HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 316/12
EN
Official Journal of the European Union
14.11.2012
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
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
standardisation process. National standardisation bodies
EUROPEAN UNION,
should also encourage and facilitate the participation of
stakeholders.
Having regard to the Treaty on the Functioning of the European
Union, and in particular Article 114 thereof,
(3) European
standardisation
also
helps
to
boost
the
competitiveness of enterprises by facilitating in particular
Having regard to the proposal from the European Commission,
the free movement of goods and services, network inter
operability, means of communication, technological
development and innovation. European standardisation
After transmission of the draft legislative act to the national
reinforces the global competitiveness of European
parliaments,
industry especially when established in coordination
with the international standardisation bodies, namely
the International Organisation for Standardisation (ISO),
Having regard to the opinion of the European Economic and
the International Electrotechnical Commission (IEC) and
Social Committee (
the International Telecommunication Union (ITU).

1 ),
Standards produce significant positive economic effects,
for example by promoting economic interpenetration on
Acting in accordance with the ordinary legislative procedure (
the internal market and encouraging the development of

2 ),
new and improved products or markets and improved
supply conditions. Standards thus normally increase
Whereas:
competition and lower output and sales costs, benefiting
economies as a whole and consumers in particular.
Standards may maintain and enhance quality, provide
(1) The
primary
objective
of
standardisation
is
the
definition
information and ensure interoperability and compati
of voluntary technical or quality specifications with
bility, thereby increasing safety and value for consumers.
which current or future products, production processes
or services may comply. Standardisation can cover
various issues, such as standardisation of different
(4)
European standards are adopted by the European stan
grades or sizes of a particular product or technical spec
dardisation organisations, namely CEN, Cenelec and ETSI.
ifications in product or services markets where compati
bility and interoperability with other products or systems
are essential.
(5) European
standards
play
a
very
important
role
within
the
internal market, for instance through the use of
(2) European
standardisation
is
organised
by
and
for
the
harmonised standards in the presumption of conformity
stakeholders concerned based on national representation
of products to be made available on the market with the
(the European Committee for Standardisation (CEN) and
essential requirements relating to those products laid
the European Committee for Electrotechnical Standard
down in the relevant Union harmonisation legislation.
isation (Cenelec)) and direct participation (the European
Those requirements should be precisely defined in
Telecommunications Standards Institute (ETSI)), and is
order to avoid misinterpretation on the part of the
founded on the principles recognised by the World
European standardisation organisations.
Trade Organisation (WTO) in the field of standardisation,
namely coherence, transparency, openness, consensus,
voluntary application, independence from special
interests and efficiency (‘the founding principles’). In
(6) Standardisation
plays
an
increasingly
important
role
in
accordance with the founding principles, it is important
international trade and the opening-up of markets. The
that all relevant interested parties, including public auth
Union should seek to promote cooperation between
orities and small and medium-sized enterprises (SMEs),
European standardisation organisations and international
are appropriately involved in the national and European
standardisation bodies. The Union should also promote
bilateral approaches with third countries to coordinate
standardisation efforts and promote European standards,
( 1 ) OJ C 376, 22.12.2011, p. 69.
for instance when negotiating agreements or by
( 2 ) Position of the European Parliament of 11 September 2012 (not yet
published in the Official Journal) and decision of the Council of
seconding standardisation experts to third countries.
4 October 2012.
Furthermore the Union should encourage contact

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between European standardisation organisations and
Member States, the provision of information to the
private forums and consortia, while maintaining the
recipient and the quality of service provision. However,
primacy of European standardisation.
Directive 98/34/EC only applies to standards for
products while standards for services are not expressly
covered by it. Furthermore, the delineation between
services and goods is becoming less relevant in the
(7) European
standardisation
is
governed
by
a
specific
legal
reality of the internal market. In practice, it is not
framework consisting of three different legal acts, namely
always possible to clearly distinguish standards for
Directive 98/34/EC of the European Parliament and of
products from standards for services. Many standards
the Council of 22 June 1998 laying down a procedure
for products have a service component while standards
for the provision of information in the field of technical
for services often also partly relate to products. Thus, it is
standards and regulations and of rules on Information
necessary to adapt the current legal framework to these
Society services ( 1 ), Decision No 1673/2006/EC of the
new circumstances by extending its scope to standards
European Parliament and of the Council of 24 October
for services.
2006 on the financing of European standardisation ( 2 )
and Council Decision 87/95/EEC of 22 December
1986 on standardisation in the field of information tech
nology and telecommunications ( 3 ). However, the current
legal framework is no longer up to date with devel
(11) Like
other
standards,
standards
for
services
are
voluntary
and should be market-driven, whereby the needs of the
opments in European standardisation over recent
economic operators and stakeholders directly or indi
decades. Therefore, the current legal framework should
rectly affected by such standards prevail, and should
be simplified and adapted in order to cover new aspects
take into account the public interest and be based on
of standardisation to reflect those latest developments
the founding principles, including consensus. They
and future challenges in European standardisation. That
should primarily focus on services linked to products
relates in particular to the increased development of
and processes.
standards for services and the evolution of standard

isation deliverables other than formal standards.
(12) The
legal
framework
allowing
the
Commission
to
request
(8) The
European
Parliament’s
Resolution
of
21
October
one or several European standardisation organisations to
2010 on the future of European standardisation ( 4 ), as
draft a European standard or European standardisation
well as the report of the Expert Panel for the Review
deliverable for services should be applied while fully
of the European Standardization System (Express) of
respecting the distribution of competences between the
February 2010 entitled ‘Standardization for a competitive
Union and the Member States as laid down in the
and innovative Europe: a vision for 2020’, have set out
Treaties. This concerns in particular Articles 14, 151,
an important number of strategic recommendations
152, 153, 165, 166 and 168 of the Treaty on the Func
regarding the review of the European standardisation
tioning of the European Union (TFEU) and Protocol (No
system.
26) on Services of General Interest annexed to the Treaty
on European Union (TEU) and to the TFEU in accordance
with which it remains the exclusive competence of the
Member States to define the fundamental principles of
(9) In
order
to
ensure
the
effectiveness
of
standards
and
their social security, vocational training and health
standardisation as policy tools for the Union, it is
systems and to shape the framework conditions for the
necessary to have an effective and efficient standard
management, financing, organisation and delivery of the
isation system which provides a flexible and transparent
services supplied within those systems, including -
platform for consensus building between all participants
without prejudice to Article 168(4) TFEU and to
and which is financially viable.
Directive 2005/36/EC of the European Parliament and
of the Council of 7 September 2005 on the recognition
of professional qualifications
( 6 ) - the definition of
requirements, quality and safety standards applicable to
(10) Directive
2006/123/EC
of
the
European
Parliament
and
them. The Commission should not, by means of such a
of the Council of 12 December 2006 on services in the
request, affect the right to negotiate, conclude and
internal market ( 5 ) establishes general provisions facili
enforce collective agreements and to take industrial
tating the exercise of the freedom of establishment for
action in accordance with national law and practices
service providers and the free movement of services,
which respect Union law.
while maintaining a high quality of services. It obliges
the Member States to encourage, in cooperation with the
Commission, the development of voluntary European
standards with the aim of facilitating compatibility
(13) The
European
standardisation
organisations
are
subject
to
between services supplied by providers in different
competition law to the extent that they can be
considered to be an undertaking or an association of
( 1 ) OJ L 204, 21.7.1998, p. 37.
undertakings within the meaning of Articles 101 and
( 2 ) OJ L 315, 15.11.2006, p. 9.
102 TFEU.
( 3 ) OJ L 36, 7.2.1987, p. 31.
( 4 ) OJ C 70 E, 8.3.2012, p. 56.
( 5 ) OJ L 376, 27.12.2006, p. 36.
( 6 ) OJ L 255, 30.9.2005, p. 22.

