Assessing merits and bottlenecks in Europe’s standardisation system

Executive summary 

The Standardisation Regulation provides a clear and stable legal framework that fosters the development of standards in line with the European standardisation principles of openness