This is a House of Commons Committee Report.
Date Published: 31 May 2022
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This EU document is politically important because:
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1.1 Standards are technical specifications that companies can use, for a fee, to ensure goods, services, systems or processes are fit for purpose and in line with industry best practice. They also facilitate international trade, not least by aligning expectations around the quality and safety of particular products even where buyers and sellers are in different jurisdictions. Standards are developed by consensus, for example within the International Standardization Organization (ISO) or, for Europe, within the three European Standardisation Organisations (ESOs): the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications Standards Institute (ETSI).
1.2 While standards are by definition voluntary, the EU also uses European standards produced by the ESOs for regulatory purposes. In particular, it can formally approve them as ‘harmonised standards’ under its product safety legislation (like the Machinery Directive2 or the General Product Safety Directive).3 Where it does so, manufacturers have legal certainty that, by using a harmonised standard, they are compliant with the relevant product requirements under EU law (known as the ‘presumption of conformity’). Due to the quasi-legislative role of standards in the EU regulatory ecosystem, the ESOs work closely with the EU even though they are independent bodies whose membership extends beyond the EU’s 27 Member States: under the EU’s ‘Standardisation Regulation‘,4 the European Commission can request specific new standards from the ESOs in support of EU policies.5 The UK has, broadly speaking, maintained this approach to the role of standards in its product safety framework post-Brexit (with Northern Ireland in a unique position, which we will return to in this chapter). However, the UK as an individual country does not make formal requests for new standards from the ESOs.6
1.3 In recent years, technical standards have taken on an increasingly political character. In particular, the UK and other countries are now explicitly looking to use standards to project their political values and generate economic opportunities by acting as global standard-setters for new and emerging technologies. Reflecting these developments, in February 2022 the European Commission published a Standardisation Strategy for the European Union.7 Seeking to address concerns that the EU’s voice is diminishing in the shaping of standards internationally, the Strategy proposes to:
1.4 Although the UK has of course left the European Union, the EU’s Standardisation Strategy is still of relevance here.
1.5 This is the case, first, because European standards developed by the ESOs play a direct role in Northern Ireland. There, EU legislation on product safety continues to apply under the Protocol on Ireland/Northern Ireland, so any ‘harmonised standards’ (as so approved by the EU, without UK input) confer a presumption of conformity that a product meets the relevant product safety requirements to be on sale in Northern Ireland.10
1.6 In addition, the Government itself has also identified11 a strategic interest in UK leadership in developing international standards for new and emerging technologies, meaning that the EU and UK may benefit from cooperation to pursue similar objectives or find themselves competing to push different standards in a given field. The potential negative impact on the role of the BSI within the ESOs as a result of the European Commission’s proposals is also relevant in that respect, as the Institution has been identified as a key player in the UK’s international efforts in the standard-setting field. It is notable that both the UK and EU are exploring structured cooperation with the United States on standards for key strategic areas, while such engagement between the UK and EU appears largely absent so far.12 In addition, how the EU shapes and uses standards as a way of qualifying for market access will also be directly relevant for many British companies, for whom the EU Single Market remains a substantial export destination.
1.7 In light of this, we have considered the background, context and substance of the EU’s Standardisation Strategy, as well as its potential implications for the UK, in more detail below. We have also written to the Department for Business, Energy and Industrial Strategy to seek further information on the Government’s plans for engagement with the EU on these matters. A copy of that letter is included at the end of this chapter.
1.8 Technical standards are, in the words of the British Standards Institution (BSI), “an agreed way of doing things”.13 The International Organization for Standardization (ISO) describes them as a “formula that describes the best way of doing something”.14 They are documents, drawn up consensually by technical experts in the relevant field, that define the recommended characteristics for all or part of a good service, process or system. Use of standards can provide both producers and end users with confidence that a product or a service is fit for purpose, safe and sustainable.15
1.9 Despite their widespread use, standards themselves are—by definition—not regulations or legislative in nature: they are voluntary measures that businesses and others can purchase from a standardisation body to help them meet their organisation’s needs (or those of their customers).16 Internationally, companies use standards extensively to reduce barriers to export thrown up by different regulatory frameworks. They can facilitate economies of scale by reducing unnecessary variations of a particular product (for example allowing manufacturers to reduce costs by producing standardised goods rather than many different varieties), as well as making it easier for buyers and sellers based in different jurisdictions to have a shared understanding of the characteristics of a product. Standards also make it easier for key characteristics of something to be communicated, and they are seen as drivers of innovation.17 The substance of a standard can also be incorporated—directly or by reference—into legislation by law-makers, giving it binding effect in a particular jurisdiction. However, at that point it ceases to be a standard.
1.10 Given the significant cross-border benefits that flow from the use of common standards, the process for their development is highly internationalised. The BSI estimates that “90% of British standards have their origins in international work”.18 In practice, standards of relevance to the UK are developed principally by three international standardisation organisations and, for the European region specifically, by their European counterparts (the “ESOs”):19
1.11 These organisations are private, non-governmental bodies, each with their own articles of association and governance arrangements.20 The ESOs are closely linked to the EU, but not part of it: their membership can include national standardisation bodies, trade associations and other stakeholders from many non-EU countries, including from the UK and Switzerland. We explore the ESOs’ governance and relationship with the EU, and how these affect the UK’s role within them, further below. Beyond the bodies listed above, there are also other non-governmental consortia and organisations which develop interoperability standards for specific sectors, especially for the operation of the internet.21
1.12 Typically, international standards—namely those set by ISO, IEC and ITU—are expected to take precedence over (and supersede) overlapping European standards, which in turn take precedence over national standards.22 In practice, the ESOs and their international counterparts work closely together to ensure convergence of their output (and a significant proportion of European standards are in fact identical to their international counterparts, especially in the field of electronics).23 However, it is possible for ‘tiers’ of different overlapping standards to develop, as there is no formal legal framework establishing an order of precedence. The ESOs can also produce standards for which there is no international counterpart, or not yet.
1.13 National standardisation bodies that are members of CEN and CENELEC, including the BSI, are normally required to implement new European standards—identified by the ‘EN’ prefix24—as national standards, which in turn facilitates their uptake by domestic businesses across Europe.25 In that way, the BSI typically implements new EN standards as British standards.26 As we explore further below, European standards also have a particular role under EU Single Market legislation, especially to ensure compliance with its product safety and quality rules. By contrast, ISO standards are only ‘recommendations’ to its members, which are “free either to follow or not to follow them”.27 The obligation to implement also does not apply to European standards for the telecommunications sector developed by ETSI.
1.14 While the majority of standards tend to be developed by and for the private sector, they are also an important tool in public policy. The European Union in particular is an active proponent of the use of standards because of their effect in reducing barriers to cross-border trade.
1.15 The key use of standards in EU policy is in relation to product safety. The EU Treaties aim to guarantee the free movement of goods: a product legally for sale in one Member State can, normally speaking, be sold across the entire EU.28 To set a ‘safety net’ in production regulation, EU law for many types of products—including toys, cosmetics, medical devices and machinery—sets “essential health, safety, and environmental protection requirements” that all Member States must apply.29 For goods in this category, known as the ‘New Legislative Framework’ standards play an important role: the EU can formally approve a European standard developed by one of the three ESOs as a ‘harmonised standard’ under a particular piece of product safety legislation:30 use of such a standard by the manufacturer means that the good benefits from a ‘presumption of conformity’ that the relevant EU product rules are met.31 The standard, while not in itself mandatory, in this way becomes an approved technical solution to meet an abstract statutory obligation under EU law. For example, the EU’s Machinery Directive specifies that an interruption of the power supply to an item of machinery “must not lead to dangerous situations”, but not how that should be achieved in practice for a particular product. The relevant harmonised standard then sets out in technical detail how a piece of machinery can be manufactured to ensure that this general statutory obligation is complied with.
