COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Harmonised standards: Enhancing transparency and legal certainty for a fully functioning Single Market
Date: 2018-11-22
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, European standard, European standardisation body, harmonisation of standards, principle of legal certainty, single market

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 22.11.2018  COM(2018) 764 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Harmonised standards: Enhancing transparency and legal certainty for a fully functioning Single Market  
 
 
The Commission has presented today a first response to the request of the European Council 
in March 2018 to assess the state-of-play, as well as the remaining barriers and opportunities 
for a fully functioning Single Market.1  

Standardisation plays an important role in this assessment considering, in particular, its role in 
eliminating technical barriers to trade. Standards help to ensure that complementary products 
and services are interoperable, facilitate the introduction of innovative products and ultimately 
build  trust  of  European  consumers  in  the  quality  of  products  and  services  offered  in  the 
Union. In the context of rapidly evolving technological developments, the digitisation of the 
European economy and newly emerging economic trends and growth models, standardisation 
plays a key role in ensuring that the development of the Single Market is future-proof and that 
European consumers and businesses reap the benefits from such changes2.  

European standards replace potentially conflicting national standards in all Member States of 
the  Union  and  so,  facilitate  market  access  for  those  that  use  them.  In  this  way,  standards 
contribute to a continuous deepening of the Single Market. By promoting a close alignment of 
European  and  international  standards,  the  European  Union  promotes  best  practices  and 
increases  synergies  in  global  value  chains.  This  enhances  trade  flows  and  opportunities  for 
European businesses to scale up their activities.  

A  European  standardisation  system  that  functions  well  contributes  to  overall  economic 
growth,  supports  innovation  and  global  competitiveness  of  the  European  industry.  It  also 
helps to ensure that the levels of safety, health and consumer and environmental protection set 
out  in  Union  legislation  are  met  in  practice3.  European  industry  is  transforming  rapidly 
through  the  adoption  of  a  wide  range  of  innovative  solutions  and  digital  technologies. 
Traditional  sectors  of  the  economy  are  also  concerned  by  this  trend.  All  have  needs  that 
require standardisation responses, supported by advanced European standards and developed 
by a a modern and agile European standardisation system.  

This Communication provides an overview of the functioning of the European standardisation 
system  and  takes  stock  of  the  initiatives  launched  in  recent  years  to  support  the 
implementation of the Standardisation Regulation, also in the light of the relevant case law of 
the Court of Justice of the European Union. The Communication explains the actions  taken 
recently by the Commission to further improve the system and also includes specific actions 
that  the  Commission  will  take  in  the  immediate  future  in  order  to  enhance  the  efficiency, 
transparency  and  legal  certainty  for  the  actors  involved  in  the  development  of  harmonised 
standards.  This  Communication  is  relevant  in  the  context  of  harmonised  standards,  that  is, 
European  standards  adopted  on  a  basis  of  a  request  made  by  the  Commission  for  the 
application of Union harmonisation legislation.4 

The  European  standardisation  system  is  based  on  a  public-private-partnership  between  the 
Commission and the standardisation community. Its uniqueness lies in the use of harmonised 
standards. These standards become part of Union law and, when used, provide manufacturers 
across  the  Single  Market  with  a  presumption  of conformity  with  the  requirements  of  Union 

1 COM(2018) 772.  
2 For instance, further development of the circular economy in the Union requires the setting up of high quality 

standards for secondary raw materials such as plastics or waste-based fertilisers. 

3 Harmonised standards also cover social inclusion issues, such as accessibility. The European Accessibility Act 

uses standards to provide presumption of conformity. 

4  It  is  not  applicable  to  other  types  of  standards,  i.e.  international  standards,  European  (non-harmonised) 
standards, national standards, technical specifications etc.  

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legislation.  This  provides  important  legal  certainty  to  users  of  harmonised  standards  and  is 
particularly  important  for  small  and  medium-sized  enterprises  as  it  allows  them  to  place 
products in compliance with Union legislation on the market without additional costs. The so-
called  ‘New  Legislative  Framework’  has  been  designed  as  a  flexible  and  market-driven 
system built around consensus by industry, small and medium-sized enterprises and other key 
stakeholders,  while  ensuring  that  products  conforming  with  harmonised  standards  comply 
with Union legislation.  

