Directive 2013/35/EU
Contents
1.2. 9 3 3 4 5 4 ALs
3. AL ELV eta
4. a b c 10 3 5 1 MRD ELVs i 4 ELVs ii iti ELVs iv
5. gt 7 89 391 EEC 9 1 a ATOR 5 8
6. e O g 8 E ii i k 6 n 1H
7. 29 6 2013 EN Official Journal of the European Union L179 25 f lt 50Hz 5 0X 10 f 2 0 X 104 50HzSf lt 1 64kHz 5 0X 10 f 1 0X10 f 1 64 f lt 3kHz 5 0X 105 f 6 1X102 3kHz f 10MHz 1 7X 102 6 1X 102 B1 1 f Az B1 2 ALs E ALs E RMS Y 2 4 14 B1 3 ALs
8. 17 ICNIRP ER RE ALs Se RT S HEME amp KIN BAR ICE NBEO MEIC 290 JA E 3 2003 7 H 22 O
9. 4 E FRIZ ALs 2 FE E I Ze 1 1 89 391 EEC 16 1 20 E TOs 2 E 3 ELVs
10. 89 391 EEC 7 11 ES RES LOREM W 5 89 391 EEC 6 3 f b ELVs ALs a 3 ELVs 2 E O d
11. ALs ALs AL s ELV s BAL s ELV s ALs 40OHz ELV s 400Hz ELV s ALs i s 4 0 OHz AL s 10 kV m 20kV m ALs ICNIRP 6 000uT 6OHz 1 0004 FS 000 4T jGIC 1 Exposure Limit Values ELVs for external magnetic flux density B0 from 0 to 1 Hz ELVs below 1 Hz are limits for static magnetic field which is not affected by the tissue of the body Sensory effects ELVs Normal working conditions Zi Localized limbs exposure 8T Health effects ELVs Controlled working conditions 8T ma re 2 Sensory effects Exposure Limit Values ELVs for internal electric field strength fr
12. i ELVs i ELVs H A2 ii ELVs FEEL K A2 HM X Al K A i 5 ii 5 4 TL B3 iii 6 iv 6 b ALs B2 PIE 4 ELVs BEI K A3 1 89 391 EEC
13. e g h i 4 5 3 7 89 391 EEC 11 EME 8 1 89 391 EEC 14
14. Vm D in situ H IL 10MHz 110MHz ERIZE PELE ARO A tcCo 4 Q H
15. AF Am CHT BI T H 1Am B 40107T 1 25 Wm W SA Okg
16. SN EP St 13 12 29 6 2013 IEN Official Journal of the European Union L179 14 2016 4 1 6 R
17. AL i ALs ALs Gi ALs ELVs ALs ELVs 2 Ye 3 Il RREELT7TZ Yayva
18. 29 6 2013 IEN Official Journal of the European Union L 179 a b 6 3 3 a 6 c d
19. A lt REHBER LO ELVs 4 ELVs 14 cm ALs ALs B2 400Hz ELVs K A3 400Hz ELVs A2 ALs B2 ELVs 3 w i JRD RCT ALs EL A2
20. O 3 ELVs lt 1 4 FE E 4 1 2 3 1
21. 4 3 ELVs ce ELVs ELVs 1 ie 29 6 2013 IEN Official Journal of the European Union L 179 a ALs MBB RB KEL BREE b ELVs TEEI K A3 ELVs A2 BBW AB
22. 153 BIST RMS ONTO Raid RS 4 2004 40 EC 5 2004 40 EC 200846 EC 4 2012711 EU 2013 4 10 31 TH
23. 2004 40 EC 3 2004 4 29 2004 40 EC 897391 EEC 16 1 18 O C43 2012 2 15 P47 L159 2004 4 30 P1 2013 6 11
24. TI a 1992 6 24 92 58 EEC 89 391 EEC 16 1 b 9 6 89 391 EEC 10
25. BED ELVs Al A3 S0Wmr 20 6 10GHz 6 10GHz 68 f19 f tk GHz ALs ELVs 5 SAR B1 100kHz 300GHz ALs ALs E ALs B ALs S Vm RMS uT RMS Wm 100kHz f lt 1MHz 6 1 X102 2 0X 105 f 1 f lt 10MHz 6 1 X 108 f 2 0 X 106 f 10 lt f lt 400MHz 61 0 2 400MHz f lt 2GHz 3X 103f 1 0 105f 2 f lt 6GHz 1 4X 102 4 5X 10 6 f 300GHz 1 4X 102 45X10 50 B1 1 f
26. ICNIRP I lt seal BRIG ELVs ELVs exposure limit values lt ELVs ELVs ELVs ELVs ELV s ELVs ELVs IE mm re SASH WRIA ZCI ALs ALs action levels ALS ELVs
27. 11 edad inten eno 4 5 11 1 2 2 E 1 Ay 2 E 2
28. ELVs 6 f 300GHz 50Wm YE A3 1 20cmz 1cm2 16 29 6 2013 EN Official Journal of the European Union L179 B ALs E ALs E B1 B ALs B B1 E BI OFT BREICBAS A ALs S B1 ALs Ic B2 ALs B2 gt ALs ALs E ALs B
29. 2 17 1 2004 40 BC 2013 6 29 2 V 18 2013 6 26 M Schulz A Shatter 29 6 2013 EN Official Journal of the European Union L179 I E
30. a ELVs b O d SMEs e O 10 Q a MRI g 100kHz 10MHz
31. A ELVs 1Hz ELVs A1 1Hz 10MHz ELVs A2 0 1Hz ELVs ELVs ELVs RAI K 4 ELVs K Al A1 0 1Hz
32. v 1993 6 14 93 42 7BEC ay EU I L169 1993 7 12 A Pl mM E 29 6 2013 EN Official Journal of the European Union L179 b
33. Mire DRC A eV ZR ELV HA 1 ELVs C369 2011 4 E12 17 14 BA te E x RAY ILD
34. 14 1 EE A BION 1Hz 400Hz ELVs 12 29 6 2013 EN Official Journal of the European Union L179 ELVs A3 A3 1 400Hz ELVs ELVs 1 lt f lt 10Hz 0 7 fVm 10 f 23Hz 0 07Vm 25 f 400Hz 0 0028fVm awe SM ML TY KIER BROWSE 14 gt A3 3 ELVs 3 A3 1 f Az A3 2
35. B ALsE ALs E ALs Ic B3 ALs Bo B4 ALs ALs ALs B1 ELVs A2 A3 ALs ELVs K A2 A3 5 6 K BI 1Hz 10MHz OBR lt RCT A ALs ALsE Vml RMS ALs E Vm RMS 1Sf lt 25Hz 2 0 X 10 2 0 X 104 13
36. 4 1 By K AY E NATO D ERDF RIC AA E E
37. 4 L114 2008 4 26 P88 KR 2013 6 20 L110 2012 4 24 P1 7 8 9 10 a1 12 29 6 2013 IEN Official Journal of the European Union L 179
38. 4 E ym 15 5 6 Aa 89 391 EEC 1
39. cm B1 4 20cmz 1cm 50Wm 20 6 10GHz 6 10GHz Az 68 f 9 f GHz B2 ALs ee ALs dc mA RMS ALs TL mA RMS 100kHz f 10MHz 40 10 f 110MHz 40 100 YE B2 1 ALs Ir 6 18 29 6 2013 EN Official Journ
40. KOE 1989 11 30 89 656 EEC 4 1 89 391 EEC 16 1 3 e Ke f 7 3 g h 2 lt ROMS L OGRE DHIE O 8
41. wee B2 3 lt RAE IC ALs ALs B 4 1 14 FRR Ff ELVs 14 F RMS 4 29 6 2013 IEN Official Journal of the European Union
42. ALs 400Hz ALs 5 6 ELVs CBE ELVs B2 1Hz 10MHz ALs WERE BE DAK ALs B ALs B uT RMS uT RMS ALs uT RMS 1 f 8Hz 2 0 105 f2 3 0 105 f 9 0 X 105 f 8 lt f lt 25Hz 2 5 X 104 f 3 0 X 105 f 9 0 X 105 f 25 lt f lt 300Hz 1 0X 103 3 0X 105 f 9 0X 105 f 300Hz lt f lt 3kHz 3 0 X 105 f 3 0 X 105 f 9 0 X 105 f 3kHz lt f lt 10MHz 1 0 X 10 1 0X 10 3 0X 10 B2 1 f Hz B2 2 ALs B Y 2
43. 5 1 89 39 1 EEC 6 2 4 3 IB KOM ORE ALs 4 ELVs ELVs ELVs
44. lt BOM h 8 sient i KERRI MADRE L ERICMIT RRRA 15 1 4 89 391 EEC 17 a AR 16 1 2016 7 1
45. ELVs B ALs 4 z RMS 72 E ALs ELVs 5 E ALsCE ALs E
46. II 3 1 2 13 1 2 11 29 5 ORE 12 E 2013 6 9 3 ee SN ee lt 3 ale
47. a 1 EU H 6 2004 40 EC as 3 6 2 31 T Oe EA am
48. SAR WkgD SAR RF SAR SAR MHz D RF CIES ELEWA B CO L E 11 29 6 2013 IEN Official Journal of the European Union L179 m I 0Hz 10MHz
49. 4 ii ELVs iv 5 8 v 3 ALs ELVs ELVs ELVs E ALs LT 5
50. ii ELVs TEEI XAI iii 5 2 1 14 iv 5 b v 6 L281 1995 11 23 P31 29 6 2013 IEN Official Journal of the European Union L179 bh O
51. 2 ELVs ul 9 FH H EN 1
52. 4 2 3 1995 10 24 95 46 ECD a ELVs TEEI X AL ca i ELVs
53. L183 D C218 2003 4 1989 6 29 E9 13 AY Pl ss PH 18 19 20 21 22 23 29 6 2013 EN Official Journal of the European Union L179 9 28 ITS Fl 2011 Lick A 5 ELVs ALs
54. L179 ELVs 14 cm B3 lc ALs ALs IO mA RMS 2 SkHz 1 0 2 5 lt f lt 100kHz 0 4f 100 Sf 10 000kHz 40 B3 1 f kHz ALs B4 ALs ALs Bo 0 5mT gt 100mT Site 15 29 6 2013 IEN Official Journal of the European Union L179 m Sf Je
55. Bo ELVs ELVs 2T lt 8T mit ad ELVs B 8T oR 1Hz 10MHz ELVs ELVs K A2 A2 1Hz 10MHz ELVs Ja RBG E ELVs 1Hz f 3kHz 1 1Vm 3kHz f 10MHz 3 8X10fVm A2 1 f Hz awe A2 2 ELVs A2 3 ELVs RMS 2 eae 4
56. 100kHz 300GHz 2K SIL lt BIRBR LT Fv av A 8 lt ELVs 100kHz 6GHz ELVs A1 Pe 0 3 6GHz ELVs A2 6GHz ELVs K A3 Al 100kHz 6GHz LVs ELVs 6 SAR ELVs 04Wkg SAR 10wken ELVs SAR ELVs 7 20Wkg
57. 1 12 a b DD i c J ELVs 2 1Hz BLUE BLAS DN EAT ALs ALKA UCHR I LOM 12 ICNIRP
58. 10 c 3 ABUSE 3 4 ELVs ELVs 4 ELVs ELVs ELVs ELVs 4 6 ELVs 89 391 EEC 15
59. kHz B1 2 ALs E P ALs B 6 RF NENO ALs 1 000 14 B1 3 ALs E ALs B ELVs 4 ELVs 17 29 6 2013 IEN Official Journal of the European Union L179 14
60. 13 14 I Bi TINT lt 897391 EEC 15 1989 4 E 6 12 897391 EEC 16 1 ELVs ALs ICNIRP 16
61. for high frequency fields L 179 10 d the conduct of the risk assessment and wherever possible the provision of simplified techniques taking into account in particular the needs of SMEs e measures aimed at avoiding or reducing risks including specific prevention measures depending on the level of exposure and the workplace characteristics f the establishment of documented working procedures as well as specific information and training measures for workers exposed to electromagnetic fields during MRI related activities falling under Article 10 1 a g the evaluation of exposures in the frequency range from 100 kHz to 10MHz where both thermal and non thermal effects are to be considered h the guidance on medical examinations and health surveillance to be provided by the employer in accordance with Article 8 2 The Commission shall work in close cooperation with the Advisory Committee for Safety and Health at Work The European Parliament shall be kept informed Article 15 Review and reporting Taking into account Article 1 4 the report on the practical implementation of this Directive shall be established in accordance with Article 17a of Directive 89 391 EEC Article 16 Transposition 1 Member States shall bring into force the laws regulations and administrative provisions necessary to comply with this Directive by 1 July 2016 Official Journal of the European Union 29 6 2013 When Member
62. 1 By way of derogation from Article 3 but without prejudice to Article 5 1 the following shall apply Official Journal of the European Union 29 6 2013 a exposure may exceed the ELVs if the exposure is related to the installation testing use development maintenance of or research related to magnetic resonance imaging MRI equipment for patients in the health sector provided that all the following conditions are met i the risk assessment carried out in accordance with Article 4 has demonstrated that the ELVs are exceeded ii given the state of the art all technical and or organisa tional measures have been applied iii the circumstances duly justify exceeding the ELVs iv the characteristics of the workplace work equipment or work practices have been taken into account and v the employer demonstrates that workers are still protected against adverse health effects and against safety risks including by ensuring that the instructions for safe use provided by the manufacturer in accordance with Council Directive 93 42 EEC of 14 June 1993 concerning medical devices 1 are followed b Member States may allow for an equivalent or more specific protection system to be implemented for personnel working in operational military installations or involved in military activities including in joint international military exercises provided that adverse health effects and safety risks are prevented c Member