1.16 This interplay between European legislation and technical standards offers certainty and predictability for producers that they have placed their goods on the EU market lawfully. By extension, it also gives industry a direct commercial interest in shaping technical standards.32 By contrast, where a manufacturer uses technical specifications not set out in a harmonised standard, it may have to provide authorities with more information on how it has met its statutory obligations (and could discover that the product is not, in fact, compliant with EU rules).
1.17 To a lesser extent the EU also uses standards for other public policy purposes, but without a view to approving them as ‘harmonised standards’ that confer a legal presumption of conformity with particular aspects of EU legislation. For example, it can request detailed standards that are then turned into technical statutory obligations for certain products within the EU,33 or use the expertise employed to develop European standards to facilitate the implementation of EU policies in other more informal ways.34 It can also ask the ESOs carry out preliminary assessments into the need and feasibility of new or updated standards in a particular area.
1.18 As noted, the EU uses European standards in a range of ways, giving the EU a particular interest in the output of the ESOs and, by extension, how those outputs are developed. It is worth emphasising again that the ESOs are not agencies of the EU, but private non-governmental bodies. However, the EU has highly formalised and institutionalised links with the ESOs because of the privileged role EU law accords them to establish standards in support of EU policies, especially its Single Market.35 The EU also provides substantial financial support to the ESOs, totalling €85 million (£72 million) over the 2015–19 period.36
1.19 The constitutional documents of the ESOs also reflect their close relationship with the EU. For example, the Statutes of both CEN and CENELEC note that one of their principal aims is “to facilitate the exchange of goods and services” within the “European Single Market”,37 and a cooperation agreement between the three ESOs also reference the role played by their output in “facilitating commerce and industry” between EU Member States.38In practice therefore, the ESOs derive much of their prominence in standard-setting, in Europe and further afield, because of the way their work feeds into the functioning of the EU’s Single Market, especially for goods. According to the Government, approximately 20% of standards produced by the ESOs are at the request of the EU, of which most are intended to become ‘harmonised standards’ for the purposes of EU product safety law.39
1.20 While numerically speaking most European standards are still developed as private sector initiatives, the ESOs have a formal role in responding to EU requests relating to standards in support of EU policies. The EU’s 2012 Standardisation Regulation40 sets out the specific procedures for the European Commission to request the ESOs to develop or update a standard in a particular area (also known as “mandates”). The day-to-day work is largely delegated to the European Commission. However, it is subject to the oversight by EU Member States and, to a lesser extent, the European Parliament, especially where standards are used to confer a presumption of conformity or are otherwise incorporated into EU law.41 Each year, the Commission produces a ‘Standardisation Work Programme’ in which it identifies strategic priorities for European standardisation for the year ahead. Based on this Work Programme, the Commission—having consulted the ESOs and other stakeholders -—draws up individual requests for specific standards, which contain requirements the envisaged standard should meet (and, in a more recent development, a deadline for its delivery). This draft request is then submitted to a vote by technical experts representing the 27 Member States in the Standardisation Committee. Only if a qualified majority of them approves, is the request formally communicated to the relevant ESOs and recorded in a public database.
1.21 If the relevant ESO approves the request to deliver a standard (which it is not required to do), they carry out the substantive technical work required.42 The procedures governing the development of standards—whether at the EU’s request or at their own initiative—are set out in the internal regulations of these bodies:
1.22 Once a standard is approved by an ESO, as described above, whether it is then used by the EU for a public policy purpose depends on the particular political and legal context (see paragraphs 0.15 to 0.17). Where the standard is meant to be used as a ‘harmonised standard’ conferring a presumption of conformity for some aspect of EU legislation, the European Commission assesses whether it suffices for that purpose. If so, the Commission publishes a reference to the standard in the Official Journal of the European Union, usually by means of a Commission Implementing Decision. The text of the standard itself must still be purchased separately by interested parties. This formally makes it a harmonised standard, subject to any objections lodged by either the European Parliament or an EU Member State.46 Twenty such objections were recorded between 2015 and 2019.47
1.23 While standards are by their nature technical, their use can also become political: they can affect the typical characteristics of a wide variety of goods, services, systems and processes, and by extension businesses, consumers and public authorities that use, deploy or rely on them. For example, standards are important in determining the quality of drinking water, the safety of toys and the security of telecommunications systems. In many cases, encouraging the development and use of standards is widely accepted to have beneficial effects from a competitive perspective. In particular, companies in jurisdictions where new standards are first developed and deployed may benefit from a commercial ‘first mover’ advantage, enabling them to bring goods or services to the market more rapidly or efficiently than competitors elsewhere.48 By extension, Governments have also increasingly expressed interest in influencing the substance of technical standards as part of their economic policy.
1.24 Even so, until relatively recently, the development and use of standards was, for the most part, a technocratic exercise with limited oversight by democratic or political institutions. However, in the EU (as elsewhere), the strategic—and industrial—element of the standardisation process has become more overt in recent years. In the EU, this is broadly speaking the result of three linked developments:
1.25 Against these political and legal shifts, the work of the ESOs in support of the EU’s laws and policies has therefore been coming under increasing scrutiny, a situation with which those organisations were previously largely unfamiliar. For example, following the 2016 judgement, the European Commission has more systematically exercised its right to participate in the work of the ESOs (often via external consultants), and became increasingly prescriptive in its requests to the ESOs (including the introduction of deadlines for the completion of new standards).52 From 2018 to 2020, the Commission also refused to approve as Harmonised Standards 371 European Standards, because of their perceived incompatibility with the EU legislation which they were intended to support.53 Indeed, some recent EU product safety laws have also included powers for the Commission to legislate for detailed technical specifications as a “fallback solution […] where harmonised standards are absent [or] insufficient”.54 This has caused political friction with the ESOs (and the business interests that largely drive them), who have found themselves more restricted in their activities.55 If the EU were to move away from using high-level statutory principles for product safety that can be met through detailed voluntary standards to prescribing detailed technical specifications in its legislation, this could also reduce the benefits of international standardisation more widely.
1.26 In February 2022, the European Commission produced a new overarching EU Standardisation Strategy56 as part of its wider Industrial Strategy.57 This document explicitly reflects the increased political salience of influencing standards internationally as a way of boosting the EU’s competitiveness. The Strategy has a particular focus on driving the EU’s influence over standards for “new and emerging technologies” such as AI, quantum computing and 6G communications, and related cyber-security aspects, saying the EU must try to compete more effectively with “private and non-European industry-led consortia” which have become “leaner and faster”. It describes the EU’s ability to shape international standards for digital products, processes and services as “essential for the EU’s competitiveness”. There is also an emphasis on the role standards can play in the ‘green transition’ to more sustainable goods and services, for example the roll-out of industrial and energy uses of hydrogen. However, the Strategy also makes clear the European Commission wants the EU to be able to regulate to ‘override’ international standards if, in its view, it is not given sufficient input in their formulation.
1.27 Reflecting these objectives, the Strategy is largely focussed on the areas of standardisation considered particularly important, and how to influence the substance of standards in those areas (both internationally and within the European standardisation bodies). It proposes the following concrete policy actions:
1.28 The Strategy and proposal appear to have been cautiously, but not universally, welcomed by stakeholders in the field. Many national standardisation bodies and industry representatives provided feedback to the Commission, underlining the significant political and commercial interests in the EU’s approach to shaping standards both at European and international level.61 CEN and CENELEC have publicly stated their “shared ambition” for supporting “the global competitiveness of European companies” by feeding into international standardisation processes.62 However, industry have warned that seeking to reduce non-EU input within the ESOs (or introducing detailed regulatory requirements instead) could risk the European standardisation regime being ‘decoupled’ from standards being developed internationally or in other regions, resulting in fragmentation that standards are meant to avoid. Trade association Digital Europe—whose membership has significant overlap with key industry players within ETSI—has been vocal, warning the Commission that its proposal to “reduce the involvement of industry in critical decisions risks weakening [ETSI’s] global influence”.63 Similarly, Business Europe, of which the UK’s CBI is still a member, has argued that changes to the ESOs’ formal governance arrangements should not risk discouraging “industry and other stakeholders” from being “in the driving seat” when developing standards.64
1.29 The Strategy, including the proposed legislation on governance of the ESOs, is now with the EU’s Council of Ministers (where Member States are represented) and the European Parliament for further consideration. In March 2022, EU leaders, meeting in the European Council, called for measures to sustain “the European Union’s capacity as an international standard setter”.65 EU Industry Ministers are expected to discuss the detail of the Strategy when they meet in Brussels in June 2022.
