COMMISSION STAFF WORKING PAPER EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT  COMMISSION STAFF WORKING PAPER EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
Date: 2011-06-01
Institutions: European Commission
Subjects: Cenelec, European Committee for Standardisation, ISO, marketing standard

EUROPEAN COMMISSION 

Brussels, 1.6.2011 
SEC(2011) 672 final 

COMMISSION STAFF WORKING PAPER 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 

Accompanying the document 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on European Standardisation and amending Council Directives 89/686/EEC and 
93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 
2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC 

{COM(2011) 315 final} 
{SEC(2011) 671 final} 

 
 
 
 
  
 
 
Disclaimer: This executive summary commits only the Commission's services involved in its 
preparation  and  does  not  prejudge  the  final  form  of  any  decision  to  be  taken  by  the 
Commission. 

1. 

PROBLEM DEFINITION 

This document only concerns the European standardisation system in which the three 
independent  European  standardisation  organisations  CEN,  CENELEC  and  ETSI 
(hereinafter  referred  to  as  “ESOs”)  play  a  key  role,  and  the  standards  for 
interoperability in the field of ICT. 

in 

the  case  of  cross-border 

Standards  and  standardisation  are  very  effective  policy  tools  for  the  EU.  The  mere 
existence  of  standards  is  trade-enhancing  because  of  their  positive  cost-decreasing 
effect  and  the  reduction  of  information  asymmetries  between  the  supply  and  the 
transactions.  Several 
demand  sides,  especially 
econometric  studies  have  established  a  clear  connection  at  a  macroeconomic  level 
between  standardisation  in  the  economy,  productivity  growth,  trade  and  overall 
economic growth. Studies show that existing standards contribute to GDP at the rate 
of  about  one  percentage  point  per  annum.  Although  standards  and  standardisation 
have  much  wider  benefits  for  the  European  economy,  they  are  used  as  policy 
instruments  to  ensure,  inter  alia,  the  functioning  of  the  single  market,  the 
interoperability  of  networks  and  systems,  in  particular  in  the  field  of  ICT,  a  high 
level  of  consumer  and  environmental  protection,  and  more  innovation  and  social 
inclusion. 

However,  the  public  consultations  of  stakeholders  and  a  report  of  the  European 
Parliament on the future of European standardisation1 indicated that certain problems 
need to be addressed. 

European  standards  play  a  very  important  part  in  the  functioning  of  the  internal 
market  for  industrial  products.  European  standards  replace  national  and  often 
conflicting standards which, as such, may create technical impediments to a national 
market.  European  standards  can,  for  the  purpose  of  this  impact  assessment,  be 
divided into 2 categories: 

•  European standards developed at the request of the Commission, on the basis of a 
so-called  “mandate”  in  which  the  ESOs  are  requested  to  draw  up  technical 
specifications  of  a  normative  nature  that  meet  the  requirements  set  out  in  the 
mandate. These standards can be subdivided into 2 subcategories: 

– 

Harmonised  standards  which  ensure  that  products  meet  the  essential 
requirements  set  out  in  EU  legislation.  Compliance  with  a  European 
“harmonised”  standard  guarantees  the  required  level  of  safety  of 
products. However, use of harmonised standards is still voluntary and a 
manufacturer may use any other technical solution which demonstrates 
that  his  product  meets  the  essential  requirements.  The  percentage  of 
European standards that are harmonised standards has increased in the 

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A7-0276/2010. 

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last two decades from 3.55% to 20% in 2009. This shows the increasing 
importance of standards as an instrument to accompany EU legislation2. 

– 

Other European standards to support European policies; 

•  The  remaining  European  standards  are  adopted  outside  EU  legislation  at  the 
initiative  of  undertakings,  NSBs  or  other  stakeholders,  or  at  the  request  of  the 
Commission.  

1.1. 

Problem  1:  the  process  for  adopting  European  standards  requested  by  the 
Commission is not fast enough 

In a rapidly changing world and society, especially in sectors characterized by very 
short  product  lives  and  development  cycles,  standards  must  keep  pace  with  rapid 
technological  development.  Some  stakeholders  argue  that  the  entire  process  of 
creating  European  standards  is  too  slow,  although  complaints  about  slowness  of 
standardisation  may  be  less  relevant  for  technologies  with  long  lead  times  for 
development and redeployment. At the moment, the development time of CEN and 
CENELEC deliverables is between 21.5 and 36 months while the typical time frame 
for ETSI is 12 to 24 months. Yet, the entire development process can be much longer 
for standards developed at the request of the Commission. For these standards, there 
are four main stages, i.e. the preparation of the mandate and the positive opinion of 
the committee set up under Directive 98/34/EC, the acceptance of the mandate by the 
ESO and the start of work on the standard, the development of the standard itself and 
the  publication  of  the  reference  of  the  harmonised  standard  in  the  OJ  and  the 
objection procedure. 

