European Union standardisation

SUMMARY OF:

Regulation (EU) No 1025/2012 on European standardisation

Regulation (EU) 2022/2480 amending Regulation (EU) No 1025/2012

WHAT IS THE AIM OF THE REGULATION?

It aims to modernise and improve standardisation in the European Union (EU), which plays a leading role in its internal market, by outlining how:
- the EU standards-setting process operates; and
- the various organisations involved in this process (at both the EU and the national level) work together.
It seeks to simplify and adapt the legislative framework to reflect the latest developments and future challenges.
Standards support market competition, reduce costs, improve safety and enhance competition, protecting health, safety, security and the environment.

KEY POINTS

The regulation includes rules governing:

cooperation between standardisation organisations, national standardisation bodies, EU Member States and the European Commission;
how market-driven European standards for products and services are established in line with EU legislation and policies;
how information and communication technology technical specifications can support this process;
financing standardisation activities, normally in the form of grants or calls for proposals in line with EU legislation and policies;
stakeholder participation.

The regulation covers standards for services and products, and environmental and public health protection must also be included among the required characteristics of a product or service.

Standardisation requests to European standardisation organisations

The Commission may request one or more European standardisation organisations (ESOs) to draft a European standard, which must be market-driven and take into account the public interest and EU policy objectives. The Commission determines the requirements and deadlines to be met. Member States will communicate to the Commission all requests made to standards institutions to draw up technical specifications or a specific product standard so that draft technical regulations can be drawn up.

Broad participation in the standards-setting process

ESOs must facilitate the effective participation of all relevant stakeholders, including small and medium-sized enterprises, consumer organisations and environmental and social stakeholders, in their standardisation work.
National standardisation bodies must facilitate the access of small and medium-sized enterprises to the standards and their development processes, sharing best practices to improve participation.
Member States must, where appropriate, encourage the participation of public authorities, including market surveillance authorities, in national standardisation activities to develop or revise standards.
To ensure that the EU’s interests, values and policy objectives, along with public interest in general, are better taken into account in the standardisation process, Regulation (EU) 2022/2480 introduces an amendment to Article 10 of Regulation (EU) No 1025/2012. The amendment brings in good governance principles within the European standardisation system by guaranteeing a balanced representation of stakeholders in the standards decision-making procedure. The new rules require each ESO to ensure that certain decisions concerning European standards and European standardisation deliverables are taken exclusively by representatives of national standardisation bodies within the relevant decision-making body of that organisation, in particular:
- decisions on the acceptance and refusal of standardisation requests from the Commission;
- decisions on the acceptance of new work items that are needed for the fulfilment of the standardisation request; and
- decisions on the adoption, revision and withdrawal of European standards or European standardisation deliverables.

Recognition and use of technical specifications

Public authorities should use the full range of relevant technical specifications when procuring hardware, software and information technology services. The technical specifications have market acceptance and do not hamper interoperability with existing EU or international standards.

Annual work programme and objections to harmonised standards

The annual work programme sets out strategic priorities, taking into account EU long-term growth strategies. The Commission will set up a notification system for all stakeholders to ensure proper consultation and market relevance before adopting the annual work programme or standardisation requests, or making decisions on any objections to harmonised standards brought by Member States or the European Parliament.

Reporting

The European standardisation organisations will send an annual report on the implementation of this regulation to the Commission.

Specific standards

The regulation explicitly covers the following specific standards:

FROM WHEN DOES THE REGULATION APPLY?

Regulation (EU) No 1025/2012 has applied since 1 January 2013.

Regulation (EU) 2022/2480 will apply as of 9 July 2023.

BACKGROUND

For further information, see:

European standards (European Commission)
Independent review of the European standardisation system (European Commission).

MAIN DOCUMENTS

Regulation (EU) No 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 No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, pp. 12–33).

Successive amendments to Regulation (EU) No 1025/2012 have been incorporated in the original text. This consolidated version is of documentary value only.

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, 19.12.2022, pp. 1–3).