COMMISSION STAFF WORKING PAPER SUMMARY OF THE IMPACT ASSESSMENT
Date: 2011-06-14
Institutions: European Commission
Subjects: accident prevention, electromagnetic interference, humanisation of work, occupational safety

EUROPEAN COMMISSION 

Brussels, 14.6.2011 
SEC(2011) 751 final 

COMMISSION STAFF WORKING PAPER 

SUMMARY OF THE IMPACT ASSESSMENT 

Accompanying document to the 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the minimum health and safety requirements regarding the exposure of workers to 
the risks arising from physical agents (electromagnetic fields) (XXth individual Directive 
within the meaning of Article 16(1) of Directive 89/391/EEC) 

{COM(2011) 348 final} 
{SEC(2011) 750 final} 

 
 
 
 
  
 
 
 
 
 
TABLE OF CONTENTS 

POLICY CONTEXT.................................................................................................... 1 

CONSULTATION AND EXPERTISE ....................................................................... 1 

PROBLEM DEFINITION ........................................................................................... 2 

OBJECTIVES .............................................................................................................. 5 

POLICY OPTIONS ..................................................................................................... 6 

ANALYSIS OF IMPACTS.......................................................................................... 7 

COMPARING THE OPTIONS ................................................................................... 8 

MONITORING AND EVALUATION ....................................................................... 9 

POLICY CONTEXT 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

1. 

This  impact  assessment  addresses  the  protection  of  workers  exposed  to  high  levels  of 
electromagnetic  fields  (EMF)  during their work. This concern forms  part of the  general  EU 
policy  set  out  in  the  Treaty  on  the  Functioning  of  the  European  Union  (TFEU)  to  provide 
workers  appropriate  health  and  safety  protection  against  risks  encountered  during  their 
professional activities. 

2. 

CONSULTATION AND EXPERTISE 

For  legislative  initiatives  in  the  social  policy  field,  the  Treaty  provides  for  a  two-stage 
consultation of the social partners. The first stage (Article 154(2) TFEU) took place between 1 
July and 10 September 2009. The Commission received 16 replies to this consultation. 

The second stage of consultation under Article 154(3) TFEU took place between 20 May and 
5 July 2010 and was carried out independently from the impact assessment. 27 responses were 
received. 

The results can be summarised as follows: 

•  In general, both trade unions and employers agree that the current Directive is not 
the  ideal  instrument  and  that  there  is  a  basic  need  for  a  new  EU  initiative  to 
protect  workers  from  electromagnetic  fields.  However,  certain  employer 
representatives  (SMEs  and  national  organisations)  indicate  their  preference  for 
non-binding instruments instead of a directive.  

•  It is commonly accepted that the limit values in the current directive are too low 
and based on too conservative assumptions; but while the employers are in favour 
of  relaxing  the  limits,  the  workers’  representatives  want  the  long-term  health 
effects to be covered in the future Directive.  

•  Exempting  some  categories  of  workers  from  the  scope  of  the  Directive  is  not 
welcomed  by  industry  employers  (except  MRI  equipment  manufacturers).  Also, 

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allowing derogations from exposure limits in specific sectors (health care) poses 
some problems for industry. 

•  The social partners confirm that no category of workers should be excluded from 
the benefits of any new legal instrument, provided that the new instrument gives 
the appropriate flexibility needed to allow activities to be continued. 

•  While employers are very much in favour of a flexible approach also allowing for 
exceptions, workers’ organisations fear that flexibility may reduce the protection 
of workers unless there are strict controls. 

•  Adaptation of the exposure limit values defined in the Directive is acceptable to 
both  employers’  and  workers’  organisations,  along  with  the  introduction  of  a 
zoning approach to allow for light risk assessments in less problematic situations. 
There is also a consensus on the importance of operational guidance. 

•  Medical  checks  after  situations  of  overexposure  above  the  limit  values  are 
welcomed  as  a  default  approach  by  the  trade  unions.  Employers’  organisations 
and  the  medical  profession  raise  doubts  as  to  whether  this  is  reasonable  for  the 
low frequency range, where it might be difficult to detect effects. 

