Report from the Commission to the Council and the European Parliament on actions taken following the resolutions on european standardisation adopted by the Council and the European Parliament in 1999
Date: 2001-09-26
Institutions: European Commission
Subjects: EU industrial policy, European standard, harmonisation of standards, report, standardisation, technical regulations

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 26.09.2001
COM(2001) 527 final

REPORT FROM THE COMMISSION
TO THE COUNCIL AND THE EUROPEAN PARLIAMENT

ON ACTIONS TAKEN FOLLOWING THE RESOLUTIONS
ON EUROPEAN STANDARDISATION
ADOPTED BY THE COUNCIL AND THE EUROPEAN PARLIAMENT IN 1999

   
REPORT FROM THE COMMISSION
TO THE COUNCIL AND THE EUROPEAN PARLIAMENT

ON ACTIONS TAKEN FOLLOWING THE RESOLUTIONS
ON EUROPEAN STANDARDISATION
ADOPTED BY THE COUNCIL AND THE EUROPEAN PARLIAMENT IN 1999

I.

1.

2.

II.

3.

INTRODUCTION

In  1999,  both  the  Council1  and  the  European  Parliament2  adopted  Resolutions  on
standardisation.  These  Resolutions  related  to  the  Commission  Communication  on
“Efficiency  and  Accountability  in  European  Standardisation  under  the  New
Approach”3.  Both  Resolutions 
the  achievements  of  European
recognised 
standardisation  under  the  New  Approach.  They  identified  the  main  challenges  and
set a clear agenda for future work. The Council Resolution turned out to be an action
plan for stakeholders in European standardisation.

This  report  from  the  Commission  aims  to  set  out  the  most  relevant  developments
since  1999,  as  requested  by  the  Council  and  Parliament.  After  setting  the  broader
context  surrounding  standardisation  in  the  Community  and  EFTA,  it  analyses
developments in the more specific key areas mentioned by the Resolutions. As some
of the actions identified in the Resolutions are still ongoing, this should be viewed as
an  interim  report.  This  report  basically  takes  a  horizontal  view  on  European
standardisation matters.

THE  BROADER  CONTEXT:  MILESTONES  SINCE  1999  AND  THEIR  BEARINGS  ON
EUROPEAN STANDARDISATION

European standardisation  is  a  voluntary activity  by  and  for  the  parties  interested  in
drawing  up  common  standards  and  technical  specifications  in  response  to  their
needs.  These  common  specifications  are  agreed  on  the  basis  of  well-established
principles  in  the  legally  recognised  European  Standards  Organisations  CEN,
CENELEC  and  ETSI.  European  standards  have  become  a  crucial  factor  in  the
functioning of the Single Market and the European Economic Area. They also play
an  important  role  in  supporting  a  number  of  other  policy  objectives  of  the
Community, including the competitiveness of enterprises, innovation, the protection
of health and safety, consumer interests, and environmental protection. The need for
common  standards  is  underlined  by  the  increasing  globalisation  of  trade  and  the
convergence of technologies.

1

2

3

Resolution of 28 October 1999 on the role of standardisation in Europe, OJ C 141, 19.5.2000.
Resolution of 12 February 1999 on the report from the Commission, OJ C 150, 28.5.1999.
COM(1998) 291 final of 13.5.1998.

2

                                                
4.

4.1.

4.2.

4.3.

4.4.

4.5.

4.6.

4

5

6

7

8

Since  1999,  some  political  milestones  have  been  reached  which  are  important  for
European standardisation:

Current  reflections  on  governance  in  Europe4  focus  on  alternative  forms  of
regulation  and  on  democratic  legitimacy  and  expertise.  Today,  the  Community’s
New  Approach,  which  is  applied  in  many  areas  of  Single  Market  legislation  and
which  uses  common  European  standards  in  support  of  legislation,  is  considered  a
well-implemented  co-regulatory  model.  The  use  of  standards  in  relation  to
Community  legislation  and  policies  requires  the  respect  of  certain  principles
regarding the standardisation process and the bodies responsible for it, in particular
concerning the full involvement of all relevant interested parties.

The Lisbon European Council5 intended to boost Europe’s competitiveness at world
level  and  coined  the  expression  e-Europe.  Subsequently  at  Feira,  the  European
Council  endorsed  the  Commission’s  proposal  for  an  e-Europe  action  plan  that  will
pave the way for the information society in Europe. Standards and common technical
specifications are a necessary condition to make e-Europe happen.

At  the  meeting  of  the  European  Council  in  Göteborg  a  strategy  for  sustainable
development was adopted6. This strategy requires that as from 2003 all proposals for
decisions in EU policy areas must be assessed with regard to their economic, social
and  ecological  effects.  “Greening”  the  market  is  seen  as  a  key  issue  for  the  Sixth
Environment  Action  Programme  ‘Our  Future  –  Our  Choice’  2001-20107.  The
program  also  signals  the  need  to  integrate  environmental  protection  requirements
into other Community policies, including standardisation. Environmental aspects are
considered to be an engine for innovation and business opportunities and should be
taken into account throughout all phases of a product’s life cycle. The Commission’s
Green  Paper  on  integrated  product  policy  (IPP)8  recognises  the  important  role
standards  could  play  in  the  design,  manufacturing,  use,  re-use  and  recycling  of
environmentally friendly products.

Global  trade  continues  to  increase.  The  use  of  international  standards  can  enhance
market  access  and  facilitate  trade.  International  standardisation  offers  globally
applicable solutions to the parties concerned. The absence of international standards
with global recognition can be a source of trade frictions.

The Community attaches great importance to ensuring a high and consistent level of
protection for consumer health and safety. The Commission has proposed to make
extensive  use  of  European  standards  under  the  Community  law  on  general  product
safety which reflects the contribution standards  can  make to the  proper functioning
of the internal market and the protection of consumer health and safety.

In the light of its commitment to sound financial management the Commission puts
an emphasis on a strong link between financial support and the implementation of its
policies,  for  instance,  through  activity-based  budgeting.  Although  European
standardisation  is  largely  financed  on  a  private  basis,  the  Commission  reviews  its

cf. European Governance: a White Paper, COM(2001) 428 final of 25.7.2001.
Lisbon European Council 23 and 24 March 2000: presidency conclusions, SN100/00.
cf. http://ue.eu.int/en/Info/eurocouncil/index.htm.
COM(2001) 31 final of 24.1.2001.
COM(2001) 68 final of 7.2.2001.

3

                                                
policy  on  granting  financial  contributions 
organisations. In many instances Community support includes a share from EFTA.

the  European  standardisation

to 

III.

KEY POLICY ISSUES

III.1.

Principles of Standardisation

5.

6.

7.

7.1.

9

10

11

12

13

Community  law  recognises  CEN,  CENELEC  and  ETSI  as  European  standards
organisations9.  There  are  also  a  number  of  Community  legal  acts  that  define  the
meaning of standards10. Although not identical, these definitions are consistent with
those  established  by  the  relevant  guides  on  general  terms  and  the  definitions
concerning standardisation and related activities published by international standards
organisations11.

In  its  1999  Resolution,  the  Council  reiterated  the  principles  of  European
standardisation by confirming that it is a voluntary, consensus-driven activity, based
on  openness  and  transparency  within  independent  and  recognised  standards
organisations.  It  further  specified  that  standards  should  have  a  high  degree  of
acceptability as a result of the full involvement of all relevant interested parties in the
standardisation  process  and  that  standards  should  be  coherent  with  each  other.  The
Council  also  emphasised  that  standards  should  be  based  on  sound  scientific
research12  and  should  allow  for  technological  innovation  and  competition.  These
principles have been implemented by the European standards organisations and their
national counterparts for a long time13.

