Regulations Amending the Radiation Emitting Devices Regulations (Laser Products): SOR/2024-196

Canada Gazette, Part II, Volume 158, Number 21

Registration
SOR/2024-196 September 27, 2024

RADIATION EMITTING DEVICES ACT

P.C. 2024-1062 September 27, 2024

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending the Radiation Emitting Devices Regulations (Laser Products) under subsection 13(1)^{footnote a} of the Radiation Emitting Devices Act ^{footnote b}.

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1 The definition Minister in section 2 of the Radiation Emitting Devices Regulations ^{footnote 1} is repealed.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 that can be made to produce or amplify electromagnetic radiation in the wavelength range of 180 nm to 1 mm, primarily by the process of controlled stimulated emission.

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, Edition 1.0, 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

• (a) words and expressions used in the standards incorporated by reference have the same meanings as in the Act;
• (b) a reference to “plaque” in the French version of IEC 60825-1 is to be read as a reference to étiquette as defined in section 2 of the French version of the Act; and
• (c) a reference to “rayonnement” in the French versions of IEC 60825-1, IEC 62471 and IEC 62471-5 is to be read as a reference to radiation as defined in section 2 of the French version of the Act.

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) The following are exempted from subsection (1):

• (a) a laser product that is a component or a repair part as set out in clause 1 of IEC 60825-1;
• (b) a laser product that is a medical device as defined in section 1 of the Medical Devices Regulations and that belongs to Class II, III or IV in accordance with the classification rules set out in Schedule 1 to those Regulations.

Exception

(3) A laser product referred to in clauses 4 and 5 of IEC 60825-1 with an emission level that does not exceed the accessible emission limit for Class 1 under all conditions of operation, maintenance, service and failure is exempt from clause 6 of IEC 60825-1 and sections 6 to 8 of this Part.

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) A laser product referred to in subsection (1) must respect the requirements of that subsection or the requirements of subsection 3(1).

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

• (a) those relating to the training of personnel referred to in subclause 6.1;
• (b) those relating to the protection against non-optical hazards referred to in subclause 6.15.1; and
• (c) those relating to the additional requirements for specific laser products referred to in clause 9.

Information and Labelling

General

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

Exceptions

(2) The following laser products are exempt from sections 7 and 8:

• (a) a laser product that is a component or a repair part, as set out in clause 1 of IEC 60825-1, and
• (b) a laser product 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.

Information

7 (1) Except as otherwise provided in this Part, the manufacturer, distributor and importer of a laser product must ensure that the product is accompanied by the information described in subclause 8.1 of IEC 60825-1 or, if applicable, the information described in subclauses 6.6 and 6.7 of IEC 62471-5.

(2) The information described in items 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 that standard, during operation, maintenance or service, that is greater than that of a Class 3R laser product, as determined in accordance with item 5.3d) of that standard.

(3) The requirements for additional information under subclause 8.2 of IEC 60825-1 do not apply to a laser product.

Labelling

8 (1) A laser product must bear labels that meet the requirements of clause 7 of IEC 60825-1 or, if applicable, subclause 6.5 of IEC 62471-5.

(2) A laser product designed to function as a conventional lamp must be labelled in accordance with the requirements of subclause 4.4 of IEC 60825-1 and, if applicable, subclauses 6.5 and 6.7 of IEC 62471-5.

(3) 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

• (a) the manufacturer’s name and the civic address of its principal place of business;
• (b) the model number of the product;
• (c) the date of manufacture of the product; and
• (d) if the product is imported for sale or lease, the distributor’s name and the civic address of its principal place of business in Canada.

(4) Despite section 6, the information referred to in paragraphs (3)(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.

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 people in Canada 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, development of ultra-short pulses) and energy sources (e.g. batteries that allow portability) have changed the landscape of laser products, many of which are now available for online purchase by people in Canada. 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 people in Canada from risks associated with their use.

Background

Health Canada’s oversight for laser products relates to the importation or sale of these devices in Canada. Provinces and territories regulate primarily in relation to the use of laser products (e.g. safe installation, operation, and training).

The Radiation Emitting Devices Act and its Radiation Emitting Devices Regulations (REDR) provide authority for post-market oversight to help protect the health and safety of people in Canada from exposure to radiation from radiation-emitting products imported into or leased or sold in Canada, including lasers. The scope of the Act includes a broad range of products that emit radiation such as consumer products and medical devices, as well as industrial products, but also extends further to many other laser products, including those used for teaching. Among other things, the REDR 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.

