Communication from the Commission to the Council and the European Parliament - Enhancing the Implementation of the New Approach Directives
Date: 2003-05-07
Institutions: European Commission
Subjects: EC conformity marking, administrative cooperation, application of EU law, approximation of laws, exchange of information, free movement of goods, legislative drafting, market supervision, standardisation

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 7.5.2003
COM(2003) 240 final

COMMUNICATION FROM THE COMMISSION
TO THE COUNCIL AND THE EUROPEAN PARLIAMENT

Enhancing the Implementation of the New Approach Directives

EXECUTIVE SUMMARY

The Commission is determined to strengthen the foundations of the system of free movement
of goods in anticipation of an enlarged European Union.

The New Approach (complemented by the Global Approach) is a legislative technique used
in  the  area  of  the  free  movement  of  goods,  widely  recognised1  as  highly  efficient  and
successful.  For  almost  15 years,  the  directives  based  on  it  have  played  a  central  role  in  the
effort to ensure free movement of goods in the single market. Economic integration and trade
facilitation has increased steadily since the initiative was taken to develop these instruments.
Over  the  years,  as  part  of  a  continuous  assessing  process,  the  tools  have  been  successfully
revised and  significantly improved.  However, no  general  review  on  its  important  horizontal
aspects has been made yet. This paper is a part of that process, designed to further strengthen
a successful tool.

With  the  purpose  of  detecting  areas  which  could  be  further  improved,  the  Commission
prepared a consultation document which identified some key elements of the New and Global
Approach, accompanied by a detailed inter-active questionnaire. The intention of this exercise
was  to  involve  those  most  directly  implicated  in  the  current  system  by  asking  them  to  put
forward their views of its operating deficiencies and strengths. The input received in response
to  this  questionnaire  has  provided  valuable  insight  to  some  of  the  issues  identified  as  key
elements  that  could  be  further  improved.  In  particular,  answers  received  indicated  that
stakeholders wish to continue with this system and to make it more effective.

The analysis of replies to this open consultation also revealed points of weakness in the fields
of  co-operation  both  within  and  between  the  relevant  authorities  in  the  Member  States  and
with  the  Commission  in  the  designation  and  notification  procedures  for  conformity
assessment  bodies.  Systems  for  the  administrative  exchange  of  information,  in  the
implementation  of  provisions  and  in  their  execution  require  strengthening.  Improving
understanding of the CE marking and a significant increase of the level of consistency of legal
requirements were also identified as important goals to be achieved in the future.

Long  experience  in  dealing  with  the  individual  New  Approach  directives  both  in  Member
States  and  the  European  Commission,  supported  by  considerable  input  from  the  Senior
Officials  Group  on  Standardisation  and  Conformity  Assessment  (SOGS)  and  the  working
groups  established  under  the  directives,  together  with  the  assessment  of  results  of  the  open
consultation, form the basis of this Communication.

The  Communication  is  addressed  to  the  European  Parliament  and  the  Council.  It  contains
recommendations  aimed  at  further  improving  the  operational  efficiency  of  the  Internal
Market,  thereby  reinforcing  the  competitiveness  of  European  industry  with  cost  effective,
targeted measures proposed by many of the stakeholders themselves.

1

Most in the Council conclusions of 28 October 1999 OJ C 2000 141/01 on the role of standardisation
in Europe.

2

                                                
1.

INTRODUCTION

1.1.

Opportunities offered by this Review

Making the free movement of goods work better in a European Union of 25 Member States is
a key part of the Commission’s new strategy for the internal market for the period 2003-2006.
This  Communication  on  the  New  Approach  is  therefore  the  first  in  a  number  of  important
proposals  in  this  area  which  the  Commission  intends  to  table.  Important  work  is  also  in
preparation to improve the free movement of goods in the non harmonised area.

Finding effective and efficient solutions to ensure that the free movement of goods functions
well after enlargement is essential. The Commission will therefore seek high quality feedback
to its ideas and then move rapidly towards making concrete proposals for action.

The principles of the New Approach have been the basis of a growing number of directives.
More  than  20 directives  are  based  on  the  New  Approach,  and  a  number  of  other  directives
rely on principles of the New or Global Approach.

Although  the  number  of  directives  is  low,  the  products  covered  by  them  represent  a  large
proportion of products that are placed on the market (see annex  II, table 1b).  It is estimated
that the trade of products covered only by the major sectors regulated by the New Approach
directives largely exceeds the volume of € 1500 billion per year.

The  Commission  and  national  authorities  have  accumulated  nearly  15 years  of  practical
experience  concerning  the  implementation  of  these  directives,  during  which  many  of  them
have been revised. Experience has shown, that the New Approach has been a successful tool
for  the  development  of  the  Internal  Market.  However,  experience,  supported  by  evidence
given  at  subsequent  consultations,  has  also  demonstrated  that  implementation  of  these
directives can be further improved in a number of ways.

At the beginning of 2002, a detailed questionnaire2 developed by the Commission was put on
the web-site of the Enterprise Directorate General, inviting comments. Stakeholders across a
wide  spectrum  of  civil  society  responded  to  the  questionnaire.  Replies  were  received  from
manufacturers,  conformity  assessment  bodies,  accreditation  bodies,  designating  authorities
from almost all Member States, and companies that can be considered to be “global players”
based  in  and  outside  the  European  Union.  In  addition,  small  and  medium  size  enterprises
(SMEs),  organisations  representing  manufacturers  or  commercial  businesses,  national
ministries  from  Member  States  and  other  Commission  services  also  replied.  Annex  1
summarises the key trends of the input received. The need to review the elements highlighted
in the questionnaire  was considered by  all  stakeholders  as necessary if the  New  and  Global
Approach  is  to  work  with  increased  effectiveness.  However,  the  measures  proposed  by  this
communication do not modify the basic principles of the New Approach, which have proved
to be effective.

The  Commission  published  in  1999  a  revised  and  expanded  edition  of  the  “Guide  to  the
implementation  of  directives  based  on  the  New  Approach  and  the  Global  Approach”3,  the

2

3

“Working document on the review of the New Approach”, closed 31 March 2002.
Office for Official Publications of the European Communities, reference C-22-99-014-EN-C. The guide
can  also  be  downloaded  from  the  Europa  web  site  in  all  11  official  languages  of  the  European
Community. See http://europa.eu.int/enterprise/newapproach/legislation/guide/legislation.htm

3

                                                
objective  of  which  is  to  provide  guidance  to  all  relevant  actors  in  understanding  the  New
Approach.  While  this  guide  is  widely  used  as  a  reference  it  cannot,  by  itself,  reinforce  the
areas that need to be strengthened.

Two additional elements underpin this review:

– 

– 

the New Approach now has an important international dimension. A more consistent
implementation  of  the  New  Approach  within  the  European  Union  will  support  the
pursuit of the objective of promoting the adoption by third countries of standards and
regulatory  approaches based on,  or compatible with, the EU  regulatory  framework.
This  applies  within  the  context  of  the  expansion  of  the  internal  market  with
Candidate  Countries  through  the  negotiation  of  PECAs  (Protocols  on  Conformity
Assessment and Acceptance of Industrial Products). The New Approach also gives a
solid basis to negotiate with third countries a variety of measures to reduce technical
barriers to trade.

this  review is  also  integral  to  the  process  of  Better  Regulation.  The  needs  of  small
and  medium  size  enterprises  (SMEs)  for  a  simple  and  transparent  legal  framework
are  particularly  important  in  this  respect.  Furthermore  the  EU  needs  to  be  in  a
position to ensure that existing internal market instruments are applied in a coherent
and consistent manner so as to achieve uniform implementation and a good level of
compliance with Community legislation.

1.2.

Legal Background

On  7  May  1985,  the  Council  adopted  a  Resolution  on  A  New  Approach  to  technical
harmonisation and standards, providing a new framework for the harmonisation of national
regulations  for  industrial  products.4  The  New  Approach  was  devised  to  facilitate  the
achievement of the Internal Market and to develop flexible and technology-neutral legislation
by  moving  from  detailed  product  specific  technical  requirements  to  defining  the  essential
requirements for types of products, thus promoting innovation and competitiveness.5

This  was  complemented  in  1989  by  the  Council  Resolution  on  a  Global  Approach  to
conformity  assessment,  followed  by  two  other  Council  Decisions6setting  out  more  detailed
specifications on testing and certification procedures and providing guidelines for the use of
the  CE  marking,  which  are  intended  to  be  used  in  the  harmonisation  directives.  There  are
provisions for the Commission to “report periodically whether conformity assessment and CE
marking procedures are working satisfactorily or need to be modified.”

Some New Approach directives include procedures that diverge from those used in “standard”
New  Approach  directives,  such  as  the  notification  procedure  in  the  Toys  Directive,  the
safeguard  clause  procedure  in  the  Low  Voltage  Directive  73/23/EEC  or  the  conformity
assessment procedures in the Construction Products Directive. The use of modules to assess
conformity with individual directives has posed some problems that were also highlighted by

4

5

6

OJ C 136/1, 4.6.1985.
The Agreement on the European Economic Area extends the Internal Market to Iceland, Liechtenstein
and Norway. Consequently, all New Approach Directives apply in these countries as they do in the EU
Member  States.  References  to  the  Internal  Market  in  this  working  document  should  be  interpreted
accordingly.
Council  Decision  90/683/EEC  of  13  December  1990  OJ  L  380/13,  31.12.1990  replaced  by  Council
Decision 93/465/EEC of 22 July 1993 OJ L 220/23, 30.08.1993.

4

                                                
the  consultation  results.  Conformity  assessment  according  to  the  modules  is  based  on  the
intervention of the manufacturer (first party) or of a notified body (third party) in the design
and/or  the  production  phase.  Some  of  these  aspects  are  sector  specific  and  will  need  to  be
addressed on a sector specific basis.

1.3.

The main elements of the New Approach

The main elements of the  New Approach have been defined in the Council Resolution on a
New Approach to technical harmonisation and standardisation7:

– 

– 

– 

– 

– 

The  definition  of  mandatory  essential  requirements  to  ensure  a  high  level  of
protection of the public interest at issue, such as health, safety, consumer protection
or the protection of the environment. Essential requirements must be worded in terms
that  can  be  uniformly  enforced  by  Member  States.  Furthermore,  they  must  enable
conformity  assessment  bodies  to  evaluate  conformity  of  products  with  essential
requirements  and  standardisation  bodies  to  develop  standards  that  ensure,  partly  or
completely, the fulfilment of those essential requirements.

