Regulating UV and Ozone Devices

Summary#

These final amendments — the Regulations Amending the Pest Control Products Regulations (Ultraviolet Radiation-emitting Devices and Ozone-generating Devices) (SOR/2022-99) — make many UV and ozone-generating devices fall under the Pest Control Products Regulations. The rules require these devices to be either registered with Health Canada or meet specific authorization conditions, and they came into force on June 8, 2022 (the day after the temporary interim order expired).

What it does#

• Adds definitions for “ultraviolet radiation-emitting device” and “ozone-generating device” that focus on devices made or sold to kill or reduce human pathogens (not including devices for swimming pools, spas, or water treatment).
• Makes those defined devices subject to the Pest Control Products Regulations so they must be either:
  • Registered (a formal Health Canada review), or
  • Authorized under specific conditions that let some products be sold without full registration.
• Sets the authorization conditions for certain UV devices (examples):
  • Must be certified to Canadian electrical safety requirements by a product certification body accredited by the Standards Council of Canada.
  • The UV lamp or UV-emitting component must be enclosed or fully shielded to prevent exposure, or meet the photobiological “Exempt group” criteria such as IEC 62471 where applicable.
  • Must have a lock or automatic shut-off to prevent access while operating.
  • Must not produce ozone or other potentially harmful byproducts during operation.
  • Label and manual must limit claims to “supplemental sanitization” and include specific warnings and usage directions.
• Exempts devices that are also medical devices classified as Class II, III or IV under the Food and Drugs Act’s Medical Devices Regulations.
• Explicitly excludes devices used in swimming pools, spas and drinking- or wastewater treatment systems from this change.
• Allows manufacture of these unregistered devices solely for export if the manufacturer prepares and keeps an export certificate and follows labeling/record rules.
• Adds new labelling rules for principal and secondary display panels and requires manufacturers to keep export and other records for five years.

Who's affected#

• Manufacturers, importers, distributors and sellers of UV and ozone-generating devices that claim to control or inactivate human pathogens.
• Facilities that buy or install these devices (commercial, industrial, educational institutions, health care facilities, and similar).
• Product certification bodies and testing labs that issue safety and photobiological certifications.
• Small businesses in this sector: Health Canada estimated about 80% of registrants would be small businesses.
• Estimated costs and fees called out in the regulatory analysis:
  • Application processing fee per device (estimate): $2,167.
  • Annual charges for registrants range from $100–$3,600 depending on sales.
  • Total incremental cost over 10 years (government and industry combined): $2,033,000.
  • Estimated cost to business over 10 years: $1,675,000.
  • Estimated cost to government over 10 years: $358,000.
• If it is unclear who is affected: devices used only for plant/animal pathogens, Class I medical devices, and some lab-specific uses were left out or deferred; Health Canada said scope could be expanded later.

Why it matters#

• Public health protection: the rules aim to reduce the risk that people will be harmed by direct UV exposure (eye and skin damage, possible long-term cancer risk) or by inhaling ozone (lung irritation and other respiratory harms).
• Consumer clarity: devices that remain on the Canadian market must either be shown to be safe and effective (registration) or meet strict design, certification and labeling rules to limit misleading claims (authorization).
• Real-world effects:
  • Some devices already sold with strong claims about killing viruses now face tighter proof or stricter labeling.
  • Buyers and facility managers should expect clearer warnings and usage instructions on devices and manuals.
  • Small manufacturers may face up-front costs to register products or to modify labels and designs to meet authorization conditions.
• Health Canada noted it could not fully quantify the benefits in dollar terms because injury data are limited, but concluded the health benefits of regulating these devices are likely significant.