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

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 Electrotechnical 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.

For consumer laser products, 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.

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 581 hand-held lasers tested and classified by Health Canada between 2011 and 2023 in accordance with clauses 4 and 5 of the IEC standard, 86% were mislabelled, unlabelled or incompletely labelled. In the absence of labels, inspectors seize the product for further examination and use laser measurement equipment and methods to test emission levels and determine the hazard classification. 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 a risk of serious harm and are increasingly available to the public.

Objective

The objectives of the proposal are as follows:

Provide better protection for people in Canada and help reduce injury from the broad and increasing range of laser technologies currently available on the market. The desired outcome is 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 and optometrists. This will be achieved by

• extending the regulatory oversight of the REDR to include laser products beyond laser scanners and demonstration lasers (except for medical lasers and their components regulated under the MDR). This will allow Health Canada to apply and strengthen requirements for the design, construction, and functioning requirements for a broader range of laser products;
• modernizing the REDR in relation to laser products to reflect the latest standards and scientific risk assessment regarding emissions classification, safety feature requirements, and warning label requirements, as set out in the IEC standard;
• supporting safe use of products across a broad range of sectors/applications. Strengthening labelling and information requirements will enable operators to better understand the hazard level of laser products; and
• aligning 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 amendments will 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 people in Canada today, and proportional to their level of hazard.

More specifically, the amendments will

• apply to all laser products except for medical devices (as defined in the MDR), non-operable laser components and repair parts (as per conditions outlined in the scope of the IEC standard), and products to which the Radiation Emitting Devices Act does not apply;
• align the REDR laser radiation safety requirements with an international standard for laser products by adopting specific sections of the IEC standard;
• introduce the IEC classification system for “laser products” that classifies products according to their degree of hazard;
• establish testing methods and rules to determine accessible emission levels and assign laser products to a particular hazard class. Laser products with an emission level that does not exceed the Class 1 accessible emission limit under all conditions of operation, maintenance, service, and failure will be exempt from engineering, labelling, and accompanying information requirements;
• require built-in engineering safety features that are appropriate for the laser class to manage exposure to hazardous levels of radiation; and
• establish labelling requirements and accompanying information to support compliance monitoring, verification, and enforcement activities (e.g. requiring specific details to uniquely identify laser products and their manufacturing origins) and help individuals who are purchasing, operating, and servicing laser products to make more informed decisions.

References to the IEC standard in these regulatory amendments are static.

Minor non-substantive amendments will 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 has included deviations from the IEC standard to reflect the Canadian context. Deviations from portions of the IEC standard are as follows:

• require mandatory product labels and user information to be available in both official languages at the time of sale, lease, or import;
• require a product identification/origin label (ID label) to uniquely distinguish a laser product from similar products for tracing purposes (for enforcement), a requirement already found in other parts of the REDR (e.g. television receivers);
• make the requirement for certain accompanying information mandatory for higher class lasers only, to reduce information burden on industry for devices that are less hazardous (i.e. instructions for assembly/maintenance/safe use, a radiation pattern description, information for selecting eye protection, and a list of controls/warning will be required for laser products with accessible emissions exceeding the Class 3R limit during operation, maintenance or service). Note that all other user information requirements of the IEC standard [items 8.1b), d), e), g), h), j), k), and l)] will be mandatory (depending on the accessible emissions of the laser product);
• exempt medical devices and their components covered under the MDR (but the REDR requirements will apply to medical laser products intended for use on animals or imported for personal use);
• exclude certain requirements (i.e. training of personnel, requirement to protect against non-radiation hazards, purchasing and servicing information requirements and all additional requirements for specific laser products such as the requirement for protective eyewear for laser classes lower than 3B and 4) as those requirements fall outside the authority of the Radiation Emitting Devices Act;
• exclude requirements to conform with all of the standards embedded/incorporated in the IEC standard with one exception: retains all references to IEC 62471 (a series of standards related to photobiological safety of lamps and lamp systems) that allow for the primary optical output of such a laser to be evaluated as a conventional lamp if four specific criteria are met, and should the regulated party so choose; and
• broaden the responsibility to conform with the IEC standard to include distributors and importers as well as manufacturers of laser products.

