Vol. 148, No. 5 — February 26, 2014

Registration

SOR/2014-25 February 7, 2014

RADIATION EMITTING DEVICES ACT

Regulations Amending the Radiation Emitting Devices Regulations (Tanning Equipment)

P.C. 2014-107 February 6, 2014

Whereas, pursuant to subsection 13(2) of the Radiation Emitting Devices Act (see footnote a), a copy of the proposed Regulations Amending the Radiation Emitting Devices Regulations (Tanning Equipment), substantially in the annexed form, was published in the Canada Gazette, Part I, on February 23, 2013 and a reasonable opportunity was afforded to interested persons to make representations to the Minister of Health with respect to the proposed Regulations;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 13(1) of the Radiation Emitting Devices Act (see footnote b), makes the annexed Regulations Amending the Radiation Emitting Devices Regulations (Tanning Equipment).

REGULATIONS AMENDING THE RADIATION EMITTING DEVICES REGULATIONS (TANNING EQUIPMENT)

AMENDMENTS

1. The definitions “double-contact medium screw lampholder”, “erythema reference action spectrum” and “single-contact medium screw lampholder” in section 1 of Part XI of Schedule II to the Radiation Emitting Devices Regulations (see footnote 1) are replaced by the following:

“double-contact medium screw lampholder” means a lampholder described in the International Electrotechnical Commission Standard IEC 60061-2, Edition 3.41, 2010-04, Sheet 7005-29-2, entitled Position of holder thread in relation to the central and intermediate contacts of the lampholder E26d, as amended from time to time. (douille à contact double pour vis moyenne)

“erythema reference action spectrum” means the erythema action spectrum set out in section 5.2 of the International Commission on Illumination Standard ISO 17166:1999(E) / CIE S 007/E-1998, first edition, entitled Erythema reference action spectrum and standard erythema dose, as amended from time to time. (spectre d’action érythémale de référence)

“single-contact medium screw lampholder” means a lampholder described in the International Electrotechnical Commission Standard IEC 60061-2, Edition 3.41, 2010-04, Sheet 7005-21A-1, entitled Lampholders E26, as amended from time to time. (douille à contact unique pour vis moyenne)

2. (1) Subparagraphs 5(b)(ii) and (iii) of Part XI of Schedule II to the Regulations are replaced by the following:

(2) Subparagraphs 5(c)(ii) and (iii) of Part XI of Schedule II to the Regulations are replaced by the following:

(3) Section 5 of Part XI of Schedule II to the Regulations is amended by striking out “and” at the end of paragraph (d) and by replacing paragraph (e) with the following:

Figure 1

Figure 1 presents tanning equiment warning label in French.

Figure 2

Figure 2 presents tanning equipment warning label.

3. Section 6 of Part XI of Schedule II to the Regulations is replaced by the following:

6. (1) Subject to subsection (2), all advertising material in relation to tanning equipment must include, in a clearly legible manner, the signal word “Danger”, followed by the attribution “According to Health Canada / Selon Santé Canada”, the primary hazard statement “Tanning Equipment Can Cause Cancer / Les appareils de bronzage peuvent causer le cancer” and the statements set out in subparagraphs 5(b)(iii) and (iv) and 5(c)(iii) and (iv).

(2) Advertising material that is in English or French only must include, in a clearly legible manner,

COMING INTO FORCE

4. These Regulations come into force three months after the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: Given the risk of developing skin cancer through the use of tanning equipment, there is a need to update tanning equipment warning labels to help inform those who use tanning equipment of the associated risks.

Description: These Regulations will update tanning equipment warning labels by replacing the primary hazard statement “Ultraviolet radiation” with “Tanning equipment can cause cancer.” The text “Not recommended for use by those under 18 years of age” and “Risk factors include skin type, photosensitivity and history of skin cancer” will also be added to the label, and the information on the label will be reorganized to improve readability and clarity. Providing clear health risk information to users of tanning equipment will help them make informed decisions.

Cost-benefit statement: The maximum total one-time cost of this proposal to Canadian stakeholders is $64,642. The costs to the tanning industry include printing new labels and a potential decline in the use of tanning equipment. However, the benefits of these Regulations will outweigh the costs. Consumers will benefit from access to more up-to-date information regarding the risks associated with the use of tanning equipment, which may contribute to a reduction in the incidence of skin cancer among users of tanning equipment.