1.30 The UK, having left the EU, is broadly speaking no longer bound by EU law that is linked to European or international standards, nor, logically, party to any EU efforts to bolster its role as a standard-setter as described in the European Commission’s recent Standardisation Strategy. However, in our view the Strategy and the accompanying proposal on the governance of the European Standardisation Organisations is still of relevance for the UK for three reasons:
1.31 We have explored these areas of relevance for the UK further below.
1.32 Both the Government and the European Commission have identified a strategic interest in cultivating leadership in setting international standards. In its 2021 Integrated Review of the UK’s foreign policy,68 the Government set itself the objective of “shaping the international order of the future”, including by “using regulatory diplomacy to influence the rules, norms and standards” (especially those “governing technology and the digital economy”). In July that year, the Government also published an action plan on “standards for the Fourth Industrial Revolution”, which underlined specifically how the UK wants to use “international standardisation [to] project UK thought leadership and protect the interests of British consumers and businesses”.69
1.33 While it is difficult to generalise, there is considerable overlap in the areas where both the Government and the EU want to act as a standard-setter and achieve a first-mover advantage for their respective industries. This notably being the case for AI software, where the EU is likely to request harmonised standards from the ESOs under its proposed new Artificial Intelligence Act70 in the near future which could affect global supply chains for such technology. The EU is also likely to seek to lead in setting standards for other emerging technologies and cyber-security, as well as for new products and services as part of the green transition. In addition, how the EU accepts standards as a way of qualifying for market access will also be directly relevant for British companies, for whom the EU Single Market remains a substantial export destination.
1.34 All of this would suggest the EU and UK would both benefit from international cooperation in this area to pursue interests jointly where they overlap (for example via the BSI, but also at political level). Both the EU and UK are already developing such cooperation, notably with the US. The Government agreed a new ‘Atlantic Charter‘ with the US in June 2021, which includes a commitment to “strengthen collaboration on digital technical standards”.71 Similarly, at the second biannual EU-US Trade and Technology Council on 16 May 2022, the two sides announced plans to “boost cooperation on […] global technology standards”, including the creation of Strategic Standardisation Information (SSI) mechanism to “enable information-sharing on international standards development”.72 The European Commission in April 2022 also announced the establishment of an EU-India Council, where cooperation and exchanges on standards are also expected to be on the agenda.
1.35 By contrast, a strategic dialogue between the UK and EU on standards appears largely absent. The EU/UK Trade and Cooperation Agreement (TCA), in effect since January 2021, does provide a basis for cooperation in this area (even if framed in non-committal, general terms).73 At the first meeting in October 2021 of the EU/UK Specialised Committee on Technical Barriers to Trade (TBT), which covers this area of the TCA, the issue of standardisation was not discussed except in relation specifically to low carbon hydrogen. It is unclear what, if any, plans the Government has to engage with the EU more structurally or strategically on matters relating to standards, either through the structures of the TCA, or outside of it (for example in a trilateral forum with both the EU and the US, as key western allies).
1.36 A second factor to be considered when appraising the relevance of the EU’s Standardisation Strategy for the UK is its interplay with the Northern Ireland Protocol and the UK Internal Market Act. When the UK left the EU in January 2020, a specific Protocol in the Withdrawal Agreement provided for a special arrangement for Northern Ireland. This essentially keeps Northern Ireland aligned with the rules of the EU Customs Union and Single Market for goods, as listed primarily in Annex 2 of the Protocol.74 In practice, under the Protocol the panoply of EU product safety laws—both in their current form and as amended in the future—would continue to apply directly in Northern Ireland until at least the end of 2026.75
1.37 As we have noted, the EU often approves European standards as harmonised standards to give companies a straightforward technical way of meeting statutory requirements for different types of manufactured goods when placing them onto the EU market.76 Those legal product safety requirements are still in effect in Northern Ireland under the Protocol. By extension, any harmonised standards approved by the European Commission under those laws also confer such a ‘presumption of conformity’ when goods are placed on the Northern Irish market. Given the widespread use of voluntary standards by manufacturers to meet their legal obligations under EU law, this means that the standards produced by the ESOs in many cases effectively continue to determine the safety and quality characteristics for goods on the market in Northern Ireland. An overview of sectors where the EU uses harmonised standards that remain of relevance to Northern Ireland under the Protocol is shown at the end of this chapter.
1.38 This arrangement is, in itself, not radically different from the situation in the rest of the UK. Following Brexit, the Government essentially copied the EU system of approving standards as conferring a presumption of conformity with relevant British product legislation. Under a variety of sectoral ‘EU Exit’ regulations, the Government can ‘designate’ a European standard for that purpose after an assessment, like the European Commission does in the European Union. Unlike the EU, the Government can also designate national or international standards developed—for example by the BSI or the ISO—in this way. Existing EU harmonised standards were also automatically converted to British ‘designated standards’ when the UK left the EU Single Market on 31 December 2020.77 Typically, the Government can also designate a new European standard which has already been approved by the EU as a harmonised standard—including those that apply in Northern Ireland—without further assessment.78
1.39 However, the difference lies in who decides on the product safety rules and standards that govern market access. Unlike in Great Britain, in Northern Ireland those decisions are effectively taken at EU-level without UK input. Indeed, because of the Protocol, UK ‘designations’ of standards as such do not confer a legal presumption of conformity with EU product safety rules for goods in Northern Ireland (meaning producers may be more likely to service that market with products using an EU harmonised standard, if different from the UK designation).79 Moreover, goods made to an EU harmonised standard can lawfully be sold into England, Wales or Scotland from Northern Ireland, irrespective of whether they meet the applicable product safety rules in Great Britain (now or in the future). This is because of the Government’s policy of ‘unfettered access’ within the Internal Market Act 2020, under which most goods lawfully on the market in Northern Ireland—by definition, under the Protocol, made to EU product rules—can be moved freely into the rest of the UK without further checks or controls.80 By contrast, the exact same good moved directly from the EU into Great Britain would face customs and regulatory formalities, and could be refused customs clearance if the relevant safety and quality rules are not met.81
1.40 The likelihood of unsafe goods entering Great Britain because of these legal complexities is unlikely to occur at present, since EU and UK product safety rules remain broadly equivalent. Therefore, any standards approved as ‘harmonised’ by the EU are likely to also ensure compliance with post-Brexit product requirements in the UK, even if not formally ‘designated’ as such. Indeed, even if the EU and British regulatory frameworks diverge, standards could be a way of facilitating cross-border trade between the two.82 It is worth noting however that substantive divergence of regulations between the EU and Northern Ireland on the one hand and Great Britain on the other is increasingly likely: the EU is considering changes to its legislation relating to general product safety, machinery and construction products, all of which are applicable in Northern Ireland under the Protocol. Further EU proposals are expected this year relating to cosmetics and toys. In all these areas, the EU uses harmonised standards to help manufacturers meet the relevant requirements. Similarly, the Government is carrying out a general post-Brexit ‘Product Safety Review‘, which may lead to legislative change in the future (although the timetable for any Government proposals is unclear at this stage). It is therefore possible that, in the future, an EU harmonised standard offering market access in Northern Ireland may no longer also ensure compliance with updated British rules. If such substantive divergence were to occur, that could have implications for intra-UK trade flows between Northern Ireland and the rest of the country, as well as for the integrity of the UK’s post-Brexit product safety framework.
