CELEX: 52011PC0315
Language: en
Date: 2011-06-01
Title: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on European Standardisation and amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the European Parliament and of the Council

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		52011PC0315
		
			Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on European Standardisation and amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the European Parliament and of the Council /* COM/2011/0315 final - COD 2011/0150 */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
1. Context of the proposal
·      Grounds for and objectives of the proposal
European standardisation results from
voluntary cooperation between industry, public authorities and other interested
parties collaborating within a system founded on openness, transparency and
consensus. For European industry, standards summarise best practice in a
specific area, because they encapsulate the collective expertise of the
participating actors. 
In the future, European standardisation
will play a crucial role in a wide variety of areas, wider than today, ranging
from supporting European competitiveness, protecting the consumer, improving
accessibility for disabled and elderly people to tackling climate change. To
respond rapidly to evolving needs in all areas, a comprehensive, inclusive,
efficient and technically up-to-date European standardisation system will be
required. This system will build on the strengths of the existing system, but
will also need to be flexible and responsive in addressing future challenges as
they arise. 
In its EUROPE 2020 strategy for smart,
sustainable and inclusive growth [COM(2010) 2020], the Commission highlighted
the necessity to improve the method of standard setting and the use of
standards in Europe to leverage European and international standards for the
long-term competitiveness of European industry and for the achievement of
important policy goals in areas such as e-government, e-health or
e-accessibility.
On 21 October 2010, the European Parliament
adopted a report on the future of European standardisation [A7-0276/2010] which
indicated that the review of European standardisation should preserve its many
successful elements, remedy its deficiencies and strike the right balance
between the European, national and international dimensions. Furthermore, it
recognises that interoperability is key to innovation and competitiveness,
especially in the ICT sector.
In its communication of 13 April 2011 on
the ‘Single market Act: Twelve levers to boost growth and confidence', the
Commission included among its twelve key priority actions to be adopted by the
EU institutions before the end of 2012 the extension of the European
standardisation system to services.
·      General context
Standards and standardisation are very
effective policy tools for the EU. Although standards and standardisation have
much wider benefits for the European economy, they are used as policy
instruments to ensure, inter alia, the functioning of the single market of
products, the interoperability of networks and systems, in particular in the
field of ICT, a high level of consumer and environmental protection, and more
innovation and social inclusion.
Standards are indispensable in the digital
society to ensure the interoperability of networks and systems, especially in
the field of ICT. In a digitally driven society, ICT solutions are used in any
economic sector as well as in our daily lives. ICT solutions, applications and
services have to be able to communicate with each other; they should be
interoperable. Interoperability requires standards. 
European standards play a very important
part in the functioning of the internal market for industrial products.
European standards replace national and often conflicting standards which, as
such, may create technical impediments to a national market. 
For the purpose of this Regulation, there
are 2 types of standards: European standards developed at the request of the
Commission, on the basis of a so-called "mandate" in which the ESOs
are requested to draw up, and the other European standards developed at the
initiative of other actors (businesses, national standardisation bodies,
stakeholders, etc.). 
This proposal addresses three major
problems:
1. In a rapidly changing world and society,
especially in sectors characterized by very short product lives and development
cycles, standards must keep pace with rapid technological development. Some
stakeholders argue that the entire process of creating European standards
developed at the request of the Commission is too slow. The main negative
consequence of a slow standard-setting process is that conflicting national
standards continue, which may create technical barriers in the supply chain or
barriers to trade if the national standard is used as a protectionist
instrument. Another consequence is that, in the absence of harmonised
standards, businesses cannot use the relevant standard to confer a presumption
of conformity and must demonstrate compliance with the essential requirements
in accordance with the conformity assessment module set out in the applicable
EU legislation. In both cases, businesses are prevented from saving costs
incurred due to fragmentation of the internal market or conformity assessment
procedures. Conflicting national standards or the absence of harmonised
standards lead to higher transaction costs and higher per-unit costs caused by
the need to produce divergent batches. Industry reacts to this situation by
establishing informal standardisation channels for the rapid development of
technical specifications to ensure interoperability which gain an international
reach.
2. SMEs encounter a series of problems with
respect to standards and standardisation. One of the most important problems,
according to many stakeholders, is that SMEs are in general under-represented
in standardisation activities, in particular at European level. Furthermore,
standards often relate to the safety and well-being of citizens, the efficiency
of networks, the environment and other public policy fields. Although standards
play a major role in society, the opinion of relevant societal stakeholders is
not sufficiently integrated in the standardisation process in the EU. In order
to address the problem of insufficient representation of SMEs and societal
stakeholders in standardisation activities, financial contributions are paid to
organisations representing SMEs and societal stakeholders. The criteria for
eligibility for these grants, the conditions for their use and the type of
financial contributions available vary widely. Some organisations receive
grants for actions while others also receive operating grants. The most
negative consequence of the problem of insufficient participation of SMEs and
societal stakeholders is their lack of influence on the process. 
3. In the field of ICT, many standards
ensuring interoperability are not elaborated by the ESOs but by other
organisations that develop standards (hereinafter "global fora and
consortia"). A concrete example are Internet and World Wide Web related
standards. Due mostly to a lack of highly specialized expertise, the
traditional standard-setting organisations do not cover the ICT domain and so
currently a major part of the global ICT standardisation work is done outside
the formal European or International standardisation system. At the moment,
referring to "Fora and Consortia Standards" in public procurement
which is subject to Directive 2004/18/CE is only possible in exceptional
circumstances. Since these standards do not, as such, fit into any of the
categories of standards to which public authorities may refer in their calls
for tenders, cautious public authorities will refrain from referring to them.
The consequence is that the ITC that they are procuring may not be
interoperable with ITC purchased by other authorities. This difficulty often
prevents public authorities from defining their ICT strategies and
architectures, including cross-border interoperability between organisations. 
·      Existing provisions in the area of the proposal
This proposal replaces a part of Directive
98/34/EC and repeals Decisions No 1673/2006/EC and 87/95/EEC. 
·      Consistency with the other policies and objectives of the Union
This initiative implements the Europe 2020
Flagship Initiatives on the Innovation Union [COM(2010)546], Industrial Policy
[COM(2010)614], a Digital Agenda for Europe [COM(2010)245] and a Resource
Efficient Europe [COM(2011)21]. It also implements the Single Market Act
[COM(2011)206], as well as the Disability Strategy 2010-2020 [COM(2010)636]. It
is part of a CWP 2011 Strategic initiative.
2. Consultation of interested parties and impact
assessment
·      Consultation of interested parties
Consultation methods, main sectors
targeted and general profile of respondents
Two general public consultations were held
in 2009 and 2010 while a more specific consultation of national authorities,
European Standards Organisations, National Standards Bodies, stakeholder
organisations and Fora and Consortia was organised in 2010. In 2009, the White
Paper on "Modernising ICT Standardisation in the EU – The Way Forward"
was adopted.
Moreover, this regulation builds on the
work of an independent expert group, the Expert Panel for the Review of the
European Standardisation System (EXPRESS), was composed of 30 experts from
European, national and international standards organisations, industry, SMEs,
NGOs, trade unions, academia, fora and consortia and public authorities from EU
Member States. EXPRESS delivered its report "Standardisation for a
competitive and innovative Europe: a vision for 2020" to the European
Commission in February 2010. 
Summary of responses and how they
have been taken into account
The responses to the consultations, the
White Paper on "Modernising ICT Standardisation in the EU – The Way
Forward" the EXPRESS report "Standardisation for a competitive and
innovative Europe: a vision for 2020" and the report of the European
Parliament constitute the basis for the policy options that were eventually
selected. 
An open consultation was conducted over the
internet from 23/03/2010 to 21/05/2010. The Commission received 483 responses.
The results are available on  
http://ec.europa.eu/enterprise/policies/european-standards/public-consultation/index_en.htm.
·     
Collection and use of expertise
There was no need for external expertise.0
·      Impact assessment
The impact assessment and its executive
summary give an overview of the different options. 
Only the combination of policy Options 1.A
(deadlines on the delivery of European standards) and 1.C (transparent and
simplified procedures for harmonised standards and other European standards
requested by the Commission), and policy options 2.C (strengthen the position
of organisations representing SMEs and societal stakeholders within the ESOs by
providing for the possibility of an operating grant) and 3.B (referencing of
"Fora and Consortia Standards" in public procurement) meet the
criteria of effectiveness, efficiency and consistency. Therefore, these 4
options constitute the basis of this proposal.
The Commission carried out an impact
assessment listed in the Work Programme, whose report is accessible on            
http://ec.europa.eu/enterprise/policies/european-standards/index_en.htm.
3. Legal elements of the proposal
·      Summary of the proposed action
1. The cooperation between national
standardisation bodies will become more transparent;
2. The use of standards developed by other
organisations in the field of information and communication technologies will
be possible in public procurement, provided that these standards comply with a
set of criteria based on the WTO principles for international standardisation
processes, in domains where there are no European standards, where European
standards have not gained market uptake or where these standards have become
obsolete.
3. The planning will be improved: the
Commission will establish an annual Work Programme, which will identify
priorities for European standardisation and the mandates required. 
4. SMEs and societal stakeholders should be
better represented in European standardisation, and the financial support to
organisations representing SMEs and societal stakeholders will be ensured.
5. A reduction of the administrative burden
imposed on the Commission and the ESOs, for example by the possibility of a
robust simplification of lump sums, clearly disconnected from any verification
of actual costs of implementation. This proposal constitutes a further shift
towards a performance-based system, based on the definition of agreed
indicators and objectives (outputs and outcomes). The speed and the efficiency
of the standard-setting process could constitute such an objective.
6. Although European standards are already
widely used for transport and logistics, postal services and electronic
communications networks and services, the voluntary European standards have
played a less prominent role in supporting the completion of the single market
for services. This proposal therefore includes service standards within its
scope in order to enable the Commission to issue mandates requesting the
development of European service standards and to finance a part of the cost of
this development. 
·      Legal basis
Article 114 TFEU
·      Subsidiarity principle
The subsidiarity principle applies insofar
as the proposal does not fall under the exclusive competence of the EU.
The objectives of the proposal cannot be
sufficiently achieved by the Member States for the following reason(s).
European standardisation supports European
legislation establishing the Single Market and contributes to increasing the
competitiveness of European industry. The harmonisation of standards of products
at European level overcomes technical barriers to trade which could be caused
by conflicting national standards. Therefore, problems relating to
standardisation at European level require a solution at European level. 
EU action will better achieve the
objectives of the proposal for the following reason(s).
The objective of ensuring the functioning
of the internal market by reducing obstacles to intra-EU trade arising from different
national standards on products could not be sufficiently achieved by Member
States. It was therefore felt appropriate in accordance with the principle of
subsidiarity, by reason of the scale and effects of the problem, to achieve
this at EU level.
European standards play a very important
part in the functioning of the internal market for industrial products.
European standards replace national and often conflicting standards which, as
such, may create technical impediments to enter a national market. Harmonised
standards ensure that products meet the essential requirements set out in EU
legislation. Compliance with a European "harmonised" standard
guarantees the required level of safety of products. However, use of harmonised
standards is still voluntary and a manufacturer may use any other technical
solution which demonstrates that his product meets the essential requirements. 
During the impact assessment process, many
non-legislative options were discarded for reasons related to subsidiarity as
set out in detail in the impact assessment.
The proposal therefore complies with the
subsidiarity principle.
·      Proportionality principle
The proposal complies with the
proportionality principle for the following reason(s).
The proposal only relates to the
functioning of standardisation at European level and the cooperation between
national standardisation bodies in order to avoid conflicting national
standards. 
This proposal does not lead to any new
administrative burden for economic operators, national governments, regional
and local authorities and citizens. 
·      Choice of instruments
Proposed instruments: regulation.
Other means would not be adequate for the
following reason(s).
The suggested options as well as the
simplification items do not require an amendment of the legislation of Member
States. This instrument only concerns the European standardisation
organisations, the cooperation between the national standardisation bodies, the
involvement of organisations representing SMEs and societal stakeholders in
European standardisation, and the Commission. Therefore, a Directive would not
be an appropriate instrument in this case. 
The legal instrument would have to be of
general application, in particular for the part on the use of Fora and
Consortia standards in procurement which would have to be directly applicable
in all Member States. In addition, the legislative instrument would contain a
number of obligations that would be directly applicable to the European
standardisation organisations, the national standardisation bodies, organisations
representing SMEs and societal stakeholders in European standardisation, and
the Commission. Therefore, the most appropriate legal instrument is a
regulation. Alternative options would not have been sufficient to achieve the
proposed objectives.
4. Budgetary implication
The budgetary implications are set out in
the financial statement.
5. Additional information
·      Simplification
The proposal provides for simplification of
legislation.
Standardisation will be extended to
services. The financial management will be simplified. For further details, see
below.
The proposal is included in the
Commission's rolling programme for up-date and simplification of the EU acquis
and its Work and Legislative Programme under the reference 2010/ENTR/0021.
·      Repeal of existing legislation
The adoption of the proposal will lead to
the repeal of existing legislation.
·      Review/revision/sunset clause
The proposal includes a review clause.
·      European Economic Area
The proposed act concerns an EEA matter and
should therefore extend to the European Economic Area.
·      Detailed explanation of the proposal
This proposal aims at revising and merging:
1. Council Decision 87/95/EEC on
standardisation in the field of information technology and telecommunications,
by the repeal of almost all its (outdated) provisions and the introduction of a
new system allowing the use, in the field of public procurement, of ICT
standards developed by organisations other than the European standardisation
bodies.
2. Directive 98/34/EC laying down a
procedure for the provision of information in the field of technical standards
and regulations and of rules on Information Society services (whereby all
articles related to the notification of draft technical regulations fall
outside the scope of the proposal and remain unaltered), through the following
measures: the European cooperation on standardisation will be extended to
services, the cooperation between national standardisation bodies will become
more transparent, SMEs and societal stakeholders will be better represented in
European standardisation, and the financial support to organisations
representing SMEs and societal stakeholders will be ensured.
3. Decision No 1673/2006/EC on the
financing of European standardisation. The main principles of this Decision
will remain unaltered but the following novelties will be introduced in line
with the proposed new Financial Regulation: a reduction of the administrative
burden imposed on operational services and the European standardisation bodies,
for example by the possibility of a robust simplification of lump sums, clearly
disconnected from any verification of actual costs of implementation. This
proposal constitutes a further shift towards a performance-based system, based
on the definition of agreed indicators and objectives (outputs and outcomes).
The speed and the efficiency of the standard-setting process constitute such an
objective.
2011/0150 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
on European Standardisation and amending
Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and
2009/23/EC of the European Parliament and of the Council
(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 Committee[1],
Acting in accordance with the ordinary
legislative procedure,
Whereas:
(1)              
The primary objective of standardisation is the
definition of voluntary technical or quality specifications with which current
or future products, production processes or services may comply.
Standardisation can cover various issues, such as standardisation of different
grades or sizes of a particular product or technical specifications in product
or services markets where compatibility and interoperability with other
products or systems is essential. 
(2)              
European standardisation also helps to boost the
competitiveness of enterprises by facilitating in particular the free movement
of goods and services, network interoperability, means of communication,
technological development and innovation. Standards produce significant
positive economic effects, for example by promoting economic interpenetration
on the internal market and encouraging the development of new and improved
products or markets and improved supply conditions. Standards thus normally
increase competition and lower output and sales costs, benefiting economies as
a whole. Standards may maintain and enhance quality, provide information and
ensure interoperability and compatibility, thereby increasing value for
consumers.
(3)              
European standards should continue to be adopted
by the European standardisation bodies, namely European Committee for
Standardisation (CEN), the European Committee for Electrotechnical
Standardisation (CENELEC) and the European Telecommunications Standards
Institute (ETSI). 
(4)              
European standards play a very important role
within the internal market, mainly through the presumption of conformity of
products to be made available on the market with the essential requirements of
those products laid down in Union harmonisation legislation.
(5)              
European standardisation is governed by a
specific legal framework consisting of three different legal acts, namely
Directive 98/34/EC of the European Parliament and the Council of 22 June 1998
