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EUROPEAN COMMISSION

Strasbourg, 6.10.2026 COM(2026) 780 final

2026/0307 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on European standardisation, repealing Regulation (EU) No 1025/2012 of the European

Parliament and of the Council

{SEC(2026) 780 final} - {SWD(2026) 785 final} - {SWD(2026) 786 final} - {SWD(2026) 787 final}

(Text with EEA relevance)

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EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

Standardisation is a pillar of the internal market, enabling the free movement of goods and

services while fostering interoperability, quality, and consumer trust. By providing a

presumption of conformity with Union legislation, harmonised standards simplify compliance

for businesses, reduce costs, and prevent market fragmentation. Beyond its role in the internal

market, standardisation has increasingly become a strategic industrial policy tool, driving

innovation, supporting the adoption of new technologies, and reinforcing the Union’s

competitiveness and strategic autonomy.

The European Council Conclusions of March 20261 underscored the need to ‘boost the

Union’s competitiveness, increase its resilience and enhance its strategic autonomy and

economic security’, placing the deepening and integration of the internal market at the heart

of the ‘One Europe, One Market’ roadmap. The Council explicitly called for ‘enhancing

enforcement of EU standards’ as a priority, building on the Commission’s Competitiveness

Compass2 and the Single Market Strategy3, which identified delays in standardisation as one

of the ‘terrible 10’ barriers to a fully functional internal market. In response, the Commission

committed to revise Regulation (EU) No 1025/2012 of the European Parliament and of the

Council4.

This proposal aims to modernise the European standardisation system by addressing four key

challenges. Excessive delays in the development of harmonised standards hinder the timely

implementation of Union legislation and weaken the Union’s ability to take the lead in

emerging technologies (e.g., AI, cybersecurity, green tech). Insufficient and unbalanced

stakeholder participation, particularly among small and medium-sized enterprises (‘SMEs’),

startups and scaleups, civil society, and research and innovation stakeholders, risk leading to

lower-quality standards that do not reflect adequately diverse societal and economic

needs. Uncertainty surrounding the financial sustainability of the European standardisation

system, following case law of the Court of Justice of the European Union (‘CJEU’)5 requiring

free access to harmonised standards, challenges the revenue model of some European

standardisation organisations. The Union influence in global standardisation is declining,

particularly in strategic technologies.

• Consistency with existing policy provisions in the policy area

Regulation (EU) No 1025/2012 establishes the legal framework for the European

standardisation system, governing the collaboration between the Commission, the European

standardisation organisations, namely the European Committee for Standardization (‘CEN’),

the Committee for Electrotechnical Standardization (‘CENELEC’) and the European

1 EUCO 1/26, European Council meeting (19 March 2026) – Conclusions. 2 COM(2025) 30 final, 29.1.2025. 3 COM(2025) 500 final, 21.5.2025. 4 Regulation (EU) 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 1673/2006/EC of the European Parliament and of the Council Text (OJ L 316,

14.11.2012, p. 12, ELI: http://data.europa.eu/eli/reg/2012/1025/oj). 5 Judgment of 27 October 2016, James Elliott Construction Ltd v Irish Asphalt Ltd., C-613/14,

EU:C:2016:821; Judgment of 5 March 2024, Public.Resource.Org and Right to Know v Commission,

C-588/21 P, EU:C:2024:201.

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Telecommunication Standards Institute (‘ETSI’), and national standardisation bodies in

developing standards and standardisation deliverables to support Union legislation and

policies. That Regulation’s primary focus is delivering harmonised standards adopted

following a Commission request to one or several European standardisation organisations to

support Union harmonisation legislation. Harmonised standards allow businesses to

demonstrate conformity with the requirements set out in Union harmonisation legislation

which those harmonised standards or parts thereof aim to cover, facilitating market access and

reducing compliance costs.

Regulation (EU) No 1025/2012 operates in synergy with the New Legislative Framework6,

which establishes a common legal framework for 31 sectoral product acts, ensuring that

products compliant with harmonised standards can circulate freely in the internal market.

Over time, the scope of standardisation in support of Union legislation and policies has

expanded beyond product harmonisation to support digital policies (e.g., cybersecurity, AI),

green transition initiatives (e.g., the Green Deal7 and the Clean Industrial Deal8), and sectoral

industrial strategies (e.g., housing9, bioeconomy10).

Key amendments to the Union regulatory framework on standardisation include:

• the 2022 revision of Regulation (EU) No 1025/201211, which restricted decision-

making on standardisation requests to EU/EEA national standardisation bodies only,

reinforcing the EU’s autonomy in standard-setting;

• the 2025 Omnibus IV proposal on digitalisation and common specifications12, which

proposed the introduction of common specifications as a fallback when harmonised

standards are unavailable, enhancing legal certainty for businesses.

The CJEU has, in particular, clarified that harmonised standards form part of EU law and

must be freely accessible under the principles of transparency and the rule of law. This aligns

with the Union’s democratic values, but poses financial challenges for European

standardisation organisations, particularly CEN and CENELEC, whose revenues rely partly

on the sales of harmonised standards. ETSI, which provides free access to its standards,

including its harmonised standards, is not affected to the same degree.

This proposal builds on the existing framework while addressing structural weaknesses to

ensure the European standardisation system remains fit for purpose in a rapidly evolving

technological and geopolitical landscape.

6 Regulation (EC) 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the

requirements for accreditation and market surveillance relating to the marketing of products and

repealing Regulation (EEC) 339/93 (OJ L 218, 13.8.2008, pp. 30, ELI:

http://data.europa.eu/eli/reg/2008/765/oj) and Decision 768/2008/EC of the European Parliament and of

the Council of 9 July 2008 on a common framework for the marketing of products, and repealing

Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82, ELI:

http://data.europa.eu/eli/dec/2008/768(1)/oj). 7 COM(2019) 640 final, 11.12.2019. 8 COM(2025) 85 final, 26.2.2025. 9 COM(2025) 991 final, 16.12.2025. 10 COM(2025) 960 final, 27.11.2025. 11 Regulation (EU) 2022/2480 of the European Parliament and of the Council of 14 December 2022

amending Regulation (EU) 1025/2012 as regards decisions of European standardisation organisations

concerning European standards and European standardisation deliverables (OJ L 323, 19.12.2022, pp.

1, ELI: http://data.europa.eu/eli/reg/2022/2480/oj). 12 COM(2025) 503 final and COM(2025) 504 final, 21.5.2025.

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• Consistency with other Union policies

Standardisation is a horizontal policy tool that contributes to the functioning of the internal

market, ensures interoperability and consumer protection, and promotes competitiveness. It

plays a critical role in implementing the Single Market Strategy and the ‘One Europe, One

Market roadmap’, and aims to reduce market fragmentation and enhance the enforcement of

Union product rules.

Standards are essential in the digital sector: they ensure the interoperability of digital

technologies and are the foundations of an effective digital single market. They also facilitate

economies of scale, foster research and innovation and promote competition by keeping

markets open. Standards underpin Union legislation in the digital sector, such as Regulation

(EU) 2024/1689 of the European Parliament and of the Council13 and Regulation (EU)

2024/2847 of the European Parliament and of the Council14, to ensure that new technologies

are safe, interoperable and align with Union values. This proposal will help in accelerating the

development of standards in these areas, supporting the Digital Decade targets15and

reinforcing the Union’s digital sovereignty.

Standardisation is also essential for the green transition, enabling the implementation of the

European Green Deal and the Clean Industrial Deal by providing technical solutions for

decarbonisation, circular economy, and sustainable resource management.

As regards the international level, the proposal builds upon the 2022 Standardisation

Strategy16, which seeks to strengthen the Union’s influence in global standard-setting bodies

and ensure that international standards reflect Union priorities and values. This is particularly

important in strategic technologies, where third countries such as the US and China are

actively shaping global standards to promote their industrial and geopolitical interests.

Finally, the proposal supports social inclusion by promoting broader stakeholder participation

in standardisation, ensuring that standards reflect the needs of SMEs, including startups and

scaleups, civil society and consumers, and benefit from the participation of the research and

innovation stakeholders.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

The legal basis for this Regulation is Article 114 of the Treaty on the Functioning of the

European Union for the adoption of measures for the approximation of the provisions laid

down by law, regulation or administrative action in Member States which have as their object

the establishment and functioning of the internal market.

13 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying

down harmonised rules on artificial intelligence and amending Regulations (EC) 300/2008, (EU)

167/2013, (EU) 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives

2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689,

12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj). 14 Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on

horizontal cybersecurity requirements for products with digital elements and amending Regulations

(EU) 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ L,

2024/2847, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2847/oj). 15 COM(2021) 118 final, 9.3.2021. 16 COM(2022) 31 final, 2.2.2022.

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• Subsidiarity (for non-exclusive competence)

The subsidiarity principle applies insofar as the proposal does not fall under the exclusive

competence of the Union. The objectives of the proposal cannot be sufficiently achieved by

Member States for the following reasons:

• European standardisation supports Union legislation and policies by facilitating the

functioning of the internal market. Harmonised standards replace conflicting national

standards, which may create technical barriers to trade. The problems affecting the

European standardisation system, such as delays in standards development and

concerns regarding financial sustainability, are shared across all Member States and

require a solution at Union level.

• Member States acting individually cannot effectively address these challenges.

Without Union action, the identified problems would persist, leading to

fragmentation, increased compliance costs, and reduced competitiveness. National

measures would be insufficient to ensure a coherent and efficient standardisation

system that fosters the same standards across the Union.

Union action will better achieve the objectives of the proposal for the following reasons:

• The proposal will improve the functioning of internal market by ensuring timely and

high-quality standards and standardisation deliverables in support of Union

legislation and policies.

• The proposal will reduce compliance costs for businesses, increase trade, and

strengthen the Union’s influence in international standardisation.

• The proposal will support key Union policies that rely on standards and

standardisation deliverables for their implementation.

Therefore, the proposal complies with the subsidiarity principle.

• Proportionality

The proposed revision respects the principle of proportionality, as set out in Article 5 of the

Treaty on European Union, and follows what is appropriate and necessary to achieve the

objectives of ensuring a more responsive, sustainable and internationally influent European

standardisation system. The proposal introduces targeted improvements to the functioning of

the European standardisation system to achieve the initiative’s objectives without imposing

unnecessary burdens on stakeholders, as outlined in the Impact Assessment of the initiative.

The measures introduced to make the European standardisation system more responsive rely

on the current framework for European standardisation and aim to improve the performance

of the European standardisation organisations, while introducing the possibility to rely on

designated standards development organisations in targeted situations, where the European

standardisation organisations would not be able to deliver high-quality standards in a timely

manner.

The proposal also increases the requirements for European standardisation organisations,

national standardisation bodies and designated standards development organisations to make

the European standardisation process more inclusive. The increased requirements are targeted

at the national level where the barriers to participate in standardisation are the highest. The

obligation to provide free and unrestricted access to referenced standards is necessary to

achieve the objective of the initiative. Its implementation takes into account the need to ensure

the financial viability of the European standardisation system.

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The improved coordination of European stakeholders in international standardisation is

necessary to consolidate the Union influence in international standardisation and is achieved

through targeted coordination mechanisms, with the participation of both the Commission and

Member States. The possibility to restrict participation to actors from the Union or to diverge

from international standards in the European standardisation process in support of Union

legislation and policies is necessary to promote the Union’s economic security and strategic

autonomy, and codifies existing practices, without undermining the ‘international first’

principle, whereby European standards should first seek to align with international standards.

• Choice of the instrument

A Regulation is the appropriate instrument for the initiative, which revises an existing

Regulation. The legal instrument must be of general application, as it concerns standards and

standardisation deliverables that aim at having a direct effect throughout the Union. In

addition, the legislative instrument contains obligations that are directly applicable to the

European standardisation organisations, the national standardisation bodies, designated

standards development organisations, European stakeholder organisations and the

Commission.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER

CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex-post evaluations/fitness checks of existing legislation

The evaluation of Regulation (EU) No 1025/201217 aimed to assess its performance and

impact between 2013 and 2023, in particular by assessing whether standards the Commission

requested under that Regulation have been delivered in an effective, inclusive and timely

manner. The evaluation provided an evidence-based assessment of the effectiveness,

efficiency, relevance, coherence and EU added value of the Regulation, and its findings

informed both the drafting process and the accompanying Impact Assessment.

In relation to the original objectives of Regulation (EU) No 1025/2012, the evaluation found

that (i) the standards-setting process was made faster (from a baseline of more than nine years

to six years currently), (ii) conflicting national standards were withdrawn in favour of

European standards, and (iii) the European standardisation system became more inclusive of

societal stakeholders and SMEs.

However, the evaluation also identified key shortcomings that directly underpin the problems

addressed in this proposal. The evaluation found that the development of harmonised

standards is still too slow, on average six years, and often misses legislative deadlines. This

supports the proposal’s focus on increasing the speed of standardisation in support of Union

legislation and policies to limit delays in the availability of standards, which increase

compliance costs and legal uncertainty for businesses.

The evaluation also pointed out the rigidity in the standard-development process set up by

Regulation (EU) No 1025/2012. Its reliance on the standardisation capabilities of the three

European standardisation organisations limits opportunities for simplification and

acceleration. The evaluation also revealed insufficient SME and stakeholder participation,

particularly in emerging technologies. The evaluation highlighted the financial challenges for

European standardisation organisations linked to providing free access to harmonised

standards in line with the recent case-law of the CJEU. Additionally, it noted growing

fragmentation linked to alternative standardisation routes such as common specifications,

17 Evaluation of Regulation (EU) 1025/2012 on European standardisation, SWD(2025) 170 final,

23.6.2025.

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supporting the proposal’s objective of creating a coherent framework for standards and

common specifications. Finally, the evaluation highlighted the Union’s declining influence in

international standardisation, which the proposal aims to address.

These findings demonstrate that the current framework falls short in speed, inclusiveness, and

global relevance, thus justifying the proposed reform of Regulation (EU) No 1025/2012.

• Stakeholder consultations

In line with the Better Regulation Guidelines, the Commission conducted an ambitious and

inclusive consultation process designed to gather reliable evidence from the full range of

standardisation stakeholders. A call for evidence ran between 23 June 2025 and 21 July 2025

generating a total of 198 valid contributions from business associations, non-governmental

organisations, businesses, public authorities and other stakeholders, overwhelmingly from EU

and EEA countries. The open public consultation on the initiative took place from 24

September to 17 December 2025. 599 valid replies were submitted from 32 different

countries, stemming in majority from business associations, businesses, including SMEs, non-

governmental organisations and citizens.

The call for evidence and the open public consultation were complemented by a targeted

survey for industry organisations and companies, including SMEs, to gather specific feedback

on costs and benefits to be expected from the different options, in-depth interviews with

European standardisation organisations, national standardisation bodies, and European

stakeholder organisations and five workshops with SMEs, national standardisation bodies and

the members of the High-Level Forum on European standardisation.

The results revealed preferences and concerns regarding the policy options for the proposal.

Industry and SMEs favoured measures to increase responsiveness, such as using technical

specifications for temporary presumption of conformity and digitalising standardisation

processes. They saw potential benefits in introducing greater flexibility for obtaining

standards and standardisation deliverables in support of Union legislation and policies, for

instance through the involvement of other standards development organisations than the

European standardisation organisations but expressed concerns about possible fragmentation

and inclusiveness. European standardisation organisations and European stakeholder

organisations supported measures that would preserve the current structure of the European

standardisation system, based on the exclusive right of European standardisation organisations

to deliver standards in support of Union legislation and policies, while supporting targeted

improvements and simplification.

European standardisation organisations and national standardisation bodies opposed the

implementation of the case-law of the CJEU on access to standards through the publication of

standards in the Official Journal of the European Union as it would threaten their revenue

models. Other stakeholders expressed support for free and unrestricted access to standards in

support of Union legislation and policies.

Industry, SMEs, European standardisation organisations and national standardisation bodies

highlighted the importance of alignment between European and international standardisation

and called for targeted possibilities for European standardisation to diverge from international

standardisation due to risks of duplication and diminished Union’s influence. All stakeholder

groups rejected an overhaul of the current European standardisation system, whereby

standards in support of Union legislation and policies could be requested to any standards

development organisations, citing risks of system fragmentation, reduced inclusiveness, and

financial instability for national standardisation bodies and European standardisation

organisations.

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The Commission considered these views carefully. Stakeholders agreed on the need for faster,

more inclusive, and globally competitive European standardisation and supported measures

that would improve the functioning of the European standardisation system in a targeted and

incremental manner, with European standardisation organisations at the centre. The

Commission implemented these views in the proposal but introduced additional flexibilities in

the standardisation process in support of Union legislation and policies, notably through the

possibility to request standards to other standards development organisations than the three

European standardisation organisations. It also proposes clear requirements on access to

standards in support of Union legislation and policies. The Commission considers these

measures necessary to address the systemic challenges identified in the evaluation,

particularly regarding the Union’s global competitiveness, the legal certainty vis-à-vis

potential future judgments from the CJEU, the need for greater flexibility in emerging

technological fields and for a European standardisation system that is future-proof.

• Collection and use of expertise

The Commission has consulted stakeholders through a call for evidence, open public

consultations, targeted surveys, in-depth interviews, bilateral meetings and workshops. It has

relied on an evaluation study on the current Regulation (EU) No 1025/201218 and on a study

supporting the impact assessment, both conducted by an external contractor19. The

Commission also regularly consulted the High-Level Forum on European standardisation.

• Impact assessment

The proposal was supported by an Impact Assessment which received a positive opinion from

the Regulatory Scrutiny Board. Following the positive opinion from the Regulatory Scrutiny

Board, the Impact Assessment was amended to incorporate the Board’s comments, in

particular to improve the analysis on the link between participation of stakeholders and

quality of the harmonised standards, to clarify the definition of the second specific objective

of the initiative and to improve the description of policy options and the efficiency analysis.

The impact assessment examined three policy options which differ mainly in the degree of

changes introduced to the current European standardisation system and in the balance they

each strike between responsiveness, financial viability, inclusiveness and strategic autonomy.

Option 1 would preserve the current architecture of the European standardisation system,

with the European standardisation organisations remaining the only organisations that may

receive standardisation requests from the Commission, while modernising the system through

targeted improvements. These improvements would include making better use of technical

specifications developed outside the European standardisation organisations by other

standards development organisations, introducing the possibility to grant presumption of

conformity to standardisation deliverables until a harmonised standard becomes available and

creating a horizontal framework for the Commission’s use of common specifications. The

option also improves the strategic planning of standardisation needs, simplifies and clarifies

procedures for requesting, implementing and assessing standards in support of Union

legislation and policies, and introduces deadlines at each step of the process. It also introduces

measures to strengthen participation, transparency and Union coordination in international

standardisation. This option is the least disruptive and preserves the current institutional and

18 European Commission: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs,

Fraunhofer ISI, Intellera Consulting and Trinomics B.V, Evaluation study of Regulation (EU)

1025/2012 on European standardisation – Final report. 19 European Commission: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs,

Intellera Consulting and Fraunhofer ISI, Impact Assessment supporting study accompanying the

Revision of the EU Standardisation Regulation No. 1025/2012 – Final report.

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financial model, notably by maintaining the status quo on access to standards in support of

Union legislation and policies. It would improve responsiveness, notably by reducing the

average time needed to obtain a harmonised standard by around one year compared to the

baseline. However, it offers limited additional flexibility where European standardisation

organisations are unable to deliver standards in a timely manner and therefore risks of falling

short of addressing urgent competitiveness or technological sovereignty needs.

Option 2 builds on Option 1 and retains the European standardisation organisations as the

cornerstone of the European standardisation system but adds two important measures to

increase its flexibility and responsiveness. First, the Commission could address

standardisation requests to designated alternative standards development organisations if

European standardisation organisations do not deliver or do not meet quality or timing

expectations, or if a standards development organisation is objectively better placed to

develop the requested standards. Second, free and unrestricted access to referenced standards

would be provided through repositories managed by the European standardisation

organisations and designated standards development organisations where relevant. This

option also strengthens inclusiveness at national level, creates a Centre of Excellence on

European Standardisation and introduces targeted derogations from the ‘international first’

principle in strategic or sovereignty-sensitive cases.

Option 2 would improve responsiveness more effectively than Option 1, because it introduces

a credible fall-back solution when the existing system is unable to deliver requested standards,

while also creating stronger incentives for timely delivery by the European standardisation

organisations. Its effect on average delivery times is expected to remain limited overall, since

recourse to alternative standards development organisations would be used only in a small

number of cases, but in those cases the benefits could be significant. Option 2 also ensures the

financial viability of the system, although requiring adaptation of the business models of some

European standardisation organisations, while improving legal certainty and inclusiveness. It

would give the Union more international influence than Option 1 because it combines

stronger Union coordination with greater strategic flexibility to protect the interests of the

Union where necessary.

Option 3 would constitute a fundamental redesign of the European standardisation system. It

would end the European standardisation organisations’ exclusive role, allowing the

Commission to choose any suitable standards development organisations for each request. It

would establish an EU Standardisation Office to manage the European standardisation system

centrally and make standards in support of Union legislation and policies publicly available in

the Official Journal of the European Union.

This option is potentially highly effective in terms of responsiveness, as it would allow

selecting the most appropriate organisation in each case. However, that benefit is uncertain in

practice, since the capacity of alternative standards development organisations to deliver

harmonised standards consistently in line with Union expectations has not yet been tested.

More importantly, this option challenges the financial viability of the European

standardisation system by removing core incentives for European standardisation

organisations and alternate standards development organisations to develop standards in

support of Union legislation and policies. This risks weakening stakeholder participation,

particularly from industry, and could undermine the stability of the system. Its effect on

international influence is overall neutral: while it increases strategic control, it could also

reduce alignment with international standards and thereby diminish the Union’s influence in

international standardisation bodies.

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On balance, Option 2 was considered to be the best policy choice. It offers the most

proportionate response to the problems identified. It preserves the key strengths of the current

European standardisation system, including the central role of the European standardisation

organisations, while introducing targeted flexibilities to address cases where the system is

currently too slow or insufficiently adaptive. It also improves public access to standards and

strengthens inclusiveness, without creating the disruption and risks associated by fully

centralising standardisation under Option 3. Compared with Option 1, it better equips the

Union to respond to urgent technological, competitiveness and strategic challenges.

Compared with Option 3, it achieves these benefits in a more predictable, legally robust and

financially sustainable manner.

Option 2 is expected to generate overall positive economic effects by improving the

responsiveness of the European standardisation system, while also creating some adjustment

costs and implementation risks for public and private actors. The main direct economic

benefit of Option 2 stems from the faster and more predictable development of harmonised

standards. The option is expected to generate annual administrative costs savings for

businesses estimated at EUR 295 million per year, linked to savings in compliance costs

stemming from the earlier availability of harmonised standards. These gains are particularly

relevant in fast-moving sectors, such as digital technologies and clean tech, where delays in

standards can slow down innovation, product deployment and regulatory compliance. Free

access to harmonised standards also creates sizeable direct benefits for users of standards.

Those indirect cost savings are estimated at approximately EUR 30 million per year for

businesses from removing paywalls for harmonised standards. These savings are expected to

overwhelmingly benefit SMEs, as smaller firms are more sensitive to access costs and

information barriers.

These benefits, however, entail administrative and compliance costs for European

standardisation organisations and national standardisation bodies. Ensuring free and

unrestricted access to harmonised standards could reduce the revenues of national

standardisation bodies by up to EUR 30 million annually, corresponding to around 15 % of

their total annual standards sales in the EU and 6 % of their total annual revenues. Additional

costs would also arise from inclusiveness requirements: the related obligations for national

standardisation bodies are estimated at around EUR 1,9 million per year. The use of

alternative standards development organisations to deliver standards in support of Union

legislation and policies could generate duplication costs for businesses to engage in potential

parallel standardisation processes or monitor multiple standard-setting channels, estimated at

EUR 4,5 million per year. The implementation of Option 2 would also require 7,5 additional

full-time equivalents (FTEs) in the Centre of Excellence on European Standardisation and in

the services of the Commission relying on this Regulation to support their legislation and

policies, through internal redeployment (5,5 FTEs) and additional external staff (2 FTEs).

The Impact Assessment has not considered the environmental and social impacts of Option 2.

As a horizontal initiative supporting sectoral products and services legislation, the direct

environmental and social impacts are negligible. Standards in support of Union legislation and

policies, however, can make an important contribution to the Union environmental, social or

societal objectives, such as for instance improving accessibility, safety and inclusivity

products and services in the internal market. However, such effects directly depend on the

sectoral legislation and on the definition of essential requirements. A more effective

standardisation system would help sectoral legislation achieve environmental and social

objectives.

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• Regulatory fitness and simplification

This initiative responds to urgent political and economic priorities set by the European

Council, the Commission’s Single Market Strategy and its Standardisation Strategy. It seeks

to strengthen the European standardisation system’s efficiency, inclusivity, and global

influence while ensuring its long-term financial viability.

The proposal will bring simplification and improved efficiency primarily through the

increased availability of harmonised standards, which are themselves simplification tools for

businesses to access the internal market. Making harmonised standards available faster will

significantly reduce businesses’ compliance costs and facilitate the conformity assessment of

their products and services. The new obligations for European standardisation organisations

and national standardisation bodies relating to inclusiveness of civil society organisations,

research and innovation stakeholders and SMEs will facilitate their participation in the

standardisation process, notably by reducing their participation costs. The repositories for

standards and standardisation deliverables in support of Union legislation and policies will

simplify access to standards for all stakeholders, not only reducing costs for users through free

access but also facilitating consultation and use.

The simplification is expected to be particularly relevant for SMEs. The Impact Assessment

estimates that 78 % of savings related to conformity assessment would accrue to SMEs,

suggesting that improved access and usability of standards in support of Union legislation and

policies could have a strong pro-SME effect. The proposal also includes measures that

specifically support SMEs’ participation in standardisation.

The proposal is expected to strengthen the Union sectoral competitiveness. Faster standard

development can give EU businesses a first-mover advantage, helping them innovate more

quickly and bring products to market sooner. Free access to harmonised standards supports

faster diffusion of innovation, as firms can integrate the latest standards into products without

additional purchase costs. Greater involvement of the research community and of public

authorities will improve the relevance of standards, support the uptake of new technologies,

including by SMEs, startups and scaleups and facilitate the identification, validation and

transfer of relevant research and innovation results into standardisation activities. The

proposal is also expected to have positive impact on trade, as the Impact Assessment

identifies a link between an increase in the stock of harmonised standards and intra- and extra-

EU trade. The alignment between European and international standards helps reduce technical

barriers to trade and improves the ability of European businesses to access international

markets.

The proposal fosters the digitalisation of the European standardisation system for the

development of standards, their evolution into ‘smart standards’, where the content of the

standards is complemented by additional data and information to facilitate their use and their

integration in the business processes of market operators, and the cooperation between the

Commission and European standardisation organisations. The creation of the EU Standards

Platform will make available up-to-date information on the development status of requested

standards and standardisation deliverables, provide detailed information on the performance

of the European standardisation system and on the implementation of this Regulation and will

foster a digital approach to standardisation in support of Union legislation and policies.

• Fundamental rights

The proposal does not impact the Charter of Fundamental Rights.

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4. BUDGETARY IMPLICATIONS

Without prejudice to the outcome of the negotiations on the 2028-2034 Multiannual Financial

Framework, the proposal is estimated to require the use of operational appropriations that are

commensurate with the current budget allocated to standardisation activities within the Single

Market Programme20. All activities, in particular all new activities created by the proposal,

could be financed under the corresponding budget within the Single Market and Customs

Programme2121, including through redeployment where necessary. The indicative estimate is

EUR 183 million over the programming period 2028-2034, at current price, based on annual

expenditures for standardisation within the Single Market Programme of EUR 23,7 million in

2027. The source of financing and scope of Union financial commitment in the post-2027

period remain subject to the outcome of interinstitutional negotiations on the 2028-2034

Multiannual Financial Framework and thereafter shall be determined through the annual

budgetary procedure.

The proposal may trigger the need to redeploy the standardisation appropriations within the

Single Market and Customs Programme. Free and unrestricted access to standards in support

of Union legislation and policies may challenge the financial sustainability of some national

standardisation bodies, which rely to various degrees on their sales, and in turn, the current

functioning of CEN and CENELEC. Free and unrestricted access to such standards implies a

shift of the financial burden of the standardisation development process from users, through

their purchase of standards, to the European standardisation organisations and national

standardisation bodies, through a loss of revenues. This additional financial burden on

European standardisation organisations and national standardisation bodies could decrease

their ability to develop standards and standardisation deliverables in support of Union

legislation and policies and to accept standardisation requests from the Commission.

The financial impact on national standardisation bodies could be mitigated by their

developing new services to users, based on the copyrights they claim on the standards they

develop, such as smart standards. However, targeted support from the Union budget may be

necessary to ensure the financial sustainability of national standardisation bodies, in particular

the national standardisation bodies most financially exposed to the free access to standards.

The Commission may, subject to the relevant provisions of the Single Market and Customs

Programme and programming decisions, grant that support through an increase in operating

grants to European standardisation organisations which would then distribute it to relevant

national standardisation bodies. This increase in operating grants would be financed through

redeployment within the Single Market and Customs Programme.

The proposal provides for the creation of a Centre of Excellence on European Standardisation,

to support its implementation. It also provides for strengthening the network of experts from

the Commission, relevant EU agencies and Member States involved in requesting, developing

and assessing standards in support of Union legislation and policies. The Centre of Excellence

would host the new tasks of the Commission stemming from the proposal, in particular

concerning requests to designated standards development organisations and the improvement

of the coordination of EU actors in international standardisation. It would also improve the

20 Regulation (EU) 2021/690 of the European parliament and of the Council of 28 April 2021 establishing

a programme for the internal market, competitiveness of enterprises, including small and medium-sized

enterprises, the area of plants, animals, food and feed, and European statistics (Single Market

Programme) and repealing Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and

(EU) No 652/2014 (OJ L 153, 3.5.2021, pp. 1–47). 21 COM(2025) 590 final, 16.07.2025.

EN 12 EN

coordination of the internal network of standardisation experts across Commission services.

The Centre of Excellence would gather a total of 20 FTEs with a central support and

coordination role. The additional resources needed to implement the proposal would be

covered through internal redeployments within the Directorate-General for Internal Market,

Industry, Entrepreneurship and SMEs (1,5 FTEs), internal redeployments within the

Commission’s services relying on the Standardisation Regulation to support their legislation

and policies (4 FTEs) and through 2 additional external FTEs, which could be financed under

the administrative line of the Single Market and Customs Programme.

Estimated impacts and staffing for 2028 and beyond are indicative and without prejudice to

the outcome of the negotiations on the 2028-2034 Multiannual Financial Framework. Further

detail is set out in the Legislative Financial and Digital Statement accompanying this

proposal.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

The improved monitoring of the implementation of this Regulation by the Commission is a

key dimension of the proposal. The Commission will monitor the improvements in the

performance and responsiveness of the European standardisation system by setting up key

performance indicators on speed, timeliness, quality and flexibility, which it will regularly

monitor, with the contribution of European standardisation organisations and designated

standards development organisations.

The overall influence of the Union in international standardisation will be monitored through

the Union’s involvement in international standardisation organisations and the ability of the

Union to ensure strategic autonomy and actual influence in international standardisation

organisations. Monitoring will rely on data reported by the European standardisation

organisations and the designated standards development organisation through the EU

Standards Platform, as well as on annual reports submitted by European standardisation

organisations and European stakeholder organisations.

In addition, the proposal requires the Commission to submit a report to the European

Parliament and the Council on the implementation of this Regulation five years after its entry

into force, and every five years thereafter, as well as an evaluation of the proposal after five

years of its application.

• Detailed explanation of the specific provisions of the proposal

Chapter I outlines the general provisions of the Regulation, namely its subject matter and

definitions. It states that the Regulation lays down rules regarding (i) requesting, developing

and referencing standards and standardisation deliverables in support of Union legislation and

policies, (ii) the functioning of the European standardisation system through the cooperation

between the actors involved, (iii) the participation of European stakeholders in standardisation

and (iv) the possibility to adopt common specifications as a fall-back option to harmonised

standards if the European standardisation system is not able to deliver quality standards or

standardisation deliverables in a timely manner. It also revises the definitions needed for the

purposes of this Regulation and, in particular, specifies that the term ‘harmonised standard’

should be used for standards developed following a standardisation request from the

Commission, the reference of which has been published in the Official Journal of the

European Union and which provides a presumption of conformity with the requirements, set

EN 13 EN

out in the relevant Union legislation, which it aims to cover. It introduces the broader concept

of referenced standards and standardisation deliverables, which includes all standards and

standardisation deliverables requested by the Commission, the references of which have been

published in the Official Journal of the European Union.

Chapter II sets out the principles for European standardisation that apply for the development

of all standards and standardisation deliverables requested by the Commission in support of

Union legislation and policies, either from European standardisation organisations or from

designated standards development organisations. It sets out that the development of such

standards and standardisation deliverables must be transparent and that referenced standards

and standardisation deliverables must be freely accessible. It also deals with digitalising the

European standardisation system, sets out objectives for the financing of the European

standardisation system by the Union, in particular to foster its financial sustainability, and

revises the strategic planning of standardisation needs to support Union legislation and

policies through the annual Union work programme on European standardisation.

Chapter III covers standards and standardisation deliverables requested from the European

standardisation organisations.

Section I sets outs the specific role European standardisation organisations and national

standardisation bodies play in the European standardisation system. It establishes the principle

of European decision-making in these organisations for standards and standardisation

deliverables requested by the Commission and introduces the possibility to amend the list of

European standardisation organisations through a delegated act. It also lays down the

cooperation between the Commission and European standardisation organisations based on

key performance indicators to be regularly assessed by the Commission. Finally, it reinforces

the rules on the transparency of the work programmes and standards and standardisation

deliverables adopted by European standardisation organisations and national standardisation

bodies.

Section II addresses the inclusiveness of the standardisation process by European

standardisation organisation and national standardisation bodies. It requires them to enable

appropriate representation of relevant stakeholders, namely SMEs, consumer organisations,

environmental and social stakeholders, research and innovation stakeholders as well as public

authorities. It introduces the European stakeholder organisations, which are selected by the

Commission based on an open and non-discriminatory process, to represent the SMEs, social,

environmental and consumer interests in the European standardisation process.

Section III establishes the obligation for the Commission to consult European standardisation

organisations before adopting a standardisation request. It also specifies the conditions that

the Commission may include in the standardisation request and establishes the procedural

steps with deadlines for adopting standardisation requests. This section also sets out the

requirements for implementing the standardisation requests by European standardisation

organisations and defines the assessment procedure, whereby the Commission assesses

whether the reference of a standard or standardisation deliverable of the European

standardisation organisations developed in response to a standardisation request should be

published in the Official Journal of the European Union.

Chapter IV sets out the framework for requesting standards and standardisation deliverables

from designated standards development organisations. It sets out the procedure and

requirements for designating standards development organisations to which the Commission

may address a standardisation request. Furthermore, it sets out the procedure for requesting

and assessing standards and standardisation deliverables from designated standards

development organisations and their implementation of the request, similar to the procedure

EN 14 EN

for European standardisation organisations. It specifies that the Commission assesses the

coherence of standards and standardisation deliverables from designated standards

development organisations with the existing referenced standards and standardisation

deliverables. It sets out the grounds and process for the Commission to adopt common

specifications. It establishes a safeguard notification mechanism to alert, and, where

necessary, withdraw common specification or the reference to a referenced standard or

standardisation deliverable, which does not satisfy the requirements it aims to cover.

Chapter V outlines the importance of international standardisation and promotes European

coordination to increase the Union’s influence in international standardisation bodies. It lays

out the international first principle, whereas European standardisation organisations should

coordinate with international standardisation bodies, as well as possible exceptions to the

principle to support the Union’s strategic autonomy. It also requires that European

standardisation organisations and designated standards development organisations inform the

Commission of cooperation agreements with other standards development organisations

which may affect their standardisation activities as regards the development of requested

standards and standardisation deliverables.

Chapter VI establishes the Centre of Excellence on European Standardisation and sets out the

rules for the implementation of this Regulation, including evaluation, monitoring, review,

exercising the delegation power and the role of the committee.

Chapter VII establishes the common, final provisions of the Regulation by setting out the

rules for entry into force and application and repeals Regulation (EU) No 1025/2012 and

Article 48 of Regulation (EU) 2023/988 of the European Parliament and of the Council22.

22 Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general

product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the

Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing

Directive 2001/95/EC of the European Parliament and of the Council and Council Directive

87/357/EEC (OJ L 135, 23.5.2023, pp. 1, ELI: http://data.europa.eu/eli/reg/2023/988/oj)

EN 15 EN

2026/0307 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on European standardisation, repealing Regulation (EU) No 1025/2012 of the European

Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular

Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee1,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) European standardisation is a key driver of the Union’s competitiveness: standards

facilitate the exchange of goods and services, foster interoperability, contribute to

quality and consumer trust, and support technological development and the uptake of

market innovation. By laying down technical or quality specifications with which

current or future products, services, processes, systems or entities may comply, based

on the consensus of market players and stakeholders, standards benefit both businesses

and consumers. Standards are also an essential building block of the innovation

process because they allow research and innovation results to spread and turn into

market-ready solutions. Standardisation can provide a first-mover advantage in

international technological races, by facilitating the adoption of new technologies and

providing industrial ecosystems with a competitive edge.

(2) European standardisation plays a fundamental role in the functioning of the internal

market, by providing common technical solutions that reduce transaction costs, foster

economies of scale and promote effective competition. The development of standards

and standardisation deliverables enable economic operators to place products and

services on the market based on transparent and predictable technical frameworks,

thereby increasing safety and value for consumers. In particular, standards have been

at the core of the harmonisation of the internal market under the New Legislative

Framework2. Furthermore, Regulation (EU) 1025/2012 of the European Parliament

1 OJ C , , p. . 2 Regulation (EC) 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the

requirements for accreditation and market surveillance relating to the marketing of products and

repealing Regulation (EEC) 339/93 (OJ L 218, 13.8.2008, pp. 30, ELI:

http://data.europa.eu/eli/reg/2008/765/oj) and Decision 768/2008/EC of the European Parliament and of

the Council of 9 July 2008 on a common framework for the marketing of products, and repealing

Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82, ELI:

EN 16 EN

and of the Council3 established the legal framework for European standardisation

providing for the cooperation between the Union and the three European

standardisation organisations listed in Annex I to that Regulation, namely the

European Committee for Standardization (‘CEN’), the European Committee for

Electrotechnical Standardization (‘CENELEC’) and the European Telecommunication

Standards Institute (‘ETSI’).

(3) European standardisation is essential for achieving the Union’s industrial policy

objectives, including the green transition, the digital transformation, industrial

resilience and preparedness, and economic security. European standardisation supports

the implementation of Union legislation and policies in areas such as decarbonisation,

circularity, cybersecurity, artificial intelligence, critical technologies and sustainable

resource use by giving effect to policy objectives through technical requirements and

test methods that are applied consistently throughout the internal market.

(4) European standardisation also contributes to the Union’s global competitiveness and

strategic autonomy by supporting access to international markets and by enabling the

Union to project its regulatory and industrial interests in global standard-setting

processes, especially when established in coordination with the international

standardisation bodies, namely the International Organization for Standardization

(‘ISO’), the International Electrotechnical Commission (‘IEC’) and the International

Telecommunication Union (‘ITU’), as well as with recognised standards development

organisations and global standardisation partnerships in their sector of

competence. Standards and standardisation deliverables can cover various issues, such

as technical characteristics of products, services, processes, systems or entities,

particularly in cases where compatibility and interoperability are essential.

(5) Standards and standardisation deliverables requested in accordance with this

Regulation can support Union legislation and policies in several ways. They can be

requested to give effect to essential requirements set out in Union harmonisation

legislation under the New Legislative Framework and provide a presumption of

conformity for product and services designed in accordance with such standards once

their reference has been published in the Official Journal of the European Union. Such

harmonised standards simplify the making of products and services available on the

internal market and reduce compliance and conformity assessment costs for

businesses, in particular for small and medium-sized enterprises (’SMEs’), startups

and scaleups. They can also lay down test, measurement or calculation methods and

criteria, such as for Regulation (EU) 2024/1781 of the European Parliament and of the

Council4 or for Regulation (EU) 2024/3110 of the European Parliament and of the

http://data.europa.eu/eli/dec/2008/768(1)/oj), and Regulation (EU) 2019/1020 of the European

Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and

amending Directive 2004/42/EC and Regulations (EC) 765/2008 and (EU) 305/2011 (OJ L 169,

25.6.2019, pp. 1, ELI: http://data.europa.eu/eli/reg/2019/1020/oj). 3 Regulation (EU) 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 1673/2006/EC of the European Parliament and of the Council (OJ L 316,

14.11.2012, p. 12, ELI: http://data.europa.eu/eli/reg/2012/1025/oj). 4 Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing

a framework for the setting of ecodesign requirements for sustainable products, amending Directive

(EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L,

2024/1781, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1781/oj).