1.41 In light of the above, the EU’s Standardisation Strategy is therefore also relevant in the context of the Northern Ireland Protocol. It envisages new European standards driven by the EU’s policy agenda, for example through a review of existing standards and new ones to reflect legislative changes to EU product rules. This could see European standards changed and updated, and—while the Protocol is in force—new EU harmonised standards will confer a presumption of conformity on goods sold in Northern Ireland (and potentially end up in the wider UK market, irrespective of whether those standards ensure compliance with post-Brexit British rules). The Government’s strategic priorities in the field of standardisation (see above) and the implications of the Northern Ireland Protocol notably overlap in the field of artificial intelligence. The EU’s proposed Artificial Intelligence Act (AIA), currently being developed, foresees the use of European standards to allow companies to meet their new statutory requirements relating to certain high-risk AI systems.83 Because the AIA would amend certain EU legal acts listed in the Northern Ireland Protocol, we raised questions about the potential applicability of the AIA under the Protocol in June 2021 and how this could affect the Government’s own ambitions in this field.84 However, we have not yet received confirmation from the Government as to whether or not the EU has indicated it envisages the Act applying in Northern Ireland.
1.42 We are of course aware that, since September 2021, the Government has been involved in talks with the EU to change the operation of the Protocol, notably to reduce the barriers it has created to the free flow of goods from Great Britain to Northern Ireland. The outcome of that process is not yet clear at this stage, including in relation to the application of EU product safety laws. However, from the Government’s Command Paper on the matter, published in July 2021, it appears that under the UK’s proposal goods that meet EU requirements—including, where relevant, demonstrated by use of a harmonised standard—would still be lawful for sale in Northern Ireland, and from there retain ‘unfettered access’ to the rest of the UK.85 Therefore, even if the Protocol were to be changed in the way envisaged by Ministers, EU harmonised standards would remain directly relevant for the UK.
1.43 The third element of the EU Standardisation Strategy we wish to highlight as being of particular relevance to the UK is the European Commission’s proposal on voting rights within the European Standardisation Organisations. In Europe, as described above, standardisation processes are driven by the three ESOs, often—but not always—in coordination with their international counterparts like the ISO. The ESOs’ work is, to a large extent, carried out by the private sector and national standardisation bodies (NSBs), as well as benefitting from input from other stakeholders.
1.44 With the increased political focus on the substance and effect of standards, the European Commission in its Standardisation Strategy also proposed changes to the processes for agreeing standards. In particular, as we noted above, the Commission is proposing an amendment to the EU’s 2012 Standardisation Regulation with the aim of ‘improving’ the governance in the European standards system. More specifically, it wants to insert a provision into the Regulation that could limit non-EU involvement in new standards requested by the EU from the ESOs (including for those intended to become harmonised standards). The aim appears to be that certain formal decisions within the ESOs relating such standards—for example, whether to accept a request from the EU, or to approve completed standard—are only taken by representatives of the National Standardisation Bodies of the 27 EU Member States and the three EFTA/EEA countries (Norway, Iceland and Liechtenstein).86 Reflecting the strategic importance of standards in new and emerging technologies, the Commission specifically argues that its proposal is intended to minimise “undue influence of actors from outside the EU and EEA in the decision-making processes during the development of standards for key areas, like cybersecurity or hydrogen standards”.87 Standards produced by the ESOs which have not been formally requested by the EU, which make up 80% of their output in terms of standards, would be unaffected: existing voting rights and procedures involving non-EEA organisations and stakeholders could remain in place in those cases.
1.45 The draft legislation relating to voting procedures within the ESOs must still be agreed jointly by the European Parliament and the Member States in the EU’s Council of Ministers before it can become EU law. On 2 May 2022, representatives of the EU Member States provisionally approved the Commission proposal without any amendments.88 The relevant Committee of the European Parliament is due to vote on the draft legislation in July, indicating that talks to agree on the final legal text are likely to take place in autumn 2022.
1.46 We are aware that the Commission’s proposal could have an impact on the British Standards Institution (BSI), the UK’s representative body within all three ESOs. Since these are not EU bodies, the BSI maintained its membership of these organisations following Brexit (although in the case of CEN and CENELEC this required a change to their statutes).89 Under the Commission proposal, the BSI’s formal voting rights with respect to new standards developed at the EU’s request in CEN and CENELEC could be affected. It is unclear at this stage if such restrictions will actually be imposed and, if so, what the impact would be on the Institution’s ability to provide its considerable technical expertise during the standard-setting process. There are, already, theoretical circumstances where the BSI might be outvoted on a new standard in those bodies (although in practice there is always a drive for consensus, and if the BSI is outvoted it is not obliged to implement the resulting European standard as a British standard). Within ETSI, BSI voting rights are—broadly speaking—negligible already, because of the peculiarities of its governance arrangements (see above). Here, the impact of the Commission proposal would be felt more acutely by industry representatives—including British companies—who would lose voting rights over standards developed at the request of the EU.
1.47 We understand that the European Commission’s proposal was not explicitly intended to affect the input of the BSI and other non-EU NSBs within the ESOs, but rather was driven by perceived shortcomings in the governance arrangements of ETSI in particular (where non-EU technology companies are dominant). Indeed, a draft report on the legislation prepared by the lead MEP within the European Parliament suggests clarifying the legal language to ensure that national standardisation bodies from third countries that are not members of the European Economic Area (EEA) could (“may”) still be involved fully in the technical work of the European standardisation organisations, provided that they do not “imped[e] the adoption of any decision concerning European standards” that are supported by the majority of EU NSBs.90 The MEP’s proposal would limit the exclusion of non-EU NSBs only to votes relating to whether to accept or refuse a standardisation request by the European Commission, not the vote on the final standard when produced.
1.48 The Under Parliamentary Secretary at the Department for Business, Energy and Industrial Strategy (Paul Scully MP) submitted an Explanatory Memorandum setting out the Government’s views on the Commission’s proposal on 10 March 2022. This seeks to reassure us that the BSI “should not be unduly affected” by the European Commission proposal, not least because it relates to only 20% of standards produced by the ESOs (namely those developed in response to requests from the European Commission). However, this number does not tell us anything about the political or economic importance of standards in that cohort, even if it is numerically smaller than the collection of standards produced by the ESOs outside of the EU framework. We are concerned at the possibility that the Commission proposal could, nevertheless, indirectly and, perhaps inadvertently, affect the BSI’s ability to provide the fullness of its technical expertise in the development of European standards. This concern also carries to standards initiated at the EU’s request (for example in relation to AI when the EU comes to implementing its Artificial Intelligence Act).91 The Government itself has underlined the importance it attaches to the BSI as a voice for the UK in international standard-setting fora.
1.49 It follows from the above that, in our view, the EU’s Standardisation Strategy is of relevance to the UK, both in terms of its own strategic interests in influencing standards internationally and under the terms of the Northern Ireland Protocol.
1.50 For that reason, we will continue to monitor its implementation, in particular with respect to proposal to modify the voting processes within the ESOs that could affect the ability of the BSI to contribute fully to European standardisation processes (not least where it involves draft EU harmonised standards that affect Northern Ireland directly under the Protocol). As part of the EU Standardisation Strategy, the European Commission is also encouraging the ESOs to undertake a broader process of reflection on their governance and will be reviewing EU standardisation regulation as a whole in 2023. These processes could lead to further changes to how the ESOs operate when producing standards in support of EU policies. This may ultimately also affect the UK’s ability to provide input in relation to new European standards considered to be of particular practical or strategic interest.
