POSITION| TECHNICAL AFFAIRS | STANDARDISATION
Revision of Regulation (EU) No 1025/2012 on European Standardisation public consultation
12 December 2025 Summary The European standardisation system is well-established and has proven its value over many years. It is a key driver of the Single Market’s success and of the European Union’s international competitiveness. The forthcoming revision of the Standardisation Regulation should therefore aim to preserve the strengths of the current framework, enhance it in a targeted way, and systematically address structural weaknesses where they have become evident. A holistic approach is essential – covering the entire process from issuing a standardisation request through development and assessment to the publication of references to harmonised standards. In addition, all accompanying implementation processes, guidelines and strategic objectives that shape and structure the system as a whole must be taken into account. Key points: ▪
Earlier initiation of the standardisation process through the issuance of a preliminary, policybased standardisation request.
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Acceleration, optimisation and digitalisation of standardisation and decision-making processes within the European Standardisation Organisations (ESOs).
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Revision and reorganisation of the currently impractical review and approval process (HAS system).
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Clear timelines for all processes within the European Commission, combined with the establishment of a central coordination unit to assume process responsibility.
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Avoidance of parallel structures through Common Specifications.
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Clarification and definition of the legal status of harmonised European Standards (hEN).
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Safeguarding alignment with international standardisation and ensuring that standardisation requests are assigned exclusively to the ESOs.
Helena Weizel | Environment, Technology and Sustainability Department | T: +49 30 2028-1589 | h.weizel@bdi.eu | www.bdi.eu
Background The European Standardisation Regulation (EU) No. 1025/2012 has provided the regulatory framework for the European standardisation system for more than a decade. It governs, in particular, the cooperation between the European Commission and the European Standardisation Organisations (ESOs). A key element is the Commission’s ability to mandate the development of harmonised European Standards (hEN) to support the technical implementation of EU legislation. The recent evaluation of the Regulation highlights current challenges within the standardisation system. For example, the system struggles to meet market needs and EU policy objectives, particularly regarding the timely availability of hEN. As this negatively affects the functioning of the Single Market, the revision of the Standardisation Regulation is intended to address these shortcomings. Given the high significance and economic impact of the European standardisation system, German industry welcomes a targeted revision of the Regulation. It is essential to build on the proven foundations and strengths of the well-established European standardisation system, while making adjustments only where structural weaknesses have become evident. This balanced approach will strengthen Europe’s competitiveness while safeguarding the integrity, legitimacy and global credibility of the system. The following positions outline key areas for action from the perspective of German industry.
1. Optimising and Accelerating all Standardisation Processes for the Timely Availability of Harmonised Standards The evaluation of the Standardisation Regulation has shown that the process leading to the final publication of a reference to a harmonised European Standard (hEN) in the Official Journal of the EU can take more than six years - slightly over three years for drafting the standard and almost three years for formal procedures such as issuing the Standardisation Request and listing the reference in the Official Journal. This timeline is incompatible with regulatory requirements driven by rapid technological change, market needs and international competitive pressure. The gap between the time-critical need to provide technical solutions through hEN and the actual pace of the entire standardisation process results from several structural challenges. These include bureaucratic procedures, a striking lack of coordination and the absence of clearly defined timelines. In addition, the strict separation of individual process steps and newly introduced, lengthy review procedures further slow down the overall process. The resulting procedural obstacles delay the publication of references to harmonised standards throughout the entire timeline (covering the Standardisation Request, drafting, assessment and listing) and thus diminish their positive impact on the competitiveness of EU businesses. When hEN are not available in time and their references are not published in the Official Journal of the EU, companies cannot rely on the presumption of conformity to meet relevant legal requirements through market-driven approaches. Instead, they face additional efforts and costs. It is essential to consider the development process for hEN as a whole and systematically review all three phases. A clear distinction must be made between weaknesses in the Regulation itself and shortcomings in its practical implementation. In addition to the fundamental provisions of the Regulation, it should be complemented by guidelines that define processes more precisely and allow for swift adjustments where necessary, without revising the legal act.