Since the Resolution, the meaning of these principles has been further substantiated.

At  international  level,  the  WTO  agreement  on  technical  barriers  to  trade  (TBT)
draws a clear distinction between standards with which compliance is voluntary and
technical regulations with which compliance is mandatory. WTO members shall use
international  standards  as  a  basis  for  technical  regulations,  provided  they  deem  the
standards appropriate for the fulfilment of legitimate objectives and for attaining the
desired  level  of  protection  at  domestic  level.  The  use  of  international  standards
allows  for  a  level  playing  field  and  creates  a  presumption  of  conformity  with
international  trade  rules.  While  the  agreement  places  an  emphasis  on  the  use  of
international standards as  a  basis for technical  regulations, it does not  specify  what
international  standards  are  or  which  organisations  produce  them.  This  situation
prompted  the  WTO  to  adopt  principles  for  the  development  of  international

Annex I of Directive 98/34/EC.
e.g.  Art. 1  of  Directive  98/34/EC;  Art. 1(3)  of  Council  Decision  87/95;  Annex III  of  Directive
93/36/EEC.
ISO/IEC Guide 2:1996.
The  European  Community  Framework  programme  for  research,  technological  development  and
demonstration  has  adopted  pre-  and  co-normative  research  as  one  of  its  priority  objectives.  Several
dedicated  calls  for  research  projects  in  support  of  standardisation  were  published  during  the
5th Framework programme and have received Community funding of about € 30 million. Furthermore,
as a  means  for the exploitation of its results, the Joint  Research  Centre provides input to the  work  of
technical  committees  and  working  groups  of  the  European  standards  organisations,  in  particular
regarding the harmonisation, validation and benchmarking of analytical methods.
cf.  Joint  CEN/CENELEC/ETSI  Statement  “Basic  principles  and  organisation  of  European  standards
work”, Luxembourg, 3-4.12.1991.

4

                                                
7.2.

7.3.

8.

9.

standards  in  relation  to  the  core  provisions  of  the  TBT  agreement.  The  WTO
considered  transparency, openness, impartiality,  consensus,  effectiveness,  relevance
and  coherence  as  key  principles  that  should  apply  to  international  standardisation
(see also III.6).

With  regard  to  the  possible  restrictions  to  competition  caused  by  horizontal  co-
operation agreements between companies operating on the same market level(s), the
Commission  published  a  notice  on  the  applicability  of  Article  81  of  the  EC
Treaty14. In this notice, standardisation is considered to be a type of horizontal co-
operation  agreement,  either  concluded  between  private  undertakings  or  determined
under the aegis of public bodies or bodies entrusted with the operation of services of
general  economic  interest,  such  as  the  standards  organisations  recognised  under
Directive 98/34/EC.

Subject  to  an  analysis  of  an  individual  case,  standards  will  almost  always  restrict
competition  if  they  are  used  in  the  context  of  a  broader  agreement  which  aims  at
excluding actual or potential competitors. They may restrict competition if they grant
the  parties  joint  control  over  production  and/or  innovation.  The  restriction  of
competition  depends  upon  the  extent  to  which  the  parties  remain  free  to  develop
alternative  standards  or  products  that  do  not  comply  with  the  agreed  standard.
Competition may also be restricted if standards grant exclusive rights for compliance
testing to certain bodies or if they impose restrictions on conformity marking, unless
this  is  imposed  by  regulatory  provisions.  The  Commission  considered  that,  in
principle,  standardisation  agreements  do  not  restrict  competition  if  the
standards  were  adopted  by  the  recognised  standards  organisations,  which  are
based on non-discriminatory, open and transparent procedures.

interested  parties.  Societal  stakeholders'  participation15 

The acceptability of standards depends to a large extent on the full involvement of
all  relevant 
the
standardisation  process  has  a  strong  accountability  dimension.  It  reinforces  the
quality of the consensus and makes the standards more representative. The Council
therefore  invited  all  interested  parties  to  participate  actively  in  the  elaboration  of
standards and to contribute to the management of the standardisation process.

in 

While standardisation will remain for most sectors a  market-driven  and self-funded
activity there is public interest in the maintenance of a standardisation infrastructure
that is open and impartial, and that operates in a transparent way. This is especially
important in areas in which standards support legislation. Standards development is
time consuming and costly in terms of the human and financial resources that have to
be provided in order to achieve a meaningful input into the process. The participation
of  small  and  medium-sized  enterprises  (SMEs)  and  societal  stakeholders  can  be
hampered  by  a  lack  of  resources  and  technical  expertise.  Significant  differences  in
the  levels  of  expertise  represented  can  also  hamper  the  consensus-finding  process
and therefore cause delays in standards development.

14

15

OJ C 3 of 6.1.2001, p. 2-30.
Societal stakeholders represent consumer, health, safety and environmental interests in standardisation.

5

                                                
10.

10.1.

10.2.

10.3.

10.4.

Financial  support  from  public  authorities  needs  to  take  this  into  account.  In  a
decentralised  European  standardisation  system  it  is  important  that  stakeholder
participation is balanced, notably at a national level since most of the European and
international  draft  standards  undergo  a  national  inquiry  before  final  adoption.  A
balanced participation of stakeholders is equally important at the European  level of
the  standardisation  process.  The  Commission  analysed  the  situation  of  various
stakeholders concerning their participation in standardisation at European level and
the following can be said:

The  European  Association  for  the  Co-ordination  of  Consumer  Representation  in
Standardisation, ANEC, was founded in 1995 and has continued to be financially
supported  by  the  Commission.  By  co-ordinating  a  network  of  technical  experts
across  Europe,  ANEC  participates  in  standardisation  work.  ANEC  calls  for  a
balanced representation of interested and concerned parties in standardisation16. They
examined the national arrangements for consumer participation in standardisation in
the  EU  and  EFTA17  and  concluded  that  the  situation  had  improved  compared  with
1995.  However,  a  gap  persisted  between  the  well-developed  consumer
representation  in  national  standardisation  in  the  north  of  Europe  and  an
unsatisfactory consumer representation in southern European countries.

The  European  Trade  Union  Technical  Bureau  for  Health  and  Safety,  TUTB,
represents  the  interests  of  employees  in  health  and  safety  aspects  of  European
standardisation and co-ordinates a network of technical experts. It has continued to
receive  financial  support  from  the  Commission.  Together  the  Commission  and
TUTB  monitor  the  work  of  CEN  and  CENELEC,  in  particular  in  relation  to  the
safety of machinery, personal protective equipment and ergonomic design.

NORMAPME, the European Office of Craft, Trades and Small and Medium-Sized
Enterprises  for  Standardisation  Technical  Office,  represents  the  interests  of  these
businesses  in  European  standardisation.  Since  1995  the  Commission  has  granted
subsidies to NORMAPME. The Commission recently launched  a call for tender
with  the  aim  of  offering  a  stable  service  to  SMEs  in  an  effort  to  promote  their
position in European standardisation18.

The  Commission  intends  to  further  collaborate  with  the  European  standards
organisations  and  concerned  parties  to  reach  its  environmental  objectives.  It  also
plans  to  support  a  service  that  will  be  in  charge  of  representing  environmental
interests  in  the  European  standards  bodies19.  For  the  full  integration  of  the
environmental dimension, the mere participation of representatives from this service
is  not  sufficient.  It  depends  also  on  the  willingness  of  all  participants  in  the
standardisation  process.  The  Commission 
to  develop  a  paper  on
standardisation and the protection of the environment in 2002.

intends 

16

17

18

19

Position paper of March 2001 on the 1999 Council Resolution on the role of standardisation in Europe,
(ANEC2001/GA/007).
Report of May 2001 on consumer participation in standardisation, (ANEC2001/GA/014).
cf. open invitation to tender 2001/S117-079423, OJ S 117 of 21.6.2001.
cf. open invitation to tender 2001/S71-048238, OJ S 71 of 11.4.2001.

