Exemptions
ANNEX IVSupplementary provisions
ANNEX IV Exemptions 1. This Regulation shall not apply to light sources specifically tested and approved to operate: (a) in radiological and nuclear medicine installations, as defined in Article 3 of Council Directive 2009/71/Euratom ( 1 ) ; (b) for emergency use; (c) in or on military or civil defence establishments, equipment, ground vehicles, marine equipment or aircraft as set out in Member States' regulations or in documents issued by the European Defence Agency; (d) in or on motor vehicles, their trailers and systems, interchangeable towed equipment, components and separate technical units, as set out in Regulation (EC) No 661/2009 of the European Parliament and of the Council ( 2 ) , Regulation (EU) No 167/2013 of the European Parliament and of the Council ( 3 ) and Regulation (EU) No 168/2013 of the European Parliament and of the Council ( 4 ) ; (e) in or on non-road mobile machinery as set out in Regulation (EU) 2016/1628 of the European Parliament and of the Council ( 5 ) and in or on their trailers; (f) in or on interchangeable equipment as set out in Directive 2006/42/EC of the European Parliament and of the Council ( 6 ) intended to be towed or to be mounted and fully raised from the ground or that cannot articulate around a vertical axis when the vehicle to which it is attached is in use on a road by vehicles as set out in Regulation (EU) No 167/2013; (g) in or on civil aviation aircraft as set out in Commission Regulation (EU) No 748/2012 ( 7 ) ; (h) in railway vehicle lighting as set out in Directive 2008/57/EC of the European Parliament and of the Council ( 8 ) ; (i) in marine equipment as set out in Directive 2014/90/EU of the European Parliament and of the Council ( 9 ) ; (j) in medical devices as set out in Council Directive 93/42/EEC ( 10 ) or Regulation (EU) 2017/745 of the European Parliament and of the Council ( 11 ) and in vitro medical devices as set out in Directive 98/79/EC of the European Parliament and of the Council ( 12 ) . For the purpose of this point, ‘specifically tested and approved’ means that the light source: — has been specifically tested for the mentioned operating condition or application, according to the European legislation mentioned or related implementing measures, or relevant European or international standards or, in the absence of these, according to relevant Member States legislation; and — is accompanied by evidence, to be included in the technical documentation, in the form of a certificate, a type approval mark, a test report, that the product has been specifically approved for the mentioned operating condition or application; and — is placed on the market specifically for the mentioned operating condition or application, as evidenced at least by the technical documentation, and except for point (d), information on the packaging and any advertising or marketing materials. 2. In addition, this Regulation shall not apply to: (a) electronic displays (e.g. televisions, computer monitors, notebooks, tablets, mobile phones, e-readers, game consoles), including but not limited to displays within the scope of Commission Regulation (EU) 2019/2021 ( 13 ) and of Commission Regulation (EU) No 617/2013 ( 14 ) ; (b) light sources in range hoods within the scope of Commission Delegated Regulation (EU) No 65/2014 ( 15 ) ; (c) light sources in battery-operated products, including but not limited to e.g. torches, mobile phones with an integrated torch light, toys including light sources, desk lamps operating only on batteries, armband lamps for cyclists, solar-powered garden lamps; (d) light sources on bicycles and other non-motorised vehicles; (e) light sources for spectroscopy and photometric applications, such as for example UV-VIS spectroscopy, molecular spectroscopy, atomic absorption spectroscopy, nondispersive infrared (NDIR), fourier-transform infrared (FTIR), medical analysis, ellipsometry, layer thickness measurement, process monitoring or environmental monitoring. 3. Any light source within the scope of this Delegated Regulation shall be exempt from the requirements of this Regulation, with the exception of the requirements set out in point 4 of Annex V, if it is specifically designed and marketed for its intended use in at least one of the following applications: (a) signalling (including, but not limited to, road-, railway-, marine- or air traffic- signalling, traffic control or airfield lamps); (b) image capture and image projection (including, but not limited to, photocopying, printing (directly or in pre-processing), lithography, film and video projection, holography); (c) light sources with specific effective ultraviolet power > 2 mW/klm and intended for use in applications requiring high UV-content; (d) light sources with a peak radiation around 253,7 nm and intended for germicidal use (destruction of DNA); (e) light sources emitting 5 % or more of total radiation power of the range 250-800 nm in the range of 250-315 nm and/or 20 % or more of total radiation power of the range 250-800 nm in the range of 315-400 nm, and intended for disinfection or fly trapping; (f) light sources having the primary purpose to emit radiation around 185,1 nm and intended to be used for the generation of ozone; (g) light sources emitting 40 % or more of total radiation power of the range 250-800 nm in the range of 400-480 nm, and intended for coral zooxanthellae symbioses; (h) FL light sources emitting 80 % or more of total radiation power of the range 250-800 nm in the range of 250-400 nm, and intended for sun-tanning; (i) HID light sources emitting 40 % or more of total radiation power of the range 250-800 nm in the range of 250-400 nm, and intended for sun-tanning; (j) light sources with a photosynthetic efficacy > 1,2 μmol/J, and/or emitting 25 % or more of total radiation power of the range 250-800 nm in the range of 700-800 nm, and intended for use in horticulture; (k) LED or OLED light sources, complying with the definition of ‘original works of art’ as defined in Directive 2001/84/EC of the European Parliament and of the Council ( 16 ) , made by the artist him/herself in a limited number below 10 pieces. ( 1 ) Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations ( OJ L 172, 2.7.2009, p. 18 ). ( 2 ) Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor ( OJ L 200, 31.7.2009, p. 1 ). ( 3 ) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles ( OJ L 60, 2.3.2013, p. 1 ). ( 4 ) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles ( OJ L 60, 2.3.2013, p. 52 ). ( 5 ) Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC ( OJ L 252, 16.9.2016, p. 53 ). ( 6 ) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) ( OJ L 157, 9.6.2006, p. 24 ). ( 7 ) Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations ( OJ L 224, 21.8.2012, p. 1 ). ( 8 ) Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (Recast) ( OJ L 191, 18.7.2008, p. 1 ). ( 9 ) Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC ( OJ L 257, 28.8.2014, p. 146 ). ( 10 ) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( OJ L 169, 12.7.1993, p. 1 ). ( 11 ) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( OJ L 117, 5.5.2017, p. 1 ). ( 12 ) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( OJ L 331, 7.12.1998, p. 1 ). ( 13 ) Commission Regulation (EU) 2019/2021 of 1 October 2019 laying down ecodesign requirements for electronic displays pursuant to Directive 2009/125/EC of the European Parliament and of the Council, amending Commission Regulation (EC) No 1275/2008 and repealing Commission Regulation (EC) 642/2009 (see page 241 of this Official Journal). ( 14 ) Commission Regulation (EU) No 617/2013 of 26 June 2013 implementing Directive 2009/125/EC of the European Parliament and of the Council with regard to ecodesign requirements for computers and computer servers ( OJ L 175, 27.6.2013, p. 13 ). ( 15 ) Commission Delegated Regulation (EU) No 65/2014 of 1 October 2013 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to the energy labelling of domestic ovens and range hoods ( OJ L 29, 31.1.2014, p. 1 ). ( 16 ) Directive 2001/84/EC of the European Parliament and of the Council of 27 September 2001 on the resale right for the benefit of the author of an original work of art ( OJ L 272, 13.10.2001, p. 32 ).