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 are essential.

European standardisation is organised by and for the stakeholders concerned based on national representation (the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec)) and direct participation (the European Telecommunications Standards Institute (ETSI)), and is founded on the principles recognised by the World Trade Organisation (WTO) in the field of standardisation, namely coherence, transparency, openness, consensus, voluntary application, independence from special interests and efficiency (‘the founding principles’). In accordance with the founding principles, it is important that all relevant interested parties, including public authorities and small and medium-sized enterprises (SMEs), are appropriately involved in the national and European standardisation process. National standardisation bodies should also encourage and facilitate the participation of stakeholders.

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. European standardisation reinforces the global competitiveness of European industry especially when established in coordination with the international standardisation bodies, namely the International Organisation for Standardisation (ISO), the International Electrotechnical Commission (IEC) and the International Telecommunication Union (ITU). 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 and consumers in particular. Standards may maintain and enhance quality, provide information and ensure interoperability and compatibility, thereby increasing safety and value for consumers.

European standards are adopted by the European standardisation organisations, namely CEN, Cenelec and ETSI.

European standards play a very important role within the internal market, for instance through the use of harmonised standards in the presumption of conformity of products to be made available on the market with the essential requirements relating to those products laid down in the relevant Union harmonisation legislation. Those requirements should be precisely defined in order to avoid misinterpretation on the part of the European standardisation organisations.

Standardisation plays an increasingly important role in international trade and the opening-up of markets. The Union should seek to promote cooperation between European standardisation organisations and international standardisation bodies. The Union should also promote bilateral approaches with third countries to coordinate standardisation efforts and promote European standards, for instance when negotiating agreements or by seconding standardisation experts to third countries. Furthermore the Union should encourage contact between European standardisation organisations and private forums and consortia, while maintaining the primacy of European standardisation.

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.

Like other standards, standards for services are voluntary and should be market-driven, whereby the needs of the economic operators and stakeholders directly or indirectly affected by such standards prevail, and should take into account the public interest and be based on the founding principles, including consensus. They should primarily focus on services linked to products and processes.

The European standardisation organisations 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 TFEU.

The Member States’ obligation to notify the Commission of their national standardisation bodies should not require the adoption of a specific national legislation for the purposes of recognition of those bodies.

The regular exchange of information between the national standardisation bodies, the European standardisation organisations and the Commission should not prevent national standardisation bodies from complying with other obligations and commitments, and in particular with Annex 3 to the Agreement on Technical Barriers to Trade.

The representation of societal interests and societal stakeholders in European standardisation activities refers to the activities of organisations and parties representing interests of greater societal relevance, for instance environmental, consumer interests or employee interests. However, the representation of social interests and social stakeholders in European standardisation activities refers particularly to the activities of organisations and parties representing employees and workers’ basic rights, for instance trade unions.

In order to speed up the decision-making process, national standardisation bodies and European standardisation organisations should facilitate accessible information on their activities through the promotion of the use of information and communication technologies (ICT) in their respective standardisation systems, for example by providing to all relevant stakeholders an easy-to-use online consultation mechanism for the submission of comments on draft standards and by organising virtual meetings, including by means of web conferencing or video conferencing, of technical committees.

Standards can contribute to helping Union policy address the major societal challenges such as climate change, sustainable resource use, innovation, ageing population, integration of people with disabilities, consumer protection, workers’ safety and working conditions. By driving the development of European or international standards for goods and technologies in the expanding markets in those areas, the Union could create a competitive advantage for its enterprises and facilitate trade, in particular for SMEs, which account for a large part of European enterprises.

Standards are important tools for the competitiveness of undertakings and especially SMEs, whose participation in the standardisation process is important for technological progress in the Union. Therefore it is necessary that the standardisation framework encourage SMEs to actively participate in and provide their innovative technology solutions to standardisation efforts. This includes improving their participation at national level where they can be more effective due to lower costs and lack of linguistic barriers. Consequently this Regulation should improve representation and participation of SMEs in both national and European technical committees and should facilitate their effective access to and awareness of standards.

European standards are of vital interest for the competitiveness of SMEs which, however, are in some cases under-represented in European standardisation activities. Thus, this Regulation should encourage and facilitate appropriate representation and participation of SMEs in the European standardisation process by an entity that is effectively in contact with, and duly representative of, SMEs and organisations representing SMEs at national level.

Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, workers’ safety and working conditions, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of societal stakeholders in the development of standards are strengthened, through the reinforced support of organisations representing consumers and environmental and social interests.

The obligation of the European standardisation organisations to encourage and facilitate representation and effective participation of all relevant stakeholders does not entail any voting rights for these stakeholders unless such voting rights are prescribed by the internal rules of procedure of the European standardisation organisations.

Due to the importance of standardisation as a tool to support Union legislation and policies and in order to avoid ex-post objections to and modifications of harmonised standards, it is important that public authorities participate in standardisation at all stages of the development of those standards where they may be involved and especially in the areas covered by Union harmonisation legislation for products.

