Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/40/EC on minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (eighteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
Date: 2007-10-26
Institutions: European Commission
Subjects: Cenelec, European standard, electromagnetic interference, occupational health, occupational safety

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.10.2007 
COM(2007) 669 final 

2007/0230 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Directive 2004/40/EC on minimum health and safety requirements regarding 
the exposure of workers to the risks arising from physical agents (electromagnetic fields) 
(eighteenth individual Directive within the meaning of Article 16(1) of Directive 
89/391/EEC) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1)  CONTEXT OF THE PROPOSAL 

•  Grounds for and objectives of the proposal 

The  aim  of  this  proposal  is  to  postpone  until  30  April  2012  the  deadline  for  the 
transposition of Directive 2004/40/EC1 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). 

In  2006,  the  medical  community  informed  the  Commission  of  its  concerns  regarding 
the implementation of this Directive, claiming that the exposure limit values laid down 
therein would limit to a disproportionate extent the use and development of magnetic 
resonance  imaging  (MRI),  considered  today  to  be  a  vital  tool  for  the  diagnosis  and 
treatment of several diseases. Other industrial sectors also subsequently expressed their 
concerns about the impact of the Directive on their activities. 

In  response  to  these  concerns,  the  Commission  has  taken  a  number  of  measures.  For 
reasons of transparency, it contacted the Member States and the European Parliament 
to inform them of the measures it planned to take. In this context, it asked the Member 
States to inform it of any difficulties associated with implementation of the Directive. 
It  also  launched  a  study  to  assess  the  real  impact  of  the  Directive  on  medical 
procedures using MRI. The results of this study will be available in early 2008 and will 
be sent to the Member States and the European Parliament. 

Meanwhile,  the  results  of  a  British  Government  study  on  the  "Assessment  of 
electromagnetic  fields  around  magnetic  resonance  imaging  (MRI)  equipment"  and 
"Comments  concerning  possible  MRI  restrictions  due  to  implementation  of  an  EU 
Directive" formulated by the Health Council (Gezondheidsraad) of the Netherlands, in 
cooperation  with  its  Belgian  counterpart,  have  recently  been  published.  These  two 
high-level scientific documents confirm the possibility that the limit values established 
in the Directive may interfere with medical procedures using MRI. 

the 

International  Commission 

for  Non-ionising  Radiation 
Moreover, 
Protection (ICNIRP) is currently reviewing the guidelines on static magnetic fields and 
low-frequency time-varying fields on which the Directive is based. In both cases, new 
recommendations  will  probably  provide  for  less  strict  limit  values  for  low-frequency 
fields than those laid down in the Directive. These changes are likely to be backed up 
by  the  new  scientific  studies  conducted  since  the  adoption  of  the  Directive.  The  new 
recommendations  of  the  ICNIRP  are  expected  in  November  2007  and  autumn  2008 
respectively. 

The  World  Health  Organisation  (WHO)  is  also  currently  revising  its  environmental 
health criteria for electromagnetic fields in order to reflect the latest scientific studies 
available. 

The  deadline  for  transposition  of  Directive  2004/40/EC  into  the  law  of  the  Member 

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OJ L 184, 24.5.2004, p. 23. 

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States is 30 April 2008. In view of the above-mentioned developments,  this deadline 
should be postponed for four years: 

-  to  allow  a  full  analysis  of  the  studies,  including  that  launched  by  the  Commission, 
regarding  the  potential  negative  impact  of  the  exposure  limit  values  set  by  the 
Directive on the medical use of MRI; 

-  pending  the  results  of  the  review  of  the  ICNIRP  recommendations,  to  take  into 
account  the  WHO's  environmental  health  criteria  for  electromagnetic  fields  based  on 
the latest scientific studies concerning the impact of electromagnetic fields on human 
health published since the adoption of the directive and, finally, 

-  to  conduct  an  in-depth  impact  analysis  of  the  Directive's  provisions  and  propose 
amendments to it in order to guarantee both a high level of health and safety protection 
for workers and the continuation and development of medical and industrial activities 
using electromagnetic fields. 

•  General context 

Directive  2004/40/EC  is  the  18th  individual  Directive  within  the  meaning  of  Article 
16(1)  of  Council  Directive  89/391/EEC  of  12  June  1989  on  the  introduction  of 
measures  to  encourage  improvements  in  the  safety  and  health  of  workers  at  work.  It 
relates  to  the  harmful  short-term  effects  of  occupational  exposure  to  electromagnetic 
fields for the health and safety of workers. 

The  provisions  of  the  Directive  are  minimum  requirements,  with  each  Member  State 
free to adopt stricter rules. 

