Laser product safety regulations update

Summary#

This is a proposed rule from Health Canada called the Regulations Amending the Radiation Emitting Devices Regulations (Laser Products), published July 1, 2023. It would update how lasers sold or imported into Canada are classified, labelled and built, and it aims to reduce injuries; interested people had 75 days to comment. If finalized, the rules would take effect one year after they appear in the Canada Gazette, Part II.

What it does#

• Replaces the old, narrow laser rules in the Radiation Emitting Devices Regulations (REDR) with a broader, hazard-based system that follows parts of the IEC 60825-1 international standard.
• Applies to most laser products (new scope listed as lasers in the wavelength range 180 nm to 1 mm), but excludes medical lasers regulated under the Medical Devices Regulations (MDR), laser components and some very low‑risk items.
• Requires manufacturers, importers and distributors to:
  • Classify lasers by hazard (the IEC class system).
  • Use specific testing rules to determine a product’s class.
  • Fit built-in safety features appropriate to the class.
  • Put identification/origin labels on products and provide user information.
  • Provide required labels and user information in both official languages for sale, lease or import.
• Keeps some differences from the IEC standard that are specific to Canada (for example, bilingual labels and a mandatory product ID label).
• Exempts certain IEC requirements from the Canadian rule (for example, some training and non‑optical hazard rules).
• Would be enforced after products are on the market (post‑market checks and testing), not by mandatory pre‑market certification.

Who's affected#

• Manufacturers, importers, and distributors of laser products sold or brought into Canada. Health Canada estimates about 96 laser firms (about 45 manufacturers and 51 non‑manufacturers) may be affected.
• Retailers and online sellers who offer laser devices to Canadian consumers.
• Consumers and specific groups at higher risk, such as children and young adults.
• Eye-care professionals and emergency responders may see fewer or different types of injury reports if the rules reduce unsafe products.
• Small businesses that make or import only for the Canadian market may face higher one-time and ongoing costs.

Costs reported in the proposal:

• Total estimated cost to business: $6.3M over 10 years.
• Estimated cost for manufacturers: $3.2M over 10 years.
• Estimated cost for importers/distributors: $3.1M over 10 years.

Why it matters#

• Health and safety: Health Canada found rising evidence of eye injuries from lasers — a survey reported 318 eye injuries from 2013–2017 and an average annual increase of 34.4% in that period. In testing, 569 handheld lasers checked between 2011 and 2021 were 85% mislabelled or unlabelled. Better labelling and class-based safety features are meant to reduce these harms.
• Makes enforcement easier: Clear class labels and product ID information let inspectors and border officials identify unsafe products without costly laboratory testing of every device.
• Trade and consistency: Aligning with the IEC 60825-1 standard should make it easier for companies already meeting international rules to sell in Canada, while preventing Canada from becoming a market for unsafe, cheap imports.
• Practical effects: Manufacturers and importers may need to change labels, add product IDs, supply bilingual user info, and possibly add safety features. Consumers should get clearer safety information when buying or using laser products.

Note: This was a proposal (published in Part I); it was not law yet. The proposed rules set an enforcement approach focused on post‑market checks rather than pre‑market certification.