Standardisation Regulation

The Standardisation Regulation was adopted on 25 October 2012, entered into force on 4 December 2012 and has applied since 1 January 2013. It replaced key elements of the previous horizontal framework, repealing Decisions 87/95/EEC and 1673/2006/EC and amending Directive 98/34/EC. The regulation establishes rules governing the cooperation between the ESOs, national standardisation bodies (NSBs), Member States and the Commission, the creation of European standards for products and services in support of EU legislation, stakeholder participation, the identification of ICT technical specifications, and EU financing (Article 1).

Under the regulation, a standard is a technical specification adopted by a recognised standardisation body for repeated or continuous application, with which compliance is not compulsory (Article 2(1)). A European standard is a standard adopted by one of the three ESOs: CEN, CENELEC or the European Telecommunications Standards Institute (ETSI). A harmonised standard is a European standard adopted on the basis of a Commission request for the application of EU harmonisation legislation. Harmonised standards are therefore a subset of European standards. Other European standards are sometimes referred to as 'non-harmonised European standards'; the regulation itself does not define this term. Common specifications are not standards; they are an alternative way of demonstrating conformity with the requirements of sectoral legislation, and may be adopted by the Commission by implementing act, including where harmonised standards are absent or insufficient. They are not established by the Standardisation Regulation.¹¹

The regulation contains provisions on inclusiveness and participation (Articles 5-7), including the involvement of small and medium-sized enterprises (SMEs), consumer, environmental and social stakeholders, and public authorities

Through Article 10 of the Standardisation Regulation, the Commission can request one or more ESOs to draft a European standard within a set deadline. The relevant ESO must indicate within one month whether it accepts the request. Where the request is made in support of EU harmonisation legislation, the resulting European standard is a harmonised standard. The Commission and the ESOs assess whether the drafted standard complies with the request (Article 10(5)). In practice, the Commission services are sometimes supported in this assessment by harmonised standards assessment (HAS) consultants.¹² Where a harmonised standard developed in response to such a request satisfies the requirements it aims to cover under the relevant Union harmonisation legislation, the Commission publishes its reference in the Official Journal of the European Union (OJEU) (see Figure 1). Under the relevant sectoral legislation, compliance with a harmonised standard whose reference has been published gives rise to a presumption of conformity with the essential requirements it covers. After the publication of the new harmonised standard, conflicting national standards must be withdrawn within a reasonable deadline (Article 3(6)).

Article 11 of the Standardisation Regulation provides a formal-objection procedure where a Member State or the European Parliament considers that a harmonised standard does not entirely satisfy the relevant legislative requirements. In such cases, the Commission decides whether to publish, not to publish, or to publish with restrictions the OJEU reference, or whether to maintain, maintain with restrictions, or withdraw an already published reference. It may also request a revision of the standard.

The regulation also enables the Commission to identify qualifying ICT technical specifications that are not national, European or international standards, so that they can be referenced in public procurement, primarily to enable interoperability (Articles 13 and 14). It also provides for Union financing of standardisation organisations and eligible European stakeholder organisations (Articles 15-17).

Source: Compiled by the authors; simplified presentation based on Articles 5, 10 and 11 of the Standardisation Regulation, as amended; graphic by Nadejda Kresnichka-Nikolchova, EPRS, 2026.

Earlier reporting on the regulation

Several reports and assessments were published before the 2025 evaluation of the Standardisation Regulation. These comprised an independent review and a Commission report under Article 25 in 2015, followed by implementation reports under Article 24(3) in 2016 and 2022; the 2016 report was accompanied by analysis of implementation.

The 2015 independent review found that the average time needed to develop European standards, measured from the formal start of work to publication, fell from around five years in 2009 to around three in 2013. At the same time, the review identified continuing issues concerning timeliness, monitoring and SME participation. The Article 25 evaluation report found that consulting Member State representatives through the Committee on Standards as part of the procedure for adopting standardisation requests had not itself created a bottleneck or delay, yet considered the available data insufficient for concrete conclusions on the effect of the new procedure.

The 2016 Article 24(3) implementation report, together with the accompanying analysis in SWD(2016) 126, found improvements in transparency and stakeholder participation, alongside continuing difficulties for SMEs and societal stakeholders, and concluded that no major problem in the application of the regulation justified a revision at that stage.