1.2. 

Problem  2:  Under-representation  of  SMEs  and  societal  stakeholders  in  the 
European standardisation process 

Several  studies  showed  that  SMEs  encounter  a  series  of  problems  with  respect  to 
standards  and  standardisation.  One  of  the  most  important  problems,  according  to 
many stakeholders, is that SMEs are in general under-represented in standardisation 
activities, in particular at European level. Furthermore, standards often relate to the 
safety  and  well-being  of  citizens,  the  efficiency  of  networks,  the  environment  and 
other  public  policy  fields.  Although  standards  play  a  major  role  in  society,  the 
opinion  of  relevant  societal  stakeholders  is  not  sufficiently  integrated  in  the 
standardisation  process  in  the  EU.  In  order  to  address  the  problem  of  insufficient 
representation  of  SMEs  and  societal  stakeholders  in  standardisation  activities, 
financial  contributions  are  paid  to  organisations  representing  SMEs  and  societal 
stakeholders. The criteria for eligibility for these grants, the conditions for their use 
and  the  type  of  financial  contributions  available  vary  widely.  Some  organisations 
receive grants for actions while others also receive operating grants.  

2 

Detailed figures can be found in Annex 3 while Annex 4 contains an overview of EU legislation using 
European standards as a means to presume conformity with the essential requirements. 

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1.3. 

Problem 3: “Fora and Consortia Standards” cannot currently be referenced in 
public procurement of ICT.  

In  the  field  of  ICT,  many  standards  ensuring  interoperability  are  not  elaborated  by 
the  ESOs  but  by  global  fora  and  consortia.  This  goes  particularly  for  Internet  and 
World  Wide  Web  related  standards.  Mostly  due  to  a  lack  of  highly  specialized 
expertise the traditional standard-setting organisations do not cover the ICT domain 
and so currently a major part of the global ICT standardisation work is done outside 
the formal European or International standardisation system.  

Referencing  of  standards  in  public  procurement  can  be  an  important  means  of 
fostering innovation while providing public authorities with the tools needed to fulfil 
their  tasks,  especially  in  lead  markets  such  as  e-health.  Public  procurement  has  to 
comply  with  Directive  2004/18/EC  which  differentiates  between  formal  standards 
and other technical specifications, for which a description of functional requirements 
is additionally requested. When public authorities refer to technical standards in their 
technical  specifications,  they  should  also  specify  whether  they  allow  tenderers  to 
prove  that  their  offer  fulfils  the  specifications  even  if  it  does  not  comply  with  the 
technical standard referred to. However, when acquiring ICT services and products, 
additional requirements may prevail. Public authorities need to be able to define their 
ICT  strategies  and  architectures,  including  cross-border  interoperability  and  will 
procure  ICT  systems/services  and  products  or  components  thereof,  that  meet  their 
requirements.  

2. 

OBJECTIVES 

2.1. 

General policy objectives 

This  initiative  aims  at  increasing  the  contribution  of  standards  and  European 
standardisation  to  a  better  functioning  internal  market,  stimulating  growth  and 
innovation and fostering the competitiveness of EU enterprises, especially SMEs.  

2.2. 

Specific objectives 

(1) 

(2) 

(3) 

Reduce the time taken by the standardisation process for standards developed 
at the request of the Commission; 

Ensure that SMEs and societal stakeholders are adequately represented in the 
standardisation  process,  especially  for  standards  developed  at  the  request  of 
the Commission; 

Broaden the use of ICT standards and thus enhance interoperability through a 
more  integrated  European  public  procurement  market  for  ICT  products  and 
services,  especially  in  connection  with  the  establishment  of  an  “e-Internal 
Market”; 

(4) 

Remove ambiguities in the existing legal framework. 

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3. 

ASSESSMENT OF IMPACTS 

3.1. 

Problem 1: the European standard-setting process is not fast enough 

3.1.1.  Policy Option 1.0: Base-line scenario 

As  described  above.  It  serves  as  a  reference  against  which  the  other  options  are 
assessed. 

