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Vol. 138, No. 11 — March 13, 2004 Regulations Amending the Radiation Emitting Devices Regulations (Tanning Equipment)Statutory Authority Radiation Emitting Devices Act Sponsoring Department Department of Health REGULATORY IMPACT Description The Radiation Emitting Devices Act prohibits or restricts the sale or importation of products that are or are likely to be a danger to the health or safety of the public. Under the authority of that Act, the Radiation Emitting Devices Regulations (Sunlamps) were introduced in 1980 to protect sunlamp users from ultraviolet overexposure effects by restricting the time of exposure to the time set on the timer provided with the device by the manufacturer. Subsequent new technology, new designs for tanning equipment and recent scientific studies have shown that the 1980 requirements need to be updated to ensure safer use of new equipment entering the market and to minimize unnecessary exposure to ultraviolet radiation. It is now well recognized in the scientific community that ultraviolet radiation overexposure is linked to the development of skin cancer. According to the International Agency for Research on Cancer (IARC), the frequent use of a sunbed, for example once per week from the age of 20, will result in an estimated doubling of the risk of non-melanocytic skin cancer by age 45. IARC also reports several studies demonstrating increased risks of cutaneous melanoma in users of sunlamps and sunbeds (IARC, 92). In March 1998, the Consumer and Clinical Radiation Protection Bureau (CCRPB) was approached by the Ministère de la Santé et des Services sociaux of Quebec to regulate sunlamps more stringently. In April 1998, a committee of experts from that province published an extensive study on the effects of artificial tanning equipment entitled Artificial Tanning in Quebec — Review of knowledge and recommendations. The study included recommendations to improve the safety for sunlamp users. Regulations on the use of tanning equipment do not exist at the provincial/territorial levels. Therefore, the Ministère de la Santé et des Services sociaux of Québec has asked CCRPB to regulate the source of radiation more stringently through the Radiation Emitting Devices Act that applies to the equipment at the time of sale or resale. Following this request, CCRPB formed a working group with medical and technical experts, including an epidemiologist, a medical doctor from a public health department, a biophysicist from the Ministère de la Santé du Québec, a biophysicist and a photobiologist from the Consumer and Clinical Radiation Protection Bureau at Health Canada. The group met regularly to discuss amendments to update the 1980 Radiation Emitting Devices Regulations (Sunlamps) to increase the safety of tanning equipment. During this exercise, the group also had the opportunity to consult with some dermatologists from the Canadian Dermatology Association. The group concluded that the Regulations needed new standards that would control more stringently the ultraviolet radiation lamps used in tanning equipment and would also make it mandatory that better and more accurate information on the health effects of ultraviolet radiation accompany the equipment at the time of sale or resale. This will give the users the opportunity to make an informed decision. The group came to that conclusion after the revision and the discussion of some recommendations from the Quebec department of Health report Artificial Tanning in Québec — Review of knowledge and recommendations and from the Federal, Provincial and Territorial Radiation Protection Committee position statement on ultraviolet radiation exposure. The proposed amendments to the Radiation Emitting Devices Regulations (Sunlamps), renamed the Radiation Emitting Devices Regulations (Tanning Equipment), set out the technical requirements for modern tanning devices and their replacement parts, sold in or imported into Canada. The proposed amendments will — update the referenced standards for double-contact and single-contact medium screw lampholders; the 1976 versions were not available anymore and were replaced by a 1991 version; technical content of the 1976 and 1991 versions is the same. — require disclosure of a new recommended exposure time for the first exposure (exposure time for the first exposure will now be calculated taking into account a first total exposure dose of 100 J/m2 of ultraviolet radiation. This dose depends on the characteristics of the lamps and varies according to the type of equipment). This is a new requirement. — require disclosure of manufacturer recommended number of exposure times per year based on a maximum dose of 15 kJ/m2 (the maximum number of exposures will be calculated taking into account a total annual dose of 15 kJ/m2. The number of exposures needed to reach that dose depends on the characteristics of the lamps and varies according to the type of equipment). This is a new requirement. — introduce a way to calculate the exposure times. This new way takes into account skin sensitivity and the characteristics of the lamps. — provide new high impact warnings to consumers related to the use of tanning equipment. The new warning signs must be permanently affixed to the external surface of the tanning equipment and bear the information, clearly legible and readily accessible to view by the user immediately before use. The warning signs must be in French and in English and include the following message:
