Canada Gazette, Part I, Volume 157, Number 26: Regulations Amending the Radiation Emitting Devices Regulations (Laser Products)

July 1, 2023

Statutory authority
Radiation Emitting Devices Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

The light from a laser is a highly focused, coherent source of optical radiation, usually in the form of a small narrow beam. Laser light sources can transfer significant energy over long distances (several kilometres). While some laser products are considered safe, others can be extremely dangerous, requiring safety measures to avoid even momentary exposure of a person to any direct or reflected portion of the beam. If sufficient laser energy is absorbed by biological tissue, serious and permanent injury to health can occur. Depending on the design of the laser product, effects can range from mild skin burns to irreversible injury to the skin and eyes (including blindness). There is increasing evidence of injury to Canadians from lasers.

Lasers are used in a wide and growing array of products and applications including industrial, consumer, medical, research, security, military, law enforcement, pest control, and transportation. Technological advances, particularly those related to optics (e.g. new wavelength bands, increased power outputs, the development of ultrashort pulses) and energy sources (e.g. batteries which allow portability) have changed the landscape of laser products, many of which are now available for purchase by Canadians online. The decreasing cost of laser componentry has increased the availability of newer applications of laser technology, including those that operate at emission levels considered unsafe for their intended use.

Unlike Canada, many other countries, including Canada’s trading partners, have moved to the classification of lasers using a recognized international standard to manage these risks. Laser classification provides information about a laser product’s potential to cause biological harm.

Given this situation, the existing regulatory framework for laser products set out in the Radiation Emitting Devices Act does not reflect the diversity of the sector, is not aligned with the current hazard-based classification scheme recognized by other countries, and does not provide adequate protection to Canadians from risks associated with their use.

Background

The Radiation Emitting Devices Act and its Radiation Emitting Devices Regulations (REDR) help protect the health and safety of Canadians from exposure to radiation from radiation-emitting products imported into or leased or sold in Canada, including lasers. Among other things, the Regulations set out radiation safety standards related to the design, construction, performance, and labelling information for only two specified classes of laser products: laser scanners (Schedule II, Part VII) and demonstration lasers (Schedule II, Part VIII). These Parts of the REDR have not been amended in over 30 years and, as a result, do not reflect current scientific knowledge of health and safety risks, only apply to a very narrow scope of products, and are out of step with international standards adopted by regulatory authorities in other countries.

The widespread availability of laser products today raises concerns because many applications may also include lasers operating at emission levels considered unsafe. For example, hand-held lasers and laser pointers that emit high levels of radiation and have the potential to cause serious harm to users and bystanders have become readily available to Canadian consumers through online purchases. Such risks include harm to human health (e.g. eye damage, tissue burn) and threat to public safety in cases of misuse (e.g. aircraft illumination incidences). This is compounded by the fact that injury can occur faster than the eye’s ability to protect itself by blinking. A 2018 Health Canada survey of Canadian optometrists and ophthalmologists reported a total of 318 eye injuries from lasers between 2013 and 2017, an annual increase of 34.4% during that period. The results revealed a strong association between the presence of retinal damage and severity of vision loss. Among the most severe cases, impairment ranged from minor to moderate, and vision impairment persisted for more than three months in half of the reported cases.

Increasingly, international regulators, including many of Canada’s trading partners, have adopted or are moving towards adopting the International Electro-technical Commission’s (IEC) IEC 60825-1, Safety of Laser Products - Part 1: Equipment classification and requirements, Ed. 3.0, 60825-1:2014 (the IEC standard) as their primary safety standard for lasers. The IEC standard sets out the methodology and rules for laser classification, labelling/ information requirements, and engineering safety features corresponding with each laser class, and is internationally recognized to support consistency and relevancy in laser hazard identification, uphold safety and facilitate trade. Under this standard, laser products are ranked from lowest to highest potential hazard with a class designation (i.e. Class 1, 1C, 1M, 2, 2M, 3R, 3B, 4), and requirements for construction and labelling are scaled to the hazard class — with the highest hazard (Class 3B and 4) having the most safety requirements. It can be applied to existing and emerging laser products because it is not based on specific products, but on the emission characteristics of the laser. Canada participated in the development of the IEC standard.

