Not cleared from scrutiny; further information requested; drawn to the attention of the Business, Energy and Industrial Strategy Select Committee
Communication to the European Parliament, the Council, the European Economic and social Committee and the Committee of the Regions: The annual Union work programme for European standardisation for 2018
Business, Energy and Industrial Strategy
(38999), 11785/17+ ADDs 1–2, COM(17) 453
9.1Standards are voluntary, market-led and developed on the basis of consensus by international standards organisations; businesses do not need to comply with them, but adherence to such standards may demonstrate compliance with existing or new legislation.
9.2European standards are developed through one of the three European Standards Organisations (ESOs): the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) and the European Telecommunications Standards Institute (ETSI).
9.3Although CEN and CENELEC are not EU agencies, 30 of the ESOs’ 34 member organisations are either from EU Member States or the EEA (the other countries being Switzerland, FYRM, Serbia and Turkey), and the EU accordingly plays a significant role in framing some of their activity. About a fifth of all European standards are developed following a standardisation request (mandate) from the European Commission to the ESOs. This is a request to draw up and adopt European standards in support of European policies and legislation. The resulting standard may be used by industry to demonstrate compliance with product safety or other requirements set out in EU legislation.
9.4Each year the Commission must publish an annual work programme that identifies EU strategic priorities for European standardisation and the standards it will ask the ESOs to develop in support of new or existing legislation and policies. On 25 August 2017 the Commission published its standardisation work programme for 2018, which highlights the role of standards in supporting the various overarching policies and strategies and recognises the strategic importance of international cooperation in order to achieve coherence between international and European standards.
9.5On 21 September 2017 the Minister of State for Small Business, Consumers and Corporate Responsibility at the Department for Business, Energy and Industrial Strategy (Margot James) produced an explanatory memorandum setting out the Government’s position in relation to the proposal. The Minister indicates that the Government is broadly supportive of European standardisation and the Commission’s proposed action plan to address the stock of unpublished harmonised standards.
9.6The Minister does not provide information about how the Government intends to approach the issue of standardisation in the context of the UK’s impending withdrawal from the European Union.
9.7We thank the Government for its explanatory memorandum in relation to the European standardisation work programme for 2018.
9.8In relation to Brexit, although European standardisation organisations (ESOs) are not, as the Government points out, EU agencies, we observe that:
9.9We ask that the Government respond to the following questions about standardisation processes which arise as a consequence of the UK’s withdrawal from the EU:
9.10We retain this document under scrutiny and ask the Government to respond by 6 December 2017. In the meantime, we draw this document to the attention of the Business, Energy and Industrial Strategy Select Committee.
Communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: The annual Union work programme for European standardisation for 2018: (38999), 11785/17, COM(2017) 453 + ADDs 1–2.
9.11Standards are market-based tools developed for and by interested parties; their usage is voluntary and they are employed when the market needs them. They may take a number of forms, including specifications for products, systems and services, methods of testing, terminology and definitions, information requirements, interfaces and processes. Standards can also support regulatory interventions.
9.12Standards cannot override the provisions of legislation; in all cases the mandatory requirements set by public authorities take precedence over voluntary standards. Legislation is mandatory, set by public authorities and accompanied by sanctions for noncompliance.
9.13However, standards can be used to support legislation. For example, legislation can make an indirect reference to a standard, as proposed by the European New Approach/New Legislative Framework, or directly incorporate a standard into a legislative text. The method of indirect reference enables the legislator to rely on the flexibility of the voluntary standardization framework. Standards will be updated when required, responding to market needs and without necessitating changes to legislation.
9.14Standards help to:
9.15There are three European standardisation organisations (ESOs): CEN (the European Committee for Standardisation); CENELEC (the European Committee for Electrotechnical Standardisation); and ETSI (the European Telecommunications Standards Institute). CEN and CENELEC have members from 34 countries (national standards organisations of EU members, plus Switzerland, Iceland, Norway, Former Yugoslav Republic of Macedonia, Serbia and Turkey). ETSI has more than 800 members from 68 countries across 5 continents.