“One-for-One” Rule and small business lens: The “One-for-One” Rule does not apply as these Regulations will not introduce new administrative burden. The small business lens does not apply as the cost of complying with these Regulations will be minimal. There is no impact on competition or trade. There will be no change in the accessibility of tanning products for consumers, though consumers will benefit from receiving more up-to-date information regarding the risk of using tanning equipment.

Domestic and international coordination and cooperation: Tanning equipment manufactured in Canada and imported into Canada will be expected to carry the revised warning labels, but aside from printing the new labels, the regulatory requirements under the Radiation Emitting Devices Regulations (Tanning Equipment) will not change. These Regulations reflect the current available evidence on the risks associated with tanning equipment use, and are aligned with similar regulatory efforts in other jurisdictions domestically and internationally.

Issues

There are approximately 3 000 tanning salons across Canada. Given the risk of developing skin cancer through the use of tanning equipment (particularly among youth), there is a need to update tanning equipment warning labels to ensure that those who use tanning equipment are fully aware of the associated risks.

The Radiation Emitting Devices Regulations (Tanning Equipment) require warning labels on tanning equipment to provide owners, operators and users with information on the health risks related to ultraviolet (UV) radiation from the equipment. Warning labels updated in 2005 did not reflect recent scientific studies that link ultraviolet radiation from tanning equipment to the risk of developing cancer, or that younger users are at risk. The risks are cumulative, meaning there is an escalating risk with total hours, sessions or years of tanning equipment use. Age of first use is also a factor: both an increased risk of developing melanoma and early onset of the disease have been linked with age at first use of tanning beds.

Skin cancer is the most common type of cancer in Canada, and melanoma is its deadliest form. While mortality rates have remained consistent in Canada, with one death occurring among every five people diagnosed, incidence of melanoma has increased threefold between 1972 and 2006. At the same time, the popularity of artificial tanning has also increased, with females in their late teens and twenties most likely to use tanning equipment. Many Canadians mistakenly believe that using indoor tanning equipment to develop a base tan before tanning in the sun can protect from sunburn, and that indoor tanning is safer than tanning in the sun.

These Regulations will also address the need to update the titles of technical standards referenced in the Radiation Emitting Devices Regulations (Tanning Equipment).

Objectives

The objective of these Regulations is to provide users of tanning equipment with clear information on the risks of using tanning equipment. Updating the health risk information on tanning equipment warning labels will respond to scientific findings that tanning equipment users are at an increased risk of developing skin cancer, and youth are at an even greater risk.

The Radiation Emitting Devices Act (REDA) provides the Minister of Health with the authority to recommend regulations to the Governor in Council respecting the labelling of radiation emitting devices, such as tanning equipment, for the purpose of protecting persons against genetic or personal injury, impairment of health or death from radiation. This includes prescribing the information that must be present on a label and the manner in which that information must be shown.

The warning labels displayed on tanning equipment are intended to provide tanning equipment owners, operators and users with information to help them gain a better understanding of the health risks associated with the use of tanning equipment. However, research conducted by various health organizations indicates that many people think artificial tanning is safer than tanning in the sun. Such findings indicate that the health risks of artificial ultraviolet radiation are not well understood. In addition, the World Health Organization (WHO) categorized tanning devices as a known carcinogen in 2009.

Studies indicate that tanning equipment use rises in correlation with age among youth up to 18 years of age: older adolescents are much more likely to use tanning equipment than those under the age of 15. As the consequences are often only seen many years later, youth under 18 years of age may not fully realize the risks of tanning equipment use and may therefore make ill-informed decisions. Tanning equipment use is an avoidable but increasingly common behaviour, and many international jurisdictions have responded by banning the use of tanning equipment by minors under the age of 18. The current recommendation in the national Guidelines for Tanning Salon Owners, Operators and Users, published by Health Canada in collaboration with the provinces and territories, is that those under 16 years of age not use tanning equipment. This recommendation fails to capture the youth age bracket that uses tanning equipment the most, those 16 and 17 years of age.

