Danger to human health or safety assessment for class 3B and class 4 handheld portable lasers

Last updated: July 4, 2023

Table 3 was first published in July 2020 to consolidate information for regulated parties in an effort to increase openness and transparency regarding Health Canada's evaluation of products that pose a danger to human health or safety. While this entry was added to Table 3 upon initial posting of the table in July 2020, the danger to human health or safety was previously communicated by Health Canada to regulated parties. This assessment does not present new decisions, and is being published for clarity on the decisions made previously.

Legislative background

The purpose of Canada Consumer Product Safety Act (CCPSA) is to protect the public by addressing or preventing dangers to human health or safety that are posed by consumer products in Canada, including those that circulate within Canada and those that are imported. Any person who manufactures, imports, advertises, sells or tests a consumer product must comply with all applicable requirements of the CCPSA and its regulations. Paragraphs 7(a) and 8(a) of the CCPSA prohibit the manufacture, importation, advertisement or sale of any consumer product that is a "danger to human health or safety". The CCPSA defines the term as follows:

Danger to human health or safety means any unreasonable hazard — existing or potential — that is posed by a consumer product during or as a result of its normal or foreseeable use and that may reasonably be expected to cause the death of an individual exposed to it or have an adverse effect on that individual's health — including an injury — whether or not the death or adverse effect occurs immediately after the exposure to the hazard, and includes any exposure to a consumer product that may reasonably be expected to have a chronic adverse effect on human health.

Definitions

Pointer

is promoted for pointing at desired objects, for amusement purposes, or sending out a signal.

Scope of affected products

Class 3B and class 4 handheld portable lasers^{Footnote 1}

Includes:

• battery-operated lasers
• laser pointers
• lasers designed for amusement
• lasers designed to be carried and supported by the hand during normal or foreseeable use
• lasers that can be operated while connected to a portable USB charger
• lasers that have a clip, lanyard, keychain or holster

Excludes:

• light emitting products that are not lasers or do not focus a beam of light
• lasers that are medical devices under the Food and Drugs Act
• lasers that are pest control products under the Pest Control Products Act
• lasers that are emergency signaling devices
• lasers requiring connection to an electrical outlet in order to operate
• lasers designed to be mounted to a stationary object during operation or that come with accessories/tools that would suggest they are used for instrumentation purposes (e.g. table or bench brackets, clamps, mounting rails, support base/stand, platform, tripod)
• lasers used for instrumentation or feedback purposes (e.g. to measure speed, dimensions, temperature, distance or to decipher codes)

Hazards of concern

Use of Class 3B or Class 4 handheld portable lasers present an increased risk to consumers of permanent eye injury than other laser products. Injuries result from the laser beam being directed in the eyes, even from short unintentional exposure.

Incidents^{Footnote 2}

Health Canada is aware of 28 reports of incidents that occurred between June 20, 2011 and December 31, 2022 involving laser products. Of the 28 reports, 14 reported injuries, two of which were Canadian incidents. Studies or incident reviews performed in the United States, United Kingdom, Germany and Sweden also indicate many incidents every year in each of these jurisdictions where these products are sold.

Additionally, Health Canada's Consumer and Clinical Radiation Protection Bureau (CCRPB) performed a survey of reported eye injuries from handheld laser devices in Canada ^{Footnote 3}. The members of the Canadian Ophthalmological Society and the Canadian Association of Optometrists were surveyed and 157 respondents (17.4 %) reported encountering at least one eye injury from a handheld laser between 2013 and 2017. A total of 318 eye injuries were reported.

Danger to human health or safety assessment

Danger to human health or safety considerations

Considerations for a product to pose a potential danger to human health or safety are outlined in Health Canada's Industry Guidance - "Danger to Human Health or Safety" Posed by Consumer Products. The main considerations assessed are:

1. Unreasonable hazard
2. Existing or potential hazard
3. Normal or foreseeable use
4. May reasonably be expected to cause
   1. Death
   2. Adverse effect on health

1. Unreasonable hazard

The consideration of unreasonable hazard includes the following components.

a. Inherent hazard

The primary purpose of a handheld portable laser is for directing visual attention toward objects or locations. It is not necessary for the laser to be as powerful as a Class 3B or Class 4 laser. Classes of lower output lasers can effectively perform the main intended uses of such products, while reducing the eye injury hazard.

b. Severity of hazard

Acute laser exposure may result in corneal or retinal burns, whereas chronic or repeated laser exposure may result in the formation of cataracts and/or permanent retinal damage.

Class 3B lasers are described by the International Electrotechnical Commission 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 International Electrotechnical Commission 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.