Standards should 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 (JRC). Thus, this Regulation should ensure that the JRC can play an active role in the European standardisation system.

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, including national market surveillance authorities, by introducing mechanisms for collecting opinions and facilitating the exchange of information among all interested parties. Since Directive 98/34/EC already provides for the possibility to request the European standardisation organisations to develop 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 organisations. It is necessary to ensure a high level of cooperation between the European standardisation organisations and the European stakeholder organisations receiving Union financing in accordance with this Regulation and the Commission in the establishment of its annual Union work programme for standardisation and in the preparation of requests for standards in order to analyse the market relevance of the proposed subject matter and the policy objectives set by the legislator, and to allow the European standardisation organisations to respond more quickly to the requested standardisation activities.

Before bringing a matter regarding requests for European standards or European standardisation deliverables, or objections to a harmonised standard before the committee set up by this Regulation, the Commission should consult experts of the Member States, for instance through the involvement of committees set up by the corresponding Union legislation or by other forms of consultation of sectoral experts, where such committees do not exist.

Technical specifications not adopted by European standardisation organisations do not hold an equivalent status to European standards. Some ICT technical specifications are not developed in accordance with the founding principles. Therefore, this Regulation should lay down a procedure for the identification of ICT technical specifications that could be referenced in public procurement, involving a broad consultation of a large spectrum of stakeholders, including the European standardisation organisations, enterprises and public authorities. This Regulation should also lay down requirements, in the form of a list of criteria, for such technical specifications and their associated development processes. The requirements for the identification of ICT technical specifications should ensure that public policy objectives and societal needs are respected, and should be based on the founding principles.

In order to further innovation and competition, the identification of a particular technical specification should not disqualify a competing technical specification from being identified in accordance with the provisions of this Regulation. Any identification should be subject to the criteria being fulfilled and to the technical specification having achieved a significant level of market acceptance.

This Regulation should not prevent European standardisation organisations from continuing to develop standards in the field of ICT and to increase their cooperation with other standard developing bodies, especially in the field of ICT, in order to ensure coherence and avoid fragmentation or duplication during implementation of standards and specifications.

The procedure for identification of ICT technical specifications provided for in this Regulation should not undermine the coherence of the European standardisation system. Therefore, this Regulation should also lay down the conditions under which it can be considered that a technical specification does not conflict with other European standards.

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 and to use wherever possible the least burdensome procedures.

Inasmuch as European standardisation organisations 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 organisations that are pursuing an objective of general European interest without applying, in the case of operating grants, the principle of annual reduction provided for in Article 113(2) of Regulation (EC, Euratom) No 1605/2002.

The financing of standardisation activities should also be capable of covering preliminary or ancillary activities in connection with the establishment of European standards or European standardisation deliverables for products and for services. 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.

Union financing should seek to establish European standards or European standardisation deliverables for products and for services, to facilitate their use by enterprises through the enhanced support for their translation into the various official Union languages, in order to allow SMEs to fully benefit from the understanding and application of the European standards, 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 relevant Union legislation.

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.

In order to update the list of European standardisation organisations and to adapt the criteria for organisations representing SMEs 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 TFEU 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. 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 to the Council.

The committee set up by this Regulation should assist the Commission in all matters related to the implementation of this Regulation, having due regard for the views of sectoral experts.

The advisory procedure should be used for the adoption of implementing acts with respect to the objections to harmonised standards and where the references to the harmonised standard concerned have not yet been published in the Official Journal of the European Union, given that the relevant standard has not yet led to the presumption of conformity with the essential requirements set out in the applicable Union harmonisation legislation.

The examination procedure should be used for each standardisation request submitted to European standardisation organisations and the adoption of implementing acts with respect to the objections to harmonised standards and where the references to the harmonised standard concerned have already been 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.

In order to achieve the main objectives of this Regulation and to facilitate speedy decision-making procedures as well as reducing the overall development time for standards, use should be made as far as possible of the procedural measures provided for in Regulation (EU) No 182/2011, which enables the chair of the relevant committee to lay down a time limit within which the committee should deliver its opinion, according to the urgency of the matter. Moreover, where justified, it should be possible for the opinion of the committee to be obtained by written procedure, and silence on the part of the committee member should be regarded as tacit agreement.

Since the objectives of this Regulation, namely to ensure the effectiveness and efficiency of standards and standardisation as policy tools for the Union through cooperation between European standardisation organisations, national standardisation bodies, Member States 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 identification of ICT technical specifications eligible for referencing, the financing of European standardisation and stakeholder participation in European standardisation cannot be sufficiently achieved by the Member States and can, therefore, by reason of their effect, be better achieved at the Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. 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 those objectives.

Directives 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, 2009/23/EC and 2009/105/EC should therefore be amended accordingly.

Decision No 1673/2006/EC and Decision 87/95/EEC should be repealed,