EN 17 EN

Council5 which specifies that compliance with such standard is mandatory, or more

generally by translating legislative requirements into technical specifications, such as

for Directive (EU) 2016/797 of the European Parliament and of the Council6 or the

proposed Regulation on public contracts and concessions7. In such cases, Union

legislation not only lays down the legal value of the requested standards and

standardisation deliverables but may also lay down the means by which their reference

should be published in the Official Journal of the European Union,whichincludes

referencing in an implementing act or a delegated act. Furthermore, standards and

standardisation deliverables can be requested to support the implementation of the

Union’s industrial policy initiatives, as building blocks of competitive industrial

ecosystems. This Regulation thus allows to provide for referenced standards and

standardisation deliverables, which are standards and standardisation deliverables

developed, revised or amended in response to a standardisation request and the

reference of which has been published in the Official Journal of the European Union.

The referenced standards and standardisation deliverables are either harmonised

standards, harmonised standardisation deliverables or standards and standardisation

deliverables in support of Union legislation and policies.

(6) The framework provided under Regulation (EU) No 1025/2012 is unfit to enable the

European standardisation system to keep up with rapid technological changes and

growing global competition. There are delays in the availability of harmonised

standards, insufficient participation of relevant stakeholders and declining influence of

Union stakeholders in international standardisation. Furthermore, the current

framework is no longer aligned with the increasing number of Union legislation and

policies that rely on standards, which include digital technologies, cybersecurity,

artificial intelligence, clean tech and strategic value chains. Moreover, it is not fit to

meet new challenges including the product-service convergence, the uptake of

standardisation deliverables other than standards and the increasing relevance of

standards development organisations other than the European standardisation

organisations in certain specialised sectors. In addition, in light of the case-law of the

Court of Justice of the European Union8 , the requirements for public access to

harmonised standards need to be updated.

(7) The legal framework should be adapted to reflect those developments while

maintaining a viable European standardisation system that is fit to address the new

challenges in the field of standardisation. The Conclusions of the European Council of

19 March 20269 adopted the ‘One Europe, One Market’ roadmap to deepen the

integration of the internal market and identified the revision of Regulation (EU) No

1025/2012 as a priority. This follows the Commission’s Competitiveness Compass of

January 202510 and the Single Market Strategy of April 202511 which identified the

5 Regulation (EU) 2024/3110 of the European Parliament and of the Council of 27 November 2024

laying down harmonised rules for the marketing of construction products and repealing Regulation

(EU) 305/2011 (OJ L, 2024/3110, 18.12.2024, ELI: http://data.europa.eu/eli/reg/2024/3110/oj). 6 Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the

interoperability of the rail system within the European Union (L 138, 26.5.2016, p. 44, ELI:

http://data.europa.eu/eli/dir/2016/797/oj). 7 COM(2026) 590 final, 9.9.2026. 8 Judgment of 27 October 2016, James Elliott Construction Ltd v Irish Asphalt Ltd., C-613/14,

EU:C:2016:821; Judgment of 5 March 2024, Public.Resource.Org and Right to Know v Commission,

C-588/21 P, EU:C:2024:201. 9 EUCO 1/26, European Council meeting (19 March 2026) – Conclusions. 10 COM(2025) 30 final, 29.1.2025. 11 COM(2025) 500 final, 21.5.2025.

EN 18 EN

slow and unpredictable standardisation process in support of Union legislation and

policies as one of the main barriers to the internal market. It is therefore necessary to

improve the responsiveness of the European standardisation system and its ability to

deliver standards in support of Union legislation and policies in a rapid, timely,

inclusive and transparent way, while preserving the specificity of standardisation as a

voluntary and market-driven tool. It is also necessary to ensure its long-term viability

and ability to deliver standards that are accessible. The European standardisation

system should also preserve its international influence in order to promote the Union’s

international competitiveness.

(8) This Regulation should thus lay down rules for the requesting, developing and

referencing of standards and standardisation deliverables to support the

implementation of Union legislation and policies. As common specifications pursue

the same objectives as harmonised standards, this Regulation should provide a

coherent framework for common specifications across Union legislation. Nevertheless,

this Regulation should be without prejudice to other applicable sectoral rules laid

down by Union legislation, including on common specifications and sectoral

procedures to set standards or technical specifications. Additionally, a Union legal act

might directly reference a standard or standardisation deliverable which has not been

requested in accordance with this Regulation and provides such a standard or

standardisation deliverable with a legal effect, insofar as it complies with requirements

established by the case-law of the Court of Justice of the European Union12.

(9) The legal framework set up by this Regulation should be applied while respecting the

distribution of competences between the Union and Member States as laid down in the

Treaties. In particular, the Commission should not, by requesting a standard or

standardisation deliverable, affect the right to negotiate, conclude and enforce

collective agreements and take industrial action in accordance with national legislation

and practices which respect Union law. European standardisation organisations and

designated standards development organisations should also refrain from conducting

standardisation activities that could affect such rights. Furthermore, they are subject to

competition law to the extent that they can be considered an undertaking or an

association of undertakings within the meaning of Articles 101 and 102 of the Treaty

on the Functioning of the European Union (TFEU).

(10) Standards and standardisation deliverables requested by the Commission should

comply with the World Trade Organization principles in the field of standardisation

such as openness, transparency, and consensus as well as impartiality, independence

from special interests and coherence. Consensus means seeking to take into account

the views of all parties concerned but does not require unanimity. The process for the

development of requested standards and standardisation deliverables should also

guarantee a high level of inclusiveness by involving all relevant interested parties,

including SMEs, civil society representatives, in particular those that are representing

environmental, social and consumer interests, including women’s rights organisations,

equality bodies and organisations representing persons with disabilities, research and

innovation stakeholders and public authorities. Such participation fosters a high level

of market adoption as well as the high quality of standards and standardisation

deliverables that reflect societal and market needs. Given the important role referenced

standards and standardisation deliverables play in supporting the implementation of

Union legislation and policies, they should be market-driven, so that the needs of

12 Cf. Judgment of 21 April 2026, Nederlandse Voedsel- en Warenautoriteit and Others v Stichting

Rookpreventie Jeugd, C-155/24, EU:C:2026:327.

EN 19 EN

economic operators and stakeholders directly or indirectly affected by such standards

are duly taken into account, and reflect the public interest and the objectives of the

Union legislation and policies they are supporting, such as competitiveness,

innovation, sustainability, health and safety, security and economic security. Standards

and standardisation deliverables should be technologically neutral, allowing fair

competition between products, services or economic operators. Referenced standards

and standardisation deliverables should also contribute to advancing the Union’s

values and fundamental rights, in particular accessibility for person with disabilities

and gender equality. In order to ensure a high level of consumer protection and to

contribute to equality between all consumers, they should take into account, where

relevant, risks arising from products and services that can affect consumers differently

on the basis of sex and gender, as recognised in the Commission’s 2026–2030 Gender

Equality Strategy13.

(11) Requested standards and standardisation deliverables should be developed and

adopted in compliance with the principles of transparency and accountability.

European standardisation organisations and designated standards development

organisations should thus make available to the public on their website the list of all

stakeholders participating in their technical bodies in the development of each

requested standard and standardisation deliverable, including organisations,

associations, employers, groups and self-employed individuals, acting on their own

behalf or on behalf of other organisations, and the interests they represent. In

particular, European standardisation organisations and designated standards

development organisations should ensure that the actual interests of stakeholders

represented through client-intermediary relationships, such as through consultants or

contractual ties, are included in the list of stakeholders made public on their website.

(12) Referenced standards and standardisation deliverables give technical expression to

legal requirements and may produce legal effects. To ensure legal certainty, effective

compliance and equal access to information necessary to comply with Union law, it is

essential that such documents be made available to natural and legal persons within

the Union free of charge, in a general, effective and non-discriminatory manner

through a readable, searchable, printable and electronically accessible format.

Economic operators from third countries having a legitimate interest would also have

access to the standards through their authorised representative. European

standardisation organisations and designated standards development organisations

should therefore ensure that such access is provided without barriers, including

mandatory pre-identification or subscription, and remains available after the reference

has been withdrawn. Such access is to be in line with Directives (EU) 2016/2102 of

the European Parliament and of the Council14. Access to referenced standards and

standardisation deliverables requested under this Regulation can be limited to parts of

the standards and standardisation deliverables which are necessary to comply with the

requirements set out in the relevant Union legislation they support, provided that these

parts constitute a self-standing document containing all necessary information. The

same access should be granted to referenced standards and standardisation deliverables

referenced under Regulation (EU) No 1025/2012. Access under this Regulation should

be granted without prejudice to the potential copyrights that the European

13 COM(2026) 113 final, 5.3.2026. 14 Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the

accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1,

ELI: http://data.europa.eu/eli/dir/2016/2102/oj).

EN 20 EN

standardisation organisations and designated standards development organisations

may claim to have on the referenced standards and standardisation deliverables.

European standardisation organisations and designated standards development

organisations may implement appropriate digital rights management measures in view

of the technological developments, in particular in Artificial Intelligence, which may

facilitate the mass extraction or re-use of content contained in referenced standards or

standardisation deliverables.

(13) The ongoing digitalisation of standardisation processes is an opportunity for the

European standardisation system to both increase its responsiveness by accelerating

the standardisation process through online standard development tools and to foster

inclusiveness by decreasing the costs of participating in the standardisation process,

particularly for SMEs, startups and scaleups, civil society stakeholders and research

and innovation stakeholders. Digitalisation also has the potential to improve the

quality of standards and standardisation deliverables, and to increase their use and

take-up by market operators. So-called ‘smart standards’, where the content of the

standards is complemented by additional data and information to facilitate their use

and their integration in the business processes of market operators, have great potential

to foster the Union’s competitiveness. European standardisation organisations and

designated standards development organisations should be encouraged to develop such

smart standards and should ensure technical and semantic interoperability of the

machine-readable formats of requested standards and standardisation deliverables and

of their associated metadata, in order to facilitate their use by market operators, that

may need to rely on several referenced standards and standardisation deliverables

originating from different European standardisation organisation and designated

standards development organisations.

(14) In order to foster the performance and accountability of the European standardisation

system, the Commission should create an online platform (the ‘EU Standards

Platform’) to make publicly available up-to-date information on requested standards

and standardisation deliverables, in particular as regards the status of their

development and referencing, and on common specifications. European

standardisation organisations and designated standards development organisations

should cooperate with the Commission to ensure that information on the EU Standards

Platform is accurate and up to date to facilitate public scrutiny of the European

standardisation system. The EU Standards Platform should be interoperable with

relevant Union information systems and portals and should take into account relevant

interoperability solutions developed or recommended under Regulation (EU)

2024/90315.

(15) Free and unrestricted access to referenced standards and standardisation deliverables

of European standardisation organisations risks having an impact on the revenues of

national standardisation bodies that currently sell these documents. While national

standardisation bodies and European standardisation organisations are developing

alternative revenue sources, notably based on new services linked to ‘smart standards’,

Member States and the Union may support funding the transition to new business

models to strengthen the long-term financial viability of the European standardisation

system. Furthermore, the Union may fund the participation of European stakeholder

organisations designated under this Regulation which is essential for an inclusive

15 Regulation (EU) 2024/903 of the European Parliament and of the Council of 13 March 2024 laying

down measures for a high level of public sector interoperability across the Union (Interoperable Europe

Act) (OJ L, 2024/903, 22.3.2024, ELI: http://data.europa.eu/eli/reg/2024/903/oj).

EN 21 EN

standardisation process and contributes to balancing public and private interests.

Funding opportunities under the Multiannual Financial Framework 2028-2034,

including through the Single Market and Customs Programme16, the European

Competitiveness Fund17 and the Horizon Europe Programme 2028-203418 and in

accordance with the objectives and conditions set out in these programmes, may

contribute to support the European standardisation activities, including to enhance the

responsiveness of the European standardisation system, to promote its global

relevance, to improve the usability and interoperability of standards and

standardisation deliverables and more generally to foster the development of standards

and standardisation deliverables that contribute to the Union’s objectives. For those

purposes, this Regulation should clarify that European standardisation organisations,

national standardisation bodies, designated standards development organisations and

European stakeholder organisations, may receive funding under the relevant Union

programmes, including as potential designated beneficiaries in accordancewith the

conditions set out in these programmes.

(16) The responsiveness of the European standardisation system, in particular its ability to

deliver standards and standardisation deliverables in time to facilitate market

operators’ compliance with Union legislation, depends on careful planning of future

standardisation needs. The annual Union work programme on European

standardisation should contribute to improve such strategic planning and coordination

within the European standardisation system and should help to start standardisation

work as soon as a need is identified. The work programme should also complement

the Union’s research and innovation policy and industrial strategy by identifying

priority areas for pre-normative work, even before a specific standardisation need has

been identified. It may be complemented by other tools allowing the early

identification of standardisation needs or pre-normative work in support of Union

legislation and policies, such as the European Rolling Plan on ICT standardisation.

(17) The European standardisation system is primarily organised by and for the relevant

stakeholders within the three European standardisation organisations CEN, CENELEC

and ETSI, based on national representation for CEN and CENELEC, and direct

participation for ETSI. The European standardisation organisations have established

strong connections with the industrial ecosystems within the Union. They cover a wide

range of sectors, ensure a high-level of inclusiveness, quality, representation and

influence of Union stakeholders, and contribute to further harmonising the internal

market through the adoption of European standards that ensure that one single

standard is available throughout the Union. They also ensure a high-level of alignment

with international standardisation in their respective areas of expertise. The European

standardisation organisations’ processes are recognised and trusted by market

operators, and they have built up expertise to deliver standards and standardisation

deliverables to support the implementation of Union legislation and policies over the

past decades. Thus, those European standardisation organisations should remain the

main partners of the Union for developing requested standards and standardisation

deliverables. The Commission should however be empowered to amend the list of

European standardisation organisations set out in Annex I, to either designate a new

European standardisation organisation to reinforce the European standardisation

system in specific sectors, or to remove a European standardisation organisation from

16 COM(2025) 590 final, l3.09.2025. 17 COM(2025) 555 final, 16.07.2025. 18 COM(2025) 543 final, 16.07.2025.

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Annex I, in particular if it no longer meets the requirements set out in this Regulation

or it fails to perform at a sufficient level over a sustained period, as monitored on the

basis of key performance indicators. As soon as the Commission identifies the

underperformance of a European standardisation organisation, it should engage with

that organisation to remedy the situation before removing the European

standardisation organisation concerned from Annex I.

(18) The European standardisation system relies on the active involvement of the national

standardisation bodies in the European standardisation organisations, in particular to

guarantee that the interests of the Union are well represented when developing

requested standards and standardisation deliverables. The participation of national

standardisation bodies from candidate countries in European standardisation

contributes to their alignement with the Union acquis and their gradual integration into

the internal market. Member States should notify the Commission of the organisations

they appoint as national standardisation bodies, and ensure, with the active

cooperation of the European standardisation organisations, that at least one of their

national standardisation bodies is a member of each European standardisation

organisation. Member States should remain responsible for the effective

implementation of this Regulation by their respective national standardisation bodies.

Without affecting the important role played by stakeholders in preparing effective

standards, the European standardisation organisations should ensure that formal

decisions regarding requested standards and standardisation deliverables are taken

exclusively by national standardisation bodies, in order to guarantee European

decision-making for such standards and standardisation deliverables.

(19) In order to improve the performance of the European standardisation organisations, the

Commission should monitor them based on key performance indicators to assess the

speed of delivery and the quality of requested standards and standardisation

deliverables, the inclusiveness of the European standardisation process and the

international influence of the European standardisation system. To foster transparency

and accountability, this assessment should be made publicly available on the EU

Standards Platform.

(20) The cooperation between the Commission and the European standardisation

organisations is essential for the performance of the European standardisation system.

They should develop a close working relationship based on sincere cooperation,

transparency and the open exchange of information. The European standardisation

organisations should ensure the timely implementation of standardisation requests and

the delivery of requested standards and standardisation deliverables in accordance with

the objectives and timeframes laid down by the Commission. They should also ensure

the participation of the Commission in their governance and technical bodies, in

particular in their working groups and technical committees, so that the Commission

might facilitate the development of requested standards and standardisation

deliverables that comply with the requirements set out in the standardisation request

and that satisfy the requirements set out in the Union legislation or the objectives set

out in Union policies which they aim to cover. Furthermore, they should cooperate

beyond requested standards and standardisation deliverables and foster the

development of European standards and European standardisation deliverables that

contribute to the Union’s competitiveness and core values. The European

standardisation organisations play an important role in informing market operators on

the availability of referenced standards and standardisation deliverables. They should

strive to provide factual and up-to-date information to market operators, notably on the

EN 23 EN

status of standardisation activities conducted in response to standardisation requests.

This would promote legal certainty and facilitate access to the internal market for

market operators. In that context, the European standardisation organisations might

cooperate for the development and maintenance of standards catalogues and serve as

an information hub to their users.

(21) The European standardisation organisations play an essential role to harmonise the

internal market by ensuring that national standards adopted by national standardisation

bodies do not conflict with referenced European standards. Therefore, European

standardisation organisations, national standardisation bodies and the Commission

should engage in exchanging information on current and future standardisation

activities. National standardisation bodies should withdraw national standards when a

new standard covering the same scope is referenced. Such exchange of information

should not prevent national standardisation bodies from complying with other

obligations and commitments, in particular with Annex 3 to the Agreement on

Technical Barriers to Trade19.

(22) The quality, legitimacy and public acceptance of European standardisation depend on

the appropriate and effective participation of all relevant stakeholders. The diverse

participation of industry and SME experts, in particular experts from all the different

segments of the value chains concerned, is essential for the rapid development of

quality standards with a high-level of market relevance. Standards also serve as

important tools for the competitiveness of SMEs, whose needs and interests may differ

from those of larger undertakings. Therefore, their participation in the standardisation

process should be ensured to increase their ability to contribute their innovation

technologies to the standardisation process, to make standards more relevant and easy

to use for SMEs, startups and scaleups, and to promote their market uptake by all

relevant market operators.

(23) Standards have a broad societal impact: they influence citizens’ safety and well-being,

the environment, workers’ safety and working conditions, the inclusion of persons

with disabilities, equality, in particular gender equality, as well as fundamental rights

and other areas of public interest. Therefore, European standardisation should

represent social, environmental and consumer interests so that standards respect Union

values, meet societal needs, reflect market realities and support a resilient, innovative

and socially balanced Union economy. The active contribution of stakeholders

representing such interests is a distinctive factor of the European standardisation

system and contributes to the adoption of standards that are both market-relevant and

support Union policy objectives and values. The European standardisation system

should take into account the 2004 United Nations Convention on the Rights of Persons

with Disabilities and should facilitate the participation of people with disabilities, in

line with the requirements set out in Directive (EU) 2019/88220 of the European

Parliament and of the Council. In particular, it is necessary for the European

standardisation organisation to facilitate the accessibility to standardisation activities

for persons with disabilities.

19 Approved by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf

of the European Community, as regards matters within its competence, of the agreements reached in the

Uruguay Round multilateral negotiations (1986-1994) (OJ L 336, 23.12.1994, p. 1). 20 Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the

accessibility requirements for products and services (OJ L 151, 7.6.2019, pp. 70, ELI:

http://data.europa.eu/eli/dir/2019/882/oj).

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(24) Standards are also a key part of the innovation value chain and facilitate the diffusion

of new technologies. Standardisation activities can bridge research with market and

societal uptake and act as a valorisation channel, as recognised in the Guiding

principles for knowledge valorisation21 and the Code of practice on standardisation in

the European Research Area22. Therefore, research and innovation stakeholders, such

as researchers, academics, research centres, startups and scaleups, and stakeholders

from the open-source community, should be actively involved in European

standardisation, because their participation enhances the technological relevance,

quality and neutrality of standards and promotes the uptake and valorisation of

research results with clear standardisation potential. European standardisation

activities should in particular build on relevant research and innovation generated

through the implementation of Union funded research projects and other research and

innovation actions, as well as owned by research and technology infrastructures which

have been funded by the Union. With the digitalisation of society and the evolution of

new technologies, open-source software and open-source solutions play an ever-

important role in supporting innovation. Open source and open standards are

complementary instruments for fostering competition, interoperability, transparency,

technological resilience and digital sovereignty within the Union. Open source can

reduce vendor lock-in and dependencies, support collaboration across borders and

sectors, facilitate the efficient re-use of digital solutions, including in the public sector

and contribute to security and resilience. In line with the EU Open Source Strategy23,

it is important to actively support the participation of open source organisations, such

as open source software stewards and open source communities in standardisation

activities, including as implementing parties.

(25) Public authorities, including market surveillance authorities, play an important role in

ensuring that standards and standardisation deliverables developed following a

standardisation request from the Commission are fit for regulatory purposes and

capable of supporting effective implementation and enforcement of Union legislation.

Member States should therefore, where appropriate, encourage the participation of

such authorities in national and European standardisation activities concerning

standards and standardisation deliverables requested by the Commission. Such

involvement helps to align technical specifications and legal requirements, while also

supporting regulatory learning from practical experience. It also reduces the risk of

non-compliance or rejection of the delivered standards and standardisation

deliverables. The Commission research facilities and relevant Union agencies also

help ensuring that Union public policy reflects and supports research and innovation

and the advancement of science as a basis for public policy. It is thus important that

they are also involved in the standardisation activities in support of Union legislation

and policies, and European standardisation organisations should ensure their free

access to the relevant standards and standardisation deliverables to conduct this work.

(26) The coordination and representation of SMEs and societal interests, which may vary

across the Union, are a challenge for the European standardisation process. In order to

facilitate the coordination of such interests and to guarantee their effective

representation, the Commission should designate European stakeholder organisations

21 Council Recommendation (EU) 2022/2415 of 2 December 2022 on the guiding principles for

knowledge valorisation. 22 Commission Recommendation (EU) 2023/498 of 1 March 2023 on a Code of Practice on

standardisation in the European Research Area. 23 COM(2026) 503 final, 03.06.2025.

EN 25 EN

representing SMEs, consumers, environmental interests and social interests based on

objective criteria and a transparent and non-discriminatory process. The selection

should take place at least every four years to ensure their ability to build up the

necessary skills and competences. The organisation representing the interests of

consumers should contribute to ensure that standards reflect the lived experiences and

needs of the entire population through the participation of equality stakeholders, in

particular women or persons with disabilities, whose interests are underrepresented in

the standardisation process. The representation of social interests and social

stakeholders in European standardisation activities particularly refers to the activities

of organisations and parties representing employees and workers’ basic rights, for

instance trade unions. European standardisation organisations should actively involve

those European stakeholder organisations at each stage of the standardisation process

of the requested standards and standardisation deliverables relevant to the interests

they represent. This obligation does not necessarily entail any voting rights for such

stakeholders. However, European standardisation organisations should do their utmost

to take the comments of such organisations into account and to explain, where

relevant, how they have been taken into consideration. Designated standards

development organisations should also ensure that these organisations can effectively

contribute to the development of requested standards and standardisation deliverables.

(27) National standardisation bodies are essential to foster the effective participation in the

European standardisation system for relevant stakeholders. Barriers to participation are

generally lower at national level, due to lower costs of participation, the absence of

linguistic barriers as well as better awareness and familiarity of stakeholders with the

national standardisation process. To achieve a high-level of participation and

inclusiveness of the European standardisation system, national standardisation bodies

should ensure the effective participation of SMEs, consumer organisations,

environmental and social stakeholders, including women’s rights organisations,

equality bodies, organisations representing persons with disabilities, research and

innovation stakeholders and public authorities. As the costs and time required for

standardisation are key barriers to participation for these stakeholders, national

standardisation bodies should facilitate the participation in their standardisation

activities without mandatory membership. They should also provide such stakeholders

with free access or reduced rates. Free access to draft standards and draft

standardisation deliverables is particularly important to allow timely and informed

participation and to improve the legitimacy, inclusiveness and practical relevance of

the resulting standards.

(28) The Commission should consult European standardisation organisations on new

standardisation needs that may trigger a standardisation request, for instance needs

identified in the annual Union work programme on European standardisation, to allow

them to indicate their ability to accept the standardisation request and to deliver high-

quality standards or standardisation deliverables in a timely manner. Based on the

consultation, the Commission should make an informed assessment of the capacity

and preparedness of European standardisation organisations to deliver the requested

standards and standardisation deliverables, based on the activities they are carrying out

in that area, the technical expertise that they are able to mobilise and the likely

duration of the process. The consultation should also contribute to identifying possible

specificities in terms of stakeholder participation, inclusiveness requirements,

restriction of participation to Union actors or the identification of existing relevant

technical specifications or standards.

EN 26 EN

(29) When, following the consultation of European standardisation organisations, the

Commission has concluded that one or more European standardisation organisations

would be best placed to develop, revise or amend the requested standards or

standardisation deliverables, it should address a standardisation request to them. To

improve the overall responsiveness of the European standardisation system, the

Commission should endeavour to adopt a standardisation request within 12 months

following receipt of the reply of the European standardisation organisations to the

consultation. The standardisation request should lay down with sufficient precision the

requirements concerning the content to be met by the requested standards and

standardisation deliverables and indicate a deadline for the delivery of each relevant

standard and standardisation deliverable. The standardisation request may also include

provisions regarding the periodic revision of the requested standards or standardisation

deliverables within the date of expiry of the request, in particular to take into account

the evolution of technologies. The standardisation request may set out the main

procedural steps, and their required timing, to be undertaken by the European

standardisation organisations for the timely delivery of the request, such as setting up a

technical committee to work on the requested standard or standardisation deliverable,

concluding adequate cooperation agreements with other standards development

organisations that would be identified in the request as well as intermediary procedural

steps linked to the European standardisation organisations’ internal procedures, such

as the date for enquiry or formal votes. The Commission should publish draft

standardisation requests on the EU Standards Platform to allow for the European

standardisation organisations, the European stakeholder organisations and the relevant

European sectoral stakeholders to submit their comments, in particular experts from

the Member States.

(30) There may be areas where the time required to deliver a harmonised standard could be

too long and slow down market uptake, for instance for digital products and services

with shorter lifecycle and a high level of innovation. The Commission should be able

in such cases to request European standardisation organisations to deliver a

harmonised standardisation deliverable covering the relevant essential requirements

necessary for providing a presumption of conformity, as an intermediate step toward a

harmonised standard. Such deliverables should be of high quality and based on an

inclusive, open and transparent standardisation process. However, they should not

necessarily have reached the same level of consensus or consultation as a fully fledged

harmonised standard. The Commission should publish the reference of the harmonised

standardisation deliverable if it complies with all the essential requirements it aims to

cover, providing a presumption of conformity for the products and services based on

such a harmonised standardisation deliverable. The European standardisation

organisations should continue to develop the corresponding harmonised standard,

which, once delivered, should replace the harmonised standardisation deliverable to

ensure that there is no conflicting standard or standardisation deliverable providing a

presumption of conformity for a given product or service.

(31) The Commission may also, in order to increase the speed of the standardisation

process and better align requested standards and standardisation deliverables with state

of the art technical specifications, specify in its standardisation request an obligation

for European standardisation organisations to take into account identified existing

technical specifications or standards. These could be technical specifications or

standards from other standards development organisations, or technical specifications

developed by Union bodies or agencies or developed within European initiatives like

the European Interoperability Framework or semantic interoperability community

EN 27 EN

(SEMIC) specifications. European standardisation organisations should be responsible

for the agreements with standards development organisations, Union bodies and

agencies that develop these standards or technical specifications, where necessary, and

ensure that the delivered standards or standardisation deliverables based on existing

technical specifications or standards comply with the obligations laid down in this

Regulation. In this regard, European standardisation organisations should build and

expand their current initiatives to evaluate and integrate such external standards and

technical specifications into their catalogue.

(32) The Commission should also be able to include specific requirements for participation

and inclusiveness in its standardisation request. For instance, for requested standards

and standardisation deliverables that support accessibility or that may have an impact

on fundamental rights, it may be essential to ensure the active and effective

participation of stakeholders which might not be usually involved in the European

standardisation process to ensure that they are aligned with the Union’s values.

Furthermore, the standardisation request may introduce specific requirement as

regards participation in the development of standards and standardisation deliverables

relating to Union strategic assets, interests, autonomy, security or economic security,

or where international standards might not be fit for the Union interests. In such cases,

it may be appropriate that the European standardisation process is restricted to

European actors or actors that share the interests of the Union. Therefore, the

Commission may specify that only certain types of stakeholders can participate in the

standardisation process or that the European standardisation process can diverge from

existing international standards or international standards that are under development,

in order to protect the Union’s strategic autonomy and its strategic interests.

(33) A European standardisation organisation that has accepted a standardisation request

should regularly report to the Commission on the activities it has undertaken and the

progress it has achieved. It should submit such a report every year but it should be

possible for the standardisation request to specify a shorter reporting frequency. The

European standardisation organisation should make available to the Commission the

relevant drafts documents in response to the request and should duly take into account

comments from the Commission to foster compliance. Where the European

standardisation organisation is unable to deliver the requested standards and

standardisation deliverables within the deadlines set out in the request, and the

Commission considers that the best option is to continue the implementation of the

standardisation request, it may amend the deadlines or expiry dates usinga simplified

procedure, without having to formally re-consult stakeholders. Where several

European standardisation organisations have accepted a standardisation request, they

should establish a structured mode of collaboration to ensure cross-participation of

experts and the efficient implementation of the standardisation request. European

standardisation organisations that have accepted a standardisation request should be

responsible for complying with the requirements set out in the request. This includes

situations where the implementation involves cooperating with other organisations, for

instance liaison organisations, or with international standardisation bodies, in

particular where the development of the requested standards and standardisation

deliverables takes place fully or partly at the international level due to an agreement

between the European standardisation organisation and an international

standardisation body.

(34) Standards and standardisation deliverables developed in response to a standardisation

request should be delivered to the Commission as soon as they are adopted by the

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European standardisation organisations. The Commission should assess the

compliance of the delivered standard or standardisation deliverable with the

requirements it aims to cover and with the procedural and content requirements set out

in the standardisation request. The European standardisation organisations should

cooperate with the Commission to facilitate this assessment, notably by ensuring that

the Commission has all the relevant documents and necessary information including,

where relevant, normative references. The Commission should conduct the assessment

within six months from the delivery of the requested standard or standardisation

deliverable to avoid uncertainties whereby a requested standard or standardisation

deliverable adopted by European standardisation organisations is available to market

operators, while its legal effect might not yet be established.

(35) When the Commission has assessed that the delivered standard or standardisation

deliverable satisfies the essential requirements, set out in Union legislation, which it

aims to cover, or where appropriate, the objectives of the relevant Union policies, and

complies with the requirements set out in the request, it should publish a reference of

that standard or standardisation deliverable without delay in the Official Journal of the

European Union. That reference allows market operators to rely on such referenced

standard or standardisation deliverable to either benefit from a presumption of

conformity with Union legislation, or from other potential legal effect set out in the

corresponding Union legislation. If the Commission concludes that the quality of a

delivered standard or standardisation deliverable is not adequate, it may reject it or

publish its reference with restrictions, indicating the requirements that are not covered

and for which the standard cannot provide a presumption of conformity or means to

comply with the relevant Union legislation. The Commission should exercise

discretion to assess the compliance with procedural requirements laid down in the

standardisation request, and should balance whether non-compliance with procedural

requirements, for instance late delivery, are sufficient to justify not referencing the

standard or standardisation deliverable.

(36) In order for the European standardisation system to respond effectively to evolving

technological and policy needs, especially where the necessary expertise might not

exist within the European standardisation organisations, the Commission should be

able to address standardisation requests to other standards development organisations,

which are not national nor international standardisation bodies. These standards

development organisations should be designated based on objective criteria ensuring

their ability to deliver a highly inclusive standardisation process which reflects

European interests. The Commission should only designate standards development

organisations that are able to comply with the principles for European standardisation

set out in this Regulation and with the best standardisation practices. Designated

standards development organisations should in particular ensure the openness,

transparency and inclusiveness of their standardisation process. They should comply

with all the specific requirements set out in this Regulation, in particular the free and

unrestricted access to referenced standards and standardisation deliverables, the

transparency and inclusiveness of the standardisation process and the publicity of

interests represented, the effective participation of Union stakeholders including

research and innovation stakeholders, SMEs, startups and scaleups, consumers,

environmental and social stakeholders, notably where relevant women’s rights

organisations, equality bodies, and organisations representing persons with disabilities.

The Commission should pay particular attention to the ability of the designated

standards development organisations to facilitate the participation of European

stakeholder organisations and European stakeholders. Designated standards

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development organisations should ensure that Union interests are effectively taken into

account where they are represented. Open source organisations may develop technical

specifications that meet the needs of the Union and could be designated as standards

development organisations as long as they comply with the criteria set out in this

Regulation.

(37) In order to ensure that addressing a standardisation request to designated standards

development organisations complements the European standardisation system rather

than fragments it, appropriate safeguards should apply concerning transparency,

information-sharing and cooperation between designated standards development

organisations and the European standardisation organisations. The designated

standards development organisations should maintain a high level of transparency in

their standardisation activities similar to the level ensured by European standardisation

organisations to avoid duplicating work, prevent inconsistencies between their

respective standards and standardisation deliverables and protect the functioning of the

internal market. They should provide access to the draft standards and standardisation

deliverables developed pursuant to a standardisation request to the European

standardisation organisations upon their request and should duly take account of

comments addressing issues of coherence between the draft standards and

standardisation deliverables and relevant referenced standards and standardisation

deliverables, especially as regards any comments indicating that a draft requested

standard or standardisation deliverable may adversely affect the internal market by

conflicting with existing relevant referenced standards or standardisation deliverables.

(38) The Commission may address a standardisation request to designated standards

development organisations when the European standardisation organisations have

indicated during the consultation that they would not accept a standardisation request,

or when the Commission has assessed that, based on their consultation, the European

standardisation organisations are not in a position to deliver timely and high-quality

standards and standardisation deliverables, notably when the scope of the

standardisation request and the relevant technical expertise clearly lies with the

competences of designated standards development organisations. The Commission

may also address a standardisation request to designated standards development

organisations when European standardisation organisations fail to deliver the

requested standard or standardisation deliverable or to appropriately comply with the

standardisation request. Such a decision should be based on the information available

from the European standardisation organisations and carefully balance the impact of

interrupting the activities of the relevant European standardisation organisations to

develop the requested standards or standardisation deliverables with the potential

benefits of addressing the request to designated standards development organisations.

In such cases, the Commission should withdraw the standardisation request to the

European standardisation organisations to prevent the existence of different standards

that address the same essential requirements.

(39) As referenced standards or standardisation deliverables developed by designated

standards development organisations have the same status as referenced standards and

standardisation deliverables developed by the European standardisation organisations,

the process and requirements for addressing, implementing and assessing

standardisation request to designated standards development organisations should be

similar as for European standardisation organisations. However, given the

particularities of requesting a standard or standardisation deliverable to designated

standards development organisations, it is appropriate that all standardisation requests

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to designated standards development organisations should be adopted by the

Commission by means of implementing acts in accordance with the examination

procedure. The Commission may simultaneously designate a standards development

organisation and address a standardisation request to it. The Commission should assess

the coherence of the delivered standards or standardisation deliverables with the

relevant referenced standards and standardisation deliverables to prevent conflicts

between referenced standards and standardisation deliverables.

(40) This Regulation provides for a horizontal framework that will promote the timely

development of harmonised standards by European standardisation organisations and

by designated standards development organisations. However, where no such

harmonised standard exists or such a standard is not expected to be delivered within a

reasonable period, the Commission should be able to adopt common specifications by

implementing acts that provide a means to comply with the essential requirements set

out in relevant Union legislation. Compliance with common specifications should

remain voluntary for businesses, which may rely on them to benefit from a

presumption of conformity or choose other appropriate methods to demonstrate

compliance with Union requirements. The Commission would ensure a highly

inclusive process to develop common specifications, and should consult relevant

European stakeholders, in particular the appropriate expert groups set out to support

the implementation of corresponding Union legislation. The Commission should also

leverage, where appropriate, the existing standardisation work conducted by European

standardisation organisations or designated standards development organisations, in

the preparation of common specifications. When European standardisation

organisations or designated standards development organisations deliver a standard

that covers the same requirements as those covered in adopted common specifications,

the Commission should assess such a standard without delay. If it satisfies the

essential requirements which it aims to cover and complies with the standardisation

request, the Commission should withdraw the common specifications at the same time

it publishes a reference to that harmonised standard.

(41) Member States, the European Parliament and the Commission, notably following

information received from market surveillance authorities, should be able to notify that

they consider a referenced standard or standardisation deliverable or common

specification does not satisfy the requirements it aims to cover. To promote legal

certainty for businesses, it is essential that such safeguard notifications are resolved as

fast as possible. It is thus appropriate that, if there is no objection to the notification,

their reference is restricted or withdrawn, or the common specification repealed.

Nevertheless, when one or more Member States, the European Parliament or the

Commission objects, the Commission should only take its decision after consulting all

involved parties and assessing the information provided by the Member States or the

European Parliament.

(42) To foster legal certainty for businesses, it is important that the references to standards

and standardisation deliverables are closely aligned with the portfolio of standards and

standardisation deliverables managed by European standardisation organisations and

designated standards development organisations. When such organisations engage in

the process of amending, revising or withdrawing a referenced standard or

standardisation deliverable, for instance because they consider that it is no longer in

line with the state of the art or with market requirements, they should notify the

Commission without delay so that the Commission could, if appropriate, update or

withdraw the reference to the amended, revised or withdrawn standards or

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standardisation deliverables. The Commission may also withdraw a reference or repeal

a common specification on its own initiative, for instance when it considers that it no

longer meets the state of the art.

(43) Given the close links between the European and international standardisation systems,

and the importance of standards for international trade and competitiveness, the

European standardisation system should promote coherence with international

standardisation while safeguarding Union interests, values and policy objectives. In

line with international practices, European standards and European standardisation

deliverables should align with international standards to foster international trade and

the Union’s competitiveness. While cooperation and alignment with their mirror

international standardisation bodies is important for the European standardisation

organisations, it is appropriate to allow for exceptions where draft or existing

international standards would be an ineffective or inappropriate means to fulfil the

Union’s policy objectives. The Commission should therefore carefully assess the

alignment with international standards and its impact on the Union’s competitiveness

and strategic autonomy.

(44) In order to strengthen the Union’s global presence in standardisation, the European

standardisation system should facilitate a coordinated Union approach in international

standardisation, in particular in emerging and strategic technologies, in light of

increasing international competition and strategic use of standards by other global

actors. The Union should promote cooperation, including through relevant experts

group, between European standardisation organisations, international standardisation

bodies and other standard development organisations when relevant, in particular

recognised standard development organisations in their sector of competence.

(45) To coordinate standardisation activities, relations with European standardisation

organisations and designated standards development organisations and promote a

Union approach in international standardisation, the Commission should create a

Centre of Excellence on European Standardisation whose mission should be to ensure

an effective implementation of this Regulation and a well-functioning European

standardisation system. The Centre of Excellence, which might be led by a Chief

Standardisation Officer, should serve as a coordinating hub for stakeholders who

contribute to the efficient development of referenced standards and standardisation

deliverables as well as of common specifications. It should in particular ensure the

cooperation with the European standardisation organisations and the identification and

cooperation with designated standards development organisations. The Centre of

Excellence should also ensure the coordination between experts from the Commission,

relevant Union agencies and public authorities from Member States to strengthen the

network of European experts active in standardisation, at both European and

international levels. The Centre of Excellence should also contribute to improve the

anticipation of standardisation needs by better articulating research and innovation

policy and standardisation activities, notably pre-normative activities.

(46) In order to foster the performance of the European standardisation system, the power

to adopt acts in accordance with Article 290 TFEU should be delegated to the

Commission in respect of amendments to Annex I to this Regulation. It is of particular

importance that the Commission carry out appropriate consultations during its

preparatory work, including at expert level, and that those consultations be conducted

in accordance with the principles laid down in the Interinstitutional Agreement of 13

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April 2016 on Better Law-Making24. In particular, to ensure equal participation in the

preparation of delegated acts, the European Parliament and the Council receive all

documents at the same time as Member States’ experts, and their experts

systematically have access to meetings of Commission expert groups dealing with the

preparation of delegated acts.

(47) The Committee established pursuant to this Regulation should assist the Commission

in matters related to the implementation of this Regulation. In order to ensure uniform

conditions for the implementation of this Regulation, implementing powers should be

conferred on the Commission. Those powers should be exercised in accordance with

Regulation (EU) 182/2011 of the European Parliament and of the Council25. The

examination procedure should be used for adopting standardisation requests addressed

to designated standards development organisations and for standardisation requests

addressed to European standardisation organisations when they include specific

requirements introduced by this Regulation, namely the request for harmonised

standardisation deliverables, the restriction of participation to the standardisation

process to actors representing Union interests and restricting requirements as regards

the usual cooperation with international standardisation bodies. For all other

standardisation requests addressed to European standardisation organisations, in order

to accelerate the standardisation process, it is appropriate for the Commission to adopt

them by way of implementing act without a committee procedure, as national interests

are represented in the European standardisation organisations and Member States can

take part in the public consultation for such requests. The examination procedure

should be used for adopting common specifications. 

