1 2 3 4 5 Scientific Committee on Emerging and Newly Identified Health Risks 6 7 SCENIHR 8 9 Preliminary Opinion on 10 11 Biological effects of ultraviolet radiation relevant to health with 12 particular reference to sunbeds for cosmetic purposes 13 14 15 16 17 18 19 20 21 22 23 24 25 26 The SCENIHR approved this Opinion for public consultation at their plenary on 27 3 December 2015 28 29 1 About the Scientific Committees 2 Three independent non-food Scientific Committees provide the Commission with the 3 scientific advice it needs when preparing policy and proposals relating to consumer 4 safety, public health and the environment. The Committees also draw the Commission's 5 attention to the new or emerging problems, which may pose an actual or potential 6 threat. 7 They are: the Scientific Committee on Consumer Safety (SCCS), the Scientific 8 Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on 9 Emerging and Newly Identified Health Risks (SCENIHR) and are made up of external 10 experts. 11 In addition, the Commission relies upon the work of the European Food Safety Authority 12 (EFSA), the European Medicines Agency (EMA), the European Centre for Disease 13 prevention and Control (ECDC) and the European Chemicals Agency (ECHA). 14 SCENIHR 15 This Committee deals with questions related to emerging or newly identified health and 16 environmental risks and on broad, complex or multidisciplinary issues requiring a 17 comprehensive assessment of risks to consumer safety or public health and related 18 issues not covered by other Community risk assessment bodies. Examples of potential 19 areas of activity include potential risks associated with interaction of risk factors, 20 synergic effects, cumulative effects, antimicrobial resistance, new technologies such as 21 nanotechnologies, medical devices including those incorporating substances of animal 22 and/or human origin, tissue engineering, blood products, fertility reduction, cancer of 23 endocrine organs, physical hazards such as noise and electromagnetic fields (from 24 mobile phones, transmitters and electronically controlled home environments), and 25 methodologies for assessing new risks. It may also be invited to address risks related to 26 public health determinants and non-transmissible diseases. 27 Scientific Committee members 28 Michelle Epstein, Igor Emri, Philippe Hartemann, Peter Hoet, Norbert Leitgeb, Luis 29 Martínez Martínez, Ana Proykova, Luigi Rizzo, Eduardo Rodriguez-Farré, Lesley Rushton, 30 Konrad Rydzynski, Theodoros Samaras, Emanuela Testai, Theo Vermeire 31 Contact: 32 European Commission 33 DG Health and Food Safety 34 Directorate C Public Health 35 Unit C2 – "Health Information and Scientific Committees" 36 Office: HTC 03/073 L-2920 Luxembourg 37 [email protected] 38 © European Union, 2016 39 ISSN 1831- ISBN 978-92-79- 40 doi:10.2772/ ND 41 The Opinions of the Scientific Committees present the views of the independent 42 scientists who are members of the committees. They do not necessarily reflect the views 43 of the European Commission. The Opinions are published by the European Commission 44 in their original language only. 45 http://ec.europa.eu/health/scientific_committees/policy/index_en.htm 2 1 ACKNOWLEDGMENTS 2 3 Members of the Working Group are acknowledged for their valuable contribution to this 4 Opinion. The members of the Working Group are: 5 6 SCENIHR 7 Philippe Hartemann 8 Ana Proykova (Rapporteur) 9 Norbert Leitgeb 10 Lesley Rushton (Chair) 11 Theodoros Samaras 12 13 SCHER 14 Claire Beausoleil 15 Greet Schoeters 16 17 SCCS 18 Pieter Jan Coenraads 19 20 External experts: 21 Rüdiger Greinert 22 Jean-Francois Dore (Rapporteur) 23 24 The additional contribution of the following experts is gratefully acknowledged: 25 Prof Colette Brogniez (Université de Lille-1, France) for communicating calculation of 26 exposure times necessary to synthesize Vitamin D. 27 Marie-Christine Chignol (Inserm, Lyon) for help in literature search. 28 29 30 31 All Declarations of Working Group members and supporting experts are available at the 32 following webpage: 33 http://ec.europa.eu/health/scientific_committees/emerging/members_wg/index_en.htm 34 35 36 37 38 39 40 41 42 3 1 ABSTRACT 2 Introduction 3 In 2006, the Scientific Committee on Consumer Products provided an Opinion on the 4 biological effects of ultraviolet radiation (UVR) from sunbeds and stated that the use of 5 UVR devices for cosmetic tanning was likely to increase the risk of malignant melanoma 6 of the skin and possibly ocular melanoma. In 2009 the International Agency for Research 7 on Cancer (IARC) reviewed all the evidence pertaining to the carcinogenic effects of UVR 8 from sunbeds, and classified use of UV-emitting devices for tanning as carcinogenic to 9 humans (Group 1). The European Commission therefore requested the SCENIHR to 10 review recent evidence in order to improve the understanding of risks associated with 11 UVR in general and with sunbeds in particular and provide an updated Opinion. 