The  Directive  establishes  exposure 
limit  values  for  electric,  magnetic  and 
electromagnetic fields, varying in time with frequencies of between 0 and 300 GHz2. 
No  worker  may  be  exposed  to  values  exceeding  these  limits,  which  are  based  on  the 
health impact and biological considerations. 

The  Directive  also  sets  action  values  for  time-varying  and  static  fields.  These  action 
values  are  levels  expressed  in  values  which  are  directly  measurable  and  indicate  a 
threshold above which employers must take one or more of the actions provided for in 
the  Directive.  Compliance  with  these  action  values  will  ensure  compliance  with  the 
relevant exposure limit values. 

The  limits  imposed  by  the  Directive  were  established  on  the  basis  of  the 
recommendations issued by the ICNIRP, the organisation internally recognised as the 
authority  on  assessment  of  the  health  impact  of  this  type  of  radiation.  The  ICNIRP 
works closely with all the relevant international organisations, such as the WHS, ILO, 
IRPA, ISO, CENELEC, IEC, CIE, IEEE, etc. 

The  Directive  is  based  on  the  prevention  philosophy  already  provided  for  in  more 
general terms in framework Directive 89/391/EEC: 

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300  GHz:  frequency  of  300  billion  hertz.  The  hertz  (abbreviation  Hz)  is  the  international  unit  of 
frequency. 

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all workers, whatever their sector of activity, exposed to the same risks have 
the same right to be protected; 

obligation on employers to determine and assess risks; 

elimination or, where this is impossible, minimisation of risks identified; 

specific  information  and  training  for  and  consultation  of  the  workers 
concerned; 

appropriate medical surveillance. 

The  Directive  applies  to  all  sectors  of  activity  without  exception  and  has  to  be 
transposed into national legislation no later than 30 April 2008. 

During the discussions preceding its adoption, the specific case of medical resonance 
imaging  was  discussed  in  detail  by  both  the  Council  and  the  European  Parliament. 
National  experts  from  institutions  such  as  the  National  Radiation  Protection  Board 
(NRPB,  UK),  the  Institut  national  de  recherche  et  de  sécurité  (INRS,  France),  the 
Finnish  Institute  of  Occupational  Health  (FIOH,  Finland)  and  the  Bundesamt  für 
Strahlenschutz  (BfS,  Germany)  provided  technical  support  for  the  negotiations  in the 
Council.  The  Council  Presidency  sought,  on  several  occasions,  the  opinion  of  the 
ICNIRP. 

In the absence of any evidence of an undesirable impact, the joint legislators adopted 
the  Directive,  with  certain  amendments  to  the  values  originally  proposed  by  the 
Commission, in particular not setting an exposure limit value for static magnetic fields, 
an essential component of MRI, because this value was being amended in the light of 
the latest scientific findings which appeared as the Directive was being adopted. 

•  Consistency with other Union policies and objectives 

This  proposal  is  consistent  with  the  objectives  of  the  other  policies  of  the  European 
Union, in particular those concerning the improvement of the regulatory framework in 
order  to  develop  a  clear,  understandable,  up-to-date  and  user-friendly  body  of 
secondary Community legislation, in the interests of citizens and economic operators. 
The report on the implementation of Directive 2004/40/EC at national level will allow 
a  better  assessment  of  its  impact  on  the  protection  of  workers  and  on  medical 
procedures  using  MRI  and  certain  industrial  procedures.  It  will  also  allow  the 
provisions of the Directive to be updated in the light of the latest scientific findings on 
the impact of electromagnetic radiation on health, which were not yet available at the 
time of its adoption. 

2)  CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Consultation of interested parties 

Consultation methods, main sectors targeted and general profile of respondents 

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Consultation of the Advisory Committee for Safety, Hygiene and Health Protection at 
Work, in accordance with the Council Decision of 22 July 2003 on the setting-up of an 
Advisory Committee on Safety, Hygiene and Health Protection at Work, which issued 
a favourable opinion. 

Consultation of the national authorities in the Member States by way of letters to the 
Permanent Representations. 

Consultation of scientific experts in this area and of the International Commission for 
Non-ionising Radiation Protection at bilateral meetings with the Commission. 

Given  the  nature  of  the  proposal,  which  affects  only  the  date  of  transposition  of  the 
Directive without amending the provisions themselves, and after consultation with the 
Legal  Service  and  the  Secretariat-General  of  the  Commission,  it  was  decided  that  it 
was not necessary in this case to consult the social partners at European level, pursuant 
to Article 138 of the EC Treaty. 