1.51 Regrettably, from the Minister’s Explanatory Memorandum it is unclear how the Government is engaging with the EU to address strategic issues of mutual interest in the field of standardisation. While both the EU and UK are independently pursuing cooperation with the United States in the field of standard-setting, in particular for new and emerging digital technologies, they appear to have no strategic engagement bilaterally. This raises questions, given that the EU/UK Trade and Cooperation Agreement covers cooperation in the field of standards and there are clear overlaps between the two sides’ respective interests in that arena. It is not clear, for example, if the UK will seek to participate in, or replicate, the EU-US ‘Strategic Standardisation Mechanism’ to exchange information systematically on key standards. We have therefore written to the Department for Business, Energy and Industrial Strategy to obtain a clearer view of the Government’s position and its engagement with the EU on these matters. A copy of that letter is included below.
1.52 In anticipation of the Minister’s reply, we draw the EU Standardisation Strategy to the attention of the Business, Energy and Industrial Strategy Committee, the International Trade Committee and—given its implications in the context of the Northern Ireland Protocol—the Northern Ireland Affairs Committee.
Thank you for your Explanatory Memorandum of 10 March on the European Commission’s proposal to amend the EU Standardisation Regulation, made as part of its wider Standardisation Strategy in February 2022.92
The Committee has today considered the Strategy and your Memorandum. We are of the view that the EU’s approach to standardisation is of continued interest, not least because European standards cited by the EU as ‘harmonised standards’ under its product safety legislation continue to confer a presumption of conformity on goods placed on the market in Northern Ireland (under the Northern Ireland Protocol). These then also benefit from ‘unfettered access’ to the wider UK internal market irrespective of any future product safety reforms under UK law. It is our understanding goods compliant with EU product safety rules, including where demonstrated by reference to an EU-approved harmonised standard, would still be available freely in Northern Ireland even under the Government’s proposals for reform of the Protocol.
Second, there is a clear overlap in the UK and EU’s strategic priorities in the field of standardisation, notably with respect to an ambition to drive the development of standards relating to new and emerging digital technologies. It appears both the EU and UK are engaging with the US on these matters, but not bilaterally with each other, even though standards Article 92 of the EU/UK Trade and Cooperation Agreement provides a basis for dialogue and cooperation in this area. The Government’s priorities in the field of standardisation and the implications of the Northern Ireland Protocol notably overlap in the field of artificial intelligence. The EU’s proposed Artificial Intelligence Act (AIA), currently being developed, foresees the use of European standards to meet statutory requirements relating to certain high-risk AI systems. As the AIA proposal would amend certain EU legal acts listed in the Northern Ireland Protocol, we asked the Government in June 2021 about the potential applicability of the AIA under the Protocol but are yet to receive confirmation either way.
In light of the above, we would be grateful if you could answer the following questions in relation to the implications of EU policy on standards for the UK.
We also note that the European Commission is seeking changes to the EU Standardisation Regulation as a way of getting the independent European Standardisation Organisations to change their governance processes, in particular to reduce “undue influence of actors from outside the EU and EEA in the decision-making processes during the development of standards for key areas” in support of EU policies.
That legislative proposal could potentially affect the role played by the British Standards Institution within the ESOs, although we understand it is in fact primarily targeted at reducing the influence of non-EU technology companies within the European standardisation process carried out by ETSI. We are grateful for the assessment in your Memorandum that the Commission’s proposals would not ‘unduly affect’ the BSI, but we intend to return to the matter with you as and when the legislation amending the EU’s Standardisation Regulation has been approved at EU-level to ascertain that this indeed remains the case.
We look forward to receiving your reply to our questions before the House rises for the summer recess.
The European Commission website lists a number of sectors for which harmonised standards are already used to allow businesses to comply with EU legislation, as shown below. For most of these, the EU legislation for which use of approved harmonised standards confer a presumption of conformity, remains applicable in Northern Ireland under the Protocol on Ireland/Northern Ireland.
The table below lists the types of goods and services for which harmonised standards are used under EU law, indicating which of the laws continue to apply in Northern Ireland. Given that harmonised standards must meet the requirements set by the legislation, the final column indicates whether the EU legislation is subject to amendment or review. Other sectors where the EU intends to use harmonised standards include Artificial Intelligence, single use plastics, batteries, and fertilisers.
|
Sector |
EU legislation with harmonised standards |
Applicable under the Northern Ireland Protocol |
|
Accessibility |
No |
|
|
Chemicals |
Chemical substances (REACH) |
Yes |
|
Yes |
||
|
Yes |
||
|
Conformity assessment |
New Legislative Framework (NLF) and Eco-Management and Audit Scheme (EMAS) |
Yes |
|
Construction |
Yes. A proposal to amend the Regulation is currently under consideration. |
|
|
Consumer goods |
Yes. A proposal to amend the Directive is expected later in 2022. |
|
|
Yes. A proposal to amend the Directive is currently under consideration. |
||
|
Yes. A proposal to amend the Directive is expected later in 2022. |
||
|
Energy efficiency |
Yes. A proposal to amend the Directive is currently under consideration |
|
|
Electric and electronic engineering |
Yes |
|
|
Yes |
||
|
Yes |
||
|
Yes |
||
|
Restriction of the use of certain hazardous substances (RoHS) |
||
|
Healthcare |
Medical devices |
Yes |
|
In vitro medical devices |
Yes |
|
|
Implantable medical devices |
Yes |
|
|
Measuring instruments |
Measuring Instruments Directive |
|
|
Non-Automatic Weighing Instruments (NAWI) |
Yes |
|
|
Mechanical engineering |
Yes |
|
|
Yes |
||
|
Yes. A proposal to amend the Directive is currently under consideration. |
||
|
Yes |
||
|
Yes |
||
|
Services |
No |
|
|
Sustainability |
Yes |
|
|
Transport |
Yes |
|
|
Yes |
||
|
Yes |
||
|
Yes |
||
|
Yes |
|
(42047) 7639/22 COM(22) 134 |
Proposal for a Regulation on European Union geographical indications for wine, spirit drinks and agricultural products, and quality schemes for agricultural products, amending Regulations (EU) No 1308/2013, (EU) 2017/1001 and (EU) 2019/787 and repealing Regulation (EU) No 1151/2012 |
|
(42049) — C(2022) 1706 |
Commission Implementing Regulation amending Regulation (EU) 2019/159 imposing a definitive safeguard measure against imports of certain steel products |
Documents drawn to the attention of select committees:
(‘SNC’ indicates that scrutiny (of the document) is not completed’; ‘SC’ indicates that scrutiny of the document is completed)
Business, Energy & Industrial Strategy Committee: Technical standards: the EU Standardisation Strategy and its potential implications for the UK [Proposed Regulation][SNC]
International Trade Committee: Technical standards: the EU Standardisation Strategy and its potential implications for the UK [Proposed Regulation][SNC]
Northern Ireland Affairs Committee: Technical standards: the EU Standardisation Strategy and its potential implications for the UK [Proposed Regulation][SNC]
Sir William Cash, in the Chair
Jon Cruddas
Richard Drax
Margaret Ferrier
Mr Marcus Fysh
Mr David Jones
Craig Mackinlay
Anne Marie Morris
Greg Smith
Draft Report, proposed by the Chair, brought up and read.
Ordered, That the draft Report be read a second time, paragraph by paragraph.
Paragraphs 1.1 to 2 agreed to.
Resolved, That the Report be the Second Report of the Committee to the House.
Ordered, That the Chair make the Report to the House.
Adjourned till Wednesday 8 June 2022 at 1.45 pm
The European Scrutiny Committee is appointed under Standing Order No.143 to examine European Union documents and—
a) to report its opinion on the legal and political importance of each such document and, where it considers appropriate, to report also on the reasons for its opinion and on any matters of principle, policy or law which may be affected;
b) to make recommendations for the further consideration of any such document pursuant to Standing Order No. 119 (European Committees); and
c) to consider any issue arising upon any such document or group of documents, or related matters.