12 Legal background 13 In the EU, placing sunbeds on the market with an input voltage between 50 and 1000 14 volts for alternating current or between 75 and 1500 volts for direct current is regulated 15 by the Low Voltage Directive (LVD) (Directive 2006/95/EC)1. This directive requires that 16 only safe products are placed on the market and covers all risks, not just the electrical 17 safety aspects. 18 The General Product Safety Directive (Directive 2001/95/EC)2 (GPSD), which requires 19 that products to provide a reasonably expected level of safety throughout the lifetime of 20 the product and contains specific obligations for producers, distributors and national 21 authorities, is applicable to sunbeds used by consumers, including in the context of a 22 service, in so far as the LVD does not already contain specific provisions governing the 23 same aspects with the same objectives. This is without prejudice of any other EU 24 applicable legislation. 25 The voluntary harmonised standard EN 60335-2-27:2013 sets out requirements for the 26 safety of sunbeds, including limits for ultraviolet radiation emission. If this standard is 27 applied, it provides a presumption of conformity with the safety objectives of Directive 28 2006/95/EC with respect to the risks covered by the standard. 29 In recent years some Member States have adopted national legislation regulating the 30 tanning services (including, for example, a ban below the age limit of 18 years, the need 31 for properly trained staff, etc.). These measures, when properly enforced, should ensure 32 that tanning studios provide a better level of protection to consumers who use these 33 devices. 34 Exposure 35 It is currently estimated that UV emission of a modern tanning appliance corresponds to 36 an UV index of 12, i.e. equivalent to midday tropical sun. There are large variations in 37 the UV output of different machines, and the UV spectrum emitted by devices used for 38 tanning has evolved in recent years towards higher UVA irradiance. 1 Directive 2006/95/EC on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits, OJ L 374, 27.12.2006, p. 10. As of 20 April 2016, it will be replaced by Directive 2014/35/EU (OJ L 96, 29.03.2014, p. 357). 2 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on General Product Safety, OJ No L 11 of 15 January 2002. 4 1 The prevalence of sunbed use for tanning purpose varies greatly from one country to 2 another and according to sex and age: it is higher in white-skinned populations from 3 Northern Europe, and in young or middle-aged women. A recent meta-analysis of data 4 from 16 Western countries (406,696 participants) showed that the overall summary 5 prevalence of ever exposure to indoor tanning was as high as 35.7% (42% N and W 6 Europe) for adults, 55.0% for university students (US studies only), and 19.3% for 7 adolescents (24% for N and W Europe). The summary prevalence of last year exposure 8 was 14.0%, 43.1% for university students, and 18.3% for adolescents, higher among 9 women. An increase in prevalence of sunbed use over time was noted; the most recent 10 estimates (2007-2012) of use in the last-year exposure to indoor tanning gave last-year 11 prevalence of 18.2% in adults, 45.2% in university students (US studies only), and 12 22.0% adolescents. These are absolute increases of 3.4% in adults, 2.1% in university 13 students (US studies only), and 1.7% in adolescents from the results of the primary 14 analyses. 15 Health effects: Non-cancer health effects 16 UV radiation has both a local (i.e. in the skin) and a systemic immunosuppressive effect. 17 There is evidence that UVB emitted from sunbeds can induce vitamin D production, but 18 excess exposure leads to photodegradation of pre-vitamin D3 in the skin. There is 19 widespread consensus that it is not necessary to use sunbeds to enhance vitamin D 20 levels even in winter. Usual exposure of face and hands to UVR from the sun (even on 21 cloudy days) and common diet are sufficient to achieve a sufficient vitamin D level. If 22 needed, dietary supplements for vitamin D are available. 23 UVB-induced immunosuppression is well established, but there is now evidence for an 24 immune suppressive effect also by UVA in the wavelength range from 350 – 390 nm. 25 Exposure to UVA as well as to UVB enhances photoaging of the skin. 26 Health effects: Melanoma, Non-melanoma skin cancer, other cancers 27 There is consistent evidence from meta-analyses, case-control studies and cohort studies 28 of a statistically significantly increased risk from cutaneous melanoma associated with 29 sunbed use, with a dose-response proportional to the number of sessions and frequency 30 of use.