63. 2 29 6 2013 IEN Official Journal of the European Union L 179 a 300GHz O ELVs ELVs b gm ALs ELVs i ii
64. L 179 3 theses cardiac pacemakers and defibrillators cochlear implants and other implants or medical devices worn on the body Interference problems especially with pace makers may occur at levels below the ALs and should therefore be the object of appropriate precautions and protective measures HAVE ADOPTED THIS DIRECTIVE CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1 This Directive which is the 20th individual Directive within the meaning of Article 16 1 of Directive 89 391 EEC lays down minimum requirements for the protection of workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields during their work 2 This Directive covers all known direct biophysical effects and indirect effects caused by electromagnetic fields 3 The exposure limit values ELVs laid down in this Directive cover only scientifically well established links between short term direct biophysical effects and exposure to electromagnetic fields 4 This Directive does not cover suggested long term effects The Commission shall keep under review the latest scientific developments If well established scientific evidence on suggested long term effects becomes available the Commission shall consider a suitable policy response including if appro priate the submission of a legislative proposal to address such effects The Commission shall through its report referred to
65. OJ C OJ L 393 30 12 1989 p 18 Official Journal of the European Union L 179 7 7 Where Article 3 4 a applies specific protection measures such as controlling movements shall be taken 8 Workers shall not be exposed above the health effects ELVs and sensory effects ELVs unless the conditions under either Article 10 1 a or c or Articles 3 3 or 4 are fulfilled If despite the measures taken by the employer the health effects ELVs and sensory effects ELVs are exceeded the employer shall take immediate action to reduce exposure below these ELVs The employer shall identify and record the reasons why the health effects ELVs and sensory effects ELVs have been exceeded and shall amend the protection and prevention measures accordingly in order to prevent them being exceeded again The amended protection and prevention measures shall be preserved in a suitable traceable form so as to permit consultation at a later stage in accordance with national law and practice 9 Where paragraphs 3 and 4 of Article 3 apply and where the worker reports transient symptoms the employer shall if necessary update the risk assessment and the prevention measures Transient symptoms may include a sensory perceptions and effects in the functioning of the central nervous system in the head evoked by time varying magnetic fields and b static magnetic field effects such as vertigo and nausea Article 6 Worker information and tra
66. r MA i C Jaran EMF Inrormation Center Directive 201 3 35 EU 26 June 2013 26 ar 2037 37 EU 2013 6 26 etc 20 1 6 7 1 IE mm re fm 201387 So7EU 2013 6 26 A XBR GOOGHz GSMACSD ET
67. 12 RERET L D L245 1992 8 26 P23 L393 1989 12 30 P18 29 6 2013 EN Official Journal of the European Union L179 4 a b ELVs ALs c d 4 O
68. 6 3 9 1 a i ELVs ii ELVs A2 o Vy Gi 5 Ef 89 391 EEC 10 au 6 eat z iv 6
69. FO ei E ELVs REO lt i 4 ELVs a Gi Gi M3 7p RF Gv 4 2 i IBRD 1 b c ie 15
70. f lt 10 MHz 10 lt f lt 400 MHz 400 MHz lt f lt 2 GHz 1 0 x 10 f 2 lt f lt 6 GHz 4 5 x 101 6 lt f lt 300 GHz 1 4 x 10 4 5 x 101 50 Note B1 1 f is the frequency expressed in hertz Hz Note B1 2 ALs E and ALs B are to be averaged over a six minute period For RF pulses the peak power density averaged over the pulse width shall not exceed 1 000 times the respective ALs S value For multi frequency fields the analysis shall be based on summation as explained in the practical guides referred to in Article 14 Note B1 3 ALs E and ALs B represent maximum calculated or measured values at the workers body position This results in a conservative exposure assessment and automatic compliance with ELVs in all non uniform exposure conditions In order to simplify the assessment of compliance with ELVs carried out in accordance with Article 4 in specific non uniform conditions criteria for the spatial averaging of measured fields based on established dosimetry will be laid down in the practical guides referred to in Article 14 In the case of a very localised source within a distance of a few centimetres from the body compliance with ELVs shall be determined dosimetrically case by case L 179 17 L 179 18 Official Journal of the European Union 29 6 2013 Note B1 4 The power density shall be averaged over any 20 cm of exposed area Spatial maximum power densities averaged over 1 c
71. 2004 40 EC 5 2 e 5 A 2 d g 5 ROA 5 4 5 3 5 5 5 6 5 7 5 4 5 8 5 9 5 5 5 3 6 6 6 a 6 a 6 b 6 b 6 c 6 AC 6 d 6 d 6 Ke 6 RO 6 Ke 6 A g 6 ROA 6 Ach 6 AWD 7 7 8 1 8 1 8 2 8 3 8 2 9 9 10 10 1 11 1 c 10 2 a 11 1 a 10 2 b 11 1 b 11 Z 12 13 14 15 13 1 16 1 13 2 16 2 17 14 18 15 19 TEEI FEEL FEEN IV 20 1 5 3 29 6 2013 Official Journal of the European Union L 179 1 I Legislative acts DIRECTIVES DIRECTIVE 2013 35 EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents electromagnetic fields 20th individual D
72. Hz 0 0028 f Vm peak Note A3 1 f is the frequency expressed in hertz Hz Note A3 2 The sensory effects ELVs for internal electric field are spatial peak values in the head of the exposed subject Note A3 3 The ELVs are peak values in time which are equal to the Root Mean Square RMS values multiplied by V2 for sinusoidal fields In the case of non sinusoidal fields the exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method filtering in time domain explained in the practical guides referred to in Article 14 but other scientifically proven and validated exposure evaluation procedures can be applied provided that they lead to approximately equivalent and comparable results B ACTION LEVELS ALs The following physical quantities and values are used to specify the action levels ALs the magnitude of which are established to ensure by simplified assessment the compliance with relevant ELVs or at which relevant protection or prevention measures specified in Article 5 must be taken Low ALs E and high ALs E for electric field strength E of time varying electric fields as specified in Table B1 Low ALs B and high ALs B for magnetic flux density B of time varying magnetic fields as specified in Table B2 ALs Ia for contact current as specified in Table B3 ALs Bo for magnetic flux density of static magnetic fields as specified in Table B4 ALs correspond to calcu
73. SAR W A1 1 SAR 10g SAR 10g oaks 0 3GHz 6GHz ELVs ELVs A2 a A2 0 3 6GHz ELVs SA 0 3 SfS6GHz 10mJkg TE A2 1 SA 10g A3 6 300GHz ELVs
74. This results in a conservative exposure assessment and automatic compliance with ELVs in all non uniform exposure conditions In the case of a very localized source within a distance of a few centimeters from the body the induced electric field shall be determined dosimetorycally case by case ike 91C 2 Action Levels ALs for exposure to magnetic fields from 1 Hz to 10 MHz Magnetic flux Magnetic flux Magnetic flux density Frequency range density Low density High ALs for exposure of ALs B uT ALs B uT limbs to a localised RMS RMS magnetic field uT RMS ZS 2 0 x 107 F 3 0 x 107 f 9 0 x 105 f 8 Hz lt f lt 29 Hz 253x104 3 0 x 10 f 9 0 x 10 f 25 Hz f 300 H2 10x10 30x10 9 0 x 10 f 300 Hz lt f lt 3 kHz 3 0 x 1077 30x 107 9 0 x 10 f 3kHzsf lt 10MHz 1 0x 102 19x10 30x 10 ALs for exposure of limbs are derived from the health effects ELVs for internal electric field related to electric stimulation of the tissues in limbs by taking into account that magnetic field is coupled more weakly to the limbs than to the whole body JGIC 3 Action Levels ALs for magnetic flux density of static magnetic fields Hazards ALs BO Interference with active implanted O05 mi devices e g cardiac pacemakers Attraction and projectile risk in the fringe field or high field strength 3mT sources gt 100 mT ma re 4 Action Levels ALs for contact current Ic Frequency ALs Ic steady
75. introduction of measures to encourage improvements in the safety and health of workers at work it follows that Directive 89 391 EEC applies to the exposure of workers to elec tromagnetic fields without prejudice to more stringent and or specific provisions contained in this Directive The physical quantities ELVs and ALs laid down in this Directive are based on the recommendations of the Inter national Commission on Non lonizing Radiation Protection ICNIRP and should be considered in accordance with ICNIRP concepts save where this Directive specifies otherwise In order to ensure that this Directive remains up to date the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of purely technical amendments of the Annexes to reflect the adoption of regulations and directives in the field of technical harmonisation and standardisation technical progress changes in the most relevant standards or spec ifications and new scientific findings concerning hazards presented by electromagnetic fields as well as to adjust ALs It is of particular importance that the Commission carry out appropriate consultations during its preparatory work including at expert level The Commission when preparing and drawing up delegated acts should ensure a simultaneous timely and appropriate transmission of relevant documents to the European Parliamen