(48) Since the objectives of this Regulation, namely to increase the responsiveness of the

European standardisation system, ensure a financially viable and inclusive European

standardisation system and consolidate the Union’s influence in international

standardisation, cannot be sufficiently achieved by the Member States alone, due to

the harmonisation effect of referenced standards and standardisation deliverables, but

can rather be better achieved at Union level, the Union may adopt measures, in

accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on

European Union. In accordance with the principle of proportionality as set out in that

Article, this Regulation does not go beyond what is necessary in order to achieve those

objectives.

(49) In the interest of clarity and legal certainty, Regulation (EU) No 1025/2012 should be

repealed and replaced by this Regulation. Additionally, in the interests of coherence,

Article 48 of Regulation (EU) 2023/988 of the European Parliament and of the

Council26 should be repealed.

(50) This Regulation should apply six months after its entry into force,

24 OJ L 123, 12.5.2016, p. 1. 25 Regulation (EU) 182/2011 of the European Parliament and of the Council of 16 February 2011 laying

down the rules and general principles concerning mechanisms for control by Member States of the

Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, pp. 13, ELI:

http://data.europa.eu/eli/reg/2011/182/oj). 26 Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general

product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the

Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing

Directive 2001/95/EC of the European Parliament and of the Council and Council Directive

87/357/EEC (OJ L 135, 23.5.2023, pp. 1, ELI: http://data.europa.eu/eli/reg/2023/988/oj).

EN 33 EN

HAVE ADOPTED THIS REGULATION:

Chapter 1

General provisions

Article 1

Subject matter

This Regulation lays down rules with regard to:

(a) the requesting, development and referencing of harmonised standards,

harmonised standardisation deliverables, and standards and standardisation

deliverables in support of Union legislation and policies;

(b) the cooperation between European standardisation organisations, national

standardisation bodies, designated standards development organisations,

Member States and the Commission;

(c) the participation of European stakeholders in European standardisation;

(d) the adoption of common specifications.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘standard’ means a technical specification, adopted by a standards development

organisation, for repeated or continuous application;

(2) ‘standardisation deliverable’ means a technical specification other than a

standard, adopted by a standards development organisation, for repeated or

continuous application;

(3) ‘technical specification’ means a document that sets out technical requirements

that are to be fulfilled by a product, service, process, system or entity;

(4) ‘requested standard and standardisation deliverable’ means a standard and

standardisation deliverable developed, revised or amended in response to a

standardisation request;

(5) ‘referenced standard and standardisation deliverable’ means a harmonised

standard, a harmonised standardisation deliverable or a standard and

standardisation deliverable in support of Union legislation or policies;

(6) ‘harmonised standard’ means a standard developed, revised or amended in

response to a standardisation request, the reference of which has been

published in the Official Journal of the European Union, and the conformity

with which provides for a presumption of conformity with the requirements, set

out in the relevant Union legislation, which it aims to cover;

(7) ‘harmonised standardisation deliverable’ means a standardisation deliverable

developed, revised or amended in response to a standardisation request, the

reference of which has been published in the Official Journal of the European

EN 34 EN

Union, and the conformity with which provides for a presumption of

conformity with the requirements, set out in the relevant Union legislation,

which it aims to cover, and which is intended to be replaced by a harmonised

standard;

(8) ‘standard and standardisation deliverable in support of Union legislation or

policies’ means a standard and standardisation deliverable developed, revised

or amended in response to a standardisation request, that does not aim at

providing presumption of conformity with requirements set out in Union

legislation, and the reference of which has been published in the Official

Journal of the European Union;

(9) ‘common specification’ means a technical specification adopted by the

Commission, the conformity with which provides for a presumption of

conformity with the requirements, set out in the relevant Union legislation,

which it aims to cover;

(10) ‘European standardisation organisation’ means an organisation listed in

Annex I;

(11) ‘national standardisation body’ means a standardisation body notified to the

Commission by a Member State in accordance with Article 11;

(12) ‘standards development organisation’ means an organisation which develops

and adopts standards and standardisation deliverables in line with

internationally recognised principles on standardisation;

(13) ‘designated standards development organisation’ means a standards

development organisation, other than a European standardisation organisation,

to which the Commission may address a standardisation request;

(14) ‘European stakeholder organisations’ means the organisations representing

micro, small and medium-sized enterprises (‘SMEs’), as defined in

Commission Recommendation 2003/361/EC27, consumers, environmental and

social interests to foster the inclusiveness of the European standardisation

system, as designated in accordance with this Regulation;

(15) ‘European standardisation system’ means the framework of actors and

processes involved in the development of referenced standards and

standardisation deliverables, and common specifications, to support Union

legislation and policies, in particular the European standardisation

organisations, the designated standards development organisations, the

European stakeholder organisations, national standardisation bodies, Member

States, the Commission as well as stakeholders taking part in the

standardisation process;

(16) ‘standardisation request’ means a decision of the Commission addressed to a

European standardisation organisation or a designated standards development

organisation requesting such an organisation to develop, revise or amend

standards or standardisation deliverables;

(17) ‘national standard’ means a standard adopted by a national standardisation

body;

27 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-

sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).

EN 35 EN

(18) ‘European standard’ means a standard adopted by a European standardisation

organisation;

(19) ‘European standardisation deliverable’ means a standardisation deliverable

adopted by a European standardisation organisation;

(20) ‘international standard’ means a standard adopted by an international

standardisation body;

(21) ‘international standardisation body’ means the International Organization for

Standardization (ISO), the International Electrotechnical Commission (IEC) or

the International Telecommunication Union (ITU).

Chapter 2

Principles of European standardisation in support of Union

legislation and policies

Article 3

Principles of European standardisation

1. Referenced standards and standardisation deliverables shall be developed in

compliance with this Regulation and in line with international good practices and

principles for the development, adoption and use of standards and standardisation

deliverables including the principles of openness, transparency, consensus,

technological neutrality and inclusiveness.

2. Referenced standards and standardisation deliverables and common specifications

shall take into account the economic and public interests and the objectives of Union

legislation and policies which they are supporting, in particular economic

competitiveness, innovation, societal needs, including climate and environmental

sustainability, health and safety, security and economic security.

Article 4

Transparency of the development of requested standards and standardisation

deliverables

European standardisation organisations and designated standards development organisations

shall make public on their website, for each requested standard and standardisation

deliverable:

(a) the list of organisations and stakeholders participating in their technical bodies

tasked with its development, revision or amendment;

(b) the interests that those organisations and stakeholders represent.

Article 5

Access to referenced standards and standardisation deliverables

1. European standardisation organisations and designated standards development

organisations shall provide unrestricted free online access to referenced standards

EN 36 EN

and standardisation deliverables, including any amendments, corrigenda and

referenced revisions thereof, in any languages that are authentic for such referenced

standards and standardisation deliverables.

2. European standardisation organisations and designated standards development

organisations shall ensure that referenced standards and standardisation deliverables

are available in a readable, searchable, printable, and electronically accessible format

and that they remain continuously available to the public, even after their references

have been withdrawn from the Official Journal of the European Union.

3. European standardisation organisations and designated standards development

organisations shall ensure that any arrangements concerning referenced standards

and standardisation deliverables do not prevent or restrict compliance with the

obligations laid down in this Article.

Article 6

Digitalisation of standard development

1. European standardisation organisations and designated standards development

organisations shall endeavour to develop requested standards and standardisation

deliverables using digital development tools and in a structured machine-readable

format, suitable for automated processing.

2. European standardisation organisations and designated standards development

organisations shall ensure the technical and semantic interoperability of the machine-

readable formats of requested standards and standardisation deliverables and of their

associated metadata.

Article 7

EU Standards Platform

1. The Commission shall establish, manage and maintain a digital platform (the ‘EU

Standards Platform’) to:

(a) list the referenced standards and standardisation deliverables, as well as

common specifications;

(b) inform users on how to access referenced standards and standardisation

deliverables pursuant to Article 5;

(c) provide information on standardisation requests and the status of their

implementation;

(d) provide information on the performance of the European standardisation

system;

(e) provide other relevant information regarding the European standardisation

system.

2. European standardisation organisations and designated standards development

organisations shall make available to the Commission, in a timely, structured and

machine-readable manner, the relevant information on their standardisation activities

under this Regulation.

EN 37 EN

Article 8

Union financing of the European standardisation system

1. The Union and the Member States may contribute to the financial sustainability of

the European standardisation system, including the standardisation activities of the

European standardisation organisations and national standardisation bodies to

develop requested standards and standardisation deliverables, as well as to the

financing of other standardisation activities in support of Union objectives.

2. The Union may grant financial support to any of the following bodies in accordance

with the objectives and conditions of the relevant Union funding programmes:

(a) European standardisation organisations;

(b) designated standards development organisations;

(c) European stakeholder organisations;

(d) national standardisation bodies.

3. By 31 March each year, European standardisation organisations shall provide the

Commission with the relevant information on their financial sustainability linked to

their activities for requested standards and standardisation deliverables.

Article 9

Annual Union work programme on European standardisation

1. Each year, the Commission shall adopt a work programme on European

standardisation.

2. The annual Union work programme referred to in paragraph 1 shall contain the

following information:

(a) the new standardisation requests that the Commission intends to adopt in the

following year;

(b) the standardisation areas for which the Commission may adopt standardisation

requests in the following years, notably based on the Commission’s work

programme and relevant Union strategies;

(c) the policy areas requiring pre-normative work, notably based on the Union

research and innovation priorities;

(d) any additional information relevant to identifying strategic priorities for

European standardisation.

3. In cases of urgency, the Commission may adopt standardisation requests without

prior indication in the annual Union work programme referred to in paragraph 1.

4. Before adopting the annual Union work programme referred to in paragraph 1, the

Commission shall publish the draft annual Union work programme on the EU

Standards Platform. Member States, the European standardisation organisations,

designated standards development organisations, European stakeholder

organisations, industry and research and innovation stakeholders may provide their

opinion within one month following the publication of the draft annual Union work

programme.

EN 38 EN

Chapter 3

Standards and standardisation deliverables from European

standardisation organisations

SECTION 1

EUROPEAN STANDARDISATION ORGANISATIONS

Article 10

Designation of the European standardisation organisations

1. The European standardisation organisations are listed in Annex I.

2. The Commission is empowered to adopt delegated acts in accordance with Article 39

to amend Annex I to designate new European standardisation organisations or to

withdraw a European standardisation organisation.

3. The Commission may designate a European standardisation organisation if it meets

all of the following requirements:

(a) it is established in the Union;

(b) it has at least one national standardisation body of each Member State among

its members;

(c) it is able to comply with the requirements set out in this Regulation.

4. The Commission may withdraw a European standardisation organisation from Annex

I where:

(a) it no longer complies with the requirements set out in this Regulation; or

(b) based on the monitoring of the key performance indicators referred to in

Article 13, it no longer ensures a sufficient level of performance in

implementing this Regulation.

Article 11

National standardisation bodies

1. Each Member State shall appoint at least one national standardisation body

established in the Union and shall ensure that at least one national standardisation

body is a member of each European standardisation organisation.

2. Member States shall inform the Commission of the national standardisation bodies

they have appointed, indicating the European standardisation organisations of which

they are a member. They shall inform the Commission without delay of any changes

to the appointed national standardisation bodies.

3. The Commission shall publish and maintain the list of national standardisation

bodies, indicating the European standardisation organisations of which they are a

member, on the EU Standards Platform.

4. Member States shall ensure that national standardisation bodies comply with their

obligations under this Regulation.

EN 39 EN

Article 12

European decision-making for requested standards and standardisation deliverables

Irrespective of other advisory opinions, each European standardisation organisation shall

ensure that all of the following decisions concerning requested standards and standardisation

deliverables are taken exclusively by representatives of the national standardisation bodies

within the competent decision-making body of that organisation:

(a) decisions on the acceptance and refusal of a standardisation request;

(b) decisions on the acceptance of new work items needed for fulfilling a

standardisation request;

(c) decisions on the adoption, revision, amendment, and withdrawal of requested

standards and standardisation deliverables.

Article 13

Key performance indicators and performance management of European

standardisation organisations

1. The Commission shall monitor the performance of the European standardisation

organisations relating to the implementation of this Regulation on the basis of key

performance indicators supporting the regular assessment of the following:

(a) the speed and timeliness of European standardisation organisations to deliver

requested standards and standardisation deliverables;

(b) the quality of the requested standards and standardisation deliverables

delivered by European standardisation organisations;

(c) the inclusiveness of the standardisation process of European standardisation

organisations for requested standards and standardisation deliverables;

(d) the cooperation between European standardisation organisations and national

standardisation bodies;

(e) the international influence of the European standardisation system;

(f) any other elements relevant for evaluating the performance of the European

standardisation organisations.

2. The Commission, after consulting the European standardisation organisations, shall

adopt, by means of implementing acts in accordance with the advisory procedure

referred to in Article 40(2), and publish, on the EU Standards Platform, the target

value, the frequency and the methodology for the calculation of the key performance

indicators referred to in paragraph 1 of this Article.

3. The Commission and the European standardisation organisations shall ensure that the

values of the key performance indicators referred to in paragraph 2 are made public

and regularly updated on the EU Standards Platform.

4. Each European standardisation organisation shall send an annual report on the

implementation of this Regulation to the Commission by 31 January each year,

covering the preceding calendar year. In that report, they shall provide details on the

key performance indicators established in accordance with paragraph 2. Each

European standardisation organisation shall publish its report on its website each

year.

EN 40 EN

5. The Commission and European standardisation organisations shall hold a high-level

structural dialogue meeting at least twice a year, to review the key performance

indicators and to foster performance and cooperation between the Commission and

the European standardisation organisations.

Article 14

Cooperation between the Commission and the European standardisation organisations

1. The Commission and the European standardisation organisations shall cooperate

closely and in a spirit of sincere cooperation as regards the preparation,

implementation and assessment of standardisation requests.

2. The cooperation shall be based on transparency, the timely exchange of information

and appropriate consultation between the Commission and the European

standardisation organisations.

3. European standardisation organisations shall allow for the participation of the

Commission in their governance decision bodies and in their technical bodies.

Article 15

Transparency of work programmes of European standardisation organisations and

national standardisation bodies

1. At least once a year, each European standardisation organisation and each national

standardisation body shall adopt its work programme. That work programme shall

contain information on the standards and standardisation deliverables which the

European standardisation organisation or national standardisation body intends to

develop, revise or amend, is developing, revising or amending, or has adopted,

revised or amended during the period of the preceding work programme, except

where those standards or standardisation deliverables are transpositions of European

standards or European standardisation deliverables.

2. The work programme shall indicate for each standard and each standardisation

deliverable:

(a) the subject matter;

(b) the stage of the development of the standard or standardisation deliverables;

(c) the expected date for their adoption;

(d) the Union legislation or policies which the standard or standardisation

deliverable supports, where relevant;

(e) the references of any international standards on which the standard or

standardisation deliverable is based, where relevant.

3. Each European standardisation organisation and each national standardisation body

shall make its work programme available on its website or any other publicly

available website.

4. Each European standardisation organisation and national standardisation body shall,

without delay, notify the other European standardisation organisations, the national

standardisation bodies and the Commission of the publication of its work

programme.

EN 41 EN

5. National standardisation bodies shall not object to a subject for standardisation in

their work programme being considered at European level by the European

standardisation organisations and shall not undertake any action which could

prejudice a decision in that regard.

6. During the development of the requested standards and standardisation deliverables,

national standardisation bodies shall not take any action which could prejudice the

intended harmonisation and, in particular, shall not publish new, revised or amended

national standards or standardisation deliverables in the field in question.

Article 16

Transparency of development of standards by European standardisation organisations

and national standardisation bodies

1. Each European standardisation organisation and national standardisation body shall

send, in electronic form, any draft requested standards and standardisation

deliverables, European standards, European standardisation deliverables and national

standards to other European standardisation organisations, national standardisation

bodies or the Commission, upon their request.

2. Each European standardisation organisation and national standardisation body shall

take due account of any comments received from other European standardisation

organisations, national standardisation bodies or the Commission with respect to

drafts referred to in paragraph 1 and reply to those comments within three months

from the date of their receipt.

3. When a national standardisation body receives comments indicating that the draft

standard or standardisation deliverable would have a negative impact on the internal

market, it shall consult the European standardisation organisations and the

Commission before it decides whether to adopt it.

4. National standardisation bodies shall:

(a) ensure access to draft national standards in such a way that all relevant parties

in particular those established in other Member States have the opportunity to

submit their comments;

(b) allow other national standardisation bodies to send an observer in the planned

activities.

5. After the Commission has published the reference of a requested standard in

accordance with Article 25 or Article 31, national standardisation bodies shall

withdraw all national standards that conflict with the referenced standard within a

reasonable timeframe and shall not publish any new national standards which are not

in line with the referenced standard.

SECTION 2

INCLUSIVENESS AND STAKEHOLDER PARTICIPATION

Article 17

Stakeholder participation in European standardisation

1. The European standardisation organisations shall enable the appropriate

representation and effective participation of all relevant stakeholders, including

EN 42 EN

SMEs, consumer organisations, environmental and social stakeholders, research and

innovation stakeholders as well as public authorities, in their standardisation

activities.

2. The European standardisation organisations shall encourage and facilitate the

appropriate representation at technical level of undertakings, research and innovation

stakeholders, including open-source organisations, and shall promote their awareness

as regards standardisation processes.

3. The European standardisation organisations shall collaborate with public authorities,

in particular with market surveillance authorities in Member States.

Article 18

European stakeholder organisations

1. The Commission shall designate as European stakeholder organisations one

European organisation representing SMEs, one European organisation representing

consumers, one European organisation representing environmental interests and one

European organisation representing social interests. The Commission shall designate

European stakeholder organisations which meet the criteria set out in Annex II by

means of implementing acts following an open, non-discriminatory and transparent

process. The designation shall take place at least every four years.

2. The European stakeholder organisations designated in accordance with paragraph 1

shall participate in the standardisation activities of the European standardisation

organisations and of the designated standards development organisations in support

of Union legislation and policies relevant to the interests they represent to ensure that

those interests are duly taken into account in the development of requested standards

and standardisation deliverables.

3. The European standardisation organisations shall facilitate the effective

representation and participation of European stakeholder organisations in all of the

following stages of the development of requested standards or standardisation

deliverables relevant to the interests they represent:

(a) the proposal and acceptance of new work items;

(b) technical discussions on proposals;

(c) the submission of comments on drafts standards and standardisation

deliverables;

(d) the revision and amendment of existing referenced standards and

standardisation deliverables.

4. The European stakeholder organisations shall ensure the dissemination of

information and awareness-building towards the stakeholders they represent on the

development, adoption, revision and amendment of requested standards and

standardisation deliverables, relevant to the interests they represent.

5. The European stakeholder organisations shall send an annual report on their activities

to the Commission by 31 January each year. This report shall contain detailed

information about the membership of such organisations and the activities

undertaken by them pursuant to paragraphs 2, 3 and 4.

EN 43 EN

Article 19

Participation of the Commission’s research facilities and Union agencies in European

standardisation

1. The Commission’s research facilities and relevant Union agencies may provide the

European standardisation organisations with scientific and technical input in their

areas of expertise, to ensure that European standards and European standardisation

deliverables promote innovation uptake and valorisation of European research and

innovation results.

2. The European standardisation organisations shall facilitate cooperation with the

Commission’s research facilities and with relevant Union agencies in the

development of European standards and European standardisation deliverables,

including by allowing free participation in their technical bodies and providing them

with free access to such standards and standardisation deliverables, as well as to

preparatory and explanatory documents.

Article 20

Stakeholder participation in national standardisation

1. National standardisation bodies shall enable effective participation of all relevant

stakeholders, including SMEs, consumer organisations, environmental and social

stakeholders, research and innovation stakeholders, as well as public authorities in

their standardisation activities.

2. National standardisation bodies shall ensure for SMEs, consumer organisations,

environmental and social stakeholders, research and innovation stakeholders as well

as public authorities all of the following:

(a) identifying, in their annual work programmes, the standardisation projects,

which are of particular interests to those stakeholders;

(b) granting access to standardisation activities, without obliging them to become

members of a national standardisation body;

(c) granting free access to participate in their standardisation activities, or allow

for such participation under reduced rates;

(d) granting free access to draft standards and standardisation deliverables;

(e) applying reduced rates for the provision of standards and standardisation

deliverables and for other services provided by national standardisation bodies

to facilitate the use of standards and standardisation deliverables.

Article 21

Participation of national public authorities in European standardisation

Member States shall, where appropriate, encourage the participation of public authorities,

including market surveillance authorities, in national standardisation activities aimed at the

development, revision or amendment of requested standards and standardisation deliverables.

EN 44 EN

SECTION 3

STANDARDISATION REQUESTS TO EUROPEAN STANDARDISATION

ORGANISATIONS

Article 22

Consultation of European standardisation organisations

1. Where the Commission services have identified the need for a standard or

standardisation deliverable, they shall first consult, by any appropriate means, the

European standardisation organisations on their ability to accept a standardisation

request on the standardisation need and to develop quality standards or

standardisation deliverables on time.

2. The consultation referred to in paragraph 1 may cover:

(a) the existence and maturity of relevant international, European or national

standardisation processes;

(b) the capacity and preparedness of the European standardisation organisations to

deliver the standard or standardisation deliverable within a set timeframe;

(c) the expected duration of the standardisation process;

(d) the expected stakeholder participation and inclusiveness of the standardisation

process;

(e) the relevance, quality and market uptake of existing technical specifications or

standards;

(f) the expected availability of the technical expertise and resources necessary for

the development of the standard or standardisation deliverable and the

possibility to restrict participation during the development process of such

standards or standardisation deliverables;

(g) any other information that the Commission may find relevant to assess the

ability of European standardisation organisations to develop quality standard or

standardisation deliverable to address the standardisation need.

3. The relevant European standardisation organisations shall reply within one month of

receipt of the consultation.

4. The Commission shall assess the response referred to in paragraph 3 of this Article,

or lack thereof, and based on that assessment, may:

(a) issue a standardisation request to one or more European standardisation

organisations in accordance with Article 23;

(b) issue a standardisation request to one or more designated standards

development organisations in accordance with Article 29;

(c) adopt common specifications in accordance with Article 32.

Article 23

Standardisation requests to European standardisation organisations

1. The Commission may address a standardisation request to one or more European

standardisation organisations to develop, revise or amend European standards or

EN 45 EN

European standardisation deliverables to be referenced in the Official Journal of the

European Union. The Commission shall adopt the standardisation request by means

of implementing acts.

2. The standardisation request shall contain all of the following:

(a) the requirements regarding the content to be met by the requested standards or

standardisation deliverables;

(b) a deadline for the delivery of each requested standard or standardisation

deliverable;

(c) a date of expiry.

3. The standardisation request may:

(a) specify the intended legal effect of the requested standards or standardisation

deliverables;

(b) specify the steps to be taken for the timely delivery of the requested standards

or standardisation deliverables;

(c) specify requirements for the cooperation between the European standardisation

organisations to which the standardisation request is addressed;

(d) specify requirements for the participation of targeted stakeholders in the

standardisation process;

(e) require the European standardisation organisations to take into account

identified existing technical specifications or standards;

(f) specify requirements for periodic revisions of the requested standards or

standardisation deliverables;

(g) require the delivery of harmonised standardisation deliverables as a step

towards harmonised standards;

(h) restrict participation in the standardisation process of requested standards or

standardisation deliverables related to Union strategic assets, interests,

autonomy or security to representatives of legal entities which are established

in Member States and have their executive management structures in the

Union, and are not subject to control by a third country or a legal entity

established in a third country, or to entities established in third countries that

effectively meet the interests of the Union;

(i) set specific requirement for the cooperation between European standardisation

organisations and international standardisation bodies, including requirements

related to the exception referred to in Article 35(2);

(j) specify any other requirements which the Commission may find necessary for

the development of the requested standards and standardisation deliverables.

4. Before adopting a standardisation request, the Commission shall publish the draft

standardisation request on the EU Standards Platform, except in justified cases or

where it intends to amend a standardisation request as regards the deadlines for the

delivery of requested standards or standardisation deliverables, the expiry date set

out in the standardisation request, or the clarification of the requirements to be met.

The European standardisation organisations, the European stakeholder organisations

and European sectoral experts may provide their opinions on the request within one

month following the publication of the draft standardisation request.

EN 46 EN

5. The Commission shall endeavour to adopt the implementing act referred to in

paragraph 1 within 12 months from the date of receipt of the response to the

consultation referred to in Article 22(3) and within three months from the end of the

consultation referred to in paragraph 4 of this Article.

6. By way of derogation to paragraph 5 of this Article, where the standardisation

request specifies requirements referred to in paragraph 3, points (g) to (i), of this

Article, the Commission shall adopt the implementing act referred to in paragraph 1

of this Article in accordance with the examination procedure referred to in Article

40(3). The Commission shall endeavour to submit the draft implementing act to the

vote of the committee referred to in Article 40(1) within 12 months from the date of

receipt of the response to the consultation referred to in Article 22(4) and within six

months from the end of the consultation referred to in paragraph 4 of this Article.

7. The relevant European standardisation organisations shall indicate whether they

accept the standardisation request within one month from the date of its notification.

The Commission shall make available the adopted standardisation request on the EU

Standards Platform and indicate on that Platform whether and which European

standardisation organisations have accepted it.

Article 24

Implementation of standardisation requests addressed to European standardisation

organisations

1. Where one or more European standardisation organisations have accepted a

standardisation request, they shall regularly report to the Commission on the

activities they have undertaken and the progress they have achieved in developing

the requested standards and standardisation deliverables to deliver them within the

deadlines set out in the standardisation request.

2. The European standardisation organisations shall provide the Commission with all

draft documents circulated for public comments or scrutiny, and relevant normative

references, and upon request any documents drafted in response to a standardisation

request. The Commission may provide its comments on the draft requested standards

and standardisation deliverables. The European standardisation organisations shall

take due account of the Commission’s comments on those draft documents to

promote compliance in view of the assessment by the Commission referred to in

Article 25(2).

Article 25

Assessment of requested standards and standardisation deliverables delivered by

European standardisation organisations

1. The European standardisation organisations shall deliver the requested standards or

standardisation deliverables to the Commission as soon as they are adopted and by

the deadline for their delivery set out in the standardisation request.

2. The Commission shall assess, with the support of the European standardisation

organisations, within six months of their delivery, the compliance of the delivered

standards or standardisation deliverables with the standardisation request and with

the requirements set out in the relevant Union legislation, or, where appropriate, with

the objectives of the relevant Union policies.

EN 47 EN

3. Where a requested standard or standardisation deliverable appropriately complies

with the standardisation request and satisfies the requirements, set out in the relevant

Union legislation, which it aims to cover, or, where appropriate, the objectives of the

relevant Union policies, the Commission shall publish its reference in the Official

Journal of the European Union eitherby means of implementing acts under this

Regulation or by other means as provided for in the relevant Union legislation. The

Commission shall endeavour to publish the reference of such a standard or

standardisation deliverable within three months from the date of the positive outcome

of the assessment referred to in paragraph 2.

4. Where a requested standard or standardisation deliverable appropriately complies

with the standardisation request and partially satisfies the requirements, set out in the

relevant Union legislation, which it aims to cover, the Commission may publish its

reference with restrictions in the Official Journal of the European Union either by

means of implementing acts under this Regulation or by other means as provided for

in the relevant Union legislation.

5. Where a requested standard or standardisation deliverable does not satisfy the

requirements, set out in the relevant Union legislation, which it aims to cover, or,

where appropriate, the objectives of the relevant Union policies, or does not

appropriately comply with the standardisation request, the Commission shall inform

the European standardisation organisations within six months from the date of the

delivery of that standard or standardisation deliverable, except in duly justified cases.

6. The European standardisation organisations shall notify the Commission without

delay when they engage in the process of revising or amending a referenced standard

or standardisation deliverable. Where the standardisation request has not expired at

the moment of delivery of the revised or amended standard or standardisation

deliverable, the Commission shall publish the reference to that standard or

standardisation deliverable in the Official Journal of the European Union either by

means of implementing acts under this Regulation, or by other means as provided for

in the relevant Union legislation. In this regard, it shall publish the reference without

the need to adopt a new standardisation request or amend the corresponding

standardisation request, if the changes to the referenced standard or standardisation

deliverable appropriately comply with the standardisation request and satisfy the

requirements, set out in the relevant Union legislation, which it aims to cover or,

where appropriate, the objectives of the relevant Union policies.

7. Where a reference of a harmonised standard has been published in the Official

Journal of the European Union in accordance with paragraph 3, the reference of the

corresponding harmonised standardisation deliverable shall be withdrawn.

8. Where the requested standards or standardisation deliverables have not been

delivered within the deadline set out in the standardisation request, the Commission

has deemed them to be non-compliant in accordance with paragraph 5 of this Article,

or it has deemed the steps referred to in Article 23(3), point (b), not to have been

appropriately taken, it may take any of the following decisions:

(a) amend the standardisation request to the European standardisation

organisation;

(b) repeal the standardisation request to the European standardisation organisation

and issue a standardisation request to one or more standards development

organisations in accordance with Article 29;

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(c) adopt common specifications in accordance with Article 32.

Chapter 4

Other standardisation processes and safeguard mechanisms

SECTION 1

STANDARDISATION REQUESTS TO DESIGNATED STANDARDS DEVELOPMENT

ORGANISATIONS

Article 26

Designation of standards development organisations

1. The Commission may, by means of implementing acts adopted in accordance with

the examination procedure referred to in Article 40(3), designate a standards

development organisation which may be requested to develop, revise or amend

standards and standardisation deliverables in accordance with Article 29.

2. The Commission may only designate, in accordance with paragraph 1 of this Article,

a standards development organisation which is able to ensure that its processes for

the development of standards and standardisation deliverables meet the requirements

set out in Article 27.

3. The Commission may, by means of implementing acts adopted in accordance with

the examination procedure referred to in Article 40(3), withdraw the designation

referred to in paragraph 1 of this Article where the standards development

organisation no longer complies with the requirements laid down in Article 27 or is

otherwise no longer able to effectively serve the interests of the Union.

4. The Commission shall publish the list of designated standards development

organisations on the EU Standards Platform.

Article 27

Requirements for the designated standards development organisations

1. Standards development organisations designated in accordance with Article 26 shall

meet all of the following requirements:

(a) not be an international standardisation body, a national standardisation body or

a standardisation body of a third country that is a member of international

standardisation bodies;

(b) comply with the principles of openness, transparency, neutrality and consensus

as set out in paragraph 2 of this Article;

(c) ensure that their processes for the development of requested standards and

standardisation deliverables meet the requirements set out in paragraph 3 of

this Article.

2. The designated standards development organisations shall ensure all of the

following:

(a) that standards and standardisation deliverables are developed on the basis of

open decision-making procedures that are accessible to all interested parties in

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the markets that are concerned by such standards and standardisation

deliverables;

(b) that their decision-making process is collaborative and consensus based and

does not favour any particular stakeholder;

(c) that their work programmes are transparent.

3. When developing standards and standardisation deliverables requested in accordance

with Article 29, designated standards development organisations shall ensure all of

the following:

(a) that their processes are inclusive, by enabling the effective participation of all

relevant stakeholders, in particular Union stakeholders and the European

stakeholder organisations referred to in Article 18;

(b) that they take due account of Union interests, insofar as those interests are

represented;

(c) that they comply with the requirements set out in this Regulation.

Article 28

Transparency of development of requested standards and standardisation deliverables

by designated standards development organisations

1. Each designated standards development organisation shall send in electronic form

any draft requested standards or standardisation deliverables to European

standardisation organisations upon their request. European standardisation

organisations may send their comments as regards the coherence of the draft

requested standards and standardisation deliverables with their referenced standards

and standardisation deliverables to designated standards development organisations

within one month from the date of receipt of the draft requested standards or

standardisation deliverables.

2. Each designated standards development organisation shall take due account of any

comments received from European standardisation organisations with respect to

drafts referred to in paragraph 1 and reply to those comments within three months

from the date of their receipt.

Article 29

Standardisation requests to designated standards development organisations

1. The Commission may address, by means of implementing acts, a standardisation

request to one or more designated standards development organisations to develop,

revise or amend standards or standardisation deliverables to be referenced in the

Official Journal of the European Union, in any of the following cases:

(a) the European standardisation organisations consulted in accordance with

Article 22 have not replied or have informed the Commission that they do not

intend to accept the standardisation request regarding the standards or

standardisation deliverables;

(b) the Commission deems that, following a consultation under Article 22, the

response given to the points referred to in paragraph 2 of that Article would not

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lead to the timely and quality delivery of the requested standards or

standardisation deliverables;

(c) none of the European standardisation organisations to which the Commission

addressed a request in accordance with Article 23 have accepted it;

(d) the requested standards or standardisation deliverables have not been delivered

within the deadline set out in the standardisation request issued in accordance

with Article 23;

(e) the Commission deems that the steps referred to in Article 23(3), point (b),

have not been appropriately taken;

(f) the Commission deems that the requested standards or standardisation

deliverables are non-compliant in accordance with Article 25(5).

2. The standardisation request shall contain all of the following:

(a) the requirements regarding the content to be met by the requested standards or

standardisation deliverables

(b) a deadline for their delivery;

(c) a set date of expiry.

3. The standardisation request may:

(a) specify the intended legal effect of the requested standards or standardisation

deliverables;

(b) specify the steps to be taken for the timely delivery of the requested standards

or standardisation deliverables;

(c) specify requirements for the cooperation between the designated standards

development organisations to which the standardisation request is addressed;

(d) specify requirements for the participation of targeted stakeholders in the

standardisation process;

(e) require the designated standards development organisations to take into

account identified existing technical specifications or standards;

(f) specify requirements for periodic revisions of the requested standards or

standardisation deliverables;

(g) restrict participation in the standardisation process of requested standards or

standardisation deliverables related to Union strategic assets, interests,

autonomy or security to representatives of legal entities which are established

in Member States and have their executive management structures in the

Union, and are not subject to control by a third country or a legal entity

established in a third country, or to entities in third countries that effectively

meet the interests of the Union;

(h) set specific requirements for the cooperation between designated standards

development organisations and international standardisation bodies, including

requirements related to the exception referred to in Article 35(2);

(i) specify any other requirements which the Commission may find necessary for

the development of the requested standards and standardisation deliverables.

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4. Before adopting a standardisation request, the Commission shall publish the draft

standardisation request on the EU Standards Platform, except in justified cases or

where it intends to amend a standardisation request as regards the deadlines for the

delivery of requested standards or standardisation deliverables, the expiry date set

out in the standardisation request, or the clarification of the requirements to be met.

The designated standards development organisations, the European stakeholder

organisations, European standardisation organisations and European sectoral experts

may provide their opinions within one month following the publication of the draft

standardisation request.

5. The Commission shall adopt the implementing act referred to in paragraph 1 of this

Article in accordance with the examination procedure referred to in Article 40(3).

The Commission shall endeavour to submit the draft implementing act to the vote of

the committee referred to in Article 40(1) within six months from the end of the

consultation referred to in paragraph 4 of this Article.

6. The relevant designated standards development organisations shall indicate whether

they accept the standardisation request within one month from the date of its

notification. The Commission shall make available the adopted standardisation

requests on the EU Standards Platform and indicate on that Platform whether and

which designated standards development organisations have accepted it.

Article 30

Implementation of standardisation requests addressed to designated standards

development organisations

1. Where one or more designated standards development organisations have accepted a

standardisation request, they shall regularly report to the Commission on the

activities they have undertaken and the progress they have achieved in developing

the requested standards and standardisation deliverables to deliver them within the

deadlines set out in the standardisation request.

2. The designated standards development organisations shall provide the Commission

with all draft documents circulated for public comments or scrutiny, and relevant

normative references, and upon request any documents drafted in response to a

standardisation request. The Commission may provide its comments on the draft

requested standards and standardisation deliverables. The designated standards

development organisations shall take due account of the Commission’s comments on

those draft documents to promote compliance in view of the assessment by the

Commission referred to in Article 31(2).

Article 31

Assessment of requested standards and standardisation deliverables delivered by

designated standards development organisations

1. The designated standards development organisations shall deliver the requested

standards or standardisation deliverables to the Commission as soon as they are

adopted and by the deadline for their delivery set out in the standardisation request.

2. The Commission shall assess, with the support of the relevant designated standards

development organisations and the relevant sectoral expert groups, within six months

of their delivery, the compliance of the delivered standards or standardisation

EN 52 EN

deliverables with the standardisation request and with the requirements set out in the

relevant Union legislation, or, where appropriate, with the objectives of the relevant

Union policies, and the coherence of the delivered standards or standardisation

deliverables with other relevant referenced standards or standardisation deliverables.

3. Where a requested standard or standardisation deliverable appropriately complies

with the standardisation request, satisfies the requirements, set out in the relevant

Union legislation, which it aims to cover, or, where appropriate the objectives of the

relevant Union policies, and is coherent with other relevant referenced standards and

standardisation deliverables, the Commission shall publish its reference in the

Official Journal of the European Union either by means of implementing acts under

this Regulation or by other means as provided for in the relevant Union legislation.

The Commission shall endeavour to publish the reference of such a standard or

standardisation deliverable within three months from the date of the positive outcome

of the assessment referred to in paragraph 2.

4. Where a requested standard or standardisation deliverable partially satisfies the

requirements, set out in the relevant Union legislation, which it aims to cover, the

Commission may publish its reference with restrictions in the Official Journal of the

European Union either by means of implementing acts under this Regulation or by

other means as provided for in the relevant Union legislation.

5. Where a requested standard or standardisation deliverable does not satisfy the

requirements, set out in the relevant Union legislation, which it aims to cover, or,

where appropriate, with the objectives of the relevant Union policies, does not

appropriately comply with the standardisation request, or is not coherent with other

relevant referenced standards and standardisation deliverables, the Commission shall

inform the relevant designated standards development organisations within six

months from the date of the delivery of that standard or standardisation deliverable,

except in duly justified cases.

6. The designated standards development organisations shall notify the Commission

without delay when they engage in the process of revising or amending a referenced

standard or standardisation deliverable. Where the standardisation request has not

expired at the moment of adoption of the revised or amended standard or

standardisation deliverable, the Commission shall publish the reference to that

standard or standardisation deliverable in the Official Journal of the European Union

either by means of implementing acts under this Regulation or by other means as

provided for in the relevant Union legislation. In this regard, it shall publish the

reference without the need to adopt a new standardisation request or amend the

corresponding standardisation request, if the changes to the referenced standard or

standardisation deliverable appropriately comply with the standardisation request,

satisfy the requirements, set out in the relevant Union legislation, which it aims to

cover, or, where appropriate, the objectives of the relevant Union policies, and are

coherent with other relevant referenced standards and standardisation deliverables.

7. Where the requested standards or standardisation deliverables have not been

delivered within the deadline set out in the standardisation request, the Commission

has deemed them to be non-compliant in accordance with paragraph 5 of this Article,

or the Commission has deemed the steps referred to in Article 29(3), point (b), not to

have been appropriately taken, it may take any of the following decisions:

(a) repeal or amend the standardisation request to the relevant designated standards

development organisation;

EN 53 EN

(b) adopt common specifications in accordance with Article 32.

SECTION 2

COMMON SPECIFICATIONS AND SAFEGUARD MECHANISMS

Article 32

Common specifications

1. The Commission may adopt implementing acts establishing common specifications

that provide presumption of conformity with the requirements set out in the relevant

Union legislation.

2. The Commission may adopt the implementing act referred to in paragraph 1 of this

Article where:

(a) the European standardisation organisations consulted in accordance with

Article 22 have not replied or have informed the Commission that they do not

intend to accept the standardisation request regarding the standards or

standardisation deliverables;

(b) the Commission deems that, following the consultation under Article 22, the

response given to the points referred to in paragraph 2 of that Article would not

lead to the timely and quality delivery of the requested standards or

standardisation deliverables; or

(c) the Commission has withdrawn the reference to a harmonised standard in

accordance with Article 33.

3. The Commission may adopt the implementing act referred to in paragraph 1 of this

Article, where it has adopted a standardisation request covering the requirements

referred to in paragraph 1 of this Article in accordance with Article 23 or 29, where

there is no harmonised standard covering the requirements referred to in paragraph 1

of this Article and no such harmonised standard is expected to be referenced within a

reasonable period, and where any of the following conditions is met:

(a) none of the European standardisation organisations or designated standards

development organisations to which the Commission addressed a request in

accordance with Article 23 or 29 respectively has accepted it;

(b) the requested standard or standardisation deliverable has not been delivered

within the deadline set out in the standardisation request;

(c) the Commission deems that the steps referred to in Article 23(4), point (b), or

29(3), point (b), have not been appropriately taken;

(d) the Commission deems that the requested standard or standardisation

deliverable is non-compliant in accordance with Article 25(5) or 31(5).

4. The Commission shall adopt the implementing act referred to in paragraph 1 of this

Article in accordance with the examination procedure referred to in Article 5 of

Regulation (EU) 182/2011. For that purpose, the competent committee shall be the

committee referred to in the corresponding Union legislation or, in the absence of

such a committee, the committee referred to in Article 40 in accordance with the

procedure referred to in Article 40(3).