The labelling changes outlined in these Regulations will provide a clear age recommendation for use. There is a growing awareness of the cancer risks associated with tanning equipment, and public and stakeholder support for a ban restricting minors from using tanning equipment is high. In May 2011, Nova Scotia’s Tanning Beds Act came into effect, making it illegal to provide access to tanning equipment to anyone under age 19. New legislation has since come into effect in British Columbia, Prince Edward Island, and Quebec that makes it illegal to provide UV tanning services to youth under age 18, and in the Northwest Territories and New Brunswick for youth under 19. Manitoba introduced informed parental consent requirements for those under 18, which came into force on June 15, 2012. Other provinces and territories are pursuing efforts to regulate the use of tanning equipment.

The Radiation Emitting Devices Regulations (Tanning Equipment) also stipulate safety and engineering requirements for tanning equipment required at the time of sale, resale, lease or importation to protect users from overexposure to ultraviolet radiation. Two standards are referenced in the current Regulations. The standards produced by the International Electrotechnical Commission (IEC) and by the International Commission on Illumination (CIE) include information about regular household lampholders (i.e. the socket the bulb screws into) with which tanning lamps should not be used, and calculations to restrict the duration of first exposure for untanned skin, maximum exposure time per session (i.e. the maximum setting on the equipment timer) and maximum number of minutes of exposure per year. The titles of the two technical standards have been updated in the time since the Radiation Emitting Devices Regulations (Tanning Equipment) came into force in 2005. The second objective of these Regulations is to provide industry with updated standards references so that industry can refer to the most current standards.

Description

The Radiation Emitting Devices Regulations (Tanning Equipment) establish the requirements for the safety and engineering of tanning equipment at the time of sale, resale, lease or importation. The Radiation Emitting Devices Regulations (Tanning Equipment) also establish requirements for information that must be displayed on tanning equipment in Canada, setting out specific requirements for the size, location and content of information to be displayed. These requirements are aimed at having tanning equipment clearly display health warning messages and information about ultraviolet radiation emitted by tanning equipment.

These Regulations will amend the Radiation Emitting Devices Regulations (Tanning Equipment) in two ways.

(1) Update tanning equipment warnings

These Regulations will update tanning equipment warning labels under section 5 of the Radiation Emitting Devices Regulations (Tanning Equipment). The updated warning labels will replace the primary hazard statement “Ultraviolet radiation” with “Tanning equipment can cause cancer.” The text “Not recommended for use by those under 18 years of age” and “Risk factors include skin type, photosensitivity and history of skin cancer” will be added to the statements in the lower portion of the label, and the information in this section will be reorganized to improve readability and clarity. New images of the proposed labels are included in these Regulations. Information on advertising material as outlined in section 6 of the current Regulations will also be updated to reflect changes to the warning labels.

(2) Provide reference to the latest editions of standards within the Radiation Emitting Devices Regulations (Tanning Equipment)

These Regulations will reflect the latest editions of two technical standards referenced in the Radiation Emitting Devices Regulations (Tanning Equipment). The first standard includes information pertaining to regular household lampholders with which tanning lamps should not be used (i.e. double-contact medium screw lampholder and single-contact medium screw lampholder). The second standard is used to calculate first and maximum exposure times (i.e. exposure times are based on the erythema reference action spectrum described below). Further, in order to ensure that the standards referenced are the most recent, these Regulations will reference the standards “as amended from time to time.”

More specifically, these Regulations will amend section 1 of the Radiation Emitting Devices Regulations (Tanning Equipment) by updating the titles of the standards referenced in the following definitions, to be replaced with the following:

Regulatory and non-regulatory options considered

Regarding the tanning equipment warning labels, the following alternatives were considered.

(1) Status quo

The Radiation Emitting Devices Regulations (Tanning Equipment) required that tanning equipment be labelled with the following messages: “Danger” and “Ultraviolet Radiation,” followed by a detailed statement about the health risks related to ultraviolet radiation exposure, which were appropriate when updated in 2005. The 2005 labels did not provide an age recommendation. Maintaining the status quo would not inform users of new information concerning the health risks associated with tanning equipment specifically, and could also set Canada apart from other jurisdictions such as the United Kingdom and Australia, where bans have been introduced and awareness campaigns launched.

