Proposal for a Directive of the European Parliament and of the Council on the approximation of the laws of the Member States relating to electromagnetic compatibility
Date: 2002-12-23
Institutions: European Commission
Subjects: EC conformity marking, administrative formalities, approximation of laws, electrical equipment, electromagnetic interference, free movement of goods, harmonisation of standards, technical regulations

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 23.12.2002
COM(2002) 759 final

2002/0306 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the approximation of the laws of the Member States relating to electromagnetic
compatibility

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. 

INTRODUCTION

This  proposal  provides  for  a  revision  of  Council  Directive  89/336/EEC  of  3  May
1989 on the approximation of laws of the Member States relating to electromagnetic
compatibility (EMC Directive).

Directive 89/336/EEC has been amended by Directives 91/263/EEC, 92/31/EEC and
93/68/EEC.  It  became  applicable  on  a  voluntary  basis  on  1  January  1992.  Since  1
January  1996  all  electrical  and  electronic  apparatus  concerned  must  satisfy  the
requirements  of  the  EMC  Directive  before  being  placed  on  the  market  within  the
European Community.

The objective of the EMC Directive is to guarantee the free movement of electrical
equipment whilst creating an acceptable electromagnetic environment within the EU.
The Directive therefore  seeks  to  ensure  that  electromagnetic  disturbances  produced
by electrical equipment do not affect the correct functioning of other such equipment,
including  telecommunication  and  electricity  distribution  networks,  and  that  such
equipment has an appropriate level  of immunity to  electromagnetic disturbances so
that it can function as intended.

Since 1992 considerable experience has been gained with the application of the EMC
Directive.  In  1997,  due  to  the  need  to  clarify  a  number  of  issues  and  in  order  to
ensure  homogeneous  application,  the  Commission  issued  an  informal  guide  to  the
application of the Directive  prepared  with  the  assistance of  national  authorities  and
other relevant stakeholders.

2. 

BACKGROUND AND KEY ELEMENTS FOR THE REVISION

2.1. 

The SLIM process

The  EMC  Guide  has  made  a  substantial  contribution  towards  homogeneous
application  of  the  Directive.  But  it  is  informal  and  therefore  cannot  provide  legal
certainty to resolve the issues.

In 1997, as a first step towards providing clarity, and giving legal weight to agreed
solutions,  and  also  to  reduce  unnecessary  regulatory  burdens  on  industry,  the
Commission,  together  with  Member  States,  identified  the  EMC  Directive  as  a
candidate for the SLIM (Simpler Legislation for the Internal Market) initiative.

During  1998  a  panel  composed  of  experts  from  Member  States  and  stakeholders
reviewed the Directive. At the end of this process the panel  gave their opinion  that
for certain aspects its application was problematic, and recommended that it should
be revised taking due account of the 1997 EMC Guide.

The Recommendations of the SLIM panel focussed on the following aspects:

–  basic principles;

–  treatment of large machines and installations;

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–  conformity assessment procedures;

–  standards;

–  EMC requirements in other Directives;

–  consideration of the solutions provided by the EMC Guide.

In its Communication to the European Parliament and the Council (COM(1999)88),
the  Commission  endorsed  most  of  the  SLIM  panel’s  recommendations.  The
Commission  then  set  up  a  working  party  consisting  of  experts  from  national
administrations  and  relevant  stakeholders  (industry,  network  operators,  conformity
assessment  and  standardisation  bodies,  users)  to  help  the  Commission  draft  a
proposal  for  revision  of  the  Directive.  During  1999  and  2000  several  drafts  were
considered  by  this  group  and,  in  order  to  ensure  transparency,  were  placed  on  the
Commission web-site to attract comments from other interested parties. The current
proposal  for revision of the EMC Directive  has been  drafted taking due  account of
comments made during this extensive and wide-ranging consultation.

2.2. 

Objectives of the revision

In  general  terms  the  proposal  for  revision  maintains  the  objectives  of  the  existing
EMC Directive, and its field of application. It follows the regulatory concept of the
New  Approach  and,  for  the  most  part,  uses  concepts  already  found  in  the  current
Directive.

The text of the proposal is recommended in pursuit of the following objectives:

–  Clarification  of  scope  by  means  of  improved  definitions,  more  clearly  defined

exclusions and inclusion of ready-made connecting devices;

–  Treatment  of  fixed  installations  by  means  of  a  more  appropriate  regulatory

regime;

–  Enhanced clarity through more detailed essential requirements;

–  Clarification of the role of harmonised standards;

–  Simplification  of  the  conformity  assessment  procedure,  reduced  to  a  single

procedure for apparatus;

–  Cutting  “red 

tape”  and 

increasing  manufacturers’  choice  by  abolishing
compulsory  third-party  intervention  where  harmonised  standards  have  not  been
applied  but  allowing  in  all  cases  for  voluntary  involvement  of  conformity
assessment bodies for apparatus;

–  Improved market surveillance through better traceability of the manufacturer.

The  structure  and  text  of  the  proposal  have  been  adapted  to  the  state  of  the  art
introduced by other New Approach Directives adopted since 1989.

In view of these modifications, it is proposed that Directive 89/336/EEC be replaced
by the proposal below.

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2.3. 

Content of the revision

In accordance with the New Approach concept, the proposal for revision lays down
the electromagnetic compatibility requirements for electrical equipment which must
be satisfied before it is placed on the market and/or put into service.

Equipment  is  the  key  term  of  reference  to  which  the  Directive  applies.  It  includes
two  sub-sets:  apparatus  and  fixed  installations.  A  number  of  provisions  of  the
Directive apply in common to both apparatus and fixed installations. This is the case
for generic electromagnetic protection requirements, and for the principle that these
protection  requirements  can  be  given  technical  expression  in  voluntary  harmonised
standards. Harmonised standards are to be adopted by the European standardisation
bodies  CEN  (European  Committee  for  Standardization),  CENELEC  (European
Committee 
(European
Telecommunications Standards Institute). Harmonised standards must be elaborated
on the basis of remits addressed by the Commission to the European standards bodies
in  accordance  with  the  procedure  laid  down  in  Directive  98/34/EC.  Harmonised
standards,  once  published  in  the  Official  Journal  of  the  EC,  confer  presumption  of
conformity  with  the  essential  protection  requirements  of  the  Directive,  in  so  far  as
they are covered by them.

for  Electrotechnical  Standardization) 

and  ETSI 

2.3.1.  Distinction between apparatus and fixed installations

One  of  the  main  reasons  for  the  revision  of  the  EMC  Directive  is  the  need  for
different  regulatory  regimes  tailored  for  apparatus  and  for  fixed  installations.
Apparatus means goods which, once they comply with the Directive, can be placed
on  the  market  and/or  put  into  service  anywhere  within  the  European  Union.  It  is
therefore up to the manufacturer to carry out, under his responsibility, a conformity
assessment  to  show  that  the  apparatus  complies  with  the  requirements  of  the
Directive. Apparatus which complies must bear the CE marking.

However, the concept of a conformity assessment procedure and the affixation of the
CE marking are not felt to be appropriate for  fixed installations. Fixed  installations
are  assemblies  of  various  apparatus  and  other  devices  installed  and  intended  to  be
used permanently at a pre-defined location within the EU (e.g. electricity distribution
networks, 
large  machinery  and  assemblies  of
machinery  on  manufacturing  sites).  The  justification  for  a  different  regime  is  that
such fixed installations may be the subject of continuous alterations, coupled with the
difficulties  experienced  in  applying  a  formal  conformity  assessment  procedure  to
such an  installation, due to its  size, its complexity,  undefined  and  variable  external
EMC conditions, operational needs etc…

telecommunication  networks, 

This viewpoint is given additional weight by the fact that competent authorities can,
following  the  identification  of  a  fixed  installation  that  might  be  the  source  of  an
unacceptable emission, request that the responsible person brings it into compliance.

During the consultation  process  it was  found that stakeholders strongly  support  the
application  of  a  particular  regime  for  fixed  installations  within  the  Directive.  Such
installations, as a source or object of potential electromagnetic disturbances, are part
of the electromagnetic environment.

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In  addition,  it  is  in  the  interest  of  the  free  circulation  of  equipment  to  establish  a
coherent  set  of  harmonised  EMC  requirements  for  equipment,  including  fixed
installations,  which  provide  a  coherent  set  of  rules  defining  all  the  aspects  of  an
acceptable electromagnetic environment.

Furthermore, the rapidly changing technologies used in such installations need to be
provided  with  a  solid  regulatory  base  and  harmonised  standards  as  tools  to  ensure
that they can be fully exploited throughout the EU.

2.3.2.  Essential requirements

The  proposals  lays  down  in  Annex  I  a  coherent  and  comprehensive  regime  of
essential  requirements  which  equipment,  i.e.  both  apparatus  and  fixed  installations,
must comply with.

The  essential  requirements  consist  of  generic  protection  requirements  covering  the
emission  and  immunity  characteristics  of  equipment.  In  addition,  more  specific
requirements are given separately for apparatus and for fixed installations.

