Report from the Commission to the Council and the European Parliament - Efficiency and accountability in European standardisation under the new approach
Date: 1998-05-13
Institutions: European Commission
Subjects: EU industrial policy, European standard, harmonisation of standards, standardisation, technical regulations

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

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Brussels, 13.05.1998 
COM( 1998) 291 final 

REPORT FROM THE COMMISSION TO THE COUNCIL 
'AND THE EUROPEAN PARLIAMENT 

EFFICIENCY AND ACCOUNTABILITY IN 
EUROPEAN  STANDARDISATION 
UNDER THE NEW  APPROACH 

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CONTENTS 

INTRODUCTION:  THE NEED FOR CONSTANT REVIEW 

I. 

THE SPECIFIC FEATURES OF THE NEW APPROACH IN RELATION TO 
STANDARDISATION 

? 

The Relationship Between the New Approach and Standardisation 
The Need for Accountability 
The Role of National Standards Bodies 
The Use of Publicly Available Specifications (PAS) 

II. 

THE  SEARCH FOR EFFICIENCY 

The concept of Efficiency 
Timetable for the Standardisation Procedure. 

III. 

PROPOSALS FOR IMPROVING THE EFFICIENCY OF THE EUROPEAN 
STANDARDISATION SYSTEM 

Management of the standardisation process. 
The role of public authorities 
A Single European Standardisation Body, or More Competition? 
Improving Awareness 
Financial Support to European Standardisation 

IV.  CONCLUSIONS 

Annex: Progress in standardisation programmes 

1 

2 

2 
4 
4 
5 

6 

6 
8 

9 

9 
11 
12 
13 
14 

15 

16 

INTRODUCTION:  THE NEED FOR CONSTANT REVIEW 

1. 

2. 

3. 

4. 

European  standards  play  a  vital  role  in  the  proper  functioning  of  the  Single 
Market.  At  its November  1997  meeting,  the  Council  for  the  Internal  Market 
asked  the  Commission  to  "prepare  a  report  on  the  efficiency  of  European 
standardisation,  in  co-operation  with  the  European  and  national  standards 
organisations, and  with the appropriate  European-level  committees".  During 
subsequent  discussions,  and  in  particular  at  the  occasion  of  the  informal 
meeting  of  Ministers  for  the  Internal  Market  held  in  Cambridge  in  February 
1998, it was agreed that the Report should focus  on the New Approach. 

This Report was produced  in response to that request.  It was prepared  in close 
collaboration with Member States, European and national  standards bodies and 
other interested parties. 

Efficiency  in European  standardisation  has  been  brought  to  political  attention 
at  various  occasions  in  the  recent  past. 
In  its  Action  Plan  for  the  Single 
Market1,  the  Commission  noted  that  considerable progress  has  been  made  in 
the area of standardisation,  but that there  is no room for  complacency.  In its 
Communication  on  "the  impact  and  effectiveness  of  the  Single  Market"2,  the 
Commission  noted  that  "some  problems  have  been  experienced  due  to  delays 
in  the  delivery  of  standards,  but  that  the  standards  bodies  have  made  great 
strides in adapting to the surge in demand put upon them.  The onus will be on 
European  industry,  if it wants the  harmonised  standards, to provide  sufficient 
resources to finish the job." 

A  recent  report  prepared  by  Denmark3  and  presented  to  the  Internal  Market 
Council highlighted the fact that a significant  number of standards for the New 
Approach  has  still  to  be  delivered  and  that  the  average  development  time  for 
standards  remains  too  long  in  most  cases.  The  Commission  welcomes  the 
initiative  taken  by  Denmark,  as it  allows  for  verifying  where  further  progress 
can be made. 

This  Report  describes  the  relationship  between  the  New  Approach  and 
standardisation,  and emphasises the need  for  accountability  in  standardisation. 
It  then  indicates  how  efficiency  can  be  assessed,  and  formulates  a number  of 
proposals for improving efficiency.  Its conclusions are that 

> 

the basic concepts of the New Approach  and of European  standardisation 
have proved  their validity for  the development of the Single Market, 

CSE(971)lfinalof4June  1997. 
COM(96)520 final  of 30 October  1996. 
The  European  standardisation  work:  analysis  and  recommendations  for  efficiency 
Report  prepared  for  the  Danish  Agency  for  Trade  and  Industry,  October  1997. 

initiatives. 

1 b 

> 

> 

the  management  of  the standardisation process  and  transparency  can be 
improved, which is a task mainly for  the European standards  bodies, 
standardisation  as  a  voluntary  system  has  its  limitations  and  public 
authorities have the responsibility to create incentives and a framework  in 
which standards can be developed in an efficient way. 

I. 

THE  SPECIFIC  FEATURES  OF  THE  NEW  APPROACH  IN  RELATION  TO 

STANDARDISATION 

The Relationship Between the New Approach and  Standardisation 

5. 

The principles  of the New Approach to technical  harmonisation  and  standards 
were laid down in  1985 (OJEC C 136 of 4.6.1985). 

large 

compatibility, 

New Approach  and New Approach-like directives 
have been adopted, covering a range of products as 
toys,  construction  products, 
diversified 
as 
electro-magnetic 
machinery, 
telecommunications  terminal  equipment,  satellite 
earth 
equipment,  medical  devices, 
station 
packaging, etc. 