laying down a procedure for the provision of information in the field of
technical standards and regulations and of rules on Information Society
services[2],
Decision No 1673/2006/EC of the European Parliament and of the Council of 24
October 2006 on the financing of European standardisation[3] and Council Decision
87/95 EEC of 22 December 1986 on standardisation in the field of
information technology and telecommunications[4].
However, the current regulatory framework is no longer up to date with the
developments of European standardisation during the last decades. Therefore,
the regulatory framework should be simplified and adapted in order to cover new
aspects of standardisation to reflect the latest developments and future
challenges in European standardisation. That relates in particular to the
increased development of service standards and the evolution of standardisation
products other than formal standards.
(6)              
In order to ensure the effectiveness of
standards and standardisation as policy tools for the Union, it is necessary to
have an effective and efficient standardisation system which provides a
flexible and transparent platform for consensus building between all
participants and which is financially viable. 
(7)              
Directive 2006/123/EC of the European Parliament
and of the Council of 12 December 2006 on services in the internal market[5] establishes general provisions
facilitating the exercise of the freedom of establishment for service providers
and the free movement of services, while maintaining a high quality of services.
It obliges the Member States, in cooperation with the Commission, to encourage
the development of voluntary European standards with the aim of facilitating
compatibility between services supplied by providers in different Member
States, information to the recipient and the quality of service provision.
However, Directive 98/34/EC only applies to standards for products while
standards for services are not expressly covered by it. However, the
delineation between services and goods is becoming less relevant in the reality
of the internal market. In practice, it is not always possible to clearly
distinguish standards on products from standards on services. Many product
standards have a service component while standards on services often also
partly relate to products. Thus, it is necessary to adapt the legal framework
to these new circumstances by extending its scope to standards on services.
(8)              
The development of voluntary standards on
services should be market-driven whereby the needs of the economic operators
and stakeholders directly or indirectly affected by the standard prevail and should
take into account the public interest and be based on consensus. They should primarily
focus on services linked to products and processes.
(9)              
The European standardisation bodies are subject
to competition law to the extent that they can be considered to be an
undertaking or an association of undertakings within the meaning of
Articles 101 and 102 of the Treaty.
(10)          
Within the Union, national standards are adopted
by national standardisation bodies which could lead to conflicting standards
and technical impediments in the internal market. Therefore, it is necessary
for the internal market and for the effectiveness of standardisation within the
Union to confirm the existing regular exchange of information between the
national standardisation bodies, the European standardisation bodies and the
Commission, about current and future standardisation work. This exchange of
information should be aligned with Annex 3 to Agreement on Technical Barriers
to Trade approved by Council Decision No 80/271/EEC of 10
December 1979 concerning the conclusion of the Multilateral Agreements
resulting from the 1973 to 1979 trade negotiations[6].
(11)          
The regular exchange of information between the
national standardisation bodies, the European standardisation bodies and the
Commission should not prevent standardisation bodies to comply with other
obligations and commitments, and in particular with Annex 3 to the Agreement on
Technical Barriers to Trade.
(12)          
Standards can contribute to helping European
policy address the major societal challenges such as climate change,
sustainable resource use, ageing, and innovation in general. By driving the
development of European or international standards for goods and technologies
in these expanding markets, Europe could create a competitive advantage for its
companies and facilitate trade. 
(13)          
Standards are important tools for undertakings
and especially small and medium-sized enterprises (hereinafter 'SME') which,
however, are not adequately involved in the standardisation system so that the
risk exists that standards do not take into account the needs and concerns of
SME. Consequently, it is essential to improve their representation and
participation in the standardisation process, particularly in the technical
committees.
(14)          
European standards are of vital interest for the
competitiveness of SMEs which, however, are in general under-represented in
standardisation activities, in particular at European level. Thus, this
Regulation should ensure an appropriate representation of SME in the European
standardisation process by an entity with appropriate qualifications.
(15)          
Standards can have a broad impact on society, in
particular on the safety and well-being of citizens, the efficiency of networks,
the environment, accessibility and other public policy fields. Therefore, it is
necessary to ensure that the role and the input of societal stakeholders in the
elaboration of standards is strengthened, through the support of organisations
representing the interests of consumers, the environment and societal
stakeholders.
(16)          
Standards should as far as possible take into
account environmental impacts throughout the life cycle of products and
services. Important and publicly available tools for evaluating such impacts
throughout the life cycle have been developed by the Commission's Joint
Research Centre.
(17)          
The viability of the cooperation between the
Commission and the European standardisation system depends on careful planning
of future requests for the development of standards. This planning could be
improved, in particular through the input of interested parties. Since
Directive 98/34/EC already provides for the possibility to request the European
standardisation bodies to elaborate European standards, it is appropriate to
put in place a better and more transparent planning in an annual work programme
which should contain an overview of all requests for standards which the
Commission intends to submit to European standardisation bodies.
(18)          
Several Directives harmonizing the conditions
for the marketing of products specify that the Commission may request the
adoption, by the European standardisation bodies, of harmonised European
standards on the basis of which conformity with the applicable essential requirements
is presumed. However, many of these legislative acts contain a wide variety of
provisions on objections to these standards when the latter do not, or not
entirely, cover all applicable requirements. Diverging provisions which lead to
uncertainty for economic operators and European standardisation bodies are in
particular contained in Council Directive 89/686/EEC of 21 December 1989 on the
approximation of the laws of the Member States relating to personal protective
equipment[7],
Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the
provisions relating to the placing on the market and supervision of explosives
for civil uses[8],
Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on
the approximation of the laws of the Member States concerning equipment and
protective systems intended for use in potentially explosive atmospheres[9], Directive 94/25/EC of the
European Parliament and of the Council of 16 June 1994 on the approximation of
the laws, regulations and administrative provisions of the Member States
relating to recreational craft[10],
Directive 95/16/EC of the European Parliament and of the Council of 29 June
1995 on the approximation of the laws of the Member States relating to lifts[11], Directive 97/23/EC of the European
Parliament and of the Council of 29 May 1997 on the approximation of the laws
of the Member States concerning pressure equipment[12], Directive 2004/22/EC of the
European Parliament and of the Council of 31 March 2004 on measuring
instruments[13],
Directive 2007/23/EC of the European Parliament and of the Council of 23 May
2007 on the placing on the market of pyrotechnic articles[14], Directive 2009/105/EC of the
European Parliament and of the Council of 16 September 2009 relating to simple
pressure vessels[15]
and Directive 2009/23/EC of the European Parliament and of the Council of 23
April 2009 on non-automatic weighing instruments[16]. 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 9 July 2008 on a
common framework for the marketing of products and repealing Council Decision
93/465/EEC[17],
and delete the relevant provisions in those Directives. 
(19)          
Public authorities should make best use of the
full range of relevant standards when procuring hardware, software and
information technology services, for example by selecting standards which can
be implemented by all interested suppliers, allowing for more competition and
reduced risk of lock-in. Directive 2004/17/EC of the European Parliament
and of the Council of 31 March 2004 coordinating the procurement procedures of
entities operating in the water, energy, transport and postal services sectors[18] and Directive 2004/18/EC of
the European Parliament and of the Council of 31 March 2004 on the coordination
of procedures for the award of public works contracts, public supply contracts
and public service contracts[19]
specify that technical specifications in public procurement should be
formulated by reference to national standards transposing European standards,
European technical approvals, common technical specifications, international
standards, other technical reference systems established by the European
standardisation bodies or - when these do not exist - to national standards,
national technical approvals or national technical specifications relating to
the design, calculation and execution of the works and use of the products, or
equivalent. Standards in the field of information and communication technologies,
however, are often developed by other standard developing organisations and do
not fall in any of the categories of standards and approvals laid down in
Directives 2004/17/EC and 2004/18/EC. Therefore, it is necessary to provide for
the possibility that technical specifications for public procurement could
refer to standards in the field of information and communication technologies,
in order to respond to the fast evolution in the field of information and
communication technologies, facilitate the provision of cross-border services,
encourage competition and promote interoperability and innovation. 
(20)          
Some standards in the field of information and
communication technologies are not developed according to the criteria set out
in Annex 3 of the Agreement on Technical Barriers to Trade. Therefore, this
Regulation should lay down a procedure for the selection of the standards in
the field of information and communication technologies that could be used in
public procurement, involving a broad consultation of a large spectrum of
stakeholders, including the European standardisation bodies, enterprises and
public authorities. This Regulation should also lay down requirements, in the
form of a list of attributes, for such standards and their associated standardisation
processes. These attributes should ensure that public policy objectives and
societal needs are respected, and should be founded on the criteria developed
within the World Trade Organisation for international standardisation
organisations. 
(21)          
In order to further innovation and competition
between standardised solutions, the recognition of a particular technical
specification should not disqualify a competing technical specification from
being recognised in accordance with the provisions of this Regulation. Any
recognition should be subject to the attributes being fulfilled and to the
technical specification having achieved a minimum level of market acceptance.
Market acceptance should not be interpreted as having been widely implemented
in the market.
(22)          
The selected standards in the field of
information and communication technologies could contribute to the
implementation of Decision No 922/2009/EC of the European Parliament
and of the Council of 16 September 2009 on interoperability solutions for
European public administrations (ISA)[20]
which establishes, for the period 2010-2015, a programme on interoperability
solutions for European public administrations and institutions and bodies of
the Union, providing common and shared solutions facilitating interoperability.
(23)          
Situations may arise in the field of information
and communication technologies where it is appropriate to encourage the use of,
or require, compliance with specified standards at Union level in order to
ensure interoperability in the single market and to improve freedom of choice
for users. In other circumstances, it may also happen that specified European
standards no longer meet consumers' needs or are hampering technological
development. For these reasons, Directive 2002/21/EC of the European Parliament
and the Council of 7 March 2002 on a common regulatory framework for electronic
communications networks and services[21]
enables the Commission, where necessary, to request European standardisation
bodies to draw up standards, to establish a list of standards and/or
specifications published in the Official Journal of the European Union with the
view to encourage their use, or to make their implementation compulsory, or to
remove standards and/or specifications from that list.
(24)          
This Regulation should not prevent European
standardisation bodies from continuing to develop standards in the field of
information and communication technologies and to increase their cooperation with
other standard developing bodies, especially in the field of information and communication
technologies, in order to ensure coherence and avoid fragmentation or
duplication during implementation of standards and specifications.
(25)          
Decision No 1673/2006/EC establishes the rules
concerning the contribution of the Union to the financing of European
standardisation in order to ensure that European standards and other European
standardisation deliverables are developed and revised in support of the
objectives, legislation and policies of the Union. It is appropriate, for the
purpose of administrative and budgetary simplification, to incorporate the
provisions of that Decision into this Regulation in line with the proposed new
Financial Regulation. 
(26)          
In view of the very broad field of involvement
of European standardisation in support of Union policies and legislation and
the different types of standardisation activity, it is necessary to provide for
different financing arrangements. This mainly concerns grants without calls for
proposals to the European and national standardisation bodies in accordance
with the second subparagraph of Article 110(1) of Council Regulation (EC,
Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to
the general budget of the European Communities[22]
and Article 168(1)(d) of Commission Regulation (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 the Financial Regulation applicable to
the general budget of the European Communities[23].
Furthermore, the same provisions should apply to those bodies which, whilst not
recognised as European standardisation bodies in this Regulation, have been
mandated in a basic act and have been entrusted with carrying out preliminary
work in support of European standardisation in cooperation with the European
standardisation bodies. 
(27)          
Inasmuch as European standardisation bodies
provide ongoing support for Union activities, they should have effective and
efficient central secretariats. The Commission should therefore be allowed to
provide grants to those bodies that are pursuing an objective of general
European interest without applying, in the case of operating grants, the
principle of annual reduction referred to in Article 113(2) of Regulation (EC,
Euratom) No 1605/2002.
(28)          
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)[24], Decision No 1926/2006/EC of
the European Parliament and of the Council of 18 December 2006 establishing a
programme of Community action in the field of consumer policy (2007-2013)[25] and Regulation (EC) No
614/2007 of the European Parliament and of the Council of 23 May 2007
concerning the Financial Instrument for the Environment (LIFE+)[26] already provide for the
possibility of financial support of European organisations representing SME,
consumers and environmental interests in standardisation, while specific grants
are paid to European organisations representing social interests in standardisation.
The financing under Decision No 1639/2006/EC, Decision No 1926/2006/EC and Regulation
(EC) No 614/2007 will end on 31 December 2013. It is essential for the
development of European standardisation to continue fostering and encouraging
the active participation of European organisations representing SME, consumers
and environmental and social interests. Such organisations pursue an aim of
general European interest and constitute, by virtue of the specific mandate
that national non-profit organisations have given them, a European network
representing non-profit bodies 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 SME, consumers and environmental and social
interests in European standardisation have a permanent role which is essential
for Union activities and policies. Therefore, the Commission should be in a
position to continue providing grants to those bodies without applying, in the
case of operating grants, the principle of annual reduction referred to in
Article 113(2) of Regulation (EC, Euratom) No 1605/2002. 
(29)          
The financing of standardisation activities
should also be capable of covering preliminary or ancillary activities in
connection with the establishment of standards or other standardisation
products. This is necessary primarily for work involving research, the
preparation of preliminary documents for legislation, inter-laboratory tests
and the validation or evaluation of standards. The promotion of standardisation
at European and international level should also continue through programmes relating
to the technical assistance to, and cooperation with, third countries. With a
view to improving market access and boosting the competitiveness of enterprises
in the Union, it should be possible to give grants to other bodies through
calls for proposals or, where necessary, by awarding contracts.
(30)          
Union financing should seek to establish
standards or other standardisation products, to facilitate their use by
enterprises through their translation into the various official Union
languages, to strengthen the cohesion of the European standardisation system
and to ensure fair and transparent access to European standards for all market
players throughout the Union. This is especially important in cases where the
use of standards enables compliance with Union legislative acts.
(31)          
In order to ensure the effective application of
this Regulation, there should be the possibility of using the requisite
expertise, particularly with regard to auditing and financial management, as
well as administrative support resources capable of facilitating
implementation, and of evaluating on a regular basis the relevance of the
activities receiving Union financing in order to ensure their usefulness and
impact. 
(32)          
Appropriate measures should also be taken to
avoid fraud and irregularities and to recover funds unduly paid in accordance
with Council Regulations (EC, Euratom) No 2988/95 of 18 December 1995 on the
protection of the European Communities financial interests[27] and (Euratom, EC) No 2185/96
of 11 November 1996 concerning on-the-spot checks and inspections carried out
by the Commission in order to protect the European Communities' financial
interests against fraud and other irregularities[28] and Regulation (EC) No
1073/1999 of the European Parliament and of the Council of 25 May 1999
concerning investigations conducted by the European Anti-Fraud Office (OLAF)[29].
(33)          
In order to update the lists of European
standardisation bodies, to adapt the criteria for recognising standards in the
field of information and communication technologies to technical developments
and to adapt the criteria for organisations representing SME and societal
stakeholders to further developments as regards their non-profit making nature
and representativity, the power to adopt acts in accordance with Article 290 of
the Treaty should be delegated to the Commission in respect of amendments to the
Annexes to this Regulation. It is of particular importance that the Commission
carry out appropriate consultations during its preparatory work, including at
expert level.
(34)          
The Commission, when preparing and drawing-up
delegated acts, should ensure a simultaneous, timely and appropriate
transmission of relevant documents to the European Parliament and Council.
(35)          
In order to ensure uniform conditions for the
implementation of this Regulation, implementing powers should be conferred on
the Commission. Those powers should be exercised in accordance with Regulation
(EU) No 182/2011 of the European Parliament and of the Council of 16 February
2011 laying down the rules and general principles concerning mechanisms for
control by the Member States of the Commission's exercise of implementing
powers[30].