Manufacturers  are  free  to  choose  any  appropriate  technical  solution  that  meets  the
essential requirements. Products that  comply  with harmonised standards, references
to which have been published in the Official Journal of the European Communities,
are  presumed  to  meet  the  corresponding  essential  requirements.  Harmonised
standards  are  produced  by  the  European  standardisation  bodies8  on  the  basis  of
mandates from the Commission.

The definition of appropriate conformity assessment procedures, taking into account,
among other things, the type of risk related to the products. Where appropriate, these
procedures  require  the  intervention  of  third  party  conformity  assessment  bodies,
known  as notified bodies. Manufacturers  may choose  between  different  conformity
assessment procedures provided for in the applicable directive(s).

The  introduction  of  the  CE  marking,  which  declares  the  fact  that  the  manufacturer
has verified that the product conforms to all the harmonisation provisions that apply
to  it  and  that  the  product  has  been  the  subject  of  the  applicable  conformity
assessment procedures.

The  obligation  on  Member  States  to  take  all  appropriate  enforcement  measures,
including market surveillance, to ensure that non-conforming products are withdrawn
from the market.

The  Commission  has  previously  addressed  the  role  of  standardisation  in  its  report  on  the
Efficiency  and  Accountability  in  European  Standardisation  under  the  New  Approach.9  This
report  was  the  basis  of  two  resolutions  adopted  by  the  European  Parliament10  and  by  the
Council11. Additionally,  the Commission  adopted  a  report describing  actions  that  have  been
taken  following  those  resolutions12.  A  further  set  of  conclusions  of  the  Council  has  been

7

8

9

10

11

12

Council Resolution of 7 May 1985 OJ C 136, 4.06.1985.
European  Committee  for  Standardisation  (CEN),  European  Committee 
Standardisation (CENELEC) and European Telecommunication Standards Institute (ETSI).
COM(1998) 291 final of 13.5.1998.
Resolution of 12 February 1999 on the report from the Commission, OJ C 150, 28.5.1999.
Resolution of 28 October 1999 on the role of standardisation in Europe, OJ C 141, 19.5.2000.
COM(2001) 527 final of 26.9.2001.

for  Electrotechnical

5

                                                
recently  published13.  This  is  the  reason  why  the  aspects  of  the  New  Approach  related  to
standardisation are not dealt with in the present communication.

2.

STRENGTHENING THE IMPLEMENTATION OF NEW APPROACH DIRECTIVES

2.1.

Introduction

New  Approach  directives  provide  controls  of  products  (depending  on  the  subject  and  risk
covered)  for  both  pre-market  (conformity  assessment  modules)  and  post-market  (market
surveillance). These controls should be considered as part of a spectrum whose common aim
is to ensure a high level of safety of products on the market.

The  appropriate  balance  between  pre-  and  post-market  controls  varies  from  one  sector  to
another  –  some  items  are  relatively  easy  to  check  and  trace  once  in  use  or  in  circulation
(industrial  machinery),  others  are  not  (toys,  electrical  appliances,  etc.).  In  some  sectors,
experience  shows  that  an  adjustment  of  the  balance  may  be  required.  This  will  need  to  be
addressed in the context of individual revision of relevant directives.

2.2.

Notified Bodies

2.2.1.

Introduction

The  conformity  assessment  procedures  included  in  the  directives  are  based  on  conformity
assessment  modules.  Most  of  the  modules  foreseen  in  New  Approach  directives  require  the
intervention of a third-party conformity assessment body known as a notified body and, as a
general  rule,  are  used  for  higher  risk  products.  It  is  therefore  essential  that  these  notified
bodies  operate  with  a  proven  high  level  of  competence,  integrity  and  professionalism.
Approximately  1000  bodies  had  been  notified  to  the  Commission  by  the  end  of  2002  (see
Tables 1a and 1b in annex II).

Notification of conformity assessment bodies is an obligation under New Approach directives
and  the  requirements  that  those  bodies  must  meet  can  be  found  in  the  annexes  to  the
respective directives. Member States are responsible for the designation, notification and the
application  of  the  defined  criteria,  when  assessing  the  ability  of  the  body  to  carry  out  the
conformity assessment procedures in question.

2.2.2. Notification procedure

Notification plays a crucial role in the functioning of the system. Most directives state that the
notification should be sent to the Commission and to the other Member States. Member States
authorities  are,  in  principle,  obliged  to  accept  certificates  issued  by  bodies  for  which  they
have  received  a  notification.  In  order  to  facilitate  this  procedure,  the  Commission  has
produced  a  guidance  document  and  developed  standard  forms  for  the  use  of  notifying
authorities.  Nevertheless,  the  procedures  are  not  always  fully  observed  by  the  notifying
authorities, especially the obligation to send the notification to all other Member States. This
may lead to  problems concerning  the recognition of notified bodies in other  Member States
and, ultimately, may result in restrictions to the free movement of goods.

13

Council conclusions of 1st March 2002 on standardisation, O.J. 2002/C 66/01.

6

                                                
The Commission calls on Member States to ensure that their  notifying  authorities are made
fully  aware  of  their  obligations  concerning  the  notification  procedure  and  that  efforts  are
made towards shortening the period of time that elapses between the decision to notify a body
and the completion of the notification procedure.

The New Approach directives require the Commission to publish the lists of notified bodies
for each directive in the Official Journal of the European Communities. However, these lists
are published for information only and have no legal effect. Since a significant period of time
can elapse between the notification of a body and the next publication of the corresponding
list, it would be impractical to rely on the lists as the sole information mechanism concerning
the status of notified bodies.

The Commission is already taking steps to make available an on-line database on the Europa
web site containing the list of notified bodies designated by EU, EEA and candidate countries
and proposes the development of an on-line notification system to replace the existing paper-
based system. This will considerably reduce the processing time and enable notified bodies to
act  with  virtually  no  delay.  Further,  the  Commission  believes  that  the  publication  of  the
relevant lists in the Official Journal of the European Communities should be abolished once
the on-line publication on the Internet is achieved.

This database will also contain information about the Conformity Assessment Bodies (CABs)
designated  by  the  third-countries  with  which  the  Community  has  concluded  Mutual
Recognition Agreements (MRAs) and the bodies designated by those candidate countries with
which  the  Community  has  concluded  Protocols  on  Conformity  Assessment  (PECAs).  This
will  also  allow  the  information  concerning  notified  bodies  to  be  publicly  available  in  “real
time” and enable notifying authorities to update information more easily. The Interchange of
Data between Administrations (IDA) programme already in place14, or its successor, could be
used as a platform to implement the measure.

2.2.3.

The legal framework for the designation of notified bodies

It is the responsibility of Member States to notify those bodies under their jurisdiction which
meet the requirements of the directives and have been designated to carry out specific tasks.
Council  Decision  93/465/EEC  sets  out  some  general  guidelines  concerning  notified  bodies.
However,  it  is  the  individual  directives  which  provide  the  legal  basis  for  notification  and
contain  the  legally  binding  criteria  that  Member  States  must  apply  when  assessing  notified
bodies. Nevertheless, the directives do not include detailed provisions on how these principles
should  be  implemented.  This  situation  reflects  a  political  decision  that  the  designation  of
bodies should remain a national competence, i.e. the assessment and designation of notified
bodies is governed by the principle of subsidiarity and the acceptance of these bodies is based
on the principle of mutual recognition.

Since  the  inception  of  New  Approach  directives,  with  few  exceptions,  there  has  been  no
systematic  exchange  of  information  between  Member  States  concerning  the  criteria  and
procedures  applied  at  national  level  for  the  assessment  and  surveillance  of  notified  bodies.
This lack of transparency has encouraged suspicions about uneven levels of implementation
which,  in  turn,  undermine  the  confidence  that  is  essential  if  the  mutual  recognition  and
acceptance of certificates issued by notified bodies is to function smoothly. Ensuring greater

14

Decision  No.  1719/1999/EC  of  the  European  Parliament  and  of  the  Council  of  12  July  1999,
O.J. L 203/1.

7

                                                
transparency  about  the  implementation  of  the  directives’  requirements  concerning  notified
bodies, and improving the implementation of those requirements, is one of the key challenges
for the functioning of New Approach directives.

Certain  differences  between  the  systems  leading  to  notification  of  conformity  assessment
bodies, and the possibility to demonstrate the  abilities of those bodies by other means, have
lead to a lack of confidence among some stakeholders.

Therefore,  in  order  to  increase  the  levels  of  confidence  and  trust,  joint  working  groups  of
Member States’ officials have been established. Efforts of Member States and the Commission
towards reaching a homogeneous designation system must be intensified.

This is important for several reasons:

– 

– 

– 

to  ensure  the  safety  of  products  and  to  avoid  restrictions  on  the  free  movement  of
goods  that  could  arise  due  to  shortcomings  in  relation  to  the  competence,
impartiality, etc. of notified bodies;

to  allow  notified  bodies  to  compete  on  a  level  playing  field,  while  ensuring  that
competition does not lead to a reduction in the quality of the service they offer;

to  demonstrate  to  third  countries  with  which  the  Community  has  concluded  trade
agreements  that  there  is  a  consistent  approach  to  the  implementation  of  EU
legislation across the Community.

Council  Decision  93/465/EEC  specifies  conditions  regarding,  for  example,  subcontracted
work (competence of the establishment operating as subcontractor, ability of the notified body
to  exercise  effective  responsibility  for  the  work  carried  out  by  the  subcontractor),  the
establishment of co-operation among notified bodies, and the transfer of files when a notified
body  ceases  its  activities.  These  conditions  are  not  normally  reflected  in  the  directives.
However,  some  directives,  due  to  the  specificity  of  the  sector,  include  similar  requirements
using different wording or specify additional requirements which are absent from other New
Approach  directives.  This  may  result  in  legal  uncertainty  and  in  diverging  approaches  by
different  designating  authorities.  This  situation  could  be  remedied  if  all  the  requirements
concerning notified bodies were to be consolidated by means of a single legal text.

The Commission considers it necessary to consolidate the requirements notified bodies have
to fulfil. This could be covered either as part of a horizontal directive or as a standard article
to be included in the respective directives. These requirements should take into consideration
differences in the wording and the option to add, if necessary, complementary requirements.

