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MEMO/10/37

Brussels, 12 February 2010

Questions and Answers

on safety of sunbeds

What was the objective of this joint action by Member States?

The main objective was to verify that new sunbeds and sunbeds offered for use in
services (e.g. tanning studios) are safe, especially with regard to the levels of UV
radiation, and the availability of instructions for safe use. It was also an opportunity
for surveillance authorities to highlight to suppliers and service providers their
obligations to ensure the safety of consumers using their products. This action, which
started in September 2008, was co-financed by the Commission under the
Consumer Policy Programme (2007-13).

Who participated?

Participants were market surveillance organisations from ten Member States;
Belgium, Cyprus, the Czech Republic, Denmark, Finland, Germany, Hungary, Latvia,
the Netherlands and Poland. The joint action was coordinated by PROSAFE, an
informal network of European market surveillance officials and was led by the
Netherlands. (See annex for list of authorities)

Why were these products and services chosen for investigation?

The reason for choosing sun beds as the subject of a cross border action was the
growing scientific consensus about the risk of cancer from UV radiation. This was
expressed in the opinion of the Scientific Committee on Consumer Products

on the

risks of artificial tanning, and led to a mandate to the standardisation bodies to adapt
the standard for sun beds to include maximum radiation levels.

What were the main conclusions of the report?

The overall conclusions from the results of the inspections in this first action on
sunbeds are as follows:

- Consumer guidance in tanning studios is not regularly given and, where it is

claimed to be given this is often not verifiable;

- The labelling of the sunbeds fails to comply in at least 20% of the cases;
- How often the maximum EWI

values for sunbeds are violated varies between

the Member States. In several Member States the percentage may be above
90%, while in others the percentage of sunbeds not complying is estimated to
be between 10%

‐ 20%.

SCCP: “Opinion on Biological effects of ultraviolet radiation relevant to health with

particular reference to sunbeds for cosmetic purposes.

http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_031b.pdf

The UV radiation emitted from the UV-tubes of a sunbed is measured as erythemally

weighted irradiation (EWI) and should not exceed 0,3 W/m2.

So, more work remains to be done?

Yes, twelve Member States

will now continue the work in a second joint project

which is being launched on 12 February 2010 and will run until December 2011. The
aim of phase two is to train more inspectors, undertake more measurements on
sunbeds and improve the information given to consumers about the possible risks of
sunbed use.

Which rules govern the safety of sunbeds and sunbed services?

With respect to the safety of sunbeds there is a combination of rules which are as
follows:

The European safety framework covering sunbeds is based on the Low Voltage
Directive (LVD)

and European Standard EN 60335-2-27

, Regulation 765/2008/EC

and the General Product Safety Directive

In accordance with the provisions of the Low Voltage Directive, products (when
placed on the EU market) shall be manufactured in accordance with good
engineering practice in safety matters. European harmonised standards (which are
voluntary), provide a presumption of conformity with the essential safety
requirements of LVD. Recently, EN 60335-2-27:2003, which is the European
standard applicable to sunbeds, was amended by the European standardisation
body Cenelec, following a mandate issued by the Commission. This amended
standard is applicable as of 1 April 2009 and imposes the limits for UV radiation (see
below).

Under the General Product Safety Directive (GPSD), market surveillance officers are
allowed to check the safety of sunbeds (according to the revised standard) used in
tanning studios for those sunbeds operated directly by the consumer. The GPSD
also allows Member States to take measures against products posing a serious risk
for the health and safety of consumers.

Furthermore, with the coming into force of Regulation 765/2008/EC on 1 January
2010, Member States must take measures against non-complying or dangerous
sunbeds, regardless of whether they are operated by consumers or by a
service provider.

Member States are also obliged to notify the Commission, via the

RAPEX

system

when they take measures against products found to be posing a serious risk to the
health and safety of consumers.

There are no EU level rules which govern the safety of sunbed services.

Belgium, Cyprus, the Czech Republic, Denmark, France, Germany, Hungary, Latvia,

Norway, Portugal, the Netherlands and the United Kingdom.

Directive 2006/95/EC, OJEU L374, 27.12.2006, p. 10

EN 60335-2-27: Household and similar electrical appliances – Safety Part 2-27: Particular

requirements for appliances for skin exposure to ultraviolet and infrared radiation

Regulation (EC) No 765/2008 setting out the requirements for accreditation and market

surveillance relating to the marketing of products, OJ L218, 13.8.2008, p.30.

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001

on general product safety OJ L 11, 15.1.2002, p. 4.

What constitutes best practice in relation to sunbed services?