(36)          
The advisory procedure should be used for the implementing
decisions with respect to the objections to harmonised standards which the
Commission considers justified and where the references to the harmonised
standard concerned were not yet published in the Official Journal of the
European Union, given that the relevant standard did not yet lead to the presumption
of conformity with the essential requirements set out in the applicable Union
harmonisation legislation.
(37)          
The examination procedure should be used for the
implementing decisions with respect to the objections to harmonised standards
which the Commission considers justified and where the references to the
harmonised standard concerned were already published in the Official Journal of
the European Union, given that such decision could have consequences on the presumption
of conformity with the applicable essential requirements. 
(38)          
Since standardisation at European level cannot
be sufficiently achieved by the Member States and can, therefore, by
reason of its scale and effect, be better achieved at the Union level, the
Union may adopt measures, in accordance with the principle of subsidiarity as
set out in Article 5 of the Treaty on European Union. In accordance with
the principle of proportionality, as set out in that Article, this Regulation does
not go beyond what is necessary in order to achieve that objective.
(39)          
Directives 98/34/EC, 89/686/EEC, 93/15/EEC,
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC,
2009/105/EC and 2009/23/EC should therefore be amended accordingly.
(40)          
Decision No 1673/2006/EC and Decision 87/95/EEC
should therefore be repealed,
HAVE ADOPTED THIS REGULATION:
Chapter I
General Provisions
Article 1
 Subject matter
This Regulation establishes rules with
regard to the cooperation between European standardisation bodies, national
standardisation bodies and the Commission, the establishment of European
standards and European standardisation deliverables for products and for services
in support of Union legislation and policies, the recognition of technical
specifications in the field of information and communication
technologies (hereinafter “ICT”) and financing of European standardisation.
Article 2
Definitions
For the purposes of this Regulation, the
following definitions shall apply:
(1)              
‘standard’ means a technical specification for
repeated or continuous application, with which compliance is not compulsory,
and which is one of the following:
(a)              
‘international standard’ means a standard adopted
by an international standardisation body; 
(b)              
‘European standard’ means a standard adopted by one
of the European standardisation bodies;
(c)              
‘harmonised standard’ means a European standard
adopted on the basis of a request made by the Commission for the application of
Union harmonisation legislation;
(d)              
‘national standard’ means a standard adopted by
a national standardisation body;
(e)              
‘ICT standard’ means a standard in the field of
information and communication technologies.
(2)              
‘European standardisation deliverable’ means any
other technical specification than a European standard, adopted by a European
standardisation body for repeated or continuous application and with which
compliance is not compulsory; 
(3)              
‘draft standard’ means a document containing the
text of the technical specifications concerning a given subject, which is being
considered for adoption in accordance with the relevant standards procedure, as
that document stands after the preparatory work and as circulated for public
comment or scrutiny;
(4)              
‘technical specification’ means a specification
contained in a document which lays down one of the following:
(a)              
the characteristics required of a product including
levels of quality, performance, interoperability, safety or dimensions,
including the requirements applicable to the product as regards the name under
which the product is sold, terminology, symbols, testing and test methods,
packaging, marking or labelling and conformity assessment procedures;
(b)              
production methods and processes used in respect
of agricultural products as referred to Article 38(1) of the Treaty, products
intended for human and animal consumption, and medicinal products, as well as
production methods and processes relating to other products, where these have
an effect on their characteristics;
(c)              
the characteristics required of a service including
levels of quality, performance, interoperability, safety, including the
requirements applicable to the provider as regards the information to be made
available to the recipient, as referred to in Article 22(1) to (3) of Directive
2006/123/EC;
(d)              
the methods and the criteria for assessing the
performance of construction products, as defined in Article 2(1) of Regulation
(EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011
laying down harmonised conditions for the marketing of construction products
and repealing Council Directive 89/106/EEC[31],
in relation to their essential characteristics.
(5)              
‘product’ means any industrially manufactured
product and any agricultural product, including fish products;
(6)              
‘service’ means any self-employed economic
activity normally provided for remuneration, as referred to in Article 57
of the Treaty; 
(7)              
‘European standardisation body’ means a body
referred to in Annex I;
(8)              
'International standardisation body" means
the International Organisation for Standardization (ISO), the International
Electrotechnical Commission (IEC) and the International Telecommunication Union
(ITU);
Chapter II
Transparency and stakeholder participation
Article 3
 Transparency of work programmes of standardisation bodies
1.                      
At least once a year, each European and national
standardisation body shall establish its work programme. That work programme
shall contain information on the standards and European standardisation
deliverables which it intends to prepare or amend, which it is preparing or
amending and which it has adopted in the preceding period, unless these are
identical or equivalent transpositions of international or European standards.
2.                      
The work programme shall for each standard and
European standardisation deliverable indicate:
(a)     the subject matter;
(b)     the stage attained in the development
of the standards and European standardisation deliverables;
(c)     the references of any international
standards taken as a basis. 
3.                      
Each European and national standardisation body
shall make its work programme available on its web site or any other publicly
available web site and a notice of the existence of the work programme in a
national or, where appropriate, European publication of standardization activities.
4.                      
No later than at the time of publication of its
work programme, any European and national standardisation body shall notify the
existence thereof to the other European and national standardisation bodies and
to the Commission.
5.                      
National standardisation bodies may not object
to the inclusion of a subject for standardisation in the work programme of a
European standardisation body.
Article 4
 Transparency of standards
1.                      
Each European and national standardisation body
shall send any draft national standard, European standard and European
standardisation deliverable to other European and national standardisation bodies
and the Commission, upon their request. 
2.                      
Each European and national standardisation body
shall promptly reply to, and take due account of, any comments received from
any other European and national standardisation body and the Commission with
respect to any such draft. 
3.                      
National standardisation bodies shall ensure the
following:
(a)     the publication of draft standards in
such a way that parties established in other Member States have the opportunity
to submit comments; 
(b)     allow other national standardisation
bodies to be involved passively or actively in the planned activities by
sending an observer.
Article 5
 Stakeholder Participation in European standardisation
1.                      
European standardisation bodies shall ensure an appropriate
representation of small and medium-sized enterprises (hereinafter 'SME'),
consumer organisations and environmental and social stakeholders, in particular
through the organisations referred to in Annex III, at the policy development
level and at least at the following stages of the development of European
standards or European standardisation deliverables: 
(a)              
the proposal and acceptance of new work items;
(b)              
the technical discussion on proposals;
(c)              
the submission of comments on drafts;
(d)              
the revision of existing European standards or
European standardisation deliverables;
(e)              
the dissemination of, and awareness-building
about, adopted European standards or European standardisation deliverables. 
2.                      
European standardisation bodies shall ensure an appropriate
representation, at technical level, of undertakings,
research centres and universities and other legal entities, in standardisation
activities concerning an emerging area with significant
policy or technical innovation implications, if the legal entities concerned
participated in a project that is related to that area and that is funded by
the Union under a multiannual framework programme for
activities in the area of research and technological development.
Chapter III
European standards and European standardisation deliverables in support of
Union legislation and policies
Article 6
European standardisation work programme of the Commission
1.                      
The Commission shall adopt an annual European
standardisation work programme which shall indicate the European standards and
European standardisation deliverables that it intends to request from the
European standardisation bodies in accordance with Article 7.
2.                      
The European standardisation work programme
referred to in paragraph 1 shall specify the specific objectives and policies
for the European standards and other European standardisation deliverables that
the Commission intends to request from the European standardisation bodies. In
cases of urgency the Commission can issue requests without prior indication.
Article 7
 Standardisation requests to European standardisation bodies 
1.                      
The Commission may request one or several European
standardisation bodies to draft a European standard or European standardisation
deliverable within a set deadline. They shall be market-driven, take into
account the public interest and based on consensus.
2.                      
The relevant European standardisation body shall
indicate, within one month following its receipt, if it accepts the request
referred to in paragraph 1. 
3.                      
The Commission shall inform the relevant European
standardisation body, within three months following the receipt of the
acceptance referred to in paragraph 2, about the award of a grant for drafting
a European standard or European standardisation deliverable.
4.                      
The European standardisation bodies shall inform
the Commission about the activities undertaken for the development of the
documents referred to in paragraph 1. 
Article 8
 Objections to harmonised standards 
1.           When a Member State
considers that a harmonised standard does not entirely satisfy the requirements
which it aims to cover and which are set out in the relevant Union legislation,
it shall inform the Commission thereof. 
2.           When the Commission
considers that the objections referred to in paragraph 1 are justified, it shall
decide:
(a)              
not to publish or to publish with restriction the
references to the harmonised standard concerned in the Official Journal of
the European Union;
(b)              
to maintain with restriction or to withdraw the
references to the harmonised standard concerned in or from the Official
Journal of the European Union. 
3.           The Commission shall
inform the European standardisation body concerned of the decision referred to
in paragraph 2 and, if necessary, request the revision of the harmonised
standards concerned.
4.           The decision referred to
in paragraph 2(a) of this Article shall be adopted in accordance with the
advisory procedure referred to in Article 18(2).
5.           The decision referred to
in paragraph 2(b) of this Article shall be adopted in accordance with the examination
procedure referred to in Article 18(3).
Chapter IV
Standards in the field of ICT
Article 9
 Recognition of technical specifications in the field of ICT
Either on proposal from a public authority
referred to in Directive 2004/18/EC or on its own initiative the Commission may
decide to recognise technical specifications which are not national, European
or international standards and meet the requirements set out in Annex II, as
ICT standards. 
Article 10
 Use of ICT standards in public procurement
ICT standards referred to in Article 9 shall
constitute common technical specifications referred to in Directives 2004/17/CE
and 2004/18/CE, and Regulation (EC) No 2342/2002.
Chapter V
Financing of European standardisation
Article 11
Financing of Standardisation bodies by the Union
1.           The financing by the Union
may be granted to the European standardisation bodies for the following
standardisation activities:
(a)              
the development and revision of European
standards or European standardisation deliverables which is necessary and
suitable for the support of policies and legislation of the Union; 
(b)              
the verification of the quality, and conformity
to the corresponding policies and legislation of the Union, of European
standards or European standardisation deliverables; 
(c)              
the performance of preliminary or ancillary work
in connection with European standardisation, including studies, cooperation
activities, seminars, evaluations, comparative analyses, research work,
laboratory work, inter-laboratory tests, conformity evaluation work and
measures to ensure that the periods for the development and the revision of
European standards or European standardisation deliverables are shortened;
(d)              
the activities of the central secretariats of
the European standardisation bodies, including policy development, the
coordination of standardisation activities, the processing of technical work
and the provision of information to interested parties;
(e)              
the translation, where required, of European
standards or European standardisation deliverables used in support of Union
policies and legislation into the official Union languages other than the
working languages of the European standardisation bodies or, in duly justified
cases into languages other than the official Union languages,
(f)                
the drawing up of information to explain,
interpret and simplify European standards or European standardisation
deliverables, including the drawing up of user guides, best practice
information and awareness-building actions;
(g)              
activities seeking to carry out programmes of
technical assistance, cooperation with third countries and the promotion and
enhancement of the European standardisation system and of European standards
and European standardisation deliverables among interested parties in the Union
and at international level.
2.           The financing by the Union
may also be granted to:
(a)              
national standardisation bodies for the
standardisation activities referred to in paragraph 1, which they jointly
undertake with the European standardisation bodies;
(b)              
other bodies which have been entrusted with
carrying out the work referred to in points (a), (c) and (g) of paragraph 1, in
cooperation with the European standardisation bodies.
Article 12
 Financing of other European Organisations by the Union 
The financing by the Union may be granted
to the organisations referred to in Annex III for the following activities:
(a)              
the functioning of these organisations and of
their activities relating to European and international standardisation, including
the processing of technical work and the provision of information to members
and other interested parties;
(b)              
legal and technical expertise, including
studies, in relation to assessment of the need for, and the development of,
European standards and European standardisation deliverables; 
(c)              
the participation in the technical work with
respect to the development and revision of European standards and European
standardisation deliverables which is necessary and suitable for the support of
policies and legislation of the Union;
(d)              
the verification of the quality, and conformity
to the corresponding policies and legislation of the Union, of European
standards and European standardisation deliverables; 
(e)              
the promotion of European standards and European
standardisation deliverables, and the information on, and use of, standards
among interested parties and SME.
Article 13
 Financing arrangements
1.                      
Financing by the Union shall be provided in the
form of:
(a)              
grants without a call for proposals, or contracts
after public procurement procedures, to:
(i)      European and national Standardisation
bodies to carry out the activities referred to in Article 11(1);
(ii)      bodies identified by a basic act,
within the meaning of Article 49 of Regulation (EC, Euratom) No 1605/2002 to carry
out, in collaboration with the European standardisation bodies the work
referred to in Article 11(1)(c) of this Regulation;
(b)              
grants after a call for proposals, or contracts
after public procurement procedures, to other bodies referred to in Article
11(2)(b) to carry out, in collaboration with the European standardisation
bodies:
(i)      the production and revision of
European standards and European standardisation deliverables referred to in
Article 11(1)(a);
(ii)      the preliminary or ancillary work
referred to in Article 11(1)(c); 
(iii)     the activities referred to in
Article 11(1)(g).
(c)              
grants after a call for proposals to the
organisations referred to in Annex III to carry out the activities referred to
in Article 12.
2.                      
The activities of the bodies referred to in
paragraph 1 may be financed by:
(a)              
grants for actions; 
(b)              
operating grants for the European
standardisation bodies and the organisations referred to in Annex III, in
accordance with the rules set out in Regulation (EC, Euratom) No 1605/2002. In
the event of renewal, operating grants shall not be automatically decreased.
3.                      
The Commission shall decide on the financing
arrangements referred to in paragraphs 1 and 2, on the amounts of the grants and,
where necessary, on the maximum percentage of financing by type of activity. 
4.                      
Except in duly justified cases, grants awarded for
the standardisation activities referred to in Article 11(1)(a) and (b) shall
take the form of lump sums to be paid upon fulfilment of the following conditions:

