Frequently Asked Questions on the Radiation Emitting Devices Regulations (Tanning Equipment)

Q1. Why were the Radiation Emitting Devices Regulations (Tanning Equipment) amended?

A1. The Radiation Emitting Devices Regulations (Sunlamps) were introduced in 1980 to protect sunlamp users from overexposure to ultraviolet radiation 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 and medical communities that ultraviolet radiation overexposure is linked to the development of skin cancer.

Q2. How does Health Canada define overexposure to ultraviolet radiation?

A2. Health Canada defines overexposure as any exposure to ultraviolet radiation that exceeds the amount needed for vitamin D production and could lead to skin or eye damage. Acute overexposure induces sunburn.

Q3. Why were the Sunlamp Regulations renamed Tanning Equipment Regulations?

A3. The Sunlamp Regulations were renamed Tanning Equipment Regulations to eliminate any confusion between the tanning equipment itself and the ultraviolet lamps or sunlamps used inside the equipment. "Tanning Equipment" therefore signifies all devices equipped with ultraviolet lamps and used for tanning.

Q4. Were consultations held in advance of the proposed amendments?

A4. Yes. In May 2002, the Consumer and Clinical Radiation Protection Bureau (CCRPB) circulated a letter with the proposed amendments to manufacturers, importers, tanning salon associations, and health authorities. Comments from interested parties were received, and the proposed amendments were revised taking into account the concerns and suggestions of the respondents.

The Radiation Emitting Devices Regulations (Tanning Equipment) was published in the Canada Gazette, Part I, on March 13, 2004. Following the publication, interested parties were given another opportunity to provide comments during a 75 days period. The proposed amendments were revised again taking some suggestions of the respondents into account.

Q5. What are the benefits foreseen from introducing these amendments?

A5. The regulations update the mandatory standards to address the new technology used in today's more powerful equipment.

They also give tanning equipment users better information on the harmful effects of ultraviolet exposure, so that they can make more informed decisions. This will consequently increase the safety of the equipment used by Canadians and help lower ultraviolet radiation exposure. Ultraviolet radiation overexposure, whatever the source is, is linked to the development of skin cancer, the most common type of cancer in Canada.

The amendments introduce a simple way to calculate the exposure times as well.

Q6. When will the amended regulations become law?

A6. The amended regulations are effective upon publication in the Canada Gazette Part II. The new regulations are not retroactive. They apply to tanning devices and their replacement parts, sold, resold, leased in or imported into Canada after the date of promulgation.

Q7. How will the amended regulations be enforced?

A7. Health Canada inspectors will continue to monitor and enforce compliance with the new regulations under the authority of the Radiation Emitting Devices Act. This means that, if Health Canada receives complaints that a tanning device does not meet the regulatory requirements, the Department will dispatch Product Safety technical inspectors to inspect the device in question. If the device is found to be non-compliant, the inspector will work with the manufacturer to get the problem fixed.

Q8. Are there any costs associated with these amendments?

A8. There are no substantive costs as a result of the proposed regulations. 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 industry and similarly low costs to the government to develop this electronic file.

Q9. What would have happened if we had kept the 1980 regulations?

A9. Maintaining the status quo puts Canadians at risk of overexposure to ultraviolet radiation, which is linked to skin cancer. Canadians would be using equipment that only has to comply to standards originally designed for older technology and less powerful equipment.

Q10. Will Health Canada also update its Guidelines for Tanning Salon Owners, Operators, and Users?

A10. Yes, Health Canada will update its "Guidelines for Tanning Salon Owners, Operators and Users" after the new regulations come into effect.

Q11. If tanning is not safe, why doesn't HC ban tanning equipment?

A11. Banning tanning equipment is not appropriate at this time because it is not scientifically justified. Yet, Health Canada remains committed to maintaining proper regulation and to informing Canadians of the harmful health effects of ultraviolet (UV) exposure and to assist them in making more informed decisions when using tanning equipment.

It must be noted that the vast majority of individuals who use tanning salons also expose themselves to natural ultraviolet radiation from the sun. The negative effects of UV on health cannot be specifically linked to one source or the other, but the combination of both type of exposure can lead to skin damage and promote skin cancer. The risk of developing health problems is increased for individuals with more sensitive skin types and for those who have accumulated a high dose of UV radiation during their lifetime. Reducing exposure to both sun and tanning equipment UV radiation contributes to a lowering of an individual's risk of developing skin cancer.

Q12. You say tanning is not safe, and yet doesn't the body get a healthy dose of Vitamin D through tanning?