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Official Journal of the European Union
14.11.2012
(14) Within
the
Union,
national
standards
are
adopted
by
(19) Standards
can
contribute
to
helping
Union
policy
address
national standardisation bodies which could lead to
the major societal challenges such as climate change,
conflicting standards and technical impediments in the
sustainable resource use, innovation, ageing population,
internal market. Therefore, it is necessary for the
integration of people with disabilities, consumer
internal market and for the effectiveness of standard
protection, workers’ safety and working conditions. By
isation within the Union to confirm the existing regular
driving the development of European or international
exchange of information between the national standard
standards for goods and technologies in the expanding
isation bodies, the European standardisation organi
markets in those areas, the Union could create a
sations and the Commission, about their current and
competitive advantage for its enterprises and facilitate
future standardisation activities as well as the standstill
trade, in particular for SMEs, which account for a large
principle applicable to the national standardisation bodies
part of European enterprises.
within the framework of the European standardisation
organisations which provides for the withdrawal of
national standards after the publication of a new
European standard. The national standardisation bodies
and European standardisation organisations should also
(20) Standards
are
important
tools
for
the
competitiveness
of
observe the provisions on exchange of information in
undertakings and especially SMEs, whose participation in
Annex 3 to the Agreement on Technical Barriers to
the standardisation process is important for technological
Trade ( 1 ).
progress in the Union. Therefore it is necessary that the
standardisation framework encourage SMEs to actively
participate in and provide their innovative technology
(15) The
Member
States’
obligation
to
notify
the
Commission
solutions to standardisation efforts. This includes
of their national standardisation bodies should not
improving their participation at national level where
require the adoption of a specific national legislation
they can be more effective due to lower costs and lack
for the purposes of recognition of those bodies.
of linguistic barriers. Consequently this Regulation should
improve representation and participation of SMEs in
both national and European technical committees and
(16) The regular exchange of information between the
should facilitate their effective access to and awareness
national standardisation bodies, the European standard
of standards.
isation organisations and the Commission should not
prevent national standardisation bodies from complying
with other obligations and commitments, and in
particular with Annex 3 to the Agreement on
Technical Barriers to Trade.
(21) European
standards
are
of
vital
interest
for
the
competi
tiveness of SMEs which, however, are in some cases
under-represented in European standardisation activities.
(17) The representation of societal interests and societal stake
Thus, this Regulation should encourage and facilitate
holders in European standardisation activities refers to
appropriate representation and participation of SMEs in
the activities of organisations and parties representing
the European standardisation process by an entity that is
interests of greater societal relevance, for instance envi
effectively in contact with, and duly representative of,
ronmental, consumer interests or employee interests.
SMEs and organisations representing SMEs at national
However, the representation of social interests and
level.
social stakeholders in European standardisation activities
refers particularly to the activities of organisations and
parties representing employees and workers’ basic rights,
for instance trade unions.
(22) Standards can have
a broad impact on society, in
particular on the safety and well-being of citizens, the
efficiency of networks, the environment, workers’ safety
(18) In order to speed up the decision-making process,
and working conditions, accessibility and other public
national standardisation bodies and European standard
policy fields. Therefore, it is necessary to ensure that
isation organisations should facilitate accessible
the role and the input of societal stakeholders in the
information on their activities through the promotion
development of standards are strengthened, through the
of the use of information and communication tech
reinforced support of organisations representing
nologies (ICT) in their respective standardisation
consumers and environmental and social interests.
systems, for example by providing to all relevant stake

holders an easy-to-use online consultation mechanism
for the submission of comments on draft standards
and by organising virtual meetings, including by means
of web conferencing or video conferencing, of technical
committees.
(23) The
obligation
of
the
European
standardisation
organi
sations to encourage and facilitate representation and
effective participation of all relevant stakeholders does
( 1 ) Approved by Council Decision 94/800/EC of 22 December 1994
not entail any voting rights for these stakeholders
concerning the conclusion on behalf of the European Community,
unless such voting rights are prescribed by the internal
as regards matters within its competence, of the agreements reached
in the Uruguay Round multilateral negotiations (1986-1994)
rules of procedure of the European standardisation
(OJ L 336, 23.12.1994, p. 1).
organisations.

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(24) The
European
standardisation
system
should
also
fully
the European standardisation organisations to respond
take into account the United Nations Convention on
more quickly to the requested standardisation activities.
the Rights of Persons with Disabilities ( 1 ). It is therefore
important that organisations representing the interests of
consumers sufficiently represent and include the interests
of people with disabilities. In addition, the participation
of people with disabilities in the standardisation process
(28) Before
bringing
a
matter
regarding
requests
for
European
should be facilitated by all available means.
standards or European standardisation deliverables, or
objections to a harmonised standard before the
committee set up by this Regulation, the Commission
should consult experts of the Member States, for
instance through the involvement of committees set up
(25) Due
to
the
importance
of
standardisation
as
a
tool
to
by the corresponding Union legislation or by other forms
support Union legislation and policies and in order to
of consultation of sectoral experts, where such
avoid ex-post objections to and modifications of
committees do not exist.
harmonised standards, it is important that public auth
orities participate in standardisation at all stages of the
development of those standards where they may be
involved and especially in the areas covered by Union
harmonisation legislation for products.
(29) Several
directives
harmonising
the
conditions
for
the
marketing of products specify that the Commission
may request the adoption, by the European standard
isation organisations, of harmonised standards on the
basis of which conformity with the applicable essential
(26) Standards should take into account environmental
requirements is presumed. However, many of those
impacts throughout the life cycle of products and
directives contain a wide variety of provisions on
services. Important and publicly available tools for
objections to these standards when the latter do not,
evaluating such impacts throughout the life cycle have
or do not entirely, cover all applicable requirements.
been developed by the Commission’s Joint Research
Diverging provisions which lead to uncertainty for
Centre (JRC). Thus, this Regulation should ensure that
economic operators and European standardisation
the JRC can play an active role in the European standard
organisations are in particular contained in Council
isation system.
Directive 89/686/EEC of 21 December 1989 on the
approximation of the laws of the Member States
relating to personal protective equipment ( 2 ), Council
Directive 93/15/EEC of 5 April 1993 on the harmon
isation of the provisions relating to the placing on the
(27) The viability of the cooperation between the Commission
market and supervision of explosives for civil uses ( 3 ),
and the European standardisation system depends on
Directive 94/9/EC of the European Parliament and the
careful planning of future requests for the development
Council of 23 March 1994 on the approximation of
of standards. This planning could be improved, in
the laws of the Member States concerning equipment
particular through the input of interested parties,
and protective systems intended for use in potentially
including national market surveillance authorities, by
explosive atmospheres ( 4 ), Directive 94/25/EC of the
introducing mechanisms for collecting opinions and
European Parliament and of the Council of 16 June
facilitating the exchange of information among all
1994 on the approximation of the laws, regulations
interested parties. Since Directive 98/34/EC already
and administrative provisions of the Member States
provides for the possibility to request the European stan
relating to recreational craft ( 5 ), European Parliament
dardisation organisations to develop European standards,
and Council Directive 95/16/EC of 29 June 1995 on
it is appropriate to put in place a better and more trans
the approximation of the laws of the Member States
parent planning in an annual work programme which
relating to lifts ( 6 ), Directive 97/23/EC of the European
should contain an overview of all requests for
Parliament and of the Council of 29 May 1997 on the
standards which the Commission intends to submit to
approximation of the laws of the Member States
European standardisation organisations. It is necessary to
concerning pressure equipment ( 7 ), Directive 2004/22/EC
ensure a high level of cooperation between the European
of the European Parliament and of the Council of
standardisation organisations and the European stake
31 March 2004 on measuring instruments ( 8 ), Directive
holder organisations receiving Union financing in
2007/23/EC of the European Parliament and of the
accordance with this Regulation and the Commission
Council of 23 May 2007 on the placing on the market
in the establishment of its annual Union work
of pyrotechnic articles ( 9 ), Directive 2009/23/EC of the
programme for standardisation and in the preparation
European Parliament and of the Council of
of requests for standards in order to analyse the
market relevance of the proposed subject matter and
( 2 ) OJ L 399, 30.12.1989, p. 18.
the policy objectives set by the legislator, and to allow
( 3 ) OJ L 121, 15.5.1993, p. 20.
( 4 ) OJ L 100, 19.4.1994, p. 1.
( 5 ) OJ L 164, 30.6.1994, p. 15.
( 1 ) Approved by Council Decision 2010/48/EC of 26 November 2009
( 6 ) OJ L 213, 7.9.1995, p. 1.
concerning the conclusion, by the European Community, of the
( 7 ) OJ L 181, 9.7.1997, p. 1.
United Nations Convention on the Rights of Persons with
( 8 ) OJ L 135, 30.4.2004, p. 1.
Disabilities (OJ L 23, 27.1.2010, p. 35).
( 9 ) OJ L 154, 14.6.2007, p. 1.