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Accelerating the standardisation process must never come at the expense of the quality of standards or of core principles such as transparency, consensus and the involvement of all relevant stakeholders. To optimise the process, we propose the following measures:
1.1 Optimisation of the Standardisation Request (SReq) and Earlier Start of the Process The process for developing hEN officially begins with the issuance or acceptance of a Standardisation Request (SReq). According to the recent evaluation, the process starts as early as the drafting phase by the Commission. The SReq is the key link between European legislation and standardisation. To accelerate the overall timeline, we propose merging certain process steps and initiating work earlier. As soon as political guidelines and related legislative proposals of the EU are published, or at the latest when the legislative process begins, the ESOs should start preparing for the corresponding standardisation work. Interest groups and expert networks for future standardisation requirements should be established from the outset to ensure that the necessary capacities are in place and available before the official process starts. This will allow the time frame set by the SReq for developing hEN to be used more efficiently and help anticipate potential challenges. A key measure to accelerate the overall process is the early alignment of legislative and standardisation timelines. Once the essential requirements of the planned regulation are defined and publicly available, a preliminary policy-based standardisation request could be issued on this basis. These essential requirements usually do not change significantly and therefore provide a reliable basis for early standardisation work and consensus-building. For ESOs, the preliminary request is an important legal foundation to start processes securely, even if the final request is not yet available. This approach gives the standardisation process a significant head start, as otherwise preparation would only begin after the adoption and translation of the legal act. Once the legislation enters into force, the preliminary request can be converted into a regular one, with only minor adjustments to ensure clarity and legal certainty. To make this approach effective, transparency and early involvement of ESOs, relevant stakeholders and technical experts during the development phase of an SReq are essential. While the acceptance of an SReq by the ESOs and the drafting of hEN are subject to clear deadlines, such timelines are currently missing for the preparation of the SReq and its associated consultation. To accelerate and harmonise the process, Article 10 (1) should therefore be supplemented with a maximum timeframe for this step. According to Article 10 (1) of the Regulation, the SReq defines the substantive requirements and the timeline. The Article should be clarified to specify which elements a Standardisation Request must contain, the permissible level of detail for technical requirements, and the areas where standardisation bodies retain decision-making flexibility. It must also be ensured that SReqs remain clearly distinct from legal acts and do not introduce additional essential requirements beyond the legal framework. Furthermore, the specified timeframe for drafting hEN should be appropriate, comprehensible and tailored to the specific sector, industry and product. A clear distinction should also be made between procedural deadlines and deadlines for technical development. The SReq should be understood as a preparatory measure rather than part of the actual standardisation process. This separation is crucial for evaluating and assessing implementation timelines, particularly in light of the six-year duration highlighted in the evaluation.
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In addition, we also propose that standardisation-related processes within the European Commission, such as the drafting of the SReq, should be managed by a central, neutral coordination unit that assumes overall process responsibility. This would be particularly beneficial for SReqs linked to EU legislation falling under the remit of more than one Directorate-General of the Commission, where central coordination could significantly improve efficiency and consistency.