•  Derogations  from  the  limit  values  for  the  medical  sector  to  facilitate  MRI 
treatment  are  viewed  with  scepticism  by  other  sectors,  whereas  trade  unions 
recommend a sunset clause to avoid the erosion of protective legislation. 

Representatives  from  Member  States,  experts  and  stakeholders  were  consulted  extensively 
during the consultation and impact assessment.  

3. 

PROBLEM DEFINITION 

What is the problem? 

This  impact  assessment  addresses  the  protection  of  workers  exposed  to  high  levels  of 
electromagnetic fields during their work. This concern forms part of general EU policy set out 
in  the  Treaty  to  provide  workers  appropriate  health  and  safety  protection  against  risks 
encountered during their professional activities. That means this document deals only with the 
(high)  exposure  of  workers  during  their  work  and  not  with  the  (much  lower)  exposure 
encountered by the general public using mobile phones, living close to power lines or passing 
through metal detectors at airports. 

Workers  can  be  exposed  to  electromagnetic  fields  in  many  sectors  of  activity:  industrial 
processes  such  as  welding,  sealing,  broadcasting,  electricity  generation,  etc.  or  medical 
procedures  such  as  magnetic  resonance  imaging  (MRI).  The  health  consequences  of 
overexposure can differ depending upon the intensity and proximity of the sources on the one 
hand  but  also  upon  the  characteristics  of  the  electromagnetic  radiation  itself,  e.g.  its 
frequency. The symptoms of acute effects are well defined. In the high frequency range (e.g. 
broadcasting, radars), severe burns may occur, while in the low frequency range (e.g. welding, 
electricity  production  and  distribution),  induced  currents  can  affect  the  functioning  of  the 
central or peripheral nervous system and exposed persons can also experience vertigo, nausea, 
metallic  taste  feelings,  or  magnetophosphenes  (flashes  in  the  eyes).  In  very  rare  cases, 

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dramatic effects are also encountered when strong magnets attract a ferromagnetic object and 
cause it to strike a person inadvertently caught between the magnet and the metallic object. 

The issue of protecting workers exposed to EMF was already dealt with at EU level in 2004 
with the adoption of Directive 2004/40/EC1 of the EP and the Council. 

Very  rapidly,  it  transpired  that  the  Directive  as  adopted,  in  particular  the  binding  exposure 
limit  values,  would  create  major  implementation  problems  and  would  even  impede  some 
essential medical procedures and related research in cutting-edge medical applications such as 
MRI.  On  the  other  hand,  a  lot  of  new  scientific  information  was  becoming  available  with 
good  evidence  that  some  exposure  limits  in  the  Directive  were  too  conservative.  The  issue 
became  critical  as  the  deadline  for  transposition  of  the  Directive  by  the  Member  States 
approached. The Commission decided to undertake a full review of the situation. 

Who is affected and how? 

Overall,  according  to  data  from  stakeholders,  more  than  1 500 000  workers  (self-employed 
excluded) in more than 200 000 workplaces are concerned in the EU. 

Sector 

Electric energy 

Health care 

Metal industry 

Telecoms & broadcast 

Rail 

Other 
Total 

Source: stakeholder information 

Workers

Workplaces/assessments 

200 000

211 000

1 019 000

39 500

120 000

50 000
1 639 500

3 000 

13 000 

162 140 

11 000 

500 

25 000 
214 640 

Workers in both the medical sector and industry can be exposed to much higher levels than 
those defined for the general public. The general public normally has no access to areas where 
high exposure levels occur.  

The  table  below  shows  the  possible  health  effects  that  can  be  encountered  in  a  variety  of 
professional activities and the associated frequency range(s). 