In  the  case  of  apparatus  the  manufacturer  will  need  to  perform  an  electromagnetic
compatibility  assessment,  in  which  all  relevant  phenomena  are  identified  and
addressed  with  a  view  to  meeting  the  protection  requirements.  If  all  relevant
harmonised EMC standards applicable to a given apparatus are met, it is deemed to
have met the obligation for an EMC assessment.

As  a  general  rule,  apparatus  will  be  required  to  meet  the  protection  requirements
without recourse to additional external devices (such as filtering or shielding) placed
separately on  the market. Apparatus must  be accompanied  by  information  enabling
the product to be clearly identified (e.g. by means of type number, batch code, etc.)
and indicating the name and address of the manufacturer. Where the manufacturer or
his authorised representative is not established within the EU, the person established
within the EU responsible for placing the apparatus on the market will be indicated.
These  provisions  aim  at  strengthening  the  means  available  to  market  surveillance
authorities  to  verify  the  compliance  of  apparatus  and  to  take  any  enforcement
measures considered necessary.

The manufacturer will need to provide information on any specific precautions to be
taken  before  installation,  assembly  and  use  of  the  apparatus  to  ensure  it  complies
with protection requirements.

In  cases  where  apparatus  will  not  comply  with  the  protection  requirements  in
residential  areas,  this  restriction  of  use  must  be  indicated.  This  requirement  has  its
origin in the discussions of the SLIM panel,  which  came to the  conclusion that  the
revised  Directive  should  define  certain  classes  of  EMC  environment  and  the
conditions  for  intended  use.  The  feedback  from  the  consultation  process  following
the SLIM recommendations did not confirm this necessity. Even so, when because of
its EMC characteristics an apparatus is not suitable for use in residential areas, it was
considered essential to indicate explicitly such a restriction of use.

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2.3.3.  Conduct of conformity assessment for apparatus under the sole responsibility of the

manufacturer

In cases where the manufacturer has not applied harmonised standards or has applied
them  only  in  part,  the  current  EMC  Directive  requires  a  technical  construction  file
including a technical report or certificate issued by a competent body.

Harmonised  standards  now  exist  for  almost  all  apparatus.  The  self-declaration
procedure by means of applying harmonised standards is now used in 95% of cases.
In  practice,  bodies  which  are  also  competent  bodies  are  often  asked  to  confirm
compliance with harmonised standards. The  proposal  will  make  the  manufacturer’s
obligations  clearer.  Experience  has  also  shown  that  the  non-application  of
harmonised standards cannot be considered as an appropriate criterion for requiring
the  involvement  of a third  party. Therefore,  the  proposal  removes  the  obligation  to
rely on a competent body. This represents a streamlining of the Directive. However,
in  accordance  with  Council  Decision  93/465/EEC  on  the  modular  concept,  the
manufacturer  must  always  establish  and  maintain  technical  documentation  which
confirms  that  the  apparatus  complies  with  the  essential  requirements,  whether
harmonised standards apply or not.

The proposal will leave with the manufacturer the decision whether to involve a third
party,  and  if  so  to  what  extent.  As  in  other  New  Approach  Directives,  conformity
assessment  bodies  will  be  called  “Notified  Bodies”.  This  change  of  name  will  not,
however, imply any additional new re-assessment of bodies already designated under
the current Directive.

Nor will this change  of  name  affect  the  current sectoral  practice that, under certain
conditions,  an  assessment  body  owned  by  a  manufacturer  may  become  a  Notified
Body for the purpose of the EMC Directive.

3. 

LEGAL BASIS

This proposal is based  on Article  95 of the  EC  Treaty.  It  aims  at  ensuring  the  free
circulation  of  equipment  throughout  the  European  Internal  Market  by  laying  down
harmonised  electromagnetic  compatibility  requirements.  Article  95  also  covers  the
EMC requirements for fixed installations. The functioning of the Internal Market can
only be ensured if both apparatus and fixed installations are designed and constructed
in accordance with a coherent and homogeneous set of EMC requirements.

The proposal has relevance for the European Economic Area.

4. 

PROPORTIONALITY AND SUBSIDIARITY

The main objective of the proposed action is to ensure the functioning of the internal
market by requiring equipment to comply with an adequate level of electromagnetic
compatibility. In accordance with the principle of subsidiarity as set out in Article 5
of the Treaty, this measure is proposed since the objectives laid down above cannot
be sufficiently achieved by Member States acting alone and can therefore, by reason
of their scale and effects, be better achieved at Community level.

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Directive 89/336/EEC follows the  principles set  out in  the Council Resolution of 7
May  1985  on  a  new  approach  to  technical  harmonization  and  standards.  In
accordance with that approach, the essential requirement laid down in this proposal
are given technical expression by harmonised European standards, to be adopted by
the various European standardisation bodies. During its ten years of applicability, the
directive has proven its accordance with the principle of proportionality as set out in
Article 5  of the  Treaty.  Based on this experience,  this  proposal  follows  exactly  the
same principles, and thus, does not go beyond what is necessary in order to achieve
those objectives.

5. 

CONTENT OF THE PROPOSAL

The main body of the revision proposal consists of four chapters:

–  Chapter 1: general provisions;

–  Chapter 2: apparatus;

–  Chapter 3: fixed installations;

–  Chapter 4: final provisions.

The provisions of the proposal are set out in further detail  where they substantially
deviate from the current Directive.

5.1. 

Chapter 1: general provisions

5.1.1.  Article 1 – Scope

Radio and telecommunication terminal equipment covered by Directive 1999/5/EC is
excluded  from  the  scope  of  the  EMC  Directive.  However,  the  R&TTE  Directive
(1999/5/EC)  refers  explicitly  to  a  number  of  specific  provisions  of  the  EMC
Directive  and  renders  them  applicable.  Due  to  the  modification  of  the  EMC
Directive,  changes  in  referencing  to  the  EMC  Directive  can  be  identified  with  the
help of the correlation table in Annex VI of the proposal.

Aircraft and equipment fitted into aircraft will be explicitly excluded from the EMC
Directive.  This  exclusion  is  a  result  of  the  conclusions  of  a  study  carried  out  by
CENELEC under a  mandate  from  the  Commission and with the help of experts  on
EMC  and  aircraft  specifications.  Aircraft  can  be  considered  as  a  very  specific
environment with regard to EMC. The needs of protection in terms of EMC can be
entirely met by specific regulations relating to aircraft.

Furthermore,  the  EMC  Directive  shall  not  apply  to  equipment  which,  due  to  the
inherent nature of its physical characteristics, is from an EMC point of view, benign.
For  example,  this  might  be  the  case  for  certain  wristwatches  or  greeting  cards
incorporating electronic devices.

5.1.2.  Article 2

This Article contains legal definitions for the most important technical terms, such as
apparatus,  fixed  installations  and  electromagnetic  compatibility.  It  should  be  noted

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that  only  components  or  sub-assemblies,  which  are  intended  to  be  incorporated  by
the  end-user  and  are  either  liable  to  generate  electromagnetic  disturbance,  or  the
performance of which is liable to be affected by such disturbance are deemed to be
apparatus in terms of the Directive.

Ready-made  connecting devices intended  for  the  transmission  of  signals  are,  under
certain conditions, deemed to be apparatus and subject to the essential requirements,
the conformity assessment regime and the CE marking provisions of the Directive. It
should  be  noted  that  this  does  not  apply  to  cables  as  such  but  only  to  ready-made
devices placed on the market separately from apparatus. A technical study carried out
for the Commission as well as the practical experience of Member States confirmed
the need to include ready-made connecting devices within the scope of the Directive.
By such an inclusion, national regulations potentially affecting the free circulation of
such devices will be avoided.

5.1.3.  Article 6

This  article  explains  that  equipment,  to  which  harmonised  standards  have  been
applied, shall benefit from a presumption of conformity to the essential requirements.
Harmonised  standards  become  the  further  technical  expression  of  the  essential
requirements  for  equipment  falling  under  their  scope.  The  coverage  of  fixed
installations  by  the  essential  requirements  and  harmonised  standards  will  prevent
national  regulations  on  EMC  matters,  which  currently  go  beyond  the  level  of
specification detailed in the Directive.

5.2. 

Chapter 2: apparatus

According to Article 7, manufacturers have to assess, under their own responsibility,
the compliance of apparatus with the essential requirements, regardless of whether or
not  products  are  manufactured  in  compliance  with  harmonised  standards.  The
conformity has to be demonstrated through a technical file and attested through the
issue  of  a  declaration  of  conformity.  The  technical  file  and  the  declaration  of
conformity  shall  be  made  available  to  the  Competent  Authorities,  upon  request,
during ten years after the last apparatus has been manufactured. The involvement of
a notified body is left to the discretion of manufacturers. Notified bodies may issue
certificates confirming full compliance with the essential requirements or only in part
with  given  requirements,  upon  a  manufacturer’s  request  (see  section  2.3.1).  The
procedure  for  the  notification  of  notified  bodies  and  the  publication  provisions
(Article  11)  generally  follow  the  requirements  to  be  found  in  other  New  Approach
Directives.