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

• the introduction of new broad laser requirements aligned with sections of the IEC standard;
• requirements for minimum engineering design features;
• appropriate warning labels;
• enhanced record-keeping requirements;
• accompanying safety information for specific laser classes/hazard levels;
• specific Canadian deviations from the IEC standard;
• class limits for specific types of laser products;
• potential impacts of repealing the existing requirements for laser scanners (Schedule II, Part VII) and demonstration lasers (Schedule II, Part VIII) under the REDR;
• required labelling and accompanying information in both official languages;
• exempting certain products from the scope of the REDR; and
• anticipated compliance costs.

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 the REDR Schedule II, Parts VII and VIII.

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

While there was broad support for the introduction of class or wavelength limits for specific laser products, at this time Health Canada is only introducing 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 regulations 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 is mitigated by the fact that the IEC standard is already available in both French and English (including descriptive wording, explanatory statements, and additional warnings).

Prepublication in the Canada Gazette, Part I

The proposed Regulations Amending the Radiation Emitting Devices Regulations (Laser Products) [the Regulations] were published in the Canada Gazette, Part I, on July 1, 2023, followed by a 75-day comment period. Twenty-three submissions were received from academia, businesses, associations, organizations, and individuals. The majority of stakeholders supported the proposed approach to align laser product requirements with those of the IEC standard and agreed that the existing Regulations needed to be updated.

Some stakeholders provided comments on aspects of laser safety such as training and protective gear requirements that, although an essential part of the safe use of these devices, were outside the scope of the proposal or Health Canada’s role in relation to radiation emitting devices. Those comments relating to safe use and installation were shared with members of the Federal Provincial Territorial Radiation Protection Committee for their consideration.

Concerns expressed from industry respondents related to the need for additional clarity around exemptions and specific aspects of labelling and information requirements such as label placement, package information, the potential to use QR codes as an alternative for product labelling, or barcodes for the date of manufacture. With respect to QR codes and barcodes, product labels must be interpretable and readable without having to go to an external, potentially unverified source. They are therefore not acceptable to meet labelling requirements. A regulated party may voluntarily add a QR or barcode to their laser product in addition to the required IEC labels and product ID/origin label, but it is not acceptable to replace the required IEC user information with a QR code. In response to these comments, the Regulations have been revised for greater clarity, and support material will be shared with stakeholders at final publication.

A few stakeholders urged class and wavelength limits for specific devices (e.g. toys). The decision to proceed with general laser classification, labelling and safety requirements that are aligned with the IEC standard allows Health Canada to apply basic laser safety requirements to a broader range of products, and enables end-product users to better understand the hazard level of laser products, and supports informed safe use. It also aligns Canadian requirements with those of other jurisdictions, thereby creating efficiencies for regulated parties that already comply with the IEC standard. Class and wavelength limits for specific products will be given further consideration in the future, as needed, based on the effectiveness of the current proposal and as specific products posing a high risk are identified.

With regard to the incorporation of the IEC standard, a few comments received urged the incorporation of a dynamic reference rather than a static reference. A static reference was selected because it allows control of content and ensures that excerpts and numbering incorporated by reference in the amendments stay consistent with the IEC standard. The Regulations are aligning with specific sections of the standard, but also include some deviations. Some of the deviations permit greater flexibility for regulated parties and some sections of the IEC standard were not incorporated because they touch on areas outside of Health Canada’s mandate. While major changes are not expected in future revisions to the IEC standard, it is possible that some would not be consistent with Canadian regulatory objectives and legislation.

Some respondents also urged the recognition of the CSA Group (formerly Canadian Standards Association) standard E60825-1. Others urged alignment with the United States or European Union regulations and standards for simplification. Although the CSA Group standard is identical to the IEC standard in many respects, it also includes additional electrical code-based requirements that are not within the scope of the REDR. The IEC standard is recognized broadly internationally and industry is familiar with it. The European Union and the United States are either moving towards incorporating the IEC standard, or already have. In addition, the deviations from the IEC standard for the Regulations are intended to reflect the Canadian context and would not be found in the United States or European Union regulations.