2.2.4.

The role of accreditation

The  Global  Approach  gave  an  important  role  to  accreditation  of  conformity  assessment
bodies.  Accordingly,  Council  Decision  93/465/EEC  states  that  bodies  that  “can  prove  their
conformity  with  harmonised  standards  (EN 45000 series),  by  submitting  an  accreditation
certificate or other documentary evidence, are presumed to conform to the requirements of the
directives.” Similarly,  New  Approach  directives  state  that  bodies  which  meet  the  criteria  of
the relevant harmonised standards are presumed to meet the corresponding minimum criteria
of  the  directives.  In  practice  most  designating  authorities  now  rely,  to  various  degrees,  on
their national accreditation bodies to assess and oversee the bodies they designate.

8

The  problems  signalled  by  the  replies  to  the  consultation  concern  the  extent  to  which
accreditation bodies integrate directive-specific requirements in their assessments of notified
bodies.  The  same  question  occurs  even  where  accreditation  is  not  used.  In  either  case,  the
assessment  of  the  body  must  comprise  an  evaluation  of  its  competence,  in  accordance  with
the  relevant  annex  of  the  directive,  in  order  to  assess  the  conformity  of  products  with  the
essential  requirements  of  the  directives.  Competence  to  assess  the  conformity  of  products
with the applicable harmonised standards is not sufficient to be designated as a notified body.

The  solutions  adopted  by  Member  States  rely,  in  most  cases,  on  the  use  of  accreditation.
Therefore the use of EN 45000 series standards has proved to be useful. However, it must also
be recognised that the EN 45000 series does not cover all criteria that need to be considered
for  notification.  Furthermore,  these  standards,  despite  their  direct  reference  in  Community
legislation, have since been superseded by international standards which need to be formally
evaluated  for  their  conformity  with  the  criteria  imposed  by  the  New  Approach  directives
and/or their completeness.

A  number  of  designating  authorities,  generally  in  co-operation  with  their  national
accreditation body, have developed directive-specific  accreditation programmes to cover the
requirements  of  the  directives.  These  programmes  are  designed  to  expand  on  the  generic
competence  requirements  contained  in  the  EN 45000  standards  although  some  additional
criteria are required for certain directives (e.g. medical devices). However, due to the nature
of  the  legal  framework  governing  the  designation  of  notified  bodies,  the  different  national
programmes have developed in an uncoordinated fashion.

The  Commission  considers  that  in  order  to  improve  this  situation,  more  comprehensive
guidance  for  the  use  of  accreditation  should  be  developed  with  the  aim  of  increasing
coherence  and  structure  for  accreditation  services  within  the  Community,  especially
regarding  the  independence  of  accreditation  bodies  from  commercial  activities  and
competition  between  different  bodies,  whilst  leaving  the  final  responsibility  to  the  Member
States.  Basic  elements  of  such  guidance  could  be  part  of  the  common  legal  provisions
referred to in 2.2.3.

Performing accreditation in a similar manner in all Member States requires clear guidance for
these bodies. Such guidance can be provided either by setting common rules of conduct or by
accreditation bodies agreeing on a common policy. The flexibility of national systems should
not  be  the  target  of  this  guidance;  it  is  the  accountability  of  the  systems  that  needs  to  be
improved. The more national authorities, and also authorities of other Member States, can rely
on a high level of credibility of results of the accreditation system, the more the differences
will disappear.

Progress is necessary in co-ordinating the actions of designating authorities and accreditation
bodies  in  the  Member  States  in  relation  to  the  assessment,  designation  and  surveillance  of
notified  bodies.  Within  the  current  legal  framework,  the  Commission’s  ability  to  steer
developments  depends  on  the  co-operation  of  national  authorities.  The  responsibility  to
achieve further progress, therefore, falls mainly upon the national authorities.

The  Commission  intends  to  establish  a  permanent  forum  of  Member  States’  authorities
responsible  for  designation,  in  order  to  facilitate  the  exchange  of  best  practices  for  the
assessment,  designation  and  surveillance  of  notified  bodies.  This  forum  could  formulate
recommendations to be followed on a voluntary basis.

9

2.2.5.

Surveillance of notified bodies

Member States have an obligation to ensure that notified bodies continue to have the technical
qualifications required by the directives. In addition, New Approach directives require that a
Member State must withdraw a body’s notification  if  the  latter  no longer  complies  with  the
requirements  of  the  directive.  These  legal  requirements  de  facto  imply  a  procedure  through
which  designating  authorities  regularly  verify  that  notified  bodies  continue  to  meet  the
applicable  requirements  of  the  directives.  Accreditation  offers  one  way  of  doing  this,  as  all
accreditation  bodies  carry  out  regular  surveillance  and  re-assessments  of  their  accredited
bodies. National authorities should not confine themselves to verifying ex ante  that  notified
bodies meet the requisite criteria, e.g. technical competence, staff, equipment, etc. They must
also verify ex post that notified bodies carry out their duties correctly. In other words, national
authorities need to apply the criteria contained in the directives as imposing an obligation of
results  on  notified  bodies.  Therefore,  Member  States  must  ensure  that  notified  bodies  that
issue  incorrect  certificates,  or  other  conformity  assessment  decisions,  either  undertake
corrective action or have their notification suspended or withdrawn. Additionally, procedures
to be followed for transferring the technical files of notified bodies that have been subject to
suspension or withdrawal of their notification, or have voluntarily ceased to be notified, need
to  be  found  and  consistently  applied.  However,  the  designating  authority  retains  the
responsibility for the designation and surveillance of notified bodies.

The exchange  of  experience  of notified bodies  is,  at  the  present  time,  not  built  on  a  legally
binding basis. The successful work of these notified bodies groups should be  continued  and
put on a legal basis.

The Commission intends to propose introducing the exchange of experience of notified bodies
as  a  requirement  of  New  Approach  directives.  Future  proposals  to  revise  New  Approach
directives  will  introduce  requirements  concerning  actions  to  be  taken  when  notified  bodies
fail to perform their duties accordingly or cease to provide such services. Alternatively, this
kind of co-operation could be foreseen in the legal requirement referred to in 2.2.3.

2.2.6. Cross-border activities of notified bodies

The  designation  of  a  notified  body  is  based  on  a  decision  of  the  respective  Member  State.
These  bodies  automatically  (by  means  of  the  mutual  recognition  principle)  have  as  their
potential market the entire internal market (even beyond its limits, where the CE Marking is
accepted) and can offer their services everywhere in the European Union. Conversely, some
notified  bodies  are  subsidiaries  of  organisations  established  outside  the  Member  State
designating it, including countries outside the EU. In some cases it is the latter that carries out
most technical activities on behalf of the notified body.

However,  designating  authorities  do  not  always  have  the  tools  to  assess  and  control  the
activities of the notified bodies they have designated, but which operate in countries outside
their  jurisdiction.  This  may  impede  them  from  taking  appropriate  measures  if  the  bodies’
activities do not conform to the applicable legal requirements set out in the directives.

In  order  to  ensure  that  notified  bodies  may  offer  their  services  without  restriction  in  the
Internal Market and to facilitate the implementation  of mutual  recognition, the  Commission
intends  to  support  the  establishment  of  an  information  exchange  procedure  between
authorities and/or accreditation bodies in the “host” country and the designating authority in
the “home” country of notified bodies, as part of reinforced administrative co-operation. The

10

Commission  believes  that  this  would  require  a  legal  basis  to  be  introduced  either  in  a
common base or in individual New Approach directives.

This  will  allow  Member  States  to  alert  each  other  about  possible  problems  concerning  the
activities of notified bodies outside their country of designation and encourage the resolution
of problems through bilateral contacts.

2.2.7.

Recognition of Notified bodies in non-EU countries

The New and Global Approaches were, and continue to be, essential building blocks for the
creation  of  the  Single  Market.  They  have  also  provided  an  essential  element  for  the
conclusion  of  Mutual  Recognition  Agreements  (MRAs)  with  a  number  of  countries  in  the
sectors covered by New Approach directives. The EU continues to receive requests, from our
trading  partners  around  the  world,  to  negotiate  further  MRAs.  One  of  the  problems  with
MRAs is the difficulty to assess the benefits of such agreements in relation to the costs, which
are substantial in terms of negotiation and implementation. Political and commercial interests
have  mainly  dictated  our  MRA  priorities.  Conditions  under  which  non-European  Economic
Area  (EEA)  conformity  assessment  bodies  can  be  active  under  the  same  conditions  as  the
notified  bodies  under  the  jurisdiction  of  EEA  States  have  been  subject  to  negotiation.  One
alternative to MRAs could be the contractual relations that some notified bodies have already
established with conformity assessment bodies in countries outside the EU aiming at reducing
the  costs  of  testing  and  certification  for  products.  In  addition,  a  recent  Commission  staff
Working Paper15 has highlighted a number of other means to facilitate international trade by
the removal of technical barriers to trade.

The  conclusion  of  PECAs16  with  candidate  countries  is  a  good  example  on  how  viable
solutions can be found. Further efforts need to be undertaken by the Commission to establish
a  structured  framework  to  allow  conformity  assessment  bodies  from  other  countries  to
perform  tasks  corresponding  to  notified  bodies  activities  under  New  Approach  directives.
Such a framework should also establish the conditions under which a reciprocal arrangement
could be negotiated with a third country.

Testing and certification procedures  are  elements that  play a major  role in ensuring that  the
efficiency  of  the  system  is  consistent.  Multilateral  Agreements  (MLAs)  on  accreditation,
certification, testing laboratories and inspection bodies can be considered to be other elements
that  can  be  applied.  The  conditions  under  which  MLAs  function  need  to  be  set  out  in
accordance  with  present  legislation  and  the  objectives  the  European  Commission  currently
pursues.

2.2.8.