The 2022 implementation report, published at the same time as the EU standardisation strategy, again recorded progress, including a substantial reduction in the backlog of harmonised standards awaiting assessment, but identified continuing weaknesses in inclusiveness, the role of national standardisation bodies and the timely delivery of harmonised standards, as well as limited information on public-authority participation. These earlier assessments therefore already identified several of the issues examined again in the 2025 evaluation.

2025 Commission evaluation

In the EU Competitiveness Compass of 29 January 2025, the Commission committed to revising the Standardisation Regulation in 2026 to make standard-setting processes faster and more accessible, particularly for SMEs and start‑ups. The Commission also emphasised the need to examine alternative routes for businesses to ensure compliance with EU law where harmonised standards do not exist or are not available.¹³

On 23 June 2025, the Commission published its evaluation of the implementation of the Standardisation Regulation against the five Better Regulation evaluation criteria: effectiveness, efficiency, coherence, EU added value, and relevance. It is based on an external accompanying study for the evaluation conducted by Intellera Consulting, Fraunhofer ISI and Trinomics B.V. The evaluation covers the period from 1 January 2013 to 1 January 2023, extended to 31 August 2024 where data were readily available. It does not constitute an evaluation of the European standardisation system as a whole, nor of the amendments made to the Standardisation Regulation in 2022.

Measured against the regulation's original objectives,¹⁴ the Commission identifies four improvements: the standards-setting process became faster, from a baseline of more than nine years to six years;¹⁵ conflicting national standards were removed in favour of European standards; the system became more inclusive for societal stakeholders and SMEs; and a structured approach to ICT standardisation was established. However, the evaluation concludes that the system struggles to meet both legislative and market needs.

On effectiveness, the Commission finds the Standardisation Regulation moderately effective in increasing the speed of standards delivery and stakeholder participation. Nevertheless, the average six-year development process – more than three years of which are spent on drafting and consensus-building – remains, in the Commission's words, 'much too slow'. Confirming concerns raised earlier by Member States (see the section on Member States views below), the evaluation finds that harmonised standards are regularly applied and cited only after the relevant legislation has begun to apply. The Commission attributes delays to procedural hurdles, recurrent quality gaps, communication and resource constraints, and insufficient use of digital technologies.

Quality also remains a concern: 68.7 % of 2 793 draft harmonised standards assessed by the HAS consultants between April 2018 and March 2022 received a negative assessment. Prioritisation has produced limited results. The 2022 annual Union work programme for European standardisation reflected the standardisation priorities identified in the 2022 standardisation strategy, and from 2023, the Commission has set a list of priorities in each annual programme (Article 8 of the Standardisation Regulation). At the time of the evaluation, only one of eight priority areas in 2022, and three of nine in 2023, had received a response from ESOs. According to the evaluation, Member States filled 41 formal objections between 2014 and April 2024, and the procedure takes 21 months on average The Commission also notes that, under the regulation, standardisation requests may be addressed only to the three ESOs, leaving it without an alternative standardisation body when harmonised standards are not delivered on time.

On efficiency, the evaluation stresses that significant data gaps prevent definitive conclusions, particularly on the cost-benefit analysis. These include fragmented data across the standards' lifecycle, limited monitoring of stakeholder and public-authority participation, and insufficient information on the efforts and costs borne by different stakeholders. At the same time, it finds indications that the regulation has been cost-effective for all affected stakeholder groups. The evaluation links increased administrative burden in the system to legal and procedural developments, notably the Commission's role in assessing draft standards and deciding on citation, combined with subsequent Court of Justice case law; however, it also considers this burden necessary to guarantee the legal effect of harmonised standards.

On coherence, the evaluation finds the regulation to be internally coherent; the challenges identified in the effectiveness analysis did not come from conflicts between its provisions, but from how they were implemented in practice. The evaluation nevertheless identifies four developments affecting external coherence. First, an increasing number of sectoral acts provide for common or technical specifications adopted as a fall-back option. Second, outside the NLF, standardisation legislation are fragmented, with a trend towards relying on bodies and means other than the ESOs to deliver common or technical specifications. Third, the General Product Safety Regulation has led to some incoherence in the terminology and application of harmonised standards. Fourth, conditions for the participation of societal stakeholders are still fragmented at national level.

With respect to EU added value, the assessment is positive. European standards reduce technical trade barriers and production and compliance costs, and allow businesses to rely on a single standard across the internal market.