6

                                                
III.2.

Standardisation and Market Needs

11.

12.

13.

14.

The  Council  Resolution  of  1999  invited  the  European  standards  organisations  to
adapt to new market needs by diversifying their range of products and services  and
developing  a  graduated  system  of  products.  It  also  requested  the  Commission  to
examine how a Community framework of principles for the use of new deliverables
of standardisation should be developed and to explore  whether  differences between
standardisation in the ICT field and other sectors could be addressed20.

Acceptance  of standardisation is related to  the  market  relevance  of  standards,
and not only to the participation of the parties  concerned. Market relevance largely
depends  on  the  quality  and  technological  state  of  advancement  of  standards,  their
applicability, their perceived neutrality and on their development time. In this context
it should be noted that while the catalogue of harmonised standards has increased in
response  to  mandates  under  New  Approach  and  other  European  directives21,  the
majority  of  European  standards  are  developed  in  response  to  pure  market  needs.
However,  as  market  needs  constantly  evolve  new  standardisation  products  and
services can bring about added value to their users and complement the existing
range of products and services offered by the standards organisations.

The rapid development of technologies and processes in some sectors, in particular in
the information and communications technology (ICT) sector, has led to a need for
the  equally  rapid  creation  of  common  specifications.  Reflections  on  the  role  of
standardisation to facilitate competition and satisfy public interest as well as on the
role  of  new  global  industry  fora  in  the  ICT  sector  need  to  be  pursued.  But  also  in
other sectors, for instance, in the environmental field the time it takes to arrive at a
European standard is of concern considering that environmental problems will persist
and perhaps get worse within this time. In view of a sometimes over-lengthy process
in standards organisations,  private  consortia and  fora  have mushroomed in order to
produce  the  specifications  required  by  the  market.  However,  renewed  interest  in
more stable business and technical solutions can be observed in the ICT field and the
beginning of a rapprochement between consortia and standards organisations may be
expected.

The  trend  for  the  development  of  common  specifications  outside  standards
organisations  has  spread  outside  the  ICT  to  other  sectors  and  the  need  for  rapid
consensus-building and speedy development of common specifications has become a
more  general  issue  in  standardisation.  The  specific  provisions  in  Community  law
relating  to  standardisation  in  the  ICT  field22,  particularly  public  procurement,
have  therefore  become  less  relevant.  There  is  also  a  tendency  for  non-technical
consensus documents like guidelines and codes of conduct to be used in a particular
sector  or  field  of  activity.  Other  back-up  activities  for  standardisation  include
counselling and support services for standards users and market watch functions.

20

21

22

Council Resolution of 28.10.1999, points 13-15, OJ C 141 of 19.5.2000.
cf. Single Market Scoreboard: N°6 of 22 May 2000, N°7 of 24 November 2000, N°8 of 28 May 2001.
cf.  Council  decision  87/95/EEC  on  standardisation  in  the  field  of  information  technology  and
telecommunications.

7

                                                
15.

16.

17.

18.

19.

23

24

The need to provide deliverables on a faster time-scale (the “time to market” factor)
has  resulted  in  a  new  portfolio  of  deliverables  from  the  European  Standards
organisations.  CEN  has  started  producing  Workshop  Agreements  (CWA).
Proposals  for  Workshops  at  European  level  may  come  from  any  interested  party.
Participation is open to all interested parties (and not only members). Agreement is
in principle based on a business plan, which is placed for comment on the Web. The
CWA represents the consensus of Workshop participants. The ETSI Standard is a
normative  document.  It  is  adopted  following  ETSI  membership  voting.  The  ETSI
Standard can be made into an EN following the appropriate procedures.

CEN,  CENELEC  and  ETSI  have  also  reached  agreement  on  three  new  common
deliverables that are to be added to their respective collection of European Standards
(ENs) and included in their product range. The Technical Specification could serve
as an entry point for specifications developed outside the formal system. The Guide
is  an  informative  document  addressing  users  as  well  as  standards  makers.  The
Technical  Report  is  an  informative  document,  which  may  discuss  technical
solutions as well as providing information on the use of standards.

European  standards  organisations  have  shown  great  flexibility  in  developing  new
deliverables  and they  have  been  prepared to respond to  political initiatives. Further
efforts  for  promoting  new  deliverables  in  response  to  (new)  market  needs  should
attract new participants. In this regard the willingness of standards organisations to
integrate, in an open and receptive manner, the work started by new participants will
be of crucial importance. The initial results concerning the expanded product range
of European standards organisations can be illustrated by the success story of CWAs.
Since  1998  more  than  30  Workshops  have  been  set  up  in  various  ICT  and  other
fields. The Workshops attracted more than 1300 participants and led to 36 CWAs.

In June 2000, the European Council of Feira, Portugal, endorsed the comprehensive
e-Europe  2002  Action  Plan,23  building  on  the  Commission’s  e-Europe  initiative  of
December 1999. The initiative aims at accelerating the uptake of digital technologies
across Europe and ensuring that all Europeans have the necessary skills to use them.
It plays a central role in the agenda of economic  and social  renewal  for  Europe  set
out by the  Commission  for  the European Council  in Lisbon.  Ambitious  targets  and
tight deadlines have been set for the achievement of the initiative. In June 2000, the
three European standards organisations produced a common rolling action plan: The
contribution of European standardisation to the e-Europe Initiative24. This joint
programme sets out and monitors the standardisation activity needed in order for the
political  targets  and  the  deadlines  to  be  met.  Subsequently,  an  agreement  was
reached  between  the  Commission  and  the  ESOs  for  Community  support  where
necessary for these standardisation actions.

Discussions took place between the Commission and the Advisory Group of Senior
Officials on Standardisation and Conformity assessment concerning the relevance of
new deliverables to public policy. Discussions concluded that public authorities may
want to monitor the development of new deliverables or examine them in the light of

COM(2001) 140 final of 13.3.2001.
http://www.cenorm.be/isss/Major_Activities/eEurope/eeur.htm
http://www.etsi.org/eeurope/eeurope.htm

8

                                                
any  possible  negative  impact  on  competition25.  In  certain  cases  it  may  be  of
interest to use new deliverables in Community policies. They could be used across
the board in Community activities and in those areas where consensus or a consensus
process is  required  in  a  relatively  short  space  of  time.  As  market  instruments,  they
are  particularly  relevant  to  activities  to  improve  the  competitiveness  of  European
enterprises,  bolster  the  internal  market  and  strengthen  the  link  with  research,
development  and  innovation.  However,  new  deliverables  should  not  be  confused
with formal standards. The discussions also showed that at this stage of development,
new deliverables seem inadequate as a replacement for harmonised standards as
a support for the New Approach directives or in dealing with subjects such as health
and occupational safety, nor is this their function.

For  new  deliverables  to  be  used  in  public  policy,  the  documents,  processes,  and
organisations that create new deliverables need to conform to certain principles that
guarantee  their  acceptability.  In  response  to  the  1999  Council  Resolution,  the
Commission services have drawn up a preliminary document26 setting out these
criteria in detail and consulted these principles with an advisory body  consisting of
Member  State  representatives.  After  further  decisions  from  the  European  standards
organisations  and  their  members  concerning  a  graduated  system  of  products  and  a
further  extended  range  of  deliverables,  this  document  will  be  reconsidered.  If
necessary, its status will be more formalised.