A12. Two kinds of Ultraviolet (UV) rays can cause tanning: UVA and UVB. It is the UVB part of the spectrum that is responsible for Vitamin D production.

The type of UV radiation emitted by current tanning equipment is mostly UVA with only a small amount of UVB radiation. It is also worth noting that tanning equipment generates about five times the amount of UVA produced by the sun. This may adversely affect an individual's immune system.

According to Vitamin D experts, exposure to sunlight around noon, for ten to fifteen minutes, two or three times a week between the months of May to October provides enough Vitamin D to the body. This period of exposure time represents about one third of the amount of time needed for tanning.

The vitamin D accumulated during the summer months, combined with a healthy diet, is usually sufficient to last through the winter months for individuals with fair skin without additional exposure to UV radiation. People with darker skin will need more exposure time to get the same effect. Please consult your physician if you wish to seek professional advice.

Technical Questions and Answers

Amendment 1.

The devices covered in the amended regulations, Part XI, should be called "Tanning Equipment" instead of "Sunlamps" to avoid any confusion between the actual tanning device and the ultraviolet lamps emitting the radiation that are part of the device.

Q13. Define what is meant by "tanning equipment" in the amended regulations:

A13. "tanning equipment" (appareils de bronzage) means a device that

1. can be equipped with one or more ultraviolet lamps; and
   
   
2. induces skin tanning or other cosmetic effects and is advertised as inducing such effects.

It does not include any such device that is advertised for use or used in the production of therapeutic effects for medical purposes.

Amendment 2.

Definitions of "exposure schedule" and "spectral transmittance" are added to the "Interpretation" Section of Part XI. These proposed new definitions are:

"exposure schedule" means a program of exposure recommended by the manufacturer that takes into account exposure times, intervals between exposures and the degree of sensitivity for each skin type. (programme d'exposition)

"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)

Q14. Why is Health Canada adding these two definitions?

A14. These definitions were added to bring a better understanding to the regulations.

Amendment 3.

A new approach to calculate exposure times is defined in the proposed regulations. It takes into account a recommended maximum dose of 100 joules per square metre for the first time exposure, weighted with the CIE Erythemal Action Spectrum curve, raising progressively to a maximum dose of 625 joules per square metre for any subsequent exposure weighted with the same curve. This amendment appears in the regulations as follow:

The recommended exposure time in seconds, as calculated using the formula:
X / ∑ ( V_λ R_λ)

where:

X is a dose not greater than 100 J/m² for the first session for untanned skin that could progressively increase to a maximum dose of 625 J/m² for the following sessions,

λ is the wavelength in nanometers,

V is the weighting factor determined in accordance with the erythema reference action spectrum; and

R is the irradiance of the tanning equipment, measured at the minimum exposure distance.

Q15. Why was it decided to use the exact value of 100 joules per square metre (J/m²) to describe the first exposure instead of half a minimal erythemal dose (MED) or standard erythemal dose (SED)?

A15. CCRPB has decided to use exact numbers to avoid any possible confusion between Canada's two official languages. MED and SED are two abbreviations used in English that do not correspond to anything in French. The value of 100 J/m²; is effectively half an MED (200 J/m²;), a number which has been adopted by the International Electrotechnical Committee (IEC) and the Commission Internationale de l'Éclairage (CIE).

Q16. How can the exposure dose jump from 100 J/m² to 625 J/m² from the first to the second exposure?

A16 To better clarify the intention of this proposed approach, it is suggested that, after a first exposure of not more than 100 J/m², a non-tanned individual may gradually expose himself to higher doses. The highest dose may never exceed 625 J/m². This should allow the maintenance of the desired tan. This regimen approximates the recommended exposure schedule that is presently enforced by the Food and Drug Administration (FDA) in the US.

For guidance on how long your tanning session should be, get a copy of Health Canada's Guidelines for Tanning Salon Owners, Operators and Users and read it carefully.

Q17. Why does Health Canada not use the erythema action spectrum modified by the FDA?

A17. Health Canada has decided to use the internationally accepted Erythema Reference Action Spectrum (EAS) defined by CIE and used by IEC. This spectrum is only marginally different from the EAS modified by FDA. Current indications are that FDA are going to use the CIE spectrum in the near future.

It should be obvious that this new approach was proposed to help the user avoid unnecessary exposure.

Amendment 4

A maximum recommended yearly dose is added to the regulation and it reads as follow: "A 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."

Q18. Why has Health Canada decided to introduce a maximum recommended annual dose in the proposed amendments?