76. order to limit or control access e in the case of exposure to electric fields measures and procedures to manage spark discharges and contact currents through technical means and through the training of workers 29 6 2013 appropriate maintenance programmes for work equipment workplaces and workstation systems g the design and layout of workplaces and workstations h limitations of the duration and intensity of the exposure and i the availability of adequate personal protection equipment 3 On the basis of the risk assessment referred to in Article 4 the employer shall devise and implement an action plan that shall include technical and or organisational measures to prevent any risks to workers at particular risk and any risks due to indirect effects referred to in Article 4 4 In addition to providing the information set out in Article 6 of this Directive the employer shall pursuant to Article 15 of Directive 89 391 EEC adapt the measures referred to in this Article to the requirements of workers at particular risk and where applicable to individual risks assess ments in particular in respect of workers who have declared the use of active or passive implanted medical devices such as cardiac pacemakers or the use of medical devices worn on the body such as insulin pumps or in respect of pregnant workers who have informed their employer of their condition 5 On the basis of the risk assessment refer
77. relevant protection or prevention measures specified in this Directive The AL terminology used in Annex II is as follows i for electric fields low ALs and high ALs means levels which relate to the specific protection or prevention measures specified in this Directive and ii for magnetic fields low ALs means levels which relate to the sensory effects ELVs and high ALs to the health effects ELVs Article 3 Exposure limit values and action levels 1 Physical quantities regarding exposure to electromagnetic fields are indicated in Annex I Health effects ELVs sensory effects ELVs and ALs are set out in Annexes II and M 2 Member States shall require that employers ensure that the exposure of workers to electromagnetic fields is limited to the health effects ELVs and sensory effects ELVs set out in Annex II for non thermal effects and in Annex III for thermal effects Compliance with health effects ELVs and sensory effects ELVs must be established by the use of relevant exposure assessment procedures referred to in Article 4 Where the exposure of workers to electromagnetic fields exceeds the ELVs the employer shall take immediate action in accordance with Article 5 8 3 For the purpose of this Directive where it is demonstrated that the relevant ALs set out in Annex II and III are not exceeded the employer shall be deemed to be in compliance with the health effects ELVs and sensory effects ELVs
78. the appropriate information that it receives from Member States take into account the latest available research and new scientific knowledge arising from the data in this area Minimum requirements should be laid down thereby giving Member States the option of maintaining or adopting more favourable provisions for the protection of workers in particular by fixing lower values for the action levels ALs or the exposure limit values ELVs for electromagnetic fields However the implementation of this Directive should not serve to justify any regression in relation to the situation already prevailing in each Member State The system of protection against electromagnetic fields should be limited to a definition which should be free of excessive detail of the objectives to be attained the prin ciples to be observed and the fundamental values to be applied in order to enable Member States to apply the minimum requirements in an equivalent manner In order to protect workers exposed to electromagnetic fields it is necessary to carry out an effective and efficient risk assessment However this obligation should be proportional to the situation encountered at the work place Therefore it is appropriate to design a protection system that groups different risks in a simple graduated and easily understandable way Consequently the reference to a number of indicators and standard situ ations to be provided by practical guides can useful
79. workplaces open to the public it is not necessary for the exposure assessment to be carried out if an evaluation has already been undertaken in accordance with the provisions on the limitation of exposure of the general public to electrom agnetic fields if the restrictions specified in those provisions are respected for workers and if the health and safety risks are excluded Where equipment intended for the public use is used as intended and complies with Union law on products Official Journal of the European Union 29 6 2013 that establishes stricter safety levels than those provided for by this Directive and no other equipment is used these conditions are deemed to be met 7 The employer shall be in possession of an assessment of the risks in accordance with Article 9 1 a of Directive 89 391 EEC and shall identify which measures must be taken in accordance with Article 5 of this Directive The risk assessment may include the reasons why the employer considers that the nature and the extent of the risks related to electromagnetic fields make a further detailed risk assessment unnecessary The risk assessment shall be updated on a regular basis particularly if there have been significant changes which could render it out of date or if the results of the health surveillance referred to in Article 8 show this to be necessary Article 5 Provisions aimed at avoiding or reducing risks 1 Taking account of technical progress and the a
80. 5 d 4 5 e L 179 20 Official Journal of the European Union 29 6 2013 Directive 2004 40 EC This Directive Article 4 5 d iv Article 4 5 e Article 4 5 f Article 4 5 f Article 4 5 g Article 4 5 h Article 4 5 i Article 4 5 g Article 4 5 j Article 4 5 h Article 4 5 k Article 4 6 Article 4 6 Article 4 7 Article 5 1 Article 5 1 Article 5 2 introductory wording Article 5 2 introductory wording Article 5 2 a to c Article 5 2 a to c Article 5 2 d Article 5 2 e Article 5 2 d to g Article 5 2 f to i Article 5 4 Article 5 3 Article 5 5 Article 5 6 Article 5 7 Article 5 4 Article 5 8 Article 5 9 Article 5 5 Article 5 3 Article 6 introductory wording Article 6 introductory wording Article 6 a Article 6 a Article 6 b Article 6 b Article 6 c Article 6 c Article 6 d Article 6 d Article 6 e Article 6 f 29 6 2013 EN Article Article Article Article Article Article Article Article Article Article Article Article Article Article Article Annex 6 e 6 f 10 1 10 2 a 10 2 b 11 13 1 13 2 14 15 Official Journal of the European Union Directive 2004 40 EC Artic Artic Artic Articl Artic Articl Artic Artic Articl Artic Artic Artic Artic Articl Artic Artic Articl Artic Artic Art
81. ISCELLANEOUS PROVISIONS Article 8 Health surveillance 1 With the objective of the prevention and the early diagnosis of any adverse health effects due to exposure to elec tromagnetic fields appropriate health surveillance shall be carried out in accordance with Article 14 of Directive 89 391 EEC Health records and their availability shall be provided for in accordance with national law and or practice 2 In accordance with national law and practice the results of health surveillance shall be preserved in a suitable form that allows them to be consulted at a later date subject to compliance with confidentiality requirements Individual workers shall at their request have access to their own personal health records If any undesired or unexpected health effect is reported by a worker or in any event where exposure above the ELVs is detected the employer shall ensure that appropriate medical examinations or individual health surveillance is provided to the worker s concerned in accordance with national law and practice Such examinations or surveillance shall be made available during hours chosen by the worker and any costs arising shall not be borne by the worker Article 9 Penalties Member States shall provide for adequate penalties applicable in the event of infringements of national legislation adopted pursuant to this Directive These penalties must be effective proportionate and dissuasive Article 10 Derogations
