Vol. 139, No. 4 — February 23, 2005

Registration
SOR/2005-33 February 8, 2005

RADIATION EMITTING DEVICES ACT

Regulations Amending the Radiation Emitting Devices Regulations (Tanning Equipment)

P.C. 2005-139 February 8, 2005

Whereas, pursuant to subsection 13(2) of the Radiation Emitting Devices Act, 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 March 13, 2004 and a reasonable opportunity was thereby afforded to manufacturers, importers, distributors and other interested persons to make representations to the Minister of Health with respect to the proposed Regulations;

Therefore, Her 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, hereby makes the annexed Regulations Amending the Radiation Emitting Devices Regulations (Tanning Equipment).

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'expositions)

"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 ultraviolet 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

(a) can be equipped with one or more ultraviolet lamps; and

(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

General

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

(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, as calculated in seconds using the formula

and converted into and expressed in minutes, where

(e) the minimum interval between consecutive exposures;

(f) the maximum number of minutes of exposure per year, as recommended by the manufacturer based on a maximum annual 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,

(c) include in the English version of the label illustrated in Figure 2 of paragraph (e), enclosed within a black border,

(d) measure

(e) conform to the following diagrams:

Figure 1

Figure 2

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", the primary hazard statements "Ultraviolet Radiation / Rayonnements ultraviolets" and the messages set out in subparagraphs 5(b)(iii) and (c)(iii).

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

(a) if it is only in French, the signal word "Danger", the primary hazard statement "Rayonnements ultraviolets" and the message set out in subparagraph 5(b)(iii); and

(b) if it is only in English, the signal word "Danger", the primary hazard statement "Ultraviolet Radiation" and the message set out in subparagraph 5(c)(iii).

7. Every ultraviolet lamp must have a tag, tape or card affixed to it 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. 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

9. 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.

10. (1) Every piece of tanning equipment must have a physical barrier between the ultraviolet lamps and the user that prevents any direct physical contact between the user and the lamps.

(2) In the case of tanning beds, the physical barrier must be constructed of plexiglass or an equivalent material.

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 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 recommended by the manufacturer;

(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 9(a).

COMING INTO FORCE

3. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

The Radiation Emitting Devices Act prohibits or restricts the sale, the leasing or the importation into Canada of products that are or are likely to be a danger to the health or safety of the public. Under the authority of this Act, the Radiation Emitting Devices Regulations (Sunlamps) were introduced in 1980 to protect sunlamp users from ultraviolet overexposure effects by restricting the duration of exposure to the time set on the sunlamp timer.

Subsequently, new technology, new designs for tanning equipment and recent scientific studies have shown that the 1980 requirements needed to be updated to ensure safer use of tanning equipment entering the market and to minimize unnecessary exposure to ultraviolet radiation. The scientific community recognizes that ultraviolet radiation overexposure is linked to the development of skin cancer. According to the International Agency for Cancer Research (IACR), the frequent use of a tanning equipment, for example once per week from 20 years of age, will result in an estimated doubling of the risk of non-melanocytic skin cancer by age 45. IACR also reports several studies demonstrating increased risk of cutaneous melanoma in users of tanning equipment.

In March 1998, the Consumer and Clinical Radiation Protection Bureau (CCRPB) of Health Canada was approached by the Ministère de la Santé et des Services sociaux du Québec with a request to regulate tanning equipment more stringently. In April of 1998, a committee of experts from that province published an extensive study on the effects of artificial tanning entitled, Artificial Tanning in Québec — 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 or territorial level. Therefore, the Ministère de la Santé et des Services sociaux du Québec asked CCRPB to regulate the source of radiation more stringently through the Radiation Emitting Devices Act.

Following this request, CCRPB formed a working group of medical and technical experts, from a public health department, the Ministère de la Santé et des Services sociaux du Québec, and CCRPB. The working 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 working group consulted dermatologists from the Canadian Dermatology Association and reviewed the recommendations from the Québec Government report, Artificial Tanning in Québec — Review of knowledge and recommendations and the Federal Provincial and Territorial Radiation Protection Committee Position Statement on ultraviolet radiation exposure. The working group concluded that the existing Regulations needed new standards that would control more stringently the ultraviolet radiation lamps used in tanning equipment and that more complete and accurate information on the health effects of ultraviolet radiation should accompany the equipment at the time of sale (including resale), lease or importation. Users would then be able to make an informed decision about the use of the equipment.