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Official Journal of the European Union
14.11.2012
23 April 2009 on non-automatic weighing instru
evolution in the field of ICT, facilitate the provision of
ments ( 1 ) and Directive 2009/105/EC of the European
cross-border services, encourage competition and
Parliament and of the Council of 16 September 2009
promote interoperability and innovation.
relating to simple pressure vessels ( 2 ). Therefore, it is
necessary to include in this Regulation the uniform
procedure provided for in Decision No 768/2008/EC
of the European Parliament and of the Council of
(31) Technical
specifications
not
adopted
by
European
stan
9 July 2008 on a common framework for the
dardisation organisations do not hold an equivalent
marketing of products ( 3 ), delete the relevant provisions
status to European standards. Some ICT technical spec
in those Directives and extend to the European
ifications are not developed in accordance with the
Parliament the right to object to a harmonised standard
founding principles. Therefore, this Regulation should
in accordance with this Regulation.
lay down a procedure for the identification of ICT
technical specifications that could be referenced in
public procurement, involving a broad consultation of
a large spectrum of stakeholders, including the
European standardisation organisations, enterprises and
(30) Public authorities should make best use of the full range
public authorities. This Regulation should also lay
of relevant technical specifications when procuring
down requirements, in the form of a list of criteria, for
hardware, software and information technology services,
such technical specifications and their associated devel
for example by selecting technical specifications which
opment processes. The requirements for the identification
can be implemented by all interested suppliers,
of ICT technical specifications should ensure that public
allowing for more competition and reduced risk of
policy objectives and societal needs are respected, and
lock-in. Directive 2004/17/EC of the European
should be based on the founding principles.
Parliament and of the Council of 31 March 2004 coor
dinating the procurement procedures of entities
operating in the water, energy, transport and postal
services sectors
( 4 ), Directive 2004/18/EC of the
European Parliament and of the Council of 31 March
(32) In
order
to
further
innovation
and
competition,
the
2004 on the coordination of procedures for the award
identification of a particular technical specification
of public works contracts, public supply contracts and
should not disqualify a competing technical specification
public service contracts (
from being identified in accordance with the provisions

5 ), Directive 2009/81/EC of the
European Parliament and of the Council of 13 July 2009
of this Regulation. Any identification should be subject
on the coordination of procedures for the award of
to the criteria being fulfilled and to the technical specifi
certain works contracts, supply contracts and service
cation having achieved a significant level of market
contracts by contracting authorities or entities in the
acceptance.
fields of defence and security ( 6 ) and Commission Regu
lation (EC, Euratom) No 2342/2002 of 23 December
2002 laying down detailed rules for the implementation
of Council Regulation (EC, Euratom) No 1605/2002 on
(33) The identified ICT technical specifications could
the Financial Regulation applicable to the general budget
contribute to the implementation of Decision No
of the European Communities ( 7 ) specify that technical
922/2009/EC of the European Parliament and of the
specifications in public procurement should be
Council of 16 September 2009 on interoperability
formulated by reference to national standards transposing
solutions for European public administrations (ISA) ( 8 )
European standards, European technical approvals,
which establishes, for the period 2010-2015, a
common technical specifications, international standards,
programme on interoperability solutions for European
other technical reference systems established by the
public administrations and institutions and bodies of
European standardisation organisations or - when these
the Union, providing common and shared solutions
do not exist - to national standards, national technical
facilitating interoperability.
approvals or national technical specifications relating to
the design, calculation and execution of the works and
use of the products, or equivalent. ICT technical specifi
cations, however, are often developed by other standard
(34) Situations
may
arise
in
the
field
of
ICT
where
it
is
appro
developing organisations and do not fall in any of the
priate to encourage the use of, or require compliance,
categories of standards and approvals laid down in
with relevant standards at Union level in order to
Directives 2004/17/EC, 2004/18/EC or 2009/81/EC or
ensure interoperability in the single market and to
Regulation (EC, Euratom) No 2342/2002. Therefore, it
improve freedom of choice for users. In other circum
is necessary to provide for the possibility that technical
stances, it may also happen that specified European
specifications for public procurement could refer to ICT
standards no longer meet consumers’ needs or are
technical specifications, in order to respond to the fast
hampering technological development. For these
reasons, Directive 2002/21/EC of the European
( 1 ) OJ L 122, 16.5.2009, p. 6.
Parliament and of the Council of 7 March 2002 on a
( 2 ) OJ L 264, 8.10.2009, p. 12.
common regulatory framework for electronic communi
( 3 ) OJ L 218, 13.8.2008, p. 82.
cations networks and services
( 9 ) enables the
( 4 ) OJ L 134, 30.4.2004, p. 1.
( 5 ) OJ L 134, 30.4.2004, p. 114.
( 6 ) OJ L 216, 20.8.2009, p. 76.
( 8 ) OJ L 260, 3.10.2009, p. 20.
( 7 ) OJ L 357, 31.12.2002, p. 1.
( 9 ) OJ L 108, 24.4.2002, p. 33.

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Commission, where necessary, to request European stan
Article 110(1) of Council Regulation (EC, Euratom) No
dardisation organisations to draw up standards, to
1605/2002 of 25 June 2002 on the Financial Regulation
establish and publish in the Official Journal of the
applicable to the general budget of the European
European Union a list of standards or specifications with
Communities ( 2 ) and point (d) of Article 168(1) of Regu
the view to encourage their use, or to make their imple
lation (EC, Euratom) No 2342/2002. Furthermore, the
mentation compulsory, or to remove standards or spec
same provisions should apply to those bodies which,
ifications from that list.
whilst not recognised as European standardisation
organisations in this Regulation, have been mandated
in a basic act and have been entrusted with carrying
out preliminary work in support of European standard
isation in cooperation with the European standardisation
(35) This
Regulation
should
not
prevent
European
standard
isation organisations from continuing to develop
organisations.
standards in the field of ICT and to increase their
cooperation with other standard developing bodies,
especially in the field of ICT, in order to ensure
(40) Inasmuch as European standardisation organisations
coherence and avoid fragmentation or duplication
provide ongoing support for Union activities, they
during implementation of standards and specifications.
should have effective and efficient central secretariats.
The Commission should therefore be allowed to
provide grants to those organisations that are pursuing
an objective of general European interest without
(36) The
procedure
for
identification
of
ICT
technical
specifi
applying, in the case of operating grants, the principle
cations provided for in this Regulation should not
of annual reduction provided for in Article 113(2) of
undermine the coherence of the European standard
Regulation (EC, Euratom) No 1605/2002.
isation system. Therefore, this Regulation should also
lay down the conditions under which it can be
considered that a technical specification does not
conflict with other European standards.
(41) Decision
No
1639/2006/EC
of
the
European
Parliament
and of the Council of 24 October 2006 establishing a
Competitiveness and Innovation Framework Programme
(2007 to 2013) ( 3 ), Decision No 1926/2006/EC of the
European Parliament and of the Council of 18 December
(37) Before
identifying
ICT
technical
specifications
which
may
2006 establishing a programme of Community action in
be eligible for referencing in public procurement, the
the field of consumer policy (2007-2013) (
Multi Stakeholder Platform established by the

4 ) and Regu
lation (EC) No 614/2007 of the European Parliament and
Commission Decision of 28 November 2011 ( 1 ) should
of the Council of 23 May 2007 concerning the Financial
be used as a forum for consultation of European and
Instrument for the Environment (LIFE+)
(
national stakeholders, European standardisation organi

5 ) already
provide for the possibility of financial support of
sations and Member States in order to ensure legitimacy
European organisations representing SMEs, consumers
of the process.
and environmental interests in standardisation, while
specific grants are paid to European organisations repre
senting social interests in standardisation. The financing
under Decision No 1639/2006/EC, Decision No
(38) Decision No 1673/2006/EC establishes the rules
1926/2006/EC and Regulation (EC) No 614/2007 will
concerning the contribution of the Union to the
end on 31 December 2013. It is essential for the devel
financing of European standardisation in order to
opment of European standardisation to continue
ensure that European standards and other European stan
fostering and encouraging the active participation of
dardisation deliverables are developed and revised in
European organisations representing SMEs, consumers
support of the objectives, legislation and policies of the
and environmental and social interests. Such organi
Union. It is appropriate, for the purpose of administrative
sations pursue an aim of general European interest and
and budgetary simplification, to incorporate the
constitute, by virtue of the specific mandate that national
provisions of that Decision into this Regulation and to
non-profit organisations have given them, a European
use wherever possible the least burdensome procedures.
network representing non-profit organisations active in
the Member States and promoting principles and
policies consistent with the objectives of the Treaties.
Because of the context in which they operate and their
statutory objectives, European organisations representing
(39) In view of the very broad field of involvement of
SMEs, consumers and environmental and social interests
European standardisation in support of Union legislation
in European standardisation have a permanent role which
and policies and the different types of standardisation
is essential for Union objectives and policies. Therefore,
activity, it is necessary to provide for different
the Commission should be in a position to continue
financing arrangements. This mainly concerns grants
providing grants to those organisations without
without calls for proposals to the European standard
isation organisations and national standardisation
bodies in accordance with the second subparagraph of
( 2 ) OJ L 248, 16.9.2002, p. 1.
( 3 ) OJ L 310, 9.11.2006, p. 15.
( 4 ) OJ L 404, 30.12.2006, p. 39.
( 1 ) OJ C 349, 30.11.2011, p. 4.
( 5 ) OJ L 149, 9.6.2007, p. 1.