(2) Public awareness initiatives

Consideration was given to using public awareness initiatives (in the absence of regulatory amendments) to increase the understanding and knowledge of the health risks associated with using tanning equipment. Such initiatives would focus on improving the communication of health risks associated with tanning equipment use and could include the use of social media, a review of the accessibility of tanning and sun safety information on the Health Canada Web site, and the coordination of health risk information messaging and products with provincial and territorial counterparts. However, it was determined that, on its own, a public awareness initiative would not necessarily reach those who are already using tanning equipment. As described below, it was determined that a regulatory approach in combination with public awareness initiatives would yield an increased awareness of the health risks.

(3) Update the National Guidelines for Tanning Salon Owners, Operators and Users

The information contained in these guidelines, published by Health Canada in collaboration with the provinces, is intended to provide tanning salon owners, operators and users a fundamental understanding of ultraviolet radiation from tanning equipment and its effects on people. Guidelines are not necessarily available at the point of use and so revisions alone would not be sufficient for communicating up-to-date information to tanning bed users. Revisions to the guidelines are being considered to reflect recent scientific evidence and regulatory and/or policy developments at the provincial, territorial and federal levels.

(4) Regulations (recommended)

In combination with ongoing public awareness initiatives and revisions to national guidelines, these Regulations will help provide tanning equipment users with readily accessible information about the risks of using tanning equipment with each use. The Regulations align with both the current available scientific information on the risks associated with tanning equipment use and similar regulatory efforts in other jurisdictions, domestically and internationally. It has been determined that the benefits of the Regulations will outweigh the costs, will have no impact on competition or trade and will impose minimal additional compliance burden.

In order to update the references to standards, Health Canada has determined that incorporation of the standards by ambulatory reference will help ensure that the Radiation Emitting Devices Regulations (Tanning Equipment) remain accurate following new versions or updates to the standards.

Benefits and costs

In 2010, the Canadian Partnership Against Cancer published a report in which they estimated the economic burden of skin cancer in Canada to be $532 million, with the majority attributable to melanoma (83.4%). The total estimated economic burden of skin cancer in Canada was expected to rise to $922 million annually by 2031, assuming the trajectory is maintained. The direct cost per melanoma case was estimated to be $6,215, increasing to $7,136 by 2031 due to increased inpatient and outpatient hospital costs per case.

There are approximately 3 000 salons across the country. However, the number of beds is difficult to estimate, as some are located in fitness clubs and non-salon environments, the number of beds varies from one salon to another, and some members of the general public purchase tanning equipment for home use. The monetary impact on all Canadian stakeholders who will be required to comply with these Regulations (i.e. approximately 71 manufacturers, distributors and importers) will not be substantial. Individual stakeholders will face a maximum one-time cost of $910.

Warning labels on tanning equipment are already a requirement under the Radiation Emitting Devices Regulations (Tanning Equipment), and these Regulations will not require any changes to the placement or size of the labels. The cost for industry to comply with these Regulations will include printing new labels, replacing the old stock of labels, and advising staff of the regulatory amendments. Industry will have sufficient time to print new warning labels: these Regulations will come into force three months after registration.

Costs

The new labelling requirements will have a minimal impact on the tanning industry. Health Canada recognizes that, in conjunction with public awareness efforts, the updated warning labels may contribute to less frequent or shorter visits to tanning salons by some consumers, which may in turn contribute to a decline in sales for these establishments. However, there are a number of initiatives, including a variety of public awareness campaigns, ongoing media coverage, as well as the introduction of age restrictions in some jurisdictions in Canada, which make it very difficult to accurately assess the potential decline in use that could be attributed to these Regulations alone.

The new label will be provided in an electronic format to be printed on adhesive tacking and placed on the equipment, a process which is consistent with previous requirements under the Radiation Emitting Devices Regulations (Tanning Equipment). As the size and placement of the labels on the tanning equipment will not change, there will be no additional requirement on the part of the manufacturer. The estimated cost of printing new labels is $111 per business, totalling $7,880 for all 71 Canadian manufacturers and distributors.

