Regulation (EU) No. 1025/2012 on European Standardisation
Input Call for Evidence
17 July 2025
Revision of Regulation (EU) No 1025/2012
The European standardisation system constitutes a fundamental pillar of the internal market and plays a decisive role in strengthening the international competitiveness of the European Union. As the representatives of German industry, we are following recent developments within the European standardisation system with increasing concern We therefore advocate for a targeted revision of Regulation (EU) No. 1025/2012, with the aim of effectively addressing current challenges and resolving structural issues in a sustainable manner.
The following aspects are of particular significance to us:
Strengthening the New Legislative Framework (NLF)
The clear separation between essential requirements laid down in legislative acts, e.g. for product safety, and their technical implementation through technical specifications described in standards in accordance with the NLF system is a cornerstone of the free movement of goods within the European Single Market. Regulation (EU) No 1025/2012 is the central element of this system, as it regulates the cooperation between the EU Commission and the European Standardisation Organisations (ESOs), as well as the development of harmonised European standards (hENs).
In our view, the revision of the Standardisation Regulation must be approached within the broader framework of the NLF and be firmly embedded in its principles. This is essential to reinforce the success of the existing model and to ensure efficient and effective cooperation between legislators, standardisation bodies, and industry stakeholders
Priority for harmonised European standards (hEN)
Harmonised European standards (hENs) must remain the primary instrument for presumption of conformity under EU legislation. Developed by standardisation experts through a transparent, consensusbased process, hENs reflect the state of the art and ensure market relevance. The integration of technical and market-related expertise into the implementation of EU legislation enables practical, innovation-friendly regulation and creates competitive advantages for European industry.
The revision of the Standardisation Regulation should therefore reaffirm the prominent role of hENs and define their legal nature in order to remove current legal uncertainties. This is particularly important given that hENs are market-driven technical specifications, developed within private-law standardisation organisations on behalf of the European Commission, and remain voluntary in their application.
Common specifications as a temporary fallback option
The use of Common Specifications must not be positioned as an alternative to the established legal framework of the New Legislative Framework (NLF) and the European standardisation system. Instead, they should be regarded strictly as a temporary fallback mechanism, to be applied only in exceptional and clearly defined cases, such as:
▪ when hENs are not available because the European Standardisation Organisations (ESOs) have not accepted the standardisation requests;
▪ when there are significant delays in the development of hENs; or
▪ when requirements of the legal act are not or insufficiently covered/addressed by the requirements in the standard.
The use of Common Specifications should be governed by a horizontal approach and permitted only under strict, limited, and transparent criteria. It is essential that the development and application of such specifications adhere to the fundamental principles of standardisation namely, the involvement of all relevant stakeholders, transparency, consensus, and alignment with international standards.
The European Commission’s proposal in the Omnibus IV package concerning Common Specifications does not meet these criteria. Instead, it grants the Commission broad discretion to act without a clearly defined legal framework. We therefore strongly advocate for the adoption of the wording set out in Article 20 of Regulation (EU) 2023/1230 on machinery, which provides a clear and balanced framework for the development, use, and withdrawal of Common Specifications.
Ensuring alignment with international standardisation
The competitiveness of the European economy depends significantly on access to global markets. The international harmonisation of technical requirements helps eliminate trade barriers and facilitates unrestricted market access.
Close alignment between European and international standardisation is therefore essential. In addition to active participation in the development of international standards, their adoption particularly within the framework of hENs used for conformity assessment should be actively supported. A decoupling of the two systems would result in divergent requirements between European and global markets, thereby weakening the international competitiveness of European industry and diminishing the attractiveness of the European market.
Accordingly, the revision of the Standardisation Regulation must be considered not only from a European perspective, but also in light of its international implications. Existing agreements such as the Vienna Agreement (with ISO) and the Frankfurt Agreement (with IEC), which promote international alignment, should be preserved and further strengthened.
Improving the standardisation process
The timely commissioning, development and citation of hEN references in the Official Journal of the European Union are essential for the effective functioning of the European standardisation system. The evaluation of the Regulation in 2024 revealed that the overall process from the initial mandate to final citation can take more than six years: approximately three years for the development of the standard and an additional three years for formal procedures, including the adoption of the standardisation request and listing in the Official Journal.
To address these delays, all three phases of the standardisation process standardisation request, drafting of the standard, and evaluation/listing must be considered. We therefore propose the following measures to speed up the process:
▪ Standardisation requests should be issued and formulated in a harmonised manner, particularly with regard to the level of technical detail and binding deadlines.
▪ A preliminary standardisation request (policy-based standardisation request) could be issued during the legislative process as soon as the basic requirements of the regulation are known in order to link the timelines of the legislative process and standardisation work at an early stage. This would allow standardisation organisations to begin drafting work in parallel timeline with the legislative process, even if the final standardisation request has not yet been issued.
▪ The standardisation processes within the ESOs should be reviewed in detail, streamlined, and made more flexible in order to shorten the development of hENs by several months compared to the current situation. The use of modern IT tools to support these processes should also be explored
▪ The assessment of the Harmonised Standards System (HAS) must be fundamentally restructured. The current review and approval process is overly complex and bureaucratic. The roles, responsibilities, and decision-making criteria of HAS consultants should be clearly
defined in a legally binding manner to reduce uncertainty and ensure proportionality. Furthermore, cooperation with standardisation bodies should be strengthened to allow submitting proposals for adjustments during the drafting phase that would otherwise result in non-compliance during the final assessment
However, speeding up the standardisation process must not come at the expense of core principles such as transparency, consensus, and the inclusive involvement of all relevant stakeholders
Standardisation requests to European Standardisation Organisations
Standardisation is a strategic and effective policy instrument that can influence a wide range of areas relevant to the public interest. In order to safeguard the strategic and political interests of the European Union, standardisation requests for the development of hENs are addressed exclusively to officially recognised European Standardisation Organisations (ESOs). This approach should be maintained in the context of the revision of the Regulation.
The involvement of other organisations should only be considered under clearly defined and transparent framework conditions We strongly oppose the establishment of entirely new structures that are disconnected from industrial practice Such an approach would risk decoupling European standardisation from international standardisation and would not address the existing challenges
Conclusion
The BDI supports a targeted and well-considered revision of Regulation (EU) No 1025/2012 in order to address current challenges and ensure that the European standardisation system remains efficient, reliable, and internationally aligned in the future. Rather than replacing the existing framework, the revision should focus on strengthening and improving it maintaining harmonised European standards (hENs) as the backbone of EU product legislation.
About the BDI
The BDI represents the interests of German industry to political decision-makers. In doing so, it supports companies in global competition. It has an extensive network in Germany and Europe, in all important markets and in international organisations. The BDI provides political support for international market development. It also offers information and economic policy advice on all topics relevant to industry. The BDI is the umbrella organisation for German industry and industry-related service providers. It represents 39 industry associations and more than 100,000 companies with around eight million employees. Membership is voluntary. Fifteen regional offices represent the interests of industry at the regional level.
Imprint
Federation of German Industries (BDI) Breite Straße 29, 10178 Berlin www.bdi.eu
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Editorial Office
Helena Weizel
Environmental, Technology and Sustainability Officer
T: +49 30 2028-1589
h weizel@bdi.eu
BDI document number: D2117