One party proposed a longer transition period (24 months rather than the proposed 12 months for the coming-into-force date) to allow industry to fully implement the proposed changes regarding product design and production. This was the only comment received related to the transition period. A 12-month period was selected due to the ongoing risk posed by the current lack of updated regulations for existing and emerging laser products. In addition, Health Canada does not wish to encourage Canada as a destination for inventories that do not comply with the IEC standard, thereby exposing people in Canada to greater risk. The majority of companies are already compliant with the IEC standard since it has existed since 2014, and the deviations related to additional required labelling (e.g. tracking ID and date of manufacture) can be applied or attached to existing inventory at low cost.

The following changes were made to the Regulations in response to comments received:

• revised REDR Schedule I, item 7, to align the definition of laser products more closely with that of the IEC standard, namely, to include the term “electromagnetic” and to include the definition for laser radiation;
• clarified that the following are exempt from the scope of the REDR, Schedule II, Part VII (including requirements for “Design, Construction and Functioning,” as well as “Information and Labelling”):
  • inoperable laser components and repair parts, per the IEC standard scope, and
  • Class II, III and IV medical devices, per the Food and Drugs Act/MDR scope;
• clarified that certain Class 1 lasers are partially exempt from the REDR, Schedule II, Part VII (e.g. from engineering, labelling, and accompanying information requirements);
• revised section 6 language requirements to replace “subsections 7(1) and 8(2)” references with “sections 7 and 8” to reflect the full sections for greater clarity;
• revised subsection 7(1) to remove the reference to “a) to l)” for greater clarity;
• revised subsection 7(2) to refer to “item(s)” instead of “subclause(s)” when statements are at the a), b), etc. level to align with language in the IEC standard;
• ensured there are no requirements for purchasing and servicing information (IEC standard, subclause 8.2); and
• clarified that the format and placement requirements (and “impractical” allowances) described in subclause 7.1 of the IEC standard also apply to the product identification/origin label required by subsection 8(2) of the REDR.

Some refinements to this Regulatory Impact Analysis Statement (RIAS) were also made to further clarify the scope of the regulatory amendments, including exemptions and elaboration on aspects of labelling and information (e.g. date of manufacture) requirements. The description of Health Canada’s activities and those of the provinces and territories in the oversight of training and use of laser products was also clarified in this RIAS.

With respect to cost-benefit analysis, one respondent questioned whether Canada-based laser manufacturers that export internationally were considered in the “Benefits and costs” section of this document. Canada-based laser manufacturers that export internationally were not included because the Radiation Emitting Devices Act does not provide the authority to regulate exported laser products, but rather only laser products imported into and/or sold or leased in Canada. Another respondent questioned whether “integrators” were considered in those calculations. Integrators are companies that acquire a laser from a manufacturer or importer/distributor and integrate it into a larger system. An integrator would generally be considered a manufacturer (as they would be selling an end product) but further Internet searches for that activity revealed additional manufacturers (19) and importers/distributors (28) that have now been included in the cost-benefit estimations.

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 was 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 options that follow.

(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 the 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, and the ability to address risks from unforeseen and new applications would be limited. 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 the REDR lagging 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 people in Canada on the risks to health posed by existing laser products to inform safe use.

(3) Amending the 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 covers 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 will essentially “future proof” the regulations for lasers. Regulatory requirements aligned with an internationally accepted standard (i.e. the IEC standard) will support clear and transparent statements on hazard classification for laser products, will facilitate identification of the actual hazard level of a laser product, and will help support informed and safe use of products by people in Canada. It should be noted that alignment with an international standard will reduce the compliance burden on regulated parties operating in more than one jurisdiction. This will 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 people in Canada at risk of harm from lasers that are mislabelled or bear no labelling at all when imported and sold into Canada. The regulatory amendments are intended to align the regulatory requirements with the IEC standard, which will benefit the health of people in Canada 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 will 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 people in Canada by minimizing exposure to hazardous radiation through requirements for built-in safety features.

Benefits to the economy, business, and trade

The 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 regulations in Canada.

Costs

Government

It is assumed that internal-to-government costs are related to the preparation of guidance, communications material, 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 the regulatory amendments are estimated at $9M undiscounted 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. Canadian companies that manufacture products exclusively for sale outside of Canada fall outside of the scope of the regulatory amendments, as the Radiation Emitting Devices Act applies only to products imported into or sold in Canada.