Frequency range 

0 Hz 

Related activities 
Magnetic resonance technology 
Lifting cranes 
Electrochemical processes 

50 Hz 

Power lines 

Potential health problems 
Safety problems: uncontrolled 
attraction of ferromagnetic 
metals 
Health problems: vertigo, 
metallic taste feeling, headaches 
Headaches, magnetophosphenes, 

1 

Directive 2004/40/EC 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  risks  arising  from  physical 
agents  (electromagnetic  fields)  (18th  individual  Directive  within  the  meaning  of  Article  16(1)  of 
Directive 89/391/EEC). OJ L 184, 24.5.2004, p. 1. 

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Unwanted effects on the 
peripheral nervous system 

Effects on the nervous system 

Burns 
Thermal stress 

100 Hz - 10 000 kHz 

9 kHz - 
30 kHz -  
300 kHz -  

3 MHz -  

300 MHz -  

3 GHz -  

30 GHz - 

Production  and  distribution  of 
electricity 
Welding 
Magnetic  resonance  technology 
(gradient fields) 
Electric welding 
Industrial induction heating 
AM radio 
Industrial induction heating 
AM radio 
Plastic welding 
Dielectric pressing 
Induction hardening 
FM radio 
Wood processing 
TV 
Diathermia 
GSM 
Dielectric vulcanising 
Anti-theft protection systems 
Radars 
Satellites  
(communication with) 
Transmission  of  digital  and 
analogue video signals 

Source: AGORIA (BE) good practice guide 

The underlying drivers of the problem 

Recent  research2  indicates  that  Directive  2004/40/EC  is  stricter  than  necessary  on  certain 
points. Since the publication in 1998 of the recommendations of the International Commission 
for  Non-Ionising  Radiation  (ICNIRP)  published,  on  which  the  Directive  is  based,  new 
scientific  data  have  become  available  on  the  effects  of  low-frequency  fields.  These  data 
suggest that some of the current limits could be too low.  

Warnings from the medical sector in particular suggest that Directive 2004/40/EC, even with 
less strict recommendations, will rule out 5-8 % of medical procedures, because the exposure 
of  medical  staff  working  with  MRI  equipment  might  exceed  the  limits.3  That  would  be 
undesirable, because the use of MRI has many advantages for patients: the technique enables 
the  diagnosis  of  diseases  where  this  was  previously  impossible  and  surgical  intervention 

2 

3 

Forschungsbericht 400: Elektromagnetische Felder am Arbeitsplatz — Abschlussbericht, ISSN 0174-
4992, März 2010 (BMAS report). ICNIRP Guidelines: Guidelines for limiting exposure to time-varying 
electric and magnetic fields (1 Hz to 100 kHz): published in December 2010. 
1)  Project  VT/2007/017:  ‘An  Investigation  into  Occupational  Exposure  to  Electromagnetic  Fields  for 
Personnel Working With and Around Medical Magnetic Resonance Imaging Equipment’; final report 4 
April 2008. 
2)  ‘Assessment  of  electromagnetic  fields  around  magnetic  resonance  (MRI)  equipment’  (2007) 
http://www.hse.gov.uk/research/rrpdf/rr570.pdf. 

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without  the  use  of  X-rays,  while  almost  every  week  new  applications  are  developed  for  the 
benefit of patients. 

On the other hand, the safety and health of medical personal also needs to be ensured. 

State of implementation of the legal framework 

The existing legal frameworks in the Member States are very different. A detailed overview 
can be found in Annex 1 of the report. Very few have already started to transpose Directive 
2004/40/EC,  sometimes  allowing  some  flexibility  to  ensure  proper  use  of  MRI  techniques 
(although  such  flexibility  is  not  permitted  by  Directive  2004/40/EC).  Other  countries  are 
currently 
ICNIRP 
recommendations as a practical reference. Member States have put on ice the introduction of 
new national legislation to transpose Directive 2004/40/EC, awaiting clarification and a new 
proposal from the Commission. 

relying  on  existing  non-binding  standards  or  are  using 

the 

If the situation remains as it is, all 27 Member States will have to transpose the provisions of 
Directive 2004/40/EC by 30 April 2012. This would of course nullify the efforts made by the 
Commission  to  find  solutions  for  the  implementation  problems  raised  and  would  definitely 
not be the outcome expected by governments, social partners and most stakeholders.  

