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: 2012-01-25
Institutions: European Commission
Subjects: electromagnetic interference, national implementing measure, occupational health

EUROPEAN COMMISSION 

Brussels, 25.1.2012 
COM(2012) 15 final 

2012/0003 (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) 

 
 
  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

Grounds for and objectives of the proposal 

The aim of this proposal is to postpone until 30 April 2014 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)  (18th  individual  Directive  within  the 
meaning of Article 16(1) of Directive 89/391/EEC). 

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

In response to these concerns, the Commission took a number of steps. 

To enable the Commission to conduct an in-depth impact analysis and propose amendments, 
the deadline for transposition of the Directive was put back from 30 April 2008 to 30 April 
2012  by  Directive  2008/46/EC2  of  the  European  Parliament  and  of  the  Council  of  23  April 
2008 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). 

The  Commission  examined  the  situation  thoroughly,  analysing  the  latest  scientific  studies, 
including  the  one  launched  by  the  Commission,  on  the  negative  impact  the  exposure  limit 
values  set  by  the  Directive  might  have  on  the  medical  use  of  imaging  technologies  using 
magnetic  resonance  (MR).  After  a  significant  number  of  consultations  of  stakeholders  and 
having due regard to the latest scientific recommendations3, the Commission adopted, on 14 
June  2011,  proposal  COM  (2011) 348  for  a  new  Directive  to  amend  and  replace  Directive 
2004/40/EC,  with  a  view  to  guaranteeing  a  high  level  of  health  and  safety  protection  for 
workers  while  at  the  same  time  enabling  medical  and  other  industrial  activities  using 
electromagnetic fields to continue and develop. Adoption had been delayed mainly by the fact 
that  the  new  international  recommendations  for  exposure  of  workers  and  the  public  to 
electromagnetic fields had only been published in December 2010, rather than in 2009, as had 
been expected. 

In  addition,  proposal  COM(2011)  348  aims  to  update  and  improve  a  significant  number  of 
other  provisions  of  Directive  2004/40/EC;  it  also  introduces  some  new  elements  to  make  it 
easier for employers, especially small businesses, to implement the measures. 

1 
2 
3 

OJ L 184, 24.5.2004, p. 23. 
OJ L 114, 26.4.2008, p. 88. 
In  particular  the  recommendations  from  the  International  Commission  for  Non  Ionising  Radiation 
Protection (ICNIRP) for static magnetic fields (April 2009) and for electric and magnetic fields in the 
1Hz to 100 kHz range (December 2010). 

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Once the Commission proposal had been adopted, the European Parliament and the Council 
immediately  started  work  with  a  view  to  amending  Directive  2004/40/EC  before  30  April 
2012. 

However, because of 

• 

• 

the  technical  complexity  of  the  subject-matter,  requiring  long  discussions  with 
national experts, 

the highly divergent views on some key provisions of the proposal,  

the  European  Parliament  and  the  Council  will  be  unlikely  to  finalise  the  adoption  process 
before 30 April 2012. 

Under these circumstances, we shall need a new Directive postponing for a second time the 
deadline for transposition of Directive 2004/40/EC. We have to prevent a very uncertain legal 
situation from arising after 30 April 2012, which is when all the Member States would have to 
transpose the current Directive 2004/40/EC by, if no further action were taken. 

This legal uncertainty would have two consequences: 

– 

– 

the Commission would in principle have to launch infringement proceedings for non-
communication of transposition measures against any Member States which have not 
transposed the Directive yet; 

Directive 2004/40/EC would start to have direct vertical effect in the national legal 
order  of  all  Member  States,  and  citizens  could  take  their  governments  to  court  for 
their failure to implement the Directive. 

We  consider  it  appropriate  to  postpone  the  transposition  deadline  for  two  years  to  allow 
sufficient  time  for  the  European  Parliament  and  the  Council  to  discuss  and  reach  a 
compromise on the basis of the Commission proposal COM (2011) 348 for a new Directive, 
which would update and improve the provisions of Directive 2004/40/EC while repealing and 
replacing the earlier Directive. 

1.2. 

Directive 2004/40/EC 

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 short-term adverse 
health effects on workers exposed to electromagnetic fields during their work. 

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 at frequencies of between 0 and 300 GHz 4. No worker may be exposed 

4 

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

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to  values  exceeding  these  limits,  which  are  based  on  health  impact  and  biological 
considerations. 