There may be a one-time cost to manufacturers and others to access copies of the standards referenced in the Radiation Emitting Devices Regulations (Tanning Equipment). These Regulations establish an ambulatory incorporation of the standards into the Radiation Emitting Devices Regulations (Tanning Equipment). Stakeholders can purchase the standards, if they do not already have them, for less than $800. However, this does not represent a new cost of business as the Radiation Emitting Devices Regulations (Tanning Equipment) already referred to the standards under their previous titles. It is likely that many of the manufacturers of tanning devices already access the standards consistent with existing regulatory requirements and will therefore experience no new costs. Nonetheless, it is estimated that there are 71 major Canadian manufacturers and distributors of tanning equipment (including eye covers), 70 of which are small businesses, and there are fewer than 500 manufacturers internationally. In a worst-case scenario, if every manufacturer, distributor and importer had to pay a maximum of $800 for the standards, in addition to labelling compliance costs, the maximum one-time cumulative cost to industry would be $64,642 for Canadian manufacturers and importers, and less than $1 million for all worldwide stakeholders ($455,225 total).

There will be no new costs to the federal government as a result of these Regulations.

Benefits

Many companies within the tanning industry promote sales of alternative tanning products, such as artificial tanning lotions and sprays. Sales of these items could potentially increase as a result of reduced reliance on artificial ultraviolet radiation, offsetting the costs incurred by lost business from a decrease in the use of tanning equipment.

These Regulations aim to provide consumers with better information on the health risks of tanning equipment, thereby contributing to the ability of users and potential users to make informed decisions. In Canada, it is estimated that approximately 9% of the population uses tanning equipment. Studies indicate higher usage rates for young females aged 16 to 24 in particular. These Regulations will help provide tanning equipment users with readily accessible information about the risks of using tanning equipment with each use, at the point of use.

The updated standards references will provide manufacturers with access to the most up-to-date titles of the standards. Three terms referenced in the Radiation Emitting Devices Regulations (Tanning Equipment) are defined in standards: two of these are defined in the IEC standards, and one term is defined in the CIE standards. In updating the current Regulations to reference the standards, “as amended from time to time,” manufacturers will be directed to the most recent versions, and therefore definitions, available.

“One-for-One” Rule

The “One-for-One” Rule does not apply to this proposal, as there is no change in administrative costs to business.

Small business lens

The small business lens does not apply because the nationwide cost impacts of these Regulations are less than $1 million annually.

Consultation

1. Comments received following targeted stakeholder consultation

A targeted stakeholder consultation was conducted from November 26 to December 21, 2010, to solicit input on proposed warning label content. A total of nine stakeholders (including tanning bed manufacturers, cancer control groups, consumer groups, and associations representing the interests of dermatologists, medical and paediatric professionals and the tanning industry) were contacted by telephone, and were invited to participate. Six stakeholders provided input.

All but one of the stakeholders strongly favoured the addition of an age recommendation (18 years) and stronger wording about cancer risks associated with tanning equipment. One respondent suggested the current warning label should be kept and that the wording on the alternative labels was too strong. The strength of the proposed health risk warning stated on the updated label is commensurate with warnings in other jurisdictions, including Australia. One respondent indicated that there had been no new data to support a regulatory change since the previous updates to the Radiation Emitting Devices Regulations (Tanning Equipment), and that the age recommendation was political and should be removed and replaced with the statement “Not recommended for those with skin type 1.”

One respondent commented that the proposed changes would make the warning labels less relevant, because the intent of the label should be to assist professional sunbed facility operators in doing their jobs to properly educate clients on correct procedure and mitigation of risk. However, the intent of these Regulations is to increase awareness of the risk associated with tanning equipment use by providing consumers with more and up-to-date information about these risks at the point of use. The REDA provides the authority to make regulations respecting the labelling of tanning equipment for the purpose of protecting persons against genetic or personal injury, impairment of health or death from radiation. Neither the Act nor its Radiation Emitting Devices Regulations (Tanning Equipment) indicates that the label is meant for the use of facility operators alone: tanning equipment users may review the information on the labels for themselves in order to make an informed choice.

These Regulations may not respond to concerns of those in favour of indoor tanning. However, they align with current available scientific findings on the cancer risks associated with tanning equipment use, and their objectives and the updated text of the warnings are similar to regulatory efforts of other jurisdictions.

Given the administrative nature of the update to the standards, no consultation was carried out on the updates to the standards referenced in the Radiation Emitting Devices Regulations (Tanning Equipment). No controversy is anticipated from stakeholders relating to the update to the technical standards references.