Class 3B lasers can emit optical radiation that is up to 500 times higher than the maximum permissible exposure (MPE) recommended by the International Commission on Non-Ionizing Radiation Protection^{Footnote 4} for the eye and are considered hazardous for direct ocular exposure. Damage can occur from exposure times shorter than the blink reflex or aversion responses (includes motor actions such as averting gaze, pupillary constriction and head movements). Therefore, exposure cannot be avoided based upon eye blink and/or other aversive actions.

Class 4 lasers emit the highest output power and are the most dangerous. These devices emit optical radiation that can cause permanent eye damage from instantaneous exposure. In addition to the hazards posed by Class 3B lasers, ocular exposure to diffuse reflections (non-mirror like reflection) from Class 4 lasers is also hazardous to the eye. Class 4 lasers can burn unprotected skin. Class 4 lasers may also pose a fire hazard as they can ignite combustible materials.

c. Intended and foreseeable users

The intended users of Class 3B or Class 4 handheld portable lasers are adults based on typical marketing or instructions. Reasonably foreseeable users of these products also include children and teenagers. Children and teenager users may be particularly vulnerable to the eye injury hazard because they may play with the laser devices and either directly stare into the beam or someone may shine the beam into their eyes. The laser beams of these devices can also be reflected by surfaces in the eyes of adults and bystanders, thus, exposing them to the same eye injury hazard.

d. Obviousness of hazard

The hazards of Class 3B or Class 4 handheld portable lasers are not obvious to most users. Due to the prevalence of lasers with lower outputs, the public is not likely to be aware of the differences in hazard levels associated with different classes of lasers. As high-powered products closely resemble safer, low-powered products, it is also not possible for the public to determine the hazard level of a laser by examining it. Furthermore, because there are no regulatory requirements for labelling, the obviousness of the hazard is further reduced. Misinformation or lack of information by laser device manufacturers and/or distributors may contribute to a lack of awareness of the hazards and promote unsafe use.

Sample testing performed by the CCRPB between 2013 and 2017 indicated that 99% of the battery-powered handheld lasers were mislabelled in terms of completeness of information, power output and laser class. Mislabelled lasers can lead to injury, as the indicated hazard classification could be misleading about the potential hazard.

e. Social utility

Handheld portable lasers are promoted for directing visual attention toward objects or locations. They may also be advertised for other uses such as alignment, aiming and entertainment. They often resemble pens or small flashlights.

f. Available alternatives

Handheld portable lasers of lower output can effectively perform the main intended uses of such products while reducing the risk of eye injury.

g. Consensus-based safety standards or government regulations

One available international consensus-based safety standard for lasers is IEC 60825-1:2014 – Safety of laser products – Part 1: Equipment classification and requirements. This standard sets out criteria that address the eye injury hazard, 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.

These criteria, in addition to the following modification, may be sufficient to mitigate the eye injury hazard:

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

Class 3B lasers are described by the 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.

There are products available in the marketplace that appear to conform to the applicable criteria outlined above.

2. Existing or potential hazard

Incident reports from Canada and international jurisdictions indicate the presence of an existing or potential eye injury hazard.

3. Normal or foreseeable use (including foreseeable misuse)

Handheld portable lasers are frequently used in classrooms or boardrooms where many people are present. Users do not always know the extent of damages to the sight that may result from product's misuse. Reflections of a laser beam emitted by a Class 4 laser is hazardous and may occur during normal or foreseeable use, which increases the risk. In addition, there is evidence of handheld portable lasers misuse, where they are directed at vehicles. For example, in 2017, there were nearly 400 reported cases of lasers aimed at aircrafts in Canada.

Of the reported incidents, many of the laser eye injuries have involved uninformed use and/or deliberate staring at a laser product by a child. The prevalence of eye injuries from handheld portable lasers reported by ophthalmologists and optometrists occurred predominately as a result of exposure from another person (67.6%) versus self-induced (26.1%).

4. May reasonably be expected to cause

a. Death

Health Canada is not aware of any deaths caused by Class 3B or Class 4 handheld portable lasers in Canada.

b. Adverse effect on health

In a Health Canada survey, 77 ophthalmologists and optometrists indicated the patient they treated with the most severe eye injuries from a handheld portable laser experienced vision loss ranging from minor to disabling. The majority of individuals with minor vision loss or moderate vision loss reported this type of impairment for more than six months.

The survey of reported eye injuries from handheld portable laser devices in Canada performed by Health Canada's Consumer and Clinical Radiation Protection Bureau (CCRPB) indicated that 157 respondents (17.4 %) reported encountering at least one eye injury from a handheld portable laser between 2013 and 2017. A total of 318 eye injuries were reported.

It is therefore reasonable to expect that handheld portable lasers that do not conform to the applicable criteria outlined above to address the eye injury hazard may cause an adverse effect on human health.

If you require additional information regarding this Danger to Human Health or Safety Assessment, please 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).