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Questions and Answers on safety of sunbeds
Commission Européenne - MEMO/10/37 12/02/2010
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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).
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 1 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:
So, more work remains to be done?
Yes, twelve Member States 3 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) 4 and European Standard EN 60335-2-27 5 , Regulation 765/2008/EC 6 and the General Product Safety Directive 7 .
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.
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 8 , 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:
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.
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. www.prosafe.org
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.
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.