2. Comments received following publication of the Regulations in the Canada Gazette, Part I

The Regulations were published in the Canada Gazette, Part I, on February 23, 2013, followed by a 75-day comment period. Comments were received from seven stakeholders, including a provincial government department, two municipal health departments, a cancer control group, an association representing paediatric professionals, an indoor tanning association, and one member of the general public. All but one of the stakeholders were supportive of the Regulations. Some sought clarification on the applicability of the Regulations to existing equipment and further provided comments in support of stronger federal government action regarding the label design, wording and age recommendation. One stakeholder expressed concern over updating tanning warning labels at all and suggested the changes were too strong. The comments received were organized according to themes and are summarized below, along with Health Canada’s responses.

As expected, there were no comments relating to the update to the technical standards references.

Application of Regulations

Five stakeholders commented on the application and scope of the Regulations. Three stakeholders sought clarification on whether the label requirement would apply only to new tanning equipment. Two stakeholders suggested that in addition to warning labels on tanning equipment, federal signs should be posted in tanning establishments. One stakeholder requested that regulations not proceed until a standardized warning label for all UV-emitting devices could be developed, as this would create a more even environment for UV-emitting devices, would be more cost-effective for Health Canada and health inspectors, and would be less confusing for the public.

Consistent with the authorities under the REDA, these Regulations will apply to tanning equipment at the time of sale, resale, lease and importation. These Regulations will apply to all tanning equipment sold, resold, leased or imported after these Regulations come into force. It is anticipated that all equipment will eventually comply with updated warning label requirements as salons replace and update existing equipment. Signage and requirements for existing equipment in operating tanning establishments are addressed at the provincial/territorial level.

Currently there are no regulations that broadly capture “UV-emitting devices” and thus no regulatory framework for developing a standardized label for UV-emitting devices. Health Canada would consider this option as necessary and based on emerging health risks.

International equivalence

One stakeholder expressed concern that the Regulations are not equivalent to other jurisdictions’ requirements, specifically that the statement “Tanning equipment can cause cancer” on the updated warning labels is stronger than labels in other countries, and that most countries do not have a requirement for warning labels.

These Regulations align with the objectives of regulatory efforts in other jurisdictions domestically and internationally. The revised primary hazard statement “Tanning equipment can cause cancer” reflects current scientific findings and strikes a balance with regard to the views expressed by various stakeholders through targeted consultations in late 2010 and reaffirmed through the Canada Gazette, Part I, process.

Warning label health risks

Two stakeholders commented on the information listed under the primary hazard statement on the warning label. One stakeholder suggested the addition of “Genetics key risk factor for UV exposure (skin type)” to the health risk information. One stakeholder suggested both health risks and benefits should be conveyed on the warning label to present a balanced view. Two stakeholders made six comments suggesting changes to the health risk information wording.

Health Canada acknowledges that some risk factors such as skin type and predisposition for UV-related health effects had not been captured in the proposed updated warning label published in the Canada Gazette, Part I, and has made revisions to the label accordingly. The statement “Risk factors include skin type, photosensitivity and history of skin cancer” has been added to the health risk information listed on the label. The six comments suggesting further changes to the health risk information, including suggestions to remove two points that were on the 2005 labels, were considered but not integrated as the information on the label remains accurate.

The REDA provides the Governor in Council authority to make regulations respecting the labelling of any radiation emitting device for the purpose of protecting persons against genetic or personal injury, impairment of health or death from radiation. It is the aim of the warning label to relay information on potential health and safety risks. UV radiation has benefits, such as sterilization or treatment for some skin conditions, and Health Canada provides information sheets that expand on the health effects of UV radiation. Given limits to the size of the label and the aim of relaying potential health and safety risks to Canadians, Health Canada feels that the warning labels as proposed are appropriate.

Warning label design

Three stakeholders commented on the design of the warning label. One stakeholder expressed support for reformatting the health risk information into bullet points. One stakeholder expressed concern that the labels are too small. One stakeholder suggested using graphic warning labels.

The decision not to increase the size of the warning label reflected concern that an increase could negatively affect the operation of the tanning equipment (e.g. venting) and place greater compliance burden on industry.