3.1.2.  Policy Option 1.A: specify deadlines on the delivery of European standards.  

The  advantage  of  this  option  is  that  European  standards  would  be  available  after  a 
fairly short period. The assumption is that ESOs would accept shorter deadlines and 
that they could persuade technical experts willing to spend more time on developing 
a  standard.  The  positive  economic  benefits  of  the  earlier  availability  of  a  standard 
could be estimated at a growth rate of about one percentage point per annum for the 
product or service covered by the standard.  

Besides the fact that this option  would only apply to the harmonised standards  and 
the European standards requested by the  Commission,  a deadline obliging ESOs to 
increase  the  speed  of  the  formal  standard-setting  processes  may  have  a  negative 
impact  on  the  quality  of  the  standard.  Time  can  only  be  gained  by  reducing 
consensus  and  correspondingly  curtailing  (or  avoiding)  one  of  the  intermediate 
consultation stages.  

Deadlines for all European standards and the production of at least the same number 
of  standards  in  less  time  could  lead  to  increased  costs  (more  frequent  meetings  for 
example) on an annual basis. There would be an estimated additional annual cost per 
standard of around €150,000 to €200,000 if standard s were to be finalised in 2 years. 
The increase in speed would only be possible if industry and other stakeholders agree 
to  share  the  additional  cost  or  if  the  Commission  finances  it.  Unless  specific 
measures  would  be  taken,  deadlines  for  all  European  standards  would  necessarily 
have a negative impact on the involvement of SMEs and societal stakeholders.  

3.1.3.  Policy Option 1.B: create a European Agency for Standards that would manage the 

standard-setting process.  

The advantage of this option is that the agency would be supervised by the European 
legislator and that it would become more difficult to decline mandates for European 
standards. The creation of a new European standardisation agency would mean that 
requests  for  harmonised  standards  would  be  handled  as  a  priority.  The  level  of 
duplication  of  administrative  resources  and  expenses  would  be  lower  and  all  the 
available  expertise  would  be  pooled.  In  addition,  the  participation  of  SMEs  in  the 
standardisation process could be improved. 

However, this option has a number of considerable drawbacks. It requires, above all, 
close  cooperation  with  the  NSBs  to  make  it  viable.  An  agency  on  European 
standardisation could not operate without their support. Moreover, an agency could 
not  provide  the  level  of  expertise  necessary  to  perform  effectively  the  tasks  of  a 
technical  committee.  Therefore,  consensus  between  the  experts  would  still  be 
necessary, regardless whether the work was done under the auspices of an ESO or an 
agency. This option would certainly lead to substantial additional costs for the EU-

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budget. The Commission currently contributes 21.2 million euro, i.e. around 47% of 
the  total  income  of  the  three  ESOs  (€44,000,000).  The  rest  of  the  ESOs  income  is 
mainly financed by members´ fees and contributions. It has to be kept in mind that 
the number of standards mandated by the Commission is a fairly small proportion of 
the total deliverables issued by ESOs.  

3.1.4.  Policy Option 1.C: transparent and simplified procedures for harmonised standards 

and other European standards requested by the Commission.  

A  more  organised  regular  annual  or  multiannual  programming  process  would 
increase  the workload of the services of the  Commission but would have a general 
positive impact. It would enable ESOs to anticipate upcoming requests and shorten 
the acceptance process so that harmonised standards would be more rapidly available 
on the market for use by businesses. This option would have a positive impact on the 
internal  market  and  the  competitiveness  of  businesses  (including  SMEs)  by 
shortening the period for issuing mandates by approximately 6 months (by removing 
the separate consultation of the committee) while another 6 months could be cut at 
the  end  of  the  process  through  efficiency  gains  when  objections  are  raised.  No 
negative impacts or supplementary costs can be identified. Although this option has 
an  overall  positive  impact  without  any  negative  impacts,  the  main  disadvantage  is 
that  it  would  only  apply  to  harmonised  standards  and  standards  developed  at  the 
request  of  the  Commission,  so  it  would  have  no  impact  on  the  speed  of  other 
European standardisation work. 

3.2. 

Problem  2:  Involvement  of  SMEs  and  societal  stakeholders  in  the  European 
standardisation process 

3.2.1.  Policy  Option  2.0:  base-line  scenario  (i.e.  the  financial  contribution  to  SME  and 

societal stakeholder representation) 

As  described  above.  It  serves  as  a  reference  against  which  the  other  options  are 
assessed. 

