Electromagnetic fields and radiation, EC Directives 2004/40/EC and 2008/46/EC

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1 Fachhochschule Köln COLOGNE UNIVERSITY OF APPLIED SCIENCES Institute of Applied Optics and Electronics Electromagnetic fields and radiation, EC Directives 2004/40/EC and 2008/46/EC Prof. emeritus Dr. Hans-Dieter Reidenbach COLOGNE UNIVERSITY OF APPLIED SCIENCES Research Laboratory on Medical Technology and Non-Ionizing Radiation Secretary of the Working Group Non-Ionizing Radiation German-Swiss Association for Protection of Radiation (FS)

2 Fachhochschule Köln COLOGNE UNIVERSITY OF APPLIED SCIENCES Institute of Applied Optics and Electronics Overview Introduction Electromagnetic fields and radiation Biological effects Regulations: Occupational and Environmental Regulations and Guidelines for EMF ICNIRP Guidelines Council Recommendation 1999/519/EC European Directive 2004/40/EC European Directive 2008/46/EC Outlook

3 EMF Spectrum and Applications RFID/ EAS (mod. WHO)

4 ELF coupling to low-frequency electric fields coupling to low-frequency magnetic fields Electric fields do not penetrate the body significantly, but they do build up a charge on its surface Magnetic fields cause circulating currents to flow in the body Capacitive coupling Inductive coupling

5 Production of Electromagnetic Radiation (Waves) Antenna Direction of wave travel Oscillating charges Plane waves (mod. Pearson Prentice Hall, 2005)

6 Electromagnetic waves Properties The ratio of the electric field to the strength of the magnetic field is set, in accordance with Ohm s law, by the resistance of the medium (wave impedance) in which the radiation is traveling. Attenuation of electromagnetic waves is exponential, material and frequency dependent It is zero in vacuum low in low conductivity materials such as dielectrics and high in conducting materials.

7 Recent and future technologies Radiofrequency applications (100 khz 300 GHz) UWB Radio astronomy (modified)

8 Biological Effects of EMF?

9 Is that s what we are expecting? EMF = electrosmog

10 Where do we get the answer from?

11 RF Radiofrequency radiation emitted by mobile telephones has been investigated in a number of studies. There is some evidence that long-term and heavy use of mobile/cellular phones may be associated with moderate increased risks of gliomas, parotid gland tumours, and acoustic neuromas; however, evidence is conflicting and a role of bias in these studies cannot be ruled out. With reference to radio frequency, available data do not show any excess risk of brain cancer and other neoplasms associated with the use of mobile phones.

12 ELF Extremely low frequency electromagnetic fields generated by electrical power transmission have been associated with an increased risk of childhood leukemia, but findings are not conclusive. Even if this association is real, the number of access cases is likely to be very small.

13 IARC INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (published 2002)

14 EU and SCENIHR Health Effects of Exposure to EMF Opinion adopted by SCENIHR at the 28th plenary on 19 January pages -

15 SCENIHR Health Effects of Exposure to EMF Radio frequency fields (RF fields) (1) It is concluded from three independent lines of evidence (epidemiological, animal and in vitro studies) that exposure to RF fields is unlikely to lead to an increase in cancer in humans. However, as the widespread duration of exposure of humans to RF fields from mobile phones is shorter than the induction time of some cancers, further studies are required to identify whether considerably longer-term (well beyond ten years) human exposure to such phones might pose some cancer risk.

16 SCENIHR Health Effects of Exposure to EMF Radio frequency fields (RF fields) (2) The conclusion that scientific studies have failed to provide support for an effect of RF fields on selfreported symptoms still holds. Scientific studies have indicated that a nocebo effect (an adverse non-specific effect that is caused by expectation or belief that something is harmful) may play a role in symptom formation. From the risk assessment perspective it is important to recognize that information on possible effects caused by RF fields in children is limited.