With regard to graphic warning labels, Health Canada acknowledges the potential effectiveness of graphic warnings. In the context of warning labels for tanning equipment, however, and as outlined earlier in this document (regulatory options considered), the updated warning labels are meant to be considered in combination with other awareness-raising options, for example signage where use of graphic labels may be facilitated due to fewer restrictions on size. Size limitations raise concerns that use of graphic warning labels would reduce space for necessary clear messaging required at the point of use.

Warning label age recommendation

Seven stakeholders commented on the age recommendation. Six stakeholders expressed support for the age recommendation being added to the tanning equipment warning labels. One stakeholder, while not necessarily supportive, expressed an understanding of the rationale for adding the age recommendation. Two stakeholders encouraged Health Canada to incorporate age restrictions into the regulatory amendments. One stakeholder expressed concern that a recommendation against use by those under 18 could be misconstrued to mean that use of tanning equipment is recommended for anyone 18 and over, and recommended that the age recommendation be reframed to state “Health Canada does not recommend the use of tanning equipment — especially for those under the age of 18.”

The use of tanning equipment, including age restrictions, is dealt with at the provincial/territorial level. Consistent with the existing authorities under the REDA, Health Canada is providing an age recommendation on the warning label to communicate that tanning equipment is not recommended for minors.

Updating the health risk information on tanning equipment warning labels responds to scientific findings that tanning equipment users are at an increased risk of developing skin cancer, and youth are at an even higher risk. Updates to the general health risk information and re-ordering of the information will help to more clearly inform all tanning equipment users of the associated health risks. The targeted age recommendation aims to make clear in a concise fashion that youth in particular are at an even greater risk. Broadening the language to include all age groups has the potential to diminish the relevancy to those considered at particular increased risk. Therefore, Health Canada feels the current wording as proposed is appropriate.

Warning label primary hazard statement

Two stakeholders commented on the primary hazard statement “Tanning equipment can cause cancer.” One stakeholder expressed concern that the statement misinterprets the actual risk, and that the statement could lead tanning equipment users to think they are at risk of developing any cancer, not specifically skin cancer. One stakeholder expressed concern that the statement implies that the tanning equipment itself causes cancer rather than the ultraviolet radiation emitted by the equipment when the equipment is turned on. One stakeholder recommended the statement be strengthened to state “Tanning equipment causes cancer.”

While the predominant cancer risk from tanning equipment is skin cancer, a number of case-control studies have demonstrated a direct link between indoor tanning and ocular melanoma. Ultraviolet radiation exposure can also result in both local and systemic immunosuppression which can make the body more susceptible to health risks, including the development of cancer.

To clarify that the risk from tanning equipment relates to situations where the machines are turned on, Health Canada contemplated changing the primary hazard statement to read “Tanning equipment use can cause cancer.” However, such a change would not address operators and others who could potentially be exposed to ultraviolet radiation from tanning equipment without using the equipment. Additionally, ultraviolet radiation emission is the function of tanning equipment. Health Canada will clarify on the label that the risk of cancer relates to the ultraviolet radiation.

Not everyone who uses tanning equipment will develop cancer. The primary hazard statement as proposed reflects the fact that those who use tanning equipment are at an increased risk of developing cancer, as supported by the WHO and other scientific findings.

Health Canada will maintain the wording “Tanning equipment can cause cancer” for the primary hazard statement, as the Department feels that the labels as proposed accurately reflect current research and findings.

Miscellaneous

Health Canada received various requests for clarification and editorial comments during the comment period. These have been taken into consideration and incorporated into the Regulations or Regulatory Impact Analysis Statement, where appropriate.

Regulatory cooperation

In June 2010, a Federal-Provincial-Territorial Radiation Protection Committee Tanning Beds Working Group was established. The working group’s mandate is to examine health and safety issues relating to the use of tanning equipment by identifying emerging and current concerns, issues and considerations relating to tanning equipment; providing input to regulations pertaining to the labelling of tanning equipment; considering revisions to the national Guidelines for Tanning Salon Owners, Operators and Users; discussing potential federal strategies related to public awareness, including the development and/or expansion of educational campaigns; and exploring provincial/territorial regulatory capacities.

These Regulations are not related to a commitment under the Joint Action Plan for the Canada-United States Regulatory Cooperation Council.