Summary of responses received 

The representatives of the social partners and the government representatives of the 27 
Member States in the Advisory Committee for Safety, Hygiene and Health Protection 
at Work confirmed, at the plenary meeting on 21 June 2007, the position presented by 
the  Working  Group  on  Electromagnetic  Radiation  responsible  for  assisting  the 
Commission  on  the  issue  of  MRI.  The  Committee  came  out  in  favour  of  an  overall 
solution  for  all  categories  of  workers  and  a  postponement  of  the  deadline  for 
transposing  the  Directive  into  national  legislation.  More  time  is  needed  to  clarify  the 
interpretation of exposure to static magnetic fields and the currents they generate and 
for the ICNIRP to definitely issue its new recommendations. Postponing the deadline 
for transposition would also mean that the levels of exposure could be evaluated and 
calculated on the basis of harmonised European standards, currently being drawn up by 
Cenelec and due in the spring of 2008. 

In their responses to the letters sent by the Commission, the Member States confirmed 
their concerns about the difficulty of applying the current text of the Directive in the 
health sector and were in favour of postponing the deadline for transposition so that the 
Commission,  during  this  period,  can  present  amendments  which  allow  MRI  to  be 
maintained and developed whilst ensuring the health protection of workers. 

The  consultations  with  the  scientific  experts  and  the  ICNIRP  confirm  the  view  that 
certain limit values defined in the Directive could be considered too binding in the light 
of  new  scientific  findings  and  thus  have  a  negative  impact  on  the  use  of  magnetic 
resonance  equipment  and  certain  industrial  procedures.  It  was  also  found  during  the 
consultations  that  the  recommendations  of  the  ICNIRP,  which  form  the  basis  of  the 
Directive, are being reviewed and that new recommendations and a new version of the 
WHO's  environmental  health  criteria  for  electromagnetic  radiation  will  be  available 
towards the end of 2008.  

•  Gathering and use of expertise 

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The  Commission  consulted  with  scientific  experts  regarding  the  impact  on  health  of 
electromagnetic radiation, recognised at international level, and drew on the results of a 
study launched by the British Government to assess the electromagnetic fields around 
MRI equipment, and on the opinion of the Netherlands Health Council. The outcome 
was  a  recommendation  to  postpone  the  date  of  transposition  of  the  Directive.  The 
Commission has also launched a study to determine exposure levels for medical staff 
and their impact on the procedures used for medical MRI, the results of which are due 
in early 2008.  

•  Impact assessment 

Option 1: Do nothing at this stage. This would oblige the Member States to transpose 
the Directive into national law by the date set and to enforce it, with potentially serious 
consequences  on  the  continuity  of  healthcare  services  using  MRI.  Certain  industrial 
activities could also be adversely affected. 

Option 2: Postponing the date of transposition would not unduly impede either the use 
of  MRI  or  other  industrial  activities.  At  the  same  time,  the  exposure  limit  values  for 
those  who  work  with  electromagnetic  fields  are  being  reviewed  by  the  scientific 
community.  Postponement  would  thus  give  sufficient  time  for  the  Directive,  in 
particular the limit values contained therein, to be updated, in the light of new scientific 
findings,  in  order  to  guarantee  both  a  high  level  of  protection  for  workers  and  the 
continuity of economic activities. 

The  proposed  amendment  affects  only  the  obligation  on  Member  States  to  transpose 
the  Directive  by  30  April  2008.  It  does  not  impose  additional  obligations  on 
enterprises. 

Given  its  nature,  this  proposal  has  not  been  subjected  to  a  more  detailed  impact 
analysis. 

3)  LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed measures 

The  proposal  amends Article 13(1) of  Directive 2004/40/EC in order to postpone the 
date of transposition until 30 April 2012. 

•  Legal basis 

Article 137(2) of the EC Treaty. 

•  Subsidiarity principle 

The  subsidiarity  principle  applies  in  so  far  as  the  proposal  concerns  a  field,  the 
protection of the health and safety of workers at work, which does not fall under the 
exclusive competence of the Community. 

The objectives of the proposal cannot be achieved sufficiently by the Member States, 

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as the provisions of directives cannot be amended or repealed at national level. 

The  objectives  of  the  proposal  can  be  achieved  only  by  Community  action,  as  this 
proposal amends an act of Community law which is in force, which cannot be done by 
the Member States themselves. 

The principle of subsidiarity is respected in as much as the proposal amends existing 
Community provisions. 

•  Proportionality principle 

The proposal complies with the proportionality principle for the following reason. 

It is restricted to postponing the date for transposing the Directive until 30 April 2012, 
in order to give the necessary time to analyse its impact, inter alia on the use of MRI, 
and to update it in line with new scientific knowledge. 