17 Biological Effects and Exposure Standards Electrophysiology and Biophysics in ELF Biophysics in RF and Microwaves Biological effects primarily due to induced fields and currents Stimulation of electrically excitable tissues and heating ( thermal effects of EMF ) Increase of body temperature (general or local)

18 Interactions as a function of frequency (E vs f) Breakdown Whole body Partial body Fibrillation Shock Stimulation H e a t i n g Resonance Hot spots Surface Safety increases S a f e R e g i o n

19 Computational modeling: Contact currents E Left to right: Hand grounded Hand and feet grounded

20 Specific Absorption (SAR): Absorbed power in Watts/kg Normalized specific absorption rate (SAR) W/kg per W/m 2 Sub resonance Range X Resonance Range Whole Body Partial Body (Head) Hot Spot Range Surface Absorption Range X X f (MHz) SAR vs. Frequency

21 Calculated SAR distribution in the human body

22 Microwave Radiation Cellular Telephones

23 Phantoms (CST Microwave Studio,

24 SAR = f(frequency) adapted DMF, SSK: Mikrodosimetrie HF, 2009 Statement by the German Commission on Radiological Protection

25 International project: Objectives To determine whether: Mobile phone use increases the risk of cancer and, specially, whether the RF emitted by mobile phones is carcinogenic. To examine the association with unknown and suspected risk factors, including: ionising radiation, occupational EMF exposure, medical history of subject and family Common core protocol 13 countries Study period: 2000 until late Largest epidemiological study of tumours like glioma, acoustic neurinoma, meningioma to date Final report still not available

26 IARC and WHO lack behind the time schedule RF-Fields 20xx?

27 DMF The German Mobile Telecommunication Research Programme (DMF) is completed. The results of research projects in the fields of biology, dosimetry, epidemiology, and risk communication, will be incorporated in the international risk assessment on the impact of high frequency electromagnetic fields on humans.

28 Regulations: Occupational and Environmental Regulations and Guidelines for EMF

29 ICNIRP develops guidelines which are intended to provide adequate protection against known adverse impacts on human health resulting from direct and indirect EMF exposure

30 ICNIRP EMF-Guidelines Guidelines for limiting exposure to timevarying electric, magnetic, and electromagnetic fields (up to 300 GHz) Health Physics 74: (1998) Guidelines on Limits of Exposure to Static Magnetic Fields Health Physics 96(4): (2009) Guidelines on Limiting Exposure to Time- Varying Electric and Magnetic Fields (1Hz to 100 khz) Currently Draft (Consultation until October, 31 th )

31 From hazard to maximum permissible values Field size Threshold Basic restriction Reference level Damage Hazard Impairment No impact on the biological system 2 10 ELF Stimulation of electrically excitable tissues RF Increase of body temperature (general or local) Occupational/ workers 2 5 Reduction factor General public Workers Basic restriction 0.4 W/kg General public 1/5 Basic quantities of the biological system Measurable quantities external of the biological system

32 Basic restrictions and reference levels Established adverse health effects due to EMF exposure Basic restrictions (Exposure limits) Reference levels (Action values) Reduction factor Additional safety Direct relation with effects in human body: body currents J (A/m 2 ) and/or difficult internal electrical field E i (V/m) to heat generation SAR (W/kg) determine SAR = σ E 2 /ρ where σ is the tissue conductivity and ρ is the density Conservative limits on: electric field strength E (V/m) more magnetic field strength H (A/m) easy to contact current I (A) measure magnetic flux density B in µt H in A/m

33 Dosimetric Parameters Used for ICNIRP Basic Restrictions Frequency Range 1 Hz 10 MHz 1 Hz 110 MHz 100 khz 10 GHz 10 GHz 300 GHz Pulsed Fields 300 MHz 10 GHz Parameter (units) J (A/m 2 ) I (A) SAR (W/kg) S (W/m 2 ) SA (J/kg) will most likely be changed to internal electrical field strength (V/m)