1.2 Optimisation and Acceleration of Development Processes within the ESOs In addition to the necessary amendments to the Regulation, the standardisation and decision-making processes within the ESOs should also be assessed in detail and systematically optimised to shorten the development of hEN by several months compared to the current situation. A key lever for improvement is the use of modern IT tools to support these processes. A good example is the Online Standards Development (OSD) platform, which enables collaborative drafting of standards and is already used at national, European and international levels. This digital tool allows real-time cooperation within working groups, giving all participants continuous access to the latest version and enabling direct contributions, while automatically checking structure and formatting. This enhances efficiency, ensures transparency and promotes the involvement of all stakeholders. Further digitalisation measures should also be considered, for example to improve processes for preparing Annex Z, verifying the validity of normative references and organising meetings more efficiently. These steps would not only save significant time but also improve the quality and effectiveness of standardisation work, as technical experts would be able to focus their resources more on contentrelated work. In addition, we call for a critical review of current consultation periods, particularly for the approval of new standardisation projects (New Work Item Proposal), the commenting phase for draft standards (Enquiry process) and the final vote (Formal Vote). Current deadlines no longer reflect today’s technology, product and innovation cycles and should be shortened by four weeks each. Alongside the introduction of modern IT tools and process optimisation, it is also essential that sufficient financial and human resources are provided by both the European Commission and the ESOs themselves. Only then can the European standardisation system be strengthened in the long term and prepared for future challenges.
1.3 Revising the Review and Approval Process Currently, almost all hEN mandated by the European Commission and developed by the ESOs undergo the complex and bureaucratic review and approval procedure of the Harmonised Standards System (HAS). In this process, external experts (consultants) assess the conformity of the standards with the requirements of the respective SReq and the relevant legal act. The references to hEN can only be published in the Official Journal of the EU after a successful HAS assessment and additional approval by the responsible Commission desk officer. We recognise the need, as outlined in Article 10 (5), for the Commission to ensure that standards meet the essential requirements and thereby safeguard the presumption of conformity with EU legislation. However, the current implementation of the HAS system represents a clear malfunction of the process.
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The HAS system, in its present form, leads to conflicts, delays and has increasingly proven itself to be impractical. Additional challenges arise from a lack of transparency, resulting in non-traceable assessment outcomes and fundamental uncertainty among standardisation committees regarding the validity of their work. Our improvement proposals start with introducing a reasonable timeframe for the Commission’s assessment process in Article 10 (5). Compliance with clearly defined timelines should apply not only to the ESOs but also to Commission procedures. This would improve predictability and streamline the overall process. Furthermore, standardisation committees should be informed early and transparently about the schedules of external consultants or other reviewers. This would allow committees to prepare for feedback deadlines and align their workflows accordingly. In addition, cooperation between external consultants or other reviewing bodies and the standardisation committees should be systematically integrated. Consultants should be given the opportunity to submit comments and proposed amendments during the drafting and consensus phase, especially those that could later lead to a “non-compliant” decision within the evaluation process. Early coordination would help identify and resolve potential conflicts in time and give committees sufficient time to work out the necessary adjustments by consensus. Such a cooperative approach would not only improve the conformity of standards but also enhance the efficiency, transparency and legitimacy of the entire review process. This is particularly relevant for the final HAS assessment, which currently takes place only after the entire drafting process has been completed. Despite previous evaluations, this involves a complete reassessment of the entire document. The often negative assessment causes the drafting process for the same standard to be restarted, causing significant delays. A specific review procedure should not be rigidly defined in the Regulation. Flexibility is needed to allow pragmatic adjustments when necessary. However, Article 10 (5) or accompanying guidelines should set clear parameters for orientation. Assessment criteria must be transparent, appropriate and comprehensible. Likewise, the responsibilities and the limits of decision-making authority for reviewing bodies should also be clearly defined to ensure proportionality in the evaluation process. Both legislative procedures and standardisation processes apply democratically legitimised and transparent principle, these should equally apply to review mechanisms. In addition, modern IT tools and digital interfaces should be used for submission, feedback and tracking. Finally, the current HAS assessment model should be fundamentally reconsidered and questioned as the implementation tool for the Standardisation Regulation. Alternatives must be urgently explored. It is also essential to secure stable funding for the review system to prevent process disruptions, for example due to new public procurement procedures. Both aspects concern implementation and do not require legislative amendments.