Right to act and subsidiarity  

Legislative action in the area of occupational health and safety is based on Article 153(1)(a) 
and (2) TFEU, which explicitly allows for European action in that field.  

Upon the adoption of Directive 2004/40/EC, the Commission, Parliament and Council were 
of  the  opinion  that  EU  action  was  the  best  way  to  protect  workers  from  risks  arising  from 
occupational exposure to electromagnetic fields. Currently, the Commission does not see any 
new evidence for deviating from the choice made by the Parliament and Council in 2004. The 
need to protect workers remains essential. Considering the situation pointed out under point 
2.5  of  the  report  and  the  need  for  review  recognised  by  all  parties,  it  appears  that  the 
Commission must act, using its right of initiative.  

4. 

OBJECTIVES 

Based on the general objective of protecting workers during their professional activities, the 
objective here is protection from harmful EMF.  

As exposure to EMF is a complex risk, there is a need is to define more specific measures to 
ensure adequate protection of workers while not unduly impeding the use and development of 
industrial  and  medical  techniques  or  imposing  disproportionate  burdens  on  enterprises,  in 
particular SMEs.  

The  operational  objective  is  to  ensure  the  effectiveness  of  the  measures  to  protect  workers 
exposed to EMF by setting appropriate limit values and  providing employers with adequate 
information on the necessary risk management measures. 

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5. 

POLICY OPTIONS 

Policy option A: ‘Do nothing’ 

In  practical  terms,  this  means  that  Directive  2004/40/EC  has  to  be  transposed  by  30  April 
2012 into legislation in all the Member States.  

Policy option B: ‘New Directive with revised exposure limits’ 

Directive 2004/40/EC is replaced by a new Directive with revised exposure limit values that 
are higher than the previous ones, but are in line with scientific evidence. Details are given in 
Annex 3 of the report. 

Policy option C1: ‘New Directive with revised exposure limits and partial exemptions’ 

Directive  2004/40/EC  is  replaced  by  a  new  Directive  with  revised  exposure  limit  values 
higher than the previous ones, but in line with scientific evidence (as in option B). In addition, 
conditional exemptions are provided for MRI, which will however remain subject to a general 
EMF risk management requirement.  

Policy option C2: ‘New Directive with revised exposure limits and complete exemption for 
MRI’ 

Directive  2004/40/EC  is  replaced  by  a  new  Directive  with  revised  exposure  limit  values 
higher than the previous ones, but in line with scientific evidence (as in option B). Medical 
MRI will be exempted entirely from all the requirements of the EMF Directive. 

Policy option D1: ‘Replacement of the Directive by a Recommendation’ 

Directive  2004/40/EC 
replaced  by  non-binding  occupational  EMF  exposure 
recommendations,  based  on  the  latest  international  recommendations.  The  form  of  these 
recommendations would be similar to the 1999 Council Recommendation on EMF exposure 
of the general public. 

is 

Policy option D2: ‘Voluntary agreements between the social partners’ 

Directive  2004/40/EC  is  replaced  by  voluntary  agreements  at  European  or  sectoral  level 
between social partners in accordance with Article 154(4) TFEU.  

Policy option E: ‘No EU legislation’ 

Directive  2004/40/EC  is  repealed  while  Directive  89/391/EEC  (Framework  Directive)  and 
existing national regulatory provisions on the subject remain in force. The absence of national 
regulations  in  some  Member  States  will  allow  unregulated  occupational  EMF  exposures, 
which  may  increase  risk,  reduce  equality,  etc.  For  this  option,  it  may  be  assumed  that  for 
example  those  countries  which  have  already  (partially)  implemented  the  EMF  Directive 
would not repeal their EMF legislation. 

These  options  were  considered  as  relevant  by  the  stakeholders.  Alternative  options  not 
analysed  in  detail  include  adopting  a  more  sectoral  approach,  restricting  legislation  to  the 
provision  of  safe  equipment  or  exclusively  focusing  on  ‘soft’  policy  instruments  such  as 
information campaigns and guidance documents. 