34 ICNIRP (1998) exposure limits for electric field strength E and power density E = 87 V/m E = 61 V/m E = 27 V/m

35 20-22 March, 2006 Berlin, ICNIRP International Workshop on EMF Dosimetry and Biophysical Aspects Relevant to Setting Exposure Guidelines

36 Revised ICNIRP guidelines Static magnetic field (2009): Primary change from ICNIRP s previous 1994 guidelines: removal of time averaging. Occupational exposure: Previously a whole-working-day timeaveraged exposure limit of 200 mt, now removed. Acute exposure limit: Head and trunk: stays at 2 T, Limbs: increased from 5 to 8T. Under controlled conditions: up to 8 Tesla General public: increased from 40 mt for continuous exposure to 400 mt (any part of the body). ELF: Draft for consultation (until October 31, 2009) Exposure limit values no longer given as current density but instead as internal electric field strength in the tissue

37 Situation in the European Union EU 27? The human exposure to EMF is regulated at European level in a twofold way

38 Situation in the European Union General Public For the general public, Council Recommendation 1999/519/EC stipulates maximum exposure limits based on the ICNIRP guidelines Nevertheless, Article 153 of the European Treaty grants the member states the right to set stricter limit values in their obligation to govern public health and safety

39 1999/519/EC (1) COUNCIL RECOMMENDATION on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz) published on 12 July 1999 Legal Basis: Article 152 of Amsterdam Treaty A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities Community action which shall complement national policies, shall be directed towards improving public health, preventing illness and disease and obviating source of danger to health But limits through:... excluding any harmonization of the laws and regulations of the Member States

40 1999/519/EC (2) The requirements could be published as recommendations only, since the EC does not have regulation competency as far as the general public is concerned Although the respective basic restrictions and reference levels are not mandatory they are treated de facto like those and are accepted in the EC

41 Situation in the European Union Workers For occupational exposure directive 2004/40/EC as individual physical agents directive issued under the occupational health and safety framework directive 89/391/EEC sets the minimum health and safety requirements based on the maximum occupational exposure limits of the ICNIRP guidelines Choice of the Member States The member states are free to either accept the given limit values as a minimum requirement or introduce lower values in national legislation

42 EU-Directive 2004/40/EC

43 History (1) In 1989 the EC Parliament mandated the EC Commission to compile directives for the protections of workers from physical agents Draft Proposal was adopted by the Commission on December 23, 1992 [COM(92) 560 final]; included 4 physical agents: Noise, Vibrations, EMF and Optical radiation in separate annexes Amended proposal after the opinion of the EP on 20 April 1994 was published on 19 August 1994 But the European Council postponed the directive

44 History (2) Discussions started at Council level in 1999 during German Presidency of the European Council. Initial proposal was split into 4 directives The Danish Presidency and the Commission services (EMPL DG4) organized a Seminar in September 2002 to update knowledge on EMF From September 2002 until October 2003: discussion in Council and European Parliament (compromise on static fields) Political agreement was adopted by the Employment, Social Policy, Health and Consumer Affairs Council on 20 th October 2003

45 History (3) The final draft was agreed upon by the Council and the European Parliament and published on April 29, 2004

46 Limitation of emissions (1999/519/EC) and assessment of the exposure of people (2004/40/EC) Mandate M/305 of 7 September 2000 instructs the European standardization organizations CEN, CENLEC and ETSI to produce emission standards for devices (Product Standards) Mandate M/351 has been addressed to CEN, CENLEC and ETSI in 2004 to develop standards for the assessment, measurement and calculation of workers' exposure CENELEC committee TC 106X Human Exposure to Electromagnetic Fields is working intensively on standards for products/ product groups and on product independent Basic- and Generic standards

47 Let s have a closer look on 2004/40/EC Article 1: Aim and Scope Risks from exposure to electromagnetic fields EMF (0 Hz to 300 GHz) Risks due to known short-term adverse effects in the human body It does not address long-term effects It does not address risks resulting from contact with live conductors

