Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) No 1025/2012 as regards the decisions of European standardisation organisations concerning European standards and European standardisation deliverables
Date: 2022-02-02
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: Cenelec, ETSI, European Commission, European Committee for Standardisation, European standard, competence of the institution, harmonisation of standards, institutional cooperation, technical specification

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   EUROPEAN COMMISSION  Brussels, 2.2.2022  COM(2022) 32 final 2022/0021 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) No 1025/2012 as regards the decisions of European standardisation organisations concerning European standards and European standardisation deliverables (Text with EEA relevance)  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

The  European  standardisation  organisations  (ESOs)  are  private  organisations,  which  have  a 
special  role  within  the  European  standardisation  system.  As  set  out  in  Regulation  (EU)  No 
1025/2012  of  the  European  Parliament  and  of  the  Council  of  25  October  20121,  European 
standardisation  is  organised  by  and  for  the  stakeholders  concerned,  based  on  national 
representation  (in  the  European  Committee  for  standardisation,  CEN,  and  the  European 
Committee  for  Electrotechnical  Standardisation,  CENELEC)  and  on  direct  member 
participation  (in  the  European  Telecommunications  Standards  Institute,  ETSI).  When  a 
request  for  standardisation  is  made  by  the  Commission,  the  European  standardisation 
organisations (as defined in Regulation (EU) No 1025/2012) are the only bodies that can issue 
standards and standardisation deliverables. They do so in line with specific procedures set out 
in  Article  10  of  Regulation  (EU)  No  1025/2012  of  the  “Standardisation  Regulation”.  The 
Standardisation Regulation also provides that the European Union may support the European 
standardisation organisations financially.  

The European standardisation organisations are defined in Article 2, point 8 and Annex I to 
the Standardisation Regulation. There are three European standardisation organisations: CEN, 
CENELEC  and  ETSI.  They  have  an  exclusive  role  to  carry  out  standardisation  work 
requested by the Commission in support of EU legislation and policies.  

This  is  mainly  due  to  historic  reasons.  In  the  1980s,  when  the  current  European 
standardisation  organisations  were  set  up  and  their  role  in  delivering  standards  was 
established, the system was mostly centred on stakeholders of the European Union.  

Today,  the  situation  is  different  and  the  ESOs’  internal  governance,  decision-making 
procedures  and  their  membership  structure  have  gone  through  multiple  changes.  The 
European  standardisation  organisations  now  cooperate  with  a  wide  range  of  stakeholders, 
including from third countries, and allow them to  participate not  only in  the technical  work 
but also in their internal policy- and decision-making. Such cooperation is welcome; however, 
when  the  European  standardisation  organisations  should  focus  on  supporting  EU  legislation 
and policies, safeguards are needed to ensure sound procedure and a balanced representation 
of  stakeholders’  interests,  in  line  with  the  strategic  priorities  and  legislative  needs.  In 
particular,  this  applies  to  internal  decisions  to  develop  standards  and  standardisation 
deliverables,  as  requested  by  the  Commission  on  the  basis  of  Article  10(1)  of  the 
Standardisation Regulation. These internal decisions can cover issues such as decisions on the 
acceptance  of  standardisation  requests,  on  the  acceptance  of  new  work  items,  and  on  the 
adoption,  revision  or  withdrawal  of  European  standardisation  deliverables.  In  these  cases, 
particularly  when  the  European  standardisation  organisations  support  the  application  of  EU 
legislation and develop standards that are crucial to the EU general public and to companies, 
the  internal  governance  of  the  European  standardisation  organisations  must  duly  take  into 

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Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on 
European  standardisation,  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,  2009/23/EC  and 
2009/105/EC  of  the  European  Parliament  and  of  the  Council  and  repealing  Council  Decision 
87/95/EEC  and  Decision  No  1673/2006/EC  of  the  European  Parliament  and  of  the  Council  (OJ  L 
316,/12 of 14.11.2012). 

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account the views of all European stakeholders (including small and medium enterprises and 
civil  society  organisations).  This  is  even  more  pertinent  given  that  some  European 
standardisation  organisations  are  mainly  composed  by  economic  operators  who  have  voting 
rights  and the participation of civil  society  organisations and public authorities is  limited in 
some cases. 

Greater  clarification  is  therefore  needed  to  ensure  that  the  whole  internal  decision-making 
process  in  issuing  standards  and  standardisation  deliverables,  requested  by  the  Commission 
on the basis of  Article 10(1) of the Standardisation Regulation,  is  in line with  what the EU 
institutions  expect  from  a  standards-developing  body  officially  recognised  as  a  European 
standards organisation.  

Requiring  a  certain  representation  and  decision-making  power  of  national  standardisation 
bodies as regards standards requested by the Commission would put in place sufficient checks 
and balances so to ensure consistency with EU legislation and policies. 

