Part INoticeVolume 157, Number 26Published: July 1, 2023
Laser Product Safety Regulations
Canada Gazette, Part I, Volume 157, Number 26: Regulations Amending the Radiation Emitting Devices Regulations (Laser Products)
REGULATORY IMPACT ANALYSIS STATEMENT
Key facts
- Published
- July 1, 2023
- Comment deadline
- September 14, 2023
- Effective date
- Unclear
Summary#
This is a proposed set of changes called the Regulations Amending the Radiation Emitting Devices Regulations (Laser Products). It would require most laser products sold or imported into Canada to carry clear hazard labels and meet an international safety classification, making it easier to spot unsafe lasers and give Health Canada stronger tools to act. The proposal was published July 1, 2023 and public comments were invited for 75 days after that date.
What it does#
- Adopts the international laser safety approach from IEC 60825-1, so lasers are classified by how hazardous they are (Class 1 up to Class 4).
- Replaces old rules that only covered laser scanners and demonstration lasers with requirements that cover most laser products (except medical lasers regulated under the Medical Devices Regulations, certain components, and a few other narrow exclusions).
- Requires product labels and user information to be available in both official languages, and adds a product identification/origin label to help trace products.
- Requires built-in safety features appropriate to a laser’s hazard class, and more detailed information to accompany higher-risk lasers (for operation, maintenance, eye protection guidance, etc.).
- Keeps some deviations from the IEC standard for Canadian needs (for example, which user information is mandatory and bilingual labelling).
- Clarifies that manufacturers, importers and distributors share responsibility for meeting the rules.
- If finalized, the regulations would come into force 12 months after they are published in the Canada Gazette, Part II.
Who's affected#
- Health Canada would use the new rules to inspect and act on unsafe lasers.
- Manufacturers, importers and distributors of lasers and laser-containing products in Canada. Health Canada estimates about 96 laser businesses: 45 manufacturers and 51 importers/distributors.
- Retailers and consumers who buy laser pointers, handheld lasers, measuring tools, entertainment lasers, and other laser products.
- Medical lasers intended for people are excluded here because they are already regulated under the Medical Devices Regulations. Lasers for animals or imported for personal use could still be covered by the new rules.
- The public in general, with a note that children and young people tend to be overrepresented in laser injury reports.
Key numbers from Health Canada’s own findings:
- A survey reported 318 eye injuries linked to lasers from 2013–2017, with an average annual increase of 34.4%.
- Of 569 handheld lasers tested between 2011 and 2021, 85% were mislabelled, unlabelled or incompletely labelled.
Why it matters#
- Makes it easier for buyers and inspectors to know a laser’s real hazard level by requiring standard classification and clearer labelling. That should reduce dangerous products reaching consumers.
- Aims to reduce eye and skin injuries from unsafe or mislabelled lasers and to improve public safety (for example, reducing incidents where lasers are pointed at aircraft).
- Aligning with an international standard should make trade easier for companies already using that standard, but Health Canada estimates compliance costs for businesses at up to $6.3M over 10 years (industry-wide estimate).
- The rules are a proposed change (not law yet). If you make, import, sell, or use laser products, the proposal is worth watching and commenting on during the public consultation period.
Key topics
Radiation Emitting Devices ActRadiation Emitting Devices RegulationsREDRIEC 60825-1IEC 62471Medical Devices RegulationsHealth Canadalaser productslaser pointerhand-held laserslaser scannersdemonstration laserslaser safetyconsumer product safety
Source: Canada Gazette