Finally, it finds that the regulation's objectives remain broadly relevant, but do not fully reflect the priorities set out in the 2022 EU standardisation strategy. The evaluation points in particular to the need for faster and better anticipation of standardisation needs, particularly in rapidly developing green and digital technologies, as well as sufficient stakeholder participation and technical expertise. It also notes that alternative options to the ESOs may be needed where regulatory deadlines cannot be met. These concerns are supported by the limited responsiveness of harmonised standards to innovation: very few are updated every five years, and a substantial share of those cited in the OJEU are more than 10 years old.

Stakeholder consultations

Parliamentary resolutions

During the ninth legislative term, in May 2023, Parliament adopted a resolution on the standardisation strategy for the single market, where it highlighted delays in standardisation. It also called on the Commission to avoid overly prescriptive requirements in standardisation requests, and called for consideration of an open-access register of EU-developed standards to increase transparency.

During the current, 10th legislative term, Parliament returned to the issue of standardisation in several resolutions.¹⁶ In May 2025, Parliament adopted its resolution on old challenges and new commercial practices in internal market, where it underlined the need to improve the agility of the standardisation framework, particularly for the emerging green and digital value chains. It also considered the need for a new mechanism with Member States and national standardisation bodies to coordinate the European approach to international standardisation. A September 2025 resolution on implementation and streamlining of EU internal market rules stressed the need to improve the system while maintaining its operational integrity, while an October 2025 resolution on a new legislative framework for products highlighted continuing delays, and called for maximum deadlines for standardisation requests and a streamlined standardisation process.

Selection of parliamentary questions

During the ninth and 10th legislative terms, and particularly following the adoption of the amending regulation, MEPs raised a wide range of industry-specific questions concerning the creation, extension, or removal of particular technical standards. Questions have, for instance, pertained to digital, electrical and electrotechnical equipment, such as common chargers for e‑bikes and their connectors, alarm and communication systems, battery-powered tools and systems, and radio equipment; safety equipment such as firefighting equipment; circular-economy matters including waste-wood recycling; and transportation.

Petitions and citizens' enquiries

Similar to the questions raised by the MEPs, following the adoption of the amending regulation, citizens have submitted petitions focusing on industry-specific standardisation issues. The petitions have ranged from consumer goods, such as clothing sizes, foot sizes, and lawn trimmers, to electrotechnical equipment, such as batteries for electric vehicles or motorcycle intercoms, and transport-related matters including carry-on luggage dimensions and low- and zero-emission zones.

European Economic and Social Committee

In an own-initiative opinion adopted in April 2026, the European Economic and Social Committee (EESC) identified several challenges in the operation of the European standardisation system. It highlighted delays throughout the process, from Commission requests to the drafting, assessment and publication of standards. It also observed that collections of non-harmonised standards cited in EU legislation or incorporated into national regulation remain largely unknown, and that Article 6(1) of the Standardisation Regulation, which requires national standardisation bodies to encourage and facilitate SME access to standards and their development, has resulted in uneven conditions for SME participation across Member States. The EESC called for clearer procedures and deadlines, more balanced stakeholder participation, easier public access and stronger monitoring. It also recommended safeguards to ensure that standardisation remains a technical instrument and does not interfere with social dialogue or collective bargaining. This EESC opinion seeks to inform the forthcoming revision of the Standardisation Regulation, and is not an independent evaluation of the Standardisation Regulation. However, the observations made provide a separate institutional perspective on timeliness, uneven national participation, and the limited visibility of non-harmonised standards.

European Union Agency for Cybersecurity

The European Union Agency for Cybersecurity (ENISA) has produced various reports about the role and impact of standardisation on cybersecurity. In April 2024, ENISA and the Commission's Joint Research Centre published a report on the cybersecurity requirements applying to manufacturers placing products with digital elements on the market under what became the Cyber Resilience Act. The report proceeded on the basis that those requirements need to be translated into harmonised standards to facilitate compliance. It identified the most relevant existing standards for each requirement, and highlighted possible gaps in their coverage.

A July 2022 report on digital identity standards, including those produced by the ESOs, proposed strong coordination and a clear division of responsibility between the ESOs to avoid duplication of efforts. An earlier report of March 2023 on cybersecurity of AI and standardisation concluded that general-purpose standards for information security and quality management can mitigate cybersecurity risks to the confidentiality, integrity and availability of artificial intelligence systems; at the same time it identified standardisation gaps concerning evolving technologies, machine learning features, cybersecurity risks, and the competences of organisations responsible for auditing, certifying and testing such systems.