There is some measure of oversight for hand-held lasers under the Canada Consumer Product Safety Act (CCPSA). For the purposes of that Act, Health Canada considers hand-held consumer laser pointers with an IEC standard hazard classification of Class 3B or 4 to be a danger to human health or safety. Consumer products within the scope of the CCPSA that meet the criteria of danger to human health or safety cannot be sold, imported, advertised, or manufactured in Canada. However, with no express regulatory requirement under the CCPSA for any laser product to bear a label stating its IEC classification, it is difficult to identify a class of laser, thereby limiting Health Canada’s ability to enforce that prohibition.

Lasers with medical applications are regulated under the Food and Drugs Act and that Act’s Medical Devices Regulations (MDR).

Health Canada has also found that many of the inexpensive laser pointers being imported to Canada are high-powered products that are mislabelled as low-powered products or lack labelling altogether. Of the 569 hand-held lasers tested by Health Canada between 2011 and 2021, 85% were mislabelled, unlabelled or incompletely labelled. In the absence of labels, inspectors seize the product for further examination in a laboratory. For ad hoc compliance verifications, this is impractical and unreasonable, given the resource implications (e.g. analysis, transportation of products, etc.), the diversity of products on the market, and the need to provide recommendations on short notice, especially with respect to admissibility into Canada at the point of import.

Without a requirement for laser products in Canada to have clear disclosure of their classification, it is impossible to know the actual hazard level of a laser product without thoroughly testing and classifying it. Health Canada needs to modernize its regulatory oversight of laser products under the REDR to address the radiation safety of a broader range of laser products that can pose risk of serious harm and are increasingly available to the public.

Objective

The objectives of the proposal are as follows:

Provide better protection for Canadians and help reduce injury from the broad and increasing range of laser technologies currently available on the market. The desired outcome would be an increase in labelled products at importation, an increase in accurate labelling verified at inspection, and a reduction in the annual rate of reported eye injuries from laser products by Canadian ophthalmologists. This would be achieved by

Align the Canadian requirements set out in the REDR with those of other jurisdictions, thereby creating efficiencies for regulated parties that already comply with the IEC standard and facilitating trade.

Description

The proposed amendments would replace the current requirements for laser scanners and demonstration lasers in the REDR with modern requirements applicable to the broad scope of laser products available to Canadians today, and proportional to their level of hazard.

More specifically, the proposed amendments would

Static references to the IEC standard are proposed.

Minor non-substantive amendments would also be made to modernize outdated terminology, and to align with more modern regulatory language or remove unnecessary definitions already defined in the Act.

In some instances, Health Canada is proposing deviations from the IEC standard to reflect the Canadian context. The proposal deviates from portions of the IEC standard as follows:

Regulatory development

Consultation

In spring 2021, Health Canada conducted a pre-Canada Gazette, Part I, consultation on proposed amendments to the REDR. The consultation was published online for 60 days, from June 30, 2021, to August 30, 2021.

Health Canada’s consultation sought input and feedback concerning

A total of 18 responses were received from importers/distributors/manufacturers, academics and research groups, professional associations, industry associations and individuals. Overall, respondents were supportive of a regulatory approach that aligns with sections of the IEC standard and expressed no objections to the repeal of REDR Parts VII and VIII.

Health Canada removed the proposed enhanced record-keeping requirement due to concerns about the administrative burden.

While there was general support for the introduction of class or wavelength limits for specific laser products, Health Canada is only proposing requirements for laser classification, engineering features, labelling and information. Class limits for specific products, e.g. toys, will be given further consideration in the future, as needed, based on the effectiveness of the current proposal and if specific products posing a high risk are identified.

With respect to introducing bilingual labelling, the ID label, and user information, most respondents were supportive, but noted challenges related to small products with limited surface area, and products used in sterile or hazardous environments where the label material itself may be hazardous or compromise desired sterility. It should be noted, however, that the IEC standard accepts engraving of equivalent labels on the laser product or panels. If product design makes labelling impractical, required labelling information must be included with the user information or on the package.

Respondents noted translation costs for proposed bilingual labels/user information as the most significant cost associated with the proposal. This would be mitigated by the fact that the IEC standard is already available in both French and English (including descriptive wording, explanatory statements, and additional warnings).