Tanning is not safe, causes skin damage and can promote the development of skin cancer. Having more stringent standards will lead to a safer use of the tanning equipment. The new standards are based on the European International Electrotechnical Commission Standard 335-2-27 : "Safety of household and similar electrical appliances" and are meant as much as possible to be in harmony with it. Ultraviolet lamps used under professional supervision by medical doctors to treat certain skin conditions are considered medical devices and, therefore, are regulated under the Food and Drugs Act (Medical Devices Regulations). Medical application equipment using ultraviolet radiation and likely to cause tanning have always been excluded from the Radiation Emitting Devices Act and its Regulations mainly because they are under adequate professional supervision. The proposed amendments to the Radiation Emitting Devices Regulations (Sunlamps) will apply only to equipment sold or resold after the amendments come into force. They will not be retroactive. Alternatives Maintaining the status quo is considered unacceptable as it puts the Canadian population at risk when using equipment that complies with mandatory standards designed for old technology and less powerful equipment. Revoking the mandatory standards in favour of either voluntary standards or no standards is also considered unacceptable. While most equipment manufactured in the world meets high standards, there may still be some equipment manufactured which does not. In the absence of mandatory regulations, Canada could become a dumping market for equipment that does not meet foreign regulatory requirements and internationally accepted standards. This could expose unaware users to high doses of ultraviolet radiation resulting in burns and long-term consequences like skin cancer. Benefits and costs There are benefits as a result of the proposed Regulations. They will update the mandatory standards to meet the more powerful equipment currently on the market and will also give tanning-equipment users better information on the harmful effects of ultraviolet exposure. This will consequently increase the safety of the equipment used by the Canadian population and help lower ultraviolet radiation overexposure, which is linked to the development of skin cancer—the most common type of cancer in Canada. There is no substantive cost as a result of the proposed Regulations. The industry would be required to change warnings, which would be available as an electronic file from Health Canada. This will impose very low, if any, compliance costs to the industry and similarly low costs to government in the form of developing this electronic file. The Department knows of only two tanning equipment manufacturers in Canada and five equipment distributors. There are only one known lamp manufacturer and three lamp distributors. Consultation In May 2002, CCRPB circulated a letter with the proposed amendments to manufacturers, importers, tanning salon associations, the Canadian Dermatology Association, the Canadian Cancer Society and public health departments. Almost all the comments came from the tanning salon associations and were mainly against any changes. Their main concerns were the new limitations to be introduced into the information to the users and the new warning signs. Health Canada also received comments from one epidemiologist asking for even more stringent standards. The tanning equipment manufacturers did not send any comments, which can be construed as their being in agreement with the proposed amendments. Health Canada sent a consolidated letter in November 2002 answering each of their concerns and explaining that these limitations were introduced as information to the user to help the user make an informed decision. Health Canada also withdrew any mention to a minimum age limitation in the Regulations (no exposure before 18 years old) as previously suggested in its former proposed amendments. Compliance and enforcement The proposed amendments do not alter existing compliance mechanisms. Compliance monitoring and enforcement will continue to be undertaken by Healthy Environments and Consumer Safety Branch inspectors under the authority of the Radiation Emitting Devices Act and its Regulations. Mrs. Pascale Reinhardt, Photobiologist, Lasers and Electro Optics Unit, Address Locator 6301B, 775 Brookfield Road, Ottawa, Ontario K1A 1C1, (613) 946-0348 (telephone), (613) 941-1734 (facsimile), reinhardt_pascale@hc-sc.gc.ca (electronic mail). Notice is hereby given, pursuant to subsection 13(2) of the Radiation Emitting Devices Act, that the Governor in Council proposes, pursuant to subsection 13(1) of that Act, to make the annexed Regulations Amending the Radiation Emitting Devices Regulations (Tanning Equipment). Manufacturers, importers, distributors and other interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Chief, Lasers and Electro-optics Division, Consumer and Clinical Radiation Protection Bureau, Department of Health, Address Locator 6301B, 775 Brookfield Road, Ottawa, Ontario K1A 1C1 (fax: (613) 941-1734). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, March 8, 2004
EILEEN BOYD