Given  the  advent  of  the  R&TTE  Directive  (1999/5/EC),  which  now  provides  the
regulatory  EMC  provisions  for  almost  all  radio  transmitters,  it  is  considered
disproportionate  to  continue  a  mandatory  third-party  regime  for  those  remaining
within  the  scope  of  the  EMC  Directive.  Residual  radio  transmitting  equipment
remaining within the scope will therefore be subject to the same provisions as other
apparatus.

5.3. 

Chapter 3: fixed installations

Article 12 provides for a particular regime for fixed installations.

8

Where  such  installations  are  built  or  modified  using  apparatus  which  are  generally
available on the market, the provisions for such apparatus are detailed in Chapter 2.
However, if the apparatus used are specifically designed for a given fixed installation
and are otherwise not commercially available, the manufacturer may decide whether
or not to follow the provisions of Chapter 2.

However, if the general provisions for apparatus (Articles 5, 7 and 8) are not applied
to  apparatus  designated  for  a  specific  installation,  such  apparatus  will  need  to  be
accompanied by more specific information indicating the site of intended use and the
precautions to be observed in view of the installation.

Article 12 does not require the conduct of a formal conformity assessment procedure
for  fixed  installations  prior  to  their  putting  into  service.  As  noted  above,  it  was
identified by the SLIM panel and during the subsequent consultation process that the
application  of  a  conformity  assessment  procedure  may  be  difficult  or  even
impossible, as well as disproportionate taking account of the technical complexity of
installations and the modifications they can be subject to during their lifetime. Where
there  are  indications  of  non-compliance,  for  example  due  to  complaints  about
disturbances  being  generated  by  such  installations,  public  authorities  may  request
evidence of compliance and, where appropriate, initiate a proper assessment. Article
12  leaves  it  to  Member  States  to  determine  under  national  law  the  person(s)  to  be
held  responsible  for  the  compliance  of  the  fixed  installation  with  the  relevant
essential requirements.

5.4. 

Chapter 4: final provisions

Directive  89/336/EEC  will  need  to  be  repealed.  In  accordance  with  the  correlation
table of Annex VI, references to Directive 89/336/EEC, for example in harmonised
standards, need to be read as referring to the revised Directive.

5.5. 

Annex I: essential requirements

See Section 2.3.2

5.6. 

Annexes II to IV

These annexes include standard provisions of the New Approach Directives.

5.7. 

Annex V

This Annex establishes that the correct application of relevant harmonised standards
shall  be  equivalent  to  the  carrying  out  of  an  EMC  assessment  as  referred  to  in
Annex I. Furthermore reference is made to standardisation documents which provide
information for manufacturers about the selection and use of harmonised standards.
These documents should be of help to manufacturers in particular in cases where the
presumption of conformity to the requirements implies the simultaneous applicability
of several standards.

6. 

CONSISTENCY WITH OTHER COMMUNITY POLICIES

The  consistency  with  other  Community  policies  is  particularly  ensured  by  the  fact
that the principles on which this Directive is based are those  set  out in the Council

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Resolution  of  7  May  1985  on  a  new  approach  to  technical  harmonisation  and
standards.  Additionally,  interface  with  other  Community  legislation  has  been
particularly  considered,  by  excluding  from  the  scope  of  the  directive  specific
equipment, as specified in Article 1, point 2 of this proposal.

7. 

EXTERNAL CONSULTATIONS

As  indicated  in  section  2.1,  the  process  of  revision  of  the  Directive  was  started
following  a  Communication 
the  Council
(COM(1999)88), where the Commission endorsed most of the Recommendations of
the SLIM panel, composed of independent experts.

the  European  Parliament  and 

to 

The preparation of a proposal for the revision of the EMC Directive was assisted by
an  EMC  SLIM  Working  Group,  made  up  of  Member  States  and  Industry
representatives (manufacturers, utility operators, certification bodies, etc).

As a result of the work of this group, several drafts of the future EMC Directive have
been prepared for discussion and published on the Internet site of the Commission, in
order to reach the widest possible audience of interested parties.

In order to provide the Commission and all other interested parties with the relevant
technical  information,  an  independent  study  was  carried  out  during  the  year  2000
under  contract  from  the  European  Commission.  Based  on  the  technical  findings  of
this study, the proposal to include ready-made connecting devices within the scope of
the Directive and to regulate specifically fixed installations has been added.

Similarly, the evaluation detailed in section 8 was supported by an independent study
carried  out  in  2001  whose  objective  was  to  perform  a  cost  benefit  analysis  on  the
proposed revision of the Directive.

8. 

EVALUATION

The assessment of what impact a revision of the Directive will have on the European
economy is based on a study carried out by an outside body.

The purpose of the study is to quantify the impact of the changes introduced by the
proposed text on the various interested parties. This represents a pilot case of the new
orientation of the Commission, whose intention is to use impact assessment as a tool
to  improve  the  quality  and  coherence  of  the  policy  development  process,  as
expressed in a recent Communication from the Commission*.

included  manufacturers, 

The study was therefore conducted on the basis of an enquiry with interested parties,
which 
installers,  certification  bodies,  private  and
professional users and the public authorities responsible for EMC. The final report of
the study is available on the web site of the Commission.

The major points considered in this assessment are the following:

*

COM(2002)276

10

                                                
–  Improving the legal certainty of the text by making available to those responsible
for observing and enforcing the Directive a clearer and more detailed text which
provides an answer to the varying interpretations of the existing text,

–  A coherent and more detailed definition of the aspects covered by the Directive,

–  Scope for action by certification bodies,

–  Specifying the essential requirements and clarifying the application of harmonised

standards,

–  Special arrangements for fixed installations.

It  emerges  from  the  study  that  most  of  those  involved  in  this  area  believe  that  the
proposal for a Directive will formalise the mechanisms implemented at present, and
the  study  recommends  the  directive  to  be  revised.  At  the  moment,  the  Directive  is
supplemented by a guide. The major qualitative advantage will be to provide a legal
basis  for  the  users  of  this  guide.  A  second  qualitative  advantage  will  be  the
anticipated reduction in the level of electromagnetic interference, chiefly benefiting
users and operators of electricity and telecommunication networks.

According to the study, the overall typical net cost for all affected parties in the EU
will  be  €  2.4  billion  discounted  over  the  8  years  that  the  amended  Directive  is
expected  to  remain  in  force.  This  amounts  to  less  than  0.1%  of  the  EU  output  of
EMC products during the same period. This net cost will be mainly (90%) borne by
the  manufacturers.  The  sensitivity  analysis  indicates  reasonably  stable  results:  the
typical cost coincides with the average and median costs; the lowest estimate is - €
the 75% quartile - € 2.9 billion and the
1.3 billion, the 25% quartile - € 1.9 billion, 
highest estimate - € 3.5 billion. The main unc ertainties in the cost/benefit estimates
are  caused,  following  the  study,  by  lack  of  clarity  in  the  use  of  standards  and
diverging  interpretations  of  the  product  scope,  product  definitions  and  regime  for
fixed installations. The Commission is of the opinion that the provisions of Articles 1
and 2 (Scope and definitions) and of Annex V (application of harmonised standards)
will reduce the  uncertainties. These provisions have received  a large support in the
consultation process.

At a more detailed level, certain specific points need clarifying:

(1) 

Changing  the  scope:  The  proposal  for  a  Directive  excludes  from  its  scope
apparatus with a low level of emission  but  specifically  includes ready-made
connecting devices intended for connection to an apparatus by an end user for
the transmission of signals. The study showed that the inclusion of the latter
made  up  a  major  cost  item  (approximately  60%  of  the  overall  gross  cost),
which is largely to be borne by the manufacturers, particularly in the field of
information  technologies.  In  the  Commission’s  opinion,  however,  this  must
be qualified by the fact that inclusion of  this  type  of  equipment,  which  was
also recommended by an independent  technical  study,  will  avoid  potentially
divergent  national  legislation.  As  it  will  ensure  the  smooth  operation  of  the
internal  market  for  the  targeted  products,  this  will  be  a  move  towards  an
overall medium-term reduction in costs. On  the  other hand, the  inclusion  of
this type of ready-made connecting device could increase the workload of the
certification bodies, but to a lesser extent. By contrast, both the end users and

11

(2) 

(3) 

the  operators  identified  a  gain  resulting  from  the  anticipated  reduction  in
electromagnetic interference. The exclusion of low-emission apparatus should
not produce any change.