Modern treaty obligations and Indigenous engagement and consultation

In accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, an analysis was undertaken to determine whether the regulatory proposal is likely to give rise to modern treaty obligations. This assessment examined the geographic scope and subject matter of the proposal in relation to modern treaties in effect and identified no modern treaty obligations, as validated by the Office of Indigenous Affairs and Engagement.

Instrument choice

Health Canada considered the following options:

1) Keeping the current regulatory regime and voluntary compliance regime:

Under this option, Canada would continue to rely on voluntary compliance with the IEC standard and make no changes to the existing regulations. Although this option is viable for some manufacturers who already operate in other jurisdictions that require meeting the IEC standard, there is growing evidence that some are circumventing or ignoring the IEC standard. The existing regulations are outdated, apply to only two types of products, and are out of alignment with other international jurisdictions. Having to comply with multiple jurisdictional regulatory requirements creates a burden on industry. By not using the most modern and recognized regulatory safeguards and guidance, Canada risks the possibility of becoming a destination for unsafe lasers. This option is therefore impractical because of the risk posed by existing laser products, and a growing number of laser products and new applications.

2) Classifying new laser applications under the Radiation Emitting Devices Act and updating existing REDR:

Alternatively, Health Canada could add new classes for other laser applications, such as laser pointers, distance and range-finding tools, and optical readers, and update the existing prescribed standards for laser scanners and demonstration lasers under the REDR. However, prescribing new classes is impractical as a long-term solution, as it would require amending the regulations repeatedly, as well as limiting the ability to address risks from unforeseen and new applications. New applications are multiplying, and this trend is expected to continue, as lasers are being integrated into more industrial, research, security, consumer, and telecommunications products. Regulating according to individual new laser applications would always result in REDR lagging behind industry progress and product market availability. As in the first option considered, Canada would not be aligned with other international partners, thereby placing a burden on industry to comply with multiple regulatory requirements. It also would not address the risk posed by increasing numbers of unsafe laser products in Canada, nor the lack of guidance for Canadians on the risks to health posed by existing laser products to inform safe use.

3) Amending REDR to align with an international laser standard:

In the spirit of having a more agile regulatory regime, the preferred option is to create a new prescribed class of radiation-emitting product that would cover all laser products, and impose a hazard-based classification system, with appropriate controls, built-in safety features and labelling congruent with the level of risk. This would essentially “future proof” the regulations for lasers. Regulatory requirements aligned with an internationally accepted standard (i.e. the IEC standard), would support clear and transparent statements on hazard classification for laser products, would facilitate identification of the actual hazard level of a laser product, and would help support informed and safe use of products by Canadians. It should be noted that alignment with an international standard would reduce the compliance burden on regulated parties operating in more than one jurisdiction. This would also address current challenges including the importation of many inexpensive mislabelled high-powered laser pointers to Canada by clearly setting out labelling requirements for regulated parties.

Regulatory analysis

Benefits and costs

An important first step in developing a cost-benefit methodology is establishing a baseline scenario against which options may be measured. For this analysis, the baseline is a scenario where no changes were made to the existing regulations and there was no requirement for regulated parties to conform to the IEC standard and meet the labelling requirements. In such a case, any costs incurred by regulated parties would be undertaken on a voluntary basis. However, this scenario puts Canadians at risk of harm from lasers that are mislabelled or bear no labelling at all when imported and sold into Canada. The proposed regulatory amendments are intended to align the regulatory requirements with the international standard, which will benefit the health of Canadians by helping to reduce the number of mislabelled or unlabelled lasers imported or sold in Canada. Assumptions for the calculation of potential costs were made in consultation with subject matter experts, preliminary consultation with regulated parties, and qualitative/quantitative evidence of businesses available online and business intelligence reports.

Benefits
Health and safety benefits

The classification and labelling provisions will support federal officials in restricting the importation of unsafe products into Canada while providing adequate warning of hazards and establish product information requirements that would allow users to make informed decisions and adopt proper safety precautions while these products are in use. The regulations will also help reduce the possibility of eye and/or skin injury to Canadians by minimizing exposure to hazardous radiation through requirements for built-in safety features.