A18. The maximum recommended yearly dose of 15 kJ/m² (weighted according to the EAS) instead of 25 kJ/m² (weighted according to the NMSC) is going to apply when the manufacturer calculates the exposure schedule. The manufacturer can then recommend a maximum number of minutes per year allowing clients to make an informed decision regarding the discretionary use of this device. This requirement will be part of the label information on the equipment at the moment of sale or resale.

Health Canada will also update its "Guidelines for Tanning Salon Owners, Operators and Users" to reflect this suggested annual limit. As a reminder, the Radiation Emitting Devices Regulations (Tanning Equipment) only apply to equipment used for tanning, not for therapeutic use.

Health Canada has received many comments questioning the use of the NMSC action spectrum. It has subsequently been decided to abandon this approach that is based on an animal model. The only spectrum used in the amended regulations will be the Erythema Reference Action Spectrum (EAS) from CIE.

Amendment 5.

A statement is added to the regulations that says: "Every ultraviolet lamp must have a label that sets out:

1. its model designation; and
   
   
2. 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."

This requirement has been changed to give the opportunity to lamp manufacturer to use a tag or a label attached to the lamp to meet the bilingualism requirement for lamp labelling.

Q19 Why use the word "Danger" on ultraviolet lamp signs? Why impose a bilingual warning?

A19. The word "Danger" is already used in the current regulations to make people aware that unprotected exposure or over-exposure to ultraviolet radiation causes immediate severe skin and eye burns ( REDA , Schedule I, Part XI, Paragraph 2, subparagraph 9, subsection (a)). CCRPB has not proposed any new changes in the required lamp markings. The only change is in the wording, the requirements will remain exactly the same as in the current regulations. If we compare with FDA requirements for ultraviolet lamps and their packaging, the only difference is that, here in Canada, lamp labelling must be bilingual. This requirement was already part of the previous regulations.

Amendment 6

A statement is added to the regulations that says: "Every piece of tanning equipment must have a physical barrier between the ultraviolet lamps and the user."

Q20. Why not specify plexiglass for the material used for the barrier between the lamps and the user?

A20. The material used for the physical barrier in sunbeds is specified.

This amendment has been requested by the industry for a long time. Introduction of this concept is necessary to protect the user against electrical shocks or other types of accidents.

Amendment 7

There are some changes in the requirements for tanning equipment advertisement. They read as follow:

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,
   
   
   1. 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
      
      
   2. 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)

Q21. What will it cost to change the present warning labels to be affixed to the tanning equipment and what costs will be involved in advertising material for the coloured labels proposed in the amendments?

A21. The new warning labels are going to be required only at the time the new regulations are promulgated. They do not apply to advertising material already printed and used before that date. CCRPB is providing an electronic file with the warning signs so that the only cost to manufacturer will be printing costs.

Amendment 8

A statement is added to the regulation that says: "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."

Q22. How can we get replacement lamps that will make the time of exposure recommended by the manufacturer of a tanning device remain in an area of ± 10 % of the time recommended with the original lamps? Is there any list available in Canada for these replacement lamps?

A22. The ±10 % requirement for replacement lamps is already a policy used in the United States and the manufacturers are able to supply a list of equivalent lamps. CCRPB is aware that CIE, as well as some other organisations, are actively working on a coding system. This new lamp coding should simplify lamp replacement in the future.

Amendment 9

A statement is added to the regulations that says:

"Protective eyewear must have a spectral transmittance that is:

1. not more than 0.001 over the wavelength range from 200 nm to 320 nm;
2. not more than 0.01 over the wavelength range from 320 nm to 400 nm; and
3. sufficient over wavelengths greater than 400 nm to enable the user to read the labels and use the control button specified in paragraph 9(a)".

Q23. Why do the new regulations change the transmittance values of the protective eyewear?

A23. Transmittance values have been changed to improve protective eyewear safety.

Amendment 10

The ultraviolet radiation warning labels must

1. be reproduced from the electronic file provided by the Minister;
   
   
2. include in the French version of the label, enclosed within a black border, the signal word "DANGER" in red, to its right the hazard symbol illustrated in paragraph (e), and the primary hazard statement "RAYONNEMENTS ULTRAVIOLETS" in yellow on a black background, with 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";
   
   
3. include in the English version of the label, enclosed within a black border, the signal word"DANGER" in red, to its right the hazard symbol illustrated in paragraph (e), and the primary hazard statement "ULTRAVIOLET RADIATION" in yellow on a black background, with 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.";
   
   
4. measure
   1. 75 mm high and 200 mm wide, in the case of tanning equipment used for full- or half-body exposure, and
   2. 50 mm high and 100 mm wide, in any other case; and
      
      
5. conform to the following diagrams:
   Top of Page

Q24. Why use the hexagonal shape with the word "Danger" for the warning sign? Where does it come from?