REGULATIONS AMENDING THE RADIATION EMITTING DEVICES REGULATIONS (TANNING EQUIPMENT) AMENDMENTS 1. Item 11 of Schedule I to the Radiation Emitting Devices Regulations (see footnote 1) is replaced by the following: 11. Tanning equipment as defined in section 1 of Part XI of Schedule II. 2. Part XI of Schedule II to the Regulations is replaced by the following: PART XI TANNING EQUIPMENT Interpretation 1. The following definitions apply in this Part. "double-contact medium screw lampholder" means a lampholder described in American National Standard for Lampholders for Electric Lamps, ANSI C81.62-1991, Standard Sheet 2-158-1, entitled Double-Contact Medium Screw Lampholder, published by the American National Standards Institute and approved on July 15, 1991. (douille à contact double pour vis moyenne) "erythema reference action spectrum" means the erythema action spectrum set out in section 5.2 of CIE Standard CIE S 007/E-1998 entitled Erythema Reference Action Spectrum and Standard Erythema Dose, published in 1998 by the Commission internationale de l'éclairage. (spectre d'action érythémale de référence) "exposure position" means any place, orientation or distance relative to the ultraviolet radiating surface of tanning equipment at which it is recommended by the manufacturer that the user be exposed. (position pendant l'exposition) "exposure schedule" means a program of exposure recommended by the manufacturer of tanning equipment that takes into account exposure times, intervals between exposures and the degree of sensitivity for each skin type. (programme d'exposition) "irradiance" means radiant power incident per unit area, expressed in watts per square metre (W/m2). (éclairement énergétique) "maximum exposure time" means the longest period for continuous exposure recommended by the manufacturer of tanning equipment. (durée maximale d'exposition) "protective eyewear" means a device that is worn by the user of tanning equipment to reduce the radiation reaching their eyes either directly or indirectly. (dispositif de protection des yeux) "single-contact medium screw lampholder" means a lampholder described in American National Standard for Lampholders for Electric Lamps, ANSI C81.62-1991, Standard Sheet 2-157-1, entitled Single-Contact Medium Screw Lampholder, published by the American National Standards Institute and approved on July 15, 1991. (douille à contact unique pour vis moyenne) "spectral irradiance" means the irradiance that results from radiation within an infinitesimally small wavelength range, expressed in watts per square metre per nanometre (W/m2/nm). (éclairement énergétique spectral) "spectral transmittance" means the ratio of the spectral irradiance that is transmitted through protective eyewear to the spectral irradiance that is incident and normal to the surface of the eyewear. (transmittance spectrale) "tanning equipment" means a device that
(b) induces skin tanning or other cosmetic effects. It does not include any such device that is used in the production of therapeutic effects for medical purposes. (appareil de bronzage) "timer" means a device that is capable of ending the emission of ultraviolet radiation from tanning equipment after a preset period. (minuterie) "ultraviolet lamp" means a device that produces ultraviolet radiation in the wavelength range from 200 nm to 400 nm and is used in tanning equipment. (lampe à rayonnements ultraviolets) "wavelength" means a wavelength as measured in air. (longueur d'onde) Information and Labelling 2. The information and labels required by this Part must be provided in both official languages. Information 3. The following information must accompany each piece of tanning equipment: (a) instructions for its operation and safe use that include
(ii) the maximum exposure time, (iii) the minimum interval between consecutive exposures recommended by the manufacturer, (iv) the maximum number of persons who may, at the same time, be exposed to ultraviolet radiation from the tanning equipment, as recommended by the manufacturer, and (v) the ultraviolet radiation warning labels described in section 5; (b) instructions for obtaining repairs and the recommended replacement components and accessories that comply with the requirements of these Regulations; and (c) a warning to always follow the instructions that accompany the equipment so as to avoid injury. Labelling 4. Every piece of tanning equipment must have permanently affixed to its external surface the following information, clearly legible and readily accessible to view by the user immediately before use: (a) the manufacturer's name and address; (b) the model designation, serial number and month and year of manufacture; (c) detailed directions for determining the exposure positions and a warning that the use of any other position may result in overexposure; (d) the recommended exposure time in seconds, as calculated using the formula X / (Σ Vλ Rλ) where X is a dose not greater than 100 J/m2 for the first exposure session for untanned skin, gradually increasing over the following sessions to a maximum of 800 J/m2 per session, λ is the wavelength in nanometers, Rλ is the irradiance of the tanning equipment, measured at the minimum exposure distance, and Vλ is the weighting factor determined in accordance with the erythema reference action spectrum; (e) the minimum interval between consecutive exposures; (f) the recommended number of exposures per year based on a maximum dose of 15 kJ/m2, weighted in accordance with the erythema reference action spectrum and taking into account the recommended exposure schedule; (g) the model designation for each type of ultraviolet lamp that is to be used in the tanning equipment; and (h) the ultraviolet radiation warning labels designed in accordance with section 5. 5. The ultraviolet radiation warning labels must (a) be reproduced from the electronic file provided by the Minister; (b) include in the French version of the label illustrated in Figure 1 of paragraph (e), enclosed within a black border,