Benefits to the economy, business, and trade

The proposed regulations will help align the Canadian labelling requirements with those of Canada’s major trading partners, many of which are in the process of harmonizing or have already harmonized with the aforementioned international standard. Some countries (including the United States, European Union, and Australia) have also imposed class limits on certain applications such as laser pointers, laser levelling tools, laser measuring tools, and children’s laser toys. Harmonizing standards benefits trade by reducing unnecessary trade barriers, facilitates market access by reducing compliance costs, and encourages innovation by reducing the time elapsed between product development and bringing a new product to market. Manufacturers already using the IEC standard to meet the regulatory requirements in other countries can more easily demonstrate compliance with the proposed regulations in Canada.

Costs
Government

It is assumed that internal-to-government costs are related to the preparation of guidance, compliance promotion and enforcement activities. These costs are not expected to be significant and will be absorbed through existing program funding.

Industry

The maximum costs to business related to this proposal are estimated at $ 6.3M over 10 years. It is expected that these costs will relate to labelling requirements to meet Canada’s bilingual requirements and to the Canadian-specific modifications. These costs are also reduced because the IEC standard and related labels are currently available in both official languages, and it is Health Canada’s understanding that most of the laser manufacturers in Canada already comply with the IEC standard for other international jurisdictions.

The Canadian laser industry is dominated by several well-known multinational corporations that, by nature of their global business, utilize the IEC standard. Similarly, many Canadian-based manufacturers that market their products globally use the IEC standard as well. The compliance burden would therefore be low for such parties. This has been confirmed during the pre-consultation process, where translation costs associated with labelling requirements, rather than IEC compliance costs, were cited as the largest cost implication for the regulatory proposal.

Health Canada estimates there are 96 laser firms in Canada: 45 manufacturers, and 51 non-manufacturers that import or distribute laser products. This estimate was based on information gathered from the following sources:

It is the responsibility of any person who sells or imports laser products in Canada to comply with the regulations; however, Health Canada recognizes that as a matter of practicality, manufacturers may be in the best position to ensure compliance due to their intimate knowledge of the engineering and technical specification of the laser products. Importers/distributors would have to take necessary steps (e.g. an auditing process) to ensure that products manufactured outside Canada are compliant with the regulatory proposal.

Note that Health Canada does not have historical data that would enable an accurate prediction on the anticipated growth of new businesses into the Canadian market. In reviewing market research for trends, however, according to MarketsandMarkets it is estimated that overall, the laser global technology market size is expected to grow from US$16.7B in 2022 to US$25.6B by 2027 and it is expected to grow at a compound annual growth rate of 8.9% from 2022 to 2027. Although there could be new products that enter the market for which costs below may apply, for the costing analysis this was acknowledged qualitatively.

Manufacturers

The total estimated cost for manufactures is $3.2M over 10 years (undiscounted).

The estimated 45 laser manufacturers can be broken down into three categories: 10 large multinational laser manufacturers that market products in countries that have a regulatory regime similar to Health Canada’s proposal, requiring their familiarity with all or part of the IEC standard, who are likely IEC compliant and already have bilingual labels; 31 multinational/foreign companies with a Canadian presence that are likely IEC compliant, but would need to accommodate the bilingual labels/information requirements; and 4 non-international manufacturers that are likely not IEC compliant nor have bilingual labels/information.

The first group of 10 manufacturers (for the North American and international markets) already include multilingual labelling and instruction/product literature (e.g. English, French), and they are already compliant with the IEC standard and language requirements. They may, however, need to adapt their product labelling to meet the ID label requirement by making a modification to their label templates (per individual laser product). It is estimated that each manufacturer would incur a $1,000 one-time cost. This assumes $100 per device for 10 devices per manufacturer. The estimated cost to all manufacturers would be $10,000.

The second group is also assumed to already be partially compliant with the IEC standard, as they market their products in countries which are compliant with the standard. The costs of compliance for these 31 businesses are expected to be limited largely to those related to meeting the bilingual labelling requirements, and are estimated to be $64,000 per business over 10 years broken down as follows:

The total cost over 10 years is estimated at $2.0M (undiscounted) for manufacturers who are partially compliant with the IEC standard.

The remaining 4 laser manufacturers in Canada produce lasers exclusively for the Canadian market, might not be familiar with the IEC standard, and could incur costs estimated at $290,000 per manufacturer over 10 years. Those costs are broken down as follows:

The total 10-year cost is estimated at $1.2M (undiscounted) for manufacturers who sell solely in the Canadian market (based on the worst-case assumption that they have zero capacity to undertake these activities). It should be noted that, during consultations, regulated parties did not cite any significant concerns with capital (i.e., equipment) and labour investments required to comply with the regulatory proposal.