3.2.2.  Policy  Option  2.A:  Facilitate  direct  representation  of  SMEs  and  societal 

stakeholders within the European standardisation organisations  

Long  term  direct  participation  of  technically  aware  staff  of  individual  SMEs  and 
societal stakeholders in the meetings and discussions of a technical committee allows 
this  staff  to  build  a  reputation  within  the  standardisation  organisations.  In  addition, 
staff can work directly to influence the process.  Participation  in the standardisation 
process  requires  a  strong  technical  understanding  of  proposed  standards  and  their 
context.  In  addition,  participants  need  to  be  prepared  to  commit  up  front  to 
substantial investments of the time and energy necessary to follow ongoing internal 
discussions about the subject of the future standard. The generally accepted guideline 
is  that  meaningful  participation  in  any  technical  committee  or  working  group 
requires a baseline of approximately 20% of a person’s time. 

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3.2.3.  Policy  Option  2.B:  Grant  voting  rights  to  organisations  representing  SMEs  and 

societal stakeholders within the European standardisation organisations  

Granting  voting  rights  to  a  very  limited  number  of  representative  organisations  on 
technical work within CEN would have a very positive impact on the involvement of 
SME  and societal  stakeholders. Other delegations with voting rights  would have to 
take  into  account  the  views  expressed  by  delegates  of  SMEs  and  societal 
stakeholders.  No  negative  impacts  could  be  identified.  However,  granting  voting 
rights to organisations other than NSBs needs to be negotiated and agreed with the 
members  of  the  ESOs,  so  the  feasibility  of  this  option  is  uncertain.  Furthermore,  it 
may entail the payment of a higher membership fee which would increase the cost of 
this option for organisations representing SMEs and societal stakeholders.  

3.2.4.  Policy Option 2.C: Strengthen the position of organisations representing SMEs and 
societal stakeholders within the ESOs by providing for the possibility of an operating 
grant 

The positive aspect of this option is that it provides for the possibility of continuous 
support  to  organisations  representing  SMEs  and  societal  stakeholders  so  that  they 
could consolidate their role in the standardisation process. The other positive aspect 
is  that  the  possibility  of  an  operating  grant  contains  a  strong  impetus  for  ESOs  to 
continue  considering  these  organisations  as  solid  partners  in  the  standardisation 
process so that the opinions of these organisations are adequately taken into account 
during  the  technical  work  on  European  standards.  However,  this  option  would 
require  an  exception  to  the  degressivity  principle  in  the  basic  act  underlying  the 
award  of  the  grants.  Furthermore,  this  option  requires  that  the  budgetary  amounts 
which  are  currently  scattered  over  several  budgetary  lines  would  be  at  least 
maintained by the budgetary authority. No negative aspects could be identified. 

3.3. 

Problem 3: “Fora and Consortia Standards” cannot currently be referenced in 
public procurement of ICT. 

3.3.1.  Policy option 3.0: base-line scenario 

As  described  above.  It  serves  as  a  reference  against  which  the  other  options  are 
assessed. 

3.3.2.  Policy  Option  3.A:  Revive  the  implementation  of  the  mechanisms  of  Council 

Decision 87/95/EEC concerning public procurement and the policy  

The  advantage  of  this  option  is  that  no  legislative  change  is  required  and  the 
corresponding  administrative  costs  for  the  EU  legislator  and  the  Member  States 
could  be  avoided.  However,  transforming  Fora  and  Consortia  standards  into 
European  standards  leads  to  supplementary  charges,  responsibilities  and  costs  for 
ESOs. A substantial part of the costs would have to be borne by the Commission. In 
addition,  the  ESOs  would  be  responsible  for  the  regular  review  and  update  of  the 
standard.  In  addition,  the  circumstances  referred  to  in  Article  5(3)  do  no  longer 
correspond to the technological reality on the market. Therefore, this possibility may 
require a very broad interpretation of the provisions of Decision 87/95/EEC. Due to 
the  lack  of  legal  certainty,  the  impacts  on  the  internal  market,  SMEs,  public 

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authorities, consumers and innovation would be minimal. However, there would be 
no budgetary impacts.  