The  Directive  also  sets  action  values  for  time-varying  and  static  fields.  These  values  are 
directly measurable and indicate a threshold above which employers must take one or more of 
the measures 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  in  1998,  the  organisation  internally  recognised  as  the  authority  on 
assessing the health impact of this type of radiation. The ICNIRP works closely with all the 
relevant  international  organisations,  such  as  the  WHO,  ILO,  IRPA,  ISO,  CENELEC,  IEC, 
CIE and IEEE. 

The Directive is based on the prevention philosophy already set out in more general terms in 
Framework Directive 89/391/EEC: 

– 

– 

– 

– 

– 

protection of all workers, whatever their sector of activity, whereby workers 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 2012 if no further action is taken. 

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  European  Parliament  and  the 
Council adopted the Directive, with certain amendments to the values originally proposed by 
the Commission. These included 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 became available at the time of  the adoption of the Directive. 

1.3. 

Proposal COM (2011) 348 for a new Directive 

The above proposal aims to update and improve the provisions of Directive 2004/40/EC while 
repealing  and  replacing  it.  It  maintains  a  number  of  important  principles  and  provisions  in 
Directive 2004/40/EC. 

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The  most  important  changes  introduced  by  the  proposal,  taking  into  account  the  latest 
scientific findings in this area, are: 

– 

– 

– 

– 

– 

– 

– 

– 

2. 

clearer  definitions,  in  particular  for  adverse  health  effects  (Article  2  of  Directive 
2004/40/EC); 

inclusion of a revised system for limit and reference values differing from the current 
limit  values  and  action  values  for  the  range  from  0  to  100  kHz  (this  will  affect 
Articles 2 and 3 of Directive 2004/40/EC plus its annex); 

introduction  of  indicators  to  facilitate  measurements  and  calculations  (Article  3(3)) 
and  to  give  guidance  on  taking  measurement  uncertainties  into  account.  Product 
safety  legislation  set  by  Directives  1999/5/EC  and  2006/95/EC  ensures  that  the 
public,  including  workers,  are  not  exposed  to  levels  beyond  those  set  by 
Recommendation  1999/519/EEC,  provided  that  the  products  are  used  as  intended. 
Since  levels  set  for  the  public  are  lower  than  those  set  for  workers  and  include 
protection  against  long-term  effects,  compliance  with  these  Directives  will  provide 
for sufficient protection in these situations; 

introduction  of  some  guidance  to  ensure  simplified  but  more  efficient  risk 
assessments (Article 4), in order to facilitate evaluation work and limit the burden on 
SMEs; 

introduction  of  limited  but  appropriate  flexibility  by  proposing  a  controlled 
framework  for  limited  derogations  for  industry  from  action  and  limit  values.  The 
proposal  includes  two  specific  derogations,  one  for  medical  magnetic  resonance 
applications  (MR),  and  another  for  the  armed  forces.  A  third  derogation  is  for 
occasional  situations,  subject  to  strict  control  and  authorisation  by  Member  States, 
followed  by  evaluation.  Member  States  must  report  to  the  Commission  on  any 
authorisations  granted.  These  three  derogations,  which  are  the  result  of  intense 
consultations  with  all  stakeholders  and  are  well  defined  in  their  scope,  guarantee  a 
high level of health and safety protection while ensuring that medical and industrial 
activities are not unduly hampered; 

inclusion of a rationale for medical surveillance (Article 8); 

special  attention  to  the  specific  case  of  medical  applications  using  magnetic 
resonance and related activities;  

provision for complementary non-binding measures such as a non-binding practical 
guide. 

CONSULTATION  OF 
ASSESSMENT 

INTERESTED 

PARTIES  AND 

IMPACT 

2.1. 

Consultation of interested parties 

Consultation of the Advisory Committee on Safety and Health at Work 

The  representatives  of  the  social  partners  and  the  government  representatives  of  the  27 
Member States in the Advisory Committee on Safety and Health at Work, meeting in plenary 

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on 1 December 2011, came out in favour of postponing the deadline for the transposition of 
Directive  2004/40/EC  into  the  national  legal  order  of  Member  States  in  order  to  avoid  a 
situation  of  legal  uncertainty  after  30  April  2012,  and  to  allow  sufficient  time  for  the 
European  Parliament  and  the  Council  to  reach  a  compromise  on  Commission  proposal 
COM(2011) 348. 