Non-manufacturers

The total anticipated cost for the estimated 51 importers and distributors is $3.1M over 10 years (undiscounted).

The estimated 51 importers and distributors are also broken down into three categories: 8 large multinational businesses that market products in countries that have a regulatory regime similar to Health Canada’s proposal, requiring their familiarity with all or part of the IEC standard, who are likely IEC compliant, and already have bilingual labels; 31 internationals that are likely IEC compliant, but would need to accommodate the bilingual labels/information requirements; and 12 non-international businesses that are likely not IEC compliant and/or do not have bilingual labels/information.

The first group of 8 importers and distributors that market their laser products for the North American and international markets already include multilingual labelling and instruction/product literature (e.g. English, French), and they are already compliant with the IEC standard and language requirements. If these companies need to adapt their product labelling capacity to meet the ID label requirement, they may incur a cost to modify their templates. It is estimated that they would incur a $1,000 one-time cost per firm. This assumes $100 for 10 devices per importer/distributor. The estimated cost to all such importers/distributors would be $8,000.

The second group is also assumed to already be partially compliant with the IEC standard, as they market their products in countries which are compliant with the standard. The costs of compliance for these 31 businesses are expected to be limited largely to those related to meeting the bilingual labelling requirements and are estimated to be $64,000 per business over 10 years, broken down as follows:

The total cost over 10 years is estimated at $2.0M (undiscounted) over 10 years for non-manufacturers who are partially compliant with the IEC standard.

The remaining 12 importers and distributors who sell or lease lasers exclusively for the Canadian market might not be familiar with the IEC standard and could incur costs estimated at $96,000 per business over 10 years. Note that these are conservative estimates because it can safely be assumed that importers and distributors would likely find alternative sources for products that already meet the IEC standard. The costs are broken down as follows:

The total non-discounted cost over 10 years is estimated at $1.1M for importers and distributors that sell solely in the Canadian market.

Small business lens

The small business lens applies as there are impacts on small businesses associated with the proposal. In application of the small business lens as set out in the Policy on Limiting Regulatory Burden on Business, the impact of the regulatory requirements of this proposal on small businesses in Canada is expected to be low. Costs associated with the proposed regulations would be related to integrating appropriate engineering features, translation, printing and application of warning and product identification labels, and printing of user information, which would typically be incurred by the manufacturer. Most small businesses in the laser supply chain are downstream (retailer to consumer); the compliance burden associated with the proposal is upstream (importers/distributers/manufacturers).

It is possible that small business retailers/importers of these products may need to switch to suppliers who are compliant with the IEC standard, which may carry higher costs. This is necessary, however, to help protect some small businesses and Canadians from the risk of using non-compliant imported laser products. Health Canada’s observation is that many prohibited laser pointers enter the country through direct-to-consumer marketing, the majority of which comes from foreign businesses, via the postal system or courier, rather than brick-and-mortar retailers.

Ultimately, the proposed regulations, by aligning with a well-known and established international standard for the industry and limiting compliance to the post-market period, would limit compliance burden for small businesses. Small businesses would require less time to learn about the requirements as they are industry standards, and compliance with these standards would serve to open international markets to any Canadian-based manufacturers. Given the safety concerns and risks of serious injury this proposal is intended to address, alternative compliance option flexibilities were not considered to be appropriate as they would run counter to the proposal’s objectives.

One-for-one rule

The one-for-one rule does not apply as there is no incremental change in the administrative burden on business.

The proposal would amend the existing regulation and not introduce a new title. While the proposed regulatory amendments set out requirements pertaining to labelling, construction, functioning, and information to accompany the product for its safe and proper operation, they do not introduce any activities that would be considered an administrative burden to importers and sellers. There are no requirements for regulated parties to demonstrate compliance through the collecting, processing, reporting, or retaining of information, or the completion of forms. Manufacturing of these products in Canada is also limited. As such, the one-for-one rule would not apply.

