The ultimate goal of regulatory agencies is to protect the consumer.
As the indoor tanning industry grows across Canada, local, state and federal
agencies are stretched to the limit in carrying out there primary objective
of protecting the consumer. It is the responsibility of indoor tanning
facilities to assure that mandatory regulations are being followed in
day-to-day operations.
The Radiation Emitting Devices Regulations (Tanning Equipment) set out
the technical requirements for modern tanning devices and their replacement
parts for sale, resale, importation or lease in Canada as follows:
The regulations apply only to equipment sold or resold after the amendments
came in to force. They are not retroactive.
RADIATION EMITTING DEVICES ACT
A summary of the federal Radiation Emitting Devices Act (RED Act) is
listed here for general information only. It is not legal text; for
complete detailed information, please contact the Consumer and Clinical
Radiation Protection Bureau at Health Canada.
Regulations
(Required in the Radiation Emitting Devices Act, section 13.)
13. (1) The Governor in Council may make regulations
(a) prescribing classes of radiation emitting devices for the
purposes of this Act;
(b) prescribing standards regulating the design, construction
and functioning of any prescribed class of radiation emitting devices
for the purpose of protecting persons against genetic or personal injury,
impairment of health or death from radiation;
(c) exempting any radiation emitting device or class of radiation
emitting device from the application of all or any of the provisions
of this Act or the regulations and prescribing the conditions of that
exemption;
(d) respecting the labeling, packaging and advertising of radiation
emitting devices, and the use of any material in the construction of
any radiation emitting device, for the purpose of protecting persons
against genetic or personal injury, impairment of health or death from
radiation;
(e) prescribing the information that must be shown on any label
or package and the manner in which that information must be shown;
(f) requiring persons who manufacture, sell, lease, import into
Canada or otherwise deal with any radiation emitting device to maintain
such books and records as the Governor in Council considers necessary
for the proper enforcement and administration of this Act and the regulations;
(g) prescribing the content of and the method of sending the
notification required by subsection 6(1);
(h) respecting the powers and duties of inspectors and analysts
and the seizure, taking away, detention, forfeiture and disposition
of radiation emitting devices; and
(i) generally, for carrying out the purposes and provisions of this
Act.
Sale, Lease and Importation Prohibitions
(Required in the Radiation Emitting Devices Act, section 4.)
4. Except as authorized by regulations made by the Governor in Council,
no person shall, sell lease or import into Canada a radiation emitting
device if the device
(a) does not comply with the standards, if any, prescribed under
paragraph 13(1)(b) and applicable thereto; or
(b) creates a risk to any person of genetic or personal injury,
impairment of health or death from radiation by reason of the fact that
it
(i) does not perform according to the performance characteristics claimed
for it,
(ii) does not accomplish its claimed purpose, or
(iii) emits radiation that is not necessary in order for it to accomplish
its claimed purpose.
Deception
(Described in the Radiation Emitting Devices Act, section 5.) 5. (1)
No person shall label, package or advertise a radiation emitting device
in a manner that is false, misleading or deceptive or is likely to create
an erroneous impression regarding its design, construction, performance,
intended use, character, value, composition, merit of safety.
Notification
(Described in the Radiation Emitting Devices Act, section 6.)
6. (1) Where a person who is the manufacturer or importer of
a radiation emitting device becomes aware, after the device has left
the person's premises, of the fact that the device
(a) does not comply with the standards, if any, prescribed under
paragraph 13(1)(b) and applicable thereto, or
(b) creates a risk to any person of genetic or personal injury,
impairment of health or death from radiation by reason of the fact that
it
(i) does not perform according to the performance characteristics claimed
for it,
(ii) does not accomplish its claimed purpose, or
(iii) emits radiation that is not necessary in order for it to accomplish
its claimed purpose, the person shall forthwith notify the Minister.
(2) Where the Minister determines,
(a) after being notified or
(b) through the Minister’s own investigation, research,
inspection or testing, that a radiation emitting device falls under
paragraph 6.(1)(a) or (b), the manufacturer or importer of the device
shall, if directed by the Minister, notify such persons as the Minister
requires of the defect or non – compliance, by such method, giving
such details and within such time period as are specified by the Minister
RADIATION EMITTING DEVICES REGULATIONS (TANNING EQUIPMENT) (published
in the Canada Gazette, Part II)
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
(i) detailed directions for determining the exposure positions,
(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, as calculated in seconds
using the formula
and converted into and expressed in minutes, 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 625 J/m2 per session,
is
the wavelength in nanometers,
is the
irradiance of the tanning equipment, measured at the minimum exposure
distance, and
is the
weighting factor determined in accordance with the erythema reference
action spectrum;
(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,
(i) in the upper portion, on a white background, the signal word "Danger"
in red with the hazard symbol to its right,
(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,
(i) in the upper portion, on a white background, the signal word "Danger"
in red with the hazard symbol to its right,
(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
(i) 75 mm high and 200 mm wide, in the case of tanning equipment used
for full- or half-body exposure, and
(ii) 50 mm high and 100 mm wide, in any other case; and
(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.
FEDERAL PROVINCIAL TERRITORIAL RADIATION PROTECTION COMMITTEE (FPTRPC)*
POSITION STATEMENT ON ULTRAVIOLET RADIATION
1. There is ample scientific evidence demonstrating that excessive
exposure to ultraviolet radiation (UVR), from sunlight or from artificial
sources, causes acute and chronic adverse health effects. The main organs
affected by UVR are the skin and the eyes. There is increasing evidence
indicating that UVR also acts as a systemic immuno- suppressor.
2. Exposure to solar and artificial ultraviolet radiation is widely
recognized as an important, and preventable, cause of skin cancer. There
is significant scientific evidence indicating that long- term exposure
to UVR also plays a role in the development of some types of cataract
and other eye and skin conditions.
3. The main source of ultraviolet radiation in the environment is the
sun. Artificial sources of UVR can be found in the work and recreation
environments. Sunlamps and sunbeds account for significant additional
UVR exposure of users.
4. The UVR dose to the population can be significantly decreased by
applying simple strategies and measures to reduce sun exposure. The
FPTRPC recommends that protective measures against excessive exposure
to solar and artificial ultraviolet radiation, such as those contained
in its overview document, be implemented by health, education, labour
and recreation authorities in all provinces and territories and adopted
by the general public.
5. The FPTRPC recommends that particular attention be given to the
reduction of UVR exposure among the following groups:
- Children. As much as 80 % of the lifetime UVR exposure takes place
before the age of 18 years.
- Sensitive people. People with lightly pigmented skin, hair and eyes
are at higher risk of developing skin cancer.
6. The FPTRPC recommends that tanning and the use of sunlamps and sunbeds,
particularly by minors, be discouraged. The FPTRPC further recommends
that provincial and territorial authorities evaluate the need for operator-
based regulation of tanning salons.
* The Federal Provincial Territorial Radiation Protection Committee
comprises a forum of delegates from each of the following government
organizations: Atomic Energy Control Board; Health Canada (Consumer
and Clinical Radiation Protection Bureau) and provincial and territorial
radiation protection programs. It was established to support federal,
provincial and territorial government radiation protection agencies
with their respective mandates in Canada. The mission of the committee
is to advance the development and harmonization of practices and standards
for radiation protection within federal, provincial and territorial
jurisdictions.