Forward Regulatory Plan 2023-2025: Regulations Amending the Radiation Emitting Devices Regulations Pertaining to Laser Devices

Title of Regulatory Initiative

Regulations Amending the Radiation Emitting Devices Regulations  Pertaining to Laser Devices

Enabling Act

Radiation Emitting Devices Act

Description

Health Canada is proposing amendments to the Radiation Emitting Devices Regulations pertaining to lasers that would  better protect people in Canada from laser radiation hazards, align Canadian requirements with international standards, and address a broader range of laser devices.

The proposed amendments would align Canada's regulations with an international standard, specifically the International Electrotechnical Commission's "IEC 60825-1, Safety of Laser Products - Part 1: Equipment classification and requirements, Ed. 3.0, 2014". This standard is used or referenced by Canada's key trading partners.

The amended regulations would enhance the safety of laser products imported, sold, leased and advertised in Canada by requiring appropriate laser warning labels and establishing minimum design safety features for specific laser classes/hazard levels. In addition, the proposed amendments would address laser devices beyond laser scanners and demonstration lasers.

This regulatory initiative is part of Health Canada's Regulatory Stock Review Plan

Regulatory cooperation efforts (domestic and international)

This initiative is not part of a formal regulatory cooperation work plan.

A new international standard for laser products (IEC 60825-1) has become available since the laser regulations were last amended. Canada's major trading partners are in the process of harmonizing (e.g., United States) or have already harmonized with this international standard (e.g., Australia, European Union, United Kingdom, Japan, South Korea).

Adoption of IEC 60825-1 standard would align Canada with the regulatory standard used internationally.

Potential impacts on people in Canada, including businesses

It is anticipated that the proposed amendments would increase public protection from accidental or inadvertent exposure to laser emissions by requiring warning labels on how to mitigate laser hazards. It would also require manufacturers to integrate safety controls/features into the laser devices.

While there are expected impacts on industry, they are anticipated to be minimal due to efforts to align with the international standard and reduce regulatory burden.

Consultations

Health Canada conducted an online public consultation process on June 30, 2021, for a period of 60 days, ending August 30, 2021.

Health Canada pre-published the proposed changes in the Canada Gazette, Part I on July 1, 2023, with a 75-day comment period.

Health Canada plans to publish the amended regulations in the Canada Gazette, Part II in fall 2024.

Further information

Additional information can be requested from the departmental contact.

Departmental contact information

Tara Bower
Director
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Health Canada

Telephone: 613-957-6371
Email: erhsdgeneral-dssergenerale@hc-sc.gc.ca

Date the regulatory initiative was first included in the Forward Regulatory

February 2021

Consult Health Canada's acts and regulations web page for:

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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