Regulatory cooperation and alignment

This proposal is not related to work or a program commitment under a formal regulatory cooperation forum. The regulatory intention is to align with specific and relevant parts of an internationally recognized standard utilized by Canada’s major trading partners, including Australia, the European Union, South Korea and Japan.

The United States Food and Drug Administration (US FDA) has also signalled its intention to harmonize with this IEC standard. The US FDA currently uses their own classification system that is similar, but not perfectly compatible, with the IEC classification system. In 2014, they published proposed rules in the Federal Register (Vol. 78, No. 121) to harmonize with the IEC, but final rules have not been published. In the interim, they have published several Laser Notices to the laser industry indicating that compliance with certain parts of the IEC is considered substantively equivalent to certain parts of Code of Federal Regulations, Title 21. In those Laser Notices, the US FDA has reiterated its intention to harmonize with relevant portions of the IEC.

Although the proposal aims to align with other international jurisdictions by adopting the IEC standard, to which Canada continues to contribute, some deviations (described above) are required to ensure compliance with Canadian legislation, and that the Department’s mandate to help protect the health of Canadians is fulfilled.

This proposal is not expected to create any technical barriers to trade.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required. The proposal is not expected to have significant impacts on the environment.

The analysis of products without labels indicating hazard classification or accompanying information on risk currently requires such products to be sent to the Health Canada optics testing lab in Ottawa to evaluate the class and risk of the device. Dangerous products are returned to the country of origin or disposed of as electronic waste. Some of these products may contain lithium, mercury, lead and other toxins, requiring additional disposal to mitigate environmental impacts. Implementation of the IEC standard classification labelling requirement would reduce the number of unlabelled products which must be sent to the Health Canada optics testing lab, thereby reducing transportation needs (and corresponding greenhouse gas emissions) and the production of electronic waste.

Gender-based analysis plus

A gender-based analysis plus (GBA+) analysis was undertaken for this proposal. Injury data collected by Health Canada indicates that with respect to eye and skin injuries from handheld laser products, children, adolescents, and young adults are overrepresented relative to the general Canadian population. Children are more at risk, as they have not developed the innate eye aversion or rapid blink responses to avoid intermittent beam exposure. Furthermore, children’s eye lenses allow the absorption of more ultraviolet and blue light, making them more susceptible to injury than adults. The data shows that the odds of Canadian males using or being exposed to a laser product are 1.12 times higher than for females. With respect to laser eye injuries, the most severe cases are predominantly in males. The information and labelling requirements would raise awareness of the inherent risks and support all Canadians in making informed decisions and taking precautions.

Implementation, compliance and enforcement, and service standards

Implementation

To support the laser industry transition, the proposed regulations would come into force twelve months after the day they are published in the Canada Gazette, Part II, to allow manufacturers, importers, distributors, and vendors sufficient time to align themselves with the amended regulations.

The IEC standard is not a certification system; regulated parties are not required to seek certification by a third party, nor would Health Canada require certification to demonstrate IEC compliance. To reduce burden on industry, HC is not proposing any pre-market certification process or record keeping requirements. Under the Radiation Emitting Devices Act, Health Canada would continue to operate using post-market surveillance, and examination of the product itself to verify compliance with regulatory requirements as needed.

Health Canada would develop guidance, accompanied by targeted communications, to assist regulated parties with the interpretation of the new laser regulations. This would include a compliance guidance document for industry, a Questions and Answers document and notice on the Health Canada website and/or social media platforms.

In addition to these compliance promotion and education activities, Health Canada would continue to provide radiation protection and safety advice to provincial and territorial jurisdictions, other federal departments, and international standards development committees for specific laser applications, to help support mandated activities.

Compliance and enforcement

Health Canada conducts compliance and enforcement activities for radiation-emitting products using a risk-based approach typically triggered by post-market monitoring, identified issues, or complaints. Under the proposed regulations for lasers, compliance verification and enforcement activities would continue to follow established Health Canada procedures. This would include sampling and testing of products (e.g. at ports of entry, business locations, or online), following up on reported incidents (e.g. by the Canadian public, public health organizations, or regulatory authorities abroad) and investigating mandatory notifications of non-compliance or defect by industry.

Within one year of implementing the amended regulations for laser products, Health Canada would undertake compliance promotion and verification activities. This would entail addressing various applications of lasers over consecutive years (based on the level of risk).