• 

Consistency with existing policy provisions in the policy area 

The  Commission  announced  that  it  would  propose  an  amendment  to  Regulation  (EU)  No 
1025/2012  in  its  initiative  Updating  the  2020  new  industry  strategy  (COM(2021)350)2 
together with a standardisation strategy, which is presented together with this proposal. 

• 

Consistency with other Union policies 

The proposed legislative amendment is in line with the political importance of standards, as 
highlighted  in  other  key  Commission  initiatives,  such  as  Shaping  Europe's  digital  future 
(COM(2020)673),  the  Global  Gateway  (JOIN(2021)304),  or  the  Council’s  statement 
welcoming ‘the Commission’s intention to develop a strategy for standardisation to strengthen 
the  European  standardisation  system  and 
its  governance’  (Council  conclusions  of 
09.06.20205). 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The  legal  basis  for  the  initiative  is  Article  114  of  the  Treaty  on  the  Functioning  of  the 
European Union. 

• 

Subsidiarity (for action where the ESOs do not have exclusive competence)  

The  question  of  subsidiarity  is  not  an  issue.  This  initiative  is  to  amend  an  EU  Regulation 
governing  the  European  standardisation  system.  It  aims  specifically  to  safeguard  good 
governance principles in the delivery of standards requested by the Commission under Article 
10(1)  of  the  Standardisation  Regulation.  This  initiative  will  reinforce  the  role  of  national 
representatives (i.e. national standardisation bodies) in the system. 

• 

Proportionality 

The proposed amendment  to  Regulation  (EU)  No  1025/2012  is  very limited and targeted to 
the  work  of  the  European  standardisation  organisations  following  a  request  from  the 

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https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2021:350:FIN 
https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:52020DC0067 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=JOIN%3A2021%3A30%3AFIN 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020XG0616%2801%29 

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Commission. These requests follow a public policy mandate and, therefore, it is important to 
ensure good governance principles in line with EU decision making. The proposal complies 
with the proportionality principle because it does not go beyond what is necessary in order to 
achieve  the  objectives  of  ensuring  that  national  representation/participation  for  the 
development  of  European  standards  and  standardisation  deliverables,  based  on  a  request 
under  Article  10  of  Regulation  (EU)  No  1025/2012,  is  guaranteed  at  every  stage  of  the 
process.  

• 

Choice of the instrument 

Regulation amending a Regulation. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Stakeholder consultations 

The Commission has carried out a targeted consultation with the stakeholders on this matter 
(notably  the  European  standardisation  organisations,  national  standardisation  bodies,  EU 
Member States, and industrial and civil society stakeholders). These stakeholders were given 
the opportunity to express their views and provide input to the Commission’s work. 

During  the  consultation  on  the  roadmap  for  the  standardisation  strategy,  stakeholders 
provided  valuable  feedback  on  the  governance  and  on  transparency  in  the  European 
standardisation  system  in  the  Commission’s  Better  Regulation  portal6.  The  Commission 
received  similar  feedback  through  the  reports  issued  by  the  European  stakeholder 
organisations under Article 24(2) of the Standardisation Regulation. 

• 

Impact assessment 

The Commission did not carry out an impact assessment (IA) for this initiative. The proposed 
initiative  regards  administrative  decisions  within  the  European  standardisation  organisations 
following  requests  from  the  Commission  based  on  a  policy  or  legal  need.  These 
administrative  decisions  cover  governance/administrative  decisions  for  Union  policies.  The 
impact  of  these  administrative  decisions  are  limited  to  identifiable  stakeholders.  In 
conclusion, there was no need for an IA and the related public consultation as the amendment 
would  be/is  limited  in  scope,  targeted  and  provides  technical  amendments  to  the  existing 
legislation regarding the issue of governance. 

4. 

BUDGETARY IMPLICATIONS 

The proposal does not have a budgetary impact for the EU institutions. 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

The proposal is to amend only two articles.  

To  enable  the  European  Standardisation  Organisations  –  where  necessary  –  to  adapt  their 
internal  rules  of  procedure,  the  amendment  provides  for  a  transition  period  of  six  months 
before entering into force. 

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https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13099-Standardisation-
strategy_en 

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The Commission  will assist  the European standardisation organisations to  help  them amend 
their internal  rules  for decision making regarding standards  and standardisation  deliverables 
requested by the Commission under Article 10(1) of the Standardisation Regulation. 

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2022/0021 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EU) No 1025/2012 as regards the decisions of European 
standardisation organisations concerning European standards and European 
standardisation deliverables 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee7,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

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Regulation  (EU)  No  1025/2012  of  the  European  Parliament  and  of  the  Council8 
establishes rules with regard to the establishment of European standards and European 
standardisation  deliverables  for  products  and  for  services  in  support  of  Union 
legislation and policies.  