The expression “European Union document” covers—
i) any proposal under the Community Treaties for legislation by the Council or the Council acting jointly with the European Parliament;
ii) any document which is published for submission to the European Council, the Council or the European Central Bank;
iii) any proposal for a common strategy, a joint action or a common position under Title V of the Treaty on European Union which is prepared for submission to the Council or to the European Council;
iv) any proposal for a common position, framework decision, decision or a convention under Title VI of the Treaty on European Union which is prepared for submission to the Council;
v) any document (not falling within (ii), (iii) or (iv) above) which is published by one Union institution for or with a view to submission to another Union institution and which does not relate exclusively to consideration of any proposal for legislation;
vi) any other document relating to European Union matters deposited in the House by a Minister of the Crown.
The Committee’s powers are set out in Standing Order No. 143.
The scrutiny reserve resolution, passed by the House, provides that Ministers should not give agreement to EU proposals which have not been cleared by the European Scrutiny Committee, or on which, when they have been recommended by the Committee for debate, the House has not yet agreed a resolution. The scrutiny reserve resolution is printed with the House’s Standing Orders, which are available at www.parliament.uk.
Sir William Cash MP (Conservative, Stone) (Chair)
Tahir Ali MP (Labour, Birmingham, Hall Green)
Jon Cruddas MP (Labour, Dagenham and Rainham)
Allan Dorans MP (Scottish National Party, Ayr Carrick and Cumnock)
Richard Drax MP (Conservative, South Dorset)
Margaret Ferrier MP (Independent, Rutherglen and Hamilton West)
Mr Marcus Fysh MP (Conservative, Yeovil)
Dame Margaret Hodge MP (Labour, Barking)
Mrs Andrea Jenkyns MP (Conservative, Morley and Outwood)
Mr David Jones MP (Conservative, Clwyd West)
Stephen Kinnock MP (Labour, Aberavon)
Mr David Lammy MP (Labour, Tottenham)
Marco Longhi MP (Conservative, Dudley North)
Craig Mackinley MP (Conservative, South Thanet)
Ann Marie Morris MP (Independent, Newton Abbot)
Greg Smith MP (Conservative, Buckingham)
1 Proposal for a Regulation amending Regulation (EU) No 1025/2012 as regards the decisions of European standardisation organisations concerning European standards and European standardisation deliverables; COM(2022) 32; Legal base: Article 114 TFEU; ordinary legislative procedure, QMV; Department: Business, Energy and Industrial Strategy; Devolved Administrations: Consulted; ESC number: 42020.
2 Directive 2006/42/EC on machinery.
3 Directive 2001/95/EC on general product safety.
4 Regulation 1025/2012 on European standardisation.
5 We explore the governance of the ESOs in more detail elsewhere in this Report chapter.
6 Although it can request them from the British Standards Institution (BSI).
7 European Commission, ‘Communication from the Commission: An EU Strategy on Standardisation Setting global standards in support of a resilient, green and digital EU single market‘ COM(2022) 2 February 2022.
8 European Commission, Proposal for a Regulation amending Regulation (EU) No 1025/2012 as regards the decisions of European standardisation organisations concerning European standards and European standardisation deliverables COM(2022) 32.
9 The Strategy also says the Commission will work with the ESOs on—unspecified—solutions and targets to speed up the process of creating harmonised standards under EU legislation, and asks the ESOs to “make proposals by the end of 2022 to modernise their governance to fully represent the public interest and interests of SMEs, civil society and users”. A full review of the EU’s Standardisation Regulation, which governs how the EU engages with the ESOs and gives them their privileged role in setting standards for the Single Market, is due to follow in 2023.
10 Moreover, under UK law, any goods on the market in Northern Ireland that meet EU-approved safety standards can be sold freely into Great Britain. This is, however, unlikely to raise any substantive issues unless UK and EU product safety rules for a particular product diverge to the point where an EU harmonised standard would no longer ensure compliance with UK safety rules.
11 Department for Business, Energy and Industrial Strategy, ‘Standards for the Fourth Industrial Revolution: HMG-NQI action plan to unlock the value of standards for innovation‘ (Policy paper, 21 July 2021).
12 The same might also be said for other key areas of strategic interest, such as cyber-security or data protection, where the EU and UK are engaging with the US bilaterally but not in-depth with each other, or trilaterally.
13 BSI, ‘What is a standard?‘ (accessed 17 May 2022).
14 ISO, Standards (accessed 17 May 2022).
15 Typically, standards are defined by their effect. They can be used to ensure interoperability between different components of a system (for example between rolling stock and the track in a railway network, or between the messaging systems of different mobile phone manufacturers), set product quality and safety standards for the benefit of consumers, or provide a common technical ‘language’ to convey descriptive information about something (such as numbering or measuring standards). Another category of standards is referred to as ‘variety-reducing’, seeking to encourage interchangeability between different companies’ goods, services, systems or processes. A prominent example of such a standard would be the A4 paper format.
16 For example, some British insurers will only pay out on a contents insurance policy after a burglary if the property was protected with a lock that meets BSI standards. Therefore, most locks sold in the UK are produced to such standards even though this is not required by law.
17 For example, standards allow producers to concentrate on a manageable number of product options instead of fragmenting their R&D efforts, increasing the efficiency of R&D investment. The process of developing standards between technical experts also facilitates knowledge sharing and can make innovations available on a non-proprietary (but commercial) basis to interested parties.
18 See BSI, ‘Standards and EU exit‘ (accessed 20 April 2022). The BSI on this website has noted that there is “a diminishing proportion of national-only standards that meet purely local needs”, which are “often developed as precursors to international work and are transferred into international processes in due course”.
19 According to the BSI, “European regional standards are developed where there are no international standards or where there are specific interests in the region that could not be addressed globally”.
20 The BSI is a member of these organisations on behalf of the UK, although its role in the ESOs has been affected by Brexit and could change under recent proposals by the European Commission, as we discuss further in paragraphs 43 to 48.
21 Examples include the World Wide Web Consortium, the Internet Engineering Taskforce and the Organization for the Advancement of Structured Information Standards (OASIS).
22 This expectation of precedence is established for example by the World Trade Organization’s ‘Code of Good Practice for the Preparation, Adoption and Application of Standards‘ and the ‘Vienna Agreement on Agreement on Technical Cooperation between ISO and CEN’.
23 See CEN/CENELEC, ‘Global Outreach Report 2021‘ (December 2021) p. 3.
24 From the German acronym for ‘Europäische Norm’ (European standard).
25 ‘Implementation’ in this context refers to adoption of a European standard as a national (e.g. British) standard, and withdrawal of any conflicting national standards. See for more information: CEN, “Finalization and implementation of European Standards“ (accessed 21 April 2022): “National Members implement the [European standard] at national level by giving it the status of a national standard […] either by publication of an identical text or by endorsement […] and withdraws any national standards conflicting with the [standard]”.
26 As standards are voluntary and not prescriptive, there is no obligation for UK companies to make use of a particular European standard even if it is implemented as a British standard.
27 ISO, ‘ISO Statues‘ (accessed 23 May 2022), Article 4.2.
28 EU law on goods is also applied in the non-EU countries Norway, Iceland and Liechtenstein under the terms of the European Economic Area (EEA) Agreement. References to the EU Single Market in this chapter should therefore, generally speaking, be read as references to the entire EEA.
29 European Commission, ‘Free movement in harmonised and non-harmonised sectors‘ (accessed 22 May 2022). For some products where the risks associated with their use are considered most significant, like vehicles, pharmaceuticals and foodstuffs, EU law contains detailed technical requirements that must be met for them to be put on the market. There is also a third category of goods, namely those not covered by any EU rules. These are described as ‘non-harmonised’ sectors, which remain subject to national rules in each Member State. However, such goods are still covered by free movement of goods, and domestic legislation for such products are subject to a notification procedure to ensure they do not create undue barriers to trade.