Non-compliant laser products would be subject to progressive and proportionate enforcement actions that are available to Health Canada inspectors under the authority of the Radiation Emitting Devices Act and its regulations. This could include voluntary commitment by industry to correct or destroy the products, negotiation with industry for the voluntary removal of products from the market, removal of imported products from Canada at the owner’s expense, seizure, or prosecution.

These compliance and enforcement activities would provide valuable data to evaluate regulatory program effectiveness and inform ongoing surveillance planning.

Contact

Interested persons may make representations concerning the proposed regulatory amendment within 75 days after the date of publication of the proposal. They are strongly encouraged to use the online commenting feature that is available on the Canada Gazette website but if they use email, mail or any other means, the representations should cite the Canada Gazette, Part I, and the date of publication, and be sent to

Tara Bower
Director
Office of Science Policy, Liaison and Coordination
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Ottawa, Ontario K1A 0K9
Email: hc.erhsdgeneral-dssergenerale.sc@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given, under subsection 13(2) of the Radiation Emitting Devices Act footnote a, that the Governor in Council proposes to make the annexed Regulations Amending the Radiation Emitting Devices Regulations (Laser Products) under section 13footnote b of that Act.

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. They are strongly encouraged to use the online commenting feature that is available on the Canada Gazette website but if they use email, mail or any other means, the representations should cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to Tara Bower, Director, Office of Science Policy, Liaison and Coordination, Department of Health, Address Locator 4908D, 269 Laurier Avenue West, Room 8-016, Ottawa, Ontario K1A 0K9 (email: erhsdgeneral- dssergenerale@hc-sc.gc.ca).

Ottawa, June 22, 2023

Wendy Nixon
Assistant Clerk of the Privy Council

Regulations Amending the Radiation Emitting Devices Regulations (Laser Products)

Amendments

1 The definition Minister in section 2 of the Radiation Emitting Devices Regulations footnote 1 is repealed.

2 Subsection 3(2) of the Regulations is replaced by the following:

(2) The standards set out or incorporated by reference in Schedule II for prescribed classes of radiation emitting devices are prescribed as standards regulating the design, construction or functioning of those prescribed classes of radiation emitting devices and their components.

3 Items 7 and 8 of Schedule I to the Regulations are replaced by the following:

7 Laser products, being devices emitting laser radiation in the wavelength range of 180 nm to 1 mm.

4 Parts VII and VIII of Schedule II to the Regulations are replaced by the following:

PART VII

Laser Products

Interpretation

1 The following definitions apply in this Part.

IEC 60825-1
means the International Electrotechnical Commission Standard IEC 60825-1, Edition 3.0, 2014-05, entitled Safety of laser products – Part 1: Equipment classification and requirements. (CEI 60825-1)
IEC 62471
means the International Electrotechnical Commission Standard IEC 62471, First edition, 2006-07, entitled Photobiological safety of lamps and lamp systems. (CEI 62471)
IEC 62471-5
means the International Electrotechnical Commission Standard IEC 62471-5, Edition 1.0, 2015-06, entitled Photobiological safety of lamps and lamp systems – Part 5: Image projectors. (CEI 62471-5)

2 For the purposes of this Part

Standards of Design, Construction and Functioning

3 (1) Except as otherwise provided in this Part, a laser product must be designed and constructed, and must function, in accordance with the applicable requirements set out in IEC 60825-1, without regard to any other standard incorporated by reference to which it refers.

(2) A laser product, including one designed to function as a conventional lamp, that is a medical device as defined in section 1 of the Medical Devices Regulations and that belongs to one of Class II, III or IV in accordance with the classification rules set out in Schedule 1 to those Regulations, is exempt from subsection (1).

4 (1) Except as otherwise provided in this Part, a laser product that is designed to function as a conventional lamp and that satisfies the criteria referred to in subclause 4.4 of IEC 60825-1 may have its emissions evaluated in accordance with the applicable requirements set out in IEC 62471 or IEC 62471-5.

(2) However, a laser product referred to in subsection (1) need only comply with that subsection or subsection 3(1).