The  use  of  harmonised  standards  offers  legal  certainty  and  stability  to  users,  which  reduces 
costs  for  manufacturers.  This  in  turn  is  important  for  investors  but  it  also  creates  increased 
public  responsibility  on  the  regulators,  who  must  oversee  these  harmonised  standards 
appropriately. 

Since  it  entered  into  force  in  2013,  Regulation  1025/2012  (hereafter  'the  Standardisation 
Regulation')5 has provided the main legal framework for the European standardisation system 
including  the  division  of  responsibilities  and  obligations  of  the  actors  involved.  Certain 
improvements  to  the  practical  implementation  of  this  framework  need  to  be  made  swiftly, 
notably in light of the case of law of the Court of Justice of the European Union.  

1. 

FUNCTIONING OF THE EUROPEAN STANDARDISATION SYSTEM  

Harmonised  standards  are  developed  by  one  of  the  three  European  Standardisation 
Organisations6  on  the  basis  of  an  official  request  from  the  Commission  ('standardisation 
request'), in order to support the implementation  of Union legislation. These standardisation 
requests  define  what  is  expected  from  the  European  Standardisation  Organisations. 
In particular,  they  specify  which  harmonised  standards  need  to  be  produced,  and  by  when. 
The Commission develops the standardisation requests in an inclusive and transparent process 
together with Member States.  

The Commission and the European Standardisation Organisations ensure  that the process of 
developing harmonised standards is  based on consensus  and is  transparent and inclusive.  In 
particular,  the  Commission  closely  monitors  whether  the  input  of  small  and  medium-sized 
enterprises and stakeholders representing all parts of society, such as consumers, workers and 
environmental interests, is taken into account in the process as their contribution enhances the 
quality of the standards. Once the European Standardisation Organisations have developed a 
harmonised standard, the Commission assesses whether it complies with the requirements of 
corresponding Union legislation and the original  standardisation request.  If the Commission 
concludes  that  the  standard  is  in  compliance  with  the  request  and  Union  legislation,  it  will 
decide to publish its reference in the Official Journal of the European Union. As a result, and 
following a Commission decision to publish the reference in the Official Journal, the standard 
will produce legal effects under the relevant Union legislation. 

Products manufactured in compliance with harmonised standards benefit from a presumption 
of  conformity  with  the  corresponding  legislative  requirements7.  By  using  the  harmonised 

5 OJ L 316, 14.11.2012, p. 12–33. 
6 The European Committee for Standardisation (CEN), the European Committee for Electrotechnical 
Standardisation (CENELEC), and the European Telecommunications Standards Institute (ETSI). 

7 There are many other acts of Union legislation that mirror the system laid down in Regulation (EU) 1025/2012 
such  as  Regulation  (EU)  305/2011  (Construction  Products  Regulation),  Directive  2001/95/EC  (General 
Product  Safety  Directive).  For  ease  of  reference,  they  are  not  examined  separately  in  this  Communication. 
However, the general considerations addressed in this Communication also apply to these acts. 

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standards, the manufacturer may benefit from a simplified conformity assessment process. In 
this  way,  harmonised  standards  reduce  the  financial  and  administrative  burden  for 
manufacturers,  particularly  small  and  medium-sized  enterprises,  and  increase  legal  certainty 
as  regards  the  compliance  of  products  with  the  Union  legislation.  That  legal  effect  and 
certainty are crucial for small and medium-sized enterprises as it allows them to manufacture 
state-of-the-art products in a competitive way8. 

The  Commission  must  therefore  pay  particular  attention  to  the  content  of  the  harmonised 
standards. The Court of Justice of the European Union has further reinforced this requirement 
in its recent case law, in particular by the Case C-613/14 'James Elliott Construction Limited 
vs. Irish Asphalt Limited'9. Through this judgment, the Court clarified the role and legal status 
of harmonised standards by concluding that harmonised standards 'form part of EU law', even 
though  they  are  developed  by  independent  private  organisations  and  their  use  remains 
voluntary.  

