KANBrief 2/25
The European Commission is currently preparing revision of the Standardisation Regulation (EU) No. 1025/2012. The Regulation has served as the statutory framework for the development of harmonized standards in the European Union since 2012.
The Standardisation Regulation governs cooperation between the European Commission and the European standards organizations, and sets out framework conditions, for example for funding of the European standardization work mandated by the Commission, and the participation of stakeholders.
In 2023, the European Commission launched its evaluation of the Standardisation Regulation. As announced in the EU Strategy on Standardisation, the Regulation was to be reviewed to determine whether, over ten years after it became applicable, it is still fit for purpose and is keeping pace with developments in standardization at national, European and international level. To this end, the European Commission consulted the wider public and industrial and social stakeholders between May and July 2024. KAN participated in the consultation by providing detailed feedback, and raised key OSH concerns (see KANBrief 3/24).
In the course of the consultation, many stakeholders at national and European level expressed the view that the Standardisation Regulation is indeed still fit for purpose, and that scope for improvement is evident only with respect to its implementation. In KAN’s view, the European standardization system is a decisive factor for the Single Market’s success. The principles enshrined in it, such as transparency, the creation of standards by consensus and the broad participation of all stakeholders, are indispensable.
The European Commission presented the preliminary results of the evaluation in November 2024. It identified residual shortcomings with regard to the participation of all stakeholders. In principle, it sees the Regulation as having largely achieved its goal of improving stakeholder participation. Representation of small and medium-sized enterprises (SMEs), trade unions, and other societal stakeholders such as consumer and environmental protection interests through what are termed the Annex III organizations, has been supported at European level since the Regulation came into force. Nevertheless, standardization activities continue to be considered too complex and cost-intensive for these stakeholders. Furthermore, representation of societal interests is governed inconsistently at national and international level. All of this presents obstacles to participation.
A major need for improvement was also identified with regard to the present pace of standardization. On average, development of a standard from beginning to end currently takes six years. Despite having been reduced in duration since the regulation entered into force, development still takes too long to meet the current needs of the Single Market and EU legislation. The European standardization system is struggling to deliver harmonized European standards as swiftly as is necessitated by the short innovation cycles of new technologies and for implementation of the European Green Deal.
In January 2025, the European Commission announced revision of the Standardisation Regulation as one of its Flagship Actions enablers within the Competitiveness Compass. Since the beginning of the new EU legislative cycle, standardization has thereby acquired even greater relevance for the EU’s competitiveness and the success of the European Single Market. The Commission wishes to speed up the standardization process and make it more accessible, particularly for SMEs and start-ups.
Barbara Bonvissuto, Director with responsibility for standards policy at the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW), explained in the European Parliament’s Committee on the Internal Market and Consumer Protection (IMCO) in February 2025 that the European standardization system is now facing further challenges. Firstly, geopolitical competition in international standardization is having an impact on areas that are critical for the safeguarding of European values and the EU’s economic interests. Secondly, the Commission still faces the task of implementing the ruling of the European Court of Justice in 2024 on free access to harmonized standards (Ruling of 5 March 2024 (C-588/21 P), the “Malamud ruling).
According to the roadmap published by the Commission in February 2025 on the “Have your say” portal, the next step is for a public consultation to be held in the second quarter of 2025 on revision of the Regulation. A concrete legislative proposal could then be published in the second quarter of 2026.
The KAN Secretariat will closely monitor the revision process as it develops in the coming years, and will advocate for the concerns of the occupational safety and health stakeholders.
Ronja Heydecke
heydecke@kan.de