Consultation of the EU social partners 

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  Commission's 
Legal Service and Secretariat-General, it was decided that there was no need in this case to 
consult the social partners formally at European level, pursuant to Article 154 of the  Treaty 
on  the  Functioning  of  the  European  Union.  Nevertheless,  the  EU  cross-industry  social 
partners were informed of the proposal by a letter from Commissioner Andor and invited to 
send their comments. 

2.2. 

Transmission of this proposal to the national parliaments 

Draft  legislative  acts,  including  proposals  from  the  Commission,  sent  to  the  European 
Parliament and to the Council must be forwarded to national parliaments in accordance with 
the Protocol (No 1) on the role of national Parliaments in the European Union, annexed to the 
Treaties. 

According  to  Article  4  of  the  Protocol,  an  eight-week  period  must  elapse  between  a  draft 
legislative act being made available to national parliaments and the date when it is placed on a 
provisional  agenda  for  the  Council  for  its  adoption  or  for  adoption  of  a  position  under  a 
legislative procedure. 

However, exceptions are possible under Article 4 in cases of urgency, the reasons for which 
must  be  stated  in  the  act  or  position  of  the  Council.  The  adoption  of  this  proposal  by  the 
European Parliament and the Council has to be considered as a case of absolute urgency for 
the reasons explained above, and which can be summarised as follows. 

Commission proposal COM(2011) 348, which is currently being discussed by the European 
Parliament  and  the  Council,  is  intended  to  update  and  improve  the  provisions  of  Directive 
2004/40/EC, while repealing and replacing it, before 30 April 2012. Consequently, the great 
majority of Member States did not transpose Directive 2004/40/EC, waiting for the adoption 
of the new updated Directive based on the above proposal. 

Nevertheless,  given  the  complexity  of  the  subject-matter  and  the  deeply  diverging  views  in 
the  Council,  there  appears  to  be  no  chance  of  the  European  Parliament  and  the  Council 
finalising the adoption process before the 30 April 2012 deadline. 

This  proposal,  whose  sole  aim  is  to  postpone  the  deadline  for  transposition  of  Directive 
2004/40/EC for two years, has therefore to be adopted as a matter of urgency within the very 
short  period  remaining.  If  the  proposal  is  not  adopted  by  the  30  April  2012  deadline,  there 
may  be  negative  legal  consequences  in  the  internal  legal  orders  of  any  Member  States  that 
have not yet transposed the Directive (see above section 1.1). 

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2.3. 

Impact assessment 

Given the urgency of the proposal and its limited impact, the proposal is not accompanied by 
a separate Impact Assessment. 

Doing nothing at this stage would oblige the great majority of Member States which have not 
yet transposed Directive 2004/40/EC into national law to do so and to enforce it within a very 
short  period  of  time,  i.e.  by  the  current  deadline  of  30  April  2012,  with  potentially  serious 
consequences for the continuity of healthcare services using MRI. Certain industrial activities 
might also be adversely affected. 

In any Member States which did not transpose the Directive by the deadline, a very uncertain 
legal  situation  would  arise.  Under  the  principle  of  vertical  direct  effect  of  EU  directives, 
established by the Court of Justice, their citizens could bring actions against them in national 
courts  for  failure  to  implement  the  Directive.  Furthermore,  the  Commission  would  in 
principle  have  to  launch  infringement  procedures  against  those  Member  States  for  non-
communication of transposition measures. 

Postponing the date of transposition will not unduly impede the use of MRI or other industrial 
activities.  At  the  same  time,  postponement  would  give  sufficient  time  for  the  Directive,  in 
particular the exposure limit values, to be updated and improved, by means of a new Directive 
based  on  Commission  proposal  COM(2011)  348.  Reflecting  new  scientific  findings,  this 
would  guarantee  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 2012, extending it to 30 April 2014. It does not alter the substance of 
the  Directive  in  question  and  does  not  therefore  impose  any  additional  obligations  on 
businesses. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Summary of the proposed measures 

The  proposal  amends  Article  13(1)  of  Directive  2004/40/EC  by  postponing  the  date  of 
transposition to 30 April 2014. 

3.2. 

Legal basis 

Article 153(2) of the Treaty on the Functioning of the European Union. 

3.3. 

Subsidiarity principle 

The  subsidiarity  principle  applies  as  the  proposal  concerns  a  field  —  the  protection  of  the 
health and safety of workers at work — which does not fall within the exclusive competence 
of the European Union. 

The objectives of the proposal cannot be achieved sufficiently by the Member States, as the 
provisions of directives cannot be amended or repealed at national level. 

