminate water and purify indoor air quality.

Ultraviolet C (UVC) is a dangerous but useful form of UV radiation. The UVC rays have more energy than UVA and UVB rays, making it more effective at decontamination. However, products using UVC for decontamination may pose health and safety risks. Factors such as the wavelength, dose and duration of exposure contribute to the severity of risk and injury, especially to the eyes and skin. An improperly designed, used or installed product can increase these risks.

COVID-19 claims

Health Canada regulates UV light-emitting decontamination products as either pest control products or medical devices based on their intended use and representation.

Manufacturers of these products should not make claims related to COVID-19 unless the claims can be supported by evidence. To date, these claims have not been substantiated in scientific literature or in applications received by Health Canada.

Health Canada has not yet authorized any UV light-emitting products with claims that they protect against or prevent SARS-CoV-2 infection and transmission. As of August 5th, 2021, Health Canada has only authorized 1 UV light-emitting decontamination product without COVID claims as a pest control product.

Manufacturers, importers and distributors making unsubstantiated claims related to the SARS-CoV-2 virus and COVID-19 will be subject to compliance and enforcement actions. These include being referred to the Competition Bureau, which is monitoring the marketplace and taking action to stop deceptive marketing practices related to COVID-19.

The Competition Act prohibits false or misleading claims about any product. It also prohibits performance claims that are not supported with adequate and proper testing. The Competition Bureau has issued warnings to a number of manufacturers and businesses, including those claiming their products filter out or inactivate SARS-CoV-2.

The Competition Bureau actively monitors the marketplace to stop deceptive claims.

Regulatory requirements as a pest control product

The Pest Management Regulatory Agency (PMRA) is the authority within Health Canada that regulates pest control products under the Pest Control Product Act (PCPA), including certain UV light-emitting products.

On June 7, 2021, the Minister of Health signed the Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices. This interim order brings the regulation of UV-emitting and ozone-generating products that control, reduce, destroy or inactivate bacteria, viruses (including SARS-CoV-2 that causes COVID-19) or other human pathogens on environmental surfaces, water or air under the scope of the PCPA.

Applicants should consult the notice of intent and questions and answers pages for more information on the interim order. If you have any questions, please contact PMRA by email: hc.pmra.subject.to.regulation-sujet.a.la.reglementation.arla.sc@canada.ca.

Regulatory requirements as a medical device

The Medical Devices Directorate (MDD) is the federal authority that regulates the sale and importation of medical devices under the Food and Drugs Act. Decontamination products using UVC that fall under MDD's scope include those intended for sterilization or high-level disinfection of reusable medical devices used for critical or semi-critical purposes (for example, invasive procedures and personal protective equipment) within a controlled space. These sterilizers and high-level disinfectants are Class II medical devices. They are used to mitigate or prevent infectious disease in humans and must not deteriorate the performance of the medical device. Therapeutic devices using UVA/UVB to treat skin conditions are also Class II medical devices.

Manufacturers of UVC decontamination devices must demonstrate high-level disinfection or sterilization of bacterial spores with an organism that offers a maximum challenge for the chosen technology (for example, Bacillus subtilis spores) or a scientifically justified surrogate organism (for example, Mycobacterium species). A high level of disinfection or sterilization is generally considered to be a minimum 6 log reduction (99.9999%).

UV light-emitting decontamination products intended for use in rooms, on environmental surfaces or household products are not considered medical devices. They do not diagnose, treat, prevent or mitigate disease in an individual. Rather, they correct or adjust environmental conditions and are therefore under the scope of the PMRA.

Other regulatory requirements

In addition to the requirements mentioned, manufacturers should be aware of other considerations:

Definitions

Cleaning: Removal of microbiological and organic contamination from an item to the extent necessary for further processing or for the intended use. Removal is done using water with detergents or enzymatic products.

Decontamination: Removal of microorganisms to leave an item safe for further handling. There are 3 levels of decontamination: cleaning, disinfection and sterilization.

Device (Food and Drugs Act): An instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in:

  1. diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals
  2. restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals
  3. diagnosing pregnancy in human beings or animals
  4. caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring or
  5. preventing conception in human beings or animals

However, a device does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal.

Disinfection: A physical and/or chemical process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects. Note: Disinfection processes do not ensure the margin of safety associated with sterilization processes.

High-level disinfectant: Destroys vegetative bacteria, mycobacteria, fungi and enveloped (lipid) and non-enveloped (non-lipid) viruses, but not necessarily bacterial spores.

Medical device (Medical Devices Regulations): A device within the meaning of the [Food and Drugs Act], but does not include any device that is intended for use in relation to animals.

Microorganisms: Entity of microscopic size encompassing bacteria, fungi, protozoa and viruses (Association for the Advancement of Medical Instrumentation, AAMI).

Pest control product (Pest Control Products Act):

  1. a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects
  2. an active ingredient that is used to manufacture anything described in paragraph (a) or
  3. any other thing that is prescribed to be a pest control product

Radiation emitting device (Radiation Emitting Devices Act):

  1. any device that is capable of producing and emitting radiation and
  2. any component of or accessory to a device described in paragraph (a)

Reprocessing: To make ready for reuse a device, instrument or piece of equipment by any or a combination of cleaning, decontamination or disinfection, repackaging and sterilization (AAMI).

Sanitization: The reduction of microorganisms on environmental inanimate surfaces, objects or air by significant numbers. Sanitizers do not destroy or eliminate all microorganisms.

Sterilization: A physical and/or chemical process that destroys or eliminates all forms of microbial life (AAMI).

Contact us

You may send your questions or comments about this notice to the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca.

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