Fixed installations: The proposal for a Directive explicitly covers equipment
designed  specifically  to  be  incorporated  in  a  fixed  installation  and  requires
that  fixed  installations  be  constructed  in  accordance  with  good  engineering
practice. As a result, a reduction in manufacturers' costs has been identified,
accompanied  by  a  foreseeable  reduction  in  the  activities  of  certification
bodies.  Nonetheless,  complaints  may  generate  substantial  costs,  since  the
Directive  requires  that  it  be  possible  to  demonstrate  conformity  with  the
requirements in this case, which may offset the anticipated benefits.

the 

Intervention  by  notified  bodies:  The  current  Directive  requires,  in  some
cases, 
issues  a
intervention  of  a  "Competent  Body"  which 
certificate/technical  report  placed  in  the  technical  file  which  proves
conformity  with  the  essential  requirements.  In  the  proposed  Directive,  the
name  of  such  bodies  has  been  changed  to  “Notified  Body”  to  make  it
consistent  with  other  New  Approach  Directives.  The  intervention  of  such  a
body is no longer mandatory and the proposal leaves it up to the manufacturer
to ask for the intervention of such a body if he considers such an intervention
appropriate. The study shows that there might be  fewer cases  of recourse to
notified bodies, thereby reducing the costs borne by  manufacturers, whereas
the  market  supervision  authorities  would  have  to  invest  more  in  technical
expertise.

(4) 

Revision of the essential requirements

(a) 

Electromagnetic compatibility assessment: Some manufacturers in the
information technology sector stressed that a maximalist interpretation
of  the  requirement  to  ensure  conformity  in  all  configurations  would
require  the  actual  testing  of  all  such  configurations,  thus  leading  to
substantial additional costs. Taking note of this finding of the impact
assessment  study,  the  proposal  for  a  Directive  has  been  amended  in
order  to  clarify  its  interpretation  by  introducing  a  more  reasonable
arrangement which does  not  require  the  testing  of  all  configurations.
Therefore,  a possible source  of additional  social  utility  loss  has been
suppressed.

(b) 

Conformity  without  external  devices:  The  proposal  for  a  Directive
requires  apparatus  to  conform  to  the  principal  requirements  without
the  aid  of  external  devices.  The  associated  one-off  design  costs  are
borne  by  the  manufacturers  and  limited  to  the  first  two  years  of
implementation of the Directive.

(c)  Making  information  available:  Manufacturers  pointed  to  high  costs
(approximately 30% of the overall gross cost) due to the requirements
for specific information to be provided with the apparatus, as set out
in Annex  I  to the proposal  for a  Directive,  as  a  result  of  the  need  to
change  the  documentation  process  and,  possibly,  the  production
process. This stricter line on documentation compared with the present
documentation requirements will fill a gap in the current Directive and

12

will  align  the  requirements  with  those  of  other  New  Approach
Directives. The proposed regime would enable the market surveillance
authorities  to  identify  cases  of  non-conformity  more  easily  and  thus
support  them  in  taking  measures  against  manufacturers  who  do  not
comply with the Directive.

(5) 

Application of harmonised standards: The proposal for a Directive clarifies
the concept of conformity to standards. Some manufacturers expressed fears
that a literal application of the standards might impose further constraints as
regards  the  testing  methods  and  instruments  to  be  used,  thereby  generating
substantial  costs.  Nevertheless,  it  is  fundamental,  in  the  interests  of  equity,
that standards, whose application remains voluntary, be applied identically by
all manufacturers, an aspect which this proposal clarifies.

The Impact Assessment study has proved to be extremely useful. The findings of the
study have led to improvement of the text of the directive, avoiding possible sources
of  social  utility  losses.  According  to  the  study,  the  proposal  of  directive  involves
extremely  low costs  for those concerned  with respect  to  market  volume.  The  study
also  concludes  that  the  proposal  of  directive  can  bring  qualitative  benefits  that  are
difficult to quantify, in particular concerning the achieved protection level.

The major cost factors identified should thus be viewed against the benefits brought
by  the  proposal.  These  benefits  will  include  improved  operation  of  the  internal
market, greater flexibility for the actors of the market, for given aspects an improved
level of protection and the improvement of the tools made available to the competent
authorities to perform market surveillance.

13

2002/0306 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the approximation of the laws of the Member States relating to electromagnetic
compatibility

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Article 95 thereof,

Having regard to the proposal from the Commission1,

Having regard to the opinion of the European Economic and Social Committee2,

Acting in accordance with the procedure referred to in Article 251 of the Treaty3,

Whereas:

(1) 

Council  Directive  89/336/EEC  of  3  May  1989  on  the  approximation  of  laws  of  the
Member  States  relating  to  electromagnetic  compatibility4  has  been  the  subject  of  a
review  under  the  initiative  known  as  Simpler  Legislation  for  the  Internal  Market
(SLIM)5.  Both  the  SLIM  process6  and  a  subsequent  in-depth  consultation  have
revealed  the  need  to  complete,  reinforce  and  clarify  the  framework  established  by
Directive 89/336/EEC.

(2)  Member  States  are  responsible  for  ensuring  that  radio-communications,  electrical
supply and telecommunications networks, as well as equipment connected thereto, are
protected against electromagnetic disturbance.

(3) 

(4) 

1

2

3

4

5

6

Provisions  of  national  law  ensuring  protection  against  electromagnetic  disturbance
should  be  harmonised  in  order  to  guarantee  the  free  movement  of  electrical  and
electronic  apparatus  without  lowering  justified  levels  of  protection  in  the  Member
States.

Protection against electromagnetic disturbance  requires  obligations  to  be  imposed  on
the  various  economic  operators.  Those  obligations  should  be  applied  in  a  fair  and
effective way in order to achieve such protection.

OJ C , , p. .
OJ C , , p. .
OJ C , , p. .
OJ L 139, 23.5.1989, p.19, as last amended by Directive 93/68/EEC (OJ L 220, 30.8.1993,p.1)
COM(1996)559
COM(1999)88

14

                                                
(5) 

(6) 

(7) 

(8) 

(9) 

The  electromagnetic  compatibility  of  equipment  should  be  regulated  with  a  view  to
ensuring  the  functioning  of  the  internal  market,  that  is  to  say,  of  an  area  without
internal frontiers in which the free movement of goods, persons, services and capital is
assured.

The  equipment  covered  by  this  Directive  should  include  both  apparatus  and  fixed
installations. However, separate provision should be made for each. This is so because,
whereas  apparatus  as  such  is  subject  to  free  movement  inside  the  Community,  fixed
installations on the other hand are installed for permanent use at a predefined location,
as assemblies of various types of apparatus and where appropriate other devices. The
composition  and  function  of  such  installations  correspond  in  most  cases  to  the
particular needs of their operators.

Radio equipment and telecommunications terminal equipment should not  be  covered
by  this  Directive  since  they  are  already  regulated  by  Directive  1999/5/EC  of  the
European  Parliament  and  of  the  Council  of  9  March  1999  on  radio  equipment  and
their
telecommunications 
conformity7.  The  electromagnetic  compatibility  requirements  in  both  Directives
achieve the same level of protection.

the  mutual  recognition  of 

terminal  equipment  and 

Aircraft or equipment intended to be fitted into aircraft should not be covered by this
Directive, since they  are  already  subject  to  special  Community  or  international  rules
governing electromagnetic compatibility.

This  Directive  need  not  regulate  equipment  which  is  inherently  benign  in  terms  of
electromagnetic compatibility.

(10)  The safety of equipment should not be a matter  covered by this Directive, since it is

dealt with by separate Community or national legislation.

(11)  Where  this  Directive  regulates  apparatus,  it  should  refer  to  finished  apparatus
commercially  available  for  the  first  time  on  the  Community  market.  Certain
components  or  sub-assemblies  should,  under  certain  conditions,  be  considered  to  be
apparatus if they are made available to the end-user. Ready-made connecting devices,
although  incapable  of  generating  electromagnetic  disturbance  in  isolation,  may
generate or transmit electromagnetic disturbance when connected to an apparatus and
should therefore be considered to be apparatus for the purposes of this Directive.

(12)  The  principles  on  which  this  Directive  is  based  are  those  set  out  in  the  Council
Resolution  of  7  May  1985  on  a  new  approach  to  technical  harmonization  and
standards8.  In  accordance  with  that  approach,  the  design  and  manufacture  of
equipment  is  subject  to  essential  requirements  in  relation  to  electromagnetic
compatibility.  Those  requirements  are  given  technical  expression  by  harmonised
European  standards,  to  be  adopted  by  the  various  European  standardisation  bodies,
CEN  (European  Committee  for  Standardisation),  CENELEC  (European  Committee
for  Electro-technical  Standardisation)  and  ETSI  (European  Telecommunications
Standards  Institute).  CEN,  CENELEC  and  ETSI  are  recognised  as  the  competent
institutions  in  the  field  of  this  Directive  for  the  adoption  of  harmonised  standards,
which  they  draw  up  in  accordance  with  the  general  guidelines  for  co-operation

7

8

OJ L 91, 7.4.1999, p.10
OJ C 136, 4.6.1985, p.1

15

                                                
between  themselves  and  the  Commission,  and  with  the  procedure  laid  down  in
Directive  98/34/EC  of  the  European  Parliament  and  of  the  Council  of  22  June  1998
laying  down  a  procedure  for  the  provision  of  information  in  the  field  of  technical
standards and regulations9.