82. RE LIMIT VALUES AND ACTION LEVELS IN THE FREQUENCY RANGE FROM 0 Hz TO 10 MHz A EXPOSURE LIMIT VALUES ELVs ELVs below 1 Hz Table A1 are limits for static magnetic field which is not affected by the tissue of the body ELVs for frequencies from 1 Hz to 10 MHz Table A2 are limits for electric fields induced in the body from exposure to time varying electric and magnetic fields ELVs for external magnetic flux density from 0 to 1 Hz The sensory effects ELV is the ELV for normal working conditions Table Al and is related to vertigo and other physiological effects related to disturbance of the human balance organ resulting mainly from moving in a static magnetic field The health effects ELV for controlled working conditions Table A1 is applicable on a temporary basis during the shift when justified by the practice or process provided that preventive measures such as controlling movements and providing information to workers have been adopted Table Al ELVs for external magnetic flux density By from 0 to 1 Hz Sensory effects ELVs Normal working conditions 2T Localised limbs exposure 8 T Health effects ELVs Controlled working conditions 8 T Health effects ELVs for internal electric field strength from 1 Hz to 10 MHz Health effects ELVs Table A2 are related to electric stimulation of all peripheral and central nervous system tissues in the body including the head Table A2 Health effects ELVs for internal el
83. States adopt those provisions they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication Member States shall determine how such a reference is to be made 2 Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive Article 17 Repeal 1 Directive 2004 40 EC is repealed from 29 June 2013 2 References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex IV Article 18 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union Article 19 Addressees This Directive is addressed to the Member States Done at Brussels 26 June 2013 For the Council The President A SHATTER For the European Parliament The President M SCHULZ 29 6 2013 Official Journal of the European Union ANNEX I PHYSICAL QUANTITIES REGARDING THE EXPOSURE TO ELECTROMAGNETIC FIELDS The following physical quantities are used to describe the exposure to electromagnetic fields Electric field strength E is a vector quantity that corresponds to the force exerted on a charged particle regardless of its motion in space It is expressed in volt per metre Vm A distinction has to be made between the environmental el
84. States may allow in duly justified circumstances and only for as long as they remain duly justified for the ELVs to be temporarily exceeded in specific sectors or for specific activities outside the scope of points a and b For the purposes of this point duly justified circumstances shall mean circumstances in which the following conditions are met i the risk assessment carried out in accordance with Article 4 has shown that the ELVs are exceeded ii given the state of the art all technical and or organisa tional measures have been applied iii the specific characteristics of the workplace work equipment or work practices have been taken into account and iv the employer demonstrates that workers are still protected against adverse health effects and safety risks including using comparable more specific and internationally recognised standards and guidelines OJ L 169 12 7 1993 p 1 29 6 2013 2 Member States shall inform the Commission of any dero gation under points b and c of paragraph 1 and shall state the reasons that justify them in the report referred to in Article 15 Article 11 Technical amendments of the Annexes 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 12 amending in a purely technical way the Annexes so as to a take into account the adoption of regulations and directives in the field of technical harmonisation and standardisa
85. Where the exposure exceeds the ALs the employer shall act in accordance with Article 5 2 unless the assessment carried out in accordance with Article 4 1 2 and 3 demonstrates that the relevant ELVs are not exceeded and that safety risks can be excluded Notwithstanding the first subparagraph exposure may exceed a low ALs for electric fields Annex II Table B1 where justified by the practice or process provided that either the sensory effects ELVs Annex II Table A3 are not exceeded or i the health effects ELVs Annex II Table A2 are not exceeded 29 6 2013 ii the excessive spark discharges and contact currents Annex II Table B3 are prevented by specific protection measures as set out in Article 5 6 and iii information on the situations referred to in point f of Article 6 has been given to workers b low ALs for magnetic fields Annex II Table B2 where justified by the practice or process including in the head and torso during the shift provided that either the sensory effects ELVs Annex II Table A3 are not exceeded or i the sensory effects ELVs are exceeded only temporarily ii the health effects ELVs Annex II Table A2 are not exceeded iii action is taken in accordance with Article 5 9 where there are transient symptoms under point a of that paragraph and iv information on the situations referred to in point f of Article 6 has been given to workers 4 No
86. al of the European Union L179 IV 443 2004 40 EC 1 1 1 1 1 2 1 2 3 1 3 1 4 1 4 1 9 1 5 1 6 2 a 2 a 2 b 2 c 2 Rb 2 ec 2 c 2 g 3 1 3 1 3 RO 3 1 3 2 3 3 3 2 3 3 4 4 1 4 1 4 2 4 RDR KUA 4 3 4 3 4 4 4 4 4 5 a 4 5 b 4 5 b 4 5 a 4 RO 4 ROX 4 ROA 4 ROA 4 5 e 4 5 d G 4 5 d i 4 RODG 4 5 d Giv 4 5 e 4 ROO 4 ROD 4 5 g 4 5 h 4 ROO 4 5 g 4 5 0 4 5 h 4 ROK 4 6 4 6 4 7 5 1 5 1 5 2 5 2 5 ROA 3 RO 5 2 qd 19 29 6 2013 EN Official Journal of the European Union i L179
87. and participation of workers The data obtained from the assessment measurement or calculation of the level of exposure shall be preserved in a suitable traceable form so as to permit consultation at a later stage in accordance with national law and practice 5 When carrying out the risk assessment pursuant to Article 6 3 of Directive 89 391 EEC the employer shall give particular attention to the following a the health effects ELVs the sensory effects ELVs and the ALs referred to in Article 3 and Annexes II and III to this Directive b the frequency the level duration and type of exposure including the distribution over the worker s body and over the volume of the workplace c any direct biophysical effects d any effects on the health and safety of workers at particular risk in particular workers who wear active or passive implanted medical devices such as cardiac pacemakers workers with medical devices worn on the body such as insulin pumps and pregnant workers e any indirect effects f the existence of replacement equipment designed to reduce the level of exposure to electromagnetic fields g appropriate information obtained from the health surveillance referred to in Article 8 h information provided by the manufacturer of equipment i other relevant health and safety related information j multiple sources of exposure k simultaneous exposure to multiple frequency fields 6 In
88. cemakers Attraction and projectile risk in the fringe field of high 3 mT field strength sources gt 100 mT L 179 15 L 179 16 Official Journal of the European Union 29 6 2013 ANNEX III THERMAL EFFECTS EXPOSURE LIMIT VALUES AND ACTION LEVELS IN THE FREQUENCY RANGE FROM 100 kHz TO 300 GHz A EXPOSURE LIMIT VALUES ELVs Health effects ELVs for frequencies from 100 kHz to 6 GHz Table A1 are limits for energy and power absorbed per unit mass of body tissue generated from exposure to electric and magnetic fields Sensory effects ELVs for frequencies from 0 3 to 6 GHz Table A2 are limits on absorbed energy in a small mass of tissue in the head from exposure to electromagnetic fields Health effects ELVs for frequencies above 6 GHz Table A3 are limits for power density of an electromagnetic wave incident on the body surface Table Al Health effects ELVs for exposure to electromagnetic fields from 100 kHz to 6 GHz Health effects ELVs SAR values averaged over any six minute period ELVs related to whole body heat stress expressed as 0 4 Wkg averaged SAR in the body ELVs related to localised heat stress in head and trunk 10 Wkg expressed as localised SAR in the body ELVs related to localised heat stress in the limbs expressed 20 Wkgt as localised SAR in the limbs Note Al 1 Localised SAR averaging mass is any 10 g of contiguous tissue the maximum SAR so obtained should be the value used for estimating ex
89. cial Journal and decision of the Council of 20 June 2013 appropriate and proportionate measures to protect workers from the risks associated with electromagnetic fields should be introduced That Directive did not address the long term effects including the possible carcinogenic effects of exposure to time varying 159 30 4 2004 p 1 OJ L OJ L 114 26 4 2008 p 88 OJ L 110 24 4 2012 p 1 L 179 2 11 electric magnetic and electromagnetic fields for which there is currently no conclusive scientific evidence estab lishing a causal relationship This Directive is intended to address all known direct biophysical effects and indirect effects caused by electromagnetic fields in order not only to ensure the health and safety of each worker on an individual basis but also to create a minimum basis of protection for all workers in the Union while reducing possible distortions of competition This Directive does not address suggested long term effects of exposure to electromagnetic fields since there is currently no well established scientific evidence of a causal relationship However if such well established scientific evidence emerges the Commission should consider the most appropriate means for addressing such effects and should through its report on the practical implementation of this Directive keep the European Parliament and Council informed in this regard In doing so the Commission should in addition to