Separation of regulated and non-regulated area

One of the important features of the New Approach at the time of its conception was the fact
that  structures  used  (i.e.  standardisation,  accreditation,  conformity  assessment  etc.)  for  the
non-regulated area could be used also for the purposes of regulation. Over the years, mainly
due  to  the  non-existence  of  a  legal  basis  for  the  non-regulated  area,  a  separation  from  this
principle has developed and it has created, in some cases, a dichotomy in the activities of the
relevant  bodies  despite  the  fact  that  most  of  them  (accreditation  bodies,  conformity

15

16

Implementing  Policy  for  External  Trade  in  the  Fields  of  Standards  and  Conformity  Assessment:
A Toolbox of Instruments, SEC(2001) 1570 of 28.9.2001.
Protocol to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products

11

                                                
assessment  bodies)  are  active  in  both  the  regulated  and  the  non-regulated  area  in  their
respective domains.17

The Commission considers that there are important public interests at stake in the area of non-
regulated conformity assessment, as for example the assurance of trust to the users of relevant
services in the single market.

The Commission  considers that in  preparing future actions (of legislative or non-legislative
nature)  in  the  field  of  conformity  assessment  no  distinction  should  be  made  between  the
regulated  and  non-regulated  areas,  taking  into  account  the  necessary  freedom  to  be  left  to
operators in the non-regulated areas.

2.2.9. Co-operation and exchange of information between notified bodies

Some  New  Approach  directives  require  notified  bodies  to  have  an  active  exchange  of
information on denied or withdrawn certificates. This is considered to be a most useful tool in
order  to  prevent  manufacturers  from  applying  more  than  once  for  a  certificate  for  the  same
(non-compliant)  product.  Some  national  authorities  have  included  in  the  terms  of  contracts
they conclude with conformity  assessment bodies, once  they wish to be notified, provisions
for  an  active  exchange  of  experience,  not  only  useful  for  detecting  problematic  cases
requiring  interpretation,  but  also  to  ensure  a  uniform  level  at  which  notified  bodies  in  the
respective  country  work.  However,  exchange  of  information,  as  described  above,  does  not
prevent  manufacturers  from  applying  for  certificates  for  non-compliant  products  at  notified
bodies in another Member State, with possibly a different result.

It is important to exchange information on denied or withdrawn certificates in order to ensure
a  uniform  implementation  of  community  legislation  and  to  prevent  deficient  products  from
being submitted for testing or certification several times. Information transmitted by notified
bodies to their colleagues in other notified bodies need only refer to the type of product and to
the  reasons  for  denial  or  withdrawal,  thus  not  covering  the  whole  product  and  possibly
making  public  confidential  information  or  technical  details  subject  to  secrecy  imposed  in
contractual  terms  between  the  applicant  and  the  notified  body.  The  activities  of  Notified
Bodies' Groups should be encouraged with the aim of ensuring a level playing field for all.

The Commission intends to propose introducing in all New Approach directives provisions for
notified bodies  to  exchange information  on  non-compliant  products  submitted  for  testing  or
certification and to support future activities of Notified Bodies Groups in order to promote the
exchange of experience among all bodies notified under the respective directive.

2.3.

Conformity assessment procedures

The  consultation  results  show  that  there  is  no  reason  to  question  the  effectiveness  of  the
modules18. However, manufacturers may face problems related to product evaluation because
of a limited choice of modules available in the directives in cases where a product is covered
by  more  than  one  directive.  On  the  one  hand,  all  applicable  directives  may  not  share  a
common  module,  thus  obliging  manufacturers  to  apply  different  modules  for  different  risk
categories. On the other hand, even when the same module can be used for all the applicable
directives,  there  is  not  always  a  single  notified  body  available,  designated  under  all  the

17

18

See also further in chapter 2.4.
Modules for conformity assessment as defined in Council Decision of 22 July 1993 (93/465/EEC).

12

                                                
applicable directives. Manufacturers must, therefore, either call upon several notified bodies
to assess the conformity of their products or agree with specific work being subcontracted by
the notified body. As each notified body should restrict its assessments to the requirements of
the  directives  for  which  it  has  been  designated,  the  intervention  of  several  notified  bodies
inevitably increases costs.

Modules H, E and D (declaration of conformity using quality systems) allow manufacturers to
produce and market their products with less frequent involvement of a notified body, which
carries  out  an  assessment  of  the  management  system  and  of  the  product-related  issues
foreseen  by  the  modules.  Quality  assurance  systems  are  product  oriented  and  allow  for  the
necessary  flexibility  to  take  into  account  differenct  types  of  risks  presented  by  a  product
covered  by  several  directives.  It  is,  therefore,  considered  that  conformity  assessment
procedures  based  upon  the  implementation  of  an  appropriate  quality  system  may  ease
certification of those products.

The  Commission  will  propose  to  introduce  modules  H,  E  or  D  in  existing  and  future  New
Approach directives where this is appropriate and to further ensure their proper application.

Some  practical  problems  related  to  the  concepts  of  placing  on  the  market  and  putting  into
service  have  also  been  raised,  including  the  need  for  harmonised  definitions  of  the
manufacturer,  of  his  representative,  and  of  placing  on  the  market,  as  well  as  differences
between consumer products and products for professional use.

The Commission will prepare a proposal, to be  applicable  on  a  horizontal  basis,  clarifying
the definitions to be applied in conformity assessment procedures.

2.4.

The CE conformity marking

The CE marking, being an indication that all requirements of  each applicable directive have
been fulfilled, is addressed to, and is protected by, the authorities of the Member States. The
legal status of the CE marking is established by the directives and is not a commercial quality
mark but should be seen as a declaration by the manufacturer, or his authorised representative,
that the product conforms to all applicable harmonised provisions. Although this distinction is
quite clear to authorities, it is not so to the public which, while it increasingly recognises the
mark,  often  mistakes  its  meaning.  In  particular,  there  is  a  tendency  to  add  elements  to  the
understanding of this marking that were never the intention of the directives.

There is a strong need for Member States and the Commission to clarify the meaning of the
CE mark and to promote its accurate representation to consumers. An information campaign
can  help  achieve  this.  Such  a  campaign  should  be  extended  beyond  the  borders  of  the
European  Union,  because  the  intention  and  meaning  of  CE  marking  is  still  not  sufficiently
well known to third country manufacturers of products intended to be placed on the Internal
Market.

Furthermore, in several sectors, products frequently carry voluntary marks in addition to the
CE  marking.  Some  of  these  marks  existed  long  before  New  Approach  directives  were
introduced, while others appeared afterwards in response to market pressures. Although they
are not legally obligatory, various economic actors such as wholesalers, distributors, installers
or insurance companies often rely upon them. Additional voluntary marks are not, per se, in
contradiction with CE marking as long as they do not cause confusion or overlap in meaning
or  purpose  with  it  and  offer  a  value-added  to  those  being  addressed  (i.e.  consumers,  users,

13

public authorities etc.). It is the duty of Member States to ensure that the integrity of the CE
mark is not violated and that it is protected accordingly.

In order to strengthen the role of CE marking, the Commission intends to take the necessary
steps to clarify and  promote  the  meaning  of  the  CE  marking,  to  introduce  enforcement  and
protection measures, including sanctions and clarify its relation to voluntary product marks.

In addition, the Commission proposes that the whole issue of the unduly affixed CE mark to
be  further  discussed  and  the  most  important  factors  identified.  The  Commission  intends  to
launch an information campaign to be initiated in close co-operation with Member States.

On the basis of experience gained, the Commission does not exclude the possibility to propose
a clearer legal text in order to exclude ambiguities and to strengthen the position of the CE-
marking.

2.5.

Enforcement and market surveillance

2.5.1.

Enforcement measures

Appropriate enforcement measures, including market surveillance, are essential to ensure that
New Approach directives are correctly applied, allowing citizens to benefit from a high level
of  protection  and  enterprises  to  operate  on  a  level  playing  field  throughout  the  Internal
Market. However, there is no assurance that levels of enforcement do not vary throughout the
Union. This undermines the credibility of the New Approach and could lead to a de facto re-
fragmentation of the Internal Market.

Monitoring the products to be placed19, or already placed, on the national market falls under
the  responsibility  of  the  national  market  surveillance  authorities.  They  are  also  the  ones  to
take necessary action if products that do not meet the provisions of national law transposing
the respective New Approach directive are found on the market.

Different needs and geographical or market particularities in the Member States have lead to
solutions  that  do  not  always  ensure  strict  separation  between  designating  authorities,
accreditation bodies, conformity assessment bodies and market surveillance authorities. Those
potential sources of conflict of interests need to be eliminated.

Although  experience  varies  from  one  directive  to  another,  the  recent  Mutual  Joint  Visit
Programme (MJVP)20 between national market surveillance experts highlighted the existence
of  different  approaches  and  levels  of  market  surveillance  in  Member  States.  Some  Member
States  have  a  “proactive”  approach  to  market  surveillance,  while  others  adopt  a  “reactive”
strategy. A reactive strategy covers activities such as response to complaints, safeguard clause
notifications  of  other  Member  States  and  basic  customs  checks.  A  proactive  approach
suggests targeted campaigns, use of risk assessment tools, co-operation with other authorities.

The  issue  of  limited  resources  features  in  every  Member  State  for  every  directive.  In  some
Member States, severe financial restrictions mean the effectiveness of market surveillance is

19

20

This is the case when products are displayed on trade fairs, commercial exhibitions, etc.
The  MJVP  was  a  Commission-funded  initiative  covering  five  sectors:  toys,  electromagnetic
compatibility,  low  voltage  equipment,  machinery,  and  personal  protective  equipment.  Experts  from
national enforcement authorities in all Member  States  plus  Norway  visited  their  counterparts  in  other
countries and reported on the content and conclusions of their visits.

14

                                                
limited.  Effective  market  surveillance  is,  however,  a  part  of  the  New  Approach  system  and
resources, both human and financial, need to be ensured. The MJVP programme identified a
number  of  means  by  which  enforcement  can  be  strengthened  and  made  more  consistent:
application  of  a  common  set  of  minimum  criteria  for  surveillance,  including  product  safety
checks  at  external  borders;  reinforced  administrative  co-operation;  and  revision  of  the
Safeguard  Clause  procedure  for  notification  of  national  measures  restricting  the  free
movement of CE marked products.

Proposals  for  additional  measures  to  achieve  these  objectives  are  set  out  in  the  following
subchapters.

2.5.2.

A common level of market surveillance throughout the Union

Member  States  can  achieve  a  common  level  of  market  surveillance  based  on  the  following
criteria:

– 

– 

– 

– 

– 

– 

21

Infrastructures  and  human  and  financial  resources  must  be  sufficient  to  ensure  that
all  products  within  the  scope  of  a  Directive  are  subject  to  surveillance  and  that  a
range of controls can be applied, as appropriate, to each product group. In some cases
where,  for example, the market size does  not  permit  viable  surveillance systems  or
expertise  is  not  available,  Member  States  could  combine  their  efforts  through
relevant co-operation agreements.