(13) 

It is in the interest of the functioning of the internal market to have standards for the
electromagnetic  compatibility  of  equipment  which  have  been  harmonised  at
Community  level;  once  the  reference  to  such  a  standard  has  been  published  in  the
Official  Journal  of  the  European  Communities,  compliance  with  it  should  raise  a
presumption  of  conformity  with  the  relevant  essential  requirements,  although  other
means of demonstrating such conformity should be permitted.

(14)  Manufacturers  of  equipment  intended  to  be  connected  to  networks  should  construct
such  equipment  in  a  way  that  prevents  networks  from  suffering  unacceptable
degradation  of  service  when  used  under  normal  operating  conditions.  Network
operators  should  construct  their  networks  in  such  a  way  that  manufacturers  of
equipment liable to be connected to networks do not suffer a disproportionate burden
in  order  to  prevent  networks  from  suffering  an  unacceptable  degradation  of  service.
The European standardisation organisations should take due account of that objective
(including the cumulative effects of the relevant types of electromagnetic phenomena)
when developing harmonised standards.

(15) 

It should be possible to place apparatus on the market or put it into service only if the
manufacturers concerned have established that such apparatus has been designed and
manufactured in conformity with the requirements of this Directive. Apparatus placed
on the market should bear the CE marking attesting to compliance with the Directive.
Although  conformity  assessment  should  be  the  responsibility  of  the  manufacturer,
independent  conformity  assessment  body,
involve  an 
without  any  need 
manufacturers should be free to use the services of such a body.

to 

(16)  The conformity assessment obligation should require the manufacturer to perform an
electromagnetic compatibility assessment of apparatus, based on relevant phenomena,
in  order  to  determine  whether  or  not  it  meets  the  protection  requirements  under  this
Directive.

(17)  Where  apparatus  can  take  different  configurations,  the  electromagnetic  compatibility
assessment should confirm that the apparatus meets the protection requirements in the
configurations foreseeable by the manufacturer as representative of normal use in the
intended applications; in such cases it should be  sufficient  to  perform  an  assessment
on the basis of the configuration  most  likely  to  cause  maximum  disturbance  and  the
configuration most susceptible to disturbance.

(18)  Fixed 

including 

installations, 

large  machines  and  networks,  may  generate
electromagnetic disturbance, or be affected by it. There may be an interface between
fixed  installations  and  apparatus,  and  the  electromagnetic  disturbances  produced  by
fixed  installations  may  affect  apparatus,  and  vice  versa.  In  terms  of  electromagnetic
compatibility, it is irrelevant whether the electromagnetic disturbance is produced by
apparatus  or  by  a  fixed  installation.  Accordingly,  fixed  installations  and  apparatus
should be subject to a coherent and comprehensive regime of essential requirements. It

9

OJ L 204, 21.7.1998, p.37 as last amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18)

16

                                                
should  be  possible  to  use  harmonised  standards  for  fixed  installations  in  order  to
demonstrate conformity with the essential requirements covered by such standards.

(19)  Due  to  their  specific  characteristics,  fixed  installations  need  not  be  subject  to  the

affixation of the CE marking or to the declaration of conformity.

(20) 

It is  not  pertinent  to  carry  out  the  conformity  assessment  of  apparatus  placed  on  the
market  for  incorporation  into  a  given  fixed  installation,  and  otherwise  not
commercially  available,  in  isolation  from  the  fixed  installation  into  which  it  is  to  be
incorporated.  Such  apparatus  should  therefore  be  exempted  from  the  conformity
assessment  procedures  normally  applicable  to  apparatus.  However,  such  apparatus
should  not  be  permitted  to  compromise  the  conformity  of  the  fixed  installation  into
which it is incorporated.

(21)  A  transitional  period  is  necessary  in  order  to  ensure  that  manufacturers  and  other

concerned parties are able to adapt to the new regulatory regime.

(22)  Directive 89/336/EEC should therefore be repealed.

(23)  Since  the  objectives  of the proposed action,  to ensure  the  functioning  of  the  internal
market  by  requiring  equipment  to  comply  with  an  adequate  level  of  electromagnetic
compatibility cannot be sufficiently achieved by Member States acting alone and can
therefore, by reason of their scale and effects, be better achieved at Community level,
the Community may adopt measures, in accordance with the principle of subsidiarity
as  set  out  in  Article  5  of  the  Treaty.  In  accordance  with  the  principle  of
proportionality,  as  set  out  in  that  Article,  this  Directive  does  not  go  beyond  what  is
necessary in order to achieve those objectives,

HAVE ADOPTED THIS DIRECTIVE:

Chapter I
GENERAL PROVISIONS

Article 1
Subject matter and scope

1. 

This  Directive  regulates  the  electromagnetic  compatibility  of  equipment.  It  aims  to
ensure the functioning of the internal market by requiring equipment to comply with
an adequate level of electromagnetic compatibility.

2. 

This Directive shall not apply to:

(a) 

(b) 

(c) 

equipment covered by Directive 1999/5/EC;

aircraft and equipment intended to be fitted into aircraft;

radio equipment which is not commercially available, including kits of
components  to  be  assembled  by  radio  amateurs,  within  the  meaning
defined  in  the  Radio  Regulations  adopted  in  the  framework  of  the
Constitution  and Convention of  the  International  Telecommunication

17

Union10, as well as commercial equipment modified by and for the use
of such radio amateurs

3. 

This  Directive  shall  not  apply  to  equipment  the  inherent  nature  of  whose  physical
characteristics is such that:

(a) 

(b) 

it is incapable of generating electromagnetic  emissions which exceed
a  level  allowing  radio  and  telecommunication  equipment  and  other
equipment to operate as intended; and

it will operate without unacceptable degradation in the presence of the
electromagnetic  disturbance  normally  consequent  upon  its  intended
use.

4. 

5. 

This  Directive  shall  not  apply  to  equipment  or  requirements  in  so  far  as  the
requirements  laid  down  in  this  Directive  are  harmonised  by  more  specific
Community legislation.

This Directive shall not  affect the  application of Community or  national  legislation
regulating the safety of equipment.

1. 

For the purposes of this Directive, the following definitions shall apply:

Article 2
Definitions

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

"Equipment" means any apparatus or fixed installation;

"Apparatus"  means  any  finished  appliance,  or  combination  thereof
made commercially available as a single functional unit, intended for
the end user, and liable to generate electromagnetic disturbance, or the
performance of which is liable to be affected by such disturbance;

"Fixed installation" means a particular combination of several types of
apparatus and, where applicable, other devices, which are assembled,
installed and intended to be used permanently at a predefined location;

"Electromagnetic  compatibility"  means  the  ability  of  equipment  to
function  satisfactorily  in  its  electromagnetic  environment  without
introducing 
to  other
intolerable  electromagnetic  disturbances 
equipment in that environment;

"Electromagnetic 
disturbance"  means 
phenomenon which may degrade the performance of equipment;

any 

electromagnetic

"Immunity"  means  the  ability  of  equipment  to  perform  as  intended
without degradation in the presence of an electromagnetic disturbance;

10

Constitution and Convention of the International Telecommunication Union adopted by the Additional
Plenipotentiary  Conference  (Geneva,  1992)  as  amended  by  the  Plenipotentiary  Conference  (Kyoto,
1994).

18

                                                
(g) 

"Harmonised  standard"  means  a  technical  specification  adopted  by  a
recognised standards body  under  a mandate from the  Commission in
conformity  with  the  procedures  laid  down  in  Directive  98/34/EC  for
the purpose of establishing a European requirement, compliance with
which is not compulsory.

2. 

For the purposes of this Directive the following shall be deemed to be an apparatus
within the meaning of paragraph 1(b):

(a) 

(b) 

"components"  or  "sub-assemblies"  intended  for  incorporation  into  an
apparatus  by 
to  generate
electromagnetic disturbance, or the performance of which is liable to
be affected by such disturbance;

the  end  user,  which  are 

liable 

"ready-made  connecting  devices"  intended  for  connection  to  an
apparatus  by  an  end  user  for  the  transmission  of  signals,  which  are
placed  on  the  market  separately  from  such  apparatus,  and  which  are
liable  to  generate  or  transmit  electromagnetic  disturbance  when
connected to it.

Article 3
Placing on the market, putting into service

Member States shall take all appropriate measures to ensure that equipment is placed on the
market and/or put into service only if it complies with the requirements of this Directive when
properly installed, maintained and used for its intended purpose.

Article 4
Free circulation of equipment

1. 

2. 

3. 

Member  States  shall  not 
to  electromagnetic
compatibility,  the  placing  on  the  market  and/or  the  putting  into  service  in  their
territory of equipment which complies with this Directive.

impede,  for  reasons  relating 

The requirements of this Directive shall not prevent the application in any Member
State  of  special  measures,  concerning  the  putting  into  service  or  use  of  equipment,
which have been taken in respect of a specific site in order to overcome an existing
or predicted electromagnetic compatibility problem, or for safety purposes to protect
the  public  telecommunications  networks  or  receiving  or  transmitting  stations  used.
Member  States  shall  notify  those  measures  in  accordance  with  the  procedure  laid
down in Directive 98/34/EC.