In  addition,  the Court reiterated the Commission's responsibility in  the process  of initiating, 
managing and monitoring of harmonised standards. The Commission has thus the obligation 
to follow the development process of harmonised standards thoroughly and to assess whether 
they  comply  with  the  requirements  set  out  in  harmonised  Union  legislation  and/or 
standardisation  requests  in  order  to  ensure  that  harmonised  standards  fully  comply  with  the 
applicable legislation. This does not only include the technical  aspects of standards but  also 
other  elements  of  the  European  Standardisation  Regulation,  such  as  whether  their 
development  process  has  been  inclusive.  It  is  the  Commission’s  intention  to  fulfil  these 
obligations in a manner which is as swift and efficient as possible. 

2. 

IMPLEMENTING THE STANDARDISATION REGULATION AND THE RELEVANT CASE LAW  

Following  the  entry  into  force  of  the  Standardisation  Regulation  in  201310  and  several 
judgments  of  the  Court  of  Justice  of  the  European  Union,  the  Commission  has  launched  a 
number  of  initiatives  to  support  the  implementation  of  the  legal  framework  and  to  improve 
how the European standardisation system functions in practice. 

In  accordance  with  the  Standardisation  Regulation11,  the  Commission  has  adopted  Annual 
Union  Work  Programmes  for  European  standardisation,  highlighting  the  importance  of 
harmonised  standards,  their  legal  effect  (presumption  of  conformity),  and  their  quality  and 
timeliness.  In  addition  to  planning  the  work  on  the  development  of  harmonised  standards, 
these programmes have also put forward specific proposals to improve the governance of the 
European  standardisation  system,  such  as  prioritising  the  European  Union  financial 
contribution to the European Standardisation Organisations on direct technical support to the 
development  of  harmonised  standards.  Moreover,  the  Commission  has  also  given  clear 
directions  to  the  European  Standardisation  Organisations  in  the  Annual  Union  Work 
Programmes,  to  strengthen  the  involvement  of  small  and  medium-sized  enterprises  and 
societal stakeholders in the European standardisation process. 

The  Commission  has  also  taken  several  initiatives  to  make  its  standardisation  policy  more 
transparent  and  accessible.  To  ensure  that  the  Standardisation  Regulation  is  implemented 
correctly,  the  Commission's  services  have  provided  guidance  on  the  role,  development, 

8 The construction product sector is subject to important deviations from general practices in standardisation. 
9 See also e.g. case T-474/15 Global Garden Products and C-630/16 Anstar. 
10 Replacing the standardisation provisions of Directive 98/34/EEC. 
11 Article 8 of Regulation (EU) 1025/2012 

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adoption  and  execution  of  standardisation  requests  in  a  2015  'Vademecum  on  European 
standardisation'12.  This  document  was  prepared  in  full  partnership  and  cooperation  with  the 
European  Standardisation  Organisations,  small  and  medium-sized  enterprises  and  societal 
stakeholders, together with Member States and industry. The Commission has also developed 
a  common  template  for  publishing  the  references  of  harmonised  standards  in  the  Official 
Journal of the European Union as well as a 2016 guidance document on the 'Verification of 
conditions for the publication of references of harmonised standards in the Official Journal'13.. 

In line with the 2015 Single Market Strategy14 and the Standardisation Package15 adopted on 
1 June 2016, the Commission has set out a shared vision for European standardisation in its 
Joint  Initiative  on  Standardisation  (the  “Joint  Initiative”),  supported  by  a  broad  range  of 
stakeholders and all Member States. The aim of the Joint Initiative is to ensure the Union’s 
sustained  efforts  to  modernise  the  European  standardisation  system  so  as  to  maintain  its 
attractiveness, to keep pace with developments, such as digitisation, within an agile, flexible, 
and inclusive framework and to speed up and better prioritise standard setting to respond in a 
timely way to market and users' needs. Specific actions of the Joint Initiative are dedicated to 
raise  awareness  and  to  improve  the  development  and  implementation  of  harmonised 
standards. The Joint Initiative also looks at the role of standards in addressing the challenges 
of  the  digital  transformation  of  the  economy.  This  digital  transformation  of  the  economy 
creates the need to accelerate the transformation of the European standardisation to make it fit 
for current and future challenges, in particular in an area such as Internet of Things, big data, 
advanced  manufacturing,  robotics,  3D  printing,  blockchain  technologies  and  artificial 
intelligence. A modern, agile and inclusive European standardisation system which can react 
quickly to new developments will help to speed up the diffusion of these new technologies.  