The  New  Approach  deals 
families  of 
with 
products  (e.g.  machinery, 
construction 
products, 
toys,  packaging,  etc),  or 
with 
risks 
horizontal 
(e.g. electro-magnetic 
compatibility). 
It  defines 
the  essential  requirements 
that  products  must  meet 
when  they  are  put  on  the 
it  does  not 
market,  but 
indicate 
technical 
means  by  which  to  meet  the  requirements.  With  the  exception  of  the 
Construction  Products  Directive,  New  Approach 
leave 
manufacturers  the  choice  of  technology.  The  New  Approach  directives, 
therefore, allow for a high degree of technological  flexibility. 

Products 
intra-Community trade. 

A list is attached in Annex* 

directives 

represent 

covered 

17% 

the 

of 

To  facilitate  the marketing  of products, the New Approach foresees  the  use of 
European  standards  as  a  fast 
to  meet  essential  requirements. 
track 
Compliance  with  such  standards  remains  voluntary,  but  provides  definite 
advantages to manufacturers  who place products on the market. 

r 

> 

Products  meeting  standards  have  a presumption  of  conformity  with  the 
essential requirements of the directives. 

In  most  New  Approach  directives,  standards  permit  a  wider  choice  of 
conformity  assessment  procedures 
instance, 
compliance  with  European  standards  can  allow  a manufacturer  to  declare 
conformity  with the Directive without third party  intervention. 

for  manufacturers.  For 

Standardisation  is,  by  its  nature,  a  voluntary  process  carried  out  within 
independent organisations.  Parties will  only  participate  in the process  if they 

perceive  a value  in doing so.  The incentive to develop standards  is mainly  an 
economic  one.  Standards  are  adopted  on  the  basis  of  consensus,  defined  by 
standards  organizations  as  the  absence  of  sustained  objection  from  major 
parties. Compliance with standards remains voluntary. 

The New Approach has, however, added a new dimension to  standardisation. 

>  Standards bodies are not entirely free to decide what standards to develop. 
They  are  required  to  meet  essential  requirements  of  large  legislative 
programmes, to  develop  a coherent  set  of  standards  that  cover  aspects  of 
the public  interest, such as safety.  The standards themselves  must  remain 
flexible  enough  to  allow  for  technological  progress  while,  at  the  same 
time,  providing  a  sufficiently  precise  level  of  specification  to  ensure 
smooth implementation of the directives. 

>  The New Approach  also  introduced  institutional  changes.  Responsibility 
for  presenting  European  standards  as  "harmonised"  standards  under  the 
New  Approach  has  been  given  to  the  European  standards  organisations. 
At  the  same  time,  public  authorities  have  committed  themselves  to  not 
insisting on approving the technical content of such standards; no positive 
decision  is  required  by  which  authorities  approve  the  standards,  even  if 
previously such technical aspects were subject  of regulation. 

7. 

In  certain  areas,  where  the  market  is  not  sufficiently  interested  in  European 
standardisation,  the  pproach  taken  by  the  European  legislator  has  not  itself 
given  rise  to  a  sufficiently  strong  incentive  to  develop  standards  at  the 
European  level.  The policy  objective  of  the  free  movement  of goods  should 
not be delegated to the voluntary standardisation  level, as standardisation  can 
only solve technical questions. 

>  For instance, the  Construction Product  Directive  (CPD) does not  create  a 
sufficiently  strong  incentive  to  elaborate  so-called  European  harmonised 
standards. As long as no such standards exist, national technical  regulation 
continues  to  exist,  and  Member  States  can  even  adopt  new  regulation. 
Consequently,  if the market is not prepared to elaborate standards, the  free 
movement  of  construction  products  is  not  guaranteed  by  harmonisation 
and remains governed by the principles of the Treaty. 

>  Another  often-cited  example  of 

the  "failure"  of 

the  European 
standardisation  system  is  the  case  of  plugs  and  sockets.  These  are 
excluded  from 
the  scope  of  the  Low  Voltage  Directive,  and  no 
standardisation  mandate  has  ever  been  given  to  CENELEC.  Given  the 
existence  of  vested  national  interests,  it  is  unlikely  that  on  a  mere 
voluntary  basis  standardisation  will  take  place.  If  harmonization  of  plugs 
and sockets should take place, a political decision is likely to be required. 

The  Need  for  Accountability 

8. 

> 

> 

if 

is 

rules 

legal 

relating 

to  policy 

to  questions 

the  possibility  for  all  interested  parties  to  participate 
effectively 
fair 
conditions; 

The  General  Guidelines  for  Cooperation  and  the  Council 
Resolution  on  the  Role  of  European  Standardisation  reflect 
principles of accountability  in: 

institutional 
such  as 
membership  of  the  standards  organisations,  access  for 
European-based 
setting 
interest  groups 
activities, dialogue with the public authorities, etc.; 

The  New  Approach  charges  European  standards  organisations  to  elaborate 
technical  specifications  the  use  of which provides  a presumption  of  conformity 
with 
requirements. 
This  can  only  be 
the 
justified 
standardization 
truly 
system 
and 
open 
if 
transparent, 
the  standard 
is 
supported  by  all 
interested 
major 
if 
parties, 
and 
is 
the  standard 
a 
applied 
in 
way 
uniform 
throughout 
the 
Community. 
These 
requirements  are 
referred  to  as  the 
accountability  of 
European  standardisation.  Principles  of  accountability  have  been  laid  down  in 
the  General  Guidelines  for  Co-operation  between  CEN  and  CENELEC  and  the 
European  Commission,  adopted  in  1984  (currently  under  revision)  and  in  the 
Council  Resolution  of  18 June  1992  on  the  role  of European  standardisation  in 
the  European  economy  (C  173 of  9.7.1992). 

the  need  to  verify  consensus  through  national  public 
enquiry, the establishment  of consensus through  national 
representation,  and,  in  certain  countries,  the  need  to 
make standards available  in the national  language; 

the  obligation  for  national  standards  bodies to  transpose 
European  standards  in an  uniform  way, and to  withdraw 
conflicting  national standards. 

standardisation  work,  under 

in 

> 

Efficiency  and  accountability  must  be  balanced. 
It  is  essential  that  all 
interested  parties  have  the  possibility  of  fully  considering  the  substance  of  a 
draft  and  of  expressing  their  views  during  the  public  inquiry,  with  associated 
comments  taken  into  consideration,  even  if this has an  impact  of  efficiency. 