Member States shall not create any obstacles to the display at trade fairs, exhibitions,
demonstrations  or  similar  events  of  equipment  which  does  not  comply  with  this
Directive provided that a visible sign clearly indicates that such equipment may not
be placed on the market or put into service until it has been brought into conformity
with this Directive.

19

Article 5
Essential requirements

The  equipment  referred  to  in  Article  1  shall  meet  the  essential  requirements  set  out  in
Annex I.

1. 

2. 

3. 

4. 

1. 

2. 

Article 6
Harmonised standards

The  compliance  of  equipment  with  the  relevant  harmonised  standards  whose
references have been published in the Official Journal of the European Communities
shall raise a presumption, on the part of the Member States, of conformity with the
essential requirements referred to in Annex I to which such standards relate.

The modalities for the application of harmonised standards are set out in Annex V.

Where a Member State or the Commission considers that a harmonised standard does
not entirely satisfy the essential requirements referred to in Annex I, it shall bring the
matter before the Standing Committee set up by Directive 98/34/EC (hereinafter “the
Committee”),  stating  its  reasons.  The  Committee  shall  deliver  an  opinion  without
delay.

Upon  receipt  of  the  Committee’s  opinion,  the  Commission  shall  take  one  of  the
following  decisions  with  regard  to  the  references  to  the  harmonised  standard
concerned:

(a) 

not to publish;

(b) 

to publish with restrictions;

(c) 

(d) 

to maintain the reference in the publication referred to in paragraph 1;

to  withdraw  the  reference  from  the  publication  referred  to  in
paragraph 1.

The Commission shall inform the Member States of its decision without delay.

Chapter II
APPARATUS

Article 7
Conformity assessment procedure for apparatus

For the purposes of demonstrating the compliance of apparatus with the provisions of
this Directive, with a view to its placing on the market and/ or putting into service,
the conformity assessment procedure set out in paragraphs 2 to 5 shall be used.

The manufacturer or his authorised representative established within the Community
shall draw up technical documentation which provides evidence of the conformity of
the apparatus with the essential requirements of this Directive.

20

The technical documentation may include a report from the notified body referred to
in Article 11 confirming the compliance of the apparatus with the relevant essential
requirements  set  out  in  Annex  I.  The  manufacturer  may  determine  the  subject  and
depth of the assessment to be carried out.

The  technical  documentation  shall  be  held  at  the  disposal  of  the  competent
authorities for a period of at least ten  years  after  the  date  on  which  such  apparatus
was last manufactured.

The compliance of apparatus with all relevant essential requirements shall be attested
by  an  EC  declaration  of  conformity  issued  by  the  manufacturer  or  his  authorised
representative established within the Community.

The  EC  declaration  of  conformity  shall  be  held  at  the  disposal  of  the  competent
authorities for a period of at least ten  years  after  the  date  on  which  such  apparatus
was last manufactured.

If neither the manufacturer nor his authorised representative is established within the
Community,  the  obligation  to  hold  the  EC  declaration  of  conformity  and  the
technical  documentation  at  the  disposal  of  the  competent  authorities  shall  be  the
responsibility of the person who places the apparatus on the Community market.

The technical documentation and the EC declaration of conformity shall be drawn up
in accordance with the provisions set out in Annex II.

Article 8
CE marking

Apparatus  whose  compliance  with  this  Directive  has  been  established  by  the
procedure laid down in Article 7 shall bear the CE marking which attests to that fact.
The affixing of the CE marking shall be the responsibility of the manufacturer or his
authorised representative established within the Community.

The CE marking shall be affixed in accordance with the provisions set out in Annex
III.

Member  States  shall  take  the  necessary  measures  to  prohibit  the  affixing  to  the
apparatus,  or  to  its  packaging,  or  to  the  instructions  for  its  use  of  marks  which  are
likely to mislead third parties in relation to the meaning and/or  graphic form of the
CE marking.

Any other mark may be affixed to the apparatus, its packaging, or the instructions for
its  use,  provided  that  neither  the  visibility  nor  the  legibility  of  the  CE  marking  is
thereby impaired.

Without  prejudice  to  Article  9,  if  a  competent  authority  establishes  that  the  CE
marking  has been unduly  affixed, the manufacturer or  his  authorised  representative
established within the Community shall bring the apparatus into conformity with the
provisions  concerning  the  CE  marking  under  conditions  imposed  by  the  Member
State concerned.

3. 

4. 

5. 

1. 

2. 

3. 

4. 

21

1. 

2. 

3. 

4. 

5. 

1. 

2. 

Article 9
Safeguards

Where a Member State ascertains that an apparatus bearing the CE marking does not
comply with the requirements of this Directive, it shall take all appropriate measures
to withdraw the apparatus from the market, to prohibit its placing on the  market or
putting into service, or to restrict its free movement.

The  Member  State  concerned  shall  immediately  inform  the  Commission  and  the
other Member States of any such measure, indicating the reasons and specifying, in
particular, whether non-compliance is due to:

(a) 

(b) 

failure  to  satisfy  the  essential  requirements  referred  to  in  Annex  I,
when  the  apparatus  does  not  comply  with  the  harmonised  standards
referred to in Article 6;

incorrect application of the harmonised standards referred to in Article
6;

(c) 

shortcomings in the harmonised standards referred to in Article 6.

The Commission  shall consult the parties  concerned  as  soon  as  possible,  following
which  it  shall  inform  the  Member  States  whether  or  not  it  finds  the  measure  to  be
justified.

Where  the  measure  referred  to  in  paragraph  1  is  attributed  to  a  shortcoming  in
harmonised  standards,  the  Commission,  after  consulting  the  parties,  shall,  if  the
Member State concerned intends to uphold the measure, bring the matter before the
Committee and initiate the procedure laid down in Article 6(3).

Where  the  non-compliant  apparatus  is  accompanied  by  the  report  referred  to  in
Article 7(2), the Member State concerned shall take appropriate action in respect of
the  author  of  that  report,  and  shall  inform  the  Commission  and  the  other  Member
States accordingly.

Article 10
Decisions with respect to the withdrawal, prohibition or restriction of free movement of
apparatus

Any  decision  taken  pursuant  to  this  Directive  to  withdraw  an  apparatus  from  the
market,  prohibit  or  restrict  its  placing  on  the  market  or  its  putting  into  service,  or
restrict  its  free  movement,  shall  state  the  exact  grounds  on  which  it  is  based.  Such
decisions  shall  be  notified  without  delay  to  the  party  concerned,  who  shall  at  the
same  time  be  informed  of  the  remedies  available  to  him  under  the  national  law  in
force in the Member State in question and of the time limits to which such remedies
are subject.

In  the  event  of  a  decision  as  referred  to  in  paragraph  1,  the  manufacturer,  his
authorised representative, or other interested party shall have the opportunity to put
forward  his  point  of  view  in  advance,  unless  such  consultation  is  not  possible
because  of  the  urgency  of  the  measure  to  be  taken  as  justified  in  particular  with
respect to public interest requirements.

22

Article 11
Notified bodies

1. 

2. 

3. 

4. 

5. 

Member States shall designate the bodies competent to draw up the reports referred
to in Article 7(2) and shall notify them (notified  bodies) to the  Commission and to
the other Member States.

Such  notification  shall  state  whether  the  bodies  are  competent  for  all  apparatus
covered by this Directive or whether their responsibility is limited to certain specific
aspects.

Member  States  shall  apply  the  criteria  listed  in  Annex  IV  for  the  assessment  of
notified bodies.

Bodies which comply with the assessment criteria fixed by the relevant harmonised
standards shall be presumed to comply with the criteria set out in Annex IV covered
by such harmonised standards. The Commission shall publish in the Official Journal
of the European Communities the references of these standards.

The Commission shall publish in the Official Journal of the European Communities
a list of notified bodies. The Commission shall ensure that the list is kept up to date.

If  a  Member  State  finds  that  a  notified  body  no  longer  meets  the  criteria  listed  in
Annex IV, it shall inform the Commission and the other Member States accordingly.
The Commission shall withdraw the reference to that body from the list referred to in
paragraph 4.

Chapter III
FIXED INSTALLATIONS

Article 12
Fixed installations

1. 

Apparatus which has been placed on the market and which may be incorporated into
a fixed  installation  is  subject  to  all  relevant  provisions  for  apparatus  set  out  in  this
Directive.

However, the provisions of Articles 5, 7 and 8 shall not be compulsory in the case of
apparatus  which  is  specifically  designed  for  incorporation  into  a  given  fixed
installation  and  is  otherwise  not  commercially  available.  In  such  cases,  the
accompanying  documentation  shall  name  the  site  of  the  fixed  installation  and
indicate  the  precautions  to  be  taken  for  the  incorporation  of  the  apparatus  into  the
fixed  installation  in  order  not  to  compromise  the  conformity  of  the  specified
installation. It shall furthermore include the information referred to in Point 4(a) and
(b) of Annex I.

2. 