(ii) in the middle portion, the primary hazard statement "RAYONNEMENTS ULTRAVIOLETS" in yellow on a black background, and (iii) in the lower portion, the following message in black on a white background: "La surexposition provoque des brûlures aux yeux et à la peau. Porter le dispositif de protection des yeux. Suivre les instructions. Médicaments et cosmétiques peuvent augmenter les effets des UV. L'exposition aux UV peut avoir des effets nocifs sur la santé et contribuer, à long terme, au vieillissement prématuré et au cancer de la peau. Ces effets sont cumulatifs. Plus l'exposition régulière commence tôt, plus les risques qui y sont associés sont élevés."; (c) include in the English version of the label illustrated in Figure 2 of paragraph (e), enclosed within a black border,
(ii) in the middle portion, the primary hazard statement "ULTRAVIOLET RADIATION" in yellow on a black background, and (iii) in the lower portion, the following message in black on a white background: "Overexposure causes skin and eye burns. Use protective eyewear. Follow instructions. Drugs and cosmetics may increase UV effects. UV exposure can be hazardous to your health and in the long term can contribute to premature skin ageing and skin cancer. UV effects are cumulative. Greater risks are associated with early and repeated exposure."; (d) measure
(ii) 50 mm high and 100 mm wide, in any other case; and (e) conform to the following diagrams: Figure 1 Figure 2 6. All advertising material in relation to tanning equipment must include an exact reproduction, except with respect to size, of the ultraviolet radiation warning labels described in section 5. 7. Every ultraviolet lamp must have a label that sets out (a) its model designation; and (b) the warning "DANGER — Ultraviolet radiation. Follow instructions. Use only in fixtures equipped with a timer./ DANGER — Rayonnements ultraviolets. Suivre les instructions. À n'utiliser qu'avec un dispositif pourvu d'une minuterie.". Construction Standards General 8. Every piece of tanning equipment must have a physical barrier between the ultraviolet lamps and the user. 9. All controls, meters, lights or other indicators of a piece of tanning equipment must be readily identifiable and clearly labelled to indicate their function. Safety Features 10. Every piece of tanning equipment must have the following safety features: (a) a control by which the person being exposed may easily turn off the tanning equipment at any time without disconnecting the electrical plug or removing the ultraviolet lamps; and (b) a timer that meets the functioning standards set out in section 16. Components and Accessories 11. Every ultraviolet lamp that is used in tanning equipment must be constructed so that it cannot be inserted and operated in a single-contact medium screw lampholder or a double-contact medium screw lampholder. 12. Every piece of tanning equipment must be accompanied by a number of sets of protective eyewear at least equal to the maximum number of persons who may, at the same time, be exposed to ultraviolet radiation from the tanning equipment, as recommended by the manufacturer of the equipment. Functioning Standards 13. Every piece of tanning equipment, whether it has its original components or replacement components recommended by the manufacturer, must, under the conditions of use specified by the manufacturer, meet the functioning standards set out in this Part. 14. Every ultraviolet lamp that is used in tanning equipment must function so that, at any distance and in any direction from the radiation source, the irradiance within the wavelength range from 200 nm to less than 260 nm does not exceed 0.003 of the irradiance within the wavelength range from 260 nm to 320 nm. 15. Every replacement ultraviolet lamp must function so that the maximum allowable exposure time remains within 10% of the maximum exposure time originally recommended by the manufacturer. 16. The timer must (a) be adjustable to preset times and have a maximum timer setting not greater than the maximum exposure time; (b) have a margin of error not greater than 10% of the maximum timer setting; and (c) not automatically reset when the tanning equipment emissions have been ended by the timer. 17. Protective eyewear must have a spectral transmittance that is (a) not more than 0.001 over the wavelength range from 200 nm to 320 nm; (b) not more than 0.01 over the wavelength range from 320 nm to 400 nm; and (c) sufficient over wavelengths greater than 400 nm to enable the user to read the labels and use the control specified in paragraph 10(a). COMING INTO FORCE 3. These Regulations come into force on the day on which they are registered. [11-1-o] C.R.C., c. 1370 |
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