New  European  standardisation  deliverables  and  services  do  not  always  seem  to  be
fully  supported  at  national  level.  However,  commitment  on  the  part  of  national
standards  organisations  and  the  Member  States  is  necessary  to  provide  support  for
new deliverables and prevent  conflicting solutions developing.  A  regular  exchange
of  information  on  new  deliverables  between  the  national  and  European  standards
organisations  would  allow  synergies  to  be  exploited  and  work  started  at  European
level, at the right time and where appropriate.

20.

21.

III.3. Role of Public Authorities

22.

23.

25

26

27

28

Public policies must compensate for market imperfections and seek  to  realise  some
of the potential socio-economic benefits of standardisation, including the promotion
of  SMEs  and  the  fostering  of  worker,  consumer  and  environmental  interests.
Likewise, innovation policy has to strike a balance between the means to protect the
rights  of  innovators,  such  as  patents,  and  the  means  to  disseminate  innovation
through  open,  voluntary  standards.  It  is  therefore  in  the  interest  of  the  public
authorities  to  maintain  a  stable  and  transparent  legal,  political  and  financial
framework for standardisation27.

The  1999  Council  Resolution28  highlighted  the  legitimate  interest  of  the  public
authorities  in  European  standardisation,  given  the  new  dimension  it  has  taken  as  a
result of the wide use made of it by Community policies. The Commission explained
the potential of standards in its Communication on the broader use of standardisation

cf. Guidelines on the applicability of  Art. 81 of the EC Treaty to  horizontal  co-operation  agreements,
OJ C 3 of 6.1.2001, p. 2-30.
SOGS N363R3.
Council Resolution of 28.10.1999, OJ C 141, 19.5.2000.
See above.

9

                                                
23.1.

23.2.

23.3.

in  Community  policy29.  Consequently,  the  European  standards  organisations
further  extended  their  areas  of  activity  in  response  to  European  policies.  This
shows  the  spirit  of  partnership  existing  between  the  European  regulator  and  the
European standards organisations, as illustrated below.

European  standards  can  play  a  major  role  in  the  defence  procurement  of  national
ministries  and  armament  agencies.  Studies  have  shown  that  replacing  national
military specifications with European or international civil standards could increase
efficiency  and  lower  procurement  costs  for  governments.  In  November  2000,  the
Commission  organised  a  conference  on  European  defence  procurement  in  the  21st
century which explored, amongst others, the possibility of harmonising, at European
level, the standardisation processes in the defence sector, and for creating interfaces
with  civil  standardisation.  European  Standards  Organisations  were  invited  to
contribute to the debate and the CEN was identified as a platform for compiling a
European Handbook of Defence Standards and Procedures.

The White Paper on Food Safety30, which was published at the beginning of 2000,
showed that the Commission regarded ensuring the highest standards of food safety
in the EU as one of its main priorities. In this regard, it should be noted that methods
of analysis are necessary to  check  compliance with safety requirements for  food or
materials that come into contact with food. As progress in the  development  of  new
analytical methods is very  rapid, in principle, the Commission tries to avoid laying
down  specific  methods  of  analysis  in  legislation,  even  if  in  some  cases,  it  was
considered appropriate. The establishment of quality criteria for validated methods is
a  more  flexible  and  preferable  approach.  Validated  methods  give  enforcement
authorities, industry and certification laboratories the means of ensuring conformity
with legal limits. The use of European standards is one possibility for bringing about
a  degree  of  harmonisation  in  this  field  and  CEN  has  already  established  about
50 standards  in  the  area  of  “Food  analysis  –  Horizontal  Methods”  and  has  been
mandated for 28 methods of analysis in the field of food contact materials.

The  new  field  of  electronic  services  and  other  developments  concerning  the
information society is  yet  another area where European standardisation can provide
support  for  European  legislation  and  political  initiatives  such  as  e-Europe.  The
Directive on  a  Community  framework  for electronic signatures  (1999/93/EC)31 and
the  Commission  proposal  for  a  directive  on  a  common  regulatory  framework  for
electronic communications networks and services32 are examples of this. The former
involves the joint work of a specialised group on electronic signatures and CEN
and  ETSI,  to  provide  the  standards  needed  to  support  the  requirements  of  the
Directive  on  electronic  signatures33.  The  latter  provides  for  the  selection  of
appropriate  technical  solutions  for  electronic  communication  services,  which,  in
order  to  preserve  coherence  and  interoperability  in  the  internal  market,  would  be
formalised by the European standards bodies.

29

30

31

32

33

COM(1995) 412 final of 30.10.1995.
COM(1999) 719 final of 12.1.2000.
Directive 1999/93/EC, OJ L 13, 19.1.2000, p.12.
COM(2000) 393 final of 12.7.2000.
More information on the European Electronic Signature Standardisation Initiative (EESSI) can be found
on http://www.ict.etsi.fr/eessi/EESSI-homepage.htm.

10

                                                
23.4.

24.

24.1.

24.2.

In the area of Road Telematics and Intelligent Transport European standardisation
is progressing in fields  such  as the  collection,  exchange  and  broadcasting  of  traffic
data,  Dedicated  Short  Range  Communication  (DSRC)  for  applications  like  tolling,
Automatic  Vehicle  Identification,  Human  Machine  Interface  Standards  and  Smart
Cards. It is important for electronic fee collection systems to be interoperable across
national borders to facilitate traffic flows in Europe. T he Commission invited CEN
to complete its work on the development, validation and testing of DSRC and other
related standards34. In addition to the work from CEN, progress was achieved in this
field by fora and consortia, and under memoranda of understanding by the interested
parties.

The  broader  use  of  standards  by  public  authorities  is  related  to  the  considerable
efforts that have been made to improve  and  simplify  the  regulatory  environment in
the  EU.  The  Lisbon  European  Council  stressed  that  business  and  citizens  need  a
regulatory  environment  which  is  clear,  effective  and  workable  in  a  rapidly
changing  global  market  place,  and  that  formal  regulation  is  not  always  the
answer35.  Alternative,  complementary  approaches  can  sometimes  provide  more
effective  solutions.  The  challenge  is  to  ensure  high  levels  of  protection  while
avoiding  over-regulation36.  The  New  Approach  to  technical  harmonisation  and
standardisation  is  a  model  that  combines  these  two  requirements  and  the  Council
invited the Commission to examine whether the New Approach can be applied to
sectors  not  yet  covered  as  a  means  of  improving  and  simplifying  legislation
wherever possible37.

The Commission proposal for a new directive on general product safety, replacing
Council Directive 92/59/EEC,38 pursues, among other things, the objective of better
defining the criteria for assessing product safety and clarifying the role of European
and  national  standards  in  this  regard.  The  proposal  ensures  -  in  line  with  the  New
Approach  philosophy  -  that  products  which  comply  with  European  standards
established  by  the  European  standards  organisations,  under  a  mandate  from  and
published  by  the  Commission,  can  be  presumed  to  comply  with  the  general  safety
requirement of the Directive.

On  7  February  2001  the  Commission  adopted  a  Green  Paper  on  Integrated
Product Policy (IPP)39. Its objective is to launch a debate on the role and possible
measures  that  could  be  taken  on  a  European  level  to  improve  the  environmental
performance  of  a  broad  range  of  products  throughout  their  entire  life  cycle.  In  the
Green  Paper  standardisation  is  recognised  as  one  of  the  potential  instruments
contributing to the goals of IPP. Accordingly the Green Paper asked for reactions on
how  the  New  Approach  could  best  be  applied  to  new  initiatives  in  the  field  of
product  design  and  how  environmental  characteristics  could  be 
integrated
systematically into product standards.

