Standardisation Regulation
PURPOSE: to modernise the European standardisation system with a view to improving EU competitiveness.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: 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. The system is currently based on cooperation between the recognised European Standardisation Organisations (CEN, CENELEC and ETSI), national standardisation bodies, industry, public authorities, consumer representatives, trade unions, environmental organisations and other stakeholders.
The legal framework for European standardisation established by Regulation (EU) No 1025/2012 is unfit to enable the European standardisation system to keep up with rapid technological changes and growing global competition. 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.
Therefore, 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.
CONTENT: the proposal aims to modernise the European standardisation system to make it faster, increase the representation of small- and medium-sized enterprises, and better equipped to support the European Union's strategic interests, by addressing four key challenges:
1) 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).
2) 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.
3) Uncertainty surrounding the financial sustainability of the European standardisation system, requiring free access to harmonised standards, challenges the revenue model of some European standardisation organisations.
4) The Union influence in global standardisation is declining, particularly in strategic technologies.
To meet these challenges, the proposal:
- 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 standardization 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.
- 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. The development of such standards and standardisation deliverables must be transparent and that referenced standards and standardisation deliverables must be freely accessible;
- sets out the specific role European standardisation organisations and national standardisation bodies play in the European standardisation system. The proposal 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;
- address the inclusiveness of the standardisation process by European standardisation organisation and national standardisation bodies. The proposal 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;
- establishes the obligation for the Commission to consult European standardisation organisations before adopting a standardisation request;
- sets out the framework for requesting standards and standardisation deliverables from designated standards development organisations. The proposal sets out the procedure and requirements for designating standards development organisations to which the Commission may address a standardisation request;
- outlines the importance of international standardisation and promotes European coordination to increase the Union’s influence in international standardisation bodies.
European Centre of Excellence for Standardisation
The Commission is also proposing to create an Expert Centre on European Standardisation to ensure stronger strategic steering, better cross-policy coordination, and closer alignment between standardisation work and EU priorities.
Lastly, the European Commission should establish, manage and maintain a digital platform (EU Standards Platform). This 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.