30 Even so, the use of these standards remains voluntary. Manufacturers are free to choose another technical solution to demonstrate compliance with the mandatory legal requirements.
31 A manufacturer’s claim that their product meets the relevant EU regulatory requirements, whether by means of a standard or otherwise, is often demonstrated by means of the ‘CE’ mark. However, this does not prove a product actually meets these requirements. While in some cases, whether a product meets the relevant EU regulatory requirements has to be assessed by an independent ‘conformity assessment body’, in many cases manufacturers self-certify that they have met their obligations. The EU has a number of ‘mutual recognition agreements’ that allow conformity assessment bodies in other jurisdictions to certify that a particular product meets the EU’s regulatory requirements (including where such compliance is achieved by adhering to a harmonised European standard). The UK has no such agreement with the EU at present.
32 Harmonised European standards can theoretically also be used to allow providers of services to achieve compliance with relevant EU law. However, this is much less common given the complexities involved. Harmonised standards exist for certain elements of postal services within the EU, and the European Commission is currently considering proposing new EU legislation to create a basis for harmonised European standards to regulate ‘key business services”.
33 For example, under Directive 2014/94/EU on the deployment of alternative fuels infrastructure or Directive (EU) 2016/797 on interoperability of rail infrastructure. The EU is also considering making an international standard for chargers mandatory for mobile phones and other electronic devices. Harmonised standards under the EU’s Construction Products Regulation also have a more binding nature. See European Scrutiny Committee, Thirteenth Report of Session 2019–21 (HC 121–xii).
34 A standard can, for example, provide the technical specifications for systems required by EU law where a ‘presumption of conformity’ is not relevant, such as for Automatic Number Plate Recognition (ANPR) under Directive (EU) 2019/520 on the interoperability of electronic road toll systems.
35 CEN was, in fact, established as a joint initiative by the European Economic Community and the European Free Trade Association in the 1960s, when the UK was still a member of the latter.
36 The EU’s funding represented 21% of CEN’s and ETSI’s income in 2019, compared to 17% for CENELEC. The ESO’s primary source of income is participation fees of NSBs, companies and other stakeholders, which in ETSI’s case also affects members’ influence over new standards (see paragraph 21).
37 See for example CEN, ‘The Statutes of CEN‘ (accessed 22 May 2022), in particular Article 4.2.
38 CEN, CENELEC and ETSI, ‘Basic Cooperation Agreement between CEN, CENELEC and ETSI‘ (accessed 17 May 2022).
39 The Commission made 44 formal standardisation requests in support of EU law and policy from 2015 to 2020.
40 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council.
41 The European Parliament’s role in these processes is limited: it has a say over any amendments to the Standardisation Regulation, but it does not vote on individual EU requests for European standards, nor—where relevant—on their publication as a “harmonised standard” under EU product legislation. However, the Parliament can lodge objections to (envisaged) harmonised standards, requiring a review by the European Commission.
42 The ESOs can reject a standardisation request by the European Commission, for example where this is disagreement over the requirements contained in the request; whether a standard is needed; or the deadline set for delivery of a standard. Six out of 44 standardisation requests were rejected from 2015 to 2020 (see European Commission document COM(2022) 30, February 2022).
43 See for more information CEN and CENELEC’s internal regulations. Different procedures may apply to other ESO deliverables, such as preparatory technical work. We consider the voting procedures applicable to the development of new European standards in more detail elsewhere in this chapter in the context of the BSI’s position.
44 See for example CEN, ‘CEN Communities‘ (accessed 26 April 2022). This shows there are 293 ‘Liaison Organisations’, which represent industry, and 10 ‘Partner Organisations’, which broadly speaking represent civil society interests such as consumers and workers.
45 Le Monde, ‘Nouvelles technologies, vaccins, hydrogène… les Européens veulent reprendre le contrôle de leurs normes‘ (2 February 2022).
46 See Article 11 of the Standardisation Regulation (Regulation 1025/2012). An EU Member State or the European Parliament can lodge an objection to a harmonised standard, arguing that it does not “entirely satisfy the requirements which it aims to cover”. The European Commission must then review its decision to approve the standard. If the standard had already been published in the Official Journal, allowing manufacturers to rely on it to achieve presumption of conformity, the Commission’s decision—to maintain, to maintain with restriction or to withdraw the references—must be made with the support of a qualified majority of Member States. If a standard had not yet been formally harmonised, the decision is for the Commission alone. Commission Decisions taken after an objection has been lodged are published on its website.
47 European Commission, ‘Report on the implementation of the Regulation (EU) No 1025/2012 from 2016 to 2020‘ COM(2022) 30 (February 2022).
48 See, ETSI ‘Calling the shots: standardization for EU competitiveness in a digital area’ (2019). This report produced for ETSI in 2019 concluded: “When global standards originate in Europe, European actors, private or public, large or small, have guaranteed access to the shaping of them and do not have to play catch up with foreign competitors. Making global standards happen first in Europe is a competitive asset that must be preserved and developed.”
49 These are three examples where the UK Government has identified as areas where standards, if developed properly, offer “opportunities […] to support the roll-out of new products and services”). See: Department for Business, Energy and Industrial Strategy, ‘Standards for the Fourth Industrial Revolution: Action Plan‘ (22 July 2021).
50 EurActiv, ‘The risk of fragmentation for international standards‘ (6 April 2022). This reports that the European Commission has been especially exercised by ETSI’s rejection of a request for a standard relating to the use of the EU’s Galileo global navigation system in mobile phones.
51 Judgement of the CJEU in case C-613/14 (James Elliott Construction Limited vs. Irish Asphalt Limited). See for more information European Commission document COM(2018) 764 (November 2018).
52 European Commission document COM(2018) 764 (November 2018).
53 European Commission document COM(2022) 30, p. 7.
54 The Commission cites as examples Regulation (EU) 2019/1009 on fertilising products and Regulation (EU) 2017/745 on medical devices, as well as draft EU legislation on Artificial Intelligence, batteries, machinery and hydrogen.
55 For example, in February 2021 BusinessEurope wrote an open letter stating that standards should remain a “market-driven implementation tool” and that the European Commission’s new approach had “impede[d] the delivery of state-of-the-art solutions in a timely and cost-efficient manner to the European businesses and consumers”.
56 European Commission, ‘Communication from the Commission: An EU Strategy on Standardisation Setting global standards in support of a resilient, green and digital EU single market‘ COM(2022) 31 (2 February 2022).
57 European Commission, ‘Communication from the Commission: A New Industrial Strategy for Europe’ COM(2020) 102 (10 March 2020). In November 2018, the European Commission had already published a policy paper outlining the initial changes it had made to its collaboration with the ESOs following the CJEU’s judgement, as well as further planned initiatives with a particular focus on streamlining the process of requesting and approving new harmonised standards. In May 2021, 17 Member States—including Germany, Spain and Ireland—warned that the Commission’s new, prescriptive approach was delaying the development of new European standards, and risked companies instead turning to standards developed internationally or elsewhere (and therefore with less European input).
58 The High Level Forum will be composed of representatives of EU Member States, European Standardisation Organisations and National Standardisation Bodies, industry, civil society and academia.
59 The Commission also wants to link EU research programmes more closely to its ambitions in the field of standardisation, in particular by systematically prompting researchers in receipt of EU funds to “anticipate early standardisation needs” that can then feed into the EU’s standardisation work programme and its international activities. A “Code of Practice for researchers on standardisation” is to be developed by mid-2022. The EU will also fund standardisation projects in non-EU countries in Southern Europe, North Africa and West Asia.
60 European Commission, ‘The 2022 annual work programme for European standardisation’ COM(2022) 546 (2 February 2022). From 2022 onwards, urgent requests will also be identified as such in the EU’s annual Work Programme on Standardisation.