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5. Before preparing the draft implementing act referred to in paragraph 1 of this Article,

the Commission shall inform the committee referred to in Article 40 that it considers

that the conditions referred to in paragraph 2 or 3 of this Article are fulfilled.

6. When preparing the draft implementing act referred to in paragraph 1 of this Article,

the Commission shall take into account the views of the relevant expert groups and

shall duly consult all relevant stakeholders. The Commission may use, where

relevant, the documents referred to in Article 24(2) or 30(2) as a basis for the

implementing act.

7. Where the Commission adopts an implementing act referred to in paragraph 1, it

shall make it available on the EU Standards Platform.

8. Where a standard is adopted following the standardisation request referred to in

paragraph 3 and where a reference to that standard is published in the Official

Journal of the European Union, the Commission shall repeal or amend the

implementing act referred to in paragraph 1, or the parts thereof, which cover the

same requirements as those covered by that standard.

Article 33

Safeguard notification of referenced standards and standardisation deliverables and

common specifications

1. Where a Member State, the European Parliament or the Commission considers that a

referenced standard or standardisation deliverable, or parts thereof, or common

specification, or parts thereof, do not satisfy the requirements, set out in the relevant

Union legislation, which they aim to cover, it shall immediately notify the other

Member States, the European Parliament, and the Commission, where applicable,

and include a detailed explanation to them.

2. If a Member State, the European Parliament or the Commission has not objected to

the notification referred to in paragraph 1 within one month following its receipt, the

Commission shall decide within six months from the notification referred to in

paragraph 1 whether to maintain with restrictions or withdraw the reference to that

standard or standardisation deliverable from the Official Journal of the European

Union either by means of implementing acts under this Regulation, or by other

means as provided for in the relevant Union legislation, or to amend or repeal the

common specification.

3. If a Member State, the European Parliament or the Commission has objected to the

notification within one month following its receipt, the Commission shall consult the

notifier and the objecting parties, assess the information received and decide within

12 months from the notification referred to in paragraph 1, whether to maintain, to

maintain with restrictions or to withdraw the reference to that standard or

standardisation deliverable from the Official Journal of the European Union either

by means of implementing acts under this Regulation, or by other means as provided

for in the relevant Union legislation, or to maintain, amend or repeal the common

specification.

Article 34

Withdrawal of referenced standards or standardisation deliverables

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The European standardisation organisations and designated standards development

organisations shall notify the Commission when they engage in the process of withdrawing a

referenced standard or standardisation deliverable. The Commission may withdraw the

reference of such a standard or standardisation deliverable from the Official Journal of the

European Union either by means of implementing acts under this Regulation or by other

means as provided for in the relevant Union legislation.

Chapter 5

Measures to improve Union coordination in international

standardisation

Article 35

International first principle and cooperation with international standardisation bodies

1. Where international standards exist or their completion is imminent, European

standardisation organisations and designated standards development organisations

shall use them, or the relevant parts thereof, as a basis for the requested standards and

standardisation deliverables that they develop.

2. If the Commission considers that an existing or draft international standard, or

relevant parts thereof, is ineffective or inappropriate for the legitimate objective

pursued, it may specify in the standardisation request in accordance with Article

23(3), point (i), or 29(3), point (h), that European standardisation organisations or

designated standards development organisations shall not use an existing or draft

international standard, or the relevant parts thereof, as a basis for the requested

standards and standardisation deliverables.

Article 36

European coordination on international standardisation

1. The Commission, in cooperation with European standardisation organisations, shall

facilitate the exchange of information with and between Member States as regards

international standardisation and shall promote the participation of European experts

in international standardisation.

2. Member States and European standardisation organisations shall regularly inform the

Commission of relevant developments in their international standardisation activities.

Article 37

Cooperation with other standards development organisations

1. European standardisation organisations and designated standards development

organisations shall inform and consult the Commission before they enter into an

agreement with a standards development organisation which affect their

standardisation activities undertaken in support of Union legislation and policies.

They shall notify the Commission without delay of any amendment, renewal,

suspension or termination of such agreements.

2. European standardisation organisations and designated standards development

organisations shall promote requested standards and standardisation deliverables

when they participate in the work of other standards development organisations.

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Chapter 6

Governance, delegated powers and committee procedures

Article 38

Centre of Excellence on European Standardisation

1. The Centre of Excellence on European Standardisation within the Commission shall

have the following tasks:

(a) coordinate the implementation of this Regulation by the Commission;

(b) promote the cooperation between the Commission and European

standardisation organisations;

(c) foster the performance of the European standardisation system, including the

contribution of European stakeholder organisations;

(d) identify standards development organisations active in areas identified in the

annual Union work programme on European standardisation, monitor their

activities and assess whether they meet the requirements set out in Article 27;

(e) coordinate the participation of sectoral experts from the Commission, the

relevant Union agencies and the Member States in standardisation activities

related to Union legislation and policies;

(f) improve coordination across European standardisation actors in international

standardisation activities;

(g) promote the integration of the Union’s research and innovation policies with

standardisation activities, and the development of education and skills on

standardisation within the Union;

(h) coordinate the development of pre-normative specifications in areas of public

relevance and support the elaboration of common specifications.

Article 39

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the

conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 10(2) is conferred on the

Commission for an indeterminate period of time from [OP: insert date of entry into

force of this Regulation].

3. The delegation of power referred to in Article 10(2) may be revoked at any time by

the European Parliament or by the Council. A decision to revoke shall put an end to

the delegation of the power specified in that decision. It shall take effect the day

following the publication of the decision in the Official Journal of the European

Union or at a later date specified therein. It shall not affect the validity of any

delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by

each Member State in accordance with the principles laid down in the

Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

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5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to

the European Parliament and to the Council.

6. Delegated acts adopted pursuant to Article 10(2) shall enter into force only if no

objection has been expressed either by the European Parliament or by the Council

within a period of two months of notification of those acts to the European

Parliament and to the Council or if, before the expiry of that period, the European

Parliament and the Council have both informed the Commission that they will not

object. That period shall be extended by two months at the initiative of the European

Parliament or of the Council.

Article 40

Committee procedure

1. The Commission shall be assisted by a committee. That committee shall be a

committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No

182/2011 shall apply.

3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No

182/2011 shall apply.

Article 41

Evaluation and review

1. By [OP: insert date of entry into force of this Regulation + five years] and every five

years thereafter, the Commission shall present a report to the European Parliament

and to the Council on the implementation of this Regulation.

2. By [OP: insert date of application of this Regulation + five years], the Commission

shall carry out an evaluation of this Regulation and present a report on the main

findings to the European Parliament and the Council.

Chapter 7

Final provisions

Article 42

Repeal

1. Regulation (EU) No 1025/2012 is repealed. References to the repealed Regulation

shall be construed as references to this Regulation and shall be read in accordance

with the correlation table in Annex III to this Regulation

2. Article 48 of Regulation (EU) of 2023/988 of the European Parliament and of the

Council is repealed.

Article 43

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in

the Official Journal of the European Union.

EN 58 EN

It shall apply from [OP: insert date of entry into force + six months].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg,

For the European Parliament For the Council

The President The President

[...] [...]

EN 1 EN

LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE ................................................. 3

1.1. Title of the proposal/initiative ...................................................................................... 3

1.2. Policy area(s) concerned .............................................................................................. 3

1.3. Objective(s) .................................................................................................................. 3

1.3.1. General objective(s) ..................................................................................................... 3

1.3.2. Specific objective(s) ..................................................................................................... 3

1.3.3. Expected result(s) and impact ...................................................................................... 3

1.3.4. Indicators of performance ............................................................................................ 3

1.4. The proposal/initiative relates to: ................................................................................. 4

1.5. Grounds for the proposal/initiative .............................................................................. 4

1.5.1. Requirement(s) to be met in the short or long term including a detailed timeline for

roll-out of the implementation of the initiative ............................................................ 4

1.5.2. Added value of EU involvement (it may result from different factors, e.g.

coordination gains, legal certainty, greater effectiveness or complementarities). For

the purposes of this section 'added value of EU involvement' is the value resulting

from EU action, that is additional to the value that would have been otherwise

created by Member States alone. ................................................................................. 4

1.5.3. Lessons learned from similar experiences in the past .................................................. 4

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments ....................................................................................... 5

1.5.5. Assessment of the different available financing options, including scope for

redeployment ................................................................................................................ 5

1.6. Duration of the proposal/initiative and of its financial impact .................................... 6

1.7. Method(s) of budget implementation planned ............................................................. 6

2. MANAGEMENT MEASURES................................................................................... 8

2.1. Monitoring and reporting rules .................................................................................... 8

2.2. Management and control system(s) ............................................................................. 8

2.2.1. Justification of the budget implementation method(s), the funding implementation

mechanism(s), the payment modalities and the control strategy proposed .................. 8

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them............................................................................................................ 8

2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio between

the control costs and the value of the related funds managed), and assessment of the

expected levels of risk of error (at payment & at closure) ........................................... 8

2.3. Measures to prevent fraud and irregularities ................................................................ 9

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE ............ 10

3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s)

affected ....................................................................................................................... 10

EN 2 EN

3.2. Estimated financial impact of the proposal on appropriations ................................... 12

3.2.1. Summary of estimated impact on operational appropriations.................................... 12

3.2.1.1. Appropriations from voted budget ............................................................................. 12

3.2.2. Estimated output funded from operational appropriations......................................... 22

3.2.3. Summary of estimated impact on administrative appropriations ............................... 24

3.2.3.1. Appropriations from voted budget .............................................................................. 24

3.2.3.2. Total appropriations ................................................................................................... 24

3.2.4. Estimated requirements of human resources.............................................................. 25

3.2.4.1. Financed from voted budget....................................................................................... 25

3.2.4.2. Total requirements of human resources ..................................................................... 26

3.2.5. Overview of estimated impact on digital technology-related investments ................ 28

3.2.6. Compatibility with the current multiannual financial framework.............................. 28

3.2.7. Third-party contributions ........................................................................................... 28

3.3. Estimated impact on revenue ..................................................................................... 29

4. DIGITAL DIMENSIONS .......................................................................................... 29

4.1. Requirements of digital relevance .............................................................................. 30

4.2. Data ............................................................................................................................ 30

4.3. Digital solutions ......................................................................................................... 31

4.4. Interoperability assessment ........................................................................................ 31

4.5. Measures to support digital implementation .............................................................. 32

EN 3 EN

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1. Title of the proposal/initiative

Proposal for a Regulation on European standardisation of the European Parliament

and of the Council, repealing Regulation (EU) No 1025/2012 of the European

Parliament and of the Council

1.2. Policy area(s) concerned

Standards policy, Single Market, Industrial Policy

1.3. Objective(s)

1.3.1. General objective(s)

The general objectives pursued by this legislative proposal are:

(a) Fostering global EU competitiveness and technological sovereignty, by

making the European standardisation system faster, more agile, more inclusive and

better coordinated, so that it supports the timely delivery of standards in strategic

areas and reinforces the EU’s role in international standard-setting;

(b) Ensuring the better functioning of the EU Single Market, by increasing the

timely availability of harmonised standards and other standards in support of Union

legislation and policies, thereby reducing divergent national approaches and

facilitating the circulation of compliant products and services across the Union;

(c) Reducing regulatory costs for EU businesses, in particular SMEs, by

improving the accessibility, clarity and usability of harmonised standards, thereby

simplifying conformity assessment and reducing legal uncertainty.

1.3.2. Specific objective(s)

Specific objective No 1

Improving the responsiveness of the European standardisation system: to accelerate

the development and delivery of harmonised standards and other standards in support

of Union legislation and policies by making the system more agile, reducing delays,

and ensuring standards are timely, high-quality and aligned with the state of the art.

Specific objective No 2

Ensuring a financially viable and inclusive European standardisation system: to

maintain a well-functioning and inclusive European standardisation system by

increasing participation from SMEs, civil society and industry experts while ensuring

financial sustainability and providing free access to harmonised standards and

standards in support of Union legislation and policies.

Specific objective No 3

Consolidating the EU’s influence in international standardisation: to strengthen the

EU’s role in global standard-setting by improving coordination among EU actors and

reinforcing strategic autonomy in key sectors.

1.3.3. Expected result(s) and impact

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.

EN 4 EN

The proposal is expected to improve the responsiveness, sustainability and

international influence of the European standardisation system, with positive effects

for the main beneficiary groups, in particular market operators and SMEs.

EU businesses would benefit from faster and more predictable delivery of standards

supporting Union legislation and policy priorities, reducing market fragmentation

and facilitating compliance. SMEs should benefit in particular from greater

transparency, stronger stakeholder participation and better access to standardisation

processes, although their capacity constraints may still limit effective engagement

without targeted support. A more coherent and timely standardisation system would

help firms bring innovative products and services to the Single Market more rapidly,

strengthen legal certainty and reduce costs linked to divergent national approaches.

Consumers are expected to benefit indirectly from standards that better reflect public

policy objectives, notably in safety, accessibility, sustainability and digital trust. This

should reinforce confidence in products and services placed on the Union market and

support a higher level of consumer protection.

European standardisation organisations and national standardisation bodies would

face some adaptation needs, including adjustments to governance, planning and

cooperation practices. At the same time, they would benefit from clearer priorities,

reinforced coordination and a more effective framework for delivering standards in

support of Union legislation and policy objectives.

Overall, the proposal is expected to generate net benefits for targeted groups, while

requiring limited but necessary organisational adjustment within the European

Standardisation System.

1.3.4. Indicators of performance

Specify the indicators for monitoring progress and achievements.

The improved monitoring of the implementation of the Standardisation Regulation

by the Commission is a key dimension of this initiative.

Specific objective No 1

The monitoring of the responsiveness of the European standardisation system will be

conducted through the monitoring of the average time for referencing a harmonised

standard or a standard in support of Union legislation and policies, from the

identification of the standardisation need to the referencing in the Official Journal of

the European Union. The duration of the standardisation process will be assessed at

each step (adoption of the standardisation request, development of the standard and

referencing of the standard). The current benchmark is 6.1 years, and the target is to

reduce the average time needed to reference a standard to 4.0 years on average. The

responsiveness will also be monitored by the quality of delivered standards in

support of Union legislation and policies, as measured by the number of delivered

harmonised standards by European standardisation organisation or standards

development organisations rejected by the Commission after their assessment. The

current proportion is 32 % at publication stage and the target would be set at below

15 %.

Specific objective No 2

The monitoring of the sustainability of the European standardisation system will be

conducted through the engagement of European standardisation organisations in

delivering standards in support of Union legislation or policies, as measured by the

EN 5 EN

share of standardisation requests rejected by European standardisation organisations

and by the share of pre-consultations of European standardisation organisations that

lead to their refusal to engage in the requests. This will be complemented by an

assessment of the level of participation of experts in the standardisation process,

inferred from the total number of experts engaged in EU standardisation activities,

including SME, civil society and R&I experts, as available in the transparency

register set up by European standardisation organisations.

Specific objective No 3

The EU influence on international standardisation will be monitored primarily

through the EU influence in international organisations ISO and IEC, measured by

the number of technical committees chaired by an EU representative, identifying

specifically technical committees active in strategic technologies.

1.4. The proposal/initiative relates to:

☑a new action

a new action following a pilot project / preparatory action1

the extension of an existing action

a merger or redirection of one or more actions towards another/a new action

1.5. Grounds for the proposal/initiative

1.5.1. Requirement(s) to be met in the short or long term including a detailed timeline for

roll-out of the implementation of the initiative

The initiative responds to the need to address the structural shortcomings of the

current European standardisation system by improving its responsiveness, ensuring

more timely and reliable delivery of harmonised standards, improving access and

inclusiveness, safeguarding the sustainability of the system, and strengthening the

Union’s influence in international standardisation.

The initiative should contribute to a more harmonised, effective, efficient and

coherent standardisation framework across the Single Market, supporting EU

competitiveness, technological sovereignty, interoperability, legal certainty and the

implementation of Union legislation and policies.

The initiative should enter into force in 2028 and could be complemented by targeted

changes to relevant sectoral legislation to align them to the new framework for

European standardisation.

1.5.2. Added value of EU involvement (it may result from different factors, e.g.

coordination gains, legal certainty, greater effectiveness or complementarities). For

the purposes of this section 'added value of EU involvement' is the value resulting

from EU action, that is additional to the value that would have been otherwise

created by Member States alone.

Reasons for action at EU level (ex-ante):

Action at Union level is justified because the problems addressed by the initiative are

structural, cross-border and inherent to the functioning of the European

standardisation system and the Single Market. Harmonised standards apply across all

Member States and the EEA and reduce barriers within the internal market by

1 As referred to in Article 58(2), point (a) or (b) of the Financial Regulation.

EN 6 EN

supporting interoperability, value-chain integration and consumer confidence; these

outcomes cannot be secured through isolated national action. In the absence of EU

action, the identified shortcomings would persist, and Member States could develop

divergent national approaches outside the common framework, increasing

fragmentation, barriers to entry and inequalities within the internal market.

Expected generated EU added value (ex-post):

The expected EU added value is a more harmonised, effective, efficient and coherent

outcome across the internal market. The European standardisation system delivers

added value through increased intra-EU and extra-EU trade, reduced compliance

costs, greater inclusiveness and stronger EU influence in international

standardisation compared with national systems. EU action is also expected to

generate economies of scale for businesses and Member States and improve legal

certainty and effectiveness through faster and higher-quality standards supporting

Union legislation and policies.

1.5.3. Lessons learned from similar experiences in the past

Experience under the current Regulation shows that the European standardisation

Regulation adopted in 2012 has produced improvements but remains insufficient to

meet present needs. The targeted revision of the Regulation (EU) 2012/1025

implemented by Regulation (EU) 2022/2480 to reinforce the representation of

national standardisation bodies of the EU in the decision-making process of

European standardisation organisations has highlighted the relevance of introducing

more oversight on the effective participation of national standardisation bodies in the

standardisation process in support of Union legislation and policies. The Omnibus IV

on digitalisation and common specifications has also confirmed the need for a

horizontal and consistent approach to common specifications as fall back to

harmonised standards when they are not available across Union legislation.

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments

The initiative will enter into force under the Multi-annual Financial Framework

(MFF) for 2028-2034. The initiative is compatible with the Union’s financial

programming for the current MFF, and without prejudice to the outcome of

negotiations on the next MFF, would be compatible with the future framework as

proposed by the Commission. Funding opportunities to support the effective

functioning of the internal market through standardisation processes may be

available under the next MFF 2028-2034, including the future Single Market and

Customs Programme, as well as the European Competitiveness Fund and the

Horizon Europe 2028-2034 programme.

1.5.5. Assessment of the different available financing options, including scope for

redeployment

Without prejudice to the outcome of negotiations on the next MFF, the

appropriations foreseen from 2028 onwards are strictly indicative.

As regards financing options, new potential needs, notably to ensure the free and

unrestricted access to standards in support of Union legislation and policies and the

financial sustainability of the European standardisation system, in particular in the

transition phase, may be covered through redeployment of resources used for

standardisation activities, pending their continuation in the next MFF.

EN 7 EN

1.6. Duration of the proposal/initiative and of its financial impact

limited duration

–  in effect from [DD/MM]YYYY to [DD/MM]YYYY

–  financial impact from YYYY to YYYY for commitment appropriations and

from YYYY to YYYY for payment appropriations.

☑unlimited duration

– Implementation with a start-up period from 2028 to 2029,

– followed by full-scale operation.

The Regulation is expected to enter into force in 2028 and remains applicable for an unlimited

duration, with a review after five years of implementation to assess the contribution of the

Regulation to its objectives.

1.7. Method(s) of budget implementation planned2

☑Direct management by the Commission

– ☑by its departments, including by its staff in the Union delegations;

– ☑by the executive agencies

Shared management with the Member States

Indirect management by entrusting budget implementation tasks to:

–  third countries or the bodies they have designated

–  international organisations and their agencies (to be specified)

–  the European Investment Bank and the European Investment Fund

–  bodies referred to in Articles 70 and 71 of the Financial Regulation

–  public law bodies

–  bodies governed by private law with a public service mission to the extent that

they are provided with adequate financial guarantees

–  bodies governed by the private law of a Member State that are entrusted with

the implementation of a public-private partnership and that are provided with

adequate financial guarantees

–  bodies or persons entrusted with the implementation of specific actions in the

common foreign and security policy pursuant to Title V of the Treaty on

European Union, and identified in the relevant basic act

– bodies established in a Member State, governed by the private law of a

Member State or Union law and eligible to be entrusted, in accordance with

sector-specific rules, with the implementation of Union funds or budgetary

guarantees, to the extent that such bodies are controlled by public law bodies or

by bodies governed by private law with a public service mission, and are provided

with adequate financial guarantees in the form of joint and several liability by the

2 Details of budget implementation methods and references to the Financial Regulation may be found on

the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-

implementation/Pages/implementation-methods.aspx.

EN 8 EN

controlling bodies or equivalent financial guarantees and which may be, for each

action, limited to the maximum amount of the Union support.

Comments

The main budget implementation method is direct management by the Commission.

Budget in support of the implementation of this Regulation can also be implemented under

direct management by an Executive Agency.

EN 9 EN

2. MANAGEMENT MEASURES

2.1. Monitoring and reporting rules

The implementation of the Regulation will be primarily monitored through the

performance framework introduced by the Regulation and the key performance

indicators that the Commission will adopt pursuant to Article 11.

All information will be made available on the EU Standard platform created pursuant

to Article 7 to allow the continuous monitoring of the contribution of the Regulation

to its objectives. In addition, European standardisation organisations will report

annually to the Commission on the implementation of the Regulation, as will

European stakeholder organisations.

This Statement concerns staff expenditures and IT investments and operational costs.

Standard rules for this type of expenditure apply.

No later than five years after the entry into force of the Regulation, the Commission

will assess the contribution of this Regulation to the competitiveness of the Union,

the functioning of the internal market, and to the simplification agenda through

reduce compliance costs for businesses, including its contribution to the specific

objectives specified in section 1.3.2.

2.2. Management and control system(s)

2.2.1. Justification of the budget implementation method(s), the funding implementation

mechanism(s), the payment modalities and the control strategy proposed

The management mode for the initiative is direct management by the Commission.

This is the most appropriate approach given the limited scope of Union expenditure

incurred by the Regulation, which mostly consists of standard administrative and

monitoring-related costs. Using established internal procedures ensures effective and

efficient controls, low error rates, fast processing of transactions and minimal control

costs.

The Regulation may also be implemented through direct management making use of

potential funding opportunities under the next 2028-2034 Multiannual Financial

Framework, including the upcoming Single Market and Customs Programme, while

not pre-judging the outcome of the negotiations on the next Multiannual Financial

Framework. Tasks may be implemented by the Commission or by the Executive

Agency under delegation arrangements.

This approach builds on established structures and avoids creating new implementing

bodies or parallel financial procedures. It is considered the most cost-effective

option, as it allows funding to be closely linked to Union policy priorities,

standardisation requests, agreed deliverables and performance indicators.

Payments will follow the modalities laid down in the relevant grant agreements and

contracts, including pre-financing, interim payments where appropriate and payment

of the balance following verification of the deliverables and eligible expenditure.

The control strategy will be based on the Commission’s internal control framework

and the Financial Regulation. It will combine proportionate ex ante operational and

financial checks, performance monitoring and risk-based ex post audits, with the aim

of ensuring legality and regularity, timely contracting and payment, and reasonable

control costs.

EN 10 EN

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them

The initiative requires staff expenditure and IT investment and maintenance

expenditures. Standard rules for this type of expenditure apply.

The main operational risk is insufficient administrative capacity to implement the

activities stipulated in the Regulation, as well as risks concerning delays or non-

delivery of standardisation work.

The financing of the operations of European standardisation organisations and

European stakeholder organisation may create a risk of concentration of funding

among a limited number of beneficiaries. These risks will be mitigated through clear

eligibility and award criteria, defined deliverables, milestones and performance

indicators in grant and contribution agreements, and regular reporting by

beneficiaries. Implementation will be monitored against the agreed performance

framework, allowing delays or underperformance to be identified at an early stage.

The internal control system will combine proportionate ex ante operational and

financial checks, ongoing monitoring and risk-based ex post audits. Payments may

be suspended, reduced or recovered where deliverables are not achieved or

expenditure is not eligible, in accordance with the Financial Regulation.

2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio between

the control costs and the value of the related funds managed), and assessment of the

expected levels of risk of error (at payment & at closure)

The costs of controls will be estimated separately at Commission and Executive

Agency level, based on their internal management and control systems and

experience in implementing the standardisation strand of the Single Market and

Customs Programme. As the Regulation will rely on existing funding mechanisms,

procedures and beneficiaries, control costs are expected to remain proportionate to

the value and risk profile of the funds managed.

Control intensity will be adapted to the type and value of each transaction and the

risks identified. It will include checks on eligibility, procurement procedures,

financial reporting, achievement of milestones and delivery of the agreed

standardisation outputs, complemented by risk-based audits and recovery procedures.

The objective is to maintain the risk of error below 2 % at payment and at closure.

Any errors detected after payment will be corrected through financial corrections,

recoveries or reductions of subsequent payments.

2.3. Measures to prevent fraud and irregularities

The existing fraud-prevention measures applicable to the Commission and the

Executive Agency will cover the expenditure under this Regulation. These include

the Commission Anti-Fraud Strategy, the relevant service-level anti-fraud strategies,

conflict-of-interest and exclusion checks, prevention of double funding, business-

partner screening, risk-based monitoring and audits, and recovery procedures. Grant

agreements and contracts will contain the standard anti-fraud, audit and access

clauses. Suspected fraud or irregularities will be reported to OLAF and, where

relevant, the EPPO. Appropriate ethics and anti-fraud guidance and training will also

be provided to staff involved in managing the funds.

EN 11 EN

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE

3.1. Heading(s) of the multiannual financial framework and expenditure budget

line(s) affected

The estimated impact on expenditure and staffing for 2028 and beyond is added for

illustrative purposes only and does not pre-judge the next Multiannual Financial

Framework. The source of financing and scope of Union financial commitment in the

post-2027 period remain subject to the outcome of interinstitutional negotiations on

the MFF 2028-2034 and thereafter shall be determined through the annual budgetary

procedure. All appropriations and staffing allocations as of 2028 are indicative.

• Existing budget lines

In order of multiannual financial framework headings and budget lines.

Heading of

multiannual

financial

framework

Budget line Type of

expenditure Contribution

Number

Diff./Non-

diff.1

from

EFTA

countries2

from

candidate

countries

and

potential

candidates3

From

other

third

countries

other assigned

revenue

2 Internal market, implementation tools,

market surveillance and European

standardisation

Diff. NO NO NO NO

• New budget lines requested

In order of multiannual financial framework headings and budget lines.

Heading of

multiannual

financial

framework

Budget line Type of

expenditure Contribution

Number

Diff./Non-

diff.

from

EFTA

countries

from

candidate

countries

and

potential

candidates

from

other

third

countries

other assigned

revenue

// // // // // // //

1 Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 2 EFTA: European Free Trade Association. 3 Candidate countries and, where applicable, potential candidates.

EN 12 EN

3.2. Estimated financial impact of the proposal on appropriations

3.2.1. Summary of estimated impact on operational appropriations

–  The proposal/initiative does not require the use of operational appropriations

– ☑ The proposal/initiative requires the use of operational appropriations, as explained below

The proposal is estimated to require the use of operational appropriations that are commensurate to the current budget allocated to standardisation

activities within the Single Market Programme.

The indicative estimate, while not pre-judging the next Multiannual Financial Framework, is EUR 177,575 million over the programming period

2028-2034 at current prices, based on the operational appropriations for standardisation within the Single Market Programme of EUR 23,714

million in 2027.

3.2.1.1. Appropriations from voted budget

EUR million (to three decimal places)

Heading of multiannual financial framework Number 2

DG GROW

Year Year Year Year Year Year Year TOTAL

MFF

2028-

2034 2028 2029 2030 2031 2032 2033 2034

Operational appropriations

Budget line

Internal market, implementation tools,

market surveillance and European

standardisation

Commitments (1a) 23,714 24,188 24,672 25,165 25,669 26,182 26,706 176,297

Payments (2a) p.m. p.m. p.m. p.m. p.m. p.m. p.m. p.m.

Appropriations of an administrative nature financed from the envelope of specific programmes1

Administrative support line of SMCP (3) 00,2130,2130,2130,2130,2130,213 1,278

1 Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.

EN 13 EN

TOTAL appropriations Commitments =1a+1b

+3 23,714 24,401 24,885 25,378 25,882 26,395 26,919 177,575

for DG GROW Payments =2a+2b

+3 p.m. p.m. p.m. p.m. p.m. p.m. p.m. p.m.

Year Year Year Year Year Year Year TOTAL

MFF 2028-

2034 2028 2029 2030 2031 2032 2033 2034

TOTAL operational

appropriations

Commitments (4) 23,714 24,188 24,672 25,165 25,669 26,182 26,706 176,297

Payments (5) p.m. p.m. p.m. p.m. p.m. p.m. p.m. p.m.

TOTAL appropriations of an

administrative nature financed from the

envelope for specific programmes

(6) 0 0,213 0,213 0,213 0,213 0,213 0,213 1,278

TOTAL

appropriations

under HEADING 2

Commitments =4+6 23,714 23,927 23,927 23,927 23,927 23,927 23,927 177,575

of the multiannual

financial framework Payments =5+6 p.m. p.m. p.m. p.m. p.m. p.m. p.m. p.m.

Year Year Year Year Year Year Year TOTAL

MFF

2028-2034 2028 2029 2030 2031 2032 2033 2034

• TOTAL

operational

appropriations (all

operational

headings)

Commitments (4) 23,714 24,401 24,885 25,378 25,882 26,395 26,919 177,575

Payments (5) p.m. p.m. p.m. p.m. p.m. p.m. p.m. p.m.

• TOTAL appropriations of an

administrative nature financed from

the envelope for specific programmes

(all operational headings)

(6) 0 0,213 0,213 0,213 0,213 0,213 0,213 1,278

EN 14 EN

TOTAL

appropriations

Under

Heading 1 to 3

Commitments =4+6 23,714 23,927 23,927 23,927 23,927 23,927 23,927 177,575

of the multiannual

financial framework Payments =5+6 p.m. p.m. p.m. p.m. p.m. p.m. p.m. p.m.

(Reference amount)

Heading of multiannual financial framework 4 ‘Administrative expenditure’2

DG GROW Year Year Year Year Year Year Year TOTAL

MFF

2028-2034 2028 2029 2030 2031 2032 2033 2034

 Human resources 2,890 3,181 3,181 3,181 3,181 3,181 3,181 21,973

 Other administrative expenditure 0 0 0 0 0 0 0 0

TOTAL DG

GROW Appropriations 2,890 3,181 3,181 3,181 3,181 3,181 3,181 21,973

Other DGs implementing standardisation requests Year Year Year Year Year Year Year TOTAL

MFF

2028-2034 2028 2029 2030 2031 2032 2033 2034

 Human resources 5,820 6,596 6,596 6,596 6,596 6,596 6,596 45,396

 Other administrative expenditure 0 0 0 0 0 0 0 0

TOTAL Other

DGs Appropriations 5,820 6,596 6,596 6,596 6,596 6,596 6,596 45,396

2 The necessary appropriations should be determined using the annual average cost figures available on the appropriate BUDGpedia webpage.

EN 15 EN

TOTAL appropriations under HEADING 4 of

the multiannual financial framework

(Total

commitments =

Total payments) 8,7109,7779,7779,7779,7779,7779,77767,369

EUR million (to three decimal places)

Year Year Year Year Year Year Year TOTAL

MFF 2028-

2034 2028 2029 2030 2031 2032 2033 2034

TOTAL

appropriations under

HEADINGS 1 to 4

Commitments 32,424 34,182 34,670 35,168 35,676 36,194 36,722 245,036

of the multiannual

financial framework Payments p.m. p.m. p.m. p.m. p.m. p.m. p.m. p.m.

3.2.2. Estimated output funded from operational appropriations (not to be completed for decentralised agencies)

Commitment appropriations in EUR million (to three decimal places)

Indicate

objectives and

outputs



Year 2028

Year 2029

Year 2030

Year 2031

Enter as many years as necessary to show the

duration of the impact (see Section1.6) TOTAL

OUTPUTS

Type3

Avera

ge

cost

N o

Cost N o

Cost N o

Cost N o

Cost N o

Cost N o

Cost N o

Cost Total

No

Total

cost

SPECIFIC OBJECTIVE No 14…

- Output

3 Outputs are products and services to be supplied (e.g. number of student exchanges financed, number of km of roads built, etc.). 4 As described in Section 1.3.2. ‘Specific objective(s)’

EN 16 EN

- Output

- Output

Subtotal for specific objective No 1

SPECIFIC OBJECTIVE No 2 ...

- Output

Subtotal for specific objective No 2

TOTALS

EN 17 EN

3.2.3. Summary of estimated impact on administrative appropriations

–  The proposal/initiative does not require the use of appropriations of an administrative nature

– ☑ The proposal/initiative requires the use of appropriations of an administrative nature, as explained below

3.2.3.1. Appropriations from voted budget

VOTED APPROPRIATIONS Year Year Year Year Year Year Year TOTAL 2028

- 2034 2028 2029 2030 2031 2032 2033 2034

HEADING 4

Human resources 8,710 9,777 9,777 9,777 9,7779,7779,777 67,369

Other administrative expenditure 0.000 0.000 0.000 0.000 0.0000.0000.000 0.000

Subtotal HEADING 4 8,710 9,777 9,777 9,777 9,777 9,777 9,777 67,369

Outside HEADING 4

Human resources 0 0,213 0,213 0,213 0,2130,2130,213 1,278

Other expenditure of an administrative nature 0.000 0.000 0.000 0.000 0.0000.0000.000 0.000

Subtotal outside HEADING 4 00,2130,2130,2130,2130,2130,213 1,278

TOTAL 8,710 9,990 9,990 9,990 9,990 9,990 9,990 68,647

3.2.3.2. Total appropriations

TOTAL

VOTED

APPROPRIATIONS

+

EXTERNAL

ASSIGNED

REVENUES

Year Year Year Year Year Year Year

TOTAL

2028 -

2034 2028 2029 2030 2031 2032 2033 2034

HEADING 4

Human resources 8,710 9,777 9,777 9,777 9,7779,7779,777 67,369

Other administrative expenditure

0.000 0.000 0.000 0.000 0.0000.0000.000 0.000

Subtotal HEADING 4 8,710 9,777 9,777 9,777 9,777 9,777 9,777 67,369

EN 18 EN

Outside HEADING 4

Human resources 0 0,213 0,213 0,213 0,2130,2130,213 1,278

Other expenditure of an

administrative nature 0.000 0.000 0.000 0.000 0.0000.0000.000 0.000

Subtotal outside

HEADING 4 0 0,213 0,213 0,213 0,213 0,213 0,213 1,278

TOTAL 8,710 9,990 9,990 9,990 9,990 9,990 9,990 68,647

The appropriations required for human resources and other expenditure of an administrative nature will be met by appropriations from the DG that are already

assigned to management of the action and/or have been redeployed within the DG, together, if necessary, with any additional allocation which may be granted to the

managing DG under the annual allocation procedure and in the light of budgetary constraints.

3.2.4. Estimated requirements of human resources

–  The proposal/initiative does not require the use of human resources

– ☑ The proposal/initiative requires the use of human resources, as explained below

3.2.4.1. Financed from voted budget

Estimate to be expressed in full-time equivalent units (FTEs)1

VOTED APPROPRIATIONS Year Year Year Year Year Year Year

2028 2029 2030 2031 2032 2033 2034

 Establishment plan posts (officials and temporary staff)

(Headquarters and Commission’s Representation

Offices) 43 48,5 48,5 48,5 48,5 48,5 48,5

(EU Delegations) 0 0 0 0 0 0 0

(Indirect research) 0 0 0 0 0 0 0

(Direct research) 0 0 0 0 0 0 0

1 Please specify below the table how many FTEs within the number indicated are already assigned to the management of the action and/or can be redeployed within your DG

and what are your net needs.

EN 19 EN

Other budget lines (specify) 0 0 0 0 0 0 0

• External staff (inFTEs)

(AC, END from the ‘global envelope’) 3,5 3,5 3,5 3,5 3,5 3,5 3,5

(AC, AL, END and JPD in the EU Delegations) 0 0 0 0 0 0 0

Admin. Support line • at Headquarters 0 0 0 0 0 0 0

[XX.01.YY.YY] • in EU Delegations 0 0 0 0 0 0 0

(AC, END - Indirect research) 0 0 0 0 0 0 0

(AC, END - Direct research) 0 0 0 0 0 0 0

Other budget lines (specify) - Heading 4 0 0 0 0 0 0 0

Other budget lines (specify) - Outside Heading 4 0 0 0 0 0 0 0

TOTAL 46,5 54 54 54 54 54 54

The estimated impact on staffing for 2028 and beyond is added for illustrative purposes only and does not pre-judge the next Multiannual Financial

Framework. The source of financing and scope of Union financial commitment in the post-2027 period remain subject to the outcome of

interinstitutional negotiations on the Multiannual Financial Framework 2028-2034 and thereafter shall be determined through the annual budgetary

procedure and the steering mechanism. All staffing allocations as of 2028 are indicative.

3.2.4.2. Total requirements of human resources

The staff required to implement the proposal (in FTEs):

To be covered by

current staff

available in the

Commission

services

Exceptional additional staff

EN 20 EN

To be financed

under Heading 4

or Research

To be financed

from BA line

To be financed

from fees

Establishment

plan posts

48,5 N/A

• External

staff (CA, SNEs,

INT)

3,5 2

Description of tasks to be carried out by:

Officials and temporary staff Task 1: Implementing the strategic planning and the increased accountability of the

European Standardisation System: 0,5 FTE, hosted in the Centre.

Task 2: Supporting the implementation of the flexibility to address requests to

designated standards development organisations and the integration of specifications

from other standards development organisations in standards and standardisation

deliverables developed by European standardisation organisations: 3 FTE hosted in

sectoral services responsible for implementing the standardisation requests.

Task 3: Improving international coordination across EU standardisation actors: 1 FTE

hosted in sectoral services responsible for implementing the standardisation requests.

Task 4: Leading the Centre: 1 FTE, hosted in the Centre.

External staff The set-up of the Expert Centre on European standardisation will improve

coordination and oversight of the implementation of the Standardisation Regulation

and will facilitate the implementation of the new tasks attributed to the Commission.

The additional resources needs to implement the new Standardisation Regulation

would be covered in majority by internal redeployments within the lead DG, DG

GROW and within the services that use the Standardisation Regulation to support their

legislation and policies. Nevertheless, despite the considerable efforts made by the

Commission to redeploy its resources in the past year, some of the new tasks may need

to be covered by an additional reinforcement of Commission staffing by 2 FTEs

external staff to increase the Commission expertise and to ensure that further

EN 21 EN

reallocation of existing human resources would not compromise the implementation of

existing tasks.

Task 2: Supporting the implementation of the flexibility to address requests to

designated standards development organisations and the integration of specifications

from other standards development organisations in standards and standardisation

deliverables developed by European standardisation organisations: 1 FTE hosted in the

Centre.

Task 3: Improving international coordination across EU standardisation actors: 1 FTE,

hosted in the Centre.

3.2.5. Overview of estimated impact on digital technology-related investments

Compulsory: the best estimate of the digital technology-related investments entailed by the proposal/initiative should be included in the table

below.

Exceptionally, when required for the implementation of the proposal/initiative, the appropriations under Heading 4 should be presented in the

designated line.

The appropriations under Headings 1-3 should be reflected as "Policy IT expenditure on operational programmes". This expenditure refers to

the operational budget to be used to re-use/ buy/ develop IT platforms/ tools directly linked to the implementation of the initiative and their

associated investments (e.g. licences, studies, data storage etc). The information provided in this table should be consistent with details

presented under Section 4 "Digital dimensions".

TOTAL Digital and IT

appropriations

Year Year Year Year Year Year Year TOTAL MFF

2028 - 2034

2028 2029 2030 2031 2032 2033 2034

HEADING 4

IT expenditure (corporate) 0 0 0 0 0 0 0 0

Subtotal HEADING 4 0 0 0 0 0 0 0 0

Outside HEADING 4

EN 22 EN

Policy IT expenditure on operational programmes

0 0 0 0 0 0 0 0

Subtotal outside HEADING 4 0 0 0 0 0 0 0 0

TOTAL 0 0 0 0 0 0 0 0

3.2.6. Compatibility with the current multiannual financial framework

The proposal/initiative:

– ☑ can be fully financed through redeployment within the relevant heading of the multiannual financial framework (MFF)

The current initiative is fully compatible with the current multi-annual financial framework and is also compatible with the proposed

Multiannual Financial Framework 2028-2034, without prejudice to the outcome of interinstitutional negotiations on the Multiannual Financial

Framework 2028-2034.