Best practice in providing tanning services should: provide consumers with sufficient
information and advice about the tanning scheme suitable for their skin type; refuse
the use of sunbeds to under 18s and give clear information about the hazards of UV
radiation; hold intake interviews with new customers and ensure that the information
and advice provided is tailored to the specific consumer; insist on the use of eye
protection, and aim to register intakes and tanning programs for customers.

The

sunbeds must carry warnings and for consumer use the UV radiation emitted is
restricted to 0,3W/m2.

What are the UV radiation emission limits for sunbeds?

The limit for effective irradiance of 0.3 W/m2 (Watt per square metre) was
recommended by the Scientific Committee on Consumer Products (SCCP) in its

opinion

on the biological effects of ultraviolet radiation on health with particular

reference to sunbeds for cosmetic purposes. This limit was subsequently added to
the European standard relevant for sunbeds, EN 60335-2-27.

Who is responsible for the safety of these products and services?

Manufacturers and importers have primary responsibility for the safety of products
(including sunbeds) they place on the EU market. In addition, other economic
operators (e.g. distributors and retailers) also have specific responsibilities with
respect to the safety of sunbeds. Service providers are responsible for the safety of
products used in their services, so tanning salons must ensure that sunbeds are safe
and that they are used sensibly.

Has industry co-operated in this project?

At the European level the tanning industry is organised under the European
Sunlight Association (ESA), which is playing an important role in ensuring
operating standards in sunbed services. In regular consultations and with support of
the market surveillance officials of the sun bed joint action ESA actively promotes
fast adoption of the rules in the tanning sector, including the 0,3W/m2 limit on UV
radiation emitted from sunbeds. To support tanning services in complying with EU
legislation ESA is developing a European Code of Conduct for tanning services,
training materials for tanning studios and organises information seminars in
cooperation with national associations in the Member States.

What action can the Commission take in order to limit the
inappropriate use of sunbeds within the EU?

The Commission has already undertaken a number of actions in this regard.

It has noted the lack of limit values for exposure to UV radiation and consulted the
scientific Committee on Consumer Products (SCCP). In line with the SCCP’s
recommendations the relevant standard was revised on the basis of a mandate from
the Commission and is applicable since 2009. The new standard specifies the limits
for all relevant product types and UV radiations, as well as the instructions for use
and marking/labelling.

The Commission has co-financed the 2008-2009 joint project by ten Member States
under the Consumer Policy Programme (2007-13) and is co-financing a second joint
project starting in February 2010.

The Commission has also supported the Member States in their efforts to tackle
cancer by providing a framework for identifying and sharing information, capacity and
expertise in cancer prevention and control, and by engaging relevant stakeholders
across the European Union in a collective effort to address cancer. This is done
through the European Partnership for Action Against Cancer. Health promotion is
one of the key areas being taken forward by the Partnership. In addition, we provide
guidance to citizens through the European Code against Cancer

, which provides11

science based recommendations for reducing cancer risk.

Are the full health effects of UV radiation tanning devices known?

The Scientific Committee on Consumer Products (SCCP) has noted that ultraviolet
radiation (UVR) tanning devices were not in widespread use before the 1990s and
the full health effects of their use are not yet known. It will take several years before
the real picture of the role of UVR tanning devices in inducing skin cancer becomes
fully apparent. This is due to the long induction period of the cancer.

Furthermore, the SCCP is of the opinion that the use of UVR tanning devices to
achieve and maintain cosmetic tanning, whether by UVB and/or UVA radiation, is
likely to increase the risk of malignant melanoma of the skin and possibly ocular
melanoma.

People with known risk factors for skin cancer, especially malignant melanoma,
should be advised not to use UVR tanning devices. Specifically, these are:

-  skin phototypes I and II and the presence of freckles
-  atypical and/or multiple moles
-  family history of melanoma

Finally, the SCCP notes that the risk of melanoma seems to be particularly high
when using sunbeds at a young age. Thus UVR tanning devices should not be used
by individuals under the age of 18 years.

http://www.cancercode.org/code.htm

Annex

List of Market Surveillance Authorities involved in the project

(Names of participants can be found on page 3 of the joint project Report)

Belgium: Federal Public Service of Economy, SMEs, Independent Professions and
Energy, Gas-Electricity Division

Cyprus: Ministry of Communications and Works, Department of Electromechanical
Services

Czech Republic: Czech Trade Inspection

Denmark: Danish Safety Technology Authority

Finland: Radiation and Nuclear Safety Authority

Germany: Bavarian Ministry for the Environment, Public Health and Consumer
Protection

Hungary: Hungarian Trade Licensing Office

Latvia: Consumer Rights Protection Centre

The Netherlands: Dutch Food and Consumer Product Safety Authority

Poland: Chief Inspectorate of Trade Inspection

Prosafe - Product Safety Enforcement Forum of Europe.