•  Choice of instruments 

Proposed instrument(s): directive. 

No other instruments would have been suitable. As this is an amendment of a directive, 
the only way forward is to adopt a directive. 

4)  BUDGETARY IMPLICATION 

The proposal has no implication for the Community budget. 

5)  ADDITIONAL INFORMATION 

•  Simplification 

The  proposal  does  not  simplify  the  legislative  framework.  It  is  aimed  solely  at 
postponing the date for transposition of Directive 2004/40/EC to 30 April 2012. 

•  Repeal of existing legislation 

The adoption of the proposal will not entail the repeal of existing legislation. 

•  European Economic Area 

This draft instrument is concerned with a subject covered by the EEA Agreement and 
must therefore be extended to cover the European Economic Area. 

•  Detailed explanation of the proposal by chapter or by article 

This  proposal  amends  the  date  of  transposition  of  Directive  2004/40/EC  to  30  April 
2012. These four extra years to transpose the provisions of the Directive into national 
law  are  justified  by  the  concerns  expressed,  and  in  some  cases  confirmed,  that  the 
exposure limit values laid down in the Directive could have a disproportionate impact 

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on the continuity of medical procedures using magnetic resonance imaging, and by the 
need  to  give  the  scientific  community  sufficient  time  to  evaluate  the  latest  scientific 
studies on the health impact of electromagnetic radiation, on which the limit values and 
the provisions of the Directive are based. 

Article  1 of  the  proposal  amends  Article  13(1)  "Transposition"  of  Directive 
2004/40/EC accordingly. 

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2007/0230 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Directive 2004/40/EC on minimum health and safety requirements regarding 
the exposure of workers to the risks arising from physical agents (electromagnetic fields) 
(eighteenth individual Directive within the meaning of Article 16(1) of Directive 
89/391/EEC) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
137(2) thereof, 

Having regard to the proposal from the Commission3, 

Having regard to the opinion of the European Economic and Social Committee4, 

Having regard to the opinion of the Committee of the Regions5, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty6, 

Whereas: 

(1) 

(2) 

Directive  2004/40/EC  of  the  European  Parliament  and  of  the  Council7  establishes 
minimum  health  and  safety  requirements  to  protect  workers  against  the  risks  arising 
from  exposure  to  electromagnetic  fields.  Article  13(1)  of  the  said  Directive  provides 
that  Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions necessary to comply with the Directive no later than 30 April 2008. 

Directive  2004/40/EC  provides  for  action  values  and  limit  values  based  on  the 
recommendations  of  the  International  Commission  for  Non-ionising  Radiation 
Protection.  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 these scientific studies are currently being examined by the International 
Commission for Non-ionising Radiation Protection as part of the ongoing review of its 
recommendations, on the one hand, and by the World Health Organisation as part of 
the  other.  These  new 
the  review  of 

its  environmental  health  criteria,  on 

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OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 184, 24.5.2004, p. 23. 

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recommendations,  due  to  be  published  by  the  end  of  2008,  are  likely  to  contain 
elements which could lead to substantial amendments to the action and limit values. 

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  by  the 
Commission  to  assess  directly  and  quantitatively  the  situation  regarding  medical 
imaging. The results of this study, which are expected in early 2008, should therefore 
be taken on board, in addition to the results of similar studies launched in the Member 
States,  in  order  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. 

Article  3(3)  of  the  Directive  provides  that  the  assessment,  measurement  and/or 
calculation of workers' exposure to electromagnetic fields are governed by harmonised 
European  standards  of  the  European  Committee  for  Electrotechnical  Standardisation 
(Cenelec).  These  harmonised  standards,  which  are  essential  for  ensuring  smooth 
application of the Directive, must be taken into account and are expected in 2008. 

The  time  required  to  obtain  and  analyse  this  new  information  and  to  draw  up  and 
adopt  a  new  proposal  for  a  directive  justifies  the  four-year  postponement  of  the 
deadline for transposition of Directive 2004/40/EC, 

(3) 

(4) 

(5) 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Article 13(1) of Directive 2004/40/EC is hereby amended as follows: 

"1.  The  Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions  necessary  to  comply  with  this  Directive  no  later  than  30  April  2012.  They  shall 
forthwith inform the Commission thereof. 

When Member States adopt these measures, they shall contain a reference to this Directive or 
shall  be  accompanied  by  such  reference  on  the  occasion  of  their  official  publication.  The 
methods of making such reference shall be laid down by Member States." 

This Directive shall enter into force on the day of its publication in the Official Journal of the 
European Union. 

Article 2 

This Directive is addressed to the Member States. 

Article 3 

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Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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