Accountability  determines  to  a  large  extent  the  role  f  national  standards 
organisations  and  of the possible  use of Publicly  Available  Specifications. 

The  Role  of National  Standards  Bodies 

Consensus  is  determined  on  the  basis  of  national  representation.  National 
standards  bodies  thus  play  an  essential  role  in  expressing  the  national  position 
and  they  will  continue  to  play  this  role.  In  addition,  national  bodies  are  a  link 
between  market  players,  in  particular  SMEs,  and  European  standardisation, 
and  provide  access  to  and  advice  on  European  standards,  as  well  as  secretarial 
support  to  Technical  Committees.  The  Commission  considers  that  national 
system. 
bodies  are  an  essential  part  of 

standardisation 

the  European 

However,  national  standards  bodies  should  also project  themselves  as  being 
part  of  a  common  European  standardization  system,  serving  common 
interests.  This 
international 
in 
standardisation. 

their  relations  with 

is  particular 

true 

Nevertheless, the possibility  of providing  secretariats  for technical  committees 
and  similar  bodies  by  European-level  sectoral  associations  (such  industrial 
federations)  should  be  considered  as  an  alternative  to  national  standards 
bodies.  This  possibility  should  not  affect  the  approval  procedures,  which 
remain with the national standards bodies. 

The Use of Publicly Available Specifications  (PAS) 

10. 

11. 

Some  Member  States  have  suggested  examining  whether,  in  the  absence  of 
European  standards, PAS  adopted  by private  consortia  of companies,  or  other 
documents of CEN, CENELEC  and ETSI, can be used for the New Approach, 
even  if they  do  not  have  the  status  of  standards.  The Commission  considers 
that  PAS  and  similar  documents  can  play  a  useful  role  as  input  to  the 
standardisation process.  Where PAS reflect  market practice, it may be  useful 
to  verify  through  the  standardisation  process  whether  that  practice  may  meet 
with  overall  consensus  and  thus  become  a  full-fledged  standard.  The 
Commission  welcomes  the procedures  developed  by  CENELEC  and  ETSI  to 
present PAS for approval as European standards. 

The advantage  associated  with the use  of such documents  is the  greater  speed 
with which they  can  be  adopted,  compared  with  standards.  The  difference  in 
speed is due mainly to the absence of the need to seek a general consensus that 
is characteristic  of the standardisation  process.  Consensus  emerges  only  from 
those who consent to the initiative.  For this reason, the direct use of PAS and 
similar documents under the New Approach  has its limitations. 

PAS  lack  the  democratic  legitimacy  and  accountability  offered  by  the 
standardisation  process.  Furthermore,  the  procedural  guarantees  on  the 
implementation  of  such  documents  are  less  stringent  compared  with  those 
applicable  to  standards.  A  number  of  practical  questions  would  have  to  be 
resolved  in order to give greater recognition to PAS under the New  Approach, 
for  example:  Who  could  write  PAS?  Should  PAS  providers  be  formally 
"recognised"?  By  whom? 
Should  PAS  become  a  new  category  of 
specifications  under  Directive 83/189?  Should  public  authorities  approve 
individual  PAS?  Could  there  be  conflicting  PAS?  How  should  workers, 
consumers,  environmental  interests  and  SMEs  be  involved  in  the  elaboration 
of PAS? 

In any  case, Directives  would  have to  be modified  in order to  assimilate  such 
documents to European standards. 

Thus, although  shortcomings  in  accountability  impede  the  direct  use  of  PAS 
under  the New  Approach,  the  use  of  PAS  as  an  input  to  the  standardisation 
process  offers  interesting perspectives  that  CEN, CENELEC and ETSI  should 

exploit. 

IL 

THE  SEARCH FOR EFFICIENCY 

The Concept of  Efficiency 

12. 

An  efficient  standardisation  system  should  provide  high-quality  standards, 
deliver  them  in  a  timely fashion,  and  the  standards  themselves  should  be 
effectively  used  in the market.  Efficient  standardisation  is, therefore,  relevant 
to public authorities, industry and the social partners. 

•  Public  authorities  are  interested  because  standardisation  is  carried  out 
within  the  policy  framework  of  the  internal  market.  Standards  need  to 
provide  a sufficient  degree  of precision  in order to  allow the  assessment  of 
compliance  with  Community 
the  capacity  of 
standardisation  to complete the internal  market  affects  the credibility  of the 
public  policy  objective. 
Inevitably,  criticisms  of  shortcomings  in  the 
standardisation  system  will  be  raised  at  the  political  level.  A  fair  balance 
must,  however,  be  maintained  between  efficiency  and  respect  for  the 
principles of accountability. 

law.  Conversely, 

•  The interest  of industry  in the efficiency  of standardisation  arises first from 
the  access  that  standards  give  to  the  market-place  in  regulated  technical 
areas. 
to 
standardisation  and  wishes  to  see  the  greatest  possible  return  from  its 
investment. 

itself  devotes  substantial 

Secondly, 

resources 

industry 

•  Workers,  consumers  and  environment  organisations  are  interested  because 
standards  quantify  the  level  of  protection  that  essential  requirements  are 
intended to provide. The accountability  of the standardisation system and its 
capacity  to  deliver  standards  providing  a  high  level  of  protection  are 
therefore  of prime importance to them. 