In accordance with Article 10 of Regulation (EU) No 1025/2012 the Commission may 
request  one  or  several  European  standardisation  organisations  to  draft  a  European 
standard or European standardisation deliverable. 

European standards and European standardisation deliverables play an important role 
for  the  internal  market.  For  instance,  harmonised  standards  may  be  used  to  confer  a 
presumption that products to be made available on the market are in conformity with 
the  essential  requirements  that  are  laid  down  in  the  relevant  Union  harmonisation 
legislation for those products when they comply with the harmonised standards. 

In the past years, the practices in the European standardisation organisations as regards 
their internal governance and decision-making procedures have changed. As a result, 
the  European  standardisation  organisations  have  increased  their  co-operation  with 
international  and  European  stakeholders.  Such  cooperation  is  welcome  as  it 

OJ C …, …, p. …. 
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on 
European  standardisation,  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,  2009/23/EC  and 
2009/105/EC  of  the  European  Parliament  and  of  the  Council  and  repealing  Council  Decision 
87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council  (OJ L 316, 
14.11.2012, p. 12). 

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contributes  to  the  transparent,  open,  impartial  and  consensus-built  standardisation 
execute 
process.  However,  when  European 
standardisation  requests  to  support  Union  legislation  and  policies,  unrestricted 
participation  of  any  stakeholder  in  their  internal  decision-making  may  lead  to 
decisions  that  do  not  entirely  take  into  account  the  interests,  policy  objectives,  and 
values of the Union as well as public interests in general. 

standardisation  organisations 

National  standardisation  bodies  play  an  essential  role  in  the  standardisation  system, 
both, at the Union level, in accordance with Regulation (EU) No 1025/2012, and at the 
level  of  Member  States.  National  standardisation  bodies  are  therefore  best  placed  to 
make  sure  that  the  interests,  policy  objectives  and  values  of  the  Union  as  well  as 
public  interests  in  general  are  duly  taken  into  account  in  European  standardisation 
organisations.  It  is  therefore  necessary  to  strengthen  their  role  in  decision-making 
bodies of the European standardisation organisations when those bodies take decisions 
concerning  European  standards  and  European  standardisation  deliverables  requested 
by the Commission under Article 10(1) of Regulation (EU) No 1025/2012. 

The decision-making bodies of the European standardisation organisations are open to 
participation  not  only  by  national  standardisation  bodies,  but  also  by  national 
standardisation organisations of acceding countries, candidate countries and potential 
candidates to the Union, among others. In order to avoid excluding those organisations 
from  participation  in  the  work  of  decision-making  bodies  concerned,  it  is  only 
necessary to provide that the decisions in those bodies concerning European standards 
and European standardisation deliverables requested under Article 10(1) of Regulation 
(EU) No 1025/2012 be taken exclusively by representatives of national standardisation 
bodies, without imposing any other requirements on the work of the decision-making 
bodies of the European standardisation organisations. 

In order for the requirement for decisions in the decision-making bodies of European 
standardisation  organisations  concerning  European  standards  and  European 
standardisation  deliverables  requested  by  the  Commission  under  Article  10(1)  of 
Regulation (EU) No 1025/2012 to be taken exclusively by representatives of national 
standardisations bodies to be effective, it is necessary to provide that the Commission 
may only make such requests to a European standardisation organisation that complies 
with that requirement. 

Regulation (EU) No 1025/2012 should therefore be amended accordingly. 

In  order  to  allow  the  European  standardisation  organisations  to  adapt,  where 
necessary, their internal rules of procedure to the requirements of this Regulation, its 
application should be deferred, 

(5) 

(6) 

(7) 

(8) 

(9) 

HAVE ADOPTED THIS REGULATION: 

Article 10 of Regulation (EU) No 1025/2012 is amended as follows: 

(1) in paragraph 1, the first sentence is replaced by the following: 

Article 1 

‘The  Commission  may  within  the  limitations  of  the  competences  laid  down  in  the 
Treaties,  request  that  one  or  several  European  standardisation  organisations  draft  a 
European standard or European standardisation deliverable within a set deadline, provided 
that the European standardisation organisation concerned complies with paragraph 2a.’; 

(2) the following paragraph 2a is inserted: 

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‘2a. 
Each  European  standardisation  organisation  shall  ensure  that  the  following 
decisions  concerning  European  standards  and  European  standardisation  deliverables 
referred  to  in  paragraph  1  are  taken  exclusively  by  representatives  of  the  national 
standardisation bodies within the competent decision-making body of that organisation:  

(a) decisions on the acceptance, refusal and execution of standardisation requests; 

(b) decisions on the acceptance of new work items;  

(c)  decisions  on  the  adoption,  revision  and  withdrawal  of  European  standards  or 
European standardisation deliverables.’. 

Article 2 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

It shall apply from … [OP: please insert the date – 6 months from the date of entry into force 
of this Regulation]. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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