34

35

36

37

38

39

COM(1998) 795 final of 21.12.1998.
COM(2001) 79 of 7.2.2001.
COM(2001) 130 of 7.3.2001.
Council Resolution on the role of standardisation in Europe, OJ C 141, 19.5.2000.
COM(2000) 139 final of 29.3.2000.
COM(2001) 68 final of 7.2.2001.

11

                                                
24.3. Work  is  underway  for  a  Commission  proposal  to  harmonise  the  requirements
concerning  the  environmentally  friendly  design  of  electrical  and  electronic
equipment  (EEE)  and  enable  use  of  harmonised  standards40.  This  Directive  is
intended  to  ensure  the  free  movement  of  these  products  within  the  internal  market
aiming  to  improve  their  overall  impact  on  the  environment,  and  thus  providing  an
efficient  use  of  resources  and  a  high  level  of  environmental  protection  compatible
with sustainable development41.

25.

26.

27.

40

41

42

43

44

45

46

The  partnership  between  the  Community  and  the  European  standards  organisations
requires  distinct  roles  for  the  each  of  the  parties.  The  Council  emphasised  this  in
1999  when  asking  for  new  mechanisms  for  cooperation  and  transparency  to  be
created42.  In  addition  to  the  General  Guidelines  for  Cooperation  between  the
European Commission and the European standardisation organisations of 198443 and
the Council Resolution of 199244 the Commission services drew up a preliminary
working  document  on  the  role  of  public  authorities  in  standardisation45.  This
document  takes  as  a  starting  point  the  need  for  authorities  to  fulfil  public  interest
obligations  while  respecting  the  voluntary  nature  of  standardisation  and  the
independence  of  standardisation  organisations.  It  focuses  on  standardisation  under
the New Approach.

If the public authorities see that a harmonised standard does not entirely satisfy the
essential  requirement(s)  of  a  New  Approach  Directive,  the  publication  of  the
references of the standard concerned or its relevant parts can be  withdrawn. This is
done  through  a  “standards  safeguard  clause”  which  is  also  called  a  “formal
objection.”  Detailed  guidelines  were  established  for  the  administrative  procedure
concerning  formal  objections  by  Member  States  or  the  Commission  against
harmonised standards, in collaboration with the Advisory Committee under Directive
98/34/EC46.  However,  it  should  be  noted  that  out  of  the  totality  of  the  harmonised
standards  under  the  New  Approach,  ten  standards  have  been  the  subject  of  formal
objections since 1999.

With  a  view  to  even  further  improving  the  system  and  preventing  formal
objections, the European standards organisations could adopt additional mechanisms
as  proposed  by  the  Council  and  the  European  Parliament.  One  option  would  be  to
further increase the transparency of the European system and to provide information
on any remaining reservations on the part of the stakeholders at national level. The
Commission  made  this  suggestion  during  discussions  with  the  European  standards
organisations. Only CEN is known to have pursued the matter.

http://europa.eu.int/comm/enterprise/electr_equipment/eee/index.htm.
See also the strategy for the integration of environmental protection and sustainable development into
internal  market  policy,  Council  document  8970/01  submitted  to  the  European  Council  in  Göteborg,
15-16 June 2001.
cf. Council Resolution of 28.10.1999, OJ C 141, 19.5.2000.
The guidelines were initially agreed between the Commission, CEN and CENELEC. They are currently
under review tacking account of the activities of the European Telecommunications Standards Institute
ETSI and other relevant developments since 1984.
cf. Council Resolution of 18.6.1992, OJ C 173, 9.7.1992.
SOGS N 302.
cf. 98/34 Committee document n° 49/99 Rev. 2 of 3 April 2000.

12

                                                
III.4.

Efficiency

28.

29.

30.

31.

47

48

49

50

Industry, the  public  authorities  and  other  concerned  parties are interested in having
an  efficient  standardisation  system  through  which  they  can  draw  up  and  agree  on
high-quality standards, available within a  reasonable  time,  so  that they can  be used
effectively  in  the  market.  The  management  of  the  standardisation  process  is,  in
the  first  place,  the  responsibility  of  the  European  standards  organisations  and
their members. Since 1999, the European standards organisations have continued to
review their processes to increase efficiency and improve consensus.

On-line  working,  the  provision  of  deliverables  free  of  charge  and  over  the
Internet  and  greater  use  of  web-based  applications  put  ETSI  at  the  forefront  of
efficiency.  In  CEN,  the  implementation  of  a  similar  project  called  e-CEN,  which
aims at working, accessing and ordering standards via the Internet is well advanced.
CEN  also  launched  a  benchmarking  initiative  to  identify  best  practices  on  a
number of issues. CENELEC installed an audit system to assess the functioning of
its technical bodies on  the  basis  of defined benchmarks.  Even  if their make-up  and
organisational arrangements are different, the three European standards organisations
could certainly learn from each other by exchanging best practices. As requested by
the Council47, ETSI made use of indicative voting in order to improve access for all
the  interested  parties  at  the  earliest  possible  stage  in  the  process  and  to  avoid
bottlenecks with the risk of unnecessary delays. Electronic working in CEN will also
open up the possibility for indicative voting.

A number of measures have been initiated at the national level: a good example is
the  benchmarking  exercise  initiated  by  the  Finnish  standards  organisation  and  to
which  the  Commission  contributed  financially.  The  project  resulted  in  the
identification  of  59  best  practices  in  the  standardisation  processes  of  four  national
standards  organisations.  Best  practices  were  identified  in  areas  such  as  customer
services, management, sales and  marketing. The exercise concluded  with  a  number
the  group  of  participating  standards
of  operational 
organisations  and  with  specific  recommendations  for  each  of  them.  The  impact  of
standards has also been examined from various angles through a number of studies48.

recommendations 

for 

To  complete  the  picture  and  to  identify  issues  for  the  further  improvement  of
standardisation and standardisation policies the Commission has initiated a study on
the overall impact of standardisation in  the  EU and EFTA, as  requested by  the
Council49.  An  external  study  team  was  commissioned  to  examine  which  aspects  of
economy  and  society  have  been  affected  by  standards,  and  to  what  extent50.  The
study  design  proposes  to  look  into  aspects  such  as  health  and  safety  of  workers,
protection  of  consumers,  environment,  innovation  and  trade.  Evidence  for  such  an
impact assessment will be collected for some of the sectors regulated under the New
Approach.  Other  sectors  to  be  looked  at  include  future  growth  sectors  where  the
potential  of  European  standards  could  be  considerable.  Another  study  is  being

Point 23 of the Resolution of 28.10.1999, OJ C 141, 19.5.2000.
cf.  DIN  Deutsches  Institut  für  Normung  e.V.  (Hrsg):  Gesamtwirtschaftlicher  Nutzen  der  Normung,
Beuth  Verlag,  GmbH,  Berlin/wien/Zürich  2000;  and,  Swann,  G.M.P.,  The  economics  of
standardisation:  report  for  the  Standards  and  Technical  Regulations  Directorate  of  the  Department  of
Trade and Industry, Manchester Business School, 2000.
Point 25 of the Resolution of 28.10.1999, OJ C 141, 19.5.2000.
cf. Award Notice Nr. 043202, OJ S 63, 30.3.2001.

13

                                                
32.

33.