–  requires use of the unallocated margin under the relevant heading of the MFF and/or use of the special instruments as defined in the

MFF Regulation

–  requires a revision of the MFF

3.2.7. Third-party contributions

The proposal/initiative:

– ☑ does not provide for co-financing by third parties

–  provides for the co-financing by third parties estimated below:

Appropriations in EUR million (to three decimal places)

Year Year Year Year Year Year Year Total

EN 23 EN

2028 2029 2030 2031 2032 2033 2034

Specify the co-financing

body

TOTAL appropriations

co-financed

3.3. Estimated impact on revenue

– ☑ The proposal/initiative has no financial impact on revenue.

–  The proposal/initiative has the following financial impact:

–  on own resources

–  on other revenue

–  please indicate, if the revenue is assigned to expenditure lines

EUR million (to three decimal places)

Budget revenue line:

Appropriations available

for the current financial

year

Impact of the proposal/initiative2

Year 2028 Year 2029 Year 2030 Year 2031 Year 2032 Year 2033 Year 2034

Article ………….

For assigned revenue, specify the budget expenditure line(s) affected.

2 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20% for collection

costs.

EN 24 EN

Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).

4. DIGITAL DIMENSIONS

4.1. Requirements of digital relevance

High-level description of the requirements of digital relevance and related categories (data, process digitalisation & automation, digital solutions

and/or digital public services)

Reference to the

requirement

Requirement

description

Actors affected or

concerned by the

requirement

High-level Processes Categories

Requirement 1

Article 7: The

Commission will

establish, manage and

maintain a digital

platform (the ‘EU

Standards Platform’) to

foster transparency and

accountability of the

European

standardisation system.

European Commission,

European

standardisation

organisations and

designated standards

development

organisations.

The platform will list

the standards and

standardisation

deliverables drafted in

support of Union

legislation and policies,

set out how to access

harmonised standards,

harmonised

standardisation

deliverables and

standards and

standardisation

deliverables in support

of Union legislation,

provide information on

standardisation requests

and their

Data; process

digitalisation and

automation; digital

solution; digital public

service.

EN 25 EN

implementation, and

provide information on

the performance of the

European

standardisation system.

European

standardisation

organisations and

designated standards

development

organisations shall make

available the relevant

information on their

standardisation activities

relating to requested

standards and

standardisation

deliverables to the

Commission through an

interoperable IT system

to ensure the accuracy

of information provided

on the EU Standards

Platform.

The information shall be

provided in a timely,

structured and machine-

readable manner, using

common identifiers,

metadata, models and

status controlled

EN 26 EN

vocabularies to ensure

its traceability and

linkage to relevant

Union legislation.

Requirement 2

Article 6(1): European

standardisation

organisations and

designated standards

development

organisations shall

endeavour to develop

requested standards and

standardisation

deliverables using

digital development

tools and shall make

them available in

electronic form and

machine-readable

format.

European

standardisation

organisations and

designated standards

development

organisations

European

standardisation

organisations and

designated standards

development

organisations should

ensure that requested

standards and

standardisation

deliverables are

available in electronic

and, where appropriate,

structured machine-

readable form, with

metadata supporting

their identification,

versioning, traceability

and reuse.

Data; process

digitalisation and

automation; digital

solution.

Requirement 3

Article 6(2): European

standardisation

organisations and

designated standards

development

organisations shall

ensure that the machine-

readable format of

European

standardisation

organisations and

designated standards

development

organisations

European

standardisation

organisations and

designated standards

development

organisations shall

ensure that machine-

readable representations

Data; process

digitalisation and

automation; digital

solution

EN 27 EN

requested standards and

standardisation

deliverables are

interoperable.

and associated metadata

support semantic and

technical

interoperability, digital

exchange and automated

processing.

Requirement 4

Article 5: European

standardisation

organisations and

designated standards

development

organisations shall

provide within the

Union unrestricted free

online access to

referenced standards and

standardisation

deliverables and shall

ensure that referenced

standards and

standardisation

deliverables are

available in a readable,

searchable, printable and

electronically accessible

format.

European

standardisation

organisations and

designated standards

development

organisations

European

standardisation

organisations and

designated standards

development

organisations shall

develop repositories of

referenced standards and

standardisation

deliverables that allow

any user to consult, print

the document and shall

ensure the compliance

with the web

accessibility Directive.

Data; process

digitalisation and

automation; digital

solution

4.2. Data

High-level description of the data in scope

EN 28 EN

Type of data Reference to the requirement(s) Standard and/or specification (if

applicable)

The data in scope for the EU Standards

Platform includes identification and

metadata for requested standards and

standardisation deliverables: title,

reference number, version, status,

adoption/publication/withdrawal dates,

responsible organisations, links to relevant

Union acts or policy areas, access

conditions/format, lifecycle data for

standardisation requests/deliverables, and

performance indicators (e.g. timeliness,

responsiveness, uptake).

Requirement 1

Technical specifications open,

documented and reusable metadata model,

(common identifiers and controlled

vocabularies. XML/, JSON) or other

appropriate serialisations, together with

documented machine-to-machine

interfaces, will support automated

exchange. Relevant European

Interoperability Framework (EIF) and

Interoperable Europe solutions will be

assessed and reused where appropriate.

Structured content of requested standards

and standardisation deliverables, including

normative provisions, definitions, tables,

references and associated metadata, in

formats suitable for digital processing,

exchange and reuse.

Requirements 2 and 3

The requirement fosters the exchange of

data between participants in the

standardisation process, as managed by

European standardisation organisations

and designated standards development

organisation, including for example draft

texts, structured content components,

structured document schemas, and

metadata in formats permitting digital

processing, search, and automated reuse

(e.g. XML).

Alignment with the European Data Strategy

Explanation of how the requirement(s) are aligned with the European Data Strategy

EN 29 EN

Requirement 1 aligns with the European Data Strategy by increasing availability, visibility, and cross-border reuse of standards data, replacing

fragmented channels with a trusted, interoperable digital platform that supports transparency, accountability, and evidence-based

policymaking.

Requirements 2 and 3 align with the European Data Strategy by promoting born-digital, structured data over unstructured documents, enabling

discoverability, computational processing, and integration with compliance systems, databases, and public services.

Alignment with the once-only principle

Explanation of how the once-only principle has been considered and how the possibility to reuse existing data has been explored

The once-only principle is applied to Requirement 1 by reusing existing data from Commission services, European standardisation

organisations, and designated standards development organisations, avoiding duplicate requests for metadata already held in source systems

(e.g. standardisation requests, adoption records, or performance reports).

Explanation of how newly created data is findable, accessible, interoperable and reusable, and meets high-quality standards

The once-only principle is applied to Requirements 2 and 3 through single-source digital authoring, where content is created once in

structured form and reused across review, adoption, publication, and platform integration, avoiding manual reformatting or duplicate

encoding.

Data flows

High-level description of the data flows

Type of data Reference(s) to the

requirement(s)

Actors who

provide the data

Actors who receive

the data

Trigger for the

data exchange

Frequency (if

applicable)

The data in scope

for the EU

Standards Platform

includes

identification and

metadata for

requested standards

and standardisation

Requirement 1

European

Commission,

European

standardisation

organisations and

designated

standards

development

European

Commission

Adoption,

amendment,

withdrawal of

standardisation

requests;

development,

adoption, revision

of standards; and

Event-driven for

changes (near real-

time) and

performance data,

with periodic

consolidation of

performance data

(quarterly/annually)

EN 30 EN

deliverables: title,

reference number,

version, status,

adoption/publicatio

n/withdrawal dates,

responsible

organisations, links

to relevant Union

acts or policy areas,

access

conditions/format,

lifecycle data for

standardisation

requests/deliverable

s, and performance

indicators (e.g.

timeliness,

responsiveness,

uptake).

organisations periodic

performance

reporting

Machine-readable

standards and

standardisation

deliverables,

together with

associated metadata

Requirement 2 and

3

European

standardisation

organisations and

designated

standards

development

organisations

European

Commission and,

subject to

applicable access

conditions, users of

the EU Standards

Platform

Delivery,

referencing,

revision or

withdrawal of a

standard or

standardisation

deliverable

Event-driven

4.3. Digital solutions

High-level description of digital solutions

EN 31 EN

Digital solution

Reference(s) to

the

requirement(s)

Main mandated

functionalities

Responsible

body

How is

accessibility

catered for?

How is

reusability

considered?

Use of AI

technologies (if

applicable)

EU Standards

Platform Requirement 1

It will bring

together all the

information

relevant to the

development of

requested

standard and

standardisation

deliverables,

including the

status of their

development

(requested,

delivered,

assessed or

rejected), the

links to relevant

legislation and

essential

requirements

they aim to

cover as well as

the relevant

contextual

information. In

addition, the EU

standard

European

Commission

The platform

shall comply

with applicable

Union

accessibility

requirements.

Machine-to-

machine access

shall

complement,

and not replace,

accessible

human-readable

interfaces.

Building on the

current eNorm

project and reuse

common

Commission

building blocks,

documented

APIs and

relevant

Interoperable

Europe

solutions. Its

metadata models

and interfaces

should be

documented and

reusable.

EN 32 EN

platform will

serve as a

performance

monitoring tool

and will display

key performance

indicators of the

European

standardisation

system, based on

data collected by

the Commission,

European

standardisation

organisations

and designated

standards

development

organisations.

For each digital solution, explanation of how the digital solution complies with applicable digital policies and legislative enactments

Digital solution #1

Digital and/or sectorial policy

(when these are applicable) Explanation on how it aligns

AI Act n.a.

EU Cybersecurity framework n.a.

eIDAS n.a.

EN 33 EN

Single Digital Gateway and IMI n.a.

Others

4.4. Interoperability assessment

High-level description of the digital public service(s) affected by the requirements

Digital public service

or category of digital

public services

Description Reference(s) to the

requirement(s)

Interoperable Europe

Solution(s)

Other interoperability

solution(s)

Access to public

information on

European

standardisation

Provide up to date and

transparent information

on the standards and

standardisation

deliverables in support

of Union legislation and

policies and on the

performance of the

European

standardisation system

Requirement 1 DCAT-AP

The EU Standards

Platform will require

interactions between the

Commission, European

standardisation

organisations and

designated standards

development

organisations. It should

build on eNorm and use

common identifiers

(common metadata

model, controlled

vocabularies,

documented machine-to-

machine interfaces) and

|relevant Interoperable

Europe Portal solutions.

European Legislation

EN 34 EN

Identifier references

should be used, where

appropriate, to link

standards information to

Union legislation.

It is likely to have a

direct and positive effect

on cross-border

interoperability because

it will function as a

common digital

reference point for

standards-related

information. In practice,

the platform could

reduce fragmentation by

acting as a single

authoritative source –

instead of or

complementing the

multiple online portals

of individual national

standardisation bodies.

Impact of the requirement(s) as per digital public service on cross-border interoperability

Digital public service #1

Assessment Measure(s) Potential remaining barriers (if

applicable)

Alignment with existing digital and Prolongation of the current eNorm project. //

EN 35 EN

sectorial policies. Please list the

applicable digital and sectorial policies

identified

Organisational measures for a smooth

cross-border digital public services

delivery. Please list the governance

measures foreseen

Prolongation of the current eNorm project. //

Measures taken to ensure a shared

understanding of the data. Please list

such measures

Use of Interoperable Europe Framework. //

Use of commonly agreed open technical

specifications and standards. Please list

such measures

Use of Interoperable Europe Framework. //

4.5. Measures to support digital implementation

High-level description of measures supporting digital implementation

Description of the

measure

Reference(s) to the

requirement(s) of

digital relevance that it

supports

Commission role (if

applicable)

Actors to be involved

(if applicable)

Expected timeline (if

applicable)

Build EU Standard

platform on current

eNorm project

Requirement 1 The Commission shall

implement this measure.

European

standardisation

organisations;

designated standards

development

The EU standard

platform should be

operational at the latest

at the date of entry into

application of the

EN 36 EN

organisations. Regulation, planned for

2028 or 2029.

EN EN

EUROPEAN COMMISSION

Strasbourg, 6.10.2026

COM(2026) 780 final

ANNEXES 1 to 3

ANNEXES

to the

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE

COUNCIL

on European Standardisation, repealing Regulation (EU) No 1025/2012 of the European

Parliament and of the Council

{SEC(2026) 780 final} - {SWD(2026) 785 final} - {SWD(2026) 786 final} -

{SWD(2026) 787 final}

EN 1 EN

ANNEX I

European standardisation organisations

1. CEN – European Committee for Standardisation

2. CENELEC – European Committee for Electrotechnical Standardisation

3. ETSI – European Telecommunications Standards Institute

EN 2 EN

ANNEX II

Criteria for selecting European stakeholder organisations

1. A European organisation representing SMEs in European standardisation activities,

shall:

(a) be a non-governmental and non-profit-making body;

(b) have as its statutory objectives and activities to represent the interests of SMEs

in the standardisation process at European level, to raise their awareness for

standardisation and conduct capacity-building initiatives, to motivate them to

become involved in the standardisation process and to ensure their participation

in technical committees;

(c) have been mandated by non-profit organisations representing SMEs in at least

two thirds of the Member States, to represent the interests of SMEs in the

standardisation process at European level.

2. A European organisation representing consumers in European standardisation

activities shall:

(a) be a non-governmental, non-profit-making body, independent of industry,

commercial and business or other conflicting interests;

(b) have as its statutory objectives and activities to represent consumer interests in

the standardisation process at European level;

(c) have been mandated by national non-profit consumer organisations in at least

two thirds of the Member States, to represent the interests of consumers in the

standardisation process at European level.

3. A European organisation representing environmental interests in European

standardisation activities shall:

(a) be a non-governmental, non-profit-making body, independent of industry,

commercial and business or other conflicting interests and working actively for

environmental sustainability;

(b) have as their statutory objectives and activities to represent environmental

interests in the standardisation process at European level;

(c) have been mandated by national non-profit environmental organisations in at

least two thirds of the Member States, to represent environmental interests in

the standardisation process at European level.

4. A European organisation representing social interests in European standardisation

activities shall:

(a) be a non-governmental, non-profit-making body, independent of industry,

commercial and business or other conflicting interests;

(b) have as its statutory objectives and activities to represent social interests in the

standardisation process at European level;

(c) have been mandated by national non-profit social organisations in at least two

thirds of the Member States, to represent social interests in the standardisation

process at European level.

EN 3 EN

ANNEX III

Correlation table

Regulation 1025/2012 This Regulation

Article 1 Article 1

Article 2 Article 2

Article 3 Article 15 and Article

Article 4 Article 16 and Article 28

Article 5(1) Article 17(1) and Article 18(3)

Article 5(2) Article 17(2)

Article 6 Article 20

Article 7 Article 21

Article 8 Article 9

Article 9 Article 19

Article 10 Articles 23 to 25

Article 10(2)(a) Article 12

Article 11 Article 33

Article 12 Article 7

Article 13

Article 14

Article 15 Article 8

Article 16 Article 8

Article 17

Article 18

Article 19

Article 20 Article 39

Article 21 Article 39

Article 22 Article 40

EN 4 EN

Regulation 1025/2012 This Regulation

Article 23 Article 41

Article 24(1) Article 13(4)

Article 24(2) Article 18(8)

Article 24(3) Article 42(1)

Article 25 Article 42(2)

Article 26

Article 27 Article 11

Article 28

Article 29 Article 43

Article 30 Article 44

ANNEX I ANNEX I

ANNEX II

ANNEX III ANNEX II

ANNEX IV ANNEX III

EN EN

EUROPEAN COMMISSION

Strasbourg, 6.10.2026 SWD(2026) 785 final

COMMISSION STAFF WORKING DOCUMENT

Subsidiarity Grid

Accompanying the document

Regulation of the European Parliament and of the Council

on European standardisation, repealing Regulation (EU) No 1025/2012 of the European

Parliament and of the Council

{COM(2026) 780 final} - {SEC(2026) 780 final} - {SWD(2026) 786 final} -

{SWD(2026) 787 final}

1

1. Can the Union act? What is the legal basis and competence of the Unions’ intended action?

1.1 Which article(s) of the Treaty are used to support the legislative proposal or policy initiative?

The legal basis for this proposal is Article 114 of the Treaty on the Functioning of the European Union (‘TFEU’) for the adoption of measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.

1.2 Is the Union competence represented by this Treaty article exclusive, shared or supporting in nature?

Pursuant to Article 4(2)(a) TFEU, competence is shared between the Union and the Member States as this proposal concerns the functioning of the internal market.

2. Subsidiarity Principle: Why should the EU act?

2.1 Does the proposal fulfil the procedural requirements of Protocol No. 21: - Has there been a wide consultation before proposing the act? - Is there a detailed statement with qualitative and, where possible, quantitative

indicators allowing an appraisal of whether the action can best be achieved at Union level?

- The Commission organised a wide consultation of stakeholders before proposing the act: it conducted a call for evidence, an open public consultation as well as targeted surveys, workshops, in-depth interviews, and bilateral meetings. The Commission also frequently consulted the High-Level Forum on European standardisation. All stakeholders concerned took part to the consultations, in particular: Member States, European standardisation organisations, national standardisation bodies, standards development organisation, businesses, representatives of civil society (European stakeholder organisations active in standardisation activities), research and innovation stakeholders and individual citizens.

- The explanatory memorandum and the Impact Assessment accompanying the proposal both contain a section on the principle of subsidiarity (see answer to question 2.2 below).

2.2 Does the explanatory memorandum (and any impact assessment) accompanying the Commission’s proposal contain an adequate justification regarding the conformity with the principle of subsidiarity?

The explanatory memorandum and Chapter 3 of the Impact Assessment accompanying this proposal provide a justification of the conformity of the proposal with the principle of subsidiarity.

1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN

2

The objectives of the proposal, in particular to set up a harmonised framework for European standardisation, cannot be sufficiently achieved by Member States for the following reasons:

- European standardisation supports Union legislation and policies by facilitating the functioning of the internal market. Harmonised standards replace conflicting national standards, which may create technical barriers to trade. The problems affecting the European standardisation system, such as delays in the development of standards and concerns regarding financial sustainability, are shared across Member States and require a solution at Union level.

- Member States acting individually cannot effectively address these challenges. Without Union action, the identified problems would persist, leading to fragmentation, increased compliance costs, and reduced competitiveness. National measures would be insufficient to ensure a coherent and efficient standardisation system that fosters the same standards across the Union.

Union action is better suited to achieve the objectives of the proposal for the following reasons:

- The proposal will improve the functioning of the internal market by ensuring timely and high-quality standards and standardisation deliverables in support of Union legislation and policies.

- The proposal will reduce compliance costs for businesses, increase trade, and strengthen the Union’s influence in international standardisation.

- The revised Regulation will support the implementation of key Union policies.

2.3 Based on the answers to the questions below, can the objectives of the proposed action be achieved sufficiently by the Member States acting alone (necessity for EU action)?

The objectives of the proposed action cannot be sufficiently achieved by Member States acting alone. The identified problems are common to all Member States, differentiated initiatives by Member States alone would be detrimental to the internal market and could negatively affect other Member States. This Regulation aims to create a harmonised framework facilitating the functioning of the internal market, by providing common technical solutions which facilitate the free movement of goods and services across Member States, strengthen interoperability, reduce transaction costs, and promote effective competition.

(a) Are there significant/appreciable transnational/cross-border aspects to the problems being tackled? Have these been quantified?

The problems identified in the Impact Assessment that the proposal aims to tackle all have a transnational dimension. Harmonised standards play a major role for the internal market, guaranteeing the interoperability, placing on the market and safety of products and services across the internal market, further facilitating a level playing field across the Union. The lengthy and complex standardisation process of European standardisation affects and stems from national standardisation systems as the European standardisation system is built on the cooperation between national standardisation bodies. The insufficient stakeholder participation in standardisation has a cross-border dimension as national standardisation systems need to be open to stakeholders from other Member States. The obligation to provide free access to harmonised standards following the case law of the Court of Justice of the European Union affects all national standardisation bodies that sell these harmonised standards, including across borders, as access needs to be guaranteed to an equal degree

3

across the Union in each Member State. The diminishing global position of the Union and its Member States in international standardisation has a transnational dimension as each national standardisation body of a Member State is an independent member of international standardisation bodies.

(b) Would national action or the absence of the EU level action conflict with core objectives of the Treaty2 or significantly damage the interests of other Member States?

National action or the absence of the EU level action would significantly damage the interests of other Member States. The proposal aims at improving the functioning of the internal market by creating a harmonised framework for European standardisation, thereby facilitating exchange of goods and services, fostering interoperability, contributing to quality and consumer trust, and supporting technological development and the uptake of market innovation. Any initiative at the level of Member States might go against the objective of harmonisation, create technical barriers to trade for business within the internal market or diminish the influence and participation of other Member States in European and international standardisation.

(c) To what extent do Member States have the ability or possibility to enact appropriate measures?

Member States acting individually cannot effectively address these challenges. Without Union action, the identified problems would persist, leading to fragmentation, increased compliance costs, and reduced competitiveness. National measures would be insufficient to ensure a coherent and efficient European standardisation system that fosters the same standards across the Union, with the same transparency in development and balanced participation of stakeholders. National action to address specific objectives of the proposal, for instance as regards improving inclusiveness or international influence, could also create an unlevel playing field within the Union.

(d) How does the problem and its causes (e.g. negative externalities, spill-over effects) vary across the national, regional and local levels of the EU?

The problems identified in the Impact Assessment are a common challenge across the Union and Member States, albeit to varying degrees. National standardisation systems all face similar challenges: lack of responsiveness, lack of balanced stakeholder participation, possibility of loss of revenues stemming from the free access to harmonised standards and declining influence at international level. The initiative has no differentiated impact at regional and local levels as standardisation is only conducted at national and European levels.

(e) Is the problem widespread across the EU or limited to a few Member States?

The problems are widespread across the EU and affect all Member States, albeit to a different extent, based on their industrial base and national standardisation systems.

(f) Are Member States overstretched in achieving the objectives of the planned measure?

2 https://europa.eu/european-union/about-eu/eu-in-brief_en

4

The proposal foresees targeted requirements on Member States to improve the functioning of their national standardisation bodies, in particular their ability to ensure an inclusive standardisation process at national level, and to share information on their participation in international standardisation activities.

(g) How do the views/preferred courses of action of national, regional and local authorities differ across the EU?

There is broad convergence of views, as expressed in the open public consultation to this proposal, that EU action is needed to achieve the objectives of the proposal and to improve the functioning of the European standardisation system. Stakeholders expressed strong support for targeted improvements to the existing European standardisation system, based on the existing horizontal framework created by Regulation (EU) No 1025/2012.

2.4 Based on the answer to the questions below, can the objectives of the proposed action be better achieved at Union level by reason of scale or effects of that action (EU added value)?

The objectives of the proposed action can be achieved better at Union level, in particular to improve the functioning of the internal market and to foster the competitiveness of the Union. Standardisation eliminates technical barriers, enabling the free movement of goods and services and reducing costs for cross-border operators. A legally and financially sustainable European standardisation system is critical to effectively implement Union legislation and for the EU’s ability to shape global standards in emerging technologies. EU- level action ensures policy coherence, supporting key priorities such as competitiveness and strategic autonomy, while avoiding the fragmentation that would result from divergent national approaches. Collective action leverages economies of scale in standardisation across Member States, mutualising standardisation costs and creating synergies, and enhances the EU’s influence in international standardisation fora, which would not be achievable through the individual efforts of Member States.

(a) Are there clear benefits from EU level action?

There are clear benefits stemming from EU level action by improving an existing horizontal framework which is key to the functioning of the internal market, by addressing problems that are common to all Member States and creating synergies across Member States in fostering participation of stakeholders in standardisation at all levels – national, European and international which benefits the entire Union.

(b) Are there economies of scale? Can the objectives be met more efficiently at EU level (larger benefits per unit cost)? Will the functioning of the internal market be improved?

The proposal will create economies of scale for businesses by reducing their compliance costs by making harmonised standards and standards in support of Union legislation and policies available earlier. This will improve the functioning of the internal market by fostering the convergence of technical solutions implemented by businesses to comply with Union legislation and access the internal market, while decreasing overall compliance costs for businesses. The Impact Assessment accompanying this proposal estimates these savings at EUR 295 million per year.

(c) What are the benefits in replacing different national policies and rules with a more homogenous policy approach?

5

This proposal will not replace national policies as this proposal builds on the existing European framework for standardisation, Regulation (EU) No 1025/2012. The proposal does not create new national obligations but amends existing obligations at national level for national standardisation bodies. However, the proposal clarifies the Member States’ responsibility to ensure the compliance of their national standardisation bodies with the Regulation.

(d) Do the benefits of EU-level action outweigh the loss of competence of the Member States and the local and regional authorities (beyond the costs and benefits of acting at national, regional and local levels)?

The proposal does not lead to the loss of competences of Member States. It builds on the current European standardisation system, which has delivered benefits outweighing the loss of competence of the Member States. By identifying standards at European level to support Union legislation, this Regulation supports the harmonisation of the internal market and the competitiveness of the Union, while promoting active national standardisation activities to support European standardisation. The proposal will further increase the benefits of the European standardisation system, by reducing compliance costs for businesses, increasing trade, and strengthening the Union’s influence in international standardisation.

(e) Will there be improved legal clarity for those having to implement the legislation?

This proposal will improve legal clarity for the actors of the European standardisation system and for the users of standards and standardisation deliverables in support of Union legislation and policies. It will increase legal certainty for business as regards the legal value of standards and standardisation deliverables, clarify the legal status of standards and standardisation deliverables requested by the Commission as well as clarify obligations of European standardisation organisations, designated standardisation organisations and national standardisation bodies for the delivery of standards and standardisation deliverables in support of Union legislation and policies.

3. Proportionality: How the EU should act

3.1 Does the explanatory memorandum (and any impact assessment) accompanying the Commission’s proposal contain an adequate justification regarding the proportionality of the proposal and a statement allowing appraisal of the compliance of the proposal with the principle of proportionality?

The proposed revision follows what is adapted and necessary to achieve the objectives of ensuring a more responsive, sustainable and internationally influent European standardisation system. The proposal introduces targeted improvements to the functioning of the European standardisation system to achieve the initiative’s objectives without imposing unnecessary burdens on stakeholders, as outlined in the Impact Assessment of the initiative. The measures introduced to foster the responsiveness of the European standardisation system rely on the current framework for European standardisation and aim at improving the performance of the European standardisation organisations, while introducing the possibility to rely on designated standardisation organisations in targeted situations, where the European standardisation organisations would not be able to deliver high-quality standards in a timely manner.

6

The proposal also increases the requirements for European standardisation organisations, national standardisation bodies and designated standard development organisations to improve the inclusiveness of the European standardisation process. These requirements target measures at the national level where the barriers to participation to standardisation are the highest. The obligation to provide free and unrestricted access to referenced standards is necessary to achieve the objective of the initiative and is balanced with the necessity to maintain a financially viable European standardisation system. Improving coordination of European stakeholders in international standardisation is necessary to consolidate the Union’s influence in international standardisation and is achieved by introducing targeted coordination mechanisms, with the participation of both the Commission and Member States. The possibility to restrict participation to actors from the Union only or to diverge from international standards in the European standardisation process in support of Union legislation and policies is necessary to promote the Union’s economic security and strategic autonomy, and codifies existing practices, without going beyond what is necessary by preserving the international first principle, whereby European standards should first seek to align with international standards.

3.2 Based on the answers to the questions below and information available from any impact assessment, the explanatory memorandum or other sources, is the proposed action an appropriate way to achieve the intended objectives?

The proposed action is an appropriate way to achieve the intended objectives as it introduces targeted changes to the current European standardisation system, which should benefit in the long-term all stakeholders concerned and can be financed through redeployments within the existing Union budget. The proposal limits itself to improving the European processes for obtaining standards and standardisation deliverables in support of Union legislation and to better coordinating the European stakeholders active in international standardisation. It implements a proportionate approach to inclusiveness and free access to harmonised standards whose costs would be borne by European standardisations organisations, national standardisation bodies, businesses, and the Union budget through redeployments.

(a) Is the initiative limited to those aspects that Member States cannot achieve satisfactorily on their own, and where the Union can do better?

The proposal is strictly limited to improving the responsiveness of the European standardisation system, which Member States cannot achieve on their own, to improving coordination across EU actors in international standardisation and to foster a balanced stakeholder participation in EU standardisation, which is better achieved at Union level in order to ensure there is no unlevel playing field in standardisation across Member States.

(b) Is the form of Union action (choice of instrument) justified, as simple as possible, and coherent with the satisfactory achievement of, and ensuring compliance with the objectives pursued (e.g. choice between regulation, (framework) directive, recommendation, or alternative regulatory methods such as co-legislation, etc.)?

A Regulation is the appropriate instrument for the initiative, which revises an existing Regulation. The legal instrument has to be of general application, as it concerns standards and standardisation deliverables that have a direct effect throughout the Union. In addition, the legislative instrument contains a number of obligations that are directly applicable to the European standardisation organisations, the national standardisation bodies,

7

designated standard development organisations, European stakeholder organisations, and the Commission.

(c) Does the Union action leave as much scope for national decision as possible while achieving satisfactorily the objectives set? (e.g. is it possible to limit the European action to minimum standards or use a less stringent policy instrument or approach?)

The proposal mostly sets out requirements on the functioning of the European standardisation system and as such does not affect national decision-making. To support the objective of ensuring a balanced stakeholder participation in the European standardisation system, the proposal also sets requirements at national level for national standardisation bodies, to promote the level playing field in standardisation across the Union and to ensure a joint minimum level of inclusiveness. This is proportionate to the objective of the Regulation as not setting joint minimum requirements could undermine the European standardisation system if some national systems would be less inclusive and more prone to imbalanced stakeholder participation.

(d) Does the initiative create financial or administrative cost for the Union, national governments, regional or local authorities, economic operators or citizens? Are these costs commensurate with the objective to be achieved?

The initiative does not create operational financial costs for the Union budget as new activities to support the viability of the European standardisation system will be financed through redeployment of existing Union budget. It creates limited additional costs for national standardisation bodies, estimated in the Impact Assessment at EUR 1.9 million per year. It would also create additional administrative costs for the Union in the form of additional human resources to support the effective implementation of the proposal that will be mostly covered through internal redeployment. Net additional administrative costs are estimated in the Legislative Financial and Digital statement at EUR 0.213 per year.

(e) While respecting the Union law, have special circumstances applying in individual Member States been taken into account?

The initiative has taken into account special circumstances applying in individual Member States, in particular the different level of dependency on the sales of harmonised standards by different national standardisation bodies. To take into account these special circumstances, the proposal foresees the possibilities for differentiated financial support to such national standardisation bodies, via the European standardisation organisations and within the possibility for redeployment of the Union budget.

EUROPEAN COMMISSION

19.06.2026

SEC(2026) 780

REGULATORY SCRUTINY BOARD OPINION

{COM(2026) 780}

{SWD(2026) 785-786-787}

Impact assessment / European Product Act – update on the rules on standardisation

________________________________

This opinion concerns a draft impact assessment which may differ from the final version.

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111

[email protected]

EUROPEAN COMMISSION REGULATORY SCRUTINY BOARD

Brussels, RSB

Opinion

Title: Impact assessment / European Product Act – update on the rules

on standardisation

Overall opinion: POSITIVE

(A) Policy context

The standardisation regulation organises the functioning of the European Standardisation

System (ESS), the partnership between the European Commission and the European and

national standardisation organisations to develop standards to support Union legislation

and policy. [This initiative aims to revise this regulation to address the shortcomings

identified in the 2025 evaluation. Its objectives are: 1) to improve the responsiveness of

the ESS by accelerating the delivery of harmonised standards; 2) to ensure the

sustainability of the ESS by balancing the requirement for free access to harmonised

standards with the financial viability of the standardisation organisations while fostering

participation from all stakeholders; 3) to consolidate the EU’s influence in international

standardisation.

(B) Key issues

The Board notes the additional information provided by lead Service(s) and

commitments to make changes to the report.

The Board gives a positive opinion. The Board considers that the report could be

further improved with respect to the following aspects:

(1) The report does not sufficiently analyse how the participation of stakeholders in

the standardisation process affects the quality of the EU harmonised standards

and their timely delivery.

(2) The second specific objective is not defined sufficiently clearly to address the

identified problems, including the issue of balanced stakeholder participation.

(3) The report does not describe in sufficient detail some of the policy measures

making the assessment of their impacts uncertain. The analysis of efficiency is

not sufficiently clear to inform the comparison of options.

2

(C) What to improve

(1) The report should draw on additional evidence to analyse the impact of stakeholder

participation from both SMEs as well as from civil society organisations on the

quality and timely delivery of standards.

(2) The report should better explain how the second specific objective relates to the

identified problems. The objective should be redefined to better reflect that it aims to

ensure a balanced stakeholder representation, inclusive access to harmonised

standards and a legally and financially viable standardisation system providing EU

harmonised standards.

(3) The report should provide, to the extent possible, more details on the policy measures

to be implemented such as requirements for stakeholder participation or approach to

deadlines and the possible costs for stakeholders. The report should be clearer and

comprehensive about the costs for all concerned stakeholders, including the EU

budget.

(4) Building on a more comprehensive assessment of the costs to all stakeholders, the

efficiency analysis should follow the standard methodology, i.e. be based on societal

benefit cost ratio. In case other approaches to efficiency assessment are used in

addition to societal benefit cost ratio, the report should explain the methodology.

(5) The limitations and uncertainties related to the analysis of the problems and the

impacts need to be further clarified as well as the extent to which they affect the

comparison of options.

Some more technical comments have been sent directly to the author Service.

(D) Conclusion

The lead Service may proceed with the initiative. The lead Service should take these

recommendations into account before launching the interservice consultation.

Full title Revision of the Regulation (EU) No 1025/2012 of the

European Parliament and of the Council of 25 October 2012

on European standardisation

Reference number PLAN/2024/2488

Submitted to RSB on 20/05/2026

Date of RSB meeting 17/06/2026

Electronically signed on 19/06/2026 12:33 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121

EN EN

EUROPEAN COMMISSION

Strasbourg, 6.10.2026 SWD(2026) 786 final

COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT REPORT

Accompanying the document

Proposal for a Regulation of the European Parliament and of the Council

on European standardisation, repealing Regulation (EU) No 1025/2012 of the European

Parliament and of the Council

{COM(2026) 780 final} - {SEC(2026) 780 final} - {SWD(2026) 785 final} - {SWD(2026) 787 final}

1

Table of contents

1. INTRODUCTION: POLITICAL AND LEGAL CONTEXT ............................................................... 4

2. PROBLEM DEFINITION ..................................................................................................................... 7

3. WHY SHOULD THE EU ACT? ......................................................................................................... 21

4. OBJECTIVES: WHAT IS TO BE ACHIEVED?................................................................................ 22

5. WHAT ARE THE AVAILABLE POLICY OPTIONS? ..................................................................... 24

6. WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ........................................................... 31

7. HOW DO THE OPTIONS COMPARE? ............................................................................................ 51

8. PREFERRED OPTION ....................................................................................................................... 56

9. HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................................. 57

ANNEX 1: PROCEDURAL INFORMATION ............................................................................................ 59

ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) ................................................ 62

ANNEX 3: WHO IS AFFECTED AND HOW? ........................................................................................... 87

ANNEX 4: ANALYTICAL METHODS ...................................................................................................... 93

ANNEX 5: COMPETITIVENESS CHECK ............................................................................................... 109

ANNEX 6: SME CHECK ........................................................................................................................... 113

ANNEX 7: SCOPE OF THE STANDARDISATION REGULATION AND OF THE PROPOSED

POLICY INTERVENTION .............................................................................................................. 121

ANNEX 8: OVERVIEW OF THE FUNCTIONING OF THE EUROPEAN STANDARDISATION

SYSTEM ........................................................................................................................................... 128

ANNEX 9: KEY ELEMENTS AND FUNCTIONING OF THE STANDARDISATION PROCESS IN

REGULATION (EU) 1025/2012 ...................................................................................................... 137

ANNEX 10: DESCRIPTION OF POLICY OPTIONS............................................................................... 149

ANNEX 11: SYSTEMIC DIFFERENCES BETWEEN EUROPEAN STANDARDISATION AND

OTHER COUNTRIES ...................................................................................................................... 157

ANNEX 12: CURRENT COMMISSION GOVERNANCE TO MANAGE THE ESS ............................. 165

ANNEX 13: ALTERNATIVE STANDARDS DEVELOPING ORGANISATIONS (SDOS) .................. 169

ANNEX 14: RELEVANT JURISPRUDENCE ADDRESSING PROVISIONS OF THE

STANDARDISATION REGULATION ........................................................................................... 174

ANNEX 15: CASE STUDIES .................................................................................................................... 184

2

Glossary

Term or acronym Meaning or definition

AI Artificial Intelligence

Annex III Specific list of societal stakeholder organisations recognised

under Regulation (EU) No 1025/2012: SBS (SMEs), ANEC

(consumers), ECOS (environment) and ETUC (workers).

Annex Z An annex to harmonised standards that identifies the legally

relevant parts of the standard offered by ESOs

ASTM International American Society for Testing and Materials International, an

organisation that develops and publishes voluntary consensus

standards for materials, products, systems and services

AUWP Annual Union Work Programme on European Standardisation

CEN European Committee for Standardisation (general sectors)

CENELEC European Committee for Electrotechnical Standardisation

(electrical engineering and electrotechnical matters)

CJEU Court of Justice of the European Union

Common

Specification (CS)

Technical specifications adopted by the Commission as a fall-

back to harmonised standards when they are not available

EN European Norms (European Standards): standards developed by

CEN, CENELEC and ETSI with a harmonisation effect across

their members.

ESO European Standardisation Organisation, as defined in the Annex I

of the Standardisation Regulation (CEN, CENELEC and ETSI).

ESS European Standardisation System

ETSI European Telecommunications Standards Institute (information

and communication technologies).

HAS Harmonised Standards consultants: external technical experts who

support the Commission by assessing the compliance of technical

standards with EU law.

hEN Harmonised European Norms (harmonised standards): European

standards developed in response to a request (a “standardisation

request”) from the Commission and, once cited in the Official

3

Journal of the European Union, can provide a presumption of

conformity with relevant EU legislation

HLF High-Level Forum on European Standardisation, an expert group

of the Commission

IEC International Electrotechnical Commission

IEEE Institute of Electrical and Electronics Engineers, a technical

professional organisation that is a SDO

ISO International Organisation for Standardisation

ISOs International Standardisation Organisations (generic term

referring to all international standardisation organisations. Not to

be confused with ISO, which refers to a specific organisation).

ITU International Telecommunication Union

NLF New Legislative Framework

NSB National Standardisation Body, the national standardisation

organisation of EU and EEA Member State.

OPC Open Public Consultation

SDOs Standards Development Organisations (generic term for any

entity - private or public - whose primary activity is developing

technical standards through a consensus-based process).

SMP / SMCP Single Market Programme and proposed Single Market and

Customs Programme

TC Technical Committee, specialised bodies of SDOs responsible for

developing and maintaining standards

3GPP 3rd Generation Partnership Project, global collaboration that

develops and maintains standards for mobile telecommunications,

including 3G, 4G, and 5G networks

4

1. INTRODUCTION: POLITICAL AND LEGAL CONTEXT

1.1. Political context

Standardisation is a key enabler of a well-functioning EU internal market: standards

facilitate the exchange of goods and services between Member States, contributing to the

harmonisation of the internal market. By ensuring interoperability, quality and consumer trust,

standards facilitate market access and reduce internal market fragmentation. Standardisation

has been at the core of the internal market harmonisation under the New Legislative Framework

(NLF)1 adopted in 2008. Harmonised standards (hENs), adopted by European Standardisation

Organisations (ESOs)2 following a request from the Commission under the Standardisation

Regulation3, are an important simplification tool for businesses: they provide access to the

entire internal market through presumption of conformity, simplifying compliance and cutting

conformity costs.

Standardisation is also increasingly becoming an industrial policy tool. Standards are an

essential building block of the innovation process; they allow research and innovation results

to spread and turn into market-ready solutions, contributing to the competitiveness of market

operators. Fast standardisation can provide a first-mover advantage in technological races,

facilitate the adoption of new technologies and give an edge to industrial ecosystems in the

international competition. Standards are also a tool to turn policy objectives – such as

decarbonisation, digitalisation, accessibility and respect for fundamental rights – into scalable,

globally recognised technical solutions. Lastly, standardisation is one of the battlegrounds of

international competition; access to international markets is dependent on compliance with

international standards, and the ability of the EU to influence international standards directly

impacts the competitiveness of EU industries and the capacity of the EU to implement its

strategic autonomy agenda.

The European Council Conclusions of March 20264 highlighted the urgent need to “boost

the Union’s competitiveness, increase its resilience and enhance its strategic autonomy and

economic security”, launching the One Europe, One Market roadmap with the deepening and

integration of the internal market at its core. The European Council called for “enhancing

enforcement of EU standards” as a priority. This follows up the Commission’s

Competitiveness Compass5, and the Single Market Strategy of April 20256, which identified

the slow and unpredictable standardisation process in support of EU legislation and policies as

1 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the

requirements for accreditation and Decision No 768/2008/EC of the European Parliament and of the Council of 9

July 2008 on a common framework for the marketing of products, OJ L 218, 13.8.2008, pp. 82–128 (hereafter the

NLF). 2 ESOs are listed in the Annex I of the Standardisation Regulation. They are the Comité Européen de Normalisation

(CEN), the Comité Européen de Normalisation Electrotechnique (CENELEC) and the European

Telecommunications Standards Institute (ETSI). 3 Regulation (EU) 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European

standardisation, OJ L 316, 14.11.2012, p. 12 (hereafter the Standardisation Regulation). 4 EUCO 1/26, European Council meeting (19 March 2026) – Conclusions 5 A Competitiveness Compass for the EU, COM(2025) 30 final, 29.1.2025, which identified the opportunity for

“making standard-setting processes faster and more accessible, in particular for SMEs and startups”. 6 The Single Market: our European home market in an uncertain world, COM(2025) 500 final, 21.5.2025.