9.16ESOs operate as independent organisations and develop voluntary standards setting out technical or quality requirements for certain products, production processes or services, often at the request of industry, other interested parties (such as consumer organisations) or national standards bodies such as the British Standards Institution. Standards are therefore based on voluntary cooperation between industry, public authorities and other interested parties and developed on the basis of consensus.
9.17The Commission may ask the ESOs to develop a harmonised standard which may be used by industry to demonstrate compliance with product safety or other requirements set out in EU legislation. About 20–25% of European Standards are used in this way to support EU policies and legislation. As compliance with standards is voluntary, businesses remain free to use alternative solutions if they wish.
9.18The European standards organizations CEN and CENELEC follow the single standard model, which is based on the adoption of one agreed standard on any given industry issue:
9.19When, in a European context, standards are to be used to support legislation and policy, the European Commission draws up a draft request through a process of consultation with a wide group of interested parties including social partners, consumers, small and medium-sized enterprises (SMEs), industry associations and EU countries. Before being formally sent to the ESOs, they are submitted to the Committee on Standards of the Regulation (EU) 1025/2012 for a vote. If this vote is positive, the Commission adopts the request as a Commission Implementing Decision.
9.20Once the Commission has issued its standardization request or ‘mandate’ it consults with the European Standardization Organizations (ESOs). The ESOs, which are independent organisations, have the right to refuse a mandate if they do not think that standards can be produced in a particular area. Due to the preceding consultation process, standardisation requests are rarely refused. The Commission eventually recognizes the standards through publication in the Official Journal of the European Union (OJEU).
9.21Three types of mandates may be identified:
9.22The ‘New Approach’, subsequently renamed the New Legislative Framework, is often referred to in relation to the European approach to standardisation. It is a co-regulatory model introduced in the EU in 1985 that is used to harmonize technical product legislation in Europe. This approach involves the European Union legislator setting ‘essential requirements’ that need to be met by enterprises that wish to place products on the market. The precise means of meeting these regulatory requirements is left to those making products available on the market. However, the European Standardization Organizations develop standards that give the technical expression to these essential requirements. After being notified to the European Commission and publication of the references of standards in the Official Journal of the European Union, compliance with these standards then gives a presumption of conformity with applicable requirements of the legislation.
9.23When European standards are adopted, National Standardisation Bodies (NSBs) must transpose them into identical national standards and withdraw any conflicting national standards.
9.24International standards are developed through ISO and IEC (international standards organizations). The European and international standards systems mirror each other. ISO mirrors CEN, in terms of the areas of standardisation that are covered, and IEC mirrors CENELEC. They have agreements with the European standardisation organisations, to maximise coordination. All standards drafts are open to public consultation.
9.25International standards are adopted in many cases by CEN and CENELEC as European standards, sometimes with amendments for European markets. Approximately 80% of CENELEC standards are identical to international, meaning that much of what CENELEC is doing is rubber stamping global standards, 35% of the standards approved by CEN are the same as international ones. However, the figures vary from sector to sector: international and European standards for many medical devices are identical, whereas the overlap is more limited for construction products for example.
9.26The British Standardisation Institution suggests that European and international standards should not be regarded as a choice: both the EU and the BSI have an international-first approach to standards, and there is a large amount of overlap between both sets of standards, and it is only if there is a specific European requirement that a European-only standard will be developed.
9.27Only around 25% of European standards are associated with public policies and legislation.
9.28The UK plays a major role in the governance, strategy and policy of CEN and CENELEC with permanent representation on their boards. If the UK, when it leaves the European Union, does not join EFTA and sign the EEA agreement, the existing categories of membership will no longer automatically include the UK.
9.29A technical amendment to the statutes of CEN and CENELEC would therefore be required. Statute changes are done in the general assembly of each organisation and require a two-thirds majority. The bodies are not especially political, and so it is not anticipated that this would be a problem, but if the issue became politicised the outcome would be difficult to predict. Standards bodies effectively do what their government asks them to.
9.30According to the BSI:
“It is essential that the UK maintains its full membership of CEN and CENELEC by continuing to support the single standard model.”
“This will allow the UK to maintain a high level of influence in the world of consensus standards and therefore remain competitive in the post-Brexit marketplace, whilst mitigating the risks and costs that divergent or multiple standards would bring.