Where there are indications of non-compliance of the fixed installation, in particular,
where  there  are  complaints  about  disturbances  being  generated  by  the  installation,
the  competent  authorities  of  the  Member  State  concerned  may  request  evidence  of
compliance of the fixed installation, and, when appropriate, initiate an assessment.

23

Where  non-compliance  is  identified,  the  competent  authorities  may  impose
appropriate  measures  to  bring  the  installation  into  compliance  with  the  protection
requirements set out in Annex I.

3. 

Member  States  shall  set  out  the  necessary  provisions  for  the  identification  of  the
person  or  persons  responsible  for  the  establishment  of  compliance  of  a  fixed
installation with the relevant essential requirements.

Chapter IV
FINAL PROVISIONS

Article 13
Repeal

Directive 89/336/EEC is hereby repealed as from [date of application11].

References to Directive 89/336/EEC shall be construed as references to this Directive and be
read in accordance with the correlation table set out in Annex VI.

Article 14
Transitional provisions

Member  States  shall  not  impede  the  placing  on  the  market  and/  or  putting  into  service  of
equipment  which  is  in  compliance  with  the  provisions  of  Directive  89/336/EEC  and  which
was placed on the market before [date of application + 2 years].

Article 15
Transposition

1. 

Member  States  shall  adopt  and  publish  the  laws,  regulations  and  administrative
provisions  necessary  to  comply  with  this  Directive  by  [date  of  application  –  6
months]  at  the  latest.  They  shall  forthwith  inform  the  Commission  thereof.
They shall apply those provisions as from [date of application].
When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this
Directive  or  be  accompanied  by  such  reference  on  the  occasion  of  their  official
publication.  The  methods  of  making  such  a  publication  shall  be  laid  down  by
Member States.

2. 

Member States shall communicate to the Commission the texts of the provisions of
national law which they adopt in the field covered by this Directive.

11

Date of application is defined as the date of publication + 30 months

24

                                                
Article 16
Entry into force

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

Article 17
Addressees

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

25

ANNEX I
Essential requirements

1. 

1. 

2. 

2. 

PROTECTION REQUIREMENTS

Equipment shall be so designed and manufactured, having regard to the state of the
art, as to ensure that:

(a) 

(b) 

the  electromagnetic  disturbance  generated  does  not  exceed  the  level
above  which  radio  and  telecommunications  equipment  or  other
equipment cannot operate as intended;

it  has  a  level  of  immunity  to  the  electromagnetic  disturbance  to  be
expected  in  its  intended  use  which  allows  it  to  operate  without
unacceptable degradation of its intended use.

SPECIFIC REQUIREMENTS FOR APPARATUS

Electromagnetic compatibility assessment:

The manufacturer shall perform an electromagnetic compatibility assessment  of  the
apparatus, based on the relevant  phenomena, with a  view to meeting the protection
requirements set out in Point 1.

The  electromagnetic  compatibility  assessment  shall  take  into  account  all  normal
intended operating conditions.

In  cases  where  the  apparatus  can  take  different  configurations,  the  electromagnetic
compatibility  assessment  shall  confirm  that  the  apparatus  meets  the  protection
requirements  set  out  in  Point  1  in  all  possible  configurations  identified  by  the
manufacturer as representative of normal use in its intended application.

3. 

External devices:

All  apparatus  shall  meet  the  protection  requirements  referred  to  in  Point  1  without
external  devices  such  as  filtering  or  shielding,  unless  those  devices,  including  the
necessary instructions for use, are placed on the market together with the apparatus
as a functional unit.

This provision shall not apply to apparatus designed and intended for installation by
a person technically competent in the field of electromagnetic compatibility. In such
cases external devices need not be placed on the market together with the apparatus,
provided  that  those  devices  are  commercially  available  and  their  required
electromagnetic  compatibility  characteristics  are  sufficiently  described  in  the
instructions for use of the apparatus;

Connecting  devices,  such  as  plugs  or  cables,  which  have  to  fulfil  specific
requirements for the compliance of the apparatus with the protection requirements set
out in Point 1, need not to be placed on the market together with the apparatus if they
are commercially available and their required properties are sufficiently described in
the instructions for use of the apparatus.

26

4. 

Information requirements:

(a) 

(b) 

(c) 

(d) 

Each  apparatus  shall  be  identified  in  terms  of  type,  batch,  serial
number or any other information allowing for the identification of the
apparatus;

Each apparatus shall be accompanied by the name and address of the
manufacturer and, if he is not established within the Community, the
name  and  address  of  his  authorised  representative  or  the  person
established  within  the  Community  responsible  for  placing  the
apparatus on the Community market;

information  on  any  specific
The  manufacturer  shall  provide 
precautions  that  have  to  be  taken  when  the  apparatus  is  assembled,
installed,  maintained  or  used,  in  order  to  ensure  that,  when  put  into
service, 
the  protection
requirements set out in Point 1;

in  conformity  with 

the  apparatus 

is 

Apparatus  for  which  compliance  with  the  protection  requirements  is
not  ensured  in  residential  areas  shall  be  accompanied  by  a  clear
indication of this restriction of use.

5. 

Ready-made connecting devices:

(a) 

(b) 

(c) 

The requirements for apparatus set out in Points 2, 3, 4(c) and (d) shall
not apply to ready-made connecting devices;

Ready-made  connecting  devices  shall  be  designed  and  manufactured
in such a way that, when connected to the apparatus for which they are
intended,  following  any  specific  precautions  as  described  below,
compliance  with  the  protection  requirements  set  out  in  Point  1  is
ensured;

Ready-made  connecting  devices  shall  be  accompanied  by  an
indication  of  the  technical  characteristics  of  the  apparatus  to  which
they  are  intended  to  be  connected,  and  information  on  any  specific
precautions  that  need  to  be  taken  regarding  the  connection  to  such
apparatus with a view to meeting the  protection requirements set out
in Point 1.

3. 

6. 

SPECIFIC REQUIREMENTS FOR FIXED INSTALLATIONS

Installation and intended use of components:

A  fixed  installation  shall  be  installed  applying  good  engineering  practice  and
respecting  the  information  on  the  intended  use  of  its  components,  with  a  view  to
meeting the protection requirements set out in Point 1.

27

ANNEX II
Technical documentation, EC declaration of conformity

1. 

TECHNICAL DOCUMENTATION

The  technical  documentation  must  enable  the  conformity  of  the  apparatus  with  the
essential  requirements  to  be  assessed.  It  must  cover  the  design  and  manufacture  of
the apparatus, in particular:

–  a general description of the apparatus;

–  a report of compliance with the harmonised standards, if any, applied in full or in

part;

–  where  the  manufacturer  has  not  applied  harmonised  standards,  or  has  applied
them  only  in  part,  a  description  and  explanation  of  the  steps  taken  to  meet  the
essential  requirements  of 
the
electromagnetic  compatibility  assessment  set  out  in  Annex  I,  results  of  design
calculations made, examinations carried out, test reports, etc.;

including  a  description  of 

the  Directive, 

–  on a voluntary basis, the manufacturer may include in the technical documentation
a report from a notified body confirming the conformity of the apparatus with the
relevant essential requirements set out in Annex I.

2. 

EC DECLARATION OF CONFORMITY

The EC declaration of conformity must contain, at least, the following:

–  reference to this Directive;

–  identification of the apparatus to which it refers, as set out in Point 4(a) of Annex

I;

–  name  and  address  of  the  manufacturer  and,  where  applicable,  the  name  and

address of his authorised representative within the Community;

–  dated reference to the specifications under which conformity is declared to ensure

the conformity of the apparatus with the provisions of this Directive;

–  date and place of issue of the declaration;

–  identification and signature of the person empowered to bind the manufacturer or

his authorised representative.

28

The CE marking shall consist in the initials "CE" taking the following form:

ANNEX III
CE marking

The  CE  marking  must  have  a  height  of  at  least  5  mm.  If  the  CE  marking  is  reduced  or
enlarged the proportions given in the above graduated drawing must be respected.

The  CE  marking  must  be  affixed  to  the  apparatus  or  to  its  data  plate.  Where  this  is  not
possible or not warranted on account of the nature of the apparatus, it must be affixed to the
packaging, if any, and to the accompanying documents.

Where  apparatus  is  the  subject  of  other  Directives  covering  other  aspects  and  which  also
provide  for  the  CE  marking,  the  latter  shall  indicate  that  the  apparatus  also  conforms  with
those other Directives.

However, where one or more of those Directives allow the manufacturer, during a transitional
period,  to  choose  which  arrangements  to  apply,  the  CE  marking  shall  indicate  conformity
only with the Directives applied by the manufacturer. In this case, particulars of the Directives
applied, as published in the Official Journal of the European Community, must be given in the
documents,  notices  or  instructions  required  by  the  Directives  and  accompanying  such
apparatus.

29

ANNEX IV
Criteria for the assessment of the bodies to be notified

1. 