(a)              
European standards or European standardisation
deliverables requested by the Commission in accordance with Article 7 are
adopted or revised within a period not exceeding the period specified in the
request referred to in Article 7;
(b)              
SME, consumer organisations and environmental
and social stakeholders are appropriately represented in European
standardisation work, as referred to in Article 5(1). 
5.                      
The common cooperation objectives and the
administrative and financial conditions relating to the grants awarded to
European standardisation bodies and the organisations referred to in Annex III shall
be defined in the framework partnership agreements signed by the Commission and
these bodies and organisations, in accordance with Regulation (EC, Euratom) No
1605/2002 and Regulation (EC, Euratom) No 2342/2002. The Commission shall
inform the European Parliament and the Council of the conclusion of those
agreements.
Article 14
 Management
The appropriations determined by the
budgetary authority for the financing of standardisation activities may also
cover the administrative expenses relating to the preparation, monitoring,
inspection, auditing and evaluation which are directly necessary for the
purposes of implementing Articles 11, 12 and 13, including studies, meetings,
information and publication activities, expenses relating to informatics
networks for the exchange of information and any other expenditure on
administrative and technical assistance which the Commission may use for
standardisation activities.
Article 15
 Protection of the financial interests of the Union
1.                      
The Commission shall ensure that, when the
activities financed under this Regulation are implemented, the financial
interests of the Union are protected by the application of preventive measures
against fraud, corruption and other illegal activities, by effective checks and
by the recovery of amounts unduly paid and, if irregularities are detected, by
effective, proportionate and dissuasive penalties, in accordance with
Regulations (EC, Euratom) No 2988/95, (Euratom,
EC) No 2185/96 and (EC) No 1073/1999.
2.                      
For the Union activities financed pursuant to
this Regulation, the notion of irregularity referred to in Article 1(2) of
Regulation (EC, Euratom) No 2988/95 shall mean any infringement of a
provision of Union law or any breach of a contractual obligation resulting from
an act or omission by an economic 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.
3.                      
Any agreements and contracts resulting from this
Regulation shall provide for monitoring and financial control by the Commission
or any representative which it authorises and for audits by the Court of
Auditors, which if necessary may be conducted on the spot.
Chapter VI
Delegated acts, committee and reporting
Article 16
 Delegated acts
The Commission shall be empowered to adopt
delegated acts in accordance with Article 17 concerning amendments to the Annexes,
in order to:
(a)              
update the list of European standardisation
bodies set out in Annex I; 
(b)              
adapt the criteria for recognising standards in
the field of ICT set out in Annex II to technical developments;
(c)              
adapt the criteria for organisations
representing SME and societal stakeholders set out in Annex III to further
developments as regards their non-profit making nature and representativity. 
Article 17
Exercise of the delegation
1.                      
The power to adopt delegated acts is conferred
on the Commission subject to conditions laid down in this Article. 
2.                      
The delegation of power referred to in Article
16 shall be conferred on the Commission for an indeterminate period of time from
1 January 2013. 
3.                      
The delegation of powers referred to in Article 16
may be revoked at any time by the European Parliament or by the Council. A decision
of revocation shall put an end to the delegation of the powers specified in
that decision. It shall take effect the day following the publication of the
Decision in the Official Journal of the European Union or at a later
date specified therein. It shall not affect the validity of the delegated acts
already in force. 
4.                      
As soon as it adopts a delegated act, the
Commission shall notify it simultaneously to the European Parliament and to the
Council.
5.                      
A delegated act adopted pursuant to Article 16
shall enter into force only if no objection has been expressed either by the
European Parliament or the Council within a period of two months of
notification of that act to the European Parliament and the Council or if,
before expiry of that period, the 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 Parliament or the
Council.
Article 18
 Committee procedure
1.                      
The Commission shall be assisted by a committee.
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2.                      
Where reference is made to this paragraph,
Article 4 of Regulation (EU) No 182/2011 shall apply.
3.                      
Where reference is made to this paragraph,
Article 5 of Regulation (EU) No 182/2011 shall apply.
4.                      
Where the opinion of the committee is to be
obtained by written procedure, that procedure shall be terminated without
result when, within the time-limit for delivery of the opinion, the chair of
the committee so decides or a simple majority of committee members so request.
Article 19
Reports
1.                      
The European Standardisation Bodies shall send
an annual report on the implementation of this Regulation to the Commission. It
shall contain detailed information on the following:
(a)              
the application of Articles 4, 5, 6, 11 and 13;
(b)              
the representation of SMEs, consumer
organisations and environmental and social stakeholders in national
standardisation bodies.
2.                      
The organisations referred to in Annex III that
received financing in accordance with this Regulation shall send an annual
report on their activities to the Commission. This report shall contain in
particular detailed information about the membership of these organisations and
the activities referred to in Article 12.
3.                      
By 31 December 2015 and every five years
thereafter, the Commission shall present a report to the European Parliament
and the Council on the implementation of this Regulation. This report shall
contain an evaluation of the relevance of the standardisation activities
receiving Union financing in the light of the requirements of policies and
legislation of the Union. 
Chapter VII
Final provisions
Article 20
Amendments
1.                      
The following provisions are deleted:
(a)              
Article 6(1) of Directive 89/686/EEC;
(b)              
Article 5 of Directive 93/15/EEC; 
(c)              
Article 6(1) of Directive 94/9/EC;
(d)              
Article 6(1) of Directive 94/25/EC;
(e)              
Article 6(1) of Directive 95/16/EC;
(f)                
Article 6 of Directive 97/23/EC;
(g)              
Article 14 of Directive 2004/22/EC;
(h)              
Article 8(4) of Directive 2007/23/EC ;
(i)                
Article 6 of Directive 2009/105/EC;
(j)                
Article 7 of Directive 2009/23/EC. 
2.                      
Directive 98/34/EC is amended as follows:
(a)              
Paragraphs 6 to 10 of Article 1 and Articles 2,
3 and 4 are deleted;
(b)              
in Article 6(1), the words “with the
representatives of the standards institutions referred to in Annexes I and II”
are deleted;
(c)              
In Article 6(3) the first indent is deleted;
(d)              
In Article 6(4) points (a), (b) and (e) are
deleted;
(e)              
In Article 11, the second sentence is replaced
by the following sentence: “The Commission shall publish annual statistics on
the notifications received in the Official Journal of the European Union.”.
(f)                
Annexes I and II are deleted.
Article 21
National standardisation bodies
Member States shall inform the Commission
of their standardisation bodies.
The Commission shall publish a list of
national standardisation bodies and any updates to that list in the Official
Journal of the European Union.
Article 22
Transitional provisions
In Union acts that provide for a presumption
of conformity with essential requirements through the application of harmonised
standards adopted in accordance with Directive 98/34/EC, references to
Directive 98/34/EC shall be construed as references to this Regulation, except
references to the committee set up by Article 5 of Directive 98/34/EC. 
Where other Union act provides for a
procedure for objection to harmonised standards, Article 8 of this Regulation
shall not apply to that act.
Article 23
 Repeal
Decision No 1673/2006/EC and Decision 87/95/EEC
are repealed.
References to the repealed Decisions shall
be construed as references to this Regulation.
Article 24
 Entry into force
This Regulation shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.
It shall apply from 1 January 2013.
This Regulation shall be binding
in its entirety and directly applicable in all Member States.
Done at Brussels, 
For the European Parliament                       For
the Council
The President                                                 The
President
                                                                       