34.

conducted  under 
the  Community  research  programme  on  Competitive  and
Sustainable  Growth.  It  deals  with  the  interaction  between  “Standardisation  and
Intellectual  Property  Rights”  51.  Its  aim  is  to  examine  the  technical,  legal  and
economic  relationship  between  the  standardisation  process  and  the  registration  of
intellectual property rights (patents, trade marks, copyright, software protection).

Work  on  European  standards  has  progressed  since  1999.  Annex  1  shows  the
evolution for the number of European standards adopted in the past 18 months.
It  illustrates  the  fact  that  only  a  small  fraction  of  the  European  standards  are
developed  under  a  mandate  from  the  Commission.  The  vast  majority  of  them  are
purely  market  initiated.  This  aspect  is  substantiated  by  the  fact  that  European
standardisation costs are borne for more than 90% by the market players.

As  regards  standardisation  in  relation  with  the  New  Approach  Directives  the
programme  of  harmonised  standards  is  near  completion  in  the  area  of  toys,  non-
automatic  weighing  instruments,  gas  appliances  and  simple  pressure  vessels.  Good
progress can be reported for personal protective equipment and medical devices, both
fields covered by New  Approach  Directives.  European  Standardisation  work  in  the
machinery  safety  area  has  advanced  and  there  are  now  more  than  360  harmonised
standards  of  which  250  give  presumption  of  conformity  with  the  requirements  of
Community law. A programme of more than 700 harmonised standards is envisaged
in relation to the Directive on pressure equipment. By mid-2001 some 450 standards
were in place, 50 of which were harmonised. A great deal of work is still expected
for  packaging  and  packaging  waste,  explosives  for  civil  use,  potentially  explosive
atmospheres and recreational craft. Standardisation work for the latter is carried out
with 
the  International  Standardisation  Organisation  (ISO).  Electro-technical
standardisation  is  also  progressing  and  by  the  end  of  2000  84%  of  the  harmonised
standards had been ratified. This work is essentially based on the corresponding work
of 
the  area  of
electromagnetic  compatibility,  electrical  equipment  in  human  and  veterinarian
medical  practice,  electrical  equipment  for  railways  and  electrical  safety  of
machinery.

International  Electrotechnical  Commission 

(IEC) 

the 

in 

Until  recently, no harmonised standards  existed  for  construction  products.  This  has
changed and an important step has come with the agreement on the first harmonised
standards on construction products. Harmonised standards for cement, fixed fire-
fighting  systems,  geotextiles,  structural  bearings  and  lifting  plants  are  among  this
first group of harmonised construction products standards. Another 60 standards are
in  their  final  stages  of  development  and  a  similar  number  are  programmed  for
completion by the  end of 2001. This  development  is  expected  to  boost  the  internal
market of construction products by removing technical barriers to trade, creating new
markets and cutting compliance costs. On a general basis and as a means to improve
efficiency under standardisation mandates the Commission has now arranged for
regular  sectoral  review  meetings  with  the  aim  of  tracing  progress  and  stopping
financial support in areas that do not progress.

51

cf. OJ S 15, 22.1.2000.

14

                                                
35.

36.

Mandates  are  reference  documents  for  standardisation  activities  by  which  public
authorities  ask  the  European  standardisation  authorities  to  develop  technical
specifications. Directive 98/34/EC provides the general framework for the drawing-
up  of  mandates  which  can  be  complemented  by  provisions  in  individual  directives
using  this  instrument.  Standardisation  mandates  are  important  interfaces  between
public  policy  and  the  voluntary  environment  of  standardisation.  Since  1999  the
Commission  has  presented  26  mandates 
the  European  standards
organisations. 13 of the mandates relate to the New Approach, 7 mandates deal with
consumer protection requirements such as for lighters, ladders, the fire-resistance of
nightwear, child safety, etc. The rest of the mandates relates to legislation in the field
of  energy,  environmental  protection  and  the  internal  market  (postal  services).
Standardisation  activities  concerning  high  speed  rail  network  interoperability  have
resulted in 52 European standards, with another 49 progressing. Another example of
a public-interest related mandate is the work requested on humanitarian de-mining.

to 

The  Council  stressed  that  mandates52  should  be  prepared  accurately  and  efficiently
and  that  standardisation  covered  by  mandates  should  be  subject  to  thorough
monitoring53.  To  further  improve  the  scope,  drawing-up  and  management  of
mandates  and  to  complement  a  future  edition  of  the  New  Approach  Guide,  the
Commission  services  have  compiled  and  discussed  with  Member  States  a
preliminary  document  on  the  role  and  preparation  of  standardisation
mandates54.  This  exercise  will  be  followed  up  with  a  similar  document  on  the
monitoring of standardisation mandates.

III.5.

Financing

37.

The  issue  of  the  future  financing  of  European  standardisation  will  increase  in
importance. For industry to continue to contribute, the system will need to maintain
its attractiveness and prove its added value to competitiveness. Except for ETSI,
which  functions  more  on  the  basis  of  members’  contributions,  the  CEN  and
CENELEC system relies heavily on the sales of standards by their national members.
Sales are coming under increasing pressure. The national standards organisations in
Europe  are  now  seeing  their  collections  of  standards  become  not  only  increasingly
similar,  but  also  more  easily  available  electronically.  The  competition  for  sales  is
becoming more acute and transnational. The question is therefore how the European
standardisation system based on decentralised national organisations of different size
will continue to remain financially viable. This issue is becoming even more urgent
with  the  prospect  in  the  next  few  years  of  European  standards  organisations
incorporating  additional  standards  organisations  from  candidate  countries,  all  of
them of a relatively small size.

38.

The  Council  raised  this  issue  and  the  Commission  suggested  that  the  European
standards organisations carry out a joint study on the matter. The three organisations
studied how best to meet the challenges ahead - in different ways, however.

52

53

54

cf. Council Resolution of 7.5.1985, OJ C 136, 4.6.1985.
cf. Council Resolution of 28.10.1999, OJ C 141, 19.5.2000.
SOGS N404.

15

                                                
38.1.

38.2.

38.3.

39.

40.

CEN commissioned a management consultancy to carry out a study on its financing
system. The study revealed that market players essentially finance the CEN system.
In  2000  they  contributed  93%  of  the  total  estimated  cost  of  €700  million.  The
relatively small contributions from the European Community and EFTA (2%) can be
seen  as  good  value  for  money  compared  to  the  relatively  strong  influence  that  EC
and  EFTA  have  in  promoting  their  policies  through  this  system.  The  study  also
makes it very clear that the commitment of the market players, notably industry, will
be conditional on improving the efficiency and user-friendliness of the system. The
study recommended that alternative ways of  financing the  standardisation activities
or new types of standardisation such as Workshop Agreements (see also III.2) have
to be further explored. It said that the diversification of standardisation products and
other  services  was  essential  if  the  CEN  system  were  to  maintain  its  attractiveness.
The  Commission  welcomes  CEN’s  initiative  to  study  their  financing  system  and
stresses that the findings of the study are by-and-large in line with the priorities for
EC/EFTA support to CEN. The Commission, however, considers the role of the CEN
Management Centre of increasing importance, notably to strengthen cohesion within
the expanding system.

The ETSI study  also  makes  it clear that  the major part of  standardisation costs are
paid  by  members  through  their  direct  participation  in  the  work.  ETSI  intends  to
maintain and extend its membership base, to include for instance “internet players”.
To retain this growing membership, ETSI sees the need to ensure high efficiency at
work,  a  broad  range  of  deliverables,  and  openness  to  projects  with  partners
committed to the principles of standardisation, as in the case of the third generation
partnership  project.  The  study  also  states  that  recognition  of  and  support  for
EC/EFTA policy is essential for ETSI members.