Accident  data  analysis  is  to  be  used  to  develop  a  strategic  market  surveillance
programme,  and,  whenever  useful,  should  be  conducted  in  co-operation  with  other
Member States.

Taking  into  account  cultural  or  practical  differences  between  Member  States,  the
sanctions  or  penalties  applied  to  non-compliant  products  must  not  only  be
proportionate  to  the  degree  of  non-compliance  identified,  but  also  sufficiently
effective  to  have  a  dissuasive  effect.  Transparency  concerning  surveillance
campaigns and enforcement measures will serve to reassure end-users that effective
action is being taken, and signal to industry that products are subject to post-market
controls.

Member States need to ensure effective communication and co-ordination at national
level between their market surveillance authorities and their other authorities which
work in the field of product safety such as occupational health and safety authorities
and  customs.  For  example,  one  essential  element  of  effective  enforcement  is  co-
operation between customs officers  and  market  surveillance  authorities.  Checks  for
conformity  with  the  rules  on  product  safety  in  the  case  of  products  imported  from
third countries21are a common base for this co-operation and Member States have to
ensure that regulations are being correctly applied.

Risk  analysis  and  risk  management  measures  envisaged  by  market  surveillance
authorities should be correlated with actions taken by customs authorities.

Additional implementation efforts may be required to ensure that both the resources
and  the  communication  mechanisms  exist  to  allow  customs  officers  and  product

Checks for conformity with the rules on product safety for products imported from third countries are
foreseen in Regulation 339/93/EC.

15

                                                
safety officers to work together as foreseen by the Regulation.  Within the Customs
2002 Programme,  the  Commission  is  supporting  Member  State  co-operation  to
provide practical guidance for customs authorities when examining safety aspects of
imported products.

– 

National authorities are called to fully participate in administrative co-operation with
their counterparts in other Member States. This particularly implies an exchange of
information  on  (potentially)  non-compliant  products,  test  results,  enforcement
actions taken, control priorities and the resulting campaigns.

The Commission calls on Member States to ensure a common level of market surveillance and
to support clear action towards this goal. Defining basic rules with which Member States will
be obliged to comply (e.g. sanctions, information exchange provisions) require a revision of
the legal framework either by means of a horizontal directive or by including these rules in
the individual directives.

Information  campaigns  and  recall  measures  made  public  will  help  market  surveillance
authorities increase the effectiveness of their activity.

Deterrent  measures  like  strong  sanctions  against  persons  or  companies  repeatedly  misusing
the  freedoms  offered  by  the  New  Approach  system,  product  recall  actions  or  information
campaigns  are  appropriate  actions  to  help  reduce  the  number  of  deficient  products  on  the
Internal Market.

2.5.3.

Reinforced administrative co-operation

Market  surveillance  must  be  accompanied  by  effective  cross-border  administrative  co-
operation.  Two  Council  Resolutions22  have  clearly  underlined  the  importance  of  this  co-
operation in  promoting  effective enforcement of  Internal Market  legislation,  and  invited  the
Member States and the Commission to intensify their efforts in this area. Several measures for
reinforcing existing administrative co-operation on enforcement issues can be identified:

– 

– 

22

23

The competent authorities  of the Member States  have  an  obligation,  resulting  from
Article 10 of the Treaty and specified in some Directives, to assist each other in the
fulfilment  of  market  surveillance  activities  and,  in  particular,  by  exchanging
information concerning product examination and its results. Enforcement authorities
frequently  benefit  from  cross-border  assistance  in  tracing  a  non-compliant  product
back  to  the  certifying  Notified  Body,  to  the  manufacturer  or  to  his  authorised
representative.  This  mutual  assistance  has  to  take  place  on  an  EU-wide  level,  or
between only those authorities concerned with a specific issue.

One forum in which co-operation takes place is that of Administrative Co-operation
Groups  of  Member  States'  market  surveillance  experts,  which  currently  meet
informally  and  only  under  some  directives23.  A  clearer  definition  of  the  status  and

Council  Resolution  of  16  June  1994  on  the  development  of  administrative  co-operation  in  the
implementation  and  enforcement  of  Community  legislation  in  the  internal  market  (Official  Journal  C
179, 1 July 1994); Council Resolution of 8 July 1996 on co-operation between administrations for the
enforcement of legislation on the internal market (Official Journal C 224, 1 August 1996).
Directive  73/23/EEC  on 
low  voltage  electrical  equipment;  89/336/EEC  on  electromagnetic
compatibility;  98/37/EC  on  machinery;  89/686/EEC  on  personal  protective  equipment;  94/25/EC  on

16

                                                
– 

– 

– 

– 

– 

objectives  of  Administrative  Co-operation  groups  and  their  legal  basis  should  be
established, in order to provide firmer operational basis.

Information  about  non-complying  products,  especially  those  that  are  subject  to
frequent  complaints,  need  to  be  passed  from  one  national  authority  to  all  other
national market surveillance authorities faster than the products can be moved from
one national market to the other. This is the objective to be reached by the authorities
in  their  co-operation,  if  the  market  surveillance  is  to  be  considered  efficient.  The
efficient use of the Interchange of Data between Administrations (IDA) programme
could  help  accomplish  this  goal.  However,  this  needs  a  clear  legal  basis  to  be
realised.

Mutual assistance is particularly important to the effective exchange of information.
Protection  of  professional  secrecy  and  different  legal  provisions  concerning  the
status  of  information  to  be  considered  public  should  not  prevent  the  sharing  of
relevant  information  with  other  surveillance  authorities,  since  this  type  of
information can be essential for the protection of health and safety.

Information relating to dangerous products is to be made available to the public; this
is particularly important concerning product identification, the nature of the risk, and
the measures taken. Detailed reflection on the modalities of information exchange is
required in order to avoid overlap of systems and duplication of effort. Information is
only to be shared when it clearly offers added value to surveillance activities.

The Commission encourages cross-border control campaigns and has provided grant
financing  for  some  clearly-defined  projects  undertaking  practical  co-operation  on
market surveillance. These projects promoted contacts and supported Member States
to  spread  best  practices  in  the  medium-term.  Such  co-operation,  supported  by  the
means of e-administration, must become a standard element of co-operation.

European  administrations  are  currently  using  with  great  success  the  Interchange  of
Data  between  Administrations  (IDA)  programme  in  a  variety  of  fields  such  as
employment,  health,  agriculture,  fisheries,  statistics  and  competition.  Inter-
institutional communication is going to be helpful also in the area of administrative
co-operation of authorities in Member States dealing with New Approach directives
by providing the advantages of new technological opportunities.

The Commission intends to propose introducing a legal basis for administrative co-operation
among Member States in the New Approach directives that do not yet foresee this in addition
to continuing practical and financial support.

As market needs do not always require the existence of bodies notified for all directives in the
different  Member  States,  and  as  the  market  for  a  certain  type  of  certification  service  is  too
small, often co-operation among Member States has proven to be a practicable solution. The
Commission encourages Member States authorities to conclude bi- or multilateral agreements
regarding mutual assistance and the sharing of infrastructure (including technical knowledge,
testing  facilities,  training  opportunities  for  the  relevant  staff)  for  market  surveillance
activities.  The  benefits  of  such  agreements  became  evident  during  negotiations  for  the
conclusion of PECAs with candidate countries.

recreational  craft;  95/16/EC  on  lifts;  99/5/EC  on  radio  equipment  and  telecommunications  terminal
equipment, 88/378/EEC on toys.

17

                                                                                                                                                        
In  order  to  avoid  areas  of  activities  not  being  covered  by  market  surveillance  authorities,
Member  States  are  encouraged  to  conclude  bi-  or  multilateral  agreements  for  mutual
assistance.

2.5.4.

The Safeguard Clause in the New Approach directives

Member States are obliged to take restrictive measures against products, covered by the scope
of a New Approach directive, which are found to be unsafe. Action may be taken at different
stages:  before  the  product  is  to  be  put  on  the  market,  if  it  is  already  on  the  market,  before
being put into service and even if found in service. The mere fact that a product should be, but
is not, CE-marked is one criterion to enable a market surveillance authority to identify that the
product  is  non-compliant.  Real  hazards  on  a  systematic  basis  must  be  demonstrated  –
therefore  the  authority  must  have  the  necessary  skills,  equipment  and  procedures  to
demonstrate  systematic  non-compliance.  This  is  a  costly  and  sometimes  burdensome
requirement needing skilled personnel. Nevertheless such action has to be taken,  as  it  is  the
legal  obligation  of  the  Member  States  to  protect  their  own  population  against  dangerous
products.

Actions, such as restrictions, bans, withdrawal of products, are to be notified by the Member
State  immediately  to  the  European  Commission  because  free  circulation  is  hindered.  The
safeguard clause procedure  foreseen  in  New  Approach  directives  allows  the  Commission to
verify the justification of national measures, which restrict the free movement of CE marked
products. However, the current procedure is lengthy and difficult to apply in practice. Lengthy
procedures also create problems to the industry (and especially SMEs) since they entail long
periods of legal uncertainty.

Therefore,  the  Commission  is  confronted  with  difficulty  in  managing  the  safeguard  clause
procedure  of  the  safeguard  clauses  as  currently  designed  in  most  of  the  New  Approach
directives. The Commission is given the task to of managing highly complex, technical cases,
on  the  basis  of  decisions  taken  at  national  level  by  technically  specialised  authorities  or
agencies, and (in certain cases) to perform a risk analysis. Due to the technical nature of such
cases,  specialised  technical  expertise,  rarely  available  within  the  administration,  is  required.
To  procure  specialised  expertise  makes  the  procedures  longer  and  compromises  their
effectiveness in terms of free circulation.

In the case of the Low Voltage Directive, the currently applied procedure is simpler and faster
and  focuses  on  the  most  problematic  cases.  A  further  advantage  relates  to  the  fact  that  the
Commission,  in  the  case  of  the  Low  Voltage  Directive,  can  make  use  of  the  technical
expertise available at the level of Member States. Therefore, whilst maintaining the concept of
the safeguard  clause  in  accordance  with  Article  95(10)  of  the  Treaty,  there  is  a  potential  to
simplify the safeguard clause procedure in the New Approach directives and to render it more
effective in view of the functioning of the Internal Market.