5

one of the “terrible 10” of the Single Market – the 10 main barriers to its completion – and

announced a review of the Standardisation Regulation7.

The Commission announced in its Work Programme 20268 that the revision of the

Standardisation Regulation will take place alongside the European Product Act (EPA). The

upcoming EPA will encompass the revision of the three pillars of the EU product legislation

framework: standardisation, market surveillance9 and the NLF. The joint revision of these

three pillars will introduce a new framework for product legislation in the EU, better suited to

the realities of 21st-century products and more capable of ensuring that the internal market

remains a key asset for EU competitiveness and strategic autonomy.

1.2. Legal context

The Standardisation Regulation organises the functioning of the European

Standardisation System (ESS), the current partnership between the Commission, ESOs and

National Standardisation Bodies (NSBs) and stakeholders10 to develop standards and

standardisation deliverables11 to support Union legislation and policy. The primary focus of the

Regulation is the process for delivering hENs, defined as a ‘European standard adopted on the

basis of a request made by the Commission for the application of Union harmonisation

legislation”12. The functioning of the ESS is described in more details in Annex 8.

The Standardisation Regulation supports the NLF, which provides a blueprint for EU

product legislation and aligns 31 legal acts covering a wide range of product markets. One of

the key principles of the NLF is to provide a presumption of conformity to products complying

with the hENs supporting the legislation applicable to those products, allowing products to

freely circulate within the internal market.

Over time, additional legislation beyond product harmonisation legislation has been relying

on the Standardisation Regulation, covering notably digital technologies, cybersecurity, data or

Artificial Intelligence (AI). In addition, key policy initiatives have leveraged standardisation as

a tool to implement their objectives, notably in the field of the green transition, such as the

Green Deal and the Clean industrial deal13, and of sectoral industrial strategies, such as the

European Strategy for Housing Construction and the Bioeconomy strategy14.

7 The European Economic and Social Committee supported the revision in its Opinion Strategic standardisation

for a stronger single market (own-initiative opinion), INT/1120. 8 2026 Commission work programme and annexes, COM(2025) 870 final, 21.10.2025. 9 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market

surveillance and compliance of products, OJ L 169, 25.6.2019, pp. 1–44. 10 The European Standardisation System is currently limited to the ESOs as the only organisations allowed to

deliver standards and standardisation deliverables in support of Union legislation and policies but could in the

future be extended to other standardisation organisations – see Section 5. 11 A ‘European standardisation deliverable’ means any other technical specification than a European standard,

adopted by a ESO for repeated or continuous application and with which compliance is not compulsory – see

Standardisation Regulation, Article 2 Definitions. 12 Standardisation Regulation, Article 2 Definitions. 13 The European Green Deal, COM(2019) 640 final, 11.12.2019; The Clean Industrial Deal: A joint roadmap for

competitiveness and decarbonisation, COM(2025) 85 final, 26.2.2025. 14 The European Strategy for Housing Construction: a more competitive and productive construction industry,

COM(2025) 991 final, 16 December 2025; A Strategic Framework for a Competitive and Sustainable EU

Bioeconomy, COM(2025) 960 final, 27.11.2025.

6

The Standardisation Regulation was amended in 202215 following the Standardisation

strategy16 to ensure that decisions related to the implementation of standardisation requests by

the ESOs are taken by NSBs of the EU and the EEA only. In May 2025, the Commission

proposed targeted modifications to key product legislation of the NLF under its Omnibus IV

proposal17to introduce the possibility for the Commission to adopt common specifications

(CS) as a fall-back option in case the ESOs fail to deliver hENs, expanding the number of Union

legislation already including such a possibility. This will contribute to improve legal certainty

for companies by enabling them to benefit from presumption of conformity through CS even if

hENs are not available.

The Court of Justice of the European Union (CJEU) has clarified that hENs form part of EU

law18 and that there is an overriding public interest in their disclosure19,based on the principles

of rule of law and transparency. The Commission, in cooperation with ESOs, has implemented

this judgment by providing access to hENs through readability platforms20. EU legislation also

directly references standards or technical specifications from ESOs or other standard

developing organisations (SDOs),without having first requested them under the

Standardisation Regulation. Such directly referenced standards21 may be made mandatory by

the legislative act, in which case they are made accessible through the readability platforms22.

While these standards are thus used to support a wide range of Union legislation and policy

with different legal and policy effects, they only represent a small part of the activities of

the ESOs. hENs make up only 12 % of all European standards23 developed by the three ESOs

(CEN, CENELEC and ETSI)24. This initiative primarily focuses on the delivery of standards

for Union legislation and policy – see Annex 7. However, there are clear synergies and inter-

linkages between the activities of the ESOs as providers of standards for legislation or policy

use and as a provider of standards that are purely market-driven.

15 Regulation (EU) 2022/2480 of the European Parliament and of the Council of 14 December 2022 amending

Regulation (EU) No 1025/2012 as regards decisions of European standardisation organisations concerning

European standards and European standardisation deliverables, OJ L 323, 19 December 2022, p.1. 16 An EU Strategy on Standardisation - Setting global standards in support of a resilient, green and digital EU

single market, COM(2022) 31 final, 2.2.2022. 17 COM(2025) 504 final, 21 May 2025. See Annex 9 for more details on the Omnibus IV proposal. 18 Judgment of 27 October 2016, James Elliott Construction Ltd v Irish Asphalt Ltd., C-613/14, EU:C:2016:821. 19 Judgement of 5 March 2024, Public.Resource.Org and Right to Know v Commission, C-588/21 P,

EU:C:2024:201. 20 Following individual requests, those that have been disclosed under Regulation (EC) No 1049/2001 (Access to

Documents Regulation) can be freely accessed on the online national readability platforms of NSBs in a read-only

format. hENs based on ISO or IEC standards can be accessed through the Commission’s readability platform after

individual requests for access to documents. 21 As of December 2025, the Commission estimates the number of standards directly referenced in EU legislation

to be around 3 500, supporting over 1 100 different legal acts and originating from 39 different SDOs. The large

majority comes from the ESOs (48%) and ISO and IEC (37%), while the remainder originates from various other

SDOs (15% ). 22 The CJEU noted that those standards should be freely accessible in its judgment of 21 April 2026, Nederlandse

Voedsel- en Warenautoriteit and Others, C-155/24, ECLI:EU:C:2026:327, para 34 and 38. 23 Standards adopted by ESOs are European standards (EN); they have a harmonisation effect in the internal market

as ESOs ensure they are no conflicting national standards with ENs. 24 As of April 2026. Data on hENs stem from Commission analysis based on the eNorm system, that consolidates

information on standardisation in support of Union legislation and policy. These shares vary across ESOs (13 %

for CEN, 10 % for CENELEC and ca. 9 % for ETSI). hENs from CEN represents 70 % of all hENs, CENELEC

25 % and ETSI 5 %.

7

1.3. Link with other initiatives

The revision of the Standardisation Regulation will take place in parallel with the revision of

the Market Surveillance Regulation and of the NLF as part of the upcoming European Product

Act. These initiatives are closely related, as product legislation falling under the NLF is among

the EU legislation most dependent on the delivery of high-quality hENs for its implementation.

The NLF and the Market Surveillance Regulation organise the accreditation, conformity

assessment and the enforcement framework in the EU, which is largely dependent on the

standardisation system for its effective functioning.

The future Single Market and Customs Programme (SMCP)25 under the next Multi-annual

Financial Framework 2028-2034 will also play an important role in the future of the ESS. One

of the objectives of the current Single Market Programme (SMP)26 is to “ensure the effective

functioning of the internal market through standardisation processes” and is instrumental in

supporting the activities of ESS. The future SMCP will continue to pursue this objective and

will be the main EU financial instrument to support the functioning of the ESS.

2. PROBLEM DEFINITION

2.1. What are the problems?

While the Standardisation Regulation has improved the functioning of the ESS, its recent

evaluation (the Evaluation)27 concluded that the current framework is unfit to meet the

challenges arising from the need to provide access to standards, rapid technological

developments, and intensifying international competition. This diagnosis supported similar

conclusions from the Letta and Draghi report, highlighting that “Member States do not

systematically exploit the benefits of coordination at the EU level, of standardisation and

interoperability”28 and that standardisation is essential in supporting EU competitiveness in

strategic areas such defence, transport and clean and emerging technologies29. The problem

analysis in this Impact Assessment complements the Evaluation’s findings with desk research,

public and targeted consultations, interviews, workshops and sectoral case studies.

2.1.1. Problem 1: lengthy and complex standardisation process prevents timely

availability of standards

The process of developing hENs is too slow to meet the legislative needs and keep pace with

technological developments30. While the Evaluation shows an overall decrease in the average

time to develop hENs31 from about 9 to 10 years before 2012 to around 6 years today, this

25 Proposal for a Regulation of the European Parliament and of the Council establishing the Single Market and

Customs Programme for the period 2028-2034, COM(2025) 590_1 final, 3.9.2025. 26 Regulation (EU) 2021/690 of the European Parliament and of the Council of 28 April 2021 Single Market

Programme, OJ L 153, 3.5.2021, pp. 1–47. 27 Evaluation of the Regulation (EU) No 1025/2012 on European standardisation, SWD(2025) 170 final, 23.6.2025

(hereafter: Evaluation). 28 Draghi Report, The future of European competitiveness, Part B, Section 1, Chapter 7, 2024. 29 Letta Report, Much More than a Market, 2024. 30 European Commission: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs,

Fraunhofer ISI, Intellera Consulting and Trinomics B.V, Evaluation study of the regulation (EU) 1025/2012 on

European standardisation – Final report, p. 99, Publications Office of the European Union, 2025 (hereafter

Evaluation Study). 31 Ibid, pp. 100-101.

8

length remains incompatible with the speed of technological, industrial and innovative cycles,

and longer than that of the EU main international competitors32. The magnitude of delays and

their cost implications varies across sectors and products, and the available evidence does not

allow a systematic sector-by-sector quantification. The analysis therefore uses aggregated

evidence and conservative assumptions to characterise the scale of the problem.

Delays in delivering hENs are frequent, and their quality often fails to meet the requirements

set out in the request, especially in fast-moving technological fields such as AI, cybersecurity

and green technologies. Over the past 5 years, the Commission has repeatedly extended

deadlines for standardisation requests, amending 21 % of the adopted requests, thereby creating

uncertainty for businesses on when standards will be available33. For instance, the hENs

requested by the Commission to support the AI Act34 are delayed by at least two years and have

not been delivered yet, while standards supporting the Cyber Resilience Act (CRA)35 are also

expected to be delivered after the deadline. In another strategic area like raw materials, despite

clear targets set by the EU Battery Regulation36 and standardisation intentions of the Critical

Raw Materials Act37, the adoption of requests is late. As the High-Level Forum on European

Standardisation (HLF)38 highlighted, standardisation in these fields is essential to ensure a

global level playing field, improve transparency across the value chain and strengthen the

Union’s strategic autonomy. Such delays hinder the EU ability to meet its regulatory targets

and weaken its position in global value chains. The situation is similar in the field of medical

devices, where the delivery of standards has been postponed by at least four years.

The delays and uncertainty as to when hENs will be delivered by the ESS impose additional

compliance costs on businesses, in particular SMEs. When hENs are unavailable, businesses

must rely on more costly third-party conformity assessments39: businesses spend between EUR

30 000 and EUR 80 000 a year per undertaking on the services of notified bodies40. The 2023

impact assessment for the revision of the Toy Safety Directive estimated that on average

EUR 500 is required per new toy model for self-certification based on a hEN, and EUR 1 000

for a conformity assessment by a third-party41 – an estimate significantly higher for more

32 ASTM International, a US standardisation organisation, claims an average standard development time of 18

months for a new standard and less than 6 months for revisions of existing standards (ASTM International, How

are ASTM standards developed?, 2025). IEEE, an international association developing standards, has conducted

nearly one revision per year of the IEEE 802.11 standards on wireless local area networks, compared with only 9

revisions in 21 years for comparable European standards. 33 Commission analysis based on eNorm. 34 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down

harmonised rules on artificial intelligence (Artificial Intelligence Act), OJ L, 2024/1689, 12.7.2024. 35 Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal

cybersecurity requirements for products with digital elements, OJ L, 2024/2847, 20.11.2024. 36 Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries

and waste batteries, OJ L 191, 28.7.2023, pp. 1–117. 37 Regulation (EU) 2024/1252 of the European Parliament and of the Council of 11 April 2024 establishing a

framework for ensuring a secure and sustainable supply of critical raw materials, OJ L 1252, 3.5.2024. 38 HLF, Workstream 15 on Critical Raw Materials - conclusions and recommendations. 39 The availability of a hENs does not automatically exempt a product from undergoing a third-party conformity

assessment as it can be a requirement for certain categories of risky or complex products. However, even in those

cases, the assessment cost becomes substantially lower as it only concerns conformity with the hEN rather than

conformity directly with the essential requirements. 40 Notified bodies services are independent conformity assessment activities (testing, inspection, and certification)

performed by designated organisations to verify that products meet EU regulatory requirements. Data sourced

from the Evaluation Study. 41 SWD(2023) 269 final, 28.6.2023.

9

complex products. The difference in costs between self-certification and certification by

notified bodies is reinforced by the very limited costs of a hEN, between EUR 100 and EUR 120

on average across the EU42. Overall, the Evaluation estimates an average cost saving for each

undertaking of EUR 3 700 per hEN used for conformity assessment43.

Beyond the financial burden on businesses, non-availability of hENs can also slow

developing and scaling of innovative solutions, weaken the EU ability to respond to global

technological developments and emerging risks, as well as undermine its role as global

standard-setter44. In sectors like unmanned aircraft systems, only one of eight requested hENs

was available before the transition deadline, forcing manufacturers to rely on more lengthy and

costly third-party conformity assessments. The Radio Equipment Directive’s cybersecurity

requirements required a postponed application date because the underlying hENs were not

ready in time. These delays leave room to more agile and active SDOs to influence the

international standardisation process45.

In the Open Public Consultation (OPC) for this IA, 66 % of participants (397 out of 599)

reported to have encountered situations in which hENs were not available or made available

with delays. 49 % (296 out of 599) agreed that hENs sufficiently reflect the state of the art.

2.1.2. Problem 2: lack of balanced stakeholder participation challenges quality

of standards

The Evaluation highlights insufficient participation of SMEs, civil society, academia and

research organisations in the standardisation process46. This affects the functioning of the

ESS, including the quality of hENs and their timely delivery, as standardisation significantly

benefits from the participation of societal stakeholders to enhance its legitimacy, acceptability

and relevance47. The lack of diverse input can also hinder the development of inclusive and

forward-looking standards. While the introduction of the Annex III organisations48 in the

Standardisation Regulation has improved inclusiveness at EU level, this has not always

translated into effective participation and influence, in particular at national level. The

Evaluation found that representation remains insufficient for civil society organisations, SMEs

and research organisations, especially in areas with significant societal implications, such as

accessibility, fundamental rights and AI, or where competing technologies are still under

consideration, including where newcomers or smaller organisations seek to contribute49. People

with disabilities continue to face barriers to participation, and accessibility considerations are

not always adequately reflected in the standardisation process.

The Evaluation’s public consultation confirmed these concerns, with stakeholders indicating

that reliance on industry technical expertise may not sufficiently address public-interest

42 The average price of a hEN has been provided by the ESOs and NSBs at the NSB workshop. It is an average

across Member States. Most companies however buy standards via subscription models. 43 Evaluation, p. 48. 44 Evaluation and Draghi Report – The Future of European competitiveness (2024). 45 India and China SDOs claim development times of less than 18 months; China reported meeting this timeframe

for ultra-high-definition video technology, green computing and the Internet of Things standards. 46 Evaluation, p. 67. 47 Impact assessment study, p. 16. 48 The Annex III organisations are: ETUC representing social interests, ANEC representing consumers, ECOS

representing environmental interests and SBS representing SMEs. They are eligible to Union financing under

Article 16 of the Standardisation Regulation to represent their interest in the EU standardisation process. 49 Evaluation, p. 32.

10

considerations, which are essential for hENs. In practice, large companies tend to dominate

technical work, particularly in complex fields such as data governance or environmental

labelling, where participation requires specialist knowledge50 and engagement at national,

European and international levels. This can limit the diversity of expertise and reduce the

relevance, legitimacy and acceptability of standards51 – further discouraging SMEs from

participating in the process as standard deliverables are less adapted to their specific needs.

Empirical evidence from the Evaluation’s public consultation shows that 39 % of respondents

strongly agreed and 42 % agreed that promoting stakeholder engagement to ensure standards

meet market and consumer needs is essential for the ESS’s strategic goals. Empirical research

on standardisation governance supports a direct link between participation and standards

quality52. Empirical evidence on environmental governance also shows that stakeholder

participation has a measurable positive effect on governance outcomes, with the representation

of non-economic interests, including civil society, being associated with stronger outcomes,

while the concentration of economic interests is associated with weaker ones53.

Stakeholder participation also affects the timeliness of hEN delivery in different ways. Broader

participation can lengthen some phases of the process because it requires reconciling a wider

range of views. At the same time, excluding key specific expertise can cause delays in the

standardisation process, as seen for the standard for equestrian helmets (EN 1384), where

insufficient input from consumer associations led to very long duration of standardisation (over

10 years). Thus, while broader participation may extend certain phases, ultimately, it can also

support more efficient and widely accepted outcomes.

Furthermore, the growing lack of experts available to engage in standardisation has become a

concerning trend in Europe. This is driven by several factors, including an ageing workforce, a

gradual loss of expertise, a declining willingness of EU industry to invest time and resources

into standardisation activities as well as an insufficient number of EU firms active in specific

technological fields54. This issue has been formally recognised at policy level: 22 Member

States and 26 member organisations of the HLF signed a pledge in 2023 to contribute to the

education of the new generation of European standardisation professionals55. In parallel,

industry associations have identified the lack of education, training and general awareness on

standardisation as key issues requiring attention56. Participation is further constrained by

limited incentives for the industry, in particular for SMEs facing resource constraints and for

which the expected costs to participate in standardisation outweigh the perceived benefits.

50 For case of ETSI, 27 % of its membership is made of SMEs (ETSI website). 51 Under-representation of those stakeholders leads to standards that lack legitimacy, risk reflecting narrow

interests and more susceptible to rejection or legal challenge. Impact assessment study, p. 16-17. 52 Wiarda, Doorn and Van de Kaa (2024), ranking eighteen criteria for the quality of standardisation processes,

find that diversity of participation is the single most important contributing factor to the quality of standardisation,

ahead of all other criteria tested. Wiarda, M., Doorn, N. and Van de Kaa, G. (2024), Towards responsible

standardisation: investigating the importance of responsible innovation for standards development, Technology

Analysis & Strategic Management. 53 Newig, J., Jager, N.W., Challies, E. and Kochskämper, E. (2023), Does stakeholder participation improve

environmental governance? Evidence from a meta-analysis of 305 case studies, Global Environmental Change.

Beyond standardisation specifically, the broader governance literature supports that inclusive stakeholder

engagement improves the quality of regulatory and rule-making processes: the OECD finds that meaningful

consultation strengthens the evidence base available to decision-makers and improves both the legitimacy and the

practical workability of resulting rules. OECD Regulatory Policy Outlook 2025. 54 Evaluation, p. 22 and 35. 55 HLF: Pledge on education & skills on standards. 56 Evaluation, p. 165.

11

In the OPC for this IA, the inclusiveness of the ESS is not perceived as the main challenge, as

the same high proportion of respondents (67 %, 401 out of 599) considered both the national

and the European level to be inclusive.

2.1.3. Problem 3: requirements for free access to hENs create uncertainty

regarding the sustainability of the ESS

Several judgments of the CJEU57 underlined that hENs,the references of which have been

published in the Official Journal of the European Union (OJEU), form part of EU law owing

to their legal effects58. Therefore, an overriding public interest justifies their disclosure, based

on the principles of the rule of law, transparency, openness and good governance59. As a result,

hENs may no longer be considered as purely technical documents aimed at facilitating

manufacturers’ access to the EU market: they are now recognised as documents which form

part of EU law and must be freely accessible. The CJEU recently held that the same rationale

should apply to standards which are directly referenced in the OJEU60.

These requirements to provide free access to hENs may challenge the financial equilibrium

of the ESS,and in particular of CEN/CENELEC and its member NSBs, whichcontribute to

developing hENs in exchange for the exclusive right to sell them in the EU – see Annex 8.

While the members of CEN/CENELEC operate on a not-for-profit basis, providing access to

hENs free of charge may lead to a decrease in their revenues and alter their business model,

limiting their ability to engage in standardisation activities to support Union legislation and

policy. ETSI is not directly impacted61, as all its standards are available free of charge for

consultation and download on its website. The assessment of this problem is affected by

significant data constraints, notably because key stakeholders seek to preserve the

confidentiality of business information and NSBs do not specifically track sales of hENs. The

analysis therefore relies on data collected through bilateral exchanges, interviews and validation

workshops with stakeholders.

The negative effects on the functioning of the ESS have already been noticeable,

particularly in relation to international standardisation organisations. Indeed, CEN/CENELEC

submitted no new hENs based on ISO and IEC international standards to the Commission for

assessment62 between May 2024 and October 2025 (for ISO) and between March 2024 and

January 2026 (for IEC). This interruption was directly linked to uncertainties regarding the

impact that disclosing their standards in line with the judgements of the CJEU would have on

ISO and IEC. As a result, delays in the implementation of EU legislation arose, creating

uncertainty for manufacturers on how to demonstrate compliance with EU legislation, for

example in the field of medical devices.

57 James Elliott Construction Limited v Irish Asphalt Limited, C-613/14 and Public.Resource.Org and Right to

Know v Commission, C-588/21 P. 58 James Elliott Construction, C-613/14, paragraph 40. 59 Public.Resource.Org and Right to Know v Commission, C-588/21 P, paragraph 89. 60 Judgment of 21 April 2026, Nederlandse Voedsel- en Warenautoriteit and Others, C-155/24,

ECLI:EU:C:2026:327, paragraphs 34 to 38. 61 ETSI is financed by membership fees – see Annex 8. 62 CEN-CENELEC may adopt ISO/IEC standards as hENs and submit them to the Commission for assessment,

ensuring alignment between hENs and existing global standards for efficiency and coherence.

12

In the OPC for this IA, only 40 % of participants indicated that it is not difficult to identify the

legally relevant content of a hEN63 (240 out of 599), the parts of hENs that cover the essential

requirements set out in sectoral legislation.

2.1.4. Problem 4: Diminishing global position and relevance of EU standards

challenge EU competitiveness

Standards can be an essential instrument of international competitiveness.Countries or

regions that project their national standards to the international stage at an early stage can gain

a competitive advantage by influencing global markets towards their own native technology,

especially in emerging markets. For instance, China’s growing influence in ISO’s committees,

allows it to shape global rules to favour its technologies and create lock-in effects in emerging

markets through its 90 Belt and Road agreements64. At the same time, fragmentation of

standards may act as a trade barrier for companies, especially for SMEs. According to the World

Bank, nearly 90 % of world trade is now shaped by non-tariff measures, mostly linked to

standards – up from 15 % in the late 1990s65.

This is reflected in the strategy of several jurisdictions that prioritise standardisation as an

instrument of their competitiveness and national security agenda.In 2021, China issued an

ambitious Standardisation Strategy66, integrated into its Belt and Road Initiative, whereas in

2023, the US published its National Standards Strategy for Critical and Emerging Technology,

and revised its United States Standards Strategy in early 202667. The US reaffirmed that US

standards should “drive the world forward” in AI, biotech and quantum computing, which it

identified as “core, vital national interests”68. Similarly, the EU fosters the strategic use of

standards to support its international competitiveness and technological sovereignty, a key

objective of its 2022 Standardisation Strategy.

While the EU maintains strong participation in international standardisation organisations

(ISOs), its influence is gradually fading, particularly in key emerging technologies. The

European and international standardisation systems are tightly connected: CEN aligns over one-

third and CENELEC more than 80% of their standards with ISO and IEC (see Annex 11) 69.In

2025, NSBs from EU Member States held the secretariat of 300 technical committees (TCs)

and sub-committees (38 % of the total in ISO, slightly below the 40 % in 201070). However,

the EU only holds two out of eleven secretariats for the strategic technologies identified in the

Competitiveness Compass as “the technologies that will matter for tomorrow’s economy”71.

Stakeholders also noted China’s growing influence in ISOs through the active participation of

63 Only certain sections of hEN may be relevant to the essential requirements set out in sectoral legislation. These

sections are usually identified in the Annex Z of the hEN, which was introduced in 2015. 64 Standardisation with Chinese Characteristics? The Missing Pillar in Rebooting Europe’s Industrial Policy,

CKN & Clingendael Report, 2025 65 Standard for Development Overview, World Bank Development Report 2025. 66 Outline for the Development of National Standardization, Beijing, 2021. 67 United States Government National Strategy for Critical and Emerging Technology, May 2023; United States

Standards Strategy 2025. 68 National Security Strategy of the USA, November 2025. 69 CEN CENELEC in figures - Quarterly, 2026 Q1 70 ISO in Figures. 71 A Competitiveness Compass for the EU, p. 5. The technologies identified are AI, semiconductor and quantum

technologies, advanced materials, biotechnologies, clean energy technologies, robotics, space technologies,

connected and autonomous mobility.

13

its experts72. Thus, the EU’s limited influence in emerging technologies, coupled with the

primacy of international standards, could impair its ability to protect its values, interests, and

competitiveness. This decline thus risks directly affecting the ESS.

In the OPC for this IA, more than half of the respondents (65 %, 391 out of 599) believe that

the EU has a strong influence on standardisation internationally, with trade unions being the

only stakeholder group in which respondents opposed to this view.

2.2. What are the problem drivers?

The problem tree in Figure 1 below summarises the problems, drivers and consequences.

Figure 1: Problem tree

2.2.1. Drivers related to Problem 1

Driver 1.1: Lengthy standard development time at each step of the process

The current lack of responsiveness of the ESS lies first and foremost in the current average

delivery time of 6 years for hENs, which is too long to cope with the speed of technological,

industrial and innovative cycles. The Evaluation highlights that the speed of the standardisation

process is hampered at all steps of the process: in the policy phase, covering the adoption of

standardisation requests by the Commission, in the delivery phase, covering the acceptance of

standardisation requests and the drafting of the standards by ESOs, and in the publication

phase, covering submission by ESOs and the publication in the OJEU, including the

compliance assessment by the Commission services.

Figure 2 summarises the key factors; Annex 9 provides a detailed analysis of each factor.

Figure 2: Process for adopting a hEN and key drivers for duration73

72 Targeted interviews with representatives of ESOs, NSBs and the industry. 73 Commission analysis based on the Evaluation, p. 28.

14

Driver 1.2: Lack of flexibility and accountability of the ESS

Another driver of slow standard delivery isthe limited flexibility provided by the current legal

framework.The Commission may only address standardisation requests to ESOs, which in

effect often means a single option as each of the ESOs has specific sectoral expertise. This

exclusive reliance on ESOs can become a bottleneck, especially in niche or highly innovative

sectors where they have limited expertise and where other SDOs are better placed to draft

technical specifications rapidly. In specific sectors, the only way for ESOs to deliver on

standardisation requests is to establish partnerships with other standards development bodies

like ASD-STAN for aerospace and drones, ESA for space or W3C for eAccessibility74 to

integrate their standards into ESOs’ standards (see Annex 13).

Moreover, the Commission has limited options to change the course of a request that will be

late or whose outcome is expected to be of insufficient quality75. There is also no mechanism

to foster standardisation when the consensus building process is blocked for other reasons

(diverging commercial interests, technical difficulties to translate essential requirements)76.

When the ESOs fail to deliver hENs, the only alternative is for the Commission to develop and

adopt CS. However, this possibility does not exist for all legislation relying on hENs, although

the Omnibus IV will increase this possibility.

The lack of flexibility of the ESS is compounded by the lack of accountability and

transparency on the status and performance at each stage of the process. No joint monitoring

tool between the ESOs and the Commission exists to date. While the Commission and ESOs

74 ASD-STAN (Association des industries aérospatiales et de défense de l'Europe – Normalisation) is the

aeronautics and defence industry association. ESA is the European Space Agency and W3C is the WorldWideWeb

Consortium. 75 This has for instance been the case in the standardisation process supporting the IA Act and the CRA. The

Commission fostered the acceleration of the process with the only tool at its disposal by financing the participation

of experts. It awarded grants to support standardisation process through the SMP, the StandICT.eu project and the

CYBERSTAND project. 76 One such example is the difficulty to agree on an international standard for Megawatt Charging Systems for

recharging heavy-duty vehicles. Consensus on an international standard was blocked by diverging technical

proposals based on different commercial interests, with the proposal made by EU and US stakeholders competing

with a different solution proposed by Japan and China.

Delivery phase:

Offering of the standard

Publication phase:

Referencing of the

standard

1.7 years 3.2 years 1.2 years

• Heavy procedural

requirements

• Long negotiations between

Commission and ESOs

• Lack of anticipation and

planning

• Difficulties in reaching

consensus

• Lack of experts / gaps in

technical knowledge

•

•

•

15

have initiated this work following a joint Task Force77, supporting IT tools are not yet fully

operational. Moreover, beyond the legal deadline set out to ESOs for the delivery of hENs,

there are no binding nor indicative deadlines on the different steps of the process, which makes

performance management difficult and leads to uncertainty on whether and when hENs would

be available. The adoption of standardisation requests can also be delayed by lack of

anticipation and planning, such as the insufficient upstream coordination between research

and innovation activities and standardisation processes – resulting in fragmented technical

approaches and limited readiness for consensus-building when standards are needed.

Driver 1.3: Low compliance of submitted hENs

One of the root causes of delays is the frequent misalignment of standards delivered by

ESOs with the legal requirements laid down in EU legislation as set out in the standardisation

requests, leading to high rejection rates (65 % at first review, 32 % at publication stage). These

compliance failures trigger repeated revision cycles, additional scrutiny, and prolonged

discussions between the Commission, HAS consultants78, experts and ESOs (see Annex 9 for

more details on low compliance and its root causes).

Contributing to these failures arediffering interpretations of essential requirements, insufficient

legal guidance during drafting, ESO internal procedures that hinder late revisions and technical

experts’ difficulties with hEN formal requirements79.The frequently long formal objection

procedure, whereby Member States can challenge the compliance of hENs with essential

requirements after they have been referenced, also adds to the uncertainty on the quality and

validity of hEN80.

Driver 1.4: Limited digitalisation

The lack of digitalisation of the standardisation process is a lost opportunity to speed up each

stage of the process. Although new ICT tools have been introduced by ESOs and NSBs, many

drafting, commenting and editorial tasks continue to be done with traditional software rather

than through collaborative digital platforms. Lack of a full digital lifecycle (editable formats,

modern commenting, integrated review workflows) slows drafting and makes roles such as

rapporteurs and editors less efficient. The Commission has digitalised its standardisation

request process through the introduction of the eNorm platform, to ensure that the entire

regulatory chain is traceable, searchable and interoperable.

2.2.2. Drivers related to Problem 2

Driver 2.1: High barriers to participation of SME and civil society

Despite the formal mechanisms for participation introduced by the Standardisation Regulation,

the actual participation of SMEs and societal stakeholders remains limited, particularly at

national level where EU-like regulation mandating inclusiveness does not systematically exist.

77 The ESOs-European Commission-EFTA Taskforce on “Timely European Standards for a Green and Digital,

Single and Global Market” delivered its conclusions on October 2023. 78 Harmonised Standards consultants: external technical experts who support the Commission in assessing the

compliance of hENs with the essential requirements. 79 Impact assessment study, p. 13. 80 Evaluation, p. 27 and 35. Between 2014 and 2024, Member States filed 41 formal objections, 22 % of which led

to restrictions (hence a limitation of the scope of applicability of the hEN). The mechanism functions slowly

requiring on average 21 months before certainty on the hEN is provided to stakeholders.

16

A 2025 Eurobarometer survey81 of over 17 000 EU SMEs identified three main barriers: lack

of resources, complexity and a perceived lack of influence.

The costs of participation remain one of the main barriers. The HLF estimated that

participation in standards-development activities can take from 25 to 30 working man-days a

year per company, a time and resource investment which is generally too high for SMEs82. The

Evaluation estimated the average annual cost of participating in standardisation activities

between EUR 60 000 and EUR 160 000 for an SME83. Moreover, financial support for SMEs

participation in standardisation is limited and uneven across Member States84.The most

common form of support is generally ad hoc, through facilitated access to mirror committees

at national level and invitation to specific TCs meetings (60 %)85; SME awareness of these

mechanisms remains low, particularly for government-led schemes86.This cost-constraint also

applies to civil society organisations and research and innovation actors.

The complexity of the standardisation process is also a specific challenge for SMEs.The

development of standards requires several consecutive rounds of drafting, technical validation

and public inquiry to harmonise the conflicting commercial and legal interests of diverse

stakeholders. The process requires highly specialised expertise and long-term coordination –

often spanning several years – to ensure specifications are technically sound, legally compliant

and interoperable across markets. For SMEs, this complexity is particularly daunting, as the

sheer number of procedural steps and extensive idle periods often exceed their more limited

administrative capacity.

Lastly, the perceived lack of influence of SME and civil society on the standardisation

process discourage their participation.WhileAnnex III organisations contribute to

standardisation in CEN and CENELEC through formal opinion on final draft standards during

the enquiry and voting stage, they have no formal vote in decision-making procedure. At ETSI

however, they participate as full members: they have direct access to ETSI documents, can take

part in the standardisation meetings and can vote on standardisation drafts, although they are

usually outnumbered by the votes from the industry, which represents the majority of ETSI’s

members. The lack of influence of Annex III organisations is amplified by the fragmented

approach at national level: between 25 % and 50 % of NSBs still do not have formal

mechanisms to involve societal stakeholders87. They face even more difficulties to take part in

standardisation at international level, which can heavily influence EU standardisation.

Driver 2.2: Lack of skilled standardisation experts

The shortage of skilled standardisation experts is hampering stakeholders’ participation and

limits the development and maintenance of high-quality standards. The Evaluation Study

identifies the ageing profile of technical expertsas a key structural factor affecting the ESS88.

Assuming a retirement age of 67, approximately one quarter of the current expert pool will have

81 Flash Eurobarometer Survey 559 - Startups, scaleups and entrepreneurship (2025) 82 High Level Forum on European Standardisation, Workstream 3 Report on NSB Peer Review. 83 Evaluation, p. 46. 84 Impact Assessment study, p. 16. 85 High Level Forum on European Standardisation, Workstream 3 Report on NSB Peer Review (including SMEs

and civil society inclusiveness), p. 9. 86 Ibid, p. 10. 87 Evaluation Study, p. 83-84. 88 Ibid, p. 35.

17

to be replaced by 203089.This demographic imbalance creates challenges for the ESOs, notably

in mobilising sufficiently specialised expertise for emerging or highly technical sectors.

The insufficient integration of researchers is another explanation of the insufficient

participation of skilled standardisation experts.Despite recent efforts by ESOs to strengthen

engagement with the research community, participation remains limited due to the cost–

incentive imbalance faced by researchers90. Barriers are similar to those faced by SMEs and

Annex III organisations, including high participation costs, but also include limited professional

incentives and recognition of researchers' contribution to standardisation-related activities in

academic career frameworks, despite the relevance of standardisation for the valorisation of

research results. ESOs have implemented measures to facilitate researchers’ participation,

notably project liaison mechanisms enabling researchers to participate in TCs, horizontal

groups on pre-normative research, dedicated research helpdesks, support staff, online

repositories and enhanced cooperation with the Joint Research Centre91. The Multi-stakeholder

Platform on ICT standardisation also set up a R&I Task Force linking research, innovation and

standardisation. However, available evidence suggests that these measures have had a limited

overall impact. The evaluation highlighted that 41 % of stakeholders did not perceive an

improvement in researcher participation, while 75 % of responding research organisations

considered that the Standardisation Regulation has not been sufficient in ensuring their effective

involvement92. The main underlying factors identified include the complexity of standardisation

processes, the financial burden associated with access to standards and participation (including

travel costs), and the time commitment required for meaningful engagement93.

2.2.3. Drivers related to Problem 3

Driver 3.1: Evolving requirements for access to standards

The judgments of the CJEU as regards the legal nature of standards in EU law have had a

significant impact on the functioning of the ESS, and in particular on CEN and CENELEC and

their member NSBs, which had to develop readability platforms to allow the public to freely

consult hENs. The CJEU did not specify how hENs should be disclosed, notably whether they

should be available for consultation or download and if access concerns the entire standard or

only the legally relevant part. Similar questions remain for directly referenced standards, as free

access to those must be “general, effective, without charge, and non-discriminatory”94. The

uncertainty regarding the appropriate conditions to provide access to hENs is reinforced by the

fact that operational solutions implemented by CEN, CENELEC and the Commission through

readability platforms are being challenged in Court. Opponents argue that these solutions fall

short of the requirements stemming from the principles of rule of law and transparency95, and

that hENs should be made directly and systematically available.

Another consequence of the judgments of the CJEU is the need for greater transparency of

the standardisation process for legislative and policy purposes. Standards forming part of EU

law should be developed along the principles of transparency, openness and good governance.

89 European standardisation panel survey – Final report (2024), p. 21. 90 Evaluation Study, p. 118. 91 Evaluation Study, p. 84-85. See JRC on the Putting Science into Standards initiative. 92 Evaluation, p. 34. 93 Evaluation Study, p. 118. 94 Judgment of 21 April 2026, Nederlandse Voedsel- en Warenautoriteit and Others, C-155/24, para. 38. 95 T-581/24 Public.Resource.Org, Inc. and Right to Know CLG v Commission; T-53/25, Public.Resource.Org and

Right to Know v Commission

18

However, despite some improvements brought by the Standardisation Regulation, the ESS

remains opaque as regards voting patterns, the position of different contributors as well as the

interests represented in the development of hENs. The absence of systematic reporting on

reconciling divergent views or the integration of public interest considerations further

exacerbates this perception of opacity. Following a complaint from a non-governmental

organisation, the European Ombudsman launched an inquiry in 202596 regarding the process

for adopting hENs supporting the AI Act. The complainant was concerned that the Commission

failed to take sufficient steps to ensure these standards are “adopted in a transparent manner

and that the process is subject to accountability”.

Driver 3.2: Reliance of the ESS on the sales of hENs

The challenges regarding the sustainability of the ESS are compounded by the impact of free

access to hENs on the financing of the CEN and CENELEC. hENs, as any standard adopted

by CEN and CENELEC, are sold by NSBs. While CEN and CENELEC and their member NSBs

have diverse business models and funding sources (industry participation fees, public subsidies,

revenues stemming from other activities such as accreditation or training), most of them rely

on the sales of standards to generate revenues and to partly finance the standardisation process

in their Member State.

Providing access to hENs through the readability portals has so far had limited effects on the

revenues of NSBs. The number of requests for access to standards to the Commission surged

since March 2024, with over 850 requests97, out of which 80 % concerned hENs. In practice,

out of the total portfolio of close to 3 100 hENs, access has been requested to 812 of them (26 %

of the total). NSBs have mentioned that no visible decrease in their revenues was observed

since March 202498. Nevertheless, they had to incur investments to set up the platforms to

provide free access to standards99. The limited impact until now can be explained by the

restrictive conditions under which access is granted to hENs (read-only, on-demand), the lack

of awareness that these standards are freely accessible and, more importantly, by the fact that

the main users of hENs (businesses) prefer to pay for having full access to the hENs they need,

often as part of commercial packages covering the entire portfolio offered by the NSBs.

However, NSBs are worried that the revenue stream stemming from their sales of hENs could

decrease more significantly or even disappear as awareness of the possibility to consult hENs

for free gains ground100.NSBs’ legal forms and business models vary widely, as do their

revenues and scope of activities (see Annex 8).The Commission has tried to identify, in close

cooperation with the NSBs, their dependency on the sales of hENs. NSBs do not specifically

track the sales of hENs, notably because many of them rely on a dual selling system based on

subscriptions (yearly fee to access the entire standards database) and individual sales of

standards101. Overall, it is estimated thatthe total sales of hENs by NSBs in the EU represents

96 Case 1974/2025/MIK of 26.09.2025, How the European Commission ensures transparency, inclusiveness and

accountability in the adoption of hENs related to artificial intelligence, European Ombudsman. 97 The Commission received over 300 requests in 2024 from March onwards, over 450 requests in 2025 and over

100 in 2026 until April. 98 Targeted interviews with NSBs. 99 The Commission granted CEN and CENELEC close to EUR 5 million for the development of the platforms for

access to standards, starting in April 2024 and expected to be completed by March 2029. 100 Targeted interviews with NSBs. 101 Targeted interviews with NSBs.