1.4 Accelerating the Publication of References to hEN in the Official Journal Article 10 (6) states that the Commission shall list references to hEN in the Official Journal of the EU without delay following successful assessment. However, the current timeframe of approximately eleven months is far too long and negatively impacts the availability and practical application of standards. Therefore, the Commission, alongside the ESOs, should take measures to accelerate its processes. Article 10 (6) should be amended to include a reasonable processing timeframe from receipt to publication in the Official Journal, enabling companies to access hEN in a timely manner and benefit from the presumption of conformity with the essential requirements of the relevant EU legislation.
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Publication of references to hEN should occur at regular intervals to provide businesses with greater planning certainty. The subsequent transition period of currently 18 months for practical implementation and adaptation to the new standard by market operators should be flexible, proportionate and tailored to the specific sector or product, taking into account input from relevant stakeholders. This will ensure that transitions are predictable and practical.
1.5 Regulation of Formal Objections to hEN Article 11 of the Standardisation Regulation governs the procedure for formal objections to hEN, which may be submitted by Member States or the European Parliament to the European Commission if they believe that a standard does not meet the requirements of the underlying legal act. Upon receiving an objection, the Commission consults sector-specific expert groups and subsequently decides whether the reference to the affected hEN should not be published, published with restrictions, or if already published removed from the Official Journal of the EU. While the possibility of formal objections serves as a quality assurance mechanism for harmonised standards, in practice it creates legal uncertainty for affected companies. A product that complies with an already published hEN does not automatically become unsafe if the reference is later restricted or removed. Such cases impose additional burdens on companies or entire sectors, requiring more extensive technical risk assessments and detailed conformity documentation. In certain situations, the involvement of a notified body becomes necessary, resulting in additional costs and competitive disadvantages due to delays in conformity assessment under the relevant EU legislation. The absence of clearly defined processes further increases pressure on industry, particularly on SMEs. To address this issue, Article 11 should be amended to include a mandatory technical dialogue between the objecting party and the responsible standardisation committee before the expert group review takes place. This would allow technical questions to be clarified early, misunderstandings to be resolved and solutions to be developed. Such an approach could help prevent formal objections or significantly accelerate the resolution process. The detailed procedures for consultation and dialogue should be set out in the accompanying guidelines to the Standardisation Regulation.
1.6 Process Responsibility through a Coordination Unit within the Commission The overall process for developing harmonised standards is extensive and complex. To standardise and coordinate the processes within the Commission that accompany standardisation, a central, neutral coordination unit is required to assume process responsibility within the Commission. Such a unit should act as an organiser for the preparation of SReqs, the assessment of harmonised standards and their listing. Clear guidelines must define the competences, tasks and obligations assigned to this unit, as well as the limits of its actions. Within the Commission, it is responsible for monitoring formal procedures and timelines – from the drafting of the SReq to the publication of the reference in the Official Journal of the EU. This includes ensuring smooth transitions, monitoring progress and facilitating dialogue between different Directorates-General of the Commission, the standardisation organisations and industry. The coordination unit is explicitly not responsible for the substantive, technical or material development of content. The same applies to the definition of requirements and the content-related work on SReqs. This approach would close existing coordination gaps and significantly improve the coherence and efficiency of the entire process. This should likewise apply to the processes for developing Common Specifications.
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2. Avoiding a Parallel System through Common Specifications The BDI has already published a comprehensive position paper in German and English on the systematic introduction of the Common Specifications (CS) instrument through the Omnibus IV package. We call for the use of CS as a fallback option to be legally regulated in the Standardisation Regulation and permitted only in narrowly defined and well‑justified exceptional cases and for a limited period, such as: ▪
hENs are not available because the ESOs have not accepted the SReq, or
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there are significant delays in the development of hENs and an extension of the deadline is not possible, or
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the requirements of the legal act are not or insufficiently covered by the requirements in the hEN.