13. 

The first objective  of European  standards under  the New  Approach  is, indeed, 
to  meet  the  essential  requirements  of  the  Directives.  Efficiency  should, 
therefore  in  the  first  place  be  assessed  on  the  basis  of  whether  standards  are 
adequate  to  meet  them.  It  makes  no  sense  to  adopt  a  lot  of  standards  if  they 
are  insufficient  to  give  presumption  of  conformity.  Industry  is,  in  any  case, 
primarily interested  in the practical results of using standards rather than in the 
efficiency  of  the  process.  However,  a  cost-benefit  analysis  of  European 
standardisation  is  still  missing.  The  Commission  stands  ready  to  support 
initiatives  to  close  this  methodological  gap.  Such  an  analysis  should  also 
encompass  benchmarking  the  impact  of  standardisation 
in  Europe  with 
standardisation 
in  other  regions  of  the  world,  including  its  effect  on 
competitiveness. 

14.  An analysis based  on the number  of standards adopted  is simply  not  sufficient 
to  assess  efficiency,  as  the  number  does  not  reflect  their  impact.  As  an 
illustration  of  this  point,  the  programmes  of  standards  for  New  Approach 

Directives  vary  widely  in  size,  independently  of  the  economic  impact  of  the 
Directives  to  which  they  refer.  For  instance,  in  each  of  the  Machinery  and 
Pressure Equipment  areas, there are programmes  of over  700 standards, whilst 
for  the  economically  comparable  area  of  medical  devices,  only  200  standards 
are foreseen.  For the  construction  area,  where  a full  programme  is  still  under 
preparation, some  1500 standards are expected. 

15. 

As a pragmatic approach to improving efficiency,  reference  can be made to the 
reduction  of  delays  that  occur  in  the  standardisation  process.  The  chart  that 
follows  describes the stages of standardisation  from  elaboration of mandates to 
the  transposition  of  European  standards  as  national  standards.  It  also  shows 
the  actors  involved  and  indicates  the  average  periods  needed  for  each  stage4. 
Although  the  nature  of  standardization  is  different  in  CEN,  CENELEC  and 
ETSI  \  comparing  the  time  taken  for  different  stages  of  the  standardisation 
process  can,  at  any  rate,  be  used  as  a  benchmark  to  identify  potential 
weaknesses and to compare methods. 

16. 

It may be concluded  from the chart that: 

•  Several  actors  are  involved:  the  Commission,  national  authorities,  the 
European  standards  organisations  and  the  national  standards  organisations. 
Efforts  to improve efficiency  can be made by each of them. 

•  Procedures  related  to  the  New  Approach  (e.g. agreement  on  the  terms  of 
mandates) and to standardisation itself (e.g. acceptance of a mandate, public 
enquiry,  voting  by  national  representation,  and  transposition  of  European 
standards  at  national  level)  in  themselves  take  several  months.  These 
procedural  periods  are  inherent  in  the  system,  even  if  improvements  are 
possible. 

•  Substantial  differences  exist between  CEN,  CENELEC  and ETSI,  covering 
an average standards elaboration period ranging from  24 to 75 months.  The 
differences  can  be  explained  in  part  by  differences  in  the  standardising 
process,  and  may  also  indicate  a  potential  scope  for  further  reductions; 
however,  determining  the  scope  for  such  reductions  will  require  a  more 
detailed analysis. 

The periods  indicated  do not necessarily  add  up.  Activities take place in parallel  and  in many  cases 
standardisation  mandates cover ongoing standardisation  activities 

As an example, the making of technology-neutral  specifications  (the usual  practice  in CEN)  is more 
difficult  and  time-consuming  than  selecting  among  available  technologies  (the  usual  practice  in 
ETSI).  Standardization  in  CENELEC  is characterised  by  the  high  share  of  international  standards 
adopted  as European  standards. 

Timetable  for the Standardisation  Procedure. 

Commission  draws  up a mandate,  in consultation  with 
83/189, and  in construction  CPD, Committee. 

6 - 12  months 

Commission  transmits  mandate  to European  standards 
organisations (ESO) 

2 months 

ESO accept the mandate 

ESO elaborate a (joint)  programme 

Only  in the case of the CPD: 
Commission  accepts  programme 

Technical  Committee (TC) elaborates draft  standard 

ESO  and  national  standards  bodies  (NSO)  organise 
Public enquiry 6 

TC considers  comments 

NSO vote/ESO ratify  6 

ESO transmit references  to the Commission, 
Including: translation  titles 

Commission  publishes the  reference 

NSO transpose European  standard. 

CEN: 2.5  months 
CLC: 6 months 
ETSI:  1-3  months 

CEN: 6-18  months 
CLC:  1-9  months 
ETSI: 6-12  months 

2 months 

CEN: 35 months 
CLC:  12-24  months 
ETSI:  15 months 

CEN: 6 months 
CLC: 6 months 
ETSI: 4 months 

CEN:  19 months 
CLC: 4 months 
ETSI: 5 months 

CEN: 4 months 
CLC: 7.5  months 
ETSI: 2 months 

CEN: 5 months 
CLC: 3 months 
ETSI:  insufficient 
experience 

4 months 
CTR7:  up to  18 months 

CEN:  12 months 
CLC:  12 months 
ETSI: 9-12  months 

6  Excluding secretarial handling in CEN, CENELEC and ETSI. 
7  Common Technical Regulation, adopted on the basis of ETSI European Standards. 

