Notice of danger to human health or safety and risk mitigation for Class 3B and Class 4 handheld portable lasers

Last updated: July 4, 2023

Health Canada's mandate includes helping to protect the public by addressing or preventing dangers to human health or safety posed by consumer products. For that purpose, Health Canada's Consumer Product Safety Program (CPSP) administers and enforces the Canada Consumer Product Safety Act (CCPSA) and its regulations.

Danger to human health or safety

Risk mitigation

Based on the information currently available, IEC 60825-1:2014 – Safety of laser products – Part 1: Equipment classification and requirements, sets out criteria that may be sufficient to mitigate the risk of eye injury, including:

• a system of classification of lasers and laser products emitting radiation in the wavelength range 180 nm to 1 mm according to their degree of optical radiation hazard;
• requirements for the manufacturer to supply information to the user so that precautions can be adopted; and,
• warning through labels and instructions to individuals of hazards associated with accessible radiation from laser products.

The criteria outlined above, in addition to the following modification, may be sufficient to mitigate the risk of eye injury:

• handheld portable lasers should not be Class 3B or Class 4 lasers.

Class 3B lasers are described by the International Electrotechnical Commission (IEC) as:

• Laser products that are normally hazardous when intrabeam ocular exposure occurs (i.e., within the nominal ocular hazard distance) including accidental short time exposure.

Class 4 lasers are described by the IEC as:

• Laser products for which intrabeam viewing and skin exposure is hazardous and for which the viewing of diffuse reflections may be hazardous. These lasers also often represent a fire hazard.

You can find additional details about the scope of products affected and the hazard in the danger to human health or safety assessment.

Responsibilities

Manufacturers, importers, advertisers and retailers are reminded that:

• Consumer products that are a danger to human health or safety are prohibited from being manufactured, imported, advertised or sold in Canada according to paragraphs 7(a) and 8(a) of the CCPSA;
• It is the responsibility of industry to ensure that the products they supply to the Canadian market comply with the CCPSA and its regulations;
• Conformance with the identified criteria does not mean that the products are fully compliant with the CCPSA;
• Health Canada recognizes that there may be other possible health or safety concerns with the use of these or similar products;
• Industry should review their products for all potential hazards and respond appropriately to make sure they are safe for consumers; and,
• The CPSP operates as a post-market regulatory regime, meaning that there is no pre-market review or approval of consumer products by Health Canada.

Health Canada may take immediate compliance and enforcement actions in line with the Department's compliance and enforcement policy framework when it has reasonable grounds to believe that a consumer product is a danger to human health or safety. Regulated parties that fail to comply voluntarily may be subject to enforcement actions under the CCPSA, which may include seizure, orders to take corrective measures, orders to recall products, administrative monetary penalties, or criminal prosecution.

Health Canada will continue to monitor the situation and may update this Notice and the associated Danger to Human Health or Safety Assessment as warranted.

Information resources

If you require additional information regarding this Notice, visit the resources below or contact a Health Canada Consumer Product Safety Office via email (hc.ccpsa-lcspc.sc@canada.ca) or telephone at 1-866-662-0666 (toll-free within Canada and the United States).

• The Canada Consumer Product Safety Act (CCPSA) and its regulations
• Industry Guidance – "Danger to Human Health or Safety" Posed by Consumer Products
• Information for Regulated Parties on the Enforcement Approach for the General Prohibitions under the Canada Consumer Product Safety Act
• IEC 60825-1:2014 – Safety of laser products – Part 1: Equipment classification and requirements

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