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 Europeanstandardisation organisations concerning European standards and Europeanstandardisation deliverables(Text with EEA relevance)

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EXPLANATORY MEMORANDUM

1.

CONTEXT OF THE PROPOSAL•Reasons for and objectives of the proposal

The European standardisation organisations (ESOs) are private organisations, which have aspecial role within the European standardisation system. As set out in Regulation (EU) No1025/2012 of the European Parliament and of the Council of 25 October 2012 1, 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 arequest 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 outin Article 10 of Regulation (EU) No 1025/2012 of the “Standardisation Regulation”. TheStandardisation 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 tothe 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 Europeanstandardisation organisations were set up and their role in delivering standards wasestablished, 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 legislationand policies, safeguards are needed to ensure sound procedure and a balanced representationof stakeholders’ interests, in line with the strategic priorities and legislative needs. In
particular, this applies to internal decisions to develop standards and standardisationdeliverables, as requested by the Commission on the basis of Article 10(1) of theStandardisation Regulation. These internal decisions can cover issues such as decisions on theacceptance of standardisation requests, on the acceptance of new work items, and on theadoption, 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 into1ENRegulation (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 and2009/105/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 L316,/12 of 14.11.2012).

1ENaccount the views of all European stakeholders (including small and medium enterprises andcivil 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 insome 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 of09.06.20205).
2.

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY•Legal basis

The legal basis for the initiative is Article 114 of the Treaty on the Functioning of theEuropean 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 nationalrepresentatives (i.e. national standardisation bodies) in the system.
•Proportionality

The proposed amendment to Regulation (EU) No 1025/2012 is very limited and targeted tothe work of the European standardisation organisations following a request from the2345EN

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 toensure 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 toachieve the objectives of ensuring that national representation/participation for thedevelopment 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 theprocess.
•Choice of the instrument

Regulation amending a Regulation.
3.

RESULTS
OFEX-POSTEVALUATIONS,CONSULTATIONS AND IMPACT ASSESSMENTS•Stakeholder consultations

STAKEHOLDER

The Commission has carried out a targeted consultation with the stakeholders on this matter(notably the European standardisation organisations, national standardisation bodies, EUMember 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 portal 6. 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. Theseadministrative 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 existinglegislation 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 theirinternal 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-Standardisationstrategy_en3EN

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 Europeanstandardisation 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)

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.

(2)

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

(3)

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

(4)

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 withinternational and European stakeholders. Such cooperation is welcome as it

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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 and2009/105/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
process. However, when European standardisation organisations executestandardisation requests to support Union legislation and policies, unrestricted
participation of any stakeholder in their internal decision-making may lead todecisions that do not entirely take into account the interests, policy objectives, andvalues of the Union as well as public interests in general.
(5)

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 thelevel of Member States. National standardisation bodies are therefore best placed tomake 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 requestedby the Commission under Article 10(1) of Regulation (EU) No 1025/2012.

(6)

The decision-making bodies of the European standardisation organisations are open toparticipation 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.

(7)

In order for the requirement for decisions in the decision-making bodies of European
standardisation organisations concerning European standards and Europeanstandardisation deliverables requested by the Commission under Article 10(1) ofRegulation (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.

(8)

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

(9)

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

HAVE ADOPTED THIS REGULATION:
Article 1Article 10 of Regulation (EU) No 1025/2012 is amended as follows:(1) in paragraph 1, the first sentence is replaced by the following:‘The Commission may within the limitations of the competences laid down in theTreaties, request that one or several European standardisation organisations draft aEuropean 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 nationalstandardisation 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 orEuropean standardisation deliverables.’.

Article 2This 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 forceof 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

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For the Council
The President

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