90. ct with specific conditions in certain activities such as the use of the magnetic resonance technique in the medical sector It is therefore necessary to take those particular conditions into account Given the specificities of the armed forces and in order to allow them to operate and interoperate effectively including in joint international military exercises Member States should be able to implement equivalent or more specific protection systems such as inter nationally agreed standards for example NATO stan dards provided that adverse health effects and safety risks are prevented Employers should be required to ensure that risks arising from electromagnetic fields at work are eliminated or reduced to a minimum It is nevertheless possible that in specific cases and in duly justified circumstances the ELVs set out in this Directive are only temporarily exceeded In such a case employers should be required to take the necessary actions in order to return to compliance with the ELVs as soon as possible A system ensuring a high level of protection as regards the adverse health effects and safety risks that may result from exposure to electromagnetic fields should take due account of specific groups of workers at particular risk and avoid interference problems with or effects on the functioning of medical devices such as metallic pros C 218 13 9 2003 p 1 C 369 17 12 2011 p 14 Official Journal of the European Union
91. d other relevant standards or guidelines provided by the Member State concerned including exposure databases Notwithstanding the employer s obligations under this Article the employer shall also be entitled where relevant to take into account the emission levels and other appropriate safety related data provided by the manufacturer or distributor for the equipment in accordance with relevant Union law including an assessment of risks if applicable to the exposure conditions at the workplace or place of installation 3 If compliance with the ELVs cannot be reliably determined on the basis of readily accessible information the assessment of the exposure shall be carried out on the basis of measurements or calculations In such a case the assessment shall take into account uncertainties concerning the measurements or calcu lations such as numerical errors source modelling phantom geometry and the electrical properties of tissues and materials determined in accordance with relevant good practice OJ L 281 23 11 1995 p 31 L 179 6 4 The assessment measurement and calculations referred to in paragraphs 1 2 and 3 of this Article shall be planned and carried out by competent services or persons at suitable intervals taking into account the guidance given under this Directive and taking particular account of Articles 7 and 11 of Directive 89 391 EEC concerning the necessary competent services or persons and the consultation
92. ded for periods of an identical duration unless the European Parliament or the Council opposes such extension not later than three months before the end of each period 3 The delegation of powers referred to in Article 11 may be revoked at any time by the European Parliament or by the Council A decision to revoke shall put an end to the delegation of the power specified in that decision It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein It shall not affect the validity of any delegated acts already in force Official Journal of the European Union L 179 9 4 As soon as it adopts a delegated act the Commission shall notify it simultaneously to the European Parliament and to the Council 5 A delegated act adopted pursuant to Article 11 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if before the expiry of that period the European Parliament and the Council have both informed the Commission that they will not object That period shall be extended by two months at the initiative of the European Parliament or of the Council Article 13 Urgency procedure 1 Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no
93. ectric field and the electric field present in the body in situ as a result of exposure to the environmental electric field Limb current I is the current in the limbs of a person exposed to electromagnetic fields in the frequency range from 10 MHz to 110 MHz as a result of contact with an object in an electromagnetic field or the flow of capacitive currents induced in the exposed body It is expressed in ampere A Contact current Ia is a current that appears when a person comes into contact with an object in an electromagnetic field It is expressed in ampere A A steady state contact current occurs when a person is in continuous contact with an object in an electromagnetic field In the process of making such contact a spark discharge may occur with associated transient currents Electric charge Q is an appropriate quantity used for spark discharge and is expressed in coulomb C Magnetic field strength H is a vector quantity that together with the magnetic flux density specifies a magnetic field at any point in space It is expressed in ampere per metre Am Magnetic flux density B is a vector quantity resulting in a force that acts on moving charges expressed in tesla T In free space and in biological materials magnetic flux density and magnetic field strength can be interchanged using the magnetic field strength of H 1 Am equivalence to magnetic flux density of B 4r 107 T approximately 1 25 microtesla Power de
94. ectric field strength from 1 Hz to 10 MHz Frequency range Health effects ELVs 1 Hz lt f lt 3 kHz 1 1 Vm peak 3 kHz lt f lt 10 MHz 3 8 x 1074 f Vm peak Note A2 1 f is the frequency expressed in hertz Hz Note A2 2 The health effects ELVs for internal electric field are spatial peak values in the entire body of the exposed subject Note A2 3 The ELVs are peak values in time which are equal to the Root Mean Square RMS values multiplied by V2 for sinusoidal fields In the case of non sinusoidal fields exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method filtering in time domain explained in the practical guides referred to in Article 14 but other scientifically proven and validated exposure evaluation procedures can be applied provided that they lead to approximately equivalent and comparable results Sensory effects ELVs for internal electric field strength from 1 Hz to 400 Hz 29 6 2013 29 6 2013 Official Journal of the European Union L 179 13 The sensory effects ELVs Table A3 are related to electric field effects on the central nervous system in the head i e retinal phosphenes and minor transient changes in some brain functions Table A3 Sensory effects ELVs for internal electric field strength from 1 to 400 Hz Frequency range Sensory effects ELVs 1 lt f lt 10Hz 0 7 f Vm peak 10 lt f lt 25 Hz 0 07 Vm peak 25 lt f lt 400
95. enetration depth as the frequency increases ACTION LEVELS ALs The following physical quantities and values are used to specify the action levels ALs the magnitude of which are established to ensure by simplified assessment the compliance with the relevant ELVs or at which relevant protection or prevention measures specified in Article 5 must be taken ALs E for electric field strength E of time varying electric field as specified in Table B1 ALs B for magnetic flux density B of time varying magnetic field as specified in Table B1 ALs S for power density of electromagnetic waves as specified in Table B1 ALs Ia for contact current as specified in Table B2 ALs I for limb current as specified in Table B2 ALs correspond to calculated or measured field values at the workplace in the absence of the worker as maximum value at the position of the body or specified part of the body Action levels ALs for exposure to electric and magnetic fields ALs E and ALs B are derived from the SAR or power density ELVs Tables Al and A3 based on the thresholds related to internal thermal effects caused by exposure to external electric and magnetic fields Frequency range 100 kHz lt f lt 1 MHz Table B1 ALs for exposure to electric and magnetic fields from 100 kHz to 300 GHz Electric field strength ALs E Magnetic flux density ALs B Vm RMS pT RMS Power density ALs S Wm 3 l lt
96. he presence of an object in an electromagnetic field which may become the cause of a safety or health hazard such as i interference with medical electronic equipment and devices including cardiac pacemakers and other implants or medical devices worn on the body ii the projectile risk from ferromagnetic objects in static magnetic fields iii the initiation of electro explosive devices detonators iv fires and explosions resulting from the ignition of flammable materials by sparks caused by induced fields contact currents or spark discharges and v contact currents d exposure limit values ELVs means values established on the basis of biophysical and biological considerations in particular on the basis of scientifically well established short term and acute direct effects i e thermal effects and electrical stimulation of tissues e health effects ELVs means those ELVs above which workers might be subject to adverse health effects such as thermal heating or stimulation of nerve and muscle tissue f sensory effects ELVs means those ELVs above which workers might be subject to transient disturbed sensory perceptions and minor changes in brain functions Official Journal of the European Union 29 6 2013 g action levels ALs means operational levels established for the purpose of simplifying the process of demonstrating the compliance with relevant ELVs or where appropriate to take