III. 

PROPOSALS  FOR 
STANDARDISATION  SYSTEM 

IMPROVING  THE  EFFICIENCY  OF  THE  EUROPEAN 

Management of the standardisation  process. 

17. 

1 

1 

1 

f  ' 

i*n  i M al 

1992  WKB& 

i9M  EBW 

CEN  -  Averag 

T 
1991 HH 

9 davelopment  time  standards 

ETSI 
been 

The  management  of  the  standardisation  process  is,  in  the  first  place,  the 
responsibility  of  the  European  standards  organisations  and  their  members. 
CEN,  CENELEC  and  ETSI  have  for  a number  of  years  been  implementing  a 
policy  of  increasing  efficiency.  As  an  illustration,  since  1993,  the  average 
developme 
nt  time  for 
standards 
in 
has 
reduced 
from  45  to 
28 
months. 
CENELE 
C  has  a 
developme 
nt  time  of 
between 
24 and 48 months.  CEN has itself set a target of 47 months (in  1991 it needed 
135 months); at present  it requires  75 months  (see  chart).  What matters  more 
than the average standards  elaboration  time  is the definition  of realistic  time 
schedules in standardisation programmes,  the capacity to respect them and the 
transparency in their implementation. 

T 
1996 HS 

1997 |HE 

OTreatnwnt Corrvnants 

1995  EMM 

|B Technical work 

u 

|-*1 

^Enqury 

•  Voting 

1 

'I 

1  -

140 

100 

120 

1 

1 

1 

1 

40 

20 

60 

80 

a 

1 

Detailed  reports  prepared  by  CEN,  CENELEC  and  ETSI,  explaining  the 
measures  taken  or  intended  to  improve  efficiency,  and  their  position  on  the 
suggestions made by Ministers during their meeting  in Cambridge  in February 
1998,  will be presented  to Member  States.  Annual  reviews  should  take  place, 
in co-operation with the European standards  organisations. 

18. 

Some  Member  States  have  suggested  that  CEN,  CENELEC  and  ETSI  should 
consider a more systematic use of voting by qualified  majority  to speed up the 
adoption  of European  standards.  Under  the  rules  of  standardisation,  standards 
are  based  on  consensus,  i.e.  the  absence  of  sustained  objection  from  major 
parties.  Consensus  is  the  guiding  principle  leading  up  to  the  vote  on  a  final 
proposal, based on national representation. A standard  is adopted  if a  qualified 
majority  of national votes is reached. 

Voting at an earlier stage will not necessarily  speed up standardisation, but can 
do  so  in  certain  cases.  Much  will  depend  on  the  skills  of  the  Chairman  of  a 
Technical  Committee. Proceeding  at an early  stage to voting might hamper the 
standardisation  process by making  it more political. Diverging  opinions  might 
be made more  visible, and arbitration between different  interests may  become 

more  complicated.  Furthermore,  those  who  fear  to  be  defeated  may  organise 
opposition  to  a  standard.  On  the  other  hand, "voting  or  indicative  voting  can 
speed  up  the  process,  for  instance  where  vested  interests  block  progress  and 
show  no  willingness  to  compromise,  or  where  hidden  commercial  interests 
block  progress.  In  such  cases,  voting  can  create  transparency  and  unlock 
situations.  The  European  standards  bodies  should  carefully  consider  the 
possibility  of speeding  up  the standardization  process  by  having  recourse  to 
voting at an earlier stage. 

19. 

CEN  and  CENELEC  should  consider  further  opening  their  structures  to 
representative European-based interested parties,  such as workers, consumers, 
environmental  interests  and  industry,  allowing  them  to  participate  in  strategic 
discussions  and  the  elaboration  of  policy.  In  contrast  to  ETSI,  in  CEN  and 
CENELEC  policy  decisions  and  strategic  discussion  remain  limited  to  their 
Boards and national  standards bodies.  Especially in CEN, which covers a very 
broad  number  of  industrial  domains,  there  is  no  visible  forum  for  the 
consultation of stakeholders on strategic aspects of standardisation. 

to 

the  organisations  representing  European  consumers  and 
According 
European  workers,  improvements  can  be  made  in  a  number  of  national 
organisations,  mainly  as  regards  representation  and  clear  procedures  for 
establishing  a  national  consensus.  Environment  organisations  feel  that  they 
are  not  sufficiently  represented  in  the  standardisation  process,  which  is 
considered to be mainly industry  driven and market  led. Their fear  is increased 
in the  light  of  the  shift  from  national  to  European,  international  and  informal 
standardisation  levels.  The  Commission  considers  that  the  participation  of  all 
interested  parties  is  important  for  consensus  building  and  accountability. 
Possibilities for  collective interests to participate  in European  standardisation 
in a balanced way should  be the subject  of further  discussion  and  monitoring 
in the enlarged 83/189 Committee. 

20. 