In  2017,  the  Commission  and  the  European  Standardisation  Organisations  reached  an 
agreement on a joint Action Plan to address the issue of harmonised standards which are not 
cited in the Official Journal following a negative assessment by the Commission. This issue 
was  raised  by  the  REFIT  Platform16  and  by  several  stakeholders,  as  it  impacts  the  sound 
functioning  of  the  European  standardisation  system.  To  respond  to  this  concern,  the 
Commission has prioritised the rapid decrease of the backlog of such harmonised standards, 
in cooperation with the European Standardisation Organisations. Dealing with the remaining 
backlog remains a priority for the Commission. 

First Action: The Commission will use its best endeavours to eliminate the remaining backlog 
as rapidly as possible. 

To ensure the timeliness and the efficiency of the citation of compliant harmonised standards 
in  the  Official  Journal,  it  is  useful  to  identify  emerging  issues  as  early  as  possible  in  the 
development  process.  The  Commission  has  set  up  a  framework  of  consultants  for  such 
purposes. The consultants provide Commission services with technical assistance in assessing 
draft  harmonised  standards,  thereby  contributing  to  strengthening  further  the  Commission 
control of the consistency of harmonised standards with the relevant legislation. 

To  enhance  coordination  within 
the 
Commission  and  the  European  Standardisation  Organisations  have  held  regular  structural 

the  public-private  standardisation  partnership, 

12SWD(2015)205 final of 27.10.2015, http://ec.europa.eu/growth/single-market/european-

standards/vademecum_en 

13 http://www.cc.cec/Ares/ext/documentInfoDetails.do?documentId=080166e5ae43cdde 
14 COM(2015) 550 final 
15 COM(2016) 358 final 
16 REFIT Platform opinion XXII.2.b. 

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dialogues.  These  dialogues  have  focused  on  technical  and  policy  aspects  of  European 
standardisation,  including  on  matters  related  to  the  quality  of  harmonised  standards  and  the 
impact they have on businesses, markets and consumers. 
To  promote  a  stronger  involvement  of  co-legislators  in  the  process  of  priority-setting  for 
European  standardisation,  the  Commission  organised  in  June  2018  an  inter-institutional 
dialogue.  The  dialogue  included  high-level  representatives  of  European  Union  institutions, 
standardisation organisations, businesses (including small and medium-sized enterprises) and 
other  relevant  stakeholders,  such  as  consumers,  workers  and  environmental  organisations. 
It focused on priority issues relevant to the process of developing harmonised standards and 
future priorities in this area, such as the digitisation and the booming collaborative economy. 

The  inter-institutional  dialogue  and  the  discussions  with  the  key  actors  in  the  European 
standardisation system have highlighted the need to further enhance legal certainty to ensure 
that the Union legislative framework for standardisation is interpreted uniformly, in particular 
in light of the Standardisation Regulation, the case law of the Court of Justice of the European 
Union and the guidance documents. 

3.   FURTHER ACTIONS TO ENHANCE TRANSPARENCY, REINFORCE LEGAL CERTAINTY AND 

SPEED OF ADOPTION 

While  significant  progress  has  been  made,  the  Commission  recognises  that  the  efforts  to 
improve the functioning of the European standardisation system need to be sustained. To this 
end,  the  Commission  will  take  a  set  of  dedicated,  immediate  actions  to  further  enhance  the 
transparency  and  efficiency  of the European standardisation process.  This  will reinforce the 
legal  certainty  for  stakeholders  and  users  and  clarify  the  roles  and  responsibilities  of  the 
different actors.  

The  Commission  is  reviewing  its  internal  decision  making  processes  with  a  view  to 
streamlining  the  procedures  for  publishing  the  references  to  harmonised  standards  in  the 
Official  Journal17.  This  review  is  based  on  best  practices  within  the  framework  of  the 
Commission’s internal rules of procedure and will ensure a co-ordinated, timely and thorough 
preparation of the necessary decisions. 

Second Action: The Commission  is  reviewing its  internal decision making  processes with a 
view to streamlining the procedures for publishing the references to harmonised standards in 
the Official Journal.  

In order to further clarify the roles and responsibilities of the different actors during all stages 
of the harmonised standards development, the Commission will prepare a guidance document.  