61 The European Commission, by default, provides an opportunity for public comments on proposals for draft legislation. Eighty-nine organisations and individuals provided feedback on its Standardisation Strategy and the proposal to restrict voting rights on standards developed at the EU’s request within the ESOs to the EEA’s national standardisation bodies. Looking ahead to the more comprehensive review of the ESOs’ functioning due for publication in 2023, several stakeholders also highlighted the lack of effective participation of SMEs and civil society within the ESOs under current arrangements.
62 CEN/CENELEC, ‘CEN and CENELEC met with the European Commission to discuss the future of European standardization‘ (14 April 2022) (accessed 23 May 2022). With respect to the proposal on voting rights within the ESOs, CEN and CENELEC—and many of their national members—submitted a paper to the Commission which appears carefully framed to strike a positive tone without explicitly endorsing the suggestion to remove formal voting rights from the non-EEA National Standardisation Bodies in relation to EU-requested standards.
63 Digital Europe, ‘DigitalEurope comments on the Standardisation Strategy‘ (April 2022). Similarly, the Japanese Business Council in Europe also raised concerns that “moving ETSI to a CEN-CENELEC like structure may create new rigidities in the system that could lead to a less dynamic European standardisation works for radio and telecommunication equipment”. It suggested “an alternative solution”, namely “restricting the voting weight of the ETSI BOARD member to a certain maximum level, rebalancing the power of SMEs and other stakeholders with multinational companies”. ETSI itself, whose current arrangements—with significant voting rights for industry stakeholders—would be most affected by the Commission proposals, has been reserved in its response.
64 More specifically, BusinessEurope argued that “the success of standards and their global market uptake rely on their technical quality and the significant legitimacy that results from the wide contribution of stakeholders to the standards-making processes”, and the proposal should not undermine the “high-level of expertise given by the valuable participation of a plurality of industry experts in the European Standardisation Organisations, nor generate situations of delays in standardisation processes”.
65 European Council, ‘Conclusions adopted by the European Council’ (25 March 2022), p. 8.
66 Department for Business, Energy and Industrial Strategy, ‘Standards for the Fourth Industrial Revolution: HMG-NQI action plan to unlock the value of standards for innovation‘ (Policy paper, 21 July 2021).
67 Department for Business, Energy and Industrial Strategy, ‘Standards for the Fourth Industrial Revolution: HMG-NQI action plan to unlock the value of standards for innovation‘ (Policy paper, 21 July 2021), p. 16.
68 Cabinet Office, ‘Global Britain in a Competitive Age: the Integrated Review of Security, Defence, Development and Foreign Policy‘, (CP 403, 16 March 2021)
69 Department for Business, Energy and Industrial Strategy, ‘Standards for the Fourth Industrial Revolution: Action Plan‘ (22 July 2021).
70 Proposal for a Regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act); Council and COM number: 8115/21 + ADDs 1–5, COM(21) 206; Legal base: Articles 16 and 114 TFEU; ordinary legislative procedure; QMV; Departments: Digital, Culture, Media, and Sport and Business, Energy and Industrial Strategy; Devolved Administrations: Consulted; ESC number: 41828.
71 Prime Minister’s Office, “New Atlantic Charter and Joint Statement agreed by the PM and President Biden“ (Policy Paper, 10 June 2021).
72 A draft version of the EU-US Council’s final communiqué was leaked to Contexte.com in April 2022.
73 In particular, Article 92 of the TCA encourages both the EU and the UK to participate in standard-setting processes and cooperate with the other side’s standardisation bodies. However, it allows either side to deviate from international standards—such as the EU using a European standard instead—where considered necessary.
74 Conversely, this also required the Government to implement customs and regulatory formalities on goods being moved between Northern Ireland and the rest of the UK, which is fully outside the Single Market.
75 The provisions of the Protocol that require Northern Ireland to remain aligned with EU law on goods (Article 5 to 10) are subject to the periodic democratic consent of the members of the Northern Ireland Assembly under Article 18 of the Protocol. They are due to vote on whether to keep those provisions in effect for the first time no later than the end of 2024, and if they reject them that element of the Protocol will become inoperative after a two-year period, i.e. from the end of 2026.
76 This is of course a generalisation: as we have noted, EU law regulates some types of manufactured goods—including chemicals and pharmaceuticals—differently and more prescriptively. Food safety legislation is also not covered here.
77 The EU Standardisation Regulation was however repealed in Great Britain and is therefore not ‘retained EU law’. The Government, unlike the European Commission, does not have a process for formally requesting the European Standardisation Organisations develop a particular standard. Instead, it would normally address ‘standardisation mandates’ to the BSI.
78 See for example Article 18B of EU Regulation 305/2011 on Construction Products as retained in UK law and amended by the Construction Products (Amendment etc.) (EU Exit) Regulations 2019.
79 In practice, there is considerable overlap between EU harmonised standards and UK designated standards.
80 See in particular sections 2 to 4 of the Internal Market Act 2020. Under the Act, the same also applies for goods moved between England, Scotland and Wales. The key difference is that the product rules there are legislated for domestically, either by Parliament or the devolved legislatures. In Northern Ireland, they are set by the EU.
81 Government policy on import formalities for EU goods brought into Great Britain, especially from Ireland, is still being developed.
82 However, the fact that a standard ensured compliance with both EU and UK requirements would not solve other related barriers to trade, such as customs formalities or conformity assessments.
83 European Scrutiny Committee, Fourth Report of Session 2019–2021 (HC 121–iv), chapter 2.
84 Letter from Sir William Cash to Matt Warman MP (23 June 2021).
85 Cabinet Office, “Northern Ireland Protocol: the way forward“ (CP 502, July 2021).
86 In practice, this only affects Iceland and Norway. Liechtenstein is not a member of any of the ESOs.
87 Even so, the proposed Regulation is not binding on the ESOs themselves directly. If the Commission proposal is approved (see below), the EU would expect them to adopt their internal procedures to make them compliant with the EU’s new approach. Refusal might jeopardise their privileged role in producing standards underpinning market access to the EU’s large Single Market. That, in turn, could risk reducing the reach and impact of the standards they develop. Conversely, as we have noted, industry stakeholders have argued that the proposed change itself risks making European standards less influential globally by reducing the involvement of non-EU expertise in their development.
88 See Council document 8449/1/22 REV 1 (2 May 2022).
89 In those two bodies, the BSI is now a voting member as a ‘non-EEA NSB’. In certain specific cases, the NSBs representing the EU/EEA countries can vote to approve a new European standard which the BSI voted against. However, in such an eventuality the BSI is under no obligation to implement the result as a British standard. See CEN-CENELEC Internal Regulations—Part 2, Section 6: Voting Policy, in particular paragraphs 6.1.4 and 6.2. See also BSI, ‘Standards and EU Exit‘ (accessed 20 April 2022).
90 European Parliament, ‘DRAFT REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 1025/2012 as regards the decisions of European standardisation organisations concerning European standards and European standardisation‘ (29 April 2022).
91 For example, the EU is expected to formally request formal standards from the ESOs relating to the use of high-risk AI systems under the EU’s new Artificial Intelligence Act in the near future. It is not clear how the BSI and other non-EEA NSBs would be involved in that process if the Commission proposal is approved by the European Parliament and the Council. As the AIA amends certain acts listed in the Northern Ireland Protocol, we have previously queried whether the Act could apply in Northern Ireland. European Scrutiny Committee, Fourth Report of Session 2019–2021 (HC 121–iv), chapter 2. See for more information Letter from Sir William Cash to Matt Warman MP, 23 June 2021.
92 Proposal for a Regulation amending Regulation (EU) No 1025/2012 as regards the decisions of European standardisation organisations concerning European standards and European standardisation deliverables; COM(2022) 32 (ESC number: 42020).