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 will therefore be low for such parties. This has been confirmed during the preconsultation 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 143 laser firms in Canada: 64 manufacturers and 79 non-manufacturers that import or distribute laser products. This estimate is based on information gathered from the following sources:

• Internet searches (e.g. lasers, photonics and optics companies participating in upcoming conferences/workshops; other government departments’ websites; directories and advertisements in online journals);
• internal data from public enquiries, communications from regulated parties and media attention to date;
• Health Canada’s Consultation and Stakeholder Information Management System, a registry for individuals and organizations wishing to participate in surveys and consultations;
• review of consultation findings in other jurisdictions; and
• search of the Canadian Importers Database (CID), which provides a list of companies (including city, province, and postal code) importing goods into Canada, by product, and by country of origin.

Also, because of additional analysis using Internet searches for companies that undertake integration of laser components (integrators) for sale or distribution, the cost-benefit analysis was revised to reflect an additional 48 companies that were not found in earlier searches.

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 will have to take necessary steps (e.g. an auditing process) to ensure that products manufactured outside Canada are compliant with the Regulations.

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 $4.6M over 10 years (undiscounted).

The estimated 64 laser manufacturers can be broken down into three categories: 20 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; 36 multinational/foreign companies with a Canadian presence that are likely IEC compliant, but will need to accommodate the bilingual labels/information requirements; and 8 non-international manufacturers that are likely not IEC compliant nor have bilingual labels/information.

The first group of 20 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 will incur a $1,000 one-time cost. This assumes $100 per device for 10 devices per manufacturer. The estimated cost to all manufacturers in this group is $20,000.

The second group is also assumed to already be partially compliant with the IEC standard, as they market their products in countries that are compliant with the standard. The costs of compliance for these 36 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:

• $15,000 per firm (one-time cost) to develop bilingual labelling capacity (bilingual label template and ID label) per individual laser product: translating ($1,000), creating ($100), storing ($100), and printing ($300) graphic vector files (first year). This assumes 10 devices per manufacturer; and
• $49,000 per firm over nine years for ongoing annual bilingual labelling costs for printing ($1,100/year over nine years) and labour (three hours per week at $27.88 per hour = $4,300/year over nine years).

The total cost over 10 years is estimated at $2.3M (undiscounted) for manufacturers who are partially compliant with the IEC standard.

The remaining eight 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:

• $475 for any firm unfamiliar with the IEC standard to purchase a copy of the IEC standard;
• $10,000 (estimated $1,000 for an average of 10 devices per establishment) for possible one-time safety engineering modifications (interlocks, key switches, etc.);
• $15,000 (one-time cost) to develop bilingual labelling capacity (bilingual label template and product ID) per individual laser product, comprised of translating ($1,000), creating ($100), storing ($100), and printing ($300) graphic vector files (first year) for an estimated 10 devices per manufacturer;
• $49,000 over nine years for ongoing annual bilingual labelling costs for printing ($1,100/year over nine years) and labour (three hours per week at $27.88 per hour = $4,300/year over nine years);
• $188,400 maximum in quality assurance/quality control (QA/QC) of their products to ensure compliance with the IEC standard, comprised of
  • $108,400 for one-time investment in measurement instrumentation and optics hardware (equipment);
  • $50,000 for developing testing conditions and measurement techniques (labour);
  • $30,000 for testing and analysis for laser class determination (labour); and
• $27,000 (over nine years) costs for servicing and maintaining the measurement instrumentation and optics.

The total 10-year cost is estimated at $2.3M (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 79 importers and distributors is $4.4M over 10 years (undiscounted).

The estimated 79 importers and distributors are also broken down into three categories: 20 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; 39 internationals that are likely IEC compliant, but will need to accommodate the bilingual labels/information requirements; and 20 non-international businesses that are likely not IEC compliant and/or do not have bilingual labels/information.

The first group of 20 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 is $20,000.

The second group is also assumed to already be partially compliant with the IEC standard, as they market their products in countries that are compliant with the standard. The costs of compliance for these 39 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:

• $15,000 (one-time cost) to develop bilingual labelling capacity (bilingual classification label and ID label template per individual laser product: translating ($1,000), creating ($100), storing ($100), and printing ($300) graphic vector files (first year) for an estimated 10 devices per importer/distributor); and
• $49,000 for ongoing annual bilingual labelling costs for printing ($1,100/year over nine years) and labour (three hours per week at $27.88 per hour = $4,300/year over nine years).

The total cost over 10 years is estimated at $2.5M (undiscounted) over 10 years for non-manufacturers who are partially compliant with the IEC standard.