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applying, in the case of operating grants, the principle of
No 1073/1999 of the European Parliament and of the
annual reduction provided for in Article 113(2) of Regu
Council of 25 May 1999 concerning investigations
lation (EC, Euratom) No 1605/2002.
conducted by the European Anti-Fraud Office (OLAF) ( 3 ).
(42) The
financing
of
standardisation
activities
should
also
be
(46) In
order
to
update
the
list
of
European
standardisation
capable of covering preliminary or ancillary activities in
organisations and to adapt the criteria for organisations
connection with the establishment of European standards
representing SMEs and societal stakeholders to further
or European standardisation deliverables for products and
developments as regards their non-profit making nature
for services. This is necessary primarily for work
and representativity, the power to adopt acts in
involving research, the preparation of preliminary
accordance with Article 290 TFEU should be delegated
documents for legislation, inter-laboratory tests and the
to the Commission in respect of amendments to the
validation or evaluation of standards. The promotion of
Annexes to this Regulation. It is of particular importance
standardisation at European and international level
that the Commission carry out appropriate consultations
should also continue through programmes relating to
during its preparatory work, including at expert level.
the technical assistance to, and cooperation with, third
The Commission, when preparing and drawing up
countries. With a view to improving market access and
delegated acts, should ensure a simultaneous, timely
boosting the competitiveness of enterprises in the Union,
and appropriate transmission of relevant documents to
it should be possible to give grants to other bodies
the European Parliament and to the Council.
through calls for proposals or, where necessary, by
awarding contracts.
(47) The committee set up by this Regulation should assist
the Commission in all matters related to the implemen
tation of this Regulation, having due regard for the views
(43) Union financing should seek to establish European
of sectoral experts.
standards or European standardisation deliverables for

products and for services, to facilitate their use by enter
prises through the enhanced support for their translation
into the various official Union languages, in order to
allow SMEs to fully benefit from the understanding and
(48) In
order
to
ensure
uniform
conditions
for
the
implemen
application of the European standards, to strengthen the
tation of this Regulation, implementing powers should be
cohesion of the European standardisation system and to
conferred on the Commission. Those powers should be
ensure fair and transparent access to European standards
exercised in accordance with Regulation (EU) No
for all market players throughout the Union. This is
182/2011 of the European Parliament and of the
especially important in cases where the use of
Council of 16 February 2011 laying down the rules
standards enables compliance with relevant Union legis
and general principles concerning mechanisms for
lation.
control by Member States of the Commission’s exercise

of implementing powers ( 4 ).
(44) In
order
to
ensure
the
effective
application
of
this
Regu
(49) The
advisory
procedure
should
be
used
for
the
adoption
lation, there should be the possibility of using the
of implementing acts with respect to the objections to
requisite expertise, particularly with regard to auditing
harmonised standards and where the references to the
and financial management, as well as administrative
harmonised standard concerned have not yet been
support resources capable of facilitating implementation,
published in the Official Journal of the European Union,
and of evaluating on a regular basis the relevance of the
given that the relevant standard has not yet led to the
activities receiving Union financing in order to ensure
presumption of conformity with the essential
their usefulness and impact.
requirements set out in the applicable Union harmon
isation legislation.
(45) Appropriate
measures
should
also
be
taken
to
avoid
fraud and irregularities and to recover funds unduly
(50) The
examination
procedure
should
be
used
for
each
stan
paid in accordance with Council Regulations (EC,
dardisation request submitted to European standard
Euratom) No 2988/95 of 18 December 1995 on the
isation organisations and the adoption of implementing
protection of the European Communities financial inter
acts with respect to the objections to harmonised
ests ( 1 ) and (Euratom, EC) No 2185/96 of 11 November
standards and where the references to the harmonised
1996 concerning on-the-spot checks and inspections
standard concerned have already been published in the
carried out by the Commission in order to protect the
Official Journal of the European Union, given that such
European Communities’ financial interests against fraud
decision could have consequences on the presumption
and other irregularities
( 2 ) and Regulation (EC)
of conformity with the applicable essential requirements.
( 1 ) OJ L 312, 23.12.1995, p. 1.
( 3 ) OJ L 136, 31.5.1999, p. 1.
( 2 ) OJ L 292, 15.11.1996, p. 2.
( 4 ) OJ L 55, 28.2.2011, p. 13.

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(51) In
order
to
achieve
the
main
objectives
of
this
Regulation
Article 2
and to facilitate speedy decision-making procedures as
well as reducing the overall development time for stan
Definitions
dards, use should be made as far as possible of the
For the purposes of this Regulation, the following definitions
procedural measures provided for in Regulation (EU)
shall apply:
No 182/2011, which enables the chair of the relevant
committee to lay down a time limit within which the
committee should deliver its opinion, according to the
(1) ‘standard’ means a technical specification, adopted by a
urgency of the matter. Moreover, where justified, it
recognised standardisation body, for repeated or
should be possible for the opinion of the committee to
continuous application, with which compliance is not
be obtained by written procedure, and silence on the part
compulsory, and which is one of the following:
of the committee member should be regarded as tacit
agreement.
(a) ‘international standard’ means a standard adopted by
an international standardisation body;
(52) Since
the
objectives
of
this
Regulation,
namely
to
ensure
the effectiveness and efficiency of standards and stan
(b) ‘European standard’ means a standard adopted by a
dardisation as policy tools for the Union through
European standardisation organisation;
cooperation between European standardisation organi
sations, national standardisation bodies, Member States
and the Commission, the establishment of European
(c) ‘harmonised standard’ means a European standard
standards and European standardisation deliverables for
adopted on the basis of a request made by the
products and for services in support of Union legislation
Commission for the application of Union harmon
and policies, the identification of ICT technical specifi
isation legislation;
cations eligible for referencing, the financing of European
standardisation and stakeholder participation in European
(d) ‘national standard’ means a standard adopted by a
standardisation cannot be sufficiently achieved by the
national standardisation body;
Member States and can, therefore, by reason of their
effect, be better achieved at the Union level, the Union
may adopt measures, in accordance with the principle of
(2) ‘European standardisation deliverable’ means any other
subsidiarity as set out in Article 5 TEU. In accordance
technical specification than a European standard, adopted
with the principle of proportionality, as set out in that
by a European standardisation organisation for repeated or
Article, this Regulation does not go beyond what is
continuous application and with which compliance is not
necessary in order to achieve those objectives.
compulsory;
(3) ‘draft standard’ means a document containing the text of
(53) Directives
89/686/EEC,
93/15/EEC,
94/9/EC,
94/25/EC,
the technical specifications concerning a given subject,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC,
which is being considered for adoption in accordance
2007/23/EC, 2009/23/EC and 2009/105/EC should
with the relevant standards procedure, as that document
therefore be amended accordingly.
stands after the preparatory work and as circulated for
public comment or scrutiny;
(54) Decision No 1673/2006/EC and Decision 87/95/EEC
should be repealed,
(4) ‘technical specification’ means a document that prescribes
technical requirements to be fulfilled by a product, process,
service or system and which lays down one or more of the
following:
HAVE ADOPTED THIS REGULATION:
(a) the characteristics required of a product including
CHAPTER I
levels of quality, performance, interoperability, envi
ronmental protection, health, safety or dimensions,
GENERAL PROVISIONS
and including the requirements applicable to the
Article 1
product as regards the name under which the
product is sold, terminology, symbols, testing and
Subject matter
test methods, packaging, marking or labelling and
conformity assessment procedures;
This Regulation establishes rules with regard to the cooperation
between European standardisation organisations, national stan
dardisation bodies, Member States and the Commission, the
(b) production methods and processes used in respect of
establishment of European standards and European standard
agricultural products as defined in Article 38(1) TFEU,
isation deliverables for products and for services in support of
products intended for human and animal
Union legislation and policies, the identification of ICT technical
consumption, and medicinal products, as well as
specifications eligible for referencing, the financing of European
production methods and processes relating to other
standardisation and stakeholder participation in European stan
products, where these have an effect on their char
dardisation.
acteristics;