19

around EUR 30 million per year,15 % of the total sales of standards in the EU by the NSBs102.

Given the diversity of business models of NSBs, their dependency on the sale of hENs varies

across the EU, ranging from 1 % to 10 % for larger NSBs that are engaged in multiple activities

to 20 % to 25 % for smaller NSBs more reliant on the sales of standards103. The magnitude of

the shock from free access to hENs on NSBs’ revenues thus depends heavily on the structure

of each NSB and its ability to generate revenues beyond the sales of hENs.

2.2.4. Drivers related to Problem 4

Driver 4.1: More geo-economic competition from third countries

Data from the AFNOR international barometer104 indicate a rise in Asia’s influence in global

TCs and working groups over the past decade. While Europe has traditionally dominated these

activities and still maintains a strong presence, also through its cooperation programmes and

free trade agreements, there has been a marked increase in participation from China, Japan and

South Korea. For instance, China's involvement in ISO committees surged significantly: the

number of TCs it led increased tenfold, while its participation in Working Groups grew by over

1 550 %105 – a rise mostly at the expense of the UK and the US. By 2025, China participated in

778 TCs, ranking as the highest globally, and managed 90 secretariats, trailing only Germany

and the US106.

The US, historically driven by a corporate-led standardisation model, maintains strong

influence through a mix of private-sector leadership and institutional representation: it holds

about 50 % of voting rights in 11 out of 39 international SDOs and 67 % of the IEEE Standards

Board membership, underlining its dominant position in core technical forums107. The US also

appears to be adopting a proactive approach to counter China's growing prominence, aiming to

safeguard its influence in critical technology sectors108. Despite this, the EU still leads in the

overall number of TCs and working groups at ISO, but the shifting dynamics underscore China's

expanding global influence and the US strategic interest in consolidating its position.

Driver 4.2: Lack of EU coordination

Recent research highlights that Europe is still a global standard maker, capable of providing a

significant competitive advantage to EU industry109. This position relies on the strong

connection between European NSBs and the global standardisation ecosystem, the quality of

the ESS as well as the collective relative weight of NSBs from the EU in ISOs.However,

limited coordination between EU actors in ISOs, across Member States, NSBs, the

Commission and European experts, hampers this position. European industry, Member States

102 Data based on submission by NSBs from CEN/CENELEC for the year 2025. This is in line with the share of

hENs the total portfolio of CEN/CENELEC (12 %). The share of hENs in new standards adopted by

CEN/CENELEC is however increasing over time and represents on average 17 % since 2019. 103 Annex 8 explains the methodology to estimate the sales of hENs by NSB belonging to CEN/CENELEC and

details the results while respecting confidentiality of the information provided by the NSBs. 104 AFNOR (2025), barometer international, Edition 2025. 105 The increasing dispute between USA and China over international standardization, Padula and Pizetta. 106 Standardisation with Chinese Characteristics?, CKN & Clingendael Report, July 2025. 107 Securing Global Standards for Innovation and Growth, Shivakumar (2022). The IEEE Standards Board

coordinates the development and revision of IEEE standards. 108 The geopolitics of technology standards: historical context for US, EU and Chinese approaches, Blancato et al.

(2024). 109 Loyau and Bijlmakers, Standards made in Europe for global use, p. 1334, Innovation: The European Journal

of Social Science Research, 2024.

20

and ESOs have expressed concern about lost opportunities linked to insufficient coordination

and sharing of information110. Before the creation of the HLF, there was no governance

structure that allowed ESOs, NSBs and Member States to exchange information and positions

on international standardisation matters, contrary to the discussions on European

standardisation that take place in the Committee of Standards. The need for more active

discussion on international standardisation matters has been reflected by the creation in 2026

within the HLF of a dedicated workstream on “Global standard setting and the EU position”.

While this represents a positive step forward, there is a general lack of awareness, training and

experience sharing across EU experts taking part in international standardisation activities111.

Last, there is no mechanism in the Standardisation Regulation to coordinate the

implementation of strategic autonomy objectives in standardisation and to address the

increased geopolitical and economic competition in international standardisation. Contrary to

existing possibilities in EU-funded research projects112, the Standardisation Regulation does

not include any mechanism to ensure standardisation in support of Union legislation and policy

is conducted by EU actors, nor the possibility to mandate ESOs to deviate from international

standards if such standards would be contrary to EU values and interest.

2.3. How likely are the problems to persist?

The structural problems and problem drivers set out above will remain and likely aggravate

failing strong policy action from the EU.

The difficulties of the ESS to deliver timely standards for legislation and policy purposes and

the lack of alternative options for the Commission will continue in the future in the absence of

any changes to the legal framework. The Standardisation Regulation, coupled with the case law

of the CJEU, embeds the lengthy and complex process for delivering standards to the

Commission. While increased cooperation with ESOs has led to improvements, the average

duration of the standardisation process is not expected to decrease significantly if no

changes are brought to the overall legal and administrative process. ESOs and the Commission

launched the joint EC/ESO/EFTA task force running over 2021-2023 to find operational

solutions to eliminate bottlenecks, maximise efficiency of processes on both sides, better

anticipate future standardisation needs and clarify respective roles and interactions. The Task

Force led to procedural improvements, notably the introduction of joint checklist for

standardisation requests and assessment of standards as well as to better integration of IT tools.

While this led to quality improvement and better cooperation between ESOs and the

Commission, this was insufficient to have measurable impact on the time needed to deliver

standards. Moreover, the Task Force identified 7 “fast-track” projects with the aim of ensuring

delivery in 18 months. However, the initial assessment is that the 18-month target will not be

met for most of these projects113.

110 Targeted interviews with NSBs, ESOs and five EU industry organisations. 111 Evaluation Study, p. 183. 112 Notably Article 22(5) of the Horizon Europe Regulation establishing the Horizon Europe Programme for

Research and Innovation, OJ L 170, 12.5.2021, pp. 1–68. 113 The 7 projects identified focusses on high priority standards from a policy perspective, in the field of cyber-

security, cyber resilience, trusted data and low carbon cement. The sensitivity and complexity of these technologies

make it very difficult to reach a fast consensus among the experts on the content of the standards, despite enhanced

cooperation with the Commission services introduced by the Task Force.

21

The insufficient participation of SMEs, civil society organisations, public authorities and

academia in standardisation remains a persistent issue, although the Standardisation Regulation

has delivered clear improvements compared to the pre-2012 framework. However, these

advances have primarily strengthened formal access, while effective and sustained participation

continues to be constrained by structural factors.

The uncertainty on the long-term sustainability of the ESS is also likely to persist.First,

several upcoming rulings by the CJEU are expected to shed light on whether the conditions

under which access is granted to hENs comply with the principles of the rule of law,

transparency, openness and good governance114. Second, while some NSBs have initiated steps

to decrease their financial reliance on the sales of hENs, some NSBs remain dependent on this

source of revenue to finance their standardisation activities and have limited opportunities to

identify alternative revenue sources115. The uncertainty regarding the financial sustainability of

the ESS also increases the risk that ESOs’ incentives to engage in the public/private partnership

for EU standardisation would decrease, thereby endangering the sustainability of the ESS in the

long run as well as the ability of the Union to rely on standards to support legislation and policy.

Last, the current trend of increasing international competition in the standardisation

process is likely to amplify as main actors plan to continue investing in standardisation (China,

the US) and other actors plan to increase their investments (e.g. India). The EU risks further

losing influence in the international standardisation system, impeding its competitiveness and

the ability to support its values in global standardisation systems.

3. WHY SHOULD THE EU ACT?

3.1. Legal basis

The Standardisation Regulation’s legal basis is Article 114 of the Treaty on the Functioning

of the European Union for the adoption of measures for the approximation of the provisions

laid down by law, regulation or administrative action in Member States which have as their

object the establishment and functioning of the internal market.

3.2. Subsidiarity: Necessity of EU action

EU-level action is necessary to ensure an efficient and harmonised ESS that contributes

to the functioning and competitiveness of the internal market. The EU faces global

competition from other major economic blocs along with various other challenges and needs to

ensure that the internal market remains competitive, accessible, innovative and continues to

promote a level playing field.

Considering the role standards play in guaranteeing the interoperability and safety of products

and services within the EU internal market, improving the ESS responsible for developing

European standards at EU level is necessary. European standards are common across all

Members States and the EEA and significantly decrease the barriers within the internal market

as they foster inter-operability, value-chain integration as well as consumer confidence across

114 T-581/24 Public.Resource.Org, Inc. and Right to Know CLG v Commission, T-53/25, Public.Resource.Org and

Right to Know v Commission. 115 Targeted interviews with NSBs.

22

Member States. Moreover, the problems affecting the functioning of the ESS are of

common EU nature and shared by all Member States.

A cost-effective and timely standardisation system to support Union policy and legislation

is unattainable by Member States acting alone. In the absence of EU level action, the

identified problems would persist, as Member States are unable to enact the appropriate

measures to foster a resilient ESS that supports the internal market and maintains EU global

competitiveness. If no such action is taken, Member States might find alternative pathways to

foster national standardisation outside of the ESS. Fragmentation in approaches by different

national and sectoral actors would erect barriers to entry and risk creating inequalities within

the internal market. Last, the measures concern actors operating at EU level, therefore national

measures would not be able to coherently enact the necessary changes.

3.3. Subsidiarity: Added value of EU action

Action at EU level to tackle the identified problems would be conducive to a more harmonised,

effective, efficient and coherent outcome across the internal market in support of the broader

strategic objectives of the Union. It would address the shortcomings in the current ESS

framework in a comprehensive manner.

The Evaluation shows that the added value of the ESS lies in its contribution to increased intra-

and extra-EU trade, reduced compliance costs, increased influence on international

standardisation and improved inclusiveness in the development of standards, compared to

national systems. Standards are essential to the effective functioning of the internal market and

to EU competitiveness, technological sovereignty and ability to conduct the green and digital

transitions. EU action to improve the functioning of the ESS and address the problems identified

would improve the functioning of the internal market through faster and higher quality hENs

and create economies of scale for Member States, notably in ensuring the inclusiveness of the

standardisation process and in consolidating the EU’s influence in international standardisation.

4. OBJECTIVES: WHAT IS TO BE ACHIEVED?

4.1. General objectives

Three general policy objectives have been identified for the revision of the Standardisation

Regulation to address the problems identified above, in line with the current objectives of the

Regulation as well as with the Union policy objectives.

Fostering global EU competitiveness and technological sovereignty

The ESS supports innovation and market access by providing a uniform technical

framework that fosters the adoption of innovation by market operators, ensures interoperability

and facilitates trade, allowing businesses to integrate new products into global supply chains

without facing unnecessary technical barriers while ensuring consumer trust in the products and

services. It can help EU technologies achieve first-mover advantages in global markets by

embedding EU-derived technical rules into international standards116. This is only possible,

however, if EU standardisation processes are sufficiently agile, inclusive and strategically

116 For example, China has been adopting several voluntary and mandatory national battery standards to support

its rapidly expanding industry – see analysis from SESEC, China Introduces Mandatory Battery and Vehicle

Standards with Implications for Foreign Stakeholders.

23

coordinated. Standards also prevent lock-in into proprietary solutions, often owned by non-EU

firms. This reduces barriers to export and allows European firms, including SMEs, to compete

more effectively against non-EU firms in strategic sectors. hENs also reduce dependency on

third-country technical regimes, thereby contributing to technological sovereignty, a central

thread of the Compass’s ambition to close the innovation gap and reduce external dependencies.

Ensuring the better functioning of the EU internal market

hENs eliminate technical barriers within the internal market by ensuring that products,

services and systems meeting these standards can circulate freely across all 27 Member States

while safeguarding a high level of consumer protection by embedding health and safety

requirements. This efficiency directly supports the Compass’s goal of removing barriers and

making it easier for companies, especially those operating across borders, to scale without

facing divergent national technical requirements, which requires the timely availability, legal

robustness and consistent application of hENs across Member States.

Reducing regulatory costs for EU businesses, in particular SMEs

hENs are a key simplification tool for businesses as they clarify technical expectations for

compliance with EU legislation. They reduce the need for bespoke compliance solutions and

lower the cost and complexity of conformity assessments. This aligns with the Compass’s target

of cutting regulatory costs, in particular for SMEs. Inclusive standardisation processes leading

to quality hENs can reduce legal uncertainty and the need for multiple national assessments.

4.2. Specific objectives

To achieve these objectives, the revision of the Regulation should address the problems and

their drivers identified in section 2. Three specific objectives have been identified.

Specific Objective 1: Improving the responsiveness of the ESS

This first specific objective focuses on the performance of the ESS. Improving its

“responsiveness” aims at addressing the persistently slow and uneven delivery of hENs, by

making the system faster, simpler and more agile. From an operational perspective, this means

(i) ensuring standards are delivered on time to support EU legislation; (ii) increasing the

overall speed of standardisation in support of EU legislation and policy; (iii) increasing the

flexibility of the ESS to increase reactivity and avoid bottlenecks, and (iv) increasing the

quality of standards, closer to the state of the art.

Specific Objective 2: Ensuring the a financially viable and inclusive ESS

The second specific objective focuses on the functioning of the system, ensuring that relevant

stakeholders actively participate in the process and that rules for access to standards with a legal

effect are stable and predictable and allow for the ESS to continue delivering standards for

Union legislation and policy purpose. From an operational perspective, this means (i) increasing

the incentives for SMEs to participate in the ESS, (ii) improving the inclusiveness of the

ESS for civil society stakeholders, (iii) ensuring continuous incentives for industry and

experts to participate in standardisation, (iv) ensuring the financial sustainability of the ESS

and (v) ensuring free access to standards and providing public information on standards-

development processes. Specific Objective 2 thus aims to address two problems identified in

the Evaluation and in the section 2 of the IA: the lack of balanced stakeholder participation and

uncertainty regarding the sustainability of the ESS linked to the new requirements for free

access to standards. The two problems are linked because they both affect the financial viability

24

of the NSBs. Legal requirements as regards free access to hENs impact the revenues of NSBs

and the financial incentives of ESOs and NSBs to develop and deliver hENs. The financial

sustainability of the NSBs is also closely linked to its inclusiveness as fostering stakeholder

participation in the standardisation process is important part of the costs of NSBs and the

functioning of the ESS. The direct link between financial sustainability and inclusiveness is

also highlighted by the Union’s financial support to the ESS that is directed either at financial

sustainability (financing of ESOs’ operating grants) or at inclusiveness (financing of Annex III

organisations and of industry participation in the standardisation process).

Specific Objective 3: Consolidating the EU influence in international standardisation

The third specific objective aims at consolidating the EU position in international

standardisation, in light of increasing geopolitical strategic competition and of the importance

of international standards for the competitiveness of EU industry. From an operational

perspective, this means (i) improving coordination and participation of EU actors in

international standardisation, and (ii) fostering the ability of the EU to maintain its strategic

autonomy in standardisation.

5. WHAT ARE THE AVAILABLE POLICY OPTIONS?

5.1. What is the baseline from which options are assessed?

The baseline scenario is based on the existing Standardisation Regulation. It is a “no-

policy-change” scenario: it assumes that non-legislative changes and relevant legislative

initiatives either adopted or proposed are implemented, i.e. the Omnibus IV (expected adoption

in 2026). A description of the current governance and resources in the Commission for

European standardisation is provided in Annex 12. No improvement to the situation identified

in Section 2 is expected, apart from three measures described below, impacting responsiveness

and sustainability of the ESS.

ESO-driven digitalisation of the ESS

While the ESS has traditionally relied on the production and use of human-readable, document-

based standards, ESOs are currently working on digitalising both the standardisation

process, through the Online Standard Development project (OSD) and its deliverables,

through the SMART (Standard Machine Applicable Readable Transferable) project117. The

objective is to move from document-centric to data-centric standards118. Expected benefits

include faster collaboration, automation and iteration, reducing the time needed to resolve

comments119, improved quality through the facilitation of knowledge transfer between research

projects and standardisation bodies, reduced human error, and simplified exchanges and quality

checks120. Moreover, digitalisation is expected to foster the inclusiveness of the standardisation

process by decreasing the costs to participate, notably cutting travel costs to take part physically

in TC meetings. The SMART project of CEN/CENELEC will also enable to develop value-

added services based on standards, such as. training, compliance support, process integration

117 Evaluation Study, p. 111. 118 Standards will become machine readable in a format that provides structured content that can be recognised

and validated by software. 119 Workshop with NSBs. 120 OSD could notably reduce manual extraction, decrease interpretation errors, improved traceability of

requirements for conformity assessment and enable earlier detection of non-compliance.

25

advice on how to apply standards or services to integrate standards in the activity of

customers121.

One of the main effects of the digitalisation process engaged by the ESOs will be to speed

up standardisation. CEN/CENELEC estimate development time could be cut by 25-50 %,

reaching 18-24 months versus the current 3-year average122. Considering that these projects are

on-going, the conservative lower end (-25 %) is retained for the baseline123. The targeted survey

to companies and industry associations confirms the potential of digitalisation: 82 % of

respondents saw digitalisation as contributing to the responsiveness of the ESS124.

The ambitious digitalisation of the ESS will require significant investments, mostly borne

by the ESOs and the NSBs. Through action grants under the Single Market Programme (SMP),

the Commission provided over EUR 1.1 million to finance the SMART and OSD projects until

end 2027125, and is in the process of financing a similar project for ETSI for EUR 0.4 million126.

The Commission also provided EUR 1.7 million127 to improve the ESOs’ IT systems and ensure

their interoperability with the eNorm system. The adjustment costs for the Commission itself

will be limited since investments have already been made to articulate the IT systems (the costs

of the eNorm system are EUR 1.0 million per year over 2025-2027).

Common specifications under Omnibus IV

The Omnibus IV proposal extends the possibility for the Commission to adopt CS to 13

Directives and 4 Regulations of the NLF128. With this proposal, 95 % of hENs would support

a legislation that includes the possibility to adopt CS, up from 50 % – see Annex 9. However,

effects will likely remain limited, as CS do not increase the speed of standardisation as they can

only be adopted when the ESOs are late or fail to deliver. CS have also until now very rarely

been used as a policy tool129. The main benefit is to increase legal certainty by ensuring market

operators can benefit from presumption of conformity even when the standardisation process is

blocked. It would in addition increase the incentives for ESOs and industry to deliver hENs as

the OPC for this IA shows that CS are not among the preferred solutions of stakeholders when

there are no hENs at the time of applicability of the legislation130.

Developing and adopting CS will incur additional administrative costs on the

Commission. It will have the responsibility to mobilise the relevant expertise to draft the CS,

121 The business-oriented benefit of smart standards in standard application processes, 2024, DIN and DKE.

Information retrieved from targeted interviews to NSBs. 122 Impact Assessment study, p. 32. 123 This assumption is reinforced by the results of the OPC, in which stakeholders identified risks in shifting work

to online platforms as this could disrupt the traditional way experts collaborate. 124 Targeted survey to companies and industry associations (203 respondents out of 247). 125 European Commission - Financial Transparency System. 126 The grant agreement supporting the ETSI project to start the process towards the implementation of smart

standards is expected to be signed in 2026 and shall last until 2028. 127 EUR 1.5 million for CEN/CENELEC and EUR 0.25 million for ETSI. European Commission - Financial

Transparency System. 128 See Annex 9 for more information about changes introduced by the Omnibus IV proposal regarding CS. 129 In recent years, the process to Commission adopted CS in the framework of the Medical Device and In Vitro

Medical Device Directives. CS were adopted after 3 to 5 years, showing that the drafting time is not shortened

compared to hEN. 130 Respondents to the OPC preferred using previous editions of standards (26 %, 83 out of 320), technical

specifications developed by ESOs (23%, 74 out of 320) or international standards (17 %, 54 out of 320) ahead of

CS (14 %, 45 out of 320). However, none of these options provides presumption of conformity.

26

notably through dedicated expert groups, and to assess if the CS accurately reflect essential

requirements. The impact would be proportional to the number of CS adopted as there are

limited economies of scale due to their technical nature. The industry would play a similar role

in developing CS as in the standardisation process and bear most of the costs by providing

resources and expertise.

Access to standards through readability platforms

The Commission, CEN-CENELEC and NSBs have cooperated to provide access to hENs free

of charge by creating European131 and national readability platforms132 that give read-only

access to hENs based on individual requests133. This has led to improved access to hENs for

industry, SMEs, and the general public, with limited direct effect on NSBs’ revenues.

Althoughthey have not been in place for a sufficient amount of time (2 years) to draw solid

conclusions, only 3 of 17 NSBs reported a meaningful use of their platform in terms of access

and loss of revenues134. The targeted survey with industry organisations and companies

indicated a very low awareness of such platforms as more than 82 % of respondents were

unaware of or rarely used the platform135. The limited impact on NSBs’ sales is also explained

by the fact that the price of hENs is not perceived as a barrier136. Thus, it is unlikely that the

current conditions of access to hENs affect NSBs revenues137.

The set-up of the readability platforms required significant initial investment from the

Commission, leveraging existing tools such as the EASE platform for access to documents and

the eNorm platform.The Commission also supported the financing of the ESOs and NSBs

platforms with a EUR 5.0 million action grant, running until end 2029138.

5.2. Description of the policy options

Three policy options are considered, while another one was discarded at an early stage.

Policy Option 1: a modernised ESOs’ monopoly retains the core structure of the current

ESS, with ESOs remaining the only standardisation organisations entitled to receive requests

from the Commission. Targeted improvements are introduced to enhance the responsiveness of

the ESS, ensure its sustainability and foster international influence. Policy Option 2: an ESS

centred on ESOs with new flexibilities retains ESOs as the cornerstone of the ESS but

introduces two key innovations:alternative routes for the Commission to request standards

and free and unrestricted access to hENs.Last, Policy Option 3: an open ESS managed by the

Commission marks a fundamental departure from the current ESS, replacing the ESOs’

131 eNorm Platform – Access to harmonised standards. 132 CEN/CENELEC has set up a portal that gives access to all the available national readability platforms:

https://harmonized.standards.eu/. 133 hENs are disclosed according under Regulation (EC) No 1049/2001 on Access to Documents. The platforms

also grant access to standards directly referenced in Union legislation with a legal effect. 134 Targeted interviews with NSBs/NCs/NSOs. Impact for these NSBs was a 6 % decrease in sales of hENs. 135 Targeted survey with industry organisations and companies. 29 % (72 respondents out of 247) were unaware,

28 % consulted rarely (68 out of 247) and 25 % never (62 out of 247). 136 Targeted survey with industry organisations and companies. 5 SMEs respondents out of 108 declared to have

requested access when a standard was considered too expensive. 137 The impact on NSBs’ sales could gradually increase with increased awareness of the readability platforms.

However, standards are purchased once and not every year, hence the impact of access on revenues is not

cumulative. In the baseline, a no-revenue loss is assumed. 138 European Commission - Financial Transparency System

27

monopoly with a publicly managed system, in which the Commission can choose the most

relevant SDO for each request and publishes hENs in the OJEU.

Policy Option 1: Modernised ESOs’ monopoly

To address Objective 1 (improving responsiveness of the ESS), a first measure is to foster the

integration of publicly available specifications from other SDOs into the ESS (Measure

1.1). ESOs would be requested specifically in standardisation requests to incorporate high-

quality technical standards or standardisation deliverables developed by other SDOs. ESOs are

already developing this possibility under the PAS (Publicly Available Specification) process,

for which they enter into structural agreements with other SDOs on the integration of their

standards or technical specifications into their own standardisation process. This approach

would enable ESOs to better leverage technical expertise where it is available and closer to the

state of the art, thereby speeding up the standardisation process for critical technologies like AI,

cybersecurity, or clean technologies. An additional measure to improve responsiveness includes

the consolidation of the use of CS by the Commission into the Standardisation Regulation

(Measure 1.2). This will streamline the conditions of use and the process for the Commission

to develop CS when ESOs fail to deliver hENs on time or meet expected quality levels,

including by clarifying the interaction between CS and hENs and allowing the Commission to

build on existing ESO work to develop CS while ESOs continue to develop a hEN to replace

the CS. The option also introduces a presumption of conformity on a temporary basis for

standardisation deliverables other than standards (Measure 1.3). This measure enables

faster market access where hENs are still under development, but essential requirements can be

covered by a standardisation deliverable that has not yet reached the full consensus stage139.

The presumption of conformity would be time-limited and subject to the continuation of the

standardisation process with the objective of transforming the standardisation deliverable into

a hEN. To foster transparency and accountability within the ESS, this measure would improve

strategic planning of standardisation by improving the anticipation of standardisation needs

to support upcoming policies and legislation (Measure 1.4). This would notably take place

through a better articulation of short- and long-term standardisation needs in the Annual Union

Work Programme on European standardisation (AUWP) and through the introduction of KPIs

on the Commission’s and ESOs’ performance, including on timeliness, quality and stakeholder

participation. The introduction of deadlines for the Commission and ESOs would also further

increase transparency about the process, better planning and reduce unnecessary delays. This

will be complemented by the simplification of the legal process to deliver hENs (Measure

1.5). Binding deadlines at key steps in the process would be introduced to improve

predictability. The measure would also accelerate the decision-making process by removing

the requirement for comitology procedure for adopting standardisation requests, by

simplifying the process for formal objections to published hENs and by mandating the

submission of digital hENs and fostering their development using online tools. It would also

introduce a collective decision mechanism on formal objections to hENs to increase legal

certainty and reduce the average duration of the formal objection process.

For Objective 2 (ensuring a financially viable and inclusive ESS),this option retains the current

system of readability platforms providing read-only access to hENs on request. This option

extends the requirements in Article 6 of the Standardisation Regulation applying to access to

139 Such standardisation deliverables could be adopted by ESOs faster through less procedural steps and even in

case no full consensus has been reached on all technical aspects, as long as a majority of stakeholders and NSBs

agree, similar to the process currently used for technical specifications. The standardisation deliverable would still

meet requirements of inclusiveness and transparency and cover the essential requirements.

28

SMEs to all civil society organisations to enhance their participation in the standardisation

process(Measure 1.6). These stricter requirements for NSBs would include financial

incentives, such as free access to draft and adopted standards or special rates for standardisation

activities, as well as procedural incentives, such as identifying relevant projects and allowing

participation without membership. This option also includes measures to increase incentives to

foster experts’ participation in standardisation, in particular targeted at the R&I community,

by increasing awareness of experts on the standardisation process and by better coordinating

public financial support (Measure 1.7). This would notably include greater awareness of

standardisation in research and academic curricula, recognition of pre-norms, closer links

between research results and standards development, free access for researchers to relevant

standards and draft standards, and awareness-raising also for industry experts, in particular

SMEs. Last, the option introduces transparency registers to allow the public identification of

interests represented and active in the standardisation process for hENs (Measure 1.8). ESOs

would be required to set up online transparency registers for this purpose.

For Objective 3 (consolidating the EU’s influence in international standardisation), this option

introduces an EU-Member States coordination mechanism (Measure 1.9) to improve sharing

of information on international standardisation and foster more coherence of NSBs’ and EU

experts’ positions. This mechanism would include regular coordination meetings chaired by the

Commission to exchange on the EU perspective on key developments in ISO, IEC or ITU,

while NSBs would retain the independence of their vote. It would also include an information-

sharing mechanism between the Commission, ESOs and NSBs. The option would also clarify

the possibility to restrict participation in ESO TCs to EU/EEA actors in specific and

targeted cases involving sensitive sovereignty or strategic areas, such as defence or critical

technologies (Measure 1.10). Any such clarification would need to remain consistent with

WTO rules. The option otherwise maintains the baseline approach to international cooperation,

based on the “international first” principle.

Policy Option 2: An ESS centred on ESOs with new flexibility

To address Objective 1 (improving the responsiveness of the ESS), this option retains measures

1.1 to 1.5 introduced in Option 1. It adds the possibility for the Commission to directly send

standardisation requests to alternative SDOs other than the ESOs (Measure 2.1). The

Commission could address requests to other SDOs under specific conditions, such as when

ESOs decline a request, fail to meet deadlines or quality expectations, or when the Commission

considers that an alternative SDOs would be objectively more relevant after having consulted

the ESOs. To ensure sufficient quality of the provided standards and notably the inclusiveness

of the process conducted by alternative SDOs, the Commission would only be authorised to

rely on vetted SDOs that respect the WTO principles for standardisation, can ensure an

inclusive standardisation process and adequately represent EU interests. These vetted

organisations would have to comply with criteria inspired by the current Annex II of the

Standardisation Regulation. This measure would not eliminate the ESOs’ central role in the

ESS, as they would be consulted first on their ability to deliver hENs. As a significant departure

from current practice, standardisation requests to alternative SDOs would be consulted and

validated by Member States through the Comitology procedure, to ensure all national interests

are taken into account as alternative SDOs would not ensure the same formal representation of

national interests currently enabled by ESOs.

This option also introduces a Chief Standardisation Officer (CSO) in the Commission,

supported by an EU Expert Centre (Measure 2.2). The Centre would be tasked with

coordinating the expertise on standardisation in the Commission and with identifying and

29

managing standardisation requests to alternative SDOs. It would also help ensure that such

requests are aligned with EU priorities, implemented in a consistent manner, while supporting

the mobilisation of experts, the elaboration of common specifications and the coordination of

EU experts in international standardisation.

For Objective 2 (ensuring a financially viable and inclusive ESS), this option introduces free

and unrestricted access to hENs (Measure 2.3). Access would be provided via a central

repository, which could be managed by ESOs, and / or by the Commission140, through an online

portal. Unlike Option 1, which only provides on-demand, read-only access upon request, this

option allows unrestricted access for any user. In practice, this would require a central

repository where users could consult hENs free of charge, under general and non-discriminatory

conditions and without having to identify themselves, with searchable consultation features and

potentially download features. This option introduces binding requirements for NSBs to

foster the participation of SMEs and civil society representatives, based on the current

measures of Article 6 of the Standardisation Regulation(Measure 2.4). This would include

financial incentives at national level, such as reduced fees, as well as measures facilitating

effective participation. The option also retains measures 1.7 and 1.8.

For Objective 3 (consolidating the EU’s influence in international standardisation), in addition

to measure 1.9 and 1.10, this option introduces the possibility to derogate from the

"international first" principle in defined cases141 (Measure 2.5). This would ensure the

possibility to adopt hENs that reflect EU values and interests in parallel to existing international

standards in strategic or sovereignty-sensitive areas. In such cases, the Commission could issue

requests requiring the EU side to lead under the Vienna/Frankfurt framework142 or,

alternatively, to pursue European standardisation separately from international standardisation,

with limitation of participation to EU-based entities where needed.

Policy option 3: An open ESS managed by the Commission

To address Objective 1 (improving the responsiveness of the ESS), this option retains measures

1.1 to 1.5. This option eliminates the ESOs’ exclusive right to receive standardisation

requests by allowing the Commission to submit standardisation requests to any SDO (Measure

3.1). Unlike Option 2, which retains a sequential preference for ESOs, this option grants the

Commission full discretion to select SDOs based solely on merit, without embedded

preferences or prior obligations. This could be implemented either through an expanded

Annex I, listing vetted SDOs meeting minimum requirements for trust, quality and

inclusiveness, or through a fully open competitive model in which requests could be addressed

to any SDO, with case-specific requirements set in the standardisation request.

To address Objective 2 (ensuring a financially viable and inclusive ESS),this option ensures

public access to hENs by publishing them in OJEU (Measure 3.3). This approach would make

140 Free and unrestricted access would also be granted to hENs stemming from alternative SDOs; this could be

done either through the ESOs/NSBs platform or through the Commission’s platform. 141 Derogations from the primacy of international standards are in principle justifiable under the WTO TBT

Agreement and EU FTAs, in cases where an international standard or relevant parts of it would be an ineffective

or inappropriate means for the fulfilment of the legitimate objectives pursued. 142 The Vienna Agreement and Frankfurt Agreement are framework accords designed to harmonize international

standards with European standards. Their primary purpose is to avoid duplicate work, pool technical expertise,

and streamline global trade by allowing a single standard to be approved simultaneously at both levels. See:

https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/standardisation-

policy/international-activities_en.

30

hENs publicly available in their entirety in all official languages, placing them in the public

domain. This would replace the current practice of publishing only references to hENs in the

OJEU and could have budgetary implications if the Commission were to compensate SDOs for

standards development. To ensure inclusiveness, this option introduces mandatory

participation and inclusiveness requirements for SDOs to be eligible to receive

Commission requests (Measure 3.4). These requirements could include compulsory lower fees

for SMEs, academia and civil society. Additional ad hoc participation requirements could also

be inserted in individual standardisation requests.

For Objective 3 (consolidating the EU’s influence in international standardisation),this option

retains measures introduced in Option 1 and 2 (Measures 1.9 and 1.10) but also provides the

possibility for the Commission to exercise full discretion on whether to align with the

"international first" principle or prioritise EU-specific standards in strategic sectors

(Measure 3.5). Since this option introduces the possibility to choose on a case-by-case basis the

SDOs requested to deliver a hEN, it would allow the EU to align standards with its priorities,

values, and interests for each standardisation request, but could also widen the gap between

European and international standards.

To support the implementation of all measures, this option establishes an EU Standardisation

Office (Measure 3.2), centralising the Commission’s expertise on standardisation.The Office

wouldidentify the most appropriate SDO for each standardisation request,ensure effective

access and inclusiveness of the standardisation process and coordinate EU positions in global

fora to strengthen global influence. It would also oversee possible compensation for standards

development or acquisition and would regroup Commission resources currently engaged in

implementing the Standardisation Regulation under a more centralised governance model.

The measures introduced in each option are listed in Figure 3 and described in Annex 10.

Options 1 and 2, although presenting important differences, build on one anotherand explore

various improvements to the current ESS without fundamentally modifying the way it

functions. The policy measures are grouped for coherence and level of ambition, with a gradual

approach from relatively lighter regulatory changes in Option 1 to more wide-ranging changes

in Option 2. Option 3 marks a more pronounced departure from both the baseline scenario

and the other two policy options, as it explores a significant change in the way the ESS is both

organised and managed.

Figure 3: Overview of policy measures and options

31

5.3. Option discarded at an early stage

During the initial scoping phase, the option to eliminate the presumption of conformity

provided by hENs was considered to combine the need to comply with the requirements to

provide free access to standards with the preservation of NSBs’ business models. The rationale

was that, without presumption of conformity, hENs would lose their legal effect, thereby

resolving conflicts regarding free public access to hENs. However, this option was discarded at

an early stage due to severe drawbacks that outweigh its benefits. The presumption of

conformity is a cornerstone of the EU’s NLF, serving as a critical tool for harmonisation in the

internal market, facilitating trade and innovation. The option would have led to:

• Increased fragmentation of the internal market: manufacturers could face divergent

national interpretations of essential requirements, increasing technical barriers to trade.

• Loss of legal certainty: businesses would lose a reliable, EU-wide compliance pathway,

increasing regulatory uncertainty and compliance costs that would have to be undertaken at

national level (e.g., duplicate testing for each Member State).

• Weakened EU competitiveness: it would have decreased industry’s incentives to

participate in standardisation to support Union legislation, thereby impeding the EU’s

ability to effectively enforce key legislation for the EU’s competitiveness.

6. WHAT ARE THE IMPACTS OF THE POLICY OPTIONS?

6.1. Methodology

As highlighted in the Evaluation, assessing the effects of the Standardisation Regulation is a

complex exercise since it supports the implementation of a wide range of sectoral legislation.

Both the use and actual benefits of hENs differ across sectoral legislation, depending on the

requirements with which hENs ensure compliance. There are also few economic literature

and conceptual frameworks on the contribution of hENs to the functioning of the internal

market, competitiveness and technological sovereignty. Last, there is a scarcity of data from

Option 1: ESS centred on ESOs Option 2: ESS centred on ESOs Option 3: Open ESS

1.1 Integration of standards from other SDOs by ESOs

1.1 Integration of standards from other SDOs by ESOs

1.1 Integration of standards from other SDOs by ESOs

1.2 Common specifications as fall- back to hENs

1.2 Common specifications as fall-back to hENs

1.2 Common specifications as fall-back to hENs

1.3 Temporary Presumption of Conformity

1.3 Temporary Presumption of Conformity

1.3 Temporary Presumption of Conformity

1.4 Improved strategic planning and accountability

1.4 Improved strategic planning and accountability

1.4 Improved strategic planning and accountability

1.5 Simplification and digitalisation 1.5 Simplification and digitalisation 1.5 Simplification and digitalisation 2.1 Flexibility to address requests to

alternative SDOs 3.1 Open selection of SDOs for

requests 2.2 EU Expert Centre led by CSO 3.2 EU Standardisation Office

0.5 Readability platforms 2.3 Free and unrestricted access from central repository

3.3 Publication of of hEN in OJEU

1.6 Strengthened obligations on NSBs towards inclusion of civil society

2.4 Binding requirements for NSBs on inclusion of SMEs and civil society

3.4 Fostering inclusiveness in all SDOs

1.7 Increased incentives to foster experts' participation

1.7 Increased incentives to foster experts' participation

1.7 Increased incentives to foster experts' participation

1.8 Transparency requirements on participation to standardisation

1.8 Transparency requirements on participation to standardisation

1.8 Transparency requirements on participation to standardisation

1.9 Improved EU coordination on positions and participation

1.9 Improved EU coordination on positions and participation

1.9 Improved EU coordination on positions and participation

1.10 Possibility to restrict participation to standardisation to EU/EEA

1.10 Possibility to restrict participation to standardisation to EU/EEA

1.10 Possibility to restrict participation to standardisation to EU/EEA

2.5 Possibility to derogate from International First principle

3.5 End of automatic international first principle

Objective 1: Increasing the

responsiveness of the ESS

Objective 2: Ensuring a

legally viable and inclusive

ESS

Objective 3: Consolidating EU

international influence

32

the industry on the costs and benefits of their participation in standardisation, as well as from

the NSBs on their business models as independent organisations. The Impact Assessment

introduces two main innovations (see Annex 4):

• It introduces a quantitative analysis of the direct effects of policy options by estimating the

average savings in compliance costs due to the availability of hENs.

• It estimates the financial impact of policy measures on the expected revenue flows of

ESOs and NSBs to assess the financial sustainability of the ESS.

Economic impacts

Policy measures are assessed based on their impact on the speed and timeliness of the

standardisation process. Benefits for businesses are then estimated based on their savings in

compliance costs, as the earlier availability of hENs decrease conformity assessment costs143.

The efficiency of policy measure is assessed across all relevant stakeholders. As many policy

measures transfer costs from one actor to the other, the analysis focusses on qualifying how

these transfers affect their incentives to support the specific objectives. The costs for the

Commission, in particular stemming from additional resources necessary to implement the

policy options, are detailed144. The macro-economic impacts of options are also assessed.

Social and environmental impacts

The assessment does not consider the environmental and social impacts of each measure.

As a horizontal initiative supporting sectoral products and services legislation, the policy

measures have negligeable direct environmental and social impacts145. hENs can make an

important contribution to the EU environmental, social or societal objectives, such as for

instance improving accessibility, safety and inclusivity of EU products and services. However,

such effects directly depend on the sectoral legislation and on the definition of essential

requirements and should be assessed in that context. A more effective standardisation system

would enhance the ability of sectoral legislation to achieve its environmental and social

objectives146.

6.2. Impacts on Specific Objective 1: increasing the responsiveness of the ESS

The quantitative assessment of impacts under Specific Objective 1 (increasing the

responsiveness of the ESS) is in particular affected by the diversity of sectors concerned and

the difficulty to use sector-specific data due to data scarcity. The impacts are therefore estimated

relying on a mix of quantitative and qualitative data, including surveys, interviews, workshops,

case studies and expert validation. In particular, the quantification of “responsiveness” requires

assumptions both on the time reduction generated by each measure and on the translation of

earlier availability of hENs into compliance cost savings for businesses. These relationships are

143 The assessment relies on the estimate of the average cost saving of EUR 3 700 per standard used for conformity

assessment identified in the Evaluation. The figure provided an estimated average across all sectors. Conformity

assessment costs may however vary widely depending on the complexity and the risk of the product, ranging from

as low as EUR 500 for a toy to over EUR 600 000 for complex medical devices. 144 The assessment of additional resources for the Commission is indicative as the revision of the Standardisation

Regulation will enter into force after 2028. All impact on financial resources of the Commission will take place

under the next Multi-annual Financial Framework. 145 One exception is the digitalisation of the ESS of the Baseline scenario. Digitalisation has a direct positive effect

on CO2 emissions as it reduces the travels required from experts to take part to TCs. These effects occur similarly

in all policy options and are thus not discriminating for identifying the preferred option. 146 Evaluation, p. 39.

33

not directly observable in all sectors and are therefore estimated using conservative

assumptions, triangulated where possible with Evaluation findings, desk research,

benchmarking against standard-setting organisations and international practices, and validation

with experts. The resulting figures should be interpreted as indicative orders of magnitude

primarily supporting the comparison of options.