The remaining 20 importers and distributors who sell or lease lasers exclusively for the Canadian market might not be familiar with the IEC standard and could bear 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 will likely find alternative sources for products that already meet the IEC standard. The costs are broken down as follows:

• $475 (one-time cost) to purchase the IEC standard for importers/distributors unfamiliar with the IEC standard;
• $10,000 one-time cost ($1,000 for an average of 10 laser products offered for sale/lease per establishment) to undertake required engineering modifications, if necessary (interlocks, key switches, etc.), for imported products;
• $15,000 (one-time cost) to develop bilingual labelling capacity (bilingual label template and ID label per individual laser product: translating ($1,000), creating ($100), storing ($100), and printing ($300) graphic vector files [first year]) for an estimated 10 devices per manufacturer;
• $49,000 for ongoing annual bilingual labelling costs for printing ($1,100/year over nine years) and labour (three hours per week at $27.88 per hour = $4,300/year over nine years); and
• $21,500 for annual outsourced QA/QC for laser products that are imported. These firms that import or distribute laser products exclusively in Canada will be expected to undertake some form of QA/QC to audit imports to ensure compliance. Unlike a manufacturer, it is doubtful that importers/distributors will purchase in-house measurement instrumentation and optics hardware, due in large part to prohibitive costs and the fact that such equipment is more useful at the manufacturing level. Therefore, it is assumed that these importers/distributors will outsource such QA/QC to testing houses (10% of total costs [$215,400] if done in-house over 10 years and includes $108,400 for purchasing measurement instrumentation and optics hardware; $50,000 for developing testing methods; $30,000 for testing/analysis labour costs for determining laser classification; and $27,000 for equipment service costs).

The total non-discounted cost over 10 years is estimated at $1.9M 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 regulatory amendments. 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 Regulations are related to integrating appropriate engineering features, translation, printing and application of warning and product identification labels, and printing of user information, which will 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/distributors/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 people in Canada 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 Regulations, by aligning with a well-known and established international standard for the industry and limiting compliance to the post-market period, will limit compliance burden for small businesses. Small businesses will require less time to learn about the requirements as they are industry standards, and compliance with these standards will 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 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 will amend the existing Regulations and not introduce a new title. While the 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 are 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. Therefore, the one-for-one rule does 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 (U.S. FDA) has also signalled its intention to harmonize with this IEC standard. The U.S. 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 U.S. 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 people in Canada is fulfilled.

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

Effects on the environment

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 will 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 will raise awareness of the inherent risks and support all people in Canada in making informed decisions and taking precautions.

Implementation, compliance and enforcement, and service standards

Implementation

To support the laser industry transition, the Regulations will come into force 12 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 will Health Canada require certification to demonstrate IEC compliance. To reduce the burden on industry, Health Canada has not included any pre-market certification process or record keeping requirements. Under the Radiation Emitting Devices Act, Health Canada will continue to operate using post-market surveillance, and examination of the product itself to verify compliance with regulatory requirements as needed.

The regulated parties are considered technically knowledgeable and likely already familiar with the IEC standard, given its long history of global use as the gold standard for laser product safety. Although the volume of questions from these parties is anticipated to be low, upon publication of the amendments in the Canada Gazette, Part II, stakeholders will receive notification of the publication of the Regulations, including a summary of regulatory amendments, focused information on topics that required clarification during the consultation period of the Canada Gazette, Part I, and contact information to request additional clarification. The notification will be emailed directly to stakeholders and posted online. Additional guidance materials will be finalized during the 12-month transition period, as informed by stakeholder questions received, and will be posted on the Health Canada Radiation Emitting Devices Act and Regulations web page.

In addition to these compliance promotion and education activities, Health Canada will 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 amended Regulations, compliance verification and enforcement activities will continue to follow established Health Canada procedures. This will 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.

Following the coming into force of the amended Regulations for laser products, Health Canada will undertake compliance verification activities. This will entail addressing various applications of lasers over consecutive years (based on the level of risk).

Non-compliant laser products will be subject to the compliance and enforcement actions, tools and level of intervention that are the most appropriate for the situation and are available 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 will provide valuable data to evaluate regulatory program effectiveness and inform ongoing surveillance planning.

Contact

Narine Martel
Director
Consumer and Clinical Radiation Protection Bureau
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Ottawa, Ontario
K1A 1C1
Email: ccrpb-pcrpcc@hc-sc.gc.ca