Use  of  electronic  means  of  communication  is  an  important  contributor  to 
In  1997,  the  Commission  gave  a  contribution  of  1.6MECU, 
efficiency. 
covering  50%  of  costs  of  participating  national  CEN  members,  to  the  INES 
(CEN  Internet  Network  for  European  Standardisation)  project.  INES  intends 
to  promote  the  use  of  modern  tools  of  communication. 
INES  covers  four 
areas: Electronic  Committee processes, Document  Management  Service, WEB 
Information  Service,  and  Standards  Deliveries  Service. 
Electronic 
standardisation  and  such  means  of  information  dissemination  already  exist  in 
ETSI  and are being  implemented  in CENELEC.  In this effort,  no  Community 
support  was  requested.  However,  co-operation  should  enhanced  between 
CEN, CENELEC and ETSI. 

21. 

New Approach Directives  state that presumption  of conformity  is linked to the 
use  of  "national  standards 
transposing  European  standards".  National 
standards  bodies  should  be  aware  of  the  importance  of  European  standards 
being  presented  to the  market,  and  should  therefore  handle  transposition  with 
all  necessary  urgency.  Transposition periods for  European  standards  should 
be  set  as  short  as  is  reasonably  possible  and  time  limits  should  be  better 

10 

respected.  Delays  in  transposition  by  national  standards  bodies  should  not 
diminish  the  benefits  of the New  Approach  for  manufacturers.  If  such  delays 
occur,  and  since  European  standards  have to  be  transposed  in  a uniform  way, 
a  manufacturer  can  rely  on  any  national  standard  transposing  a  European 
standard or directly on the European  standard. 

22. 

in 

the  European  standards  organisations 

The  quality  of  standards  and  the  efficiency  of  the process  can  be  improved  if 
the  work 
is  preceded  or 
complemented  with  well-targeted  pre-normative  research  actions.  On  the  one 
hand,  pre-normative  research  promotes  the  development  of  new  standards 
while  on  the  other  hand  the  standards  can  better  disseminate  the  results  of 
research.  As  announced  in  its  document  "Research  and  standardisation"8,  the 
Commission  will  continue  promoting  pre-normative  research  in  close  co 
operation  with  the  European  standards  organizations  and  the  economic 
operators involved in standardisation. 

The role of the public  authorities 

23. 

Some  Member  States  have  suggested  that  mandates  should  be  made  more 
precise.  Mandates  have  been  agreed  with  Member  States  through  the 
83/189 Committee.  The  only  area  where  the  work  of  mandating  and 
programming  is  not  yet  completed  is  in  construction,  although  all  final 
mandates are expected by mid-1998.  The elaboration  of final  mandates for the 
Construction Products Directive was in itself a difficult  exercise, mainly due to 
the  need  to  identify  national  technical  specifications  that  should  become 
subject  of  European  standardisation.  Therefore,  the  average  time  for  their 
elaboration  was much  longer than for  other areas. Similarly, the elaboration  of 
standardization  programmes  by  CEN  is  a  long  process.  Where  mandates  are 
given,  it  is  important  to  integrate  essential  issues,  such  as  the  protection  of 
safety, health and environment. 

If  in  the  course  of  standardisation  work  a  need  arises  for  more  precise 
indications  regarding  the  terms  of  the  related  mandates,  the  European 
standards organisations should raise that question  with the Commission, who, 
in co-operation  with the relevant  Committees,  will  address  such questions  and 
clarify  the  mandate.  Questions  can  also  be  raised  directly  in  the  various 
Committees  and  groups  in  which  the  European  standards  organisations  are 
invited  to  participate.  However,  when  interested  parties  cannot  agree  on 
technical  specifications,  the  Commission  should  not  be considered  as a  "court 
of appeal" to make technological  choices. 

24. 

Standardisation  programmes,  containing  priorities  and  timetables,  have  been 
examined  by the  83/189  Committee  and  sectoral  committees  or  expert  groups 

11 

25. 

26. 

in  place  for  all  the  New  Approach  directives8.  The Commission  and  national 
authorities  should  reinforce the monitoring  of progress  in the  implementation 
of programmes.  Progress  in  standardisation  under  the  New  Approach  will 
also be covered in the Internal Market  Scoreboard. 

A recent  survey by the Commission  services has revealed that the operation of 
Community  Committees  and  expert  groups 
in  several  cases  could  be 
improved.  The  Commission  intends  to  address  the  efficiency  of  Committees 
and  expert groups  in  a  Report  to  be further  examined  in  collaboration  with 
Member  States.  In  the  management  of  committees,  sufficient  periods  should 
to  Member  States  to  adopt  a  national  position,  and  national 
be  left 
administrations  should  ensure  that  co-ordination  amongst  all 
interested 
national  services  takes  place  in  due  time.  More  electronic  transmission  of 
documents,  as  well  as  electronic  consultations  between  the  Commission  and 
Member  States,  should  take  place,  the  more  given  the  continual  budgetary 
constraint on the operation of such Committees and expert groups. 

The  participation  of  public  authorities  in  the  standardisation  process 
_. 
raises  the  question  of  the  balance  between  their  different  roles:  on  the  one 
hand,  they  participate  in  the  standards  making  process  at  the  same  level  as 
industry, workers, consumers, SMEs, environment  interests; on the other hand, 
they  act  as an authority  with  a duty  to protect  the public  interest.  Once  public 
authorities have agreed on a mandate, the search for  technical solutions  should 
in  principle  be  left  to  the  interested  parties.  In  certain  areas  such  as 
environment,  health  and  safety,  the participation  of public  authorities  on  a 
technical  level  is important  in the standardisation  process.  Efficiency  can  be 
improved  if the  technical  expertise  of public  authorities  is present  at the  level 
of  working  groups.  Furthermore,  when  a mandate  is  given,  public  authorities 
should examine draft  standards, particularly  when submitted to public  enquiry, 
in order to ensure that the draft  standards meet the requested  safety,  health and 
environmental  levels. 