48 Article 2: Definitions Electromagnetic fields: static magnetic and time-varying electric, magnetic and electromagnetic fields with frequencies up to 300 GHz ^ Exposure Limit Values = Occupational Basic Restrictions Action Values = ^ Occupational Reference Levels

49 Article 3: Exposure limit values and action values Based on ICNIRP recommendations No ceiling values for Static Magnetic fields Annexes of the directive (Tables 1 and 2) Exposure limit values are quantities directly related to biological considerations: up to 10 MHz: Induced body current densities in A/m 2 above 100 khz: Specific Absorption Rate (SAR) in W/kg However, these quantities are difficult to measure For practical exposure assessment action values are derived from the exposure limit values in terms of electric field strength or magnetic flux density. Compliance with the action values ensure compliance with the relevant exposure limit values

50 Table 1 Exposure limit values (ELVs)

51 Table 2 Action values (AVs) (=measured without the presence of workers)

52 Article 4: Determination of exposure and assessment of risks (1) The employer shall assess and, if necessary measure and calculate the level of EMF to which workers are exposed On the basis of the assessment, if the Action Values are exceeded, the employer shall assess and calculate whether the exposure Limit Values are exceeded The assessment, measurement and calculations may not be carried out in workplaces open to the public provided that an evaluation has been undertaken in accordance with 1999/519/EC Council Recommendation The assessment, measurement and calculations shall be planned and carried out at suitable intervals. Data shall be preserved

53 Article 4: Determination of exposure and assessment of risks (2) The employer shall give particular attention to: The level, frequency spectrum, duration and type of exposure The Exposure Limit Values and Action Values Any effects concerning the health and safety of workers Any indirect effects such as: interference with medical electronic devices; projectile ferromagnetic objects in static magnetic fields; initiation of electro-explosive devices; ignition of flammable material by sparks caused by induced fields and/or contact currents or spark discharges The existence of replacement equipment to reduce the levels of exposure Appropriate information obtained from health surveillance Multiple sources of exposure, and simultaneous exposure to multiple frequency fields

54 Article 5: Provisions aimed at avoiding or reducing risks The risk shall be controlled at the source, eliminated or reduced to a minimum If the Action Values are exceeded and unless it is demonstrated that the Exposure Limit Values are not exceeded, the employer shall devise and implement an action plan to prevent exposure exceeding the Limit Values, taking into account: Other working methods that entail less exposure The choice of equipment emitting less EMF Technical measures to reduce the emission including the use of interlocks Appropriate maintenance programs The design and layout of workplaces Limitation of the duration and intensity of the exposure The availability of adequate PPE (personal protective equipment)

55 Articles 6, 7, 8 and 9 Article 6: Workers information and training The employer shall ensure that workers who are exposed to EMF receive any necessary information and training Article 7: Consultation and participation of workers In accordance with Article 11 of Directive 89/391/EEC Article 8: Health surveillance Appropriate health surveillance shall be carried out according to Articles 14 and 15 of Directive 89/391/EEC Article 9: Sanctions

56 Article 10: Technical amendments Modifications of exposure Limit Values and Action Values in accordance with Article 137(2) of the Treaty Amendments to the Annex of a strictly technical nature, in accordance with procedure in Article 10 of this Directive

57 Articles 11, 12 and 13 Article 11: Committee The Commission shall be assisted by the Committee referred to in Article 17 of the Directive 89/391/EEC Article 12: Reports Article 13: Transposition Not later than 4 years after the entry into force (30 April 2008)

58 2004/40/EC Compromises No exposure limit value set for static magnetic fields Reinforcement of provisions relating to information of workers Reinforcement of provisions relating to medical surveillance Regime of sanctions Review of situation after 5 years

59 Non-binding guide

60 Implementation problems Concerns recently reported to the Commission: In welding In medical MRI Reason: The requirement in any event, workers shall not be exposed above the limit values results in a severe conflict with the application of MR, according to the MRI-Lobby

61 EMF Fields Directive Status Quo Physical Agents (Electromagnetic Fields) Directive (2004/40/EC amended by 2008/46/EC) Originally Member States had to implement the Directive until 30 April Amended by a new Directive 2008/46/EC which has reset the implementation date to 30 April Legal basis: Article 137, to implement improvements of the working environment to protect workers health and safety.