A24. The stop sign with an irradiated human silhouette inside is a Workplace Hazardous Materials Information System (WHMIS) symbol and corresponds to a sign already used under the REDA to indicate that there is an immediate acute danger. In the case of this device, the danger is severe eye and skin burns or severe photoreactions from drugs or other products present on skin.

Q25. Why is the newly proposed warning sign different from the one proposed by the IEC and that of the FDA?

A25. The warning sign contains essentially the same information as that proposed by IEC and FDA, but is more eye catching. This is the way CCRPB has chosen to pass on to the Canadian population a message that should make people more aware of the consequences of exposing themselves to UV radiation for cosmetic purposes.

Q26. Would the Sunlamp Regulations be amended even if there was a certification program for operators implemented by the provincial and territorial governments?

A26. Yes, the federal regulations had to be updated. The regulations dated from 1980 did not reflect today's tanning equipment market. Technology and scientific knowledge on tanning effects have evolved. Standards had to be revised to meet the new equipment designs and ensure safer operation of tanning devices. Even if the provincial and territorial governments decide to implement a regulation under their jurisdiction that would oblige certification of tanning equipment operators, it would not affect the necessity of amendments to the federal legislation.

Q27. What is overexposure? What is underexposure?

A27. Health Canada considers overexposure to be any exposure to ultraviolet radiation that will lead to skin damage and trigger a reaction of the skin. Acute overexposure causes sunburn. Chronic overexposure may be avoided if the recommended annual limit of 15 kJ/m²; (EAS weighted) to the user is respected.

An underexposure is not easily defined, but, generally speaking, it could occur if an individual is not exposed to enough UVB to meet his or her body's need in Vitamin D.

According to several scientific references, sub-erythemal doses of UVB generate sufficient levels of vitamin D to stay healthy. Walking outside three times a week for 15 minutes and getting the face exposed to sunlight appears to be enough to stimulate a normal blood level of vitamin D. In addition to getting short periods of sunlight, a good diet, including milk and fish, should be sufficient for normal vitamin D levels.

There could be some deficiency in elderly people who remain indoors most of the time, but they should have vitamin D supplements prescribed by their physician, if needed.

Q28. Why does Health Canada not support the use of UV radiation from a tanning device to ensure vitamin D production?

A28. Health Canada doesn't believe that there is sufficient data to support the contention that one has to expose oneself to UV radiation in a tanning salon to get sufficient levels of vitamin D.

The scientific community corroborates the fact that one does not have to expose oneself to extra UVB to get sufficient levels of vitamin D. To be considered deficient, the level of vitamin D has to be under 25 nanomoles/litre (nmol). Exposure to sub-erythemal doses of UVB during the summer months should be sufficient to get through the worst period of winter when the amount of UVB from the sun to produce vitamin D is not abundant.

Q29. What is Health Canada's position on UV exposure for cosmetic purposes?

A29. For at least 20 years, Health Canada has advised Canadians to protect themselves from UV radiation overexposure through a well-implemented education program. A tan is a reaction of the skin against an assault from UV and implies damage to DNA. Of course, the damage can be repaired by some repair mechanisms inside the cell. However, the repair could be imperfect if the system is continually stimulated and overused. This may contribute to the incidence of mutations that might later lead to the development of skin cancer.

Whatever the origin of the ultraviolet radiation, be it via the sun or tanning lamps, if the spectra of the sources are comparable, the effects are the same. For this reason Health Canada recommends a limit to exposure.

Q30. Who is going to test the equipment and suggest the exposure schedule?

A30. Manufacturers of tanning equipment should already be equipped to measure the output spectral of the devices they are selling. They are responsible for recommending exposure times and schedules according to the different levels of sensitivity found in various skin types. As a requirement of tanning regulations, this material will be part of the information that has to be affixed on the tanning device.

Q31. Do you know what the cost of implementing these amendments will be to the industry?

A31. As required by Canadian law, the impact of the proposed regulations and the cost of their implementation on those affected was assessed as part of the regulatory process. The departmental evaluation concludes that the industry would be required to change the warning sign on the product, a design which is available as an electronic file from Health Canada. The compliance cost will be minimal to the industry.

The regulations are not applied retroactively. Therefore, any labelling or action imposed by the amendments are for new equipment or equipment already on the market being resold, leased in or imported into Canada.