27. 

The  Commission  will  take practical  measures  to  improve  the publication  of 
references of European standards  in the Official Journal,  a condition  for  such 
standards  to  become  effective  under  the  New  Approach.  The  electronic 
sending  of  titles  and  references  for  publication  of  references  of  European 
standards  in  the  Official  Journal  is  an  important  instrument  to  make  further 
progress.  In  particular,  CEN  should  accelerate  the  translation  of  titles  of  the 
standards into the Community  languages. 

A Single European  Standardisation  Body, or More  Competition? 

28. 

There have been suggestions that CEN and CENELEC  should be merged.  The 
independent 
Commission 

that  CEN  and  CENELEC 

considers 

are 

8  Reports  prepared  by  CEN,  CENELEC  and  ETSI  on  the  state  of  progress  of  European 

standardisation  under New Approach  directives are made available to Member States. 

12 

organizations  and  that  a  decision  on  a  merger  belongs  to  the  CEN  and 
CENELEC  constituencies.  In  the  Commission's  opinion,  it  is  unlikely  that  a 
merger  at European  level  would  improve  efficiency  unless  it  was  matched  by 
corresponding  structural  reorganisations  at the  national  level.  In  many  cases, 
the structure  of CEN  and CENELEC  reflects  corresponding  national  structure, 
and  each  organisation  has  its  own  constituency,  its  own  fields  of  competence 
and own  links to the  international  and  national  standardisation  levels.  Modern 
management  tools,  such  as  benchmarking,  should  be  promoted  amongst  the 
European and the national standards organisations. 

29. 

Efficiency  is  not  likely  to  be  enhanced  by  the  recognition  of  new  standards 
bodies.  New organisations would have to cope with the same tension  between 
efficiency  and  accountability  as  CEN,  CENELEC  and  ETSL  As  they  would 
not  be  members  of  the  international  standards  organisations  ISO/IEC/ITU, 
they  would  not  be  in  a  position  to  represent  Europe's  interest  at  the 
international  level, which is becoming increasingly  important. 

Improving Awareness. 

30. 

31. 

32 

It  is  necessary  to  bring  standardisation  and  standards  to  the  attention  of 
market participants,  in particular  SMEs.  This  is mainly  a task  of the  national 
standards  organisations,  national  authorities  and  national 
federations 
representing  industry.  In  order  to  give  impetus  to  a  European  policy  in  this 
area,  a  Memorandum  of  Understanding  was  agreed  in  1995  between  the 
Commission  and  the  European  standards  organisations.  It  aimed  to  improve 
policy  on awareness.  NORMAPME, who  represents  SMEs  and  craft  interests 
in European standardisation, takes part in the implementation of this MoU. 

Progress  reports  on  New  Approach  areas  should  be  made  available  on  the 
Internet  by the European  standards  organisations.  Links  should  be  foreseen 
with  information  on  directives,  mandates,  lists  of  references  of  European 
standards  published  for  individual  New  Approach  directives,  lists  of  notified 
bodies and related information  at the national level. 

In  order  to  give  a  high  visibility  to  the  efficiency  issue,  the  Commission 
envisages to organise a conference with all  interested parties.  Other  questions 
that  might  be  dealt  with  in  such  a  conference  are  the  relations  with 
international  standardisation  and  the  relations  with  Central  and  Eastern 
European countries. 

13 

Financial Support to European  Standardisation 

33. 

Financial  support  has  been  one  of the  main  means  by  which  the  Community 
has promoted  European  standardisation.  Since  1986, a total  of 60 MECU  has 
been  committed  to  New  Approach  standardisation  work  at  European  level; 
amongst  the  most  substantial  beneficiaries  are  construction  (21 MECU), 
machinery  (17.8 MECU)  and medical  devices  (10.3 MECU).  For work  under 
a  large  area  such  as  the  low-voltage  directive,  no  financial  support  was 
requested.  The  average  contribution  requested  for  standards  was  gradually 
reduced from  50,000 to 30, 000 ECU. As a consequence  of the progress of the 
work,  the  financial  contribution  to  standardisation  from  the  Commission  has 
been continuously reduced over recent years. 

COMMITMENTS BS4140 
SHARE NEW APPROACH ON OVERALL COMMITMENTS 

20.000.000 

- • - NA 

• - T O BI 

] 

\ 
/  \ 

/ 
/ 

^ 

A\ 

5 000.000 

,» 

. 

i/\y 

--»  / 

\ 

^**«. 

\ 

\— 

0 

* 

IMS 

1987 

1M* 

IMt 

1990 

IH1 

1M2 

19*1 

1994 

1t»S 

im 

ittr 

Review  meetings  between  the  Commission  and  the  European  standards 
organisations  concerning  the  implementation  of  contracts  and  the  financial 
consequences to be drawn from delays will  be intensified.  Alternative  ways  of 
providing financial support will be developed if this would increase efficiency. 

34. 

Following  a  review  of  standardisation  policy  carried  out  in  1996  and  1997, 
policy  for  financial  support  has  been  adapted  in  order  to  emphasise  the 
market-driven nature of standardisation: 

>  Support  is  now  provided  mainly  to  contribute  to  maintaining  a  strong 
infrastructure  for  European  standardisation.  Consequently  the  Central 
Secretariats  of  CEN,  CENELEC  and  ETSI  are  financially  supported  to 
ensure respectively 45%,  17% and  15% of their operational costs. 