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

The  principle  of  subsidiarity  is  complied  with  in  that  the  proposal  amends  existing  EU 
legislation. 

3.4. 

Proportionality principle 

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

It does not alter the substance of the current EU legislation: it is restricted to postponing the 
date  for  the  transposition  of  Directive  2004/40/EC  until  30  April  2014,  in  order  to  avoid  a 
situation  of  legal  uncertainty  after  the  current  deadline  has  expired  and  to  allow  sufficient 
time for the European Parliament and the Council to discuss and to reach a compromise on 
Commission proposal COM(2011) 348, which seeks to update and improve the provisions of 
Directive 2004/40/EC while repealing and replacing it. 

3.5. 

Choice of instruments 

Proposed instrument(s): directive. 

No other instrument would have been suitable. As this is an amended directive, the only way 
forward is to adopt another directive. 

4. 

– 

5. 

• 

BUDGETARY IMPLICATION 

The proposal has no implication for the EU budget. 

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 2014. 

• 

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 postpones the date of transposition of Directive 2004/40/EC to 30 April 2014. 
These  extra  two  years  for  transposing  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 might have a disproportionate impact on the continuity of 

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medical  procedures  which  use  magnetic  resonance  imaging.  The  postponement  will  give 
sufficient time for the Directive, and particularly the exposure limit values, to be updated and 
improved,  by  means  of  a  new  Directive  based  on  Commission  proposal  COM(2011)  348, 
which is currently being discussed in the Council and the EP and which aims to guarantee a 
high  level  of  protection  for  workers  and  the  continuity  of  medical  procedures  and  other 
economic  activities.  The  two-year  postponement  will  also  avoid  any  negative  legal 
consequences  in  the  legal  orders  of  Member  States  which  have  not  yet  transposed  the 
Directive. 

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

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2012/0003 (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  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 153(2) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee5, 

Having regard to the opinion of the Committee of the Regions6, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

After the entry into force of 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)7,  serious  concerns  were  expressed  by  stakeholders,  in 
particular in the medical community, about the potential impact of implementation of 
that Directive on the use of medical procedures based on medical imaging. Concerns 
were also expressed as to the impact of the Directive on certain industrial activities. 

(2) 

The Commission examined the arguments put forward by stakeholders and decided to 
reconsider  some  provisions  of  Directive  2004/40/EC,  on  the  basis  of  new  scientific 
evidence. 

5 
6 
7 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 184, 24.5.2004, p. 1. 

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

The deadline for transposition of Directive 2004/40/EC was therefore postponed until 
30  April  2012  by  Directive  2008/46/EC  of  23  April  20088,  in  order  to  allow  the 
adoption of a new directive based on the most recent evidence. 

On 14 June 2011 the Commission adopted a proposal for a new Directive to replace 
Directive  2004/40/EC.  The  new  Directive  should  ensure  both  a  high  level  of  health 
and  safety  protection  for  workers  and  the  continuation  and  development  of  medical 
and other industrial activities using electromagnetic fields. Consequently, the majority 
of Member States have not yet transposed Directive 2004/40/EC, pending the adoption 
of the new Directive. 

However,  given  the  technical  complexity  of  the  subject-matter  it  is  unlikely  that  the 
new  Directive  will  be  adopted  before  the  deadline  for  transposition  of  Directive 
2004/40/EC.  

Consequently, that deadline should be extended.  

In view of the above and given the very short period of time left before the time limit 
of  30  April  2012,  it  must  be  ensured  that  this  Directive  is  adopted  by  the  European 
Parliament and the Council as a matter of urgency and that it enters into force without 
delay.  

Consequently, as regards the transmission to national Parliaments in accordance with 
Protocol  (No  1)  on  the  role  of  national  Parliaments  in  the  European  Union,  the 
exception for urgent cases provided for in Article 4 of this Protocol has been applied 
in this case with regard to the eight-week period to elapse between a draft legislative 
act being made available to national Parliaments and the date when it is placed on a 
provisional agenda for the Council for its adoption or for adoption of a position under 
a legislative procedure. 

HAVE ADOPTED THIS DIRECTIVE: 

In Article 13(1)  of Directive  2004/40/EC the date "30 April  2012"  is replaced by "30  April 
2014."  

Article 1 

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

Article 2 

8 

OJ L 114, 26.4.2008, p. 88-89. 

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Article 3 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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