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(c) the characteristics required of a service including levels
2. The
work
programme
shall
indicate,
in
respect
of
each
of quality, performance, interoperability, environmental
standard and European standardisation deliverable:
protection, health or safety, and including the
requirements applicable to the provider as regards
the information to be made available to the recipient,
(a) the subject matter;
as specified in Article 22(1) to (3) of Directive
2006/123/EC;
(b) the stage attained in the development of the standards and
(d) the methods and the criteria for assessing the
European standardisation deliverables;
performance of construction products, as defined in
point 1 of Article 2 of Regulation (EU) No
305/2011 of the European Parliament and of the
(c) the references of any international standards taken as a
Council of 9 March 2011 laying down harmonised
basis.
conditions for the marketing of construction prod
ucts ( 1 ), in relation to their essential characteristics;
3. Each
European
standardisation
organisation
and
national
standardisation body shall make its work programme available
(5) ‘ICT technical specification’ means a technical specification
on its website or any other publicly available website, as well as
in the field of information and communication technol
make a notice of the existence of the work programme available
ogies;
in a national or, where appropriate, European publication of
standardisation activities.
(6) ‘product’ means any industrially manufactured product and
any agricultural product, including fish products;
4. No
later
than
at
the
time
of
publication
of
its
work
programme, each European standardisation organisation and
national standardisation body shall notify the existence thereof
(7) ‘service’ means any self-employed economic activity
to the other European standardisation organisations and
normally provided for remuneration, as defined in
national standardisation bodies and to the Commission. The
Article 57 TFEU;
Commission shall make that information available to the
Member States via the committee referred to in Article 22.
(8) ‘European standardisation organisation’ means an organi
sation listed in Annex I;
5. National
standardisation
bodies
may
not
object
to
a
subject for standardisation in their work programme being
(9) ‘international standardisation body’ means the Inter
considered at European level in accordance with the rules laid
national Organisation for Standardisation (ISO), the Inter
down by the European standardisation organisations and may
national Electrotechnical Commission (IEC) and the Inter
not undertake any action which could prejudice a decision in
national Telecommunication Union (ITU);
this regard.
(10) ‘national standardisation body’ means a body notified to
6. During
the
preparation
of
a
harmonised
standard
or
after
the Commission by a Member State in accordance with
its approval, national standardisation bodies shall not take any
Article 27 of this Regulation.
action which could prejudice the harmonisation intended and,
in particular, shall not publish in the field in question a new or
revised national standard which is not completely in line with
CHAPTER II
an existing harmonised standard. After publication of a new
harmonised standard, all conflicting national standards shall
TRANSPARENCY AND STAKEHOLDER PARTICIPATION
be withdrawn within a reasonable deadline.
Article 3
Transparency of work programmes of standardisation
Article 4
bodies
Transparency of standards
1. At
least
once
a
year,
each
European
standardisation
organisation and national standardisation body shall establish
1. Each
European
standardisation
organisation
and
national
its work programme. That work programme shall contain
standardisation body shall send at least in electronic form any
information on the standards and European standardisation
draft national standard, European standard or European stan
deliverables which a European standardisation organisation or
dardisation deliverable to other European standardisation
national standardisation body intends to prepare or amend,
organisations, national standardisation bodies or the
which it is preparing or amending and which it has adopted
Commission, upon their request.
in the period of the preceding work programme, unless these
are identical or equivalent transpositions of international or
European standards.
2. Each
European
standardisation
organisation
and
national
standardisation body shall within three months reply to, and
( 1 ) OJ L 88, 4.4.2011, p. 5.
take due account of, any comments received from any other

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Union L
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European standardisation organisation, national standardisation
legal entities concerned participated in a project that is related
body or the Commission with respect to any draft referred to in
to that area and that is funded by the Union under a multi
paragraph 1.
annual framework programme for activities in the area of
research, innovation and technological development, adopted
pursuant to Article 182 TFEU.
3. When
a
national
standardisation
body
receives
comments
indicating that the draft standard would have a negative impact
on the internal market, it shall consult the European standard
Article 6
isation organisations and the Commission before adopting it.
Access of SMEs to standards
1. National
standardisation
bodies
shall
encourage
and
4. National
standardisation
bodies
shall:
facilitate the access of SMEs to standards and standards devel
opment processes in order to reach a higher level of partici
pation in the standardisation system, for instance by:
(a) ensure access to draft national standards in such a way that
all relevant parties in particular those established in other
Member States have the opportunity to submit comments;
(a) identifying, in their annual work programmes, the standard
isation projects, which are of particular interests to SMEs;
(b) allow other national standardisation bodies to be involved
passively or actively, by sending an observer, in the planned
activities.
(b) giving access to standardisation activities without obliging
SMEs to become a member of a national standardisation
body;
Article 5
Stakeholder participation in European standardisation
(c) providing free access or special rates to participate in stan
1. European
standardisation
organisations
shall
encourage
dardisation activities;
and facilitate an appropriate representation and effective partici
pation of all relevant stakeholders, including SMEs, consumer
organisations and environmental and social stakeholders in their
(d) providing free access to draft standards;
standardisation activities. They shall in particular encourage and
facilitate such representation and participation through the
European stakeholder organisations receiving Union financing
in accordance with this Regulation at the policy development
(e) making available free of charge on their website abstracts of
level and at the following stages of the development of
standards;
European standards or European standardisation deliverables:
(f) applying special rates for the provision of standards or
(a) the proposal and acceptance of new work items;
providing bundles of standards at a reduced price.
(b) the technical discussion on proposals;
2. National
standardisation
bodies
shall
exchange
best
practices aiming to enhance the participation of SMEs in stan
dardisation activities and to increase and facilitate the use of
(c) the submission of comments on drafts;
standards by SMEs.
(d) the revision of existing European standards or European
standardisation deliverables;
3. National
standardisation
bodies
shall
send
annual
reports
to the European standardisation organisations with regards to
their activities in paragraphs 1 and 2 and all other measures to
(e) the dissemination of information of, and awareness-building
improve conditions for SMEs to use standards and to participate
about, adopted European standards or European standard
in the standards development process. The national standard
isation deliverables.
isation bodies shall publish those reports on their websites.
2. In
addition
to
the
collaboration
with
market
surveillance
Article 7
authorities in the Member States, research facilities of the
Participation of public authorities in European
Commission and the European stakeholder organisations
standardisation
receiving Union financing in accordance with this Regulation,
European standardisation organisations shall encourage and
Member States shall, where appropriate, encourage participation
facilitate appropriate representation, at technical level, of under
of public authorities, including market surveillance authorities,
takings, research centres, universities and other legal entities, in
in national standardisation activities aimed at the development
standardisation activities concerning an emerging area with
or revision of standards requested by the Commission in
significant policy or technical innovation implications, if the
accordance with Article 10.