Rationale

Indoor ultraviolet tanning is associated with an increased risk of developing skin cancer, and is a risk factor for early-onset skin cancer. Recent studies have increasingly demonstrated a dose-response effect; that is, more tanning equipment exposures lead to increased risk of developing skin cancer. Most of these studies have only been published since the last update to the Radiation Emitting Devices Regulations (Tanning Equipment) in 2005. The WHO’s International Agency for Research on Cancer (IARC) monograph on radiation, updated in 2012 by an interdisciplinary working group of expert scientists, confirmed that there is sufficient evidence in humans for the carcinogenicity of ultraviolet-emitting tanning devices. Based on the strength of the evidence demonstrating the carcinogenic effects of tanning devices, the WHO has stated that restricting youth under 18 years from accessing tanning devices should be of highest regulatory priority for governments.

Updated warning labels, as part of these Regulations, will serve to inform consumers of the risk associated with using tanning equipment and may ultimately contribute to a decrease in the incidence of skin cancer. In 2007, the U.S. Food and Drug Administration (FDA) conducted a consumer study of labelling information on the relationship between the use of indoor tanning devices and development of skin cancer. Based on its analysis, the U.S. FDA determined that participants in the study found that the use of a paragraph format on ultraviolet radiation warning labels (as is currently used on Health Canada’s warning labels) made it difficult to focus on and read the warning statement. Alternatively, almost all participants said that they would be more likely to read a label with a bulleted format, that the shorter length of the text made it easier to focus on the risks and directives, and that the shorter and bulleted format sent a stronger message about the dangers associated with indoor tanning equipment.

The goal of increasing awareness of the health risks associated with the use of tanning equipment will be achieved by providing tanning equipment users with readily accessible information, including information on the increased risk of developing skin cancer, and by raising the recommended age of use. A review of other jurisdictions has been undertaken and the objectives and updated warnings outlined in these Regulations will align with the regulatory efforts of other countries such as the United Kingdom and Australia. On May 9, 2013, the U.S. FDA published a proposal to reclassify tanning beds from class I to class II medical devices, allowing for special controls on tanning equipment, including updated warning label requirements. The labelling requirements aim to discourage use of tanning products by populations that are especially susceptible to the risk of skin cancer, and would require the statement “Attention: this sunlamp product should not be used on persons under the age of 18 years” to appear on all tanning product fixtures. The federal government has coordinated with the provinces and territories on developing options to reduce the incidence of avoidable skin cancer due to ultraviolet radiation from tanning equipment through the Federal-Provincial-Territorial Radiation Protection Committee’s Tanning Beds Working Group. As the updated label in these Regulations provides a minimum age of use recommendation, and the Regulations do not propose to ban access to tanning equipment by minors, it will not conflict with existing and proposed legislative initiatives in Canada’s provinces and territories, such as Nova Scotia’s under-19 age restriction, or Manitoba’s requirement for minors under 18 to have parental consent to use tanning equipment. The label will complement public awareness campaigns that have been mounted by several public health bodies, non-profit organizations and other government health departments across Canada to warn against ultraviolet tanning equipment, particularly by minors.

The minimal costs associated with these Regulations will be outweighed by the potential benefits of reducing incidence of skin cancer.

Implementation, enforcement and service standards

As described earlier, implementation of these Regulations will align with efforts of other jurisdictions, including the provinces and territories, and with broader public awareness initiatives. In order to assist the tanning industry in transitioning smoothly to the new requirements, the Regulations will come into force three months after registration.

These Regulations will not alter existing compliance mechanisms. Provinces will remain responsible for the licensing of salons and their adherence to provincial legislation. Under subsection 5(3) of the REDA, “No person shall fail to comply with the regulations respecting the labelling, packaging or advertising of radiation emitting devices.” Compliance and enforcement will continue to be undertaken by Health Canada inspectors under the authority of the REDA and the Radiation Emitting Devices Regulations (Tanning Equipment).

Contact

Tara Bower
Director
Office of Science Policy, Liaison and Coordination
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Address Locator 4908D
269 Laurier Avenue W
Ottawa, Ontario
K1A 0K9
Fax: 613-952-5397
Email: tara.bower@hc-sc.gc.ca