CENELEC seems to deal with the same challenges, but took a less proactive attitude
in  addressing  them,  having  decided  to  base  their  reactions  on  the  findings  of  the
study undertaken by CEN.

Since 1990, the European Community and EFTA have focused their support for the
European  standardisation  system  on  the  production  of  harmonised  standards  for
implementing New Approach Directives. From 1998 onwards EC/EFTA financial
support  was  based  on  three  pillars.  Support  was  dedicated,  (a)  to  the  central
secretariats  of  the  European  standards  organisations,  (b)  to  the  quality  of  the
standardisation process, and (c) to the preparation of specific work items. Measures
to  enhance  quality  included  the  work  of  the  "New  Approach"  consultants  and
translations  into  the  less  common  Community  languages.  Specific  work  items
included the production of harmonised standards related to New Approach directives,
European  standards related to  Community  policies  such  as  consumer  protection,  or
standards activities related to European policy initiatives such as e-Europe.

In  2001,  EC/EFTA  support  for  the  European  standards  organisations  was
reviewed  in  order  to  increase  the  coherence,  efficiency  and  visibility  of  European
standardisation,  at  both  European  and  international  levels.  To  better  achieve  these
objectives and in line with sound financial management principles, the Commission
agreed a list of tasks with the three European standards organisations and asked for
regular  reports  on  the  individual  tasks.  The  new  arrangement  sets  priorities  (a)  to
improve awareness building for and planning of new standardisation activities; (b) to
ensure  better  management  of  standardisation  work  and  the  respective  financial
procedures; (c) to implement electronic working tools to speed up the standardisation

16

process and to enable broader participation; (d) to enhance performance and market
relevance  through  the  launch  of  a  benchmarking  programme  between  the  three
European 
information  and
communication  on  the  benefits  of  European  standardisation  in  support  of  EU
policies.

standards  organisations;  and 

increase 

(e) 

to 

III.6.

Enlargement of the EU and the international dimension

41.

42.

43.

44.

Standards, particularly international standards, are able to facilitate trade and market
access, to improve the quality and safety of products and services, and to disseminate
knowledge, technology  and management practices across borders. This is  why they
have become a crucial element in economic integration and world trade. With regard
to European integration, the Council explicitly welcomed in 1999 the  efforts  of  the
candidate countries and their standards bodies to become members of the European
standards organisations55.

in 

the  European  Conference  on  Postal 

Nearly  all  candidate  countries  are  full  members  of  ETSI,  mostly  through  their
established  membership 
and
Telecommunications  Administrations  (CEPT)  and  via  the  direct  participation  of
enterprises  and  administrations  in  ETSI.  In  addition,  the  standards  bodies  of  the
candidate  countries  are  affiliate  members  of  CEN  and  CENELEC  with  the  aim  of
becoming  full  members.  The  national  standards  body  of  the  Czech  Republic  had
become  full  members  of  CEN  and  CENELEC  by  1997.  Since  1999  the  affiliate
members of the European standards organisations have made significant efforts
in preparing for full membership. The most important criteria for qualifying as full
members  are  the  transposition  of  80%  of  European  standards  (ENs)  and  the
acceptance  of  the  copyright  policy  of  CEN  and  CENELEC.  Furthermore,  the
candidate  countries  need  to  put  in  place  a  legal  framework  under  which
standardisation  can  be  carried  out  as  a  voluntary,  non-governmental  activity.
According  to  information  from  CEN  and  CENELEC,  some  national  standards
bodies  of  applicant  countries  have  submitted  their  formal  application  for  full
membership in 2001. More are expected to follow by 2002.

The efforts made by the candidate countries and their standard bodies to become full
members of CEN and  CENELEC  were  accompanied  by  financial  support  from  the
Community’s regional technical assistance programme which aimed at improving the
overall quality assurance systems in the candidate countries (PRAQ) 56. The PRAQIII
programme  expired  by  the  end  of  2000.  Further  financial  support  and  technical
assistance  will  continue  to  be  provided  via  the  PHARE  programme  on  a
country-by-country  basis  under  the  Accession  Partnerships  taking  into  account
the specific needs of the beneficiaries in the respective candidate country.

It is important that the extension of the membership of CEN and CENELEC does not
lag  behind  the  enlargement  of  the  Community.  It  would  be  detrimental  to  the
functioning of an expanded internal market if new Member States had the legislation
in place but failed to be part of the European standardisation system which supports
Community  legislation  and  policies.  Extending  the  membership  of  CEN  and
CENELEC  will  also  require  changes  to  their  internal  procedures.  CEN  and

55

56

Council Resolution of 28.10.1999, §17, OJ C 141 of 19.5.2000.
Programme régional relatif à l'Assurance Qualité (PRAQ).

17

                                                
CENELEC  are  therefore  currently  preparing  recommendations  for  structural
institutional
and  procedural  changes, 
arrangements  and  rules  for  the  Community  which  are  provided  for  in  the  Nice
Treaty. The Commission welcomes these initiatives.

including  consideration  of 

the  new 

45.

46.

46.1.

Internationally  traded  goods  need  international  standards  wherever  possible.
As  standardisation  is  a  mainly  market-driven  activity,  it  is  of  key  interest  to
European  stakeholders  to  promote  the  European  system  and  foster  close  links  with
international standardisation outside Europe. The Commission encourages European
stakeholders to continue their  efforts  in this  respect. Standardisation  and  the  use  of
standards  are  also  part  of  the  Community’s  external  trade  policy57,  and  the
Community must comply with international agreements concerning standards such as
the WTO Agreement on Technical Barriers to Trade (TBT Agreement). In addition,
the Commission services drew up a document on the European policy principles on
international standardisation.58 The document was drawn up  in consultation with
European  stakeholders  in  international  standardisation.  It  recapitulates  and  further
clarifies existing policy in order to achieve better co-ordination and coherence. It can
serve as a reference document and guidance material as requested by the Council.

The  Community  policy  in  relation  to  standards  and  standardisation  plays  a  role  in
international and multilateral negotiations as well as in bilateral and region-to-region
agreements. In principles there are three types of Community activity in this regard.
The  Community  (1)  promotes  a  common  understanding  on  principles  for
international standardisation, (2) encourages the creation of standards-receptive legal
conditions,  and  (3)  it  provides  technical  assistance  to  third  countries  to  help  them
align  their  regulations,  standards  and  conformity  assessment  infrastructure  with
European and international requirements. One of the objectives of the Community’s
technical  assistance  is  to  better  integrate  developing  countries  into  the  world
economy  by  enhancing  their  effective  participation  in  international  standardisation.
Since 1999, a number of activities have been pursued in these fields.

the  principles  concerning 

the  Community’s  views59  on 

The  second  triennial  review  of  the  TBT  Agreement  offered  the  opportunity  to
international
share 
standardisation  with  some  140  countries.  The  Community  explained 
that
international  standards  used  in  legislation  needed  to  be  drawn  up  in  a  spirit  of
openness and impartiality towards any participating nation, as well as transparently.
The Community stressed that international standards had to be coherent, that is, they
should  not  specify  requirements  that  differed  or  contradicted.  Consequently,  the
Community  considers  the  status  of  the  bodies  that  draw  up  international  standards
important.  Constitution  as  an  international  body  is  seen  as  a  condition  for
guaranteeing  impartial  treatment  of  national  positions  and  for  ensuring  consistency
between international standards. During the discussions in the WTO the Community
endorsed the principle of singularity, that is, in each area of standardisation no more
than one international body should be active60.