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CHAPTER III
deadline. European standards and European standardisation
deliverables shall be market-driven, take into account the
EUROPEAN STANDARDS AND EUROPEAN
public interest as well as the policy objectives clearly stated in
STANDARDISATION DELIVERABLES IN SUPPORT OF UNION
the Commission’s request and based on consensus. The
LEGISLATION AND POLICIES
Commission shall determine the requirements as to the
Article 8
content to be met by the requested document and a deadline
for its adoption.
The annual Union work programme for European
standardisation
1. The
Commission
shall
adopt
an
annual
Union
work 2. The
decisions
referred
to
in
paragraph
1
shall
be
adopted
programme for European standardisation which shall identify
in accordance with the procedure laid down in Article 22(3)
strategic priorities for European standardisation, taking into
after consultation of the European standardisation organisations
account Union long-term strategies for growth. It shall
and the European stakeholder organisations receiving Union
indicate the European standards and European standardisation
financing in accordance with this Regulation as well as the
deliverables that the Commission intends to request from the
committee set up by the corresponding Union legislation,
European standardisation organisations in accordance with
when such a committee exists, or after other forms of consul
Article 10.
tation of sectoral experts.
2. The
annual
Union
work
programme
for
European
stan
3. The
relevant
European
standardisation
organisation
shall
dardisation shall define the specific objectives and policies for
indicate, within one month following its receipt, if it accepts the
the European standards and European standardisation
request referred to in paragraph 1.
deliverables that the Commission intends to request from the
European standardisation organisations in accordance with
Article 10. In cases of urgency the Commission can issue
4. Where a request for funding is made, the Commission
requests without prior indication.
shall inform the relevant European standardisation organi
sations, within two months following the receipt of the
acceptance referred to in paragraph 3, about the award of a
3. The
annual
Union
work
programme
for
European
stan
grant for drafting a European standard or a European standard
dardisation shall also include objectives for the international
isation deliverable.
dimension of European standardisation, in support of Union
legislation and policies.
5. The
European
standardisation
organisations
shall
inform
the Commission about the activities undertaken for the devel
4. The
annual
Union
work
programme
for
European
stan
opment of the documents referred to in paragraph 1. The
dardisation shall be adopted after having conducted a broad
Commission together with the European standardisation organi
consultation of relevant stakeholders, including European stan
sations shall assess the compliance of the documents drafted by
dardisation organisations and European stakeholder organi
the European standardisation organisations with its initial
sations receiving Union financing in accordance with this Regu
request.
lation, and Member States via the committee referred to in
Article 22 of this Regulation.
6. Where
a
harmonised
standard
satisfies
the
requirements
5. After
its
adoption,
the
Commission
shall
make
the
annual which it aims to cover and which are set out in the
Union work programme for European standardisation available
corresponding Union harmonisation legislation, the
on its website.
Commission shall publish a reference of such harmonised
standard without delay in the Official Journal of the European
Union or by other means in accordance with the conditions
Article 9
laid down in the corresponding act of Union harmonisation
legislation.
Cooperation with research facilities
The Commission’s research facilities shall contribute to the
preparation of the annual Union work programme for
Article 11
European standardisation referred to in Article 8 and provide
Formal objections to harmonised standards
European standardisation organisations with scientific input, in
their areas of expertise, to ensure that European standards take
1. When
a
Member
State
or
the
European
Parliament
into account economic competitiveness and societal needs such
considers that a harmonised standard does not entirely satisfy
as environmental sustainability and safety and security concerns.
the requirements which it aims to cover and which are set out
in the relevant Union harmonisation legislation, it shall inform
the Commission thereof with a detailed explanation and the
Article 10
Commission shall, after consulting the committee set up by
Standardisation requests to European standardisation
the corresponding Union harmonisation legislation, if it exists,
organisations
or after other forms of consultation of sectoral experts, decide:
1. The
Commission
may
within
the
limitations
of
the
competences laid down in the Treaties, request one or several
(a) to publish, not to publish or to publish with restriction the
European standardisation organisations to draft a European
references to the harmonised standard concerned in the
standard or European standardisation deliverable within a set
Official Journal of the European Union;

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(b) to maintain, to maintain with restriction or to withdraw the
longer meets the requirements set out in Annex II, the
references to the harmonised standard concerned in or from
Commission may decide to identify the modified ICT
the Official Journal of the European Union.
technical specification or to withdraw the identification.
2. The
Commission
shall
publish
information
on
its
website
on the harmonised standards that have been subject to the
3. The decisions provided for in paragraphs 1 and 2 shall be
decision referred to in paragraph 1.
adopted after consultation of the European multi-stakeholder
platform on ICT standardisation, which includes European stan
dardisation organisations, Member States and relevant stake
3. The
Commission
shall
inform
the
European
standard
holders, and after consultation of the committee set up by
isation organisation concerned of the decision referred to in
the corresponding Union legislation, if it exists, or after other
paragraph 1 and, if necessary, request the revision of the
forms of consultation of sectoral experts, if such a committee
harmonised standards concerned.
does not exist.
4. The
decision
referred
to
in
point
(a)
of
paragraph
1
of
this
Article shall be adopted in accordance with the advisory
Article 14
procedure referred to in Article 22(2).
Use of ICT technical specifications in public procurement
5. The
decision
referred
to
in
point
(b)
of
paragraph
1
of
this The ICT technical specifications referred to in Article 13 of this
Article shall be adopted in accordance with the examination
Regulation shall constitute common technical specifications
procedure referred to in Article 22(3).
referred to in Directives 2004/17/EC, 2004/18/EC and
2009/81/EC, and Regulation (EC, Euratom) No 2342/2002.
Article 12
Notification of stakeholder organisations
CHAPTER V
The Commission shall establish a notification system for all
FINANCING OF EUROPEAN STANDARDISATION
stakeholders, including European standardisation organisations
and European stakeholder organisations receiving Union
Article 15
financing in accordance with this Regulation in order to
Financing of standardisation organisations by the Union
ensure proper consultation and market relevance prior to:
1. The
financing
by
the
Union
may
be
granted
to
the
European standardisation organisations for the following stan
(a) adopting the annual Union work programme for European
dardisation activities:
standardisation referred to in Article 8(1);
(b) adopting standardisation requests referred to in Article 10;
(a) the development and revision of European standards or
European standardisation deliverables which is necessary
(c) taking a decision on formal objections to harmonised stan
and suitable for the support of Union legislation and
dards, as referred to in Article 11(1);
policies;
(d) taking a decision on identifications of ICT technical specifi
(b) the verification of the quality, and conformity to the
cations referred to in Article 13;
corresponding Union legislation and policies, of European
standards or European standardisation deliverables;
(e) adopting delegated acts referred to in Article 20.
CHAPTER IV
(c) the performance of preliminary or ancillary work in
connection with European standardisation, including
ICT TECHNICAL SPECIFICATIONS
studies, cooperation activities, including international
cooperation, seminars, evaluations, comparative analyses,
Article 13
research work, laboratory work, inter-laboratory tests,
Identification of ICT technical specifications eligible for
conformity evaluation work and measures to ensure that
referencing
the periods for the development and the revision of
European standards or European standardisation deliverables
1. Either on proposal from a Member State or on its own
are shortened without prejudice to the founding principles,
initiative the Commission may decide to identify ICT technical
especially the principles of openness, quality, transparency
specifications that are not national, European or international
and consensus among all stakeholders;
standards, but meet the requirements set out in Annex II, which
may be referenced, primarily to enable interoperability, in public
procurement.
(d) the activities of the central secretariats of the European
standardisation organisations, including policy development,
2. Either on proposal from a Member State or on its own
the coordination of standardisation activities, the processing
initiative, when an ICT technical specification identified in
of technical work and the provision of information to
accordance with paragraph 1 is modified, withdrawn or no
interested parties;

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(e) the translation of European standards or European standard
European standardisation deliverables which is necessary
isation deliverables used in support of Union legislation and
and suitable for the support of Union legislation and
policies into the official Union languages other than the
policies;
working languages of the European standardisation organi
sations or, in duly justified cases into languages other than
the official Union languages;
(d) the promotion of European standards and European stan
dardisation deliverables, and the information on, and use of,
standards among interested parties, including SMEs and
consumers.
(f) the drawing up of information to explain, interpret and
simplify European standards or European standardisation
deliverables, including the drawing up of user guides,
Article 17
abstracts of standards, best practice information and
awareness-building actions, strategies and training
Financing arrangements
programmes;
1. Financing by the Union shall be provided in the form of:
(a) grants without a call for proposals, or contracts after public
(g) activities seeking to carry out programmes of technical
procurement procedures, to:
assistance, cooperation with third countries and the
promotion and enhancement of the European standard
isation system and of European standards and European
(i) European standardisation organisations and national
standardisation deliverables among interested parties in the
standardisation bodies to carry out the activities
Union and at international level.
referred to in Article 15(1);
(ii) bodies identified by a basic act, within the meaning of
2. The
financing
by
the
Union
may
also
be
granted
to:
Article 49 of Regulation (EC, Euratom) No 1605/2002,
to carry out, in collaboration with the European stan
dardisation organisations the activities referred to in
(a) national standardisation bodies for the standardisation
point (c) of Article 15(1) of this Regulation;
activities referred to in paragraph 1, which they jointly
undertake with the European standardisation organisations;
(b) grants after a call for proposals, or contracts after public
procurement procedures, to other bodies referred to in
point (b) of Article 15(2):
(b) other bodies which have been entrusted with contributing
to the activities referred to in point (a) of paragraph 1, or
carrying out the activities referred to in points (c) and (g) of
(i) for contributing to the development and revision of
paragraph 1, in cooperation with the European standard
European standards or European standardisation
isation organisations.
deliverables referred to in point (a) of Article 15(1);
(ii) for carrying out the preliminary or ancillary work
Article 16
referred to in point (c) of Article 15(1);
Financing of other European organisations by the Union
The financing by the Union may be granted to the European
(iii) for carrying out the activities referred to in point (g) of
stakeholder organisations meeting the criteria set out in Annex
Article 15(1);
III to this Regulation for the following activities:
(c) grants after a call for proposals to the European stakeholder
organisations meeting the criteria set out in Annex III to
(a) the functioning of these organisations and of their activities
this Regulation to carry out the activities referred to in
relating to European and international standardisation,
Article 16.
including the processing of technical work and the
provision of information to members and other interested
parties;
2. The
activities
of
the
bodies
referred
to
in
paragraph
1
may
be financed by:
(b) the provision of legal and technical expertise, including
(a) grants for actions;
studies, in relation to assessment of the need for, and the
development of, European standards and European stan
dardisation deliverables and training of experts;
(b) operating grants for the European standardisation organi
sations and the European stakeholder organisations
meeting the criteria set out in Annex III to this Regulation
in accordance with the rules set out in Regulation (EC,
(c) the participation in the technical work with respect to the
Euratom) No 1605/2002. In the event of renewal,
development and revision of European standards and
operating grants shall not be automatically decreased.