97. icl This Directive 10 11 1 11 1 a 11 1 b 12 13 14 15 16 1 16 2 17 18 19 Annex I Annex II and Annex III Annex IV L 179 21
98. ime domain explained in practical guides referred to in Article 14 but other scientifically proven and validated exposure evaluation procedures can be applied provided that they lead to approximately equivalent and comparable results 29 6 2013 29 6 2013 Official Journal of the European Union Note B2 3 ALs for exposure to magnetic fields represent maximum values at the workers body position This results in a conservative exposure assessment and automatic compliance with ELVs in all non uniform exposure conditions In order to simplify the assessment of compliance with ELVs carried out in accordance with Article 4 in specific non uniform conditions criteria for the spatial averaging of measured fields based on established dosimetry will be laid down in the practical guides referred to in Article 14 In the case of a very localised source within a distance of a few centimetres from the body the induced electric field shall be determined dosimetrically case by case Table B3 ALs for contact current Ic Frequency ALs I steady state contact current mA RMS up to 2 5 kHz 1 0 2 5 lt f lt 100 kHz 0 4 f 100 lt f lt 10000 kHz 40 Note B3 1 f is the frequency expressed in kilohertz kHz Action levels ALs for magnetic flux density of static magnetic fields Table B4 ALs for magnetic flux density of static magnetic fields Hazards ALs Bo Interference with active implanted devices e g cardiac 0 5 mT pa
99. in Article 15 keep the European Parliament and the Council informed in this regard 5 This Directive does not cover the risks resulting from contact with live conductors 6 Without prejudice to the more stringent or more specific provisions in this Directive Directive 89 391 EEC shall continue to apply in full to the whole area referred to in paragraph 1 Article 2 Definitions For the purposes of this Directive the following definitions shall apply a electromagnetic fields means static electric static magnetic and time varying electric magnetic and electromagnetic fields with frequencies up to 300 GHz L 179 4 b direct biophysical effects means effects in the human body directly caused by its presence in an electromagnetic field including i thermal effects such as tissue heating through energy absorption from electromagnetic fields in the tissue ii non thermal effects such as the stimulation of muscles nerves or sensory organs These effects might have a detrimental effect on the mental and physical health of exposed workers Moreover the stimulation of sensory organs may lead to transient symptoms such as vertigo or phosphenes These effects might create temporary annoyance or affect cognition or other brain or muscle functions and may thereby affect the ability of a worker to work safely i e safety risks and iii limb currents c indirect effects means effects caused by t
100. ining Without prejudice to Articles 10 and 12 of Directive 89 391 EEC the employer shall ensure that workers who are likely to be exposed to risks from electromagnetic fields at work and or their representatives receive any necessary information and training relating to the outcome of the risk assessment provided for in Article 4 of this Directive concerning in particular a measures taken in application of this Directive b the values and concepts of the ELVs and ALs the associated possible risks and the preventive measures taken c the possible indirect effects of exposure d the results of the assessment measurement or calculations of the levels of exposure to electromagnetic fields carried out in accordance with Article 4 of this Directive e how to detect adverse health effects of exposure and how to report them f the possibility of transient symptoms and sensations related to effects in the central or peripheral nervous system L 179 8 g the circumstances in which workers are entitled to health surveillance h safe working practices to minimise risks resulting from exposure i workers at particular risk as referred to in Article 4 5 d and Article 5 3 and 4 of this Directive Article 7 Consultation and participation of workers Consultation and participation of workers and or their represen tatives shall take place in accordance with Article 11 of Directive 89 391 EEC CHAPTER III M
101. irective within the meaning of Article 16 1 of Directive 89 391 EEC and repealing Directive 2004 40 EC THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE 3 Following the entry into force of Directive 2004 40 EC EUROPEAN UNION of the European Parliament and of the Council of 29 April 2004 on the minimum health and safety requirements regarding the exposure of workers to the Having regard to the Treaty on the Functioning of the European risks arising from physical agents electromagnetic fields Union and in particular Article 153 2 thereof 18th individual Directive within the meaning of Article 16 1 of Directive 89 391 EEC 3 serious concerns were expressed by stakeholders in particular Having regard to the proposal from the European Commission those from the medical community as to the potential impact of the implementation of that Directive on the use of medical procedures based on medical imaging After transmission of the draft legislative act to the national Concerns were also expressed as to the impact of the parliaments Directive on certain industrial activities Having regard to the opinion of the European Economic and o f Social Committee 1 4 The Commission examined attentively the arguments put forward by stakeholders and after several consultations decided to thoroughly reconsider some provisions of After consulting the Committee of the Regions Directive 2004 40 EC on the basis of new scientific information produced by i
102. lated or measured electric and magnetic field values at the workplace in the absence of the worker Action levels ALs for exposure to electric fields Low ALs Table B1 for external electric field are based on limiting the internal electric field below the ELVs Tables A2 and A3 and limiting spark discharges in the working environment Below high ALs the internal electric field does not exceed the ELVs Tables A2 and A3 and annoying spark discharges are prevented provided that the protection measures referred to in Article 5 6 are taken Table B1 ALs for exposure to electric fields from 1 Hz to 10 MHz Electric field strength Low ALs F Vm Electric field strength High ALs E Vm_ Frequency range RMS RMS 1 lt f lt 25Hz 2 0 x 10 2 0 x 10 25 lt f lt 50Hz 5 0 x 10 f 2 0 x 104 50 Hz lt f lt 1 64 kHz 5 0 x 10 f 1 0 x 109 f Official Journal of the European Union Electric field strength Low ALs E Vm7 Electric field strength High ALs E Vm Frequency range RMS RMS 1 64 lt f lt 3 kHz 5 0 x 10 f 6 1 x 107 3 kHz lt f lt 10 MHz 6 1 x 10 Note B1 1 f is the frequency expressed in hertz Hz Note B1 2 The low ALs E and high ALs E are the Root Mean Square RMS values of the electric field strength which are equal to the peak values divided by V2 for sinusoidal fields In the case of non sinusoidal fields the exposure evaluation carried out in accordance with Ar
103. ly assist employers in fulfilling their obligations The undesired effects on the human body depend on the frequency of the electromagnetic field or radiation to which it is exposed Therefore exposure limitation systems need to be exposure pattern and frequency Official Journal of the European Union 13 14 15 16 29 6 2013 dependent in order to adequately protect workers exposed to electromagnetic fields The level of exposure to electromagnetic fields can be more effectively reduced by incorporating preventive measures into the design of workstations and by giving priority when selecting work equipment procedures and methods to reducing risks at source Provisions relating to work equipment and methods thereby contribute to the protection of the workers involved There is however a need to avoid duplication of assessments where work equipment meets the requirements of relevant Union law on products that establishes stricter safety levels than those provided for by this Directive This allows for simplified assessment in a large number of cases Employers should make adjustments in the light of technical progress and scientific knowledge regarding the risks related to exposure to electromagnetic fields with a view to improving the safety and health protection of workers Since this Directive is an individual Directive within the meaning of Article 16 1 of Council Directive 89 391 EEC of 12 June 1989 on the