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6. 

ANALYSIS OF IMPACTS 

Starting point for the analysis of impacts 

The  baseline  for  the  analysis  is  to  assume  that  the  Framework  Directive  has  been  fully 
implemented but the specific EMF Directive has not yet been implemented. This corresponds 
to the actual legal situation. 

Discussions with experts and stakeholders have indicated that environmental impacts are not 
likely, so they have not been assessed.  

Social impacts 

The  main  social  impacts  are  the  potential  health  impact  on  about  1.5  million  workers, 
including  in  particular  a  much  smaller  number  of  particularly  sensitive  workers,  e.g.  those 
with  a  medical  implant  or  pregnant  women.  In  this  respect,  there  is  a  clear  preference  for 
options A, B and C1. Option A being most stringent, this might result in stringent protection 
only  on  paper.  Option  C2  ranks  behind  these  three,  as  the  protection  of  workers  in  high-
exposure areas is clearly weaker than with the other options. 

Other prominent social impacts are the benefits of critical medical MRI applications for the 
public. Options A and B will not provide sufficient flexibility to allow for all such treatments. 
All other options can provide this flexibility. 

Economic impacts 

Consistent  European  rules  that  allow  for  mobility  and  exchange  are  among  the  positive 
economic impacts. These are best guaranteed with options A, B, C1 and C2, whereas options 
D1, D2 and E are more likely to maintain a high level of insecurity. 

Another  important  economic  aspect  is  the  possibility  to  develop  a  business  with  as  few 
restrictions as possible, thus facilitating growth and maintaining or even creating employment 
in  Europe.  In  that  respect,  options  A  and  B  are  seen  as  rather  restrictive  and  hindering 
economic development in some areas to an extent not expected with any of the other options. 

Compliance and administrative costs 

Summary of total compliance and administrative costs for each option: 

Policy option 

Total costs (million euros) 

A: no change to 
EC/2004/40 

B: new ELVs for 
all sectors 

C1: possibility 
for derogation 
from ELVs 

C2: some 

660.3 

526.9 

511.7* 

497.4 

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workers excluded 

D1: non-binding 
recommendations 
only 

D2: sectoral 
agreements only 

E: no EU action 

437.1 

420.2 

474.0 

*including reinforced training for MRI 

Option A is the most expensive to implement. Option B involves lower implementation costs 
than  option  A  since  many  activities  in  the  metal  industry  such  as  induction  heating  and 
electrolysis would fall in most cases below the revised limits. Consequently, employers in the 
metal  industry  would  not  need  to  take  extensive  measures  to  reduce  exposure  by  changing 
working  practices.  However,  Option  B  is  more  expensive  than  other  options  because  of  the 
costs specifically associated with MRI. The other options will have very similar costs. 

Policy options C2 and E are evaluated under the assumption that employers will need to carry 
out a risk assessment additional to that required by the Framework Directive. Residual costs 
will occur for instance in the telecommunications and power generation/transmission sectors, 
which  would  continue  to  work  to  ICNIRP  recommendations  as  provided  for  in  Directive 
2004/40/EC because they do not represent a problem for them. 

SMEs  want  simplified  information  at  EU  level.  Simple  and  short  sector-specific  guidance 
documents  (checklist  type)  will  hence  be  needed  whichever  option  is  chosen.  Equipment 
labelling  and  better  manufacturer  information  might  help  identify  those  situations  where  no 
detailed assessment is required. 

7. 

COMPARING THE OPTIONS 

Whatever the option, the benefits cannot be described without difficulty. Health benefits can 
only  be  indicated  to  the  extent  that  no  adverse  effect  will  occur  below  the  current  or  future 
limits. This should favour options A to C2. 

Given  new  scientific  evidence  indicating  that  exposure  limits  under  option  B  will  ensure 
protection  against  overexposure,  option  A  only  adds  the  disadvantages  of  restricting  some 
activities and overall less willingness to comply.  