ANNEX I
EUROPEAN
STANDARDISATION BODIES:
1.         CEN - European Committee for
Standardisation
2.         CENELEC - European Committee for
Electrotechnical Standardisation
3.         ETSI - European
Telecommunications Standards Institute
ANNEX II
REQUIREMENTS
FOR THE RECOGNITION OF TECHNICAL SPECIFICATIONS IN THE FIELD OF ICT
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 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 standards in the field
of information and communication technologies and which is not a European,
national or international standardisation 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 operators in the
market or markets affected by the standard. 
(b)     consensus: 
the standardisation 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 widely announced through suitable and accessible means. 
(iii)     participation of all interested
categories of interested stakeholders was sought with a view to achieving
balance.
(iv)     consideration and response were given
to comments by interested parties.
3.           the technical
specifications reflect 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 characteristics;
(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.
(f)      quality: 
(i)      the quality and level of detail are
sufficient to permit the development of a variety of competing implementations
of interoperable products and services; 
(ii)      standardised interfaces are not
hidden or controlled by anyone other than the organisations that adopted the
technical specifications.
ANNEX III
EUROPEAN
STAKEHOLDER ORGANISATIONS
(a)              
A European organisation representing SME in
European standardisation activities which:
(i)      is non-governmental and non-profit-making.