Should these cases arise, the Commission must disclose and justify why the SReq was not accepted by the ESOs, why the deadline was exceeded, or why the technical requirements are insufficient. With regard to the development of CS, we emphasise that the process of drafting technical requirements for the implementation of EU legal acts must, without exception, always begin with a SReq addressed to the officially recognised European Standardisation Organisations. Only if one of the exceptional cases outlined above applies, resulting in the unavailability of a hEN, can the development of CS be considered as a fallback option. This must already be defined in the SReq. The development of CS must ensure transparency and the involvement of the necessary technical expertise and market understanding by qualified experts. The validity of the specifications should be limited in time and automatically end as soon as an equivalent hEN or the originally intended hEN becomes available. It is essential that the introduction of CS as a fallback option does not lead to the establishment of a permanent parallel structure alongside the established standardisation system. Harmonised standards must remain the primary instrument for presumption of conformity under EU legislation. Available resources should therefore be invested in optimising and accelerating the existing European standardisation system rather than creating new structures disconnected from industrial practice. The potential negative side effects of using CS must also be taken into account. On the one hand, parallel structures would tie up the already scarce resource of technical experts from industry and exacerbate the shortage. On the other hand, CS would undermine the international alignment of technical solutions. Unlike hEN, CS are not linked to international standardisation within the framework of ISO and IEC and could therefore create technical barriers to trade in global markets. For these reasons, the introduction of CS should be carefully reconsidered. Existing fallback solutions within the ESOs should be given priority. Other technical documents, such as Technical Specifications and the newly introduced European Agile Specifications (EAS) at CEN/CENELEC, could be used as temporary measures to trigger presumption of conformity for a limited period. These alternatives can be developed more quickly, draw on the existing expert network of the ESOs and provide rapid technical guidance before a final harmonised standard is adopted. This option for alternative fallback solutions within the ESOs should be enabled by extending Article 10 (6) of the Standardisation Regulation and by adapting the relevant provisions of the NLF (Decision No 768/2008/EC, Article 3 (2). Access to these alternatives should be subject to the same conditions as those already outlined for access to Common Specifications.
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3. Clarification of the Legal Status of hEN Recent rulings by the Court of Justice of the European Union (CJEU) have had significant implications for the foundations of the European standardisation system. In the “James Elliott” case (C‑613/14), the CJEU stated that hEN form part of Union law, while the judgment in the “Malamud” case (C‑588/21P) concluded that natural or legal persons must have access to hEN due to overriding public interest. At the same time, the ruling reaffirmed that hEN continue to be developed by privately organised standardisation bodies on behalf of the Commission and remain voluntary in their application. This partly contradictory classification raises fundamental questions regarding the formal design and legal embedding of hEN. To date, the Commission has not provided a detailed statement on these rulings and has not clarified which formal requirements harmonised standards must meet in future to fulfil the claim of being “part of Union law”. We therefore call for a clear definition of the legal status and formal requirements of hEN as part of the revision of the Standardisation Regulation, in order to eliminate the current legal uncertainties. It must be emphasised that hEN are technical specifications reflecting the state of the art and developed by technical committees with the involvement of relevant market actors. A key element is the voluntary application of technical solutions to implement legal requirements. Consequently, hEN must not be equated with binding legal provisions. The revision of the Standardisation Regulation must therefore ensure a clear separation between mandatory legal requirements and voluntary normative requirements. Furthermore, industry should be systematically involved in, or at least continuously informed about, negotiations between the European Commission and the ESOs. Industry is the main contributor to the standardisation system in terms of finance, personnel and expertise. It is therefore not only a user of standards but also significantly affected and should have a voice in the process. Its expertise is crucial for any potential restructuring of the system.