The Commission will propose to modify the safeguard clause procedure in the New Approach
directives  in  order  to  ensure  a  more  uniform  approach  throughout  the  New  Approach
directives, to  simplify  and  shorten  the  process  and  to  render  it  more  effective  to  ensure  the
functioning  of  the  Internal  Market..  This  proposal  would  require  a  revision  of  the  legal
framework.

Involvement of Member States not directly concerned by the notified national measure in the
analysis  of  technical  files  justifying  the  safeguard  clause  could  be  considered.  This  would
provide the opportunity for authorities to transmit relevant information from past controls and

18

tests.  In  addition,  there  is  a  need  to  be  certain  that  other  Member  States  take  appropriate
actions on their national markets once the Commission finds that a notified action is justified.
Only in this way can legislation be uniformly enforced across the EU.

Notifications or, in some cases, the information exchange preceding them, should take place
within  the  framework  of  a  systematic  confidential  exchange  of  information  related  to
potentially dangerous products through a telematics-based system. This system would allow a
comprehensive  information  exchange  concerning  enforcement  measures  taken  or  envisaged
by national authorities. Such information should be available to competent authorities in the
Member States and not to the public. Should one of the aforementioned authorities consider it
appropriate, it can release confidential information, also to the public e.g. for recall actions, on
the basis of national legal provisions.

2.5.5.

Relationship with the Directive on General Product Safety

The  recent  revision  of  the  General  Product  Safety  Directive  (GPSD)24  has  important
implications  for  consumer  products  covered  by  New  Approach  legislation.  The  GPSD
functions as a safety net, meaning that its safety requirements apply to consumer products for
which  other  Community  law  does  not  contain  provisions  on  safety  and  risks.  Since  New
Approach  directives  regulate  all  aspects  of  safety  and  categories  of  risk  relating  to  the
products to which they apply, the safety requirements of the General Product Safety Directive
do not apply to those products.

However,  New  Approach  directives  do  not  contain  detailed  provisions  regarding  means  of
enforcement. Therefore, the  relevant  enforcement provisions of  the  revised  General  Product
Safety  Directive  apply  to  consumer  products  covered  by  New  Approach  legislation.  Such
provisions include, for example the requirement for Member States to define the organisation
and tasks of their surveillance authorities, the RAPEX procedure and imposing the obligation
on  manufacturers  to  order  the  recall  of  dangerous  products.  This  situation  will  mean  that
industrial  and  consumer  products  covered  by  the  same  New  Approach  directive  could,  in
practice, be subject to different market surveillance provisions.

The RAPEX procedure requires notification of  measures  taken  against a product  or product
batch which presents a serious  and immediate risk to  the  health  and safety  of consumers.  It
applies  to  consumer  products  covered  by  New  Approach  directives,  such  as  toys  and  low
voltage electrical equipment, for which the directives do not provide an equivalent procedure.
RAPEX  is  quite  distinct  from  the  Safeguard  Clause  procedure  and  it  does  not  exempt  a
Member State from applying the Safeguard Clause procedure if the conditions for its use are
fulfilled.

The Commission intends to propose introducing provisions in New Approach directives for an
information exchange concerning industrial products which present a serious and immediate
risk to users. This information exchange will involve authorities in all Member States and the
Commission services.

24

2001/95/EC, OJ L 11, 15.01.2002.

19

                                                
2.6.

Consistent and effective implementation of New Approach directives

2.6.1.

Revision of the legal framework

A  number  of  weaknesses  that  can  best  be  addressed  by  revising  the  legal  framework  have
been  identified.  The  need  for  a  more  coherent  approach  to  the  assessment,  designation  and
surveillance of notified bodies, the revision of the safeguard clause procedure and the need to
strengthen  enforcement  measures,  including  market  surveillance  are  core  issues  to  be
addressed. There are a number of options to achieve this. One possibility is to introduce the
appropriate requirements in all sectoral directives. This was the approach taken when the CE
marking provisions were introduced through directive 93/68/EEC. This would allow the needs
of each sector to be taken into account. However, it is a lengthy process and does not allow
the problems to be addressed in a horizontal manner.

As  products  may  be  governed  by  more  than  one  New  Approach  directive,  since  different
hazards may be dealt with under different directives, the simultaneous application of several
directives can create problems:

– 

– 

– 

– 

unintentional  differences  can  be  found  in  sectoral  New  Approach  directives.  For
example,  in  relation  to  notified  bodies,  the  relationship  between  the  minimum
requirements set out in the relevant annex of directives and harmonised standards is
phrased differently in each directive. The differences are sometimes  subtle,  but  can
have important legal  or practical  implications.  In some cases, the consequences  are
not fully appreciated by all the parties concerned. This can reduce legal certainty;

products falling under more than one directive may create confusion on the meaning,
operation and procedures (including conformity assessment procedures) if these  are
different in the directives concerned;

the  original  intention  of  the  New  Approach  was  to  provide  a  common  doctrine
concerning key concepts that would be used in all directives. However, in practice,
specific definitions have been introduced in some directives and even new  types of
modules have been created in New Approach directives going beyond the placing on
the market and having thus in service provisions for the products they deal with. This
can  lead  to  problems  if  these  definitions  are  incompatible  with  definitions  or  with
prevailing interpretations in other directives applying to the same product;

solutions have been found in some sectors which could be equally useful in others.
For  example,  Article  17 of  directive  97/23/EC  on  pressure  equipment  provides  a
legal basis for administrative co-operation, missing from other directives. However,
the  need  for  effective  administrative  co-operation  is  common  to  all  directives.  It  is
therefore useful to create a single legal basis that applies to all sectors.

It is considered to be more efficient, and will ensure consistency, if the Commission were to
establish a working group to develop the wording of “standard articles” dealing with elements
common to all New Approach directives, as well as any additional provisions clarifying  the
procedures  to  be  followed  in  the  implementation  and  application  of  the  revised  directives.
This would enable the preparation of the “all-in-one” solution of a common base directive, as
being a simple means of reducing legislative work in the longer term.

A common base  directive  would avoid  many  of the problems identified  above  and  simplify
the  legislative  process,  as  each  sectoral  directive  would  then  contain  only  the  provisions

20

specific  to  the  sector  concerned,  mainly  the  definition  of  essential  requirements  and  the
appropriate conformity assessment modules. Still, the question needs to be assessed carefully,
because:

– 

– 

the adoption of a common base directive implies the revision of all New  Approach
directives.  A  common  base  directive  is  only  justified  if  it  also  introduces  new
substantive requirements. This requires a decision to move ahead with at least some
of the proposals set out in this communication;

the adoption of a common base directive will not solve all problems. For example in
the  case  of  conformity  assessment  procedures  to  be  applied,  where  more  than  one
directive applies to a product, where product specific approaches when dealing with
issues like potential to harm, manufacturing conditions or surveillance measures are
to  be  taken  into  account,  close  consultation  with  all  stakeholders  and  Commission
services and co-operation will be necessary when elaborating the solutions. Some of
these issues could be addressed directly, when revising the respective directives.

The  Commission  proposes  to  start  examining  the  benefits  and  disadvantages  of  a  common
base directive and of the inclusion of standard articles on horizontal issues in New Approach
directives in order to detect the best solution and the largest extent of such horizontal issues
to be taken into consideration. The Commission believes that a common base directive will be
the better solution because of reduction of legislative work in future directives and the more
homogeneous handling of identical or similar issues in New Approach directives.

2.6.2. Outsourcing to support implementation

The  implementation  of  New  Approach  directives  places  a  significant  administrative  burden
not  only  on  the  Member  States  but  also  on  the  Commission,  in  particular  in  relation  to  the
technical  analysis  relating  to  the  application  of  safeguard  clauses.  Annex  III  sets  out  some
statistics on the number of notifications received. This indicates a growing trend, attributable
in part to a more active enforcement policy by national authorities in relation to a number of
directives.  Nevertheless,  experience  indicates  that  many  measures  are  still  not  notified.  The
Commission  expects  the  number  of  safeguard  clause  notifications  to  continue  growing,  a
trend that will be reinforced by the enlargement of the Community.

If the current trend is maintained, the question of appropriate financial and human resources
might arise. The revision of the safeguard clause procedure considered above  will  offer  one
means  to  reduce  the  administrative  burden  faced  by  the  Commission.  Even  the  limited
number  of  notifications  received  at  the  moment  place  a  considerable  strain  on  available
resources, which inevitably lengthens the time required  to issue  the  Commission’s Opinion.
Moreover, the Commission services often  work  at  the  limits of their  possibilities due to the
multiplicity  of  areas  when  analysing  notifications  which  they,  on  a  case  by  case  basis,  also
contract to external consultants. Finding  consultants  who  have  both the  necessary  degree  of
expertise and of independence from the parties concerned can be difficult.

Another  option  would  be  to  outsource  certain  operations  to  a  body  staffed  by  technically
competent experts in the fields covered by New Approach directives, thus allowing a speedier
analysis  of  safeguard  clauses.  Such  specialisation  would  enable  the  building  of  a
comprehensive picture of problems relating  to non-conformities encountered  and to identify
emerging  trends,  thus  providing  the  Commission  and  Member  States  with  a  better  basis  to
judge the effectiveness of the directives. It could also be entrusted with other logistical tasks,
such  as  the  management  of  the  information  exchange  mechanism,  designation  of  notified

21

bodies related issues and of the database of notified bodies, co-ordination of notified bodies
groups,  information  to  the  public,  etc.  Such  a  body  could,  depending  on  its  organisational
structure and degree of dependence from the Commission, create a “pooling” of the expertise
already available at Member States level in a way similar to that of the European Medicines
Evaluation Agency (EMEA).

The Commission, in conjunction with the Member States, will examine  all options  available
and will make the appropriate proposals in due time..

3.

CONCLUSIONS

The benefits of increasing the level of uniformity in the New Approach directives and of their
implementation  and  application  are  evident.  Synchronising  the  efforts  of  all  Member  States
and  the  European  Commission  to  have  a  better  regulation,  and  thus  reducing  the  cost  to  a
minimum, is a considerable incentive.