(ii)      has as its statutory objectives and
activities to represent the interests of SME in the standardisation process at
European level; 
(iii)     has been mandated by non-profit organisations
representing SME in at least two thirds of the Member States, to represent the
interests of SME in the standardisation process at European level.
(b)              
A European organisation representing consumers
in European standardisation activities which:
(i)      is non-governmental,
non-profit-making, and independent of industry, commercial and business or
other conflicting interests. 
(ii)      has as its statutory objectives and
activities to represent consumer interests in the standardisation process at
European level;
(iii)     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.
(c)              
A European organisation representing
environmental interests in European standardisation activities which:
(i)      is non-governmental,
non-profit-making, and independent of industry, commercial and business or
other conflicting interests. 
(ii)      has as its statutory objectives and
activities to represent environmental interests in the standardisation process
at European level; 
(iii)     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.
(d)              
A European organisation representing social
interests in European standardisation activities which:
(i)      is non-governmental,
non-profit-making, and independent of industry, commercial and business or
other conflicting interests. 
(ii)      has as its statutory objectives and
activities to represent social interests in the standardisation process at
European level; 
(iii)     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.
LEGISLATIVE FINANCIAL STATEMENT
1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE 
              1.1.    Title of the proposal/initiative
              1.2.    Policy
area(s) concerned in the ABM/ABB structure
              1.3.    Nature
of the proposal/initiative
              1.4.    Objective(s)
              1.5.    Grounds
for the proposal/initiative
              1.6.    Duration
and financial impact
              1.7.    Management
method(s) envisaged
2.           MANAGEMENT MEASURES
              2.1.    Monitoring
and reporting rules
              2.2.    Management
and control system
              2.3.    Measures
to prevent fraud and irregularities
3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE 
              3.1.    Heading(s)
of the multiannual financial framework and expenditure budget line(s) affected 
              3.2.    Estimated
impact on expenditure 
              3.2.1. Summary of estimated
impact on expenditure 
              3.2.2. Estimated impact
on operational appropriations 
              3.2.3. Estimated impact
on appropriations of an administrative nature
              3.2.4. Compatibility
with the current multiannual financial framework
              3.2.5. Third-party
participation in financing 
              3.3.    Estimated impact on revenue
LEGISLATIVE FINANCIAL STATEMENT

1.                      
FRAMEWORK OF THE PROPOSAL 
1.1.                
Title of the proposal

Proposal for a Regulation of the European
Parliament and the Council on European Standardisation and amending Council
Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC,
97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the
European Parliament and of the Council.

1.2.                
Policy area(s) concerned in
the ABM/ABB structure[32] 

Title 2 – Enterprise - Chapter 02 03: Internal
market for goods and sectoral policies

1.3.                
Nature of the proposal 

The proposal relates to the
extension of an existing action. 
It should be noted that the
amounts set out in this legislative financial statement do not prejudice the
forthcoming Commission proposal for the post-2013 multi-annual financial
framework. Budgetary appropriations allocated to this action will be proposed
by the Commission in the annual budgetary procedure. Consequently, this
financial statement is limited to one year (2013). 

1.4.                
Objectives
1.4.1.          
The Commission's multiannual
strategic objective(s) targeted by the proposal 

1a. Competitiveness for growth and employment

1.4.2.          
Specific objective(s) and
ABM/ABB activity(ies) concerned 

Specific objective No 1.
To continually review existing internal market
acquis and propose new legislative or non-legislative action whenever
appropriate.

1.4.3.          
Expected result(s) and impact

The proposal sets out the general framework for
European standardisation. It contains a number of elements without budgetary
impacts (e.g. the cooperation between the European standardisation bodies, the
national standardisation bodies and the Commission) as well as the legal basis
for the financing of part of the standardisation activities performed by the
European standardisation bodies CEN, CENELEC and ETSI (hereinafter referred to
as “ESOs”) and the legal basis for financial support to European organisations
representing SMEs, consumers, environmental and social interests.
The financing of a part of the European
standardisation system through the ESOs is vital for the internal market and
should be continued. Nevertheless, the system should become more efficient. On
the one hand, measures are taken to increase the speed of standard-setting for
European standards elaborated at the request of the Commission. Financial tools
will be used to encourage ESOs to search more actively for a consensus on
contentious topics and to revise some internal processes. On the other hand,
this proposal contains a shift to a radically simpler, faster and more stable
arrangement to increase the efficiency of the financial support granted by the
EU. A significantly simpler and less bureaucratic set of arrangements will
alleviate the administrative burden imposed on operational services and
beneficiaries. This burden prevents services from using their resources on
policy objectives and on timely delivery, while it creates excessive red tape
for the ESOs. This proposal reforms the financing of the ESOs by including the
possibility to shift it gradually towards a performance-based system, based on
the definition of agreed indicators and objectives (outputs and outcomes) and
on a simplification of lump sums, clearly disconnected from any verification of
actual costs of implementation. 
The financial support to European organisations
representing SMEs, consumers, environmental and social interests should also be
continued. Until now, they were financed through various programmes, most of
which expire on 31 December 2013. Consequently, it is appropriate to streamline
these support schemes and to regroup them under the same legal basis. The
criteria for eligibility for these grants, the conditions for their use and the
type of financial contributions are aligned and adapted to the specific needs
of the corresponding group of stakeholders so that, for example, operating
grants can be given to one European organisation per field of economic or societal
interest. 
The principle of gradual decrease for operating
grants which are not flat-rate grants pursuant to Article 113 of the Financial
Regulation, does not apply to the ESOs, according to Decision No 1673/2006/EC
of the European Parliament and of the Council of 24 October 2006 on the
financing of European standardisation. This exception should be maintained for
the future.
Moreover, the basic philosophy of operating
grants is that they should provide temporary support for an organisation to
allow it to achieve financial independence in the longer term. However, this
degressivity would contradict the EU policy under which the position of SMEs
and societal stakeholders must be strengthened in order to ensure the
inclusiveness of the European standardisation system. In the likely event that
more European standards will be developed in the future, the workload of
organisations representing SMEs and societal stakeholders in the European
standardisation system will increase. These organisations have a permanent role
which is essential for EU activities and policies because of the context in
which they operate and their statutory objectives. It is
essential for the development of European standardisation to continue fostering
and encouraging the active participation of European organisations representing
SME, consumers and environmental and social interests. Such organisations pursue
an aim of general European interest and constitute, by virtue of the specific
mandate that national non-profit organisations have given them or through their
exclusive representation of the interests of SME and societal stakeholders, a
European network representing non-profit bodies 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 SME, consumers and environmental and social interests in European
standardisation have a permanent role which is
essential for Union activities and policies. In addition, the development of a
standard takes between 1 to 3 years which requires a long-term commitment to
the technical process. On-going and active participation in a technical
committee or working group requires a very significant commitment of time over
a longer period. Therefore, it is necessary to extend the exception to the
degressivity principle to the selected European organisations representing
SMEs, consumers, environmental and social interests.