This guidance, complementing existing documents18 will in particular explain the substantive 
and  procedural  aspects  of  the  new  format  of  the  standardisation  request  which  the 
Commission is developing with the aim of ensuring greater transparency and predictability in 
the development of the standards. It will also clarify the role of the Commission and its expert 
consultants. Finally, it will provide additional guidance to improve the consistency and speed 
of the assessment procedure of harmonised standards across the all relevant sectors. 

Third  Action:  The  Commission  will  elaborate  over  the  next  months  in  consultation  with 
stakeholders, a guidance document on practical aspects of implementing the Standardisation 

17 As of 1 December 2018, these Decisions will be taken by accelerated written procedure by the Commission. 
18 Vademecum on standardisation, the Blue Guide etc. 

5 

 
 
 
 
                                                           
Regulation,  paying  particular  attention  to  the  division  of  roles  and  responsibilities  in  the 
development process of harmonised standards as well as to efficiency and speed. 

In  order  to  ensure  better  upstream  coordination  in  the  process  of  assessing  harmonised 
standards, which the European Standardisation Organisations are in the process of developing, 
the Commission will continue to rely on the scientific input of the Joint Research Centre and, 
at  the  same  time,  will  reinforce  its  liaison  with  the  technical  committees  in  charge  of 
developing standards through the recently introduced system of expert consultants. The goal 
will be to maximise the speed, quality and accuracy of the assessments to improve the quality 
of  the  process  and  to  ensure  that  the  references  to  harmonised  standards  are  published  as 
quickly as possible in the Official Journal. Measures will include: 

- 

- 

- 

- 

- 

- 

reinforcing links between the relevant Commission services in charge of harmonised 
legislation  and  the  technical  committees  in  charge  of  developing  harmonised 
standards; 

expanding  the  pool  of  expert  consultants  and  their  skills-sets  to  ensure  the  expertise 
required for high-quality assessments and the resilience of the system; 

refining the structure of the work procedures and task allocation to expert consultants;  

focussing  on  continuous  quality  review  of  the  consultants'  input;  including  training 
programmes for expert consultants; 

enhancing  the  horizontal  coherence  of  the  assessments  by  applying  streamlined 
guidance across all sectors; 

appropriate management of possible conflicts of interest. 

Fourth  Action:  The  Commission  will  reinforce,  on  an  on-going  basis,  the  system  of 
consultants  to  support  swift  and  robust  assessments  of  harmonised  standards  and  timely 
citation in the Official Journal of the European Union.  

CONCLUSION  

The European standardisation system has been instrumental for the development of the Single 
Market.  The  presumption  of  conformity  with  the  relevant  Union  legislation  provides 
important  legal  certainty  to  all  standard  users  and  small  and  medium-sized  companies  in 
particular. The Standardisation Regulation, which came into force in 2013, introduced a new 
division  of  roles  and  responsibilities  of  the  actors  in  the  system  based  on  a  public  private 
partnership.  It  also  established  a  strong  framework  for  inclusiveness  requirements,  allowing 
interests  of  small  and  medium-sized  enterprises,  consumers  and  workers,  as  well  as 
environmental interests to be taken into consideration in the standardisation process. The joint 
objective  of  all  partners  in  the  European  standardisation  system  is  to  ensure  that  the 
Standardisation Regulation and other relevant Union laws are implemented as effectively as 
possible. 

The  Commission  is  entrusted  with  the  responsibility  for  the  assessment  of  European 
harmonised  standards.  The  Commission  also  needs  to  ensure  that  these  standards  are 
compatible with the requirements of the relevant harmonised Union legislation. The case law 
of  the  Court  of  Justice  of  the  European  Union  has  confirmed  the  importance  of  this 
responsibility and highlighted its legal implications.  

While the current system is functional, the Commission recognises that further improvement 
is necessary. The four actions outlined above will be initiated immediately in order to achieve 

6 

 
 
 
 
further  progress  with  regard  to  inclusiveness,  legal  certainty,  predictability  and  the  rapid 
delivery  of  the  benefits  of  harmonised  standards  for  the  Single  Market.  Innovation  and  the 
protection  of  citizens  and  the  environment  are  also  key  objectives  in  this  context.  The 
Commission will continue to work with all relevant partners to ensure the continued success 
of European standardisation as a cornerstone of a fully functioning Single Market.  

7