6.2.1. Policy Option 1: Modernised ESO monopoly

Measure 1.1: Integration of standards from other SDOs by ESOs

The facilitation of the integration of publicly available specifications from other SDOs into the

standardisation process of ESOs could make a significant contribution to cutting the time

necessary for the delivery phase. While the actual time reduction would depend on each

specific case, and on the actual availability of technical specifications developed by SDOs, it

can be estimated to decrease the delivery time to 12 months on average147. This estimation is

based on the current practice of ESOs to develop Workshop Agreements, a fast-track

standardisation process developed in a temporary setting with direct participation of all

interested stakeholders that can deliver in 10 to 12 months148. The total yearly savings in

compliance costs for businesses linked to such reduced duration to deliver hENs are estimated

at EUR 23.5 million overall149. This assumes that this measure would mostly apply to sectors

where alternative SDOs are active and ahead of the state of the art compared to ESOs150.

The measure is considered effective by stakeholders: 75 % of industry respondents (185 out

of 247) considered the use of existing standards from alternative SDOs to accelerate the

standardisation process151 and 57 % (140 out of 247) viewed the use of existing standards as

a benefit152. ESOs are also supporting this measure and actively engaging with other SDOs to

better integrate their specifications153.

Beyond the direct impacts on hENs’ development time, the measure would also contribute to

increase the quality and diffusion of hENs, by ensuring they rely on state-of-the art

discussions held in specialised fora, while benefitting from the inclusive and quality

development process from the ESOs. The measure would also increase the incentives of the

industry and experts, in particular in highly technological areas, to engage in the

standardisation process in specialised SDOs, knowing that this investment would in turn feed

the development of hENs, contributing to limiting duplication of investments.

147 A good example of such potential time gains is given by the case study 3 on electric vehicle charging

infrastructure, See Annex 15. 148 Impact assessment study, p. 40. 149 This figure is obtained by multiplying the expected time reduction multiplied by the reduction in conformity

assessment cost and the number of conformity assessments and companies in scope. The methodology is set out

in Annex 4. 150 The measure is assumed to apply to 10 % of new requested hENs as the upcoming hENs in the digital and new

technology sectors represent 10 % of all expected standards. 151 Targeted survey to industry organisations and companies. 152 Targeted survey to industry organisations and companies. Case study 3 on electric vehicle charging

infrastructure highlight a concrete example of how ESOs using existing standards and technical specifications

from other SDOs could improve standardisation outcomes. See Annex 15. 153 Targeted interviews with ESOs.

34

Limited additional costs for the ESS are expected from the measure154. ESOs may incur

some adjustment costs linked to engaging and formalising agreements with other SDOs, which

could lead to some compensation to use technical specifications. These costs are hard to assess

and many SDOs have indicated the possibility to agree to agreements without compensation155.

This could also require additional human resources for the ESOs to identify, engage and

integrate deliverables from other SDOs in the current standardisation development process. The

Commission will incur limited additional costs as the measure would not change the assessment

process but would require more active monitoring of the activities of other SDOs to identify

relevant technical specifications, estimated at 1 additional FTE156.

Measure 1.2: Common specifications as fall-back to hENs

This measure expands the scope of legislation covered by CS by ensuring that all legislation

providing presumption of conformity through hENs can also rely on CS adopted by the

Commission when the standardisation process fails. However, in practice, only a few pieces of

legislation would be added, covering 5 % of the current portfolio of hENs157. Looking

ahead, only 24 of 767 hENs planned for the next 5 years (3.2 %) concern legislation not yet

covered by CS158, confirming the measure's limited direct impact and negligible cost

implications. The measure can however indirectly contribute to the responsiveness of the ESS

by streamlining the possible use of CS and ensuring they are a credible fall-back to hEN, as

mentioned in Section 5.

Measure 1.3: Temporary presumption of conformity

Introducing temporary presumption of conformity to standardisation deliverables other than

hENs would significantly decrease the delivery phase by up to 1 year, as a technical

specification takes on average 24 months from initiation to publication, and can be developed

in 18 months159. This solution could be particularly useful in cases where no previous standards

exist and there is a legislative deadline which would be difficult to meet by the normal

standardisation process needed to develop standards160. The total yearly savings from

conformity assessment costs for businesses is estimated at EUR 23.5 million161. Given its

innovative nature for the ESS and the NLF, this measure may not be applicable to some sectors,

which reduces its overall impact162.

154 Only 18 % (45 out of 247) of respondents to the targeted survey to industry organisations and companies regard

this measure as a potential cost. 155 Targeted interviews with alternative SDOs and ESOs. However, concluding these agreements can be difficult,

in particular to solve intellectual property rights issue, as shown by the example of the cooperation between ESOs

and the open-source community in the development of hENs supporting the CRA. 156 Throughout the IA and in line with Better Regulation practice, the total annual costs of 1 FTE in the Commission

are estimated at EUR 194 000. 157 The main pieces of Union legislation not already including the possibility to adopt CS and not covered by

Omnibus IV are the General Safety Product Regulation (2023/988/EU), the Explosive for Civil Use Directive

(2014/28/EU) and the Pyrotechnic Articles Directive (2013/29/EU). 158 All 24 are requested to support the Pyrotechnic Articles Directive under Standardisation Request M/583. 159 Based on CEN-CENELEC estimates in their Call for Evidence position paper and targeted interviews. 160 This is the situation described in the case study 2 on AI (see Annex 15). 161 This figure is obtained by multiplying the expected time reduction multiplied by the reduction in conformity

assessment cost and the number of conformity assessments and companies in scope. The methodology is set out

in Annex 4. 162 This measure would for instance not be relevant for products with very long lifecycle, such as in the construction

sector (see case study 1 in Annex 15). The measure is assumed to apply to 10 % of new requests. The EUR 23.5

million estimates take into account the fact that the measure would only apply to 10 % of new requests.

35

Stakeholders generally support this policy measure and consider it effective: most

respondents to the targeted survey, including a majority of SMEs, indicated that the use of

technical specifications developed by ESOs as a basis for temporary presumption of conformity

could help accelerate the development of high-quality standards163. CEN/CENELEC's

European Agile Specifications (EAS) pilot projects are specifically designed for this purpose164,

providing a harmonisation effect within the internal market t and effectively preparing the

adoption and diffusion of hENs165. Annex III organisations also support this measure as it

allows ESOs to remain central actors of the ESS166. The measure can however decrease the

inclusiveness of the standardisation process, as the standardisation deliverables providing

temporary presumption of conformity do not benefit from the same level of consensus as a hEN.

The policy measure could incur additional costs to the industry if there are important

changes between the deliverable providing temporary presumption of conformity and the final

hEN.This could trigger additional adjustment costs for businesses to comply with the final

hEN. Businesses however see this risk as limited167. No additional Commission resources

would be required, as compliance assessments are already conducted on a continuous basis

during development.

Measure 1.4: Improved strategic planning and accountability of the ESS

Better strategic planning and foresight of EU standardisation needs can have a direct effect on

the timeliness of the standardisation process. This would notably facilitate the ESOs’

preparatory work, in particular the identification and mobilisation of relevant industry experts

as well as the inclusion of the potentially relevant alternative SDOs in their standardisation

framework. Better strategic planning can reduce the time required for the Commission to

adopt standardisation requests, particularly by shortening the consultation phase on draft

requests. By better anticipating strategic standardisation needs, the Commission would be able

to start the consultation process earlier and thus to cut the overall delivery time. While it is

difficult to quantify this effect consistently, it is estimated that better strategic planning could

lead on average to a decrease of 3 months in the Policy phase168.

However, improved strategic planning can yield measurable effects only if the accountability

of the standardisation process is ensured, and if there is increased trust that each step would be

finalised according to the planning. The measure thus also foresees a more active monitoring

of the standardisation process of ESOs by the Commission, notably through the implementation

of deadlines for ESOs and the Commission at each step of the process. Increased transparency

and accountability on performance can also lead to improvements in the publication phase,

163 In the targeted survey to industry organisations and companies, 75 % of respondents (186 out of 247) indicated

that technical specifications developed by ESOs would be a helpful measure where ESOs are unable to deliver

hENs in a timely manner. 164 Contributions from Call for Evidence and OPC; Targeted interviews to ESOs. 165 The EAS would not have to be systematically implemented at national level by NSBs but NSBs would ensure

that EAS do not conflict with existing ENs. This ensures the coherence of the standards’ catalogue across the EU

and the harmonisation effect across the internal market of the temporary presumption of conformity associated to

the EAS. Targeted interviews with CEN/CENELEC. 166 Targeted interviews with Annex III organisations. 167 In the targeted survey to industry organisations and companies, 55 % (136 out of 247) of respondents considered

a temporary presumption of conformity for technical specifications developed by ESOs to be a benefit for their

organisation compared with only 20 % (49 out of 247) who considered it a cost. 168 Stakeholders in targeted interviews have notably pointed out to the following sectors where lack of anticipation

led to delays or no response by the ESOs: hydrogen infrastructure, low-carbon cement, cybersecurity, digital

product passport, cybersecurity, quantum technology, and data exchange.

36

where the lack of coordination between Commission, HAS consultants and ESOs leads to

delays in the hENs’ assessments. The potential improvement is estimated at 2 months169. The

total duration of the policy and publication phases could be cut by 5 months in total, generating

savings for the industry estimated at EUR 109 million170 thanks to earlier availability of all

hENs.

Stakeholders confirm the positive effect of improved strategic planning on the

responsiveness of the ESS,identifying the HLF and the AUWP as the tools to implement better

planning171. However, views are mixed as regards increasing the accountability of the ESS

through stronger ESO obligations, monitoring and KPIs. The targeted survey to industry

organisations and companies shows that 62 % (154 out of 247) of respondents consider

increased accountability to contribute at most to a moderate extent to responsiveness172.

Industry fears binding deadlines and KPIs could undermine consensus-building173, while Annex

III organisations and societal stakeholders strongly support them174.

Improving strategic planning and increasing accountability of the ESS would incur

limited additional costs to actors of the ESS. Only 9 % (23 out of 247) of industry respondents

identified greater HLF engagement as a burden175. Ongoing digitalisation through the eNorm

system will absorb increased ESO reporting requirements without raising administrative

costs176. The Commission will have to mobilise 1 additional FTE to improve strategic planning

and to monitor the performance of the ESS on a more systematic basis (based on current

resources mobilised for the AUWP and the HLF).

Measure 1.5: Simplification and digitalisation

The proposed simplification measures have a direct effect on the responsiveness of the ESS by

cutting the time required by the Commission for the phases of the standardisation process

it is responsible. For the policy phase, the estimated gains in the adoption of standardisation

requests are estimated at 3 months, mostly stemming from the Comitology procedure177. For

the publication phase, the estimated gains of simplifying the referencing procedure coupled

with better coordination of the assessment by HAS consultants could lead to an additional 2-

month gain178. hENs would thus be available on average 5 months earlier than the baseline,

leading to savings for businesses of EUR 109 million, as this would apply to all hENs.

169 Impact assessment study, p. 44. Based on interviews with ESOs. 170 This figure is obtained by multiplying the expected time reduction multiplied by the reduction in conformity

assessment cost and the number of conformity assessments and companies in scope. The methodology is set out

in Annex 4. 171 In the targeted survey with industry organisations and companies, 64 % (158 out of 247) of respondents

considered improved strategic planning aimed at addressing standardisation needs earlier in the technological life

cycle to be a benefit. 172 Targeted survey with industry organisations and companies. 173 Contributions to the Call for Evidence and OPC; Targeted interviews with ESOs. 174 Targeted interviews with Annex III organisations. 175 Targeted survey with industry organisations and companies. 176 The Evaluation estimated the total annual administrative costs linked to the Regulation at EUR 0.5 million

combined for the 3 ESOs. The impact of the measure on such costs is estimated to be neutral compared to this

baseline, given that the increased monitoring efforts would be compensated by the facilitated reporting through

better integration of IT systems. 177 Impact assessment study, p. 44. See also Annex 9. The estimated time for the Comitology procedure is between

2 and 6 months, with a minimum time for voting of 2 months. 178 Impact assessment study, p. 44.

37

The measure will further contribute to the responsiveness of the ESS by ensuring that the gains

from digitalisation by ESOs described in the baseline are materialised through the legal

requirement to offer standards in a machine-readable format. A strong consensus over this

measure was registered in the survey sent to industry organisations and companies179.This

would also allow to speed up the assessment phase as HAS consultants would have easier access

to the offered standards. The simplification exercise would be coupled with the introduction of

internal but transparent deadlines at each step of the Commission’s processes, with monitoring

activities conducted under measure 1.4. This would foster actual compliance with the new

shorter process. In addition, in the OPC, 85 % of businesses agreed that the Commission’s

procedures for the request, evaluation and citation of hENs should be simplified180.

This measure, while contributing overall to the responsiveness of the ESS, may also in some

cases lead to increased uncertainty. The comitology procedure, while in a very large majority

of cases mostly formal, contributes to the alignment of interests between the Commission,

Member States, ESOs and Annex III organisations. While removing comitology could increase

Member State disagreements and use of the formal objection mechanism, this risk is mitigated

by the simultaneous simplification of that procedure.

The simplification measure will not induce any additional costs to the actors of the ESS;

it would bring limited administrative costs reduction for the Commission by reducing the

administrative process linked to the comitology procedure, partially offset by increased

resources to manage formal objections and estimated as a reduction of 0.5 FTEs.

6.2.2. Policy Option 2: ESS centred on ESOs with new flexibilities

Measure 2.1: Flexibility to address standardisation requests to alternative SDOs

The flexibility for the Commission to directly address a standardisation request to an alternative

SDO could lead to a significant decrease in the time to deliver hENs. This could be achieved

either through their faster delivery in their field of expertise, or by directly requesting them

existing standards or technical specifications that would already cover essential requirements.

As outlined in section 2.1.1, many alternative SDOs claim a faster standard delivery time than

the current average by ESOs, with an average duration process between 6 and 18 months181.

The estimated time for obtaining a hEN from a SDO is thus estimated at 12 months,

considering that the Commission will only use this possibility when the expectations of fast

delivery would be high, based on consultation with ESOs and alternative SDOs. This faster

delivery time would however be limited by the need to pre-consult ESOs prior to addressing

the request to an alternative SDO as well as by the validation by Member States of the

standardisation request through the Comitology procedure, adding an estimated 3 months to the

179 77 % (190 out of 247) of respondents to the targeted survey to industry organisations and companies supported

a fully digitalised standard development process, including an integrated OSD platform and machine-readable

formats. Case study 1 on construction products highlights the strong support for digitalisation of standards to

improve efficiency, traceability and accessibility, while also facilitating their integration in emerging new tools

such as DPP and reduce administrative burdens on SMEs. See Annex 15. 180 Contributions from OPC, sorted by companies and industry associations, (225 respondents out of 301). 181 One sector-specific SDO reported in the OPC to be able to provide a standard in 6 months.

38

policy phase182. Overall, this could bring the total standard delivery time in such cases to

3.3 years.

The measure is expected to generate annual savings for businesses estimated at EUR 52

million overall183.Its impact depends largely on the extent to which it will be used and on the

number of requests that will be addressed to alternative SDOs. While it is difficult to forecast

precisely the extent to which the Commission will implement the new flexibility, it will remain

a supporting option, targeted at sectors where alternative SDOs can be more efficient than

ESOs, in particular in the digital sector and the transport sector. Based on the upcoming

planning of standardisation requests in the AUWP, it is estimated that no more than 10 % of

standardisation requests would be addressed to alternative SDOs – for an average of 1 or 2

requests per year. The estimation of savings for the industry is of course sensitive to this

assumption, as well as to the ability of alternative SDOs to effectively deliver hENs within the

shorter timeframe.

Stakeholders expressed uncertainty regarding the possibility of opening the ESS to other

SDOs. In the OPC, 61 % of businesses’ respondents (182 out of 297) disagreed that the

Commission should have the option to request the development of new standards to alternative

SDOs even under the conditions that they work in an inclusive manner with balanced

participation of relevant European stakeholders184. The remaining 39 % (115 out of 297) either

agreed or were neutral, suggesting divergent views across sectors and company sizes, in line

with the design of the measure targeted at specific cases. The case study on critical space

technology showed for example that this sector would support standardisation requests to be

addressed to alternative SDOs, in the absence of a competent ESO for upstream space

technologies185. Furthermore, industry’s resistance often stems from implementation concerns

(e.g., ensuring coherence with existing frameworks, avoiding fragmentation, or maintaining the

ESS’s global credibility) rather than outright rejection of flexibility186. NSBs are likewise

divided on the possibility of requesting, using and referencing standards from alternative SDOs,

with 57 % (21 out of 37 respondents) expressing opposition to this measure.

The possibility of addressing standardisation requests to alternative SDOs, coupled with the

right of ESOs to assess requests in priority, will also increase competition across SDOs and

put more pressure on ESOs to improve their process to continue delivering hENs to the

Commission. This will also create dynamic benefits as ESOs would have additional incentives

to deliver hENs on time for the requests they have accepted to prevent the Commission to

address future requests to SDOs. The pre-consultation mechanism between the Commission

and ESOs will also help identify the best-placed SDO for each request, based on sectoral

expertise, reducing the number of cases where hENs are delivered late or not at all.

182 As a significant departure from current practice of the ESS, addressing a standardisation request to an alternative

SDO would require consultation and validation from the Member States, in particular since the different national

interests would not be formally represented in the standardisation process managed by an alternative SDO contrary

to the process managed by ESOs where NSBs are instrumental in aggregating national participation through the

national delegation principle. 183 See Annex 4 for methodology. 184 Results of the OPC, sorted by companies and industry associations. 185 See case study 4 in Annex 15. 186 For example, the EU has already adopted alternative models in certain areas (e.g., the Corporate Sustainability

Reporting Directive’s EFRAG standards or the European Health Data Space’s CS, see Annex 13), showing that

exceptions are possible when aligned with strategic priorities.

39

The measure will incur adjustment costs for stakeholders of the ESS, ascompanies

concerned may need to duplicate their investments in standardisation to participate both in

ESOs and alternative SDOs – in particular if they concern overlapping technologies. While the

OPC showed that companies view this more as a cost than a benefit (37 % of respondents

expected high or very high costs, 41 % low or very low benefits187), this measure is expected

to be applied in a small number of cases188 and in specific sectors. These costs could be a

relatively higher barrier to participation for SMEs and Annex III organisations, whose ability

to engage in multiple SDOs is lower. A rough and upper-bound estimate of such additional

costs for businesses would be EUR 4.5 million per year189 and for Annex III organisations

EUR 0.1 million per year190.

The measure will also incur additional administrative costs for the Commission to organise

and manage the use of the flexibility to address standardisation requests to alternative SDOs.

The Commission will first have to mobilise additional resources to identify relevant alternative

SDOs and assess if they comply with the quality criteria necessary to deliver hENs. In addition,

it will have to monitor the activities of alternative SDOs to assess on which sectors and

technologies they could bring value added in the delivery of hENs, in a more proactive manner

than for measure 1.2. Last, the management of the standardisation requests to alternative SDOs

will likely require more oversight from the Commission, at least for the first requests addressed

to each new alternative SDO. As these are largely new tasks for the Commission, there is no

benchmark to accurately assess the resources needed, but a conservative estimate would be 3

FTEs, based on the experience of the CRA standards, which involve other standardisation fora

together with the ESOs.

Measure 2.2: EU Expert Centre led by a CSO

The creation of an EU Expert Centre led by a CSO aims to support the implementation of Policy

Option 2. It would host the new tasks of the Commission, in particular relating to requests to

alternative SDOs, as well as formalise the coordination of the internal network of

standardisation experts across Commission services. It will improve the Commission’s

oversight and coordination in standardisation, increasing the accountability of the ESS and its

international influence. 58 % of respondents to the targeted survey to industry (144 out of 247)

organisations and companies support its creation due to its potential to improve coordination

and EU influence in standardisation191. ESOs and NSBs also support the measure192. The Expert

Centre would gather a total of 20 FTEs193 with a central supporting role and coordinate the

network of over 60 staff regularly involved in standardisation within the Commission, which

would have to conduct new additional tasks at sectoral level. This organisation would allow to

187 Results of OPC, sorted by companies and industry associations. 188 This impact assessment assumes 10 % of request will be submitted to alternative SDOs. 189 A DG GROW 2021 study estimates the total costs of developing a EN at EUR 0.8-1.0 million. Considering an

average duration for hEN of 3 years, the duplication of the full participation costs for all standards requested to

alternative SDOs would lead to EUR 4-5 million additional costs compared to the baseline (assuming 10 % of new

hENs requested to alternative SDOs). Study on the Functions and Effects of European Standards and

Standardisation in the EU and EFTA Member States, November 2021, pp. 72-73. 190 The Evaluation estimated the annual average costs of participating in technical discussions for all Annex III

organisations at EUR 1.3 million (Evaluation of the Standardisation Regulation, p. 45). Duplicating participation

in alternative SDOs for 10 % of hENs would lead to an increase of EUR 0.1 million, which would in practice

require increased financing by the Commission. This effect is considered negligeable. 191 Targeted survey to companies and industry associations. 192 Workshop with NSBs. 193 The 16.5 FTEs of the current standards policy unit, plus the 4 additional FTE required for the new tasks

identified at central level, minus 0.5 FTE linked to implementation of Measure 1.4.

40

increase synergies across the Commission’s standardisation activities and to enable the new

needs to be covered through redeployment of existing resources. The new tasks and additional

resources’ needs of the Expert Centre would include194:

• Supporting the integration of specifications from other SDOs by ESOs (Measure 1.1): 1

FTE, decentralised in the sectoral services.

• Implementing the strategic planning and the increased accountability of the ESS (Measure

1.4): 1 FTEs, centralised in the Centre.

• Supporting the implementation of the flexibility to address requests to alternative SDOs

(Measure 2.1): 3 FTEs, out of which 1 centralised in the Centre.

• Improving international coordination across EU standardisation actors (Measure 1.9 and

Measure 2.5): 2 FTEs, out of which 1 centralised in the Centre.

• Leading the Centre (CSO, Measure 2.2): 1 FTE.

6.2.3. Policy Option 3: Open ESS managed by the Commission

Measure 3.1: Open selection of SDOs for standardisation requests

This measure enables the Commission to address standardisation requests to any SDO, leading

to an increased number of hENs requested to SDOs compared to Measure 2.1. Its effectiveness

relies on the assumption that alternative SDOs would be on average more efficient than

the current ESOs, either because they have better expertise in a given field or because existing

ESOs face resource constraints. This would introduce higher competition for the delivery of

hENs to the Commission and can indirectly contribute to improve the responsiveness of all

actors, alternative SDOs and ESOs. However, this approach can carry risks to both quality, as

the trust and legitimacy of the ESS could be undermined by a decreased reliance on ESOs, and

inclusiveness, as the representation of societal interests could be lower in alternative SDOs. The

annual savings for businesses compared to the baseline is estimated at EUR 171 million195.

ESOs and NSBs would incur no additional costs but are opposed to this measure, as they

expect it would fragment the ESS, duplicate resources, and undermine the consensus-based

approach guaranteed by the current system196. Stakeholders’ views are also overall negative,

55 % of companies and business associations disagreed with opening the standardisation

framework to other organisations while 32 % agreed197. The measure will likely lead to

duplication of industries’ participation costs (adjustment costs)198, more than the targeted

flexibility of measure 2.1 since it would cover a wider range of hENs. Estimating these

additional participation costs is challenging as this would largely depend on the degree of

194 The additional costs from these tasks have been allocated to each corresponding policy measure. The only

additional resource from this measure specifically is the position of the CSO. 195 The measure could reduce the time for the delivery phase to 1.8 years on average, assuming that ESOs would

deliver hENs according to the average duration of Policy Option 1 and SDOs according to the average duration of

Measure 2.1. Given their wide sectoral expertise and well-established position as lead standardisation bodies in

the EU, it is estimated that ESOs will continue delivering 67 % of requests. 196 In the OPC, 78 % of NSBs (28 out of 36 respondents) strongly disagreed with introducing open selection of

SDOs for standardisation requests. The workshop with NSBs confirmed their strong opposition to the measure. 197 Results of OPC, sorted by companies and industry associations. 161 respondents out of 291 disagreed, 92

agreed. 198 Targeted survey with companies and industry associations. Respondents were uncertain about the impact of

this measure on their organisations, with 37 % (92 out of 247) considering open procurement of standards without

preferential treatment for ESOs to represent a cost, while 32 % (79 out of 247) regarded it as a benefit.

41

sectoral overlaps across SDOs delivering hENs to the Commission. A rough estimate of such

annual additional costs for businesses would be EUR 15 million199.

The Commission would also bear additional administrative costs due to the need to monitor

a more complex standardisation system.The Commission would have to mobilise resources

beyond those introduced to support Measure 2.1 as it would have to manage more requests

addressed to more SDOs. Based on current resources mobilised to manage the ESS, the

Commission would need 6 additional FTEs compared to the baseline200.

Table 1: Overview of savings for businesses for Specific Objective 1 by Policy option201

Measure 3.2: EU Standardisation Office

The creation of an EU Standardisation Office is necessary for Measure 3.1 to function

effectively as the Commission will have to organise the selection of SDOs for each

standardisation request and manage the financing of EU standardisation needs. The Office

would regroup all existing and additional resources in the Commission involved in the

implementation of the Standardisation Regulation for a total of 61.5 FTEs: the existing

standards policy unit (16.5 FTEs), an additional estimated 15 FTEs required for carrying the

new tasks under policy option 3, as well as the current resources in sectoral services of the

199 The same methodology as for Measure 2.1 is used, with a larger extent of possible duplication. 200 The resources needs are based on one third of the current team in charge of managing the ESS to mirror the

share of request from hENs, thus 6 FTEs. 201 The table presents the savings for each path used to request hEN in each Option, resulting from the relevant

combination of policy measures assessed in Section 6.2. For instance, standards obtained in Policy Option 1 from

ESOs through measure 1.1 benefit from the effects of measure 1.1 and from the effects of measure 1.4 (strategic

planning) and 1.5 (simplification) that apply to all hENs. Details of the breakdown by policy measure is provided

in Table 4.2 in Annex 4. Totals may differ due to rounding.

Phase A: Policy phase

Phase B: Delivery

phase

Phase C: Publication

phase

Total average duration

Share of use of hEN path

Financial savings

(EUR million)

Current situation 1.7 3.2 1.2 6.1 Baseline 1.7 2.4 1.2 5.3 Policy option 1* 1.2 2.2 0.9 4.3 265

Standards obtained from ESOs through measures 1.1

1.2 1.5 0.9 3.6 10% 45

Standards obtained from ESOs through measure 1.3

1.2 1.5 0.9 3.6 10% 45

Other standards obtained from ESOs

1.2 2.4 0.9 4.5 80% 174

Policy option 2* 1.2 2.1 0.9 4.2 295 Standards obtained from ESOs through measure 1.1

1.2 1.5 0.9 3.6 10% 45

Standards obtained from ESOs through measure 1.3

1.2 1.5 0.9 3.6 10% 45

Other standards obtained from ESOs

1.2 2.4 0.9 4.5 70% 152

Standards obtained from alternate SDOs through measure

1.5 1.0 0.9 3.3 10% 52

Policy option 3 1.3 1.8 0.9 4.0 348 Standards obtained through ESOs (based on PO1)

1.2 2.2 0.9 4.3 67% 177

Standards obtained through other SDOs (based on 2.1)

1.5 1.0 0.9 3.3 33% 171

Total duration of each phase in years and savings for businesses compared to the Baseline

42

Commission implementing the Standardisation Regulation (30 FTEs, see Annex 12). The new

tasks and additional resources’ needs of the EU Office202 would include:

• The relevant tasks and resources of the Expert Centre, including the CSO: 8 FTEs203;

• The additional resources needed to manage the requests addressed to SDOs other than the

ESOs, including the additional support to Annex III organisations to be involved in SDOs’

standardisation process (measure 3.1 and 3.4): 4 FTEs.

• The management of the budget and the negotiations of agreements to ensure publication of

hENs in the OJEU (measure 3.3): 2 FTEs.

• The support to the international dimension of the open system (measure 3.5): 1 FTE.

Such an Office centralising the Commission’s resources active in standardisation could

generate efficiency gains and a better implementation of the Regulation, through experience

and expertise building. However, it would bear the important risk of losing the sectoral expertise

necessary to steer the standardisation process and to assess whether hENs satisfy the

requirements they aim to cover. The possibility to have the tasks of an EU Standardisation

Office aggregated into a joint office or Authority for NLF and Market Surveillance (the other

elements of the upcoming EPA) was considered, but no potential synergies or overlaps were

identified which would justify such a joint Office. The tasks considered under measure 3.2 do

not have any direct relevance for market surveillance nor for the implementation of the NLF

provisions.

6.3. Impacts on Specific Objective 2: Ensuring a financially viable and inclusive

ESS

The assessment under this objective combines monetised and non-monetised impacts.

Quantification is feasible for some effects, notably certain costs for NSBs and transfers linked

to access to hENs, but more limited for other elements such as the quality of participation or

the practical influence of societal stakeholders. The analysis therefore combines cost estimates

with qualitative evidence from interviews, surveys, case studies and validation workshops.

6.3.1. Policy Option 1: Modernised ESO monopoly

Measure 1.6: Strengthened obligations on NSBs to include civil society organisations

As mentioned in section 2.2.2, civil society organisations face a specific challenge to participate

in standardisation at national level. If implemented by NSBs, the measure can have a

moderate positive effect on the inclusiveness at EU level by addressing one of the key “gaps”

in ESS inclusiveness. Annex III organisations and societal stakeholders consulted expressed

strong support for this measure, as it would help increase inclusiveness by levelling the

differences currently present at national level204. However, the measure remains voluntary for

NSBs, and its impact depends on the number of NSBs implementing the best practices

identified in Article 6 of the Standardisation Regulation and the extent of their implementation.

Its impact should not be overestimated as Annex III organisations have limited representation

at national level and they face resources constraints, such as staff availability, beyond the

headline cost of participation205. While increasing inclusiveness may lengthen time for

202 The additional costs from these tasks have been allocated to each corresponding policy measure. There are no

additional costs relating to setting up of the Office itself. 203 All tasks identified for the Expert Centre, excluding savings from Measure 1.4 not applying in Option 3. 204 Impact assessment study, p. 52. 205 For instance, ECOS is the only EU organisation representing environmental interest in standardisation.

43

consensus building, this risk remains limited as the measure fosters broader early-stage

participation and will be further facilitated by the digitalisation of the standardisation process206.

The measure will create adjustment costs for the NSBs which will be borne principally by

those that do not have such mechanisms in place. These costs are driven by a large set of

different measures across NSBs to extend Article 6 best practices to civil society organisations

and reflect both direct resource allocation and foregone revenue associated with facilitating

participation. These costs are estimated at EUR 1.2 million per year207.

Measure 1.7: Increased incentives to foster experts’ participation in standardisation

This measure is expected to be effective in improving the sustainability of the ESSby

increasing the participation of experts in the standardisation process, in particular from the

R&I community. Addressing the targeted barriers to R&I experts’ participation could

significantly increase the quality of hENs as expertise is the key driver of a successful

standardisation process208 and could contribute to the renewal of standardisation experts, further

strengthening the sustainability of the ESS. The case study on additive manufacturing indicated

that facilitating participation of experts from the R&I community could help reducing the gap

in these technological sectors209.

The results of the targeted survey with industry organisations and companies, including

SMEs, confirm the effectiveness of such measures. 70 % (173 out of 247) of respondents

agree that promoting a standardisation ecosystem better connected to innovation and pre-

normative work would be beneficial210. The results of the OPC also outlined a wide level of

agreement among Annex III organisations and societal stakeholders on fostering capacity

building of European experts211. Stakeholders also highlighted that the main effect on

participation of experts would be achieved through increased public financial support212.

Measure 1.7 is not expected to generate significant direct costs for stakeholders. The main

project conducted so far in the framework of the HLF workstream on Education and Skills (the

pan-European standardisation certificate213) has been collectively developed for free through

the mobilisation of the standardisation community. Some adjustment costs could incur to the

ESOs and NSBs to provide access to draft standards to researchers for free214. The improved

206 Targeted interviews with Annex III organisations. 207 Impact assessment study, p. 52-53. The average costs per NSB to extend the inclusiveness best practices for

SMEs to civil society organisations are estimated based on the costs of the current measure in place for SMEs.

The estimates have been derived from data provided by 14 NSBs through targeted interviews and surveys. The

total additional adjustment costs are estimated considering that only the NSBs that do not already provide such

types of measures would implement them. 208 Targeted interviews with ESOs and the industry. 209 See Annex 15.5. 210 Targeted survey to industry organisations and companies. 211 Results of the OPC. 71 % of civil society respondents strongly agree (27 out 38) and 26 % somewhat agree (6

out of 38). 212 Financial support or free access measures to facilitate SME participation in TC received notable support in the

OPC. In the dedicated SME Workshop, participants identified these measures as one of the key factors to

encourage SMEs participation, notably in international standardisation. 213 Recommendation on the pan-European Certificate of Knowledge in Standardisation, HLF. 214 Free access to draft standards has been estimated at EUR 25 000 per NSBs for SMEs in Measure 1.6; granting

similar access to researchers would likely bring only marginal additional costs.

44

coordination of existing scattered EU public financial support to experts’ participation in

standardisation would also not increase the costs for the Union but could lead to efficiencies215.

Measure 1.8: Transparency requirements for participation in standardisation

Introducing transparency requirements to participate in standardisation wouldprovide greater

legitimacy to hENs that are part of EU law and would ensure that their development complies

with the principles of transparency, openness and good governance. Transparency regarding

the interests represented and active in the standardisation process can also contribute to foster

participation from under-represented interests, notably civil society and SMEs, and could lead

to increase the overall quality of the process. While transparency requirements may also have

a chilling effect on the participation of some actors, it is overall considered a measure with a

positive effect for the sustainability of the ESS, as outlined by the results of the OPC216. Annex

III organisations and societal stakeholders highlight the need to enhance transparency regarding

the stakeholders involved in TCs developing hEN217 and for ESOs to strengthen their

monitoring and recording activities of the composition of TCs working on hENs.

This measure is expected to generate administrative costs for ESOs as they would have to

set up public platforms disclosing entities and interests working on hENs. As the information

is largely already available to ESOs, the main costs are the platform set-up (estimated at EUR

0.5 million one-off) and maintenance (estimated at EUR 0.6 million per year) to systematically

track participation of the 90 000 experts active in standardisation218.

6.3.2. Policy Option 2: An ESS centred on ESOs with new flexibilities

Measure 2.3: Free and unrestricted access to hENs from central repository

This measure would improve the conditions of access to hENs and reinforce the legal

sustainability of the ESS. Free and unrestricted access through a repository accessible without

prior authentication would significantly contribute to improve access to hENs and compliance

with the judgments of the CJEU. In the OPC, most industry actors and societal stakeholders

agreed that hENs should be freely accessible, while ESOs and NSBs held the opposite view219.

The measure can also have positive spill-over effects as it wouldfoster the use of hENs by all

stakeholders – industry, SMEs as well as civil society representatives and the general public

and decrease compliance costs of businesses as they would no longer have to pay for hENs,

saving EUR 30 million per year.

215 Since the revision of the Standardisation Regulation will enter into force during the next MFF, there is no

information on the future available EU budget for standardisation. It is assumed to be constant. However, the new

MFF organisation, and notably the future European Competitiveness Fund (ECF), is an opportunity to better

coordinate EU investments in standardisation, in line with the objectives of the ECF. 216 In the OPC, 57 % of NSBs (20 out of 35 respondents) indicated they strongly agree with the measure. 217 OPC results, 74 % of Annex III organisations and societal stakeholder strongly agreed. 218 Impact assessment study, p. 57. One-off costs to set up such platforms are usually low. The maintenance of the

platform will require resources to monitor that the information is up-to-date, complete and accurate. 219 OPC results, 71 % of industry respondents (204 out of 291) and 74 % of Annex III and societal stakeholders

respondents (29 out of 39) agreed that the legally relevant content of standards should be published and freely

accessible. ESOs and NSBs disagree with the statement at 83 % (29 respondents out of 35).

45

However, this measure may challenge the financial sustainability of some NSBs, and in turn,

the current functioning of CEN/CENELEC220.NSBs’ business models rely to various degrees

on the sale of hENs to finance their activities – see section 2.2.3 and Annex 8. The measure

could thus endanger the financial viability of certain NSBs, putting the national delegation

principle on which CEN/CENELEC model is based at risk. It could also endanger CEN-

CENELEC and NSBs’ capacities to finance their part of the standardisation development

process, if they cannot recoup their investments in delivering hENs. The free and unrestricted

access to hENs implies a shift of the financial burden of the standardisation development

process currently borne by the users of hENs (through their purchase of hENs) to the ESOs and

NSBs (through a loss of revenues). This additional financial burden on ESOs and NSBs could

decrease their ability to develop hENs and to accept standardisation requests from the

Commission. The contributions from industry to the Call for Evidence and the OPC point out

to the need to compensate the foregone revenues for CEN/CENELEC and its NSBs due to the

free and unrestricted access to hENs to ensure the economic sustainability of the ESS. At the

same time, as the cost to develop hENs is mostly borne by the industry and is broadly

disconnected from the revenues generated by the sales of those hENs by NSBs, the measure is

unlikely to affect the industry’s incentives to participate in standardisation221.

The measure will result for CEN/CENELEC and its NSBs in a maximum revenue loss of

EUR 30 million per year, amounting to the total annual sales of hENs. However, the actual

impact on revenues could be lower due to several factors linked to the requirements on access:

• Conditions of access: downloadable versions of hENs would likely lead to a higher impact

on revenues losses for NSBs.

• Business practices linked to purchasing standards: many users have a subscription to the

platforms of NSBs providing access to the entire standards portfolio, which is not limited

to hENs (which only represent a small share – 12 % – of this portfolio).

• Object of access: access could be granted to the full hENs or only to its legally relevant

part222. In the latter case, most businesses consider that this would not be sufficient for their

work223. Hence it is likely that many users will continue purchasing the full hENs if only

the legally relevant part is accessible free of charge.

There is insufficient information on the marketing activities of CEN/CENELEC and NSBs to

precisely assess how such factors would impact the actual revenue loss. Moreover, the impact

could be further mitigated as they are moving from a document-centric model towards a

data-centric model for standards and hENs – see section 5.1. The digital transformation of

ESOs and NSBs could enable them to compensate the foregone revenues of hENs by new value-

added services to the industry through SMART standards, based on the copyrights they claim

220 The financial sustainability of ETSI would not be affected by the measure, as ETSI standards already benefit

from free and unrestricted access, the costs of the standardisation process for hENs being mostly borne by the

participants to the standardisation process through membership fees. 221 Industries are not financially compensated for their participation in standardisation activities. Instead, they

benefit from having a voice in shaping market trends and from the efficiency linked to adopted standards. 222 Extracting the legally relevant parts from the existing hENs (based on the Annex Z) or developing legally

relevant parts distinctively from the rest of the standard in new hENs could be challenging in practice.

CEN/CENELEC could choose to grant free access to the full hENs rather than only the legally relevant parts

independently from legal requirements. 223 Results of the OPC. Access to the legally relevant part would be insufficient for 66 % of industry respondents

(190 out of 289).

46

on hENs, ensuring that ESOs and NSBs retain a financial interest in developing hENs at the

request of the Commission. Many NSBs are already selling, and expanding, such services224.

The measure will impact mostly the NSBs that are more reliant on the sales of hENs and

are less ready to move to a data-centric model, either due to lack of resources or lack of a

perceived market for such services in their Member States225. Targeted support could be

necessary to ensure the financial sustainability of all NSBs and of the ESS. The annual cost to

support the NSBs most financially exposed to the free access to standards could be around EUR

6 million,assuming that access to the full hENs is granted226. This compensation could be

granted by the Commission through an increase in operating grants to ESOs, that would then

distribute it across relevant NSBs227. This increased compensation could be absorbed by the

current EU budget earmarked for standardisation. However, this would decrease by the same

amount the action grants of the Commission to finance experts’ participation (mostly benefiting

businesses) to standardisation.

The measure entails limited direct operational costs for ESOs to set up the repository.

NSBs have indicated a willingness to manage such a repository and to host the hENs to which

access is granted, which would allow them to maintain their relationship with their customers.

The investments already incurred to set up the readability platforms are likely to cover the costs

of the central repository as only limited changes would be necessary. CEN/CENELEC are also

considering hosting hENs from other SDOs on their repository to be able to provide a

comprehensive service of access to hENs. However, the repository would fulfil a legal

requirement and a public service that the Commission will have to enforce. This could be

achieved through a repository managed directly by the Commission, based on the current

eNorm database, that would ensure centralised access to the catalogue of hENs and the

integration of hENs from alternative SDOs, redirecting users to the ESOs’ repository. Limited

additional costs are expected in view of the investments already incurred to develop the

readability platform of the Commission228.

Measure 2.4: Binding requirements on NSBs on including SMEs and civil society

The effects of this measure will be similar to the effects of measure1.6but with a higher