1.4.4.          
Indicators of results and impact 

(1)              
The number of European standards adopted by the
ESOs following a request by the Commission;
(2)              
The time between the acceptance, by the ESOs, of
the request to draft a European standard and the formal adoption of the
standard;
(3)              
The actual participation rate of the European
organisations representing SMEs, consumers, environmental and social interests
in the European standardisation process;
(4)              
The actual changes to the standardisation
structures and governance and their impact on the number of adopted standards,
the speed of standard-setting and the participation of the European
organisations representing SMEs, consumers, environmental and social interests
in the European standardisation process.

1.5.                
Grounds for the proposal 
1.5.1.          
Requirement(s) to be met in the short or long
term 

The requirements to be met by the proposal can
be summarised as follows;
(1)              
European standardisation is an important and
effective tool to support European policy and legislation. It has and will have
a significant impact in underpinning the single market of goods and services
and preventing the creation of barriers trade within the EU. Therefore, the
adoption of European standards by the ESOs should continue and should be
co-financed by the EU. In addition, the legal basis should not only cover
standards on products but also standards on services.
(2)              
Standardisation within the EU makes a
significant contribution to the European economy. The use of standards is a
powerful strategic tool for businesses to increase their competitiveness. It is
therefore important that standards keep pace with ever faster product
development cycles and that the speed of European standard-setting is improved.
(3)              
Standards will affect more and more groups in
European society, including businesses of all sorts and many individual
citizens. A standard is the result of a consensus reached by those
participating in its development. A sufficiently wide range of participants is
essential for a standard to be accepted both by businesses and consumers. The
proposal should ensure that the European standardisation system therefore
becomes as inclusive as possible, with all partners committed to a system
rooted in the core values of openness, transparency and scientific solidity,
and through a process of continuous improvement of standardisation structures
and governance.
(4)              
Standards need to be available to assure the
interoperability between services and applications in the field of information
and communications technologies so that Europe can reap the full benefits of
ICT. The most relevant ICT standards developed by specialised fora and
consortia should play a more prominent role in domains where the ESOs are not
active, where ESO standards have not gained market uptake or where these
standards have become obsolete. Consequently, these standards should be
formally recognised so that they can be used by public authorities for public
procurement purposes.

1.5.2.          
Added value of EU involvement

European standards play a very important part
in the functioning of the internal market for industrial products. European
standards replace national and often conflicting standards which, as such, may
create technical impediments to a national market. European standards can be
divided into 2 categories:
a) European standards developed at the request
of the Commission, on the basis of a so-called “mandate” in which the ESOs are
requested to draw up technical specifications of a normative nature that meet
the requirements set out in the mandate. These standards can be subdivided into
2 subcategories:
- European harmonised standards which ensure
that products meet the essential requirements set out in EU legislation.
Compliance with a European “harmonised” standard guarantees the required level
of safety of products. However, use of harmonised standards is still voluntary
and a manufacturer may use any other technical solution which demonstrates that
his product meets the essential requirements. The percentage of European
harmonised standards has increased in the last two decades from 3.55% to 20% in
2009. 
- Other European standards to support European
policies.
b) The remaining European standards are adopted
outside EU legislation on the initiative of undertakings, NSBs or other
stakeholders, or at the request of the Commission. 
European standards and especially harmonised
standards are cornerstones for the functioning of the internal market for goods.
Yet, elaborating standards is a labour-intensive and time-consuming activity
done by national experts. Therefore, Decision No 1673/2006/EC sets out the
legal basis for the financial support to the Central Secretariats of European
standardisation bodies with the aim of improving the quality of harmonised
standards and promoting European standardisation at international level. The
European Commission and EFTA establish Framework Partnership Agreements (FPAs)
with each ESO, under which proposals for financing can be addressed to the
Commission. The FPAs fix the administrative and financial rules concerning the
financing of standardisation activities and set out the general context and
terms under which financial support can be allocated. This proposal replaces
Decision No 1673/2006/EC.

1.5.3.          
Lessons learned from similar experiences in the
past

This proposal takes into account the
evaluations that were made in the context of Decision No 1673/2006/EC and to
which the impact assessment refers.

1.5.4.          
Coherence and possible synergy with other
relevant instruments

This proposal is entirely coherent with the
other relevant instruments, i.e. all legislative acts set out in Annex 4 of the
accompanying impact assessment. 

1.6.                
Duration and financial impact 

Proposal of unlimited duration

1.7.                
Management mode(s) envisaged[33] 

Centralised direct management by the Commission

2.                      
MANAGEMENT MEASURES 
2.1.                
Monitoring and reporting rules 

The common cooperation objectives and the
administrative and financial conditions relating to the grants awarded to
European standardisation bodies and the other organisations referred to in the
proposal will be defined in the framework partnership agreements that will be
signed by the Commission and these bodies and organisations, in accordance with
the Financial Regulation and Regulation (EC, Euratom) No 2342/2002. These
agreements as well as the grant agreements will specify the monitoring and
reporting rules.
In addition, the proposal obliges the European
standardisation bodies and the other organisations referred to in the proposal
to submit annual reports to the Commission on the implementation of their
obligations. 

2.2.                
Management and control system 
2.2.1.          
Risk(s) identified 

The European standardisation bodies have a
solid financial basis. The calls for proposals for the other organisations
referred to in the proposal will contain financial selection criteria in order
to prevent any financial risks. Consequently, no financial risks could be
identified.

2.2.2.          
Control method(s) envisaged 

The control methods envisaged are laid down in
the Financial Regulation and Regulation (EC, Euratom) No 2342/2002. They will
be specified in greater detail in the framework partnership agreements and the
grant agreements that will be signed by the Commission and the European
standardisation bodies and the other organisations referred to in the proposal.
The proposal also expressly specifies that any agreements and contracts
resulting from the Regulation must provide for monitoring and financial control
by the Commission or any representative which it authorises and for audits by
the Court of Auditors, which if necessary may be conducted on the spot.

2.3.                
Measures to prevent fraud and irregularities 

This proposal contains a provision according to
which the Commission must ensure that the financial interests of the Union are
protected by the application of preventive measures against fraud, corruption
and other illegal activities, by effective checks and by the recovery of
amounts unduly paid and, if irregularities are detected, by effective,
proportionate and dissuasive penalties, in accordance with Regulations (EC,
Euratom) No 2988/95, (Euratom, EC) No 2185/96 and (EC) No 1073/1999. 

3.                      
ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL 
3.1.                
Heading(s) of the multiannual financial
framework and expenditure budget line(s) affected 

·      Existing expenditure budget lines 
 Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution 
 DA/NDA ([34]) || from EFTA[35] countries || from candidate countries[36] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation 
 1a. Competitiveness for growth and employment || Article 02 03 04 — Standardisation and approximation of legislation || DA || YES || NO || NO || NO 
·      New budget lines requested: Article 02 03 04 should be divided into
two separate articles: 
–     
Article 02 03 04 01 should replace the former
Article 02 03 04 and should contain the credits earmarked to it, covering the
financial support to the standardisation activities of CEN, CENELEC and ETSI;
–     
Article 02 03 04 02 will consist of the
following credits which were previously committed and paid under articles
02.02.01, 17.02.02.00 and 07.03.07 for activities related to standardisation:
2,1 EUR million from budget line 02.02.01, 1,4 EUR million from budget line
17.02.02.00 and 0,2 EUR million from budget line 07.03.07 will be transferred
to the new budget line 02 03 04 02.
–     
Articles 02.02.01, 17.02.02.00 and 07.03.07 will
be decreased in the financial programming by the above amounts corresponding to
standardisation activities.The latter articles will be decreased by the amounts
corresponding to standardisation activities.
–     
The credits for grants to other organisations
representing societal stakeholders in the field of standardisation are included
in other budgetary articles (e.g. 04.03.03.02). 
 Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution 
 Diff./non-diff. || from EFTA countries || from candidate countries || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation 
 1a. Competitiveness for growth and employment || Article 02 03 04 01 — Support to standardisation activities performed by CEN, CENELEC and ETSI || DA || YES || NO || NO || NO 
 1a. Competitiveness for growth and employment || Article 02 03 04 02 — Support to organisations representing SMEs and societal stakeholders in standardisation activities || DA || YES || NO || NO || NO 