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the
European
Union L
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3. The Commission shall decide on the financing proportionate and dissuasive penalties, in accordance with
arrangements referred to in paragraphs 1 and 2, on the
Regulations (EC, Euratom) No 2988/95, (Euratom, EC) No
amounts of the grants and, where necessary, on the
2185/96 and (EC) No 1073/1999.
maximum percentage of financing by type of activity.
2. For
the
Union
activities
financed
pursuant
to
this
Regu
4. Except
in
duly
justified
cases,
grants
awarded
for
the
stan
lation, the notion of irregularity defined in Article 1(2) of Regu
dardisation activities referred to in points (a) and (b) of
lation (EC, Euratom) No 2988/95 shall mean any infringement
Article 15(1) shall take the form of lump sums and for the
of a provision of Union law or any breach of a contractual
standardisation activities referred to in point (a) of Article 15(1)
obligation resulting from an act or omission by an economic
shall be paid upon fulfilment of the following conditions:
operator which has, or would have, the effect of prejudicing the
general budget of the Union or budgets managed by it by an
unjustified item of expenditure.
(a) European standards or European standardisation deliverables
requested by the Commission in accordance with Article 10
are adopted or revised within a period not exceeding the
3. Any
agreements
and
contracts
resulting
from
this
Regu
period specified in the request referred to in that Article;
lation shall provide for monitoring and financial control by the
Commission or any representative which it authorises and for
audits by the European Court of Auditors, which if necessary
may be conducted on the spot.
(b) SMEs, consumer organisations and environmental and social
stakeholders are appropriately represented and can
participate in European standardisation activities, as
referred to in Article 5(1).
CHAPTER VI
DELEGATED ACTS, COMMITTEE AND REPORTING
Article 20
5. The
common
cooperation
objectives
and
the
adminis
trative and financial conditions relating to the grants awarded
Delegated acts
to European standardisation organisations and the European
The Commission shall be empowered to adopt delegated acts in
stakeholder organisations meeting the criteria set out in
accordance with Article 21 concerning amendments to the
Annex III to this Regulation shall be defined in the
Annexes, in order to:
framework partnership agreements between the Commission
and those standardisation and stakeholder organisations, in
accordance with Regulations (EC, Euratom) No 1605/2002
and (EC, Euratom) No 2342/2002. The Commission shall
(a) update the list of European standardisation organisations set
inform the European Parliament and the Council of the
out in Annex I to take into account changes in their name
conclusion of those agreements.
or structure;
Article 18
(b) adapt the criteria for European stakeholder organisations set
out in Annex III to this Regulation to further developments
Management
as regards their non-profit making nature and representa
The appropriations determined by the budgetary authority for
tivity. Such adaptations shall not have the effect of creating
the financing of standardisation activities may also cover the
any new criteria or abolishing any existing criteria or
administrative expenses relating to the preparation, monitoring,
category of organisation.
inspection, auditing and evaluation which are directly necessary
for the purposes of implementing Articles 15, 16 and 17,
including studies, meetings, information and publication activ
Article 21
ities, expenses relating to informatics networks for the exchange
of information and any other expenditure on administrative and
Exercise of the delegation
technical assistance which the Commission may use for stan
1. The
power
to
adopt
delegated
acts
is
conferred
on
the
dardisation activities.
Commission subject to the conditions laid down in this Article.
Article 19
2.
The power to adopt delegated acts referred to in Article 20
Protection of the financial interests of the Union
shall be conferred on the Commission for a period of five years
from 1 January 2013. The Commission shall draw up a report
1. The
Commission
shall
ensure
that,
when
the
activities in respect of the delegation of power not later than nine
financed under this Regulation are implemented, the financial
months before the end of the five-year period. The delegation
interests of the Union are protected by the application of
of power shall be tacitly extended for periods of an identical
preventive measures against fraud, corruption and other illegal
duration, unless the European Parliament or the Council
activities, by effective checks and by the recovery of amounts
opposes such extension not later than three months before
unduly paid and, if irregularities are detected, by effective,
the end of each period.

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Official Journal of the European Union
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3. The
delegation
of
power
referred
to
in
Article
20
may
be
(b) the representation of SMEs, consumer organisations and
revoked at any time by the European Parliament or by the
environmental and social stakeholders in national standard
Council. A decision to revoke shall put an end to the delegation
isation bodies;
of the power specified in that decision. It shall take effect the
day following the publication of the decision in the Official
(c) the representation of SMEs on the basis of the annual
Journal of the European Union or at a later date specified
reports referred to in Article 6(3);
therein. It shall not affect the validity of any delegated acts
already in force.
(d) the use of ICT in the standardisation system;
4. As
soon
as
it
adopts
a
delegated
act,
the
Commission
shall
notify it simultaneously to the European Parliament and to the
(e) cooperation between the national standardisation bodies
Council.
and European standardisation organisations.
2. The
European
stakeholder
organisations
that
received
5. A
delegated
act
adopted
pursuant
to
Article
20
shall
enter Union financing in accordance with this Regulation shall send
into force only if no objection has been expressed either by the
an annual report on their activities to the Commission. This
European Parliament or the Council within a period of two
report shall contain in particular detailed information about the
months of notification of that act to the European Parliament
membership of these organisations and the activities referred to
and the Council or if, before the expiry of that period, the
in Article 16.
European Parliament and the Council have both informed the
Commission that they will not object. That period shall be
extended by two months at the initiative of the European
3. By
31
December
2015
and
every
five
years
thereafter,
the
Parliament or of the Council.
Commission shall present a report to the European Parliament
and to the Council on the implementation of this Regulation.
This report shall contain an analysis of the annual reports
Article 22
referred to in paragraphs 1 and 2, an evaluation of the
relevance of the standardisation activities receiving Union
Committee procedure
financing in the light of the requirements of Union legislation
1. The
Commission
shall
be
assisted
by
a
committee.
That and policies as well as an assessment of potential new measures
committee shall be a committee within the meaning of Regu
to simplify the financing of European standardisation and to
lation (EU) No 182/2011.
reduce the administrative burden for the European standard
isation organisations.
2. Where
reference
is
made
to
this
paragraph,
Article
4
of
Article 25
Regulation (EU) No 182/2011 shall apply.
Review
3. Where
reference
is
made
to
this
paragraph,
Article
5
of By 2 January 2015, the Commission shall evaluate the impact
Regulation (EU) No 182/2011 shall apply.
of the procedure established by Article 10 of this Regulation on
the timeframe for issuing standardisation requests. The
Commission shall present its conclusions in a report to the
4. Where the opinion of the committee is to be obtained by
European Parliament and to the Council. Where appropriate,
written procedure, that procedure shall be terminated without
that report shall be accompanied by a legislative proposal to
result when, within the time-limit for delivery of the opinion,
amend this Regulation.
the chair of the committee so decides or a simple majority of
committee members so request.
CHAPTER VII
Article 23
FINAL PROVISIONS
Committee cooperation with standardisation organisations
Article 26
and stakeholders
Amendments
The committee referred to in Article 22(1) shall work in
1. The
following
provisions
are
deleted:
cooperation with the European standardisation organisations
and the European stakeholder organisations receiving Union
financing in accordance with this Regulation.
(a) Article 6(1) of Directive 89/686/EEC;
(b) Article 5 of Directive 93/15/EEC;
Article 24
Reports
(c) Article 6(1) of Directive 94/9/EC;
1. The
European
standardisation
organisations
shall
send
an
annual report on the implementation of this Regulation to the
(d) Article 6(1) of Directive 94/25/EC;
Commission. It shall contain detailed information on the
following:
(e) Article 6(1) of Directive 95/16/EC;
(a) the application of Articles 4, 5, 10, 15 and 17;
(f) Article 6 of Directive 97/23/EC;