57

58

59

60

COM(96) 564 final of 13.11.1996.
SEC(2001) 1296 of 26.7.2001.
G/TBT/W/87, 14.9.1998 and Rev. 1, 30.9.1999; G/TBT/W/133, 11.4.2000; G/TBT/W/149, 1.11.2000
cf. G/TBT/W/149, 1.11.2000.

18

                                                
46.2.

46.3.

46.4.

46.5.

By  November  2000  the  second  triennial  review  of  the  TBT  Agreement  concluded,
amongst  other  things,  with  a  decision  on  the  principles  for  the  development  of
international standards61. The Community considered the agreement a suitable way
of  improving  the  implementation  of  the  TBT  Agreement.  Although  not  explicitly
comprising criteria applicable to the bodies that draw up international standards, the
decision  ensures  that  participation  in  a  particular  international  standardisation
activity is open to the relevant bodies of at least all WTO members62. It stresses that
participation should take place, where possible, through one delegation representing
the relevant standardisation activity in the territory of a WTO member. Furthermore,
the  set  of  criteria  ensures  that  international  standards  are  consistent  and  do  not
conflict with each other. From the Commission’s point of view, international bodies
that  operate  on  the  basis  of  national  representation  are  suitable  for  implementing
these principles.

The  role  international  standards  can  play  in  trade  facilitation  and  market  access  is
hampered  if  ignored  by  regulation.  The  Council  also  called  upon  Europe’s  trading
partners  to  introduce  standards-receptive  regulatory  models63.  First  steps  have
been taken to achieve greater convergence with trading partners on this. For instance,
the ASEM64 Standards and Conformity Assessment Meeting agreed upon guidelines
for best regulatory practice. While the application of these guidelines is voluntary,
they  serve  as  practical  references  for  the  ASEM  partners  in  the  fulfilment  of  their
obligations under the TBT Agreement. Amongst other things, the guidelines specify
that regulation, if regulation is needed, should be specified in terms of performance
characteristics and may be met or presumed to be met by compliance with standards
which should be aligned with international standards to the greatest possible extent.

The benefits of standards-receptive regulatory models have also been subject to
discussions in the OECD. In this field, the OECD has analysed and discussed some
of their members’ experiences with regulatory reform. It concluded that international
harmonisation of technical rules, for instance, through international standards may be
one means of avoiding unnecessary barriers to trade. To this end, a new project was
started  in  order  to  explore  the  possibilities  and  preconditions  for  international
harmonisation  and  the  role  standards  can  play  in  the  field  of  telecommunications
terminal equipment65.

The  United  Nations  Economic  Commission  for  Europe  (UN/ECE),  in  particular
its  Working  Party  on  Technical  Harmonisation  and  Standardisation  Policies,
provides an interface between the regulatory and the standardisation community. For
two years, an ad-hoc  group of  experts on standardisation and regulatory techniques
has been working on an international model for technical harmonisation via the
use of international standards66. This concept allows governmental co-operation on
essential legal requirements, if regulations are needed for certain products or groups

61

62

63

64

65

66

Annex 4 of G/TBT/9, 10.11.2000.
cf. Council Resolution point 39, OJ C 141, 19.5.2000, stressing that interested parties such as workers’,
consumers’ and environmental interest groups should be fully involved in the standardisation process at
all relevant stages.
cf. Council Resolution point 34, OJ C 141, 19.5.2000.
The  Asia-Europe  Meeting  consists  of  the  15  Member  States  of  the  EU  and  10  Asian  states:  Brunei
Darussalam, China, Indonesia, Japan, Korea, Malaysia, Philippines, Singapore, Thailand, Vietnam
TDTC/WP(2001)11 Rev. 1.
UN/ECE/TRADE/WP.6/2000/8 .

19

                                                
47.

48.

49.

of  products.  Governments  would  also  identify  the  relevant  international  standards
and  conformity  assessment  procedure  applicable  to  meet  the  common  regulatory
objectives.

With regard to the interface between regulation and standardisation and in respect of
the  independence  of  the  respective  parties,  the  Council  stressed  the  need  to  ensure
that European interests be coherently presented in international standards bodies and
intergovernmental  fora67.  This  requires  appropriate  mechanisms  for  exchange  of
information and consultation between the relevant parties. The Commission services
have  started  to  operate  a  newsgroup  for  exchange  of  relevant  information  with
senior officials from Member States, EFTA and the candidate countries. There is also
a  regular  exchange  on  international  matters  with  the  Advisory  Group  of  Senior
Officials  on  Standardisation  and  Conformity  Assessment  and  with  the  Advisory68
Committee under Directive 98/34/EC.

Closer  working  relationships  have  also  been  established  with  the  European
standards  organisations.  Relevant  international  developments  are  very  attentively
followed  by  ETSI.  CENELEC  has  created  a  platform  for  their  members  which  is
active  in  international  standardisation.  CEN  has  created  a  group  which  regularly
meets  to  discuss  international  issues.  Commission  staff  are  invited  to  participate  in
this group with observer status. It should be noted that the three European standards
organisations have also created closer links with regional standards entities in South
and  Latin  America,  such  as  with  AMN, 
the  Mercosur  Association  for
Standardisation.

if  applicable.  The  Council  explicitly  referred 

While reaffirming Europe’s strong commitment to international standardisation – the
Council stressed the exemplary nature of the cooperation agreements between the
European  standards  organisations  and  their  international  partners  –  the
European  parties  need  to  take  account  of  Community  legislation  and  national
requirements, 
to  essential
requirements  of  Community  legislation  and  national  requirements  in  the  non-
harmonised field, such as occupational health and safety provisions69. This results in
case-by-case consideration of whether and to what extent, for instance, a harmonised
standard can be based on relevant international work. For CEN and CENELEC this
assessment is carried out under their framework arrangements with ISO and IEC, the
Vienna  and  Dresden  Agreement,  respectively.  In  the  telecommunications  field,  a
cooperation agreement has been concluded between the ITU and ETSI. To facilitate
the transposition of international standards and to allow for a maximum of coherence
it  is  considered  important  that  standards  are  written  in  a  modular  fashion,  and  that
standards treat product-related aspects separately from related processes, production
methods and environmental requirements, if applicable.

67

68

69

Council Resolution of 28.10.1999, point 37, OJ C 141, 19.5.2000.
The Advisory Committee under Directive 98/34/EC meets twice a year with its participating observers,
the national and European standards bodies.
Point 38 of the Council Resolution of 28.10.1999, OJ C 141, 19.5.2000.

20

                                                
IV.

50.

CONCLUSION

This  document  is  a  mid-term  report  in  response  to  the  1999  Resolutions  of  the
Council and the European Parliament. It describes a number of initiatives that have
taken  place  or  are  ongoing  with  a  view  to  further  improving  the  European
standardisation system, to make it fit for extended membership and to promote it at
international level. The Commission proposes to discuss this report with the Council
and  the  European  Parliament  with  a  view  to  receiving  opinions  and  guidance
concerning further work and reporting.

21

Annex 1

Number of European Standards as of 31.10.1999 and 30.6.2001

European Standards

mandated

Not Mandated

9000

8000

7000

6000

5000

4000

3000

2000

1000

0

ETSI
(31/10/99)

ETSI
(30/6/01)

mandated

Not Mandated

114

2269

203

3051

CEN
(31/10/99)

CEN
(30/6/01)

717

5462

1029

6862

CENELEC
(31/10/99)

CENELEC
(30/6/01)

754

3309

790

3795

22