EU: Results of the evaluation of the EU standardization strategy

The EU Commission has published the results of its evaluation of the EU standardization regulation (Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardization).

On 1 January 2013, Regulation (EU) 1025/2012 entered into force, establishing a new legal framework to govern the relationship between the European Commission and the largely private European standardisation system. The Regulation supports the development of harmonised standards that underpin EU policies and legislation. Its specific aims were to accelerate the development of standards requested by the Commission, ensure adequate representation of small and medium-sized enterprises (SMEs) and societal stakeholders in standardisation processes, expand the use of ICT standards, and resolve ambiguities in the previous legal framework.

To achieve these objectives, the Regulation sets out key principles of governance—such as inclusiveness—for the development of standards supporting EU legislation and policies. It also outlines procedures, financial arrangements, and mechanisms for addressing disputes.

The purpose of this evaluation is to assess how the Regulation has performed in terms of effectiveness, efficiency, coherence, EU added value, and relevance, particularly against the backdrop of significant political and economic shifts. Ongoing green and digital transitions in the EU economy, combined with current geo-economic challenges, are testing the robustness of the European standardisation system. The EU’s 2022 Standardisation Strategy, which reflects this new context, announced the evaluation of Regulation (EU) 1025/2012. In addition, case law from the Court of Justice of the European Union (CJEU) over the past decade has had a considerable impact on the Regulation’s implementation.

The evaluation was informed by a supporting study commissioned by the European Commission and conducted by a consortium of Intellera Consulting, Fraunhofer ISI, and Trinomics B.V. It also drew on stakeholder consultations, expert workshops, and academic input.

1. Effectiveness

The Regulation has been moderately successful in shortening the time required to develop harmonised standards in support of EU legislation. Nevertheless, the average timeline—approximately six years, with three years typically devoted to drafting and consensus-building—is still considered too lengthy, especially given legislative timelines, market demands, and global competition.

Delays and inefficiencies in the standardisation process reduce the potential benefits of harmonised standards for EU industry competitiveness. Key issues include:

• Procedural barriers;
• Recurring quality problems in draft standards, exacerbated by new controls arising from CJEU rulings;
• Growing pressure on European standardisation organisations (ESOs) to meet legislative and market expectations;
• Weak communication and coordination;
• Insufficient uptake of digital technologies.

While ESOs and national standardisation bodies (NSBs) are motivated to develop harmonised standards due to their legal significance, they heavily depend on stakeholder engagement and may lack incentives to innovate or speed up their processes. The Regulation allows standardisation requests to be addressed only to the three ESOs, with no alternatives in cases where timely delivery is not achieved.

The Regulation has also partially succeeded in increasing the involvement of SMEs and civil society stakeholders. However, their actual influence remains limited, as they often lack the resources, expertise, and time to participate effectively at EU, national, and international levels.

In terms of promoting the use of ICT specifications, progress has been modest. Still, the gap has been partly bridged by newer digital laws that rely on harmonised standards.

2. Efficiency

Assessing efficiency was challenging due to data limitations, particularly regarding cost-benefit analysis. The evaluation relied on public consultations, targeted surveys, interviews, and triangulated evidence.

The Regulation has imposed some reporting obligations on ESOs, NSBs, Annex III organisations (representing SMEs and civil society), and the European Commission, but these were deemed proportionate, partly due to earlier simplification efforts.

Administrative costs—particularly related to funding applications and reporting—have increased but remain consistent with the EU’s Financial Regulations. Although data on indirect compliance costs (for businesses and NGOs) is limited, the evaluation suggests that the Regulation’s benefits outweigh its costs overall. However, expert participation in standardisation remains costly.

While ESOs have adopted some digital tools to support standardisation, they are not keeping pace with other global standards bodies. The formal objection process to harmonised standards is considered lengthy, complex, and inefficient.

Although the Commission originally aimed to simplify procedures, subsequent procedural layers were added to align with CJEU case law, which clarified that harmonised standards are part of EU law and reinforced the Commission’s role in their development. These additions have increased the overall procedural burden.

Opportunities for simplification include better reporting and monitoring, more efficient procedures, and faster standard development. However, the rigid framework of the Regulation and exclusive reliance on the three ESOs limit the potential for major simplification or acceleration.

3. Coherence

The Regulation has shown internal coherence and has contributed to greater external consistency in how harmonised standards are used across EU legislation—particularly under the New Legislative Framework. Some inconsistencies remain, such as differing terminology in the General Product Safety Regulation.

In certain policy areas, however, alternative standardisation models have been adopted. For instance, the Corporate Sustainability Reporting Directive established its own standards body, while the European Health Data Space Regulation empowers the Commission to adopt common specifications through implementing acts.

4. EU Added Value

The Regulation has demonstrated clear EU added value. Stakeholders generally view European standardisation positively. One of its major achievements has been eliminating conflicting national standards. Replacing it with national frameworks would significantly disrupt trade within the Single Market.

5. Relevance

While the Regulation’s original goals remain valid, they no longer fully align with today’s strategic priorities as outlined in the 2022 Standardisation Strategy. Several external factors have exposed weaknesses in the current system:

• Rapid technological advances, especially in digital and green sectors;
• A shrinking pool of technical experts;
• Changing geo-economic dynamics;
• Increasing influence of non-EU actors in international standardisation;
• Legal developments from CJEU rulings.

The existing framework struggles to meet the demands of emerging technologies critical to the EU’s policy goals and competitiveness. The EU’s global leadership in standard-setting is under pressure, and faster, more coordinated international engagement is essential.

Currently, many harmonised standards listed in the Official Journal of the European Union are over five years old. This highlights the need for improved foresight and responsiveness, particularly at the pre-normative stage.

Moreover, the implementation of CJEU case law has introduced additional procedural complexity and underscored the need for greater transparency and accessibility in the standardisation system. The growing interest in alternative pathways to standardisation suggests that more flexible approaches may be necessary to meet future challenges.

To find out more about the EU standardization policy, please do not hesitate to contact the Product Compliance Institute.