104. m should not exceed 20 times the value of 50 Wm Power densities from 6 to 10 GHz are to be averaged over any six minute period Above 10 GHz the power density shall be averaged over any 68 f minute period where f is the frequency in GHz to compensate for progressively shorter penetration depth as the frequency increases Table B2 ALs for steady state contact currents and induced limb currents Steady state contact current ALs Ia mA Induced limb current in any limb ALs Frequency range RMS mA RMS 100 kHz lt f lt 10 MHz 40 10 lt f lt 110 MHz 40 100 Note B2 1 ALs I is to be averaged over a six minute period 29 6 2013 Directive 2004 40 EC Article 1 1 Article 1 2 Article 1 3 Article 1 4 Article 1 5 Article 2 a Article 2 b Article 2 c Article 3 1 Article 3 2 Article 3 3 Article 4 1 Article 4 2 Article 4 3 Article 4 4 Article 4 5 a Article 4 5 b Article 4 5 c Article 4 5 d Article 4 5 d i Article 4 5 d i Article 4 5 d iii ANNEX IV Official Journal of the European Union L 179 19 Correlation table Artic Artic Artic Artic Articl Artic Artic Articl Artic Artic Artic Artic Articl Artic Artic Artic Artic Articl Artic Artic Articl Artic Artic Artic e e e e e e e e This Directive 4 4 4 5 b 4 5 a 4 5 c 4
105. n Gi 1 c ELVs ELVs ALs 2 T i ELVs ELVs ELVs ELVs Ci
106. nsity S is an appropriate quantity used for very high frequencies where the depth of penetration in the body is low It is the radiant power incident perpendicular to a surface divided by the area of the surface It is expressed in watt per square metre Wm Specific energy absorption SA is an energy absorbed per unit mass of biological tissue expressed in joule per kilogram kg In this Directive it is used for establishing limits for effects from pulsed microwave radiation Specific energy absorption rate SAR averaged over the whole body or over parts of the body is the rate at which energy is absorbed per unit mass of body tissue and is expressed in watt per kilogram Wkg Whole body SAR is a widely accepted quantity for relating adverse thermal effects to radio frequency RF exposure Besides the whole body average SAR local SAR values are necessary to evaluate and limit excessive energy deposition in small parts of the body resulting from special exposure conditions Examples of such conditions include an individual exposed to RF in the low MHz range e g from dielectric heaters and individuals exposed in the near field of an antenna Of these quantities magnetic flux density B contact current I limb current 1 electric field strength E magnetic field strength H and power density S can be measured directly L 179 11 L 179 12 Official Journal of the European Union ANNEX II NON THERMAL EFFECTS EXPOSU
107. nsures that health effects ELVs are not exceeded but the effects related to retinal phosphenes and minor transient changes in brain activity are possible if the exposure of the head exceeds the low ALs for exposures up to 400 Hz In such a case Article 5 6 applies ALs for exposure of limbs are derived from the health effects ELVs for internal electric field related to electric stimulation of the tissues in limbs by taking into account that the magnetic field is coupled more weakly to the limbs than to the whole body Table B2 ALs for exposure to magnetic fields from 1 Hz to 10 MHz Magnetic flux density ALs for exposure of limbs to a localised magnetic field uT RMS Magnetic flux density Low Magnetic flux density High Frequency range ALs B T RMS ALs B uT RMS 1 lt f lt 8Hz 2 0 x 10 f 3 0 x 10 f 9 0 x 10 f 8 lt f lt 25 Hz 2 5 x 104 f 3 0 x 10 f 9 0 x 10 f 25 lt f lt 300 Hz 1 0 x 103 3 0 x 10 f 9 0 x 10 f 300 Hz lt f lt 3 kHz 3 0 x 10 f 3 0 x 10 f 9 0 x 10 f 3 kHz lt f lt 10 MHz 1 0 x 10 1 0 x 107 3 0 x 107 Note B2 1 f is the frequency expressed in hertz Hz Note B2 2 The low ALs and the high ALs are the Root Mean Square RMS values which are equal to the peak values divided by V2 for sinusoidal fields In the case of non sinusoidal fields the exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method filtering in t
108. nternationally recognised experts Acting in accordance with the ordinary legislative procedure 5 Directive 2004 40 EC was amended by Directive Whereas 2008 46 EC of the European Parliament and of the Council with the effect of postponing by four years the deadline for the transposition of Directive 1 Under the Treaty the European Parliament and the 2004 40 EC and subsequently by Directive 2012 11 EU Council may by means of directives adopt mamn of the European Parliament and of the Council with ee for the encouragement of improvements the effect of postponing that deadline for transposition in particular of the working environment to guarantee until 31 October 2013 This was to allow the a better level of protection of the health and safety of Commission to present a new proposal and the co legis workers Such directives are to avon d imposing adminis lators to adopt a new directive based on fresher and trative financial and legal constraints in a way which sounder evidenc would hold back the creation and development of small and medium sized undertakings 6 Directive 2004 40 EC should be repealed and more Article 31 1 of the Charter of Fundamental Rights of the European Union provides that every worker has the right to working conditions which respect his or her health safety and dignity OJ C 43 15 2 2012 p 47 C Position of the European Parliament of 11 June 2013 not yet published in the Offi
109. objection is expressed in accordance with paragraph 2 The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure which shall relate to the health and protection of workers 2 Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 12 5 In such a case the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council CHAPTER IV FINAL PROVISIONS Article 14 Practical guides In order to facilitate the implementation of this Directive the Commission shall make available non binding practical guides at the latest six months before 1 July 2016 Those practical guides shall in particular relate to the following issues a the determination of exposure taking into account appro priate European or international standards including calculation methods for the assessment of the ELVs spatial averaging of external electric and magnetic fields guidance for dealing with measurements and calcu lations uncertainties b guidance on demonstrating compliance in special types of non uniform exposure in specific situations based on well established dosimetry c the description of the weighted peak method for the low frequency fields and of the multifrequency fields summation
110. om 1 Hz to 400 Hz Sensory effects ELVs are related to electric field effects on the central nervous system in the head i e retinal phosphenes and minor transient changes in some brain functions Frequency range Sensory effects ELVs THZ 10 FZ 0 7 f VIm peak 10Hz lt 1 lt 25 Hz 0 07f V m peak 25 lt f s 400 Hz 0 0028 f V m peak 3 Health effects Exposure Limit Values ELVs for internal electric field strength from 1 Hz to 10 MHz Health effects ELVs are related to electric stimulation of all peripheral and central nervous system tissues in the body including the head Frequency range f Hz Health effects ELVs PZ S KR 1 1 V m peak 3 kHz lt f lt 10 MHz 3 8 x 104f V m peak The health effects ELVs for internal electric field are spatial peak values in the entire body of the exposed subject The ELVs are peak values in time which are equal to the Root Mean Square RMS values multiplied by V2 for sinusoidal fields ma PC 1 Action Levels ALs for exposure to electric fields from 1 Hz to 10 MHz Electric field Frequency range strength Low ALs E V m RMS WZ lt f 25 biz 20x 104 25 hz lt f lt 50 HZ 30X 102 f 5OlaZ lt 1 64 kez 50x10 1 64 kHz sf lt 3kHz 5 0x 10 7f Kz 1 ONMNZ er 10 Electric field strength High ALs E V m RMS 20x10 2 0 x 104 1 0 x 10 F 61x10 6 1x10 Note ALs represent maximum calculated or measured values at the workers body position
111. posure This 10 g of tissue is intended to be a mass of contiguous tissue with roughly homogeneous electrical properties In specifying a contiguous mass of tissue it is recognised that this concept may be used in computational dosimetry but may present difficulties for direct physical measurements A simple geometry such as cubic or spheric tissue mass can be used Sensory effects ELVs from 0 3 GHz to 6 GHz This sensory effects ELVs Table A2 is related to avoiding auditory effects caused by exposures of the head to pulsed microwave radiation Table A2 Sensory effects ELVs for exposure to electromagnetic fields from 0 3 to 6 GHz Frequency range Localised specific energy absorption SA 0 3 lt f lt 6 GHz 10 mJkg Note A2 1 Localised SA averaging mass is 10 g of tissue Table A3 Health effects ELVs for exposure to electromagnetic fields from 6 to 300 GHz Frequency range Health effects ELVs related to power density 6 lt f lt 300 GHz 50 Wm 29 6 2013 Note A3 1 Official Journal of the European Union The power density shall be averaged over any 20 cm of exposed area Spatial maximum power densities averaged over 1 cm should not exceed 20 times the value of 50 Wm Power densities from 6 to 10 GHz are to be averaged over any six minute period Above 10 GHz the power density shall be averaged over any 68 f gt minute period where f is the frequency in GHz to compensate for progressively shorter p