3.3.3.  Policy Option 3.B: Allow for the referencing of “Fora and Consortia Standards”  

The main advantage of this option is that the possibility of referencing selected Fora 
and Consortia Standards for procurement purposes on a firm legal basis is expected 
to counter the tendency towards market fragmentation and to have a positive impact 
on  the  internal  market,  especially  for  businesses  delivering  goods  or  services 
complying with these Fora and Consortia Standards. This option would have positive 
indirect  impacts  on  public  authorities,  SMEs  and  consumers,  considering  the 
proliferation of high-tech consumer electronic products that exhibit network effects.  

These positive impacts, however, could have corresponding risks. An important risk 
is that Fora and Consortia Standards could contain proprietary technologies, whereby 
a factual monopoly in a technology would result in a factual monopoly in the market 
for services and products based on the technology. This would then favour the single 
supplier of that technology. Thus, it would be necessary that the Fora and Consortia 
Standards  at  least  observe  FRAND  IPR  policies,  as  is  the  case  with  the  ESOs,  or 
operate on a royalty free basis. This is among the predefined criteria or attributes3 in 
the light of which they should be selected and assessed by the Commission with the 
assistance from stakeholders through a consultative “Platform” consisting of a very 
wide  range  of  stakeholders  and  interested  parties  and  without  recourse  to 
remunerated external expertise.  

3.3.4.  Policy  Option  3.C:  Grant  Selected  Private  fora  and  consortia  the  Status  of 

Recognized Entities under Directive 98/34/EC.  

The  impacts  of  this  option  depend  on  a  number  of  external  factors,  such  as  the 
willingness  of  the  selected  fora  and  consortia  to  be  recognised  and  to  submit  to 
controls  with  respect  to  the  WTO-criteria  on  standardisation.  Fora  and  consortia 
might be reluctant to apply for recognition due to the additional cost of accreditation, 
its periodical renewal (e.g. cost for internal audit) and the costs related to compliance 
with the process requirements and considerations regarding their “independence”. In 
case of recognition, fora and consortia would have to comply with certain procedural 
aspects  of  formal  standardisation  which  may  slow  down  future  standard 
development. The recognition of private fora and consortia would pose some notable 
governance  and  co-ordination  problems.  Private  fora  and  consortia  usually  have 
sizeable  membership  fees,  which  could  discourage  SME  participation  to  the 
standardization  process  and  represent  a  discrimination  factor.  SMEs  would  face 
increased  challenges  in  actively  participating  in  consortia,  but  fewer  problems  in 
passively observing their activities. Consequently, larger companies are more likely 
to gain by their active standardisation engagements. In any event, this option would 
require  careful  scrutiny  of  the  procedural  guarantees  offered  by  the  fora  and 
consortia, as part of the selection process.  

3 

A list of possible attributes is set out in point 2.1 of the Commission’s White Paper on “Modernising 
ICT Standardisation in the EU – The Way Forward” - COM(2009) 324, 3.7.2009. 

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This  option  would  entail  additional  costs  for  the  fora  and  consortia,  especially  in 
demonstrating  compliance  with  WTO-criteria  and  in  particular  for  the  process 
requirements  and  considerations  regarding  their  “independence”.  In  case  of 
recognition, the fora and consortia would have to comply with the procedural aspects 
of  formal  standardisation and would  have  to  fulfil the duties of  a recognized body. 
Neither  of  these  aspects  adds  value  to  the  content  and  quality  of  the  standard.  It 
would  also  require  additional  resources  from  the  EU  budget  since  it  would  be 
reasonable for organisations complying with all criteria to be entitled to benefit from 
a financial contribution from the EU. 

4. 

COMPARISON OF OPTIONS 

The policy options for the three problem areas are compared according to the criteria 
of effectiveness (i.e. to what extent they fulfil the specific objectives), efficiency (i.e. 
at which costs they do so) and coherence with other EU policies. On this basis, it is 
suggested that the following options be retained: 

•  The  combination  of  policy  Options  1.A  (deadlines  on  the  delivery  of  European 
standards)  and  1.C  (Transparent  and  simplified  procedures  for  harmonised 
standards and other European standards requested by the Commission); 

•  Policy  Option  2.C:  Strengthen  the  position  of  organisations  representing  SMEs 
and  societal  stakeholders  within  the  ESOs  by  providing  for  the  possibility  of  an 
operating grant. 

•  Policy  Option  3.B:  Allow  for 

the  referencing  of  “Fora  and  Consortia 

Specifications”. 

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