3.2.                
Estimated impact on expenditure[37]
3.2.1.          
Summary of estimated impact on expenditure 

EUR million (to 3 decimal places)
 Heading of multiannual financial framework: || Number || 1a. Competitiveness for growth and employment 
   ||   ||   || Year N[38] || Year N+1 || Year N+2 || Year N+3 || Years N+4 to 6 || TOTAL 
  Operational appropriations ||   ||   ||   ||   ||   ||   ||   ||   
 Article 02 03 04 01 — Support to standardisation activities performed by CEN, CENELEC and ETSI || Commitments || (1) || 23.5 || -- || -- || -- || -- || -- || -- || -- 
 Payments || (2) || 9 || -- || -- || -- || -- || -- || -- || -- 
 Article 02 03 04 02 — Support to organisations representing SMEs and societal stakeholders in standardisation activities || Commitments || (1a) || 3.7 || -- || -- || -- || -- || -- || -- || -- 
 Payments || (2a) || 3.7 || -- || -- || -- || -- || -- || -- || -- 
 Appropriations of an administrative nature financed  from the envelop of specific programs[39] ||   ||   ||   || -- || -- || -- || -- || -- 
 Article 02 01 04 02 - ||   || (3) || 0.2 || -- || -- || -- || -- || -- || -- || -- 
 For information purposes only, the following lines will be decreased (these amount are not reflected in the totals): ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Article 02.02.01(heading 1a) || Commitments ||   || -2.1 || -- || -- || -- || -- || -- || -- || -- 
 Payments ||   || -2.1 || -- || -- || -- || -- || -- || -- || -- 
 Article 17.02.02.00 (heading 3 b) || Commitments ||   || -1.4 || -- || -- || -- || -- || -- || -- || -- 
 Payments ||   || -1.4 || -- || -- || -- || -- || -- || -- || -- 
 Article 07.03.07 (heading 2) || Commitments ||   || -0.2 || -- || -- || -- || -- || -- || -- || -- 
 Payments ||   || -0.2 || -- || -- || -- || -- || -- || -- || -- 
 TOTAL appropriations under HEADING 1.a of the multiannual financial framework || Commitments || =1+1a +3 || 27.4 || -- || -- || -- || -- || -- || -- || -- 
 Payments || =2+2a +3 || 12.9 || -- || -- || -- || -- || -- || -- || -- 
 Heading of multiannual financial framework: || 5 || "Administrative expenditure" 
EUR million (to 3 decimal places)
   ||   ||   || Year N || Year N+1 || Year N+2 || Year N+3 || Years N+4 to 6 || TOTAL 
 DG: ENTR, SANCO, MARKT, MOVE, ENV and INFSO || 
  Human resources || 3.5 || -- || -- || -- || -- || -- || -- || -- 
  Other administrative expenditure || 0.3 || -- || -- || -- || -- || -- || -- || -- 
 TOTAL || Appropriations || -- || -- || -- || -- || -- || -- || -- ||   
 TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 3.8 || -- || -- || -- || -- || -- || -- || -- ||   
EUR million (to 3 decimal places)
   ||   ||   || 2013 || 2014 || 2015 || 2016 || 2017-2020 || TOTAL 
 TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 3.8 || -- || -- || -- || -- || -- || -- || -- 
 Payments || 3.8 || -- || -- || -- || -- || -- || -- || -- 

3.2.2.          
Estimated impact on operational appropriations 

The proposal requires the use of operational
appropriations, as explained below:
Commitment appropriations in EUR million (to 3 decimal
places)
 Indicate objectives and outputs   ò ||   || Year N || Year N+1 || Year N+2 || Year N+3 || Years N+4 to 6 || TOTAL 
 OUTPUTS 
 Type of output[40] || Average cost of the output || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Total number of outputs || Total cost 
 SPECIFIC OBJECTIVE No 1: To continually review existing internal market acquis and propose new legislative or non-legislative action whenever appropriate. ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Central secretariat of ESOs   || (A) || 3.35 || 3 || 10 || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 
 Translation of standards || (B) || 0.55 || 2 || 1.1 || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 
 Standardisation work (including ICT) || (C) || 0.4 || 25 || 11 || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 
 Promotion of European standards || (D) || 0.1 || 1 || 0.1 || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 
 Audits, evaluations, and specific projects || (E) || 0.8 || 1 || 0.8 || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 
 Studies and technical assistance || (D) (E) || 1.2 || 0 || 0 || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 
 Promotion and development of Eurocodes || (D) (E) || 0.5 || 1 || 0.5 || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 
 Support to organisations representing SMEs || (A) to (E) || 2.0 || 1 || 2.0 || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 
 Support to organisations representing societal stakeholders || (A) to (E) || 0.75 || 2 || 1.5 || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 
 Sub-total for specific objective N°1 ||   ||   || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 
 TOTAL COST || 36 || 27 || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- || -- 

3.2.3.          
Estimated impact on appropriations of an
administrative nature
3.2.3.1.    
Summary 

The proposal requires the use of administrative
appropriations, as explained below:
EUR million (to 3
decimal places)
   || Year N || Year N+1 || Year N+2 || Year N+3 || Years N+4 to 6 || TOTAL 
 HEADING 5 of the multiannual financial framework ||   ||   ||   ||   ||   ||   ||   ||   
 Human resources || 3.5 || -- || -- || -- || -- || -- || -- || -- 
 Other administrative expenditure || 0.3 || -- || -- || -- || -- || -- || -- || -- 
 Subtotal HEADING 5 of the multiannual financial framework || 3.8 || -- || -- || -- || -- || -- || -- || -- 
 Outside HEADING 5[41] of the multiannual financial framework ||   ||   ||   ||   ||   ||   ||   ||   
 Human resources || 0 || -- || -- || -- || -- || -- || -- || -- 
 Other expenditure of an administrative nature || 0.2 || -- || -- || -- || -- || -- || -- || -- 
 Subtotal outside HEADING 5 of the multiannual financial framework || 0.2 || -- || -- || -- || -- || -- || -- || -- 
 TOTAL || 4 || -- || -- || -- || -- || -- || -- || -- 

3.2.3.2.    
 Estimated requirements of human resources 

The proposal requires the use of human
resources, as explained below:
Estimate to be expressed in full amounts
(or at most to one decimal place)
   || Year N || Year N+1 || Year N+2 || Year N+3 || Years N+4 to 6 
  Establishment plan posts (officials and temporary agents) || 
 XX 01 01 01 (Headquarters and Commission’s Representation Offices) || 2.9 || -- || -- || -- || -- || -- || -- 
 XX 01 01 02 (Delegations) || 0 || -- || -- || -- || -- || -- || -- 
 XX 01 05 01 (Indirect research) || 0 || -- || -- || -- || -- || -- || -- 
 10 01 05 01 (Direct research) || 0 || -- || -- || -- || -- || -- || -- 
   External personnel (in Full Time Equivalent unit: FTE)[42] || 
 XX 01 02 01 (CA, INT, SNE from the "global envelope") || 0.6 || -- || -- || -- || -- || -- || -- 
 XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) || 0 || -- || -- || -- || -- || -- || -- 
 XX 01 05 02 (CA, INT, SNE - Indirect research) || 0 || -- || -- || -- || -- || -- || -- 
 10 01 05 02 (CA, INT, SNE - Direct research) || 0 || -- || -- || -- || -- || -- || -- 
 Other budget lines (specify) || 0 || -- || -- || -- || -- || -- || -- 
 TOTAL || 7 || -- || -- || -- || -- || -- || -- 
XX is the policy
area or budget title concerned.
The human resources required will be met by staff
from the DG who are already assigned to management of the action and/or have
been redeployed within the DG, together if necessary with any additional
allocation which may be granted to the managing DG under the annual allocation
procedure and in the light of budgetary constraints.
Description of
tasks to be carried out:
 Officials and temporary agents || Implementation of the Regulation (i.e. manage standardisation activities and their financing, including on ICT, and manage the grants to organisations representing SMEs and societal stakeholders) 
 External personnel || Seconded National Experts will contribute to the follow-up of standardisation activities, including on ICT. Contract agents will mainly perform executive tasks. 

3.2.4.          
Compatibility with the current multiannual
financial framework 

The proposal is compatible with the current
multiannual financial framework. Some credits might be moved from other
budgetary titles to title 2 (Enterprise) as set out in section 3.1.

3.2.5.          
Third-party contributions 

The proposal provides for the co-financing
estimated below:
Appropriations in EUR million (to 3 decimal places)
   || Year N || Year N+1 || Year N+2 || Year N+3 || Years N+4 to 6 || Total 
 Specify the co-financing body || EFTA || EFTA || EFTA || EFTA || EFTA || EFTA || EFTA || EFTA 
 TOTAL appropriations cofinanced || 0.7 || -- || -- || -- || -- || -- || -- || -- 

3.3.                
Estimated impact on revenue 

The proposal has no financial impact on
revenue.
[1]               OJ C […], […], p. […].
[2]               OJ L 24, 21.7.1998, p. 37.
[3]               OJ L 315, 15.11.2006, p. 9.
[4]               OJ L 36, 7.2.1987, p. 31.
[5]               OJ L376, 27.12.2006.
[6]               OJ L 71, 17.3.1980, p. 1.
[7]               OJ L 399, 30.12.1989, p.18.
[8]               OJ L 121, 15.5.1993,
p. 20.
[9]               OJ L 100, 19.4.1994, p. 1.
[10]             OJ L 164, 30.6.1994, p.15.
[11]             OJ L 213, 7.9.1995, p. 1.
[12]             OJ L 181, 9.7.1997, p. 1.
[13]             OJ L 135, 30.4.2004, p. 1.
[14]             OJ L 154, 14.6.2007, p. 1.
[15]             OJ L 264, 8.10.2009, p. 12.
[16]             OJ L 122, 16.5.2009, p. 6.
[17]             OJ L 218, 13.8.2008, p. 82.
[18]             OJ L 134, 30.4.2004, p. 1.
[19]             OJ L 134, 30.4.2004, p. 114.
[20]             OJ L 260, 3.10.2009, p. 20.
[21]             OJ L 108, 24.4.2002, p. 33.
[22]             OJ L 248, 16.9.2002, p. 1.
[23]             OJ L 357, 31.12.2002, p. 1.
[24]             OJ L 310, 9.11.2006, p. 15.
[25]             OJ L 404, 30.12.2006, p. 39.
[26]             OJ L 149, 9.6.2007, p. 1.
[27]             OJ L 312, 23.12.1995, p. 1.
[28]             OJ L 292, 15.11.1996, p. 2.
[29]             OJ L 136, 31.5.1999, p. 1.
[30]             OJ L 55, 28.2.2011, p. 13.
[31]             OJ L 88, 4.4.2011, p. 5.
[32]             ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.
[33]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html
[34]             DA= Differentiated appropriations / DNA=
Non-Differentiated Appropriations
[35]             EFTA: European Free Trade Association. 
[36]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.
[37]             The amounts set out in the tables in section 3.2 should
be adapted to inflation and eventually should be adjusted accordingly.
[38]             Year N is the year in which implementation of the
proposal is likely to start, namely 2013. 
[39]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.
[40]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.). (A)=
administrative support, (B)= translation services, (C)= actual standardisation
work, (D)= promotion and publicity, including conferences and (E)= other
intellectual services
[41]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.
[42]             CA= Contract Agent; INT= agency staff ("Intérimaire");
JED= "Jeune Expert en Délégation" (Young Experts in
Delegations); LA= Local Agent; SNE= Seconded National Expert;