62 Reasons for 2008/46/EC New scientific studies on the impact on health of exposure to electromagnetic radiation, made public after the Directive was adopted, have been brought to the attention of the European Parliament, the Council and the Commission. The results of those scientific studies are currently being examined by the ICNIRP as part of the on going review of its recommendations on the one hand, and by the World Health Organization as part of the review of its environmental health criteria on the other. Those new recommendations, due to be published by the end of 2008, are likely to contain elements that could lead to substantial amendments to the action and limit values.

63 2008/46/EC In this context, the potential impact of the implementation of Directive 2004/40/EC on the use of medical procedures based on medical imaging and certain industrial activities should be reconsidered thoroughly. A study has been launched in 2007 by the Commission to assess directly and quantitatively the situation regarding medical imaging. to ensure a balance between the prevention of potential risks to the health of workers and access to the benefits available from the effective use of the medical technologies in question. In addition harmonized standards, which are essential for ensuring smooth application of the Directive, must be taken into account and are expected in 2008.

64 Work already done and current work Adoption of directive 2008/46/EC of 23 April 2008 by EP and Council Preparation of a new substantial proposal on the basis of new & the most recent elements Action 1: analyze MRI study (April 2008) Action 2: call for tender for a study to support an Impact Assessment (September 2009) Action 3: analysis of other recent studies and new ICNIRP recommendations ( static, May 2009; ELF draft July 2009) Action 4: discussions with social partners and stakeholders

65 The way forward ideal scenario Challenge 1: timing Ideal plan: Commission proposal to Council and EP adopted by end of April 2010! By April 2011 (?): new directive adopted by EP and Council (2011/XY/EC) By April 2012 (?): new directive transposed by Member States

66 Formal, compulsory steps 1st phase of consultation of Social Partners (Art 138 (2) of Treaty) 2.To this end, before submitting proposals in the social policy field, the Commission shall consult management and labour on the possible direction of Community action. 2nd phase of consultation of Social Partners (Art 138 (3) of Treaty) 3. If, after such consultation, the Commission considers Community action advisable, it shall consult management and labour on the content of the envisaged proposal. Management and labour shall forward to the Commission an opinion or, where appropriate, a recommendation. Comprehensive Impact Assessment

67 1st phase of consultation Options proposed: No change: directive 2004/40/EC applies New binding legislation (+due flexibility) Only non binding recommendations No Community action for EMF: political decision 6 July - 25 September formal answers received BUSINESS EUROPE, CBI, CEEMET, CEEP, CER, DGB, EEF, EFBWW, EMC, ENTSO-E, EPSU, ETUC, EURELECTRIC, HOSPEEM, UEAPME

68 IMPACT OF DIFFERENT POLICY OPTIONS (1) A Current Directive as such B New (ICNIRP) limits C1 Requirement to do EMF risk assessment, possibility to move beyond (new) limits C2 Sector/industry/activity exemptions D1 Non-binding Recommendation D2 Voluntary sector/eu-level agreements E Withdraw Directive

69 IMPACT OF DIFFERENT POLICY OPTIONS (2) Option A was generally considered to have disproportionate economic costs, especially for SMEs Option B has been difficult to assess in the absence of new exposure guidelines from ICNIRP; it has rather high economic consequences but scores well on social and health impact Option C1 was the only option to score consistently positively in the stakeholder-based analysis Options D and E scored badly on health and social impact grounds Option E especially was unpopular with most stakeholders

70 2nd consultation of Social Partners (Art 138 (3) of Treaty) More concrete proposals Main points addressed Identified problems Exposure Limit Values & Action Values (Art. 2 & 3) Assessment, measurement & calculation (Art. 3.3) Guidance for Risk Assessment (Art. 4) Difficulties for SMEs (general)

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