“This sentiment is echoed by consumer organizations and by businesses across the UK. The single standard model does not depend on harmonized regulation; divergence of regulation over time can be accommodated within a single international or European standard model. Such a solution provides maximum flexibility for the UK economy.”
9.31The annual Union work programme for European standardisation for 2018 acknowledges the Commission’s support for the voluntary application of standards and recognises industry’s leading role in their development. It explains the relevance of standardisation in supporting Union legislation and policies, highlighting the role of standards in supporting the following policies and strategies:
9.32The document recognises the strategic importance of international cooperation in order to achieve coherence between international and European standards and to raise awareness and promote the advantages of standards, for example in EU regulatory and policy dialogue and in negotiations around technical barriers to trade (TBT) chapters in free trade agreements. It also:
9.33The document makes no proposals to change the governance of the European standardisation system, which is based on public-private partnership.
9.34The document states that it is working with the European Standards Organisations to develop an action plan to address the stock of unpublished harmonised standards, and states the Commission’s intention to propose a minimum percentage of the financing from EU operating grants to support standards committees.
9.35The document identifies priorities for the year for the Joint Initiative on Standardisation, a programme announced in 2016, which aims to bring together European and national standards bodies, industry, SMEs, consumer groups, trade unions, environmental organisations, Member States and the Commission. The priorities for 2018 are identified as supporting EU-level assessment of the impact of standards, improving the timely delivery of standards, and greater inclusiveness and stakeholder involvement.
9.36The “annex on standards in support of Union legislation and policies” identifies the relevance of standards to support policy priorities around: a new boost for jobs, growth and investment; a connected digital single market; a resilient energy union and forward-looking climate change policy; a deeper and fairer internal market with a strengthened industrial base; areas of justice and fundamental rights based on mutual trust; and a stronger global actor.
9.37The commission staff working document on “the implementation of the actions foreseen” lists in tabular format which actions the Commission proposes to take for each of the policy areas, including requests to the European standards organisations to develop harmonised standards, and the development of new standards or amendment of existing standards.
9.38The Minister of State for Small Business, Consumers and Corporate Responsibility at the Department for Business, Energy and Industrial Strategy (Margot James) indicates that the Government is broadly supportive of European standardisation:
“European standardisation is a process of voluntary cooperation between industry, consumers, public authorities and other interested parties collaborating within a system to achieve the development of standards based on openness, transparency and consensus. While they have a wider benefit for the EU economy and national economies, standards also play an important role as policy instruments to aid the functioning of the internal market. The Commission’s proposed action plan to address the stock of unpublished harmonised standards will be a welcome step and requires agreement between the Commission and the European Standards Organisations. We would also support steps towards the timely delivery of standards, but the detail of the Commission’s proposal in that area is not yet known.”
9.39She adds that:
“The UK’s national standards body and the UK member of CEN and CENELEC is BSI, the British Standards Institution. We are working with BSI to ensure that our future relationship with CEN and CENELEC continues to support a productive, open and competitive business environment in the UK.”
9.40On the implications of exiting the EU, the Minister provides the Government’s standard comments about the importance of respecting the result of the referendum, the UK remaining a full member of the EU, and the Government’s intention to continue to negotiate, implement and apply EU legislation during this period.
9.41However, the Minister states that “The European Standardisation System is a voluntary system covering an area wider than the EU”. She explains that:
“Two of the European Standards Organisations (CEN, the European Committee for Standardisation, and CENELEC the European Committee for Electrotechnical Standardisation) are not EU bodies and have members from 34 countries (national standards organisations of EU members, plus Switzerland, Iceland, Norway, Former Yugoslav Republic of Macedonia, Serbia and Turkey). The third European Standards Organisation, ETSI (European Telecommunications Standards Institute), numbers the national standards organisations among its more than 800 members.”
55 An in the Evening Standard, a BEIS spokesperson referred to engagement with industry stakeholders.
56 For a more comprehensive account of how standardisation and in particular formal European standardisation processes work, see:
57 European Commission, (Accessed 17 October 2017).
62 CEN and CENELEC have provided a step by step account of the standards-making process where the EU issues a mandate for the development of a standard. See Chapter 4: The standards-making process supporting regulation, in:
20 November 2017