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the
European
Union L
316/27
(g) Article 14 of Directive 2004/22/EC;
References to those deleted provisions shall be construed as
references to this Regulation and shall be read in accordance
(h) Article 8(4) of Directive 2007/23/EC;
with the correlation table set out in Annex IV to this Regu
lation.
(i) Article 7 of Directive 2009/23/EC;
Article 27
(j) Article 6 of Directive 2009/105/EC.
National standardisation bodies
Member States shall inform the Commission of their standard
References to those deleted provisions shall be construed as
isation bodies.
references to Article 11 of this Regulation.
The Commission shall publish a list of national standardisation
bodies and any updates to that list in the Official Journal of the
2. Directive
98/34/EC
is
hereby
amended
as
follows:
European Union.
(a) in Article 1, paragraphs 6 to 10 are deleted;
Article 28
Transitional provisions
(b) Articles 2, 3 and 4 are deleted;
In Union acts that provide for a presumption of conformity
with essential requirements through the application of
(c) in Article 6(1), the words ‘with the representatives of the
harmonised standards adopted in accordance with Directive
standards institutions referred to in Annexes I and II’ are
98/34/EC, references to Directive 98/34/EC shall be construed
deleted;
as references to this Regulation, except references to the
committee set up by Article 5 of Directive 98/34/EC
(d) in Article 6(3), the first indent is deleted;
regarding technical regulations.
(e) in Article 6(4), points (a), (b) and (e) are deleted;
Where a Union act provides for a procedure for objection to
harmonised standards, Article 11 of this Regulation shall not
apply to that act.
(f) Article 7 is replaced by the following:
Article 29
‘Article 7
Repeal
Member States shall communicate to the Commission, in
Decision No 1673/2006/EC and Decision 87/95/EEC are hereby
accordance with Article 8(1), all requests made to standards
repealed.
institutions to draw up technical specifications or a standard
for specific products for the purpose of enacting a technical
References to the repealed Decisions shall be construed as
regulation for such products as draft technical regulations,
references to this Regulation and shall be read in accordance
and shall state the grounds for their enactment.’;
with the correlation table set out in Annex IV to this Regu
lation.
(g) in Article 11, the second sentence is replaced by the
following sentence:
Article 30
Entry into force
‘The Commission shall publish annual statistics on the
notifications received in the Official Journal of the European
This Regulation shall enter into force on the twentieth day
Union.’;
following that of its publication in the Official Journal of the
European Union.
(h) Annexes I and II are deleted.
It shall apply from 1 January 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 25 October 2012.
For the European Parliament
For the Council
The President
The President
M. SCHULZ
A. D. MAVROYIANNIS

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L 316/28
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Official Journal of the European Union
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ANNEX I
EUROPEAN STANDARDISATION ORGANISATIONS
1. CEN — European Committee for Standardisation
2. Cenelec — European Committee for Electrotechnical Standardisation
3. ETSI — European Telecommunications Standards Institute

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European
Union L
316/29
ANNEX II
REQUIREMENTS FOR THE IDENTIFICATION OF ICT TECHNICAL SPECIFICATIONS
1. The technical specifications have market acceptance and their implementations do not hamper interoperability with
the implementations of existing European or international standards. Market acceptance can be demonstrated by
operational examples of compliant implementations from different vendors.
2. The technical specifications are coherent as they do not conflict with European standards, that is to say they cover
domains where the adoption of new European standards is not foreseen within a reasonable period, where existing
standards have not gained market uptake or where these standards have become obsolete, and where the transposition
of the technical specifications into European standardisation deliverables is not foreseen within a reasonable period.
3. The technical specifications were developed by a non-profit making organisation which is a professional society,
industry or trade association or any other membership organisation that within its area of expertise develops ICT
technical specifications and which is not a European standardisation organisation, national or international standard
isation body, through processes which fulfil the following criteria:
(a) openness:
the technical specifications were developed on the basis of open decision-making accessible to all interested parties
in the market or markets affected by those technical specifications;
(b) consensus:
the decision-making process was collaborative and consensus based and did not favour any particular stakeholder.
Consensus means a general agreement, characterised by the absence of sustained opposition to substantial issues
by any important part of the concerned interests and by a process that involves seeking to take into account the
views of all parties concerned and to reconcile any conflicting arguments. Consensus does not imply unanimity;
(c) transparency:
(i) all information concerning technical discussions and decision making was archived and identified;
(ii) information on new standardisation activities was publicly and widely announced through suitable and
accessible means;
(iii) participation of all relevant categories of interested parties was sought with a view to achieving balance;
(iv) consideration and response were given to comments by interested parties.
4. The technical specifications meet the following requirements:
(a) maintenance: ongoing support and maintenance of published specifications are guaranteed over a long period;
(b) availability: specifications are publicly available for implementation and use on reasonable terms (including for a
reasonable fee or free of charge);
(c) intellectual property rights essential to the implementation of specifications are licensed to applicants on a (fair)
reasonable and non-discriminatory basis ((F)RAND), which includes, at the discretion of the intellectual property
right-holder, licensing essential intellectual property without compensation;
(d) relevance:
(i) the specifications are effective and relevant;
(ii) specifications need to respond to market needs and regulatory requirements;
(e) neutrality and stability:
(i) specifications whenever possible are performance oriented rather than based on design or descriptive char
acteristics;
(ii) specifications do not distort the market or limit the possibilities for implementers to develop competition and
innovation based upon them;
(iii) specifications are based on advanced scientific and technological developments;

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Official Journal of the European Union
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(f) quality:
(i) the quality and level of detail are sufficient to permit the development of a variety of competing implemen
tations of interoperable products and services;
(ii) standardised interfaces are not hidden or controlled by anyone other than the organisations that adopted the
technical specifications.

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of
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European
Union L
316/31
ANNEX III
EUROPEAN STAKEHOLDER ORGANISATIONS ELIGIBLE FOR UNION FINANCING
1. A European organisation representing SMEs in European standardisation activities which:
(a) is non-governmental and non-profit-making;
(b) has as its statutory objectives and activities to represent the interests of SMEs in the standardisation process at
European level, to raise their awareness for standardisation and to motivate them to become involved in the
standardisation process;
(c) has been mandated by non-profit organisations representing SMEs in at least two thirds of the Member States, to
represent the interests of SMEs in the standardisation process at European level.
2. A European organisation representing consumers in European standardisation activities which:
(a) is non-governmental, non-profit-making, and independent of industry, commercial and business or other
conflicting interests;
(b) has as its statutory objectives and activities to represent consumer interests in the standardisation process at
European level;
(c) has been mandated by national non-profit consumer organisations in at least two thirds of the Member States, to
represent the interests of consumers in the standardisation process at European level.
3. A European organisation representing environmental interests in European standardisation activities which:
(a) is non-governmental, non-profit-making, and independent of industry, commercial and business or other
conflicting interests;
(b) has as its statutory objectives and activities to represent environmental interests in the standardisation process at
European level;
(c) has been mandated by national non-profit environmental organisations in at least two thirds of the Member States,
to represent environmental interests in the standardisation process at European level.
4. A European organisation representing social interests in European standardisation activities which:
(a) is non-governmental, non-profit-making, and independent of industry, commercial and business or other
conflicting interests;
(b) has as its statutory objectives and activities to represent social interests in the standardisation process at European
level;
(c) has been mandated by national non-profit social organisations in at least two thirds of the Member States, to
represent social interests in the standardisation process at European level.

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ANNEX IV
CORRELATION TABLE
Directive 98/34/EC This
Regulation
Article 1, first paragraph, point (6) Article
2(1)
Article 1, first paragraph, point (7)
—
Article 1, first paragraph, point (8) Article
2(3)
Article 1, first paragraph, point (9) Article
2(8)
Article 1, first paragraph, point (10) Article
2(10)
Article 2(1) Article
3(1)
Article 2(2) Article
3(2)
Article 2(3) Article
3(3)
and
(4)
Article 2(4) Article
27
Article 2(5) Article
20(a)
Article 3 Article
4(1)
Article 4(1)
Article 3(3) and (5) and Article 4(4)
Article 4(2)
—
Article 6(3), first indent
—
Article 6(4)(a) Article
20(a)
Article 6(4)(b)
—
Article 6(4)(e) Article
10(2)
Annex I Annex
I
Annex II Article
27
Decision No 1673/2006/EC This
Regulation
Article 1 Article
1
Articles 2 and 3 Article
15
Article 4
—
Article 5 Article
17
Article 6(1) Article
18
Article 6(2) Article
24(3)
Article 7 Article
19
Decision 87/95/EEC This
Regulation
Article 1 Article
2
Article 2 Article
3
Article 3 Article
13

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European
Union L
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Decision 87/95/EEC This
Regulation
Article 4 Article
8
Article 5 Article
14
Article 6
—
Article 7
—
Article 8 Article
24(3)
Article 9
—

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