112. red to in Article 4 workplaces where workers are likely to be exposed to electrom agnetic fields that exceed the ALs shall be indicated by appro priate signs in accordance with Annexes II and III and with Council Directive 92 58 EEC of 24 June 1992 on the minimum requirements for the provision of safety and or health signs at work ninth individual Directive within the meaning of Article 16 1 of Directive 89 391 EEC The areas in question shall be identified and access to them limited as appropriate Where access to these areas is suitably restricted for other reasons and workers are informed of the risks arising from electromagnetic fields signs and access restrictions specific to electromagnetic fields shall not be required 6 Where Article 3 3 a applies specific protection measures shall be taken such as the training of workers in accordance with Article 6 and the use of technical means and personal protection for example the grounding of work objects the bonding of workers with work objects equipotential bonding and where appropriate and in accordance with Article 4 1 a of Council Directive 89 656 EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace third indi vidual directive within the meaning of Article 16 1 of Directive 89 391 EEC the use of insulating shoes gloves and protective clothing 6 L 245 26 8 1992 p 23
113. state contact current mA RMS up to 2 5 kHz 1 0 2 5 kHz sf lt 100 kHz 0 4 f 100 kHz sf lt 10 000 kHz 40 Note f is the frequency expressed in kilohertz KHZ ma re 1 5 2 29 6 2013 EN Official Journal of the European Union L 179 2013 6 26 2013 35 EU 89 391 EEC 16 1 20 2004 40 EC EU
114. t and to the Council 1 OJ L 183 29 6 1989 p 1 29 6 2013 17 If amendments of a purely technical nature to the 18 19 20 21 22 23 e OJ 0 Annexes become necessary the Commission should work in close cooperation with the Advisory Committee for Safety and Health at Work set up by Council Decision of 22 July 2003 In exceptional cases where imperative grounds of urgency so require such as possible imminent risks to workers health and safety arising from their exposure to electromagnetic fields the possibility should be given to apply the urgency procedure to delegated acts adopted by the Commission In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents 7 Member States have undertaken to accompany in justified cases the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments With regard to this Directive the legislator considers the transmission of such documents to be justified A system including ELVs and ALs where applicable should be seen as a means to facilitate the provision of a high level of protection against the adverse health effects and safety risks that may result from exposure to electromagnetic fields However such a system may confli
115. tic fields at the workplace and if necessary measure or calculate the levels of electromagnetic fields to which workers are exposed Without prejudice to Article 10 of Directive 89 391 EEC and Article 6 of this Directive that assessment can be made public on request in accordance with relevant Union and national laws In particular in the case of processing the personal data of employees in the course of such an assessment any publication shall comply with Directive 95 46 EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and the national laws of the Member States implementing that Directive Unless there is an overriding public interest in disclosure public authorities that are in possession of a copy of the assessment may refuse a request for access to it or a request to make it public where disclosure would undermine the protection of commercial interests of the employer including those relating to intellectual property Employers may refuse to disclose or make public the assessment under the same conditions in accordance with the relevant Union and national laws 2 For the purpose of the assessment provided for in paragraph 1 of this Article the employer shall identify and assess electromagnetic fields at the workplace taking into account the relevant practical guides referred to in Article 14 an
116. ticle 4 shall be based on the weighted peak method filtering in time domain explained in the practical guides referred to in Article 14 but other scientifically proven and validated exposure evaluation procedures can be applied provided that they lead to approximately equivalent and comparable results Note B1 3 ALs represent maximum calculated or measured values at the workers body position This results in a conservative exposure assessment and automatic compliance with ELVs in all non uniform exposure conditions In order to simplify the assessment of compliance with ELVs carried out in accordance with Article 4 in specific non uniform conditions criteria for the spatial averaging of measured fields based on established dosimetry will be laid down in the practical guides referred to in Article 14 In the case of a very localised source within a distance of a few centimetres from the body the induced electric field shall be determined dosimetrically case by case Action levels ALs for exposure to magnetic fields Low ALs Table B2 are for frequencies below 400 Hz derived from the sensory effects ELVs Table A3 and for frequencies above 400 Hz from the health effects ELVs for internal electric field Table A2 High ALs Table B2 are derived from the health effects ELVs for internal electric field related to electric stimulation of peripheral and autonomous nerve tissues in head and trunk Table A2 Compliance with the high ALs e
117. tion with regard to the design building manufacture or construction of work equipment or workplaces b take into account technical progress changes in the most relevant standards or specifications and new scientific findings concerning electromagnetic fields c make adjustments to the ALs where there is new scientific evidence provided that employers continue to be bound by the existing ELVs set out in Annexes II and MI 2 The Commission shall adopt a delegated act in accordance with Article 12 to insert into Annex II the ICNIRP guidelines for limiting exposure to electric fields induced by movement of the human body in a static magnetic field and by time varying magnetic fields below 1 Hz as soon as they are available 3 Where in the case of the amendments referred to in paragraphs 1 and 2 imperative grounds of urgency so require the procedure provided for in Article 13 shall apply to delegated acts adopted pursuant to this Article Article 12 Exercise of the delegation 1 The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article 2 The power to adopt delegated acts referred to in Article 11 shall be conferred on the Commission for a period of five years from 29 June 2013 The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period The delegation of power shall be tacitly exten
118. twithstanding paragraphs 2 and 3 exposure may exceed a the sensory effects ELVs Annex II Table A1 during the shift where justified by the practice or process provided that i they are exceeded only temporarily ii the health effects ELVs Annex IL Table A1 are not exceeded iii specific protection measures have been taken in accordance with Article 5 7 iv action is taken in accordance with Article 5 9 where there are transient symptoms under point b of that paragraph and v information on the situations referred to in point f of Article 6 has been given to workers b the sensory effects ELVs Annex II Table A3 and Annex III Table A2 during the shift where justified by the practice or process provided that i they are exceeded only temporarily ii the health effects ELVs Annex II Table A2 and Annex Il Table A1 and Table A3 are not exceeded Official Journal of the European Union L 179 5 iii action is taken in accordance with Article 5 9 where there are transient symptoms under point a of that paragraph and iv information on the situations referred to in point f of Article 6 has been given to workers CHAPTER II OBLIGATIONS OF EMPLOYERS Article 4 Assessment of risks and determination of exposure 1 In carrying out the obligations laid down in Articles 6 3 and 9 1 of Directive 89 391 EEC the employer shall assess all risks for workers arising from electromagne
119. vailability of measures to control the production of electromagnetic fields at the source the employer shall take the necessary actions to ensure that risks arising from electromagnetic fields at the workplace are eliminated or reduced to a minimum The reduction of risks arising from exposure to electromagnetic fields shall be based on the general principles of prevention set out in Article 6 2 of Directive 89 391 EEC 2 On the basis of the risk assessment referred to in Article 4 once the relevant ALs referred to in Article 3 and in Annexes II and III are exceeded and unless the assessment carried out in accordance with Article 4 1 2 and 3 demonstrates that the relevant ELVs are not exceeded and that safety risks can be excluded the employer shall devise and implement an action plan that shall include technical and or organisational measures to prevent exposure exceeding the health effects ELVs and sensory effects ELVs taking into account in particular a other working methods that entail less exposure to elec tromagnetic fields b the choice of equipment emitting less intense electrom agnetic fields taking account of the work to be done c technical measures to reduce the emission of electrom agnetic fields including where necessary the use of inter locks shielding or similar health protection mechanisms d appropriate delimitation and access measures such as signals labels floor markings barriers in
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