>  Particularly  important  is  support  for  the  current  17  New  Approach 
Consultants,  appointed  by  common  agreement  between  the  Commission 
and  the  European  standards  organisations.  Their  task  is  to  verify  as 
independent  experts  whether  standards  respect  the  essential  requirements 
and the terms of the mandate. 

>  Translation  into  the  so-called  "minority"  languages  absorbs  a  large 
amount of funds.  Such funds  are used mainly to support national  standards 

14 

bodies  in  the  translation  of  European  standards  for  transposition  as 
national standards. 

>  Priority  will  be  given,  within  the  limits  of  budgets  available,  to 
standardisation  work in new areas, such as protection of consumers  and of 
the environment. 

> 

for 

In  order  to  assess  the  achievements  of  the  past  and  to  identify  the  future 
financial  needs 
the  maintenance  of  an  effective  European 
standardisation  system,  the  Commission  invites  CEN,  CENELEC  and 
ETSI  to  launch  an  independent  evaluation  of  the  financing  of  European 
standardisation.  The  results  of  the  evaluation  should  be  examined  in 
collaboration with the Commission and Member States. 

IV. 

CONCLUSIONS 

1. 

2. 

3. 

4. 

5. 

6. 

improved 
European  standardisation  has  had  a  difficult  start,  but  has 
considerably.  Nevertheless,  the  management  of  processes  needs  to  be 
improved, notably by adopting better management techniques.  More openness 
in  strategic  standardisation  policy-making,  (particularly  in  CEN,  given  its 
horizontal  competence),  will  contribute  to  an  increase  in  efficiency  and 
accountability. 

CEN, CENELEC  and ETSI are independent  organisations. It is therefore  their 
responsibility to ensure efficiency  and respect for time schedules. 

Standardisation  is a voluntary,  consensus-driven  process;  standards  cannot  be 
imposed. In some cases, apparent failures  of standardisation must be explained 
by  the  nature  of  standardisation  itself.  There  are  limits  to  the  capacity  of 
market  participants  to  self-regulate.  In  the  case  where  public  interest  is  at 
stake,  public  authorities  should  create  a  sufficiently  strong  incentive  for 
standardisation, or take other measures as appropriate. 

The Commission intends to hold regular reviews, together with Member  States 
and European  Standards Organisations, to examine measures  for  efficiency  on 
the basis of reports prepared by CEN, CENELEC and ETSI. 

Transparency  on  progress  should  be  improved.  The  standards  organisations 
are  invited  to  make  reports  on  the  progress  of  standardisation  in  New 
Approach areas available on the Internet, and to continually update them. 

A number of aspects, such as the an analysis  of the impact  of standards on the 
market, the working of sectoral committees  and expert groups, the visibility  of 
European  standardisation,  and  the  financing  of  European  standardisation 
requires continuous  follow-up,  involving the co-operation  of standards bodies, 
national authorities and the Commission. 

15 

ANNEXE 

PROGRESS STANDARDISATION ACTIVITIES IN THE FRAMEWORK OF THE NEW APPROACH {*) 

(*) excluding construction products, for which a standardisation programme is still under development. 
(**) including active implantable medical devices. 

UNDER  DEVELOPPMENT 

•UNDER  APPROVAL 

GRATIFIED 

M 

STANDARDISATION  ACTIVITIES  RELATED  TO  THE 
NEW APPROACH 

DIRECTIVE 

REFERENCES 

AREAS 

MANDATED 

RATIFIED 

90/384/EEC< 

Non-automatic  weighing 
instruments 

87/404/EEC 

Simple pressure vessels 

88/378/EEC 

Safety of toys 

89/392/EEC 

Safety of machinery 

89/686/EEC 

Personal protective  equipment 

90/385/EEC 

Medical devices,  including 

93/42/EEC 

active implantable  medical 
devices 

90/396/EEC 

Gas appliances 

1 

47 

10 

894 

300 

248 

91 

1 

38 

6 

214 

159 

127 

45 

UNDER 

UNDER 

APPROVAL 

DEVELOPPME 
NT 

5 

1 

370 

47 

60 

32 

4 

3 

310 

94 

61 

14 

44-

93/15/EEC 

Explosive for civil uses 

94/9/EEC 

Potentially  explosive 
atmospheres 

94/25/EEC 

Recreational  craft 

95/16/EEC 

Lifts 

94/62/EC 

Packaging  and packaging waste 

89/336/EEC 

Electromagnetic  compatibility 

92/75/EEC 

Energy  labelling 

91/263/EEC 

Telecommunication  terminal 
equipment 

51 

50 

49 

17 

21 

128 

5 

30 

93/97/EEC 

Satellite earth station equipment 

8 

0 

5 

15 

4 

0 

79 

3 

25 

0 

8 

11 

3 

0 

11 

1 

89/106/EEC 

Construction  products : 

Overal programme under development 

97/23/EC 

Pressure  equipment 

COM/96/0643 
final 

In vitro diagnostic  medical 
devices 

COM/97/0034  Railways  equipment 
final 

COM/93/322 
final 

Precious  metals 

771 

22 

104 

250 

4 

28 

280 

0 

12 

0 

51 

37 

23 

10 

21 

38% 

1 

5 

241 

18 

64 

<4Z 

ISSN 0254-1475 

COM(98) 291 final 

DOCUMENTS 

EN 

10  01  02 

Catalogue  number  :  CB-CO-98-320-EN-C 

ISBN  92-78-36153-4 

Office  for  Official  Publications  of the European  Communities 

L-2985  Luxembourg 

A<\