4. Maintaining the Link to International Standardisation The competitiveness of the European economy depends heavily on access to global markets. When technical requirements are harmonised globally, trade barriers are reduced and market access becomes easier. For this reason, close alignment between European and international standardisation – and vice versa – is essential. To maintain and further strengthen Europe’s strong presence and involvement in developing international standards at ISO and IEC, industry must be reinforced in key areas and standardisation activities strategically promoted, for example through tax incentives or the establishment of a “Delegation Fund” to enable participation in international meetings. A decline in the involvement of European experts would lead to global standards evolving in ways that do not adequately reflect European values, priorities or the regulatory framework. Decision-makers at all levels must recognise and actively leverage the strategic advantage of standardisation. Standardisation should be understood as an integral part of industrial policy and embedded in every competitiveness strategy. Competition in international standardisation is increasing. Other countries have recognised its strategic value and are pursuing geo-strategic and geo-economic objectives through international standardisation. To avoid losing ground in this competition, the European Commission and the Member States must act jointly to ensure that European standards continue to shape the future both within and beyond Europe.
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In addition, the adoption of international standards should be supported. In particular, harmonised standards used for conformity assessment should primarily be based on existing international standards. Decoupling the two systems would lead to divergent requirements in Europe and the rest of the world, thereby weakening and making the European market less attractive in global competition. Against this background, the revision of the Standardisation Regulation must be conceived not only from a European but also from an international perspective. The international alignment and the benefits of existing agreements, such as the Vienna Agreement (with ISO) and the Frankfurt Agreement (with IEC), should be explicitly taken into account.
5. Issuing SReqs exclusively to European Standardisation Organisations Standardisation is part of Europe’s quality infrastructure and a strategic instrument that influences many areas of public interest. Harmonised standards are particularly system-relevant, as they translate the essential protection objectives of EU legal acts into technical requirements and provide presumption of conformity with applicable obligations. To safeguard the political interests of the European Union and for strategic and security-related reasons, SReqs from the European Commission for the development of hEN must be issued exclusively to the officially recognised European Standardisation Organisations listed in Annex I of the Standardisation Regulation. These organisations in turn apply the “international first principle” and decide which existing international standards can be adopted for hEN. This is already enshrined in the Standardisation Regulation and should be maintained in the revision. We categorically reject the issuing of SReqs to standardisation bodies from third countries for the reasons outlined above. The European standardisation system should be strengthened and optimised from within, not eroded by opening up to competition from non-European standardisation bodies. In particular, we would like to address the IT sector, which is significantly regulated by new legislation such as the Cyber Resilience Act, the Artificial Intelligence (AI) Act and the Data Act. A central problem is the lack of clear allocation of IT topics to one of the ESOs. Competition for these topics leads to duplication of work, multiple memberships in standardisation committees and further exacerbates the shortage of expert resources. Against this background, and considering the respective areas of expertise, competences and resources of the ESOs, adjustments should be made within the organisations to consolidate expertise effectively and better prepare standardisation for future developments in the IT sector. Another possible solution to gain additional resources would be the involvement of further organisations or other technical specifications as a complement to the existing European standardisation system. However, they should remain excluded from SReqs by the European Commission, and any cooperation should take place solely on the basis of clearly defined framework conditions. For example, the ESOs already offer the possibility of liaison arrangements and are currently discussing a so-called “PAS Submitter Process” (“PAS” stands for “Publicly Available Specification”).
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About the BDI The BDI represents the interests of German industry to political decision-makers. In doing so, it supports companies in global competition. It has an extensive network in Germany and Europe, in all important markets and in international organisations. The BDI provides political support for international market development. It also offers information and economic policy advice on all industry-related topics. The BDI is the umbrella organisation for German industry and industry-related service providers. It represents 39 industry associations and more than 100,000 companies with around eight million employees. Membership is voluntary. Fifteen regional offices represent the interests of industry at the regional level.
Imprint Federation of German Industries (BDI) Breite Straße 29, 10178 Berlin www.bdi.eu T: +49 30 2028-0 German Lobbying Register number R000534 EU Transparency Register: 1771817758-48
Editorial Office Helena Weizel Environmental, Technology and Sustainability Senior Manager T: +49 30 2028-1589 h.weizel@bdi.eu
BDI document number: D2210
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