The amendments to the Radiation Emitting Devices Regulations (Sunlamps), renamed the Radiation Emitting Devices Regulations (Tanning Equipment), set out the technical requirements for contemporary tanning equipment and their replacement parts sold, leased in, or imported into Canada. The new Regulations include the following revisions:

• the referenced standards for double-contact and single-contact medium screw lampholders have been updated;
• the manufacturer would recommend the exposure time for first exposure. Exposure time for the first exposure will be calculated taking into account a first total exposure dose of 100 J/m² of ultraviolet radiation. The time to deliver this dose depends on the characteristics of the lamps and varies according to the type of equipment. This is a new requirement;
• the manufacturer would recommend the number of exposure times per year based on a maximum dose of 15 kJ/m². The number of exposures needed to reach this dose depends on the characteristics of the lamps and varies according to the type of equipment. This is a new requirement;
• the calculation of exposure times would take into account skin sensitivity and the characteristics of the lamps;
• there is a provision for new high impact warnings to users. The new coloured warning signs must be permanently affixed to the external surface of the tanning equipment, be 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 wording:

Having more stringent standards in the Regulations will lead to a safer use of the tanning equipment. The new standards are harmonized with on the European International Electrotechnical Commission Standard 335-2-27: "Safety of household and similar electrical appliances".

Ultraviolet lamps used under supervision of medical practitioners to treat certain skin conditions are considered medical devices and are regulated under the Food and Drugs Act (Medical Devices Regulations).

The Radiation Emitting Devices Regulations (Tanning Equipment) will apply only to tanning equipment sold, leased or imported after the Regulations come into force. They will not be applied retroactively.

Alternatives

Maintaining the status quo is considered unacceptable as it puts the Canadian public at risk. The Radiation Emitting Devices Regulations (Sunlamps) are designed for old technology and less powerful equipment.

Revoking the Regulations in favor of either a voluntary standard or no Regulations is also considered unacceptable. While most tanning equipment manufactured in the world meets high standards, there may still be some existing tanning equipment that does not. In the absence of appropriate regulations, Canada could become a dumping market for tanning 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 Regulations. They update the mandatory standards to meet the more powerful equipment currently on the market, and also give tanning equipment users better information on the harmful effects of ultraviolet exposure. This consequently increases the safety of tanning equipment used by the public in Canada and lowers ultraviolet radiation overexposure which is linked to the development of skin cancer, the most common type of cancer in Canada.

There are no substantive costs as a result of the Regulations. Industry is required to affix the new warnings to tanning equipment at the time of sale, lease or importation. Health Canada will provide an electronic version of the new warning label at no charge to the industry. This imposes very low, if any, compliance costs to industry and similarly low costs to Health Canada for the development of this electronic file. Health Canada knows of four tanning equipment manufacturers in Canada, and approximately 90 tanning equipment distributors. There are two known lamp manufacturers and less than ten lamp distributors.

Consultation

In May 2002, CCRPB forwarded letters 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 who were mainly against any changes. Their main concerns were the new duration of exposure recommended by the manufacturers and the new warning signs. Health Canada received comments from one epidemiologist asking for more stringent standards. The tanning equipment manufacturers did not make any comments. Health Canada sent a letter in November 2002 in which all the concerns were answered and further explained that these limits were introduced to help each user make an informed decision.

Modifications to the proposed amendments made as a result of pre-publication on March 13, 2004 in the Canada Gazette, Part I:

• Paragraph 4(d): the maximum recommended dose per session is lowered to 625 Joules/m², as in the Radiation Emitting Devices Regulations (Sunlamps). This modification is made to address concerns from the manufacturers and from the tanning salon industry, that 800 Joules/m² was a too strong dose for any individual. It is noted that this is also the dose recommended in the United States of America. A statement is added to clarify that the exposure time is converted and expressed in minutes.
• Paragraph 4(f): rather than the manufacturer recommending a number of exposures per year using the calculation based on an annual dose of 15 kJ/m², the manufacturer must provide the total number of minutes that correspond to the annual dose recommended. This will allow individuals to choose how this annual number of minutes will be used, taking into consideration session duration corresponding to their skin sensitivity.
• Subparagraph 5(d)(i): the dimension of each warning label is reduced to 75 mm X 200 mm to better fit the space available on the tanning equipment.
• Section 6: advertising material for tanning equipment must have the warning label. The label may be in black and white and match the language of the advertisement material in French or in English.
• Section 7: the label required with each ultraviolet lamp may be on the lamp or in the form of a tag attached to the lamp. This is to address concerns expressed by manufacturers that some lamps are too small to bear any labelling on their surface.
• Section 16: the statement "recommended by the manufacturer" is added for clarification.
• Other editorial changes were also made.

Compliance and Enforcement

The regulatory amendments do not alter existing compliance mechanisms. Compliance monitoring and enforcement will continue to be undertaken by inspectors from the Healthy Environments and Consumer Safety Branch under the authority of the Radiation Emitting Devices Act and its Regulations.

Contact

Mrs. Pascale Reinhardt
Photobiologist
Lasers and Electro Optics Division
Health Canada
P.L. 6301B
775 Brookfield Road
Ottawa, Ontario
K1A 1C1
Telephone: (613) 946-0348
FAX: (613) 941-1734
E-mail: pascale_reinhardt@hc-sc.gc.ca

Footnote 1

C.R.C., c. 1370

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