The  bodies  notified  by  the  Member  States  shall  fulfil  the  following  minimum
conditions:

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

availability of personnel and of the necessary means and equipment;

technical competence and professional integrity of personnel;

independence in preparing the reports and performing the verification
function provided for in this Directive;

independence  of  staff  and  technical  personnel  in  relation  to  all
interested  parties,  groups  or  persons  directly  or  indirectly  concerned
with the equipment in question;

maintenance of professional secrecy by personnel;

possession  of  civil  liability  insurance  unless  such  liability  is  covered
by the State under national law.

2. 

Fulfilment  of  the  conditions  under  Point  1  shall  be  verified  at  intervals  by  the
competent authorities of the Member States.

30

ANNEX V
Application of harmonised standards

1. 

2. 

3. 

4. 

The  correct  application  of  all  the  relevant  harmonised  standards  whose  references
have  been  published  in  the  Official  Journal  of  the  European  Communities  shall  be
equivalent  to  the  carrying  out  of  the  electromagnetic  compatibility  assessment
referred to in Point 2 of Annex I.

Compliance  with  a harmonised standard  means  conformity with its provisions  (e.g.
limits) and demonstration thereof by the methods the harmonised standard describes
or refers to.

Presumption of conformity via application of harmonised standard(s) is limited to the
scope of the harmonised standard(s) applied and the relevant essential requirements
covered by such harmonised standard(s).

Harmonised standards are to be selected and used in accordance with the provisions
of the relevant standardisation documents. The reference to those documents shall be
published in the Official Journal of the European Communities.

31

ANNEX VI
Correlation Table

Directive 89/336/EEC

This Directive

Article 1, point 1)

Article 1, point 2)

Article 1, point 3)

Article 1, point 4)

Article 2, points 1(a), 1(b), 1(c)

Article 2, point 1(e)

Article 2, point 1(f)

Article 2 point 1(d)

Article 1 points 5 and 6)

-

Article 2 point 1.

Article 2 point 2.

Article 2 point 3.

Article 3

Article 4

Article 5

Article 6

Article 7 point 1.(a)

Article 7 point 1(b)

Article 7 point 2.

Article 7 point 3.

Article 8 point 1.

Article 8 point 2.

Article 9 point 1.

Article 9 point 2.

Article 9 point 3.

Article 9 point 4.

Article 10 point 1 1st paragraph

Article 10 point 1 2nd paragraph

Article 1 point 1.

Article 1 point 4.

Article 1 point 2(c)

Article 3.

Article 5 and Annex I

Article 4 point 1.

Article 4 point 2.

Article 6 points 1. and 2., Annex V

-

-

-

Article 6 points 3. and 4.

-

Article 9, points 1. and 2.

Article 9, points 3. and 4.

Article 9, point 5.

Article 9, point 3.

Article 7

Article 8

32

Article 10 point 2

Article 10 point 3

Article 10 point 4

Article 10 point 5

Article 10 point 6

Article 11

Article 12

Article 13

Annex I, section 1

Annex I, section 2

Annex II

Annex III

Article 7

-

-

Article 7

Article 11

Article 13

Article 15

Article 17

Annex II, section 2

Annex III

Annex IV

-

33

IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE
TO SMALL AND MEDIUM-SIZED ENTERPRISES (SMEs)

TITLE OF PROPOSAL

Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  on
electromagnetic compatibility, amending Directive 89/336/EEC

DOCUMENT REFERENCE NUMBER

THE PROPOSAL

The  aim  of  this  proposal  for  a  Directive  is  to  ensure  the  free  movement  of  the
products  referred  to  in  it  by  guaranteeing  a  homogeneous  electromagnetic
environment  and  ensuring  the  proper  functioning  of  the  products  concerned.  The
products  concerned  are  essentially  electrical  and  electronic  apparatus,  ready-made
connecting  devices  intended  for  connection  to  an  apparatus  by  an  end  user  for  the
transmission of signals, and fixed installations created using such apparatus.

This  proposal  for  a  Directive  is  based  on  Article  95  of  the  Treaty  establishing  the
European Community and revises Directive 89/336/EEC, which is currently in force.
It  meets  the  request  for  simplification  expressed  by  all  economic  operators  by
establishing a better definition of certain concepts and clarifying the wording of texts
which caused difficulties in applying the current Directive. Moreover, the scope has
been redefined to make it clearer and to include certain products.

This proposal for a Directive originates from phase III  of  the  SLIM programme, in
particular  from  the  recommendation  from  the  SLIM  team,  endorsed  by  the
Commission (COM(1999)88).

The  proposal  has,  to  a  very  large  extent,  been  favourably  received  by  the  parties
concerned and is  seen  as  being suited  to  the  market requirements.  It  complies  with
the principles of subsidiarity and proportionality required by Community texts.

THE IMPACT ON BUSINESS

This  proposal  for  a  Directive  covers  all  electrical  and  electronic  sectors,  including
domestic appliances, information technology and telecommunications.

As  further  developed  in  the  explanatory  memorandum,  the  impact  on  business  is
based  on  both  an  independent  impact  analysis  study  (“Cost  benefit  analysis  on  the
draft  amendment  of  the  EC  Directive  on  electromagnetic  compatibility”,  RPA  Ltd,
January  2002)  and  an  internal  market  business  test  panel  initiated  by  the
Commission. The impact analysis study based its finding on a enquiry process during
which  contact  was  made  with  more  than  410  European  and  International
organisations,  representing  manufacturers  of  apparatus,  installers  and  users  of
installations,  certifying  laboratories,  professional  and  end-user  of  equipment  and

34

consumers  of  appliances,  users  and  operators  of  radio,  telecommunications  and
electricity networks, together with public authorities.

Both studies showed that small and medium-sized enterprises made up around 60%
of the enterprises covered, representing an annual total of 800 million products, and
the  total  annual  turnover  of  the  sector  amounted  to  around  €400  billion.  These
enterprises  are  spread  throughout  the  territory  of  the  Community,  with  Germany,
France,  Italy  and  the  United  Kingdom  accounting  for  75%  of  the  equipment
produced.

The  majority  of  the  enterprises  manufacturing  the  products  referred  to  in  this
proposal  for  a  Directive  are  already  required  to  apply  Directive  89/336/EEC.
Consequently, they will not have to take any particular measures in order to comply
with the new  text.  The  sector  which  has  now  been  included  in  its  scope  comprises
chiefly manufacturers of ready-made connecting devices intended for connection to
an apparatus by an end user for the transmission of signals and these are, in the main,
small  and  medium-sized  enterprises.  The  proposal  will  therefore  not  have  a  major
effect on the economy as a whole. It is thus not expected that the proposal will have
effects neither on employment nor on investment or creation of new businesses, with
the possible exception of an increase in the business of competent bodies. In figures,
the  impact  analysis  concluded  that  there  would  be  a  net  utility  loss  for  all  EU
manufacturers  of  EMC  products  of  €2.1  billion,  which  amounts  to  0.1%  of  the
sector's turnover, discounted over a period of 8 years.

This  proposal  does  not  contain  any  specific  measure  applicable  to  small  and
medium-sized  enterprises.  This  is  because,  in  the  proposal  for  a  Directive,  the
conformity assessment procedures have already been reduced to a simple declaration
of  conformity  made  by  the  manufacturer  without  the  compulsory  intervention  of  a
third party.

CONSULTATION

From the beginning of the work on this proposal, the Commission has, via the "EMC
SLIM" working group, associated all the professional bodies concerned in the work,
including  manufacturers,  utility  operators,  certification  bodies,  etc...  During  the
elaboration  of  this  proposal  for  a  Directive,  eight  drafts  have  been  elaborated  and
discussed by this SLIM working group, and made available on the Internet site of the
Commission, in order to reach the widest possible audience of interested parties. The
federations and organisations consulted include the following:

(1)  Manufacturers

–  ORGALIME

Liaison  Group  of 
Electronic and Metalworking Industries

the  European  Mechanical,  Electrical,

–  EURELECTRIC Union of Electricity Industry

–  EICTA European  Information,  Communications  and  Consumer  Electronics

Technology Industry Association

–  EACM European Association of Consumer Electronics Manufacturers

35

–  EUROPACABLE

European  Confederation  of  National  Associations  of

Manufactures of Insulated Wire and Cable

(2) 

Users

–  ANEC

European Association for the co-ordination of consumer representation

in standardisation

(3)  Others

–  CEN

European Committee for Standardization

–  CENELEC

European Committee for Electrotechnical Standardization

–  ETSI

European Telecommunications Standards Institute

–  ECACB European EMC Competent Bodies group

CONCLUSIONS

The  impact  analysis  study  has  recommended  the  revision  of  the  directive.
Additionally, in Commission’s opinion, net social utility loss identified should  thus
be viewed against the benefits brought by the proposal. These benefits will include
improved  operation  of  the  internal  market,  greater  flexibility  for  the  actors  of  the
market, and  for  given  products,  an  improved  level  of  protection.  The  proposal  will
also include an improvement of the tools made available to the competent authorities
to perform market surveillance,  which will ensure  a  fairer competition between  the
actors of the market.

36