A  high  quality,  efficient  system  is  the  goal.  The  benefits  are  obvious  –  better  products  in
terms  of  safety,  at  a  lesser  cost,  will  make  them  even  more  competitive.  Clearer  rules  of
application of the New Approach directives make them easier to understand to the authorities
in  the  accession  candidate  countries  and,  thus  speed  up  the  process  of  adopting  the  acquis
communautaire by these countries.

Finally,  trade  partners,  manufacturers  and  authorities  in  third  countries  would  perceive  the
qualities  of  the  European  legislative  framework,  of  its  reliability  in  practice,  of  the  added
value  of  conformity  assessment  under  the  European  system.  A  growing  number  of  third
countries are  interested  in  the  New Approach as they are  convinced  of  the  reliability  of  the
system, leading to growing success in promoting the New Approach to other economic areas,
simplifying the exchange of goods and eliminating barriers to trade.

Proposals  have  been  elaborated  with  the  aim  of  increasing  the  efficacy  of  the  system,  to
improve its transparency, as well as its smoother functioning, for the benefit of all involved
partners  –  manufacturers,  conformity  assessment  bodies,  authorities  and,  above  all,  product
users.

With  this  in  mind,  the  Commission  intends  to  support  Member  States'  efforts  to  increase
transparency  and  to  strengthen  where  necessary  the  system  at  the  level  of  implementation.
The recommendations of the Commission are given in the text of the present Communication
in the form of text boxes. For facilitation of the reading they are recapitulated in Annex IV.

Therefore, the Commission invites the European Parliament and the Council to:

– 

– 

– 

– 

take  note  of  the  proposed  improvements  to  be  made  in  the  application  of  New
Approach directives and to support the proposals of the Commission outlined above;

lend  its  support  to  initiatives  aiming  to  strengthen  the  system  by  legislative  and
administrative means for the benefits of product safety and public health;

invite  the  Member  States  to  take  all  necessary  measures  and  support  all  action
targeted  to  ensure  a  better  application  of  the  New  Approach  and  of  the  respective
directives;

call  on  Member  States  to  ensure  that  their  designating,  notifying,  and  market
surveillance authorities are fully aware of their obligations and continue to do so;

22

– 

to  join  in  the  reflection  on  the  appropriate  approach  for  guaranteeing  the  required
financial and human resources.

23

Annex I: Analysis of the Results of the Online Consultation

As  part  of  the  preparation  of  this  Communication  to  review  certain  aspects  of  the
implementation of the New Approach, the Enterprise Directorate General produced, towards
the end of 2001, a Consultation Document concerning the functioning of the New Approach
directives. This was published on the Commission’s Europa internet web site in January 2002,
along with an interactive questionnaire based on a set of questions derived from the content of
the  Consultation  Document.  The  document  and  questionnaire  remained  open  online  for
contributions  for  a  period  of  three  months.  The  purpose  of  the  consultation  was  to  elicit  a
broad  range  of  assessment  and  feedback  from  stakeholders,  especially  enterprises,  so  that
more  detailed  proposals  could  be  elaborated  and  eventually  put  forward 
the
Communication.  The  following  is  a  résumé  of  the  results  of  the  consultation  by  interactive
questionnaire,  based  on  an  analysis  of  the  numerical  results.25  A  total  number  of  135
contributions were made in response to the online consultation.

in 

Input by country and sector

Of the EU Member States, there were responses from all except Denmark and Luxembourg.
The greatest number of contributions came from Germany (27), UK (23)  and Belgium (19).
The EEA countries from which there were replies were Iceland (2), and Switzerland (6). No
responses came from Liechtenstein or Norway. Of the Candidate Countries, only Bulgaria and
the  Czech  Republic  responded,  with  one  contribution  from  each.  There  were  no  other
European contributions; five came from North America and one from Asia/Pacific, but none
from either Africa or South/Central America.

All  the  sectors  indicated  in  NACE  responded,  with  the  exception  of  Recycling  &  Waste
Management,  Wholesale,  Retail  and  Post  &  Telecommunication.  The  highest  number  of
contributions  was  from  Public  Administration/Other  Organisations  (56),  and  Electrical  &
Electronic Equipment (34). The lowest number of contributions was from the Food Industry,
Textiles, Clothing & Leather, Wood, Paper, Publishing & Printing, and Chemicals, Rubber &
Plastics (1 each).

Reaction to the proposals put forward in the Consultation Document

The following is a summary of the feedback received, both positive and negative, in relation
to the principal themes of the Consultation Document.

1.

CONFORMITY ASSESSMENT PROCEDURES AND NOTIFIED BODIES

There  was  positive  support  for  the  conformity  assessment  modules  as  defined  in  Council
Decision 93/465/EEC. A majority of the respondents considered them to be efficient for their
intended  purpose,  but  thought  it  would  be  useful  to  reduce  the  choice  of  modules  in  New
Approach  directives.  Most  agreed  that  linking  specific  modules  with  the  use  by  the
manufacturer  of  harmonised  standards  would  simplify  the  procedures.  In  terms  of  negative
responses, a majority of respondents disagreed with the idea that a more systematic recourse

25

The  results  analysed  here  are  those  which  were  contributed  online  via  the  Internet  interactive
questionnaire. Some additional contributions were sent to the drafting service by mail and e-mail, and
while  these  have  been  taken  into  consideration  in  the  drafting  of  the  final  text,  they  have  not  been
included in this separate résumé.

24

                                                
to  module  H  (full  quality  assurance)  or  one  of  its  variants  would  increase  coherence  in
conformity assessment.

With  regard  to  notified  bodies,  there  was  positive  support  for  the  suggestion  that  if  the
Commission were to publish a database of notified bodies on the Internet, the publication of
lists  of  notified  bodies  in  the  Official  Journal  could  be  discontinued.  A  significant  majority
was  in  favour  of  the  proposal  that  the  procedure  for  notification  of  conformity  assessment
bodies could be streamlined,  and  thought  that  an electronic  notification  procedure would be
the  appropriate  solution.  Of  the  measures  considered  most  appropriate  to  increase  the
effectiveness  of  the  notification  system,  the  one  thought  to  be  most  effective  was  that  of
including in all New Approach directives a requirement to withdraw or suspend notification
from  a  body  that  has  repeatedly  issued  incorrect  certificates  or  otherwise  misapplied  the
provision of the directive. Measures also thought to be effective were the establishment of a
forum bringing together designating authorities to exchange experience and information, and
of  a  horizontal  guidance  document  on  best  practices,  on  the  assessment,  designation  and
surveillance of notified bodies.

2.

CE MARKING

A majority of the respondents  had encountered problems  related  to  voluntary  quality  marks
for products covered by a New Approach directive, and thought that the meaning of the CE
marking and its relationship to voluntary quality product marks should be clarified. Most were
against the establishment of a code of conduct for voluntary quality marks that would address
transparency, impartiality, openness.

3.

ENFORCEMENT AND MARKET SURVEILLANCE

Most of the respondents thought that criteria for enforcement, including market surveillance,
should be defined,  and  agreed with the proposal to introduce in New  Approach directives a
legal  basis  for  administrative  co-operation.  There  was  also  very  positive  support  for  the
proposals  to  simplify  and  improve  the  safeguard  clause  procedure,  and  for  the  proposal  to
introduce  a  rapid  information  exchange  mechanism  for  industrial  products  covered  by  New
Approach directives. A majority expressed dissatisfaction with the current management of the
safeguard clause procedure.

Of  the  market  surveillance  approaches  described  in  paragraph  2.5  of  the  consultation
document,  those  considered  most  appropriate  to  ensure  a  cost-effective  implementation  of
New Approach directives were, in descending order of preference:

– 

– 

– 

– 

– 

– 

- co-operation between authorities (pro-active)

- targeted campaign (pro-active)

- rapid exchange of information (reactive)

- response to complaints (reactive)

- risk assessment tools (pro-active)

- safeguard clauses (reactive).

25

4.

IMPLEMENTATION OF THE NEW APPROACH

A majority of respondents thought that more consistency is needed in the legal requirements
covering  equivalent  elements  in  all  sectoral  New  Approach  directives,  and  that  the
Commission should  examine  further application  of New Approach  principles  as  a  means  of
improving and simplifying legislation. There was positive support for the idea that a common
base directive covering elements common to all or most New Approach directives would be
appropriate to increase consistency. Of those who did not support this idea, a majority thought
that  a  revision  of  all  sectoral  directives  would  be  justified,  inter  alia  to  improve  their
consistency and to adopt some of the proposals identified in the consultation document.

26

Annex II: Notified bodies

Table 1a: Notified bodies per country*

EU 15

EEA-EFTA

Country

N° bodies Country

N° bodies

Iceland

Liechtenstein

Norway

EEA-EFTA Total

2

0

16

18

Austria

Belgium

Denmark

Finland

France

Germany

Greece

Ireland

Italy

Luxembourg

Netherlands

Portugal

Spain

Sweden

United
Kingdom

EU 15 Total

37

31

22

15

81

185

14

4

227

5

29

22

54

47

224

997

Note: Information up to 30.10.2002

27

Directive

N° bodies Directive

Table 1b: Notified bodies per directive

87/404/EEC Simple pressure vessels

88/378/EEC Toys

79

56

94/25/EC Recreational craft

94/9/EC Potentially explosive atmospheres

89/106/EEC Construction products

183

95/16/EC Lifts

89/336/EEC
Electromagnetic compatibility
89/686/EEC
Personal protective equipment

90/384/EEC  Non-automatic  weighing
instruments

40

96/48/EC High-speed rail systems

103

96/98/EC Marine equipment

320

97/23/EC Pressure equipment

90/385/EEC  Active  implantable  medical
devices

18

98/37/EC Machinery

N°
bodies

22

31

156

20

28

88

146

90/396/EEC Gas appliances

37

98/79/EC 
devices

In  vitro  diagnostic  medical

17

92/42/EEC Hot water boilers

39

99/36/EC Transportable pressure equipment

93/15/EEC Civil explosives

93/42/EEC Medical devices

6

99/5/EC  Radio  and 
terminal equipment

telecommunications

2000/9/EC  Cableway  installations  designed
to carry persons

60

2000/14/EC  Noise  from  equipment  for
outdoor use

92

54

2

41

Note: Information up to 30.10.2002. Some bodies are notified under more than one directive.
The total number of bodies in Table 1a (listed  by Member State) is therefore lower than the
total number of bodies in Table 1b (listed by directives).