5 The following provisions of IEC 60825-1 do not apply to a laser product:

Information and Labelling

General

6 The information referred to in subsections 7(1) and 8(2) must be provided in both official languages.

Information

7 (1) Subject to subsection (2), the manufacturer, distributor and importer of a laser product must ensure that it is accompanied by the information described in subclauses 8.1a) to l) of IEC 60825-1 or, if applicable, the information described in subclause 6.6 of IEC 62471-5.

(2) The information described in subclauses 8.1a), c), f) and i) of IEC 60825-1 is required for a laser product with an accessible emission, as defined in subclause 3.2 of IEC 60825-1, during operation, maintenance or service, greater than that of a Class 3R laser product, as set out in subclause 5.3d) of IEC 60825-1.

Labelling

8 (1) A laser product must bear labels that meet the requirements of subclause 7.1 of IEC 60825-1 or, if applicable, subclause 6.5 of IEC 62471-5.

(2) In addition to the information referred to in subclause 4.4 and clause 7 of IEC 60825-1, the labels of a laser product, including one designed to function as a conventional lamp, must contain:

(3) Despite section 6, the information set out in paragraphs 2(a) to (d) must be shown in at least one official language.

Coming into Force

5 These Regulations come into force on the first anniversary of the day on which they are published in the Canada Gazette, Part II.

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It is your responsibility to ensure that the comments you provide do not:

  • contain personal information
  • contain protected or classified information of the Government of Canada
  • express or incite discrimination on the basis of race, sex, religion, sexual orientation or against any other group protected under the Canadian Human Rights Act or the Canadian Charter of Rights and Freedoms
  • contain hateful, defamatory, or obscene language
  • contain threatening, violent, intimidating or harassing language
  • contain language contrary to any federal, provincial or territorial laws of Canada
  • constitute impersonation, advertising or spam
  • encourage or incite any criminal activity
  • contain external links
  • contain a language other than English or French
  • otherwise violate this notice

The federal institution managing the proposed regulatory change retains the right to review and remove personal information, hate speech, or other information deemed inappropriate for public posting as listed above.

Confidential Business Information should only be posted in the specific Confidential Business Information text box. In general, Confidential Business Information includes information that (i) is not publicly available, (ii) is treated in a confidential manner by the person to whose business the information relates, and (iii) has actual or potential economic value to the person or their competitors because it is not publicly available and whose disclosure would result in financial loss to the person or a material gain to their competitors. Comments that you provide in the Confidential Business Information section that satisfy this description will not be made publicly available. The federal institution managing the proposed regulatory change retains the right to post the comment publicly if it is not deemed to be Confidential Business Information.

Your comments will be posted on the Canada Gazette website for public review. However, you have the right to submit your comments anonymously. If you choose to remain anonymous, your comments will be made public and attributed to an anonymous individual. No other information about you will be made publicly available.

Comments will remain posted on the Canada Gazette website for at least 10 years.

Please note that public email is not secure, if the attachment you wish to send contains sensitive information, please contact the departmental email to discuss ways in which you can transmit sensitive information.

Privacy notice

The information you provide is collected under the authority of the Financial Administration Act, the Department of Public Works and Government Services Act, the Canada–United States–Mexico Agreement Implementation Act,and applicable regulators’ enabling statutes for the purpose of collecting comments related to the proposed regulatory changes. Your comments and documents are collected for the purpose of increasing transparency in the regulatory process and making Government more accessible to Canadians.

Personal information submitted is collected, used, disclosed, retained, and protected from unauthorized persons and/or agencies pursuant to the provisions of the Privacy Act and the Privacy Regulations. Individual names that are submitted will not be posted online but will be kept for contact if needed. The names of organizations that submit comments will be posted online.

Submitted information, including personal information, will be accessible to Public Services and Procurement Canada, who is responsible for the Canada Gazette webpage, and the federal institution managing the proposed regulatory change.

You have the right of access to and correction of your personal information. To seek access or correction of your personal information, contact the Access to Information and Privacy (ATIP) Office of the federal institution managing the proposed regulatory change.

You have the right to file a complaint to the Privacy Commission of Canada regarding any federal institution’s handling of your personal information.

The personal information provided is included in Personal Information Bank PSU 938 Outreach Activities. Individuals requesting access to their personal information under the Privacy Act should submit their request to the appropriate regulator with sufficient information for that federal institution to retrieve their personal information. For individuals who choose to submit comments anonymously, requests for their information may not be reasonably retrievable by the government institution.