At  the  other  end  of  the  spectrum  of  possibilities,  options  D1  (Recommendation),  D2 
(Voluntary  agreement)  and  E  (No  EU  legislation)  can  be  rejected.  Stakeholders  and  experts 
expressed  a  strong  preference  for  consistent  European  legislation  giving  employers  and 
employees  legal  and  physical  security.  Although  EMF  on  its  own  is  not  a  major  issue, 
consistent  European  legislation  in  the  field  is  seen  as  contributing  to  the  single  European 
market.  Furthermore,  abstaining  from  any  European  action  on  EMF  would  significantly 
reduce the attention paid to the risks of EMF and could have negative health impacts.  

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The three remaining options are B (revised exposure limits), C1 (revised exposure limits and 
conditional  exemptions  limited  to  some  provisions  for  medical  MRI)  and  C2  (revised 
exposure limits and complete exemptions of some activities from the Directive).  

Option B has the advantage of consistent rules on EMF with exposure limits that are already 
high enough for a considerable number of workplaces, so that there is no longer a threat of 
overexposure. Compared to option A, the number of situations with potential overexposure is 
significantly  lower.  Option  B  is  in  line  with  recent  scientific  evidence.  The  disadvantage  of 
this  option  is  that  there  are  some  activities  (like  some  MRI  treatments)  where  temporary 
overexposure  is  possible.  Completely  stopping  these  activities  —  which  are  in  some  cases 
closely linked to technological progress and directly contribute to the health and well-being of 
the public — is problematic. 

Option C1 has the advantage of consistent rules on EMF in most areas, as for Option B, while 
allowing  derogations  from  exposure  limits  for  medical  MRI  with  reinforced  preventive 
measures in situations where there is a threat of overexposure. As in the case of option B, this 
relies  on  recent  scientific  evidence.  However, it  would  be  more  flexible  than  option  B.  The 
disadvantage of option C1 is that in the case of derogations it requires a more stringent and 
more controlled working environment.  

Option C2 also has the advantages of consistent rules on EMF in most areas, and allows for 
flexible  solutions  in  situations  where  there  is  a  threat  of  overexposure.  The  obligations  in 
terms  of  risk  assessment  are  lower  for  the  exempted  sector.  This  also  reduces  compliance 
costs.  The  disadvantage  of  this  option  is  the  risk  of  it  leading  to  lower  levels  of  worker 
protection. Furthermore, it would encourage greater variation in the protection of employees, 
going against both the letter and spirit of the Framework Directive. 

Conclusion on costs: The cost of Option C1 is higher than for the less stringent options C2 to 
E. However, for a rather limited increase in cost, Option C1 scores much better than the latter 
options  for  other,  more  qualitative  impacts,  and  guarantees  a  high  level  of  protection  for 
workers. The cost of Option C1 is significantly lower than for Option A and almost equivalent 
to Option B, while offering to the MRI sector and industry the flexibility they need.  

Consequently,  based  on  these  considerations  and  in  line  with  the  survey  results,  the 
Commission therefore prefers option C1. 

Survey assessment 

During  preparation  of  the  impact  assessment,  a  survey  was  carried  out  and  received  166 
replies.  Overall,  the  survey  results  consistently  show  that  option  C1  is  preferred  by 
stakeholders.  

8. 

MONITORING AND EVALUATION  

Framework  Directive  89/391/EEC  and  the  subsequent  19  individual  directives  under  its 
Article  16(1)  provide  for  regular  review  of  the  effectiveness  of  their  implementation.  Since 
2007, this systematic review has been harmonised and is performed every 5 years by all the 
Member  States  for  all  risks  covered  by  the  directives.  A  report  is  then  prepared  by  the 
Commission.  

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Also, committees bringing together national experts from EU Member States are an important 
part of the process of evaluating and monitoring EU legislation on health and safety at work. 
In particular, these include the tripartite Advisory Committee for Safety and Health at Work, 
set  up  by  Council  Decision  2003/C  218/01,  and  the  Senior  Labour  Inspectors  Committee 
(SLIC), set up by Commission Decision 95/319/EC.  

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