28

Annex III: Safeguard clauses

This annex provides a summary of available statistics concerning safeguard clauses received by
the Commission.

Table 1: Safeguard clause notifications received in 2001.

Directive

voltage 

Low 
(73/23/EEC, 
93/68/EEC)

equipment
amendment

N°

428

Directive

Civil explosives (93/15/EEC)

N°

0

pressure 

Simple 
(87/404/EEC, 
90/488/EEC and 93/68/EEC)

vessels
amendments

Toys  (88/378/EEC,  amendment
93/68/EEC)

Construction 
(89/106/EEC, 
93/68/EEC)

Products
amendment

Electromagnetic 
(89/336/EEC, 
92/31/EEC and 93/68/EEC)

compatibility
amendments

Machinery 
amendment 98/79/EC)

(98/37/EC,

Personal  protective  equipment
amendments
(89/686/EEC, 
93/68/EEC, 
and
96/58/EC)

93/95/EEC 

Non-automatic 
instruments 
amendment 93/68/EEC)

weighing
(90/384/EEC,

implantable  medical
Active 
devices 
(90/385/EEC,
amendments  93/42/EEC  and
93/68/EEC)

Gas  appliances 
amendment 93/68/EEC)

(90/396/EEC,

0

1

0

73

15

3

0

0

7

Medical  devices 
amendment 98/79/EC)

(93/42/EEC,

Potentially 
atmospheres (94/9/EC)

explosive

Recreational craft (94/25/EC)

Lifts (95/16/EC)

Pressure equipment (97/23/EC)

In  vitro  diagnostic  medical
devices (98/79/EC)

Radio  and  telecommunications
terminal equipment (99/5/EC)

Cableway  installations  designed
to carry passengers (2000/9/EC)

2

0

0

0

0

0

0

0

Total:

530

29

Figure 1: Safeguard clause notifications - low voltage directive (73/23/EEC)

s
e
s
u
a
l
c

f
o
°
N

450

400

350

300

250

200

150

100

50

0

1997

1998

1999

2000

2001

Figure 2: Safeguard clause notifications – gas appliances directive (90/396/EEC)

s
n
o
i
t
a
c
i
f
i
t
o
n
°
N

18
16

14
12
10

8
6

4
2
0

1997

1998

1999

2000

2001

30

 
 
 
Annex IV: Recapitulation of recommendations of the Commission

Regarding the notification procedure the Commission

– 

– 

calls on Member States to ensure that their notifying authorities are made fully aware of
their obligations concerning the notification procedure and that efforts are made towards
shortening the period of time that elapses between the decision to notify a body and the
completion of the notification procedure;

is  already  taking  steps  to  make  available  an  on-line  database  on  the  Europa  web  site
containing  the  list  of  notified  bodies  designated  by  EU,  EEA  and  candidate  countries
and proposes the development of an on-line notification system to replace the existing
paper-based  system.  This  will  considerably  reduce  the  processing  time  and  enable
notified bodies to act with virtually no delay. Further, the Commission believes that the
publication  of  the  relevant  lists  in  the  Official  Journal  of  the  European  Communities
should be abolished once the on-line publication on the Internet is achieved;

Regarding the legal framework for the designation of notified bodies the Commission

– 

– 

proposes  to  intensify  the  efforts  of  Member  States  and  the  Commission  towards
reaching  a  homogeneous  designation  system  by  supporting  the  activities  of  already
established joint working groups of Member States' officials;

considers it necessary to consolidate the requirements notified bodies have to fulfil. This
could  be  covered  either  as  part  of  a  horizontal  directive  or  as  a  standard  article  to  be
included in the respective directives. These requirements should take into consideration
differences  in  the  wording  and  the  option  to  add,  if  necessary,  complementary
requirements;

Regarding the role of accreditation the Commission

– 

– 

considers that in order to improve this situation, more comprehensive guidance for the
use  of  accreditation  should  be  developed  with  the  aim  of  increasing  coherence  and
structure  for  accreditation  services  within  the  Community,  especially  regarding  the
independence  of  accreditation  bodies  from  commercial  activities  and  competition
between different  bodies,  whilst leaving  the final  responsibility  to  the  Member  States.
Basic elements of such guidance could be part of the common legal provisions referred
to in 2.2.3.

intends  to  establish  a  permanent  forum  of  Member  States’  authorities,  responsible  for
designation,  in  order  to  facilitate  the  exchange  of  best  practices  for  the  assessment,
designation  and  surveillance  of  notified  bodies.  This  forum  could  formulate
recommendations to be followed on a voluntary basis.

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Regarding the surveillance of notified bodies the Commission

– 

intends  to  propose  to  introduce  the  exchange  of  experience  of  notified  bodies  as  a
requirement  of  New  Approach  directives.  Future  proposals  to  revise  New  Approach
directives  will  introduce  requirements  concerning  actions  to  be  taken  when  notified
bodies  fail  to  perform  their  duties  accordingly  or  cease  to  provide  such  services.
Alternatively,  this  kind  of  co-operation  could  be  foreseen  in  the  legal  requirement
referred to in 2.2.3.

Regarding cross-border activities of notified bodies the Commission

– 

intends  to  support  the  establishment  of  an  information  exchange  procedure  between
authorities  and/or  accreditation  bodies  in  the  “host”  country  and  the  designating
authority  in  the  “home”  country  of  notified  bodies,  as  part  of  the  reinforced
administrative  co-operation.  The  Commission  believes  that  this  would  require  a  legal
basis  to  be  introduced  either  in  a  common  base  or  in  individual  New  Approach
directives;

Regarding the relationship between the regulated and non-regulated area the Commission

– 

considers that in preparing future actions (of legislative or non-legislative nature) in the
field of conformity assessment no distinction should be made between the regulated and
non-regulated areas, taking into account the necessary freedom to be left to operators in
the non-regulated areas;

Regarding  the  co-operation  and  exchange  of  information  between  notified  bodies  the
Commission

– 

intends  to  propose  introducing  in  all  New  Approach  directives  provisions  for  notified
bodies  to  exchange  information  on  non-compliant  products  submitted  for  testing  or
certification  and  to  support  future  activities  of  Notified  Bodies  Groups  in  order  to
promote  the  exchange  of  experience  among  all  bodies  notified  under  the  respective
directive;

Regarding the conformity assessment procedures the Commission

– 

– 

will  propose  to  introduce  module  H  or  a  variant  in  future  New  Approach  directives
where this is considered useful and to further ensure its proper application;

will prepare a proposal, to be applicable on a horizontal basis, clarifying the definitions
to be applied in conformity assessment procedures as far as possible;

Regarding the CE conformity marking the Commission

– 

intends  to  take  the  necessary  steps  to  promote  the  meaning  of  the  CE-marking,  to
introduce  enforcement  and  protection  measures,  including  sanctions  and  clarify  its
relation to voluntary product marks in order to strengthen the role of CE-marking;

32

– 

proposes that the whole issue of the unduly affixed CE-mark to be further discussed and
the  most  important  factors  identified.  The  Commission  intends  to  launch  a  publicity
campaign to be initiated in close co-operation with Member States and, on the basis of
experience  gained,  does  not  exclude  the  possibility  to  propose  a  clearer  legal  text  in
order to exclude ambiguities and to strengthen the position of the CE marking;

Regarding the enforcement and market surveillance the Commission

– 

calls on Member States to ensure a common level of market surveillance and to support
clear action towards this goal. Defining basic rules with which Member States will be
obliged to comply (e.g. sanctions, information exchange provisions) require a  revision
of  the  legal  framework  either  by  means  of  a  common  base  directive  or  by  including
these rules in the individual directives;

Regarding the reinforced administrative co-operation the Commission

– 

– 

intends  to  propose  introducing  a  legal  basis  for  administrative  co-operation  among
Member States in the New Approach directives that do not yet foresee this in addition to
continuing practical and financial support;

encourages the conclusion of bi- or multilateral agreements for mutual assistance among
Member  States  in  order  to  avoid  areas  of  activities  not  being  covered  by  market
surveillance authorities;

Regarding the Safeguard clauses in the New Approach directives the Commission

– 

will propose to modify the safeguard clause procedure in the New Approach directives
with  the  aim  of  ensuring  a  more  uniform  approach  throughout  the  New  Approach
directives, to simplify and shorten the process and to render it more effective to ensure
the good functioning of the Internal Market. This proposal would require a revision of
the legal framework;

Regarding the Relationship with the Directive on General Product Safety and the exchange
of information concerning dangerous products the Commission

– 

intends  to  propose  introducing  provisions  in  New  Approach  directives  for  an
information  exchange  concerning  industrial  products  which  present  a  serious  and
immediate  risk  to  users.  This  information  exchange  will  involve  authorities  in  all
Member States and the Commission services;

Regarding the revision of the legal framework the Commission

– 

proposes to start examining the benefits and disadvantages of a common base directive
and  of  the  inclusion  of  standard  articles  on  horizontal  issues  of  New  Approach
directives  in order  to detect the best solution and  the  largest  extent  of  such  horizontal
issues  to  be  taken  into  consideration.  The  Commission  believes  that  a  common  base
directive  will  be  the  better  solution  because  of  reduction  of  legislative  work  in  future

33

directives  and  the  more  homogeneous  handling  of  identical  or  similar  issues  in  New
Approach directives;

Regarding the possibility of outsourcing to support implementation the Commission

– 

believes  that  outsourcing,  wholly  or  partly,  some  activities  will  speed  up  the  process.
Activities that could be outsourced include:

– 

– 

– 

– 

– 

– 

– 

– 

– 

the  technical  preparation  of  the  safeguard  clause  procedures  for  products
(depending on the sensitivity of the matter),

the management of the information exchange mechanisms,

issues related to designation and notification of notified bodies,

the management of the database of notified bodies,

the co-ordination of notified bodies groups, and of information campaigns,

technical and legal analysis and objections against harmonised standards,

elaboration of technical documents related to questions of the interpretation of the
essential requirements of directives,

mandates to standardisation bodies

co-ordination of co-operation activities of national authorities.

– 

This  would  leave  the  Commission  services  the  freedom  to  use  existing  capacities  for
other fields.  The  “pooling” of expertise already  available  in  Member  States  should  be
one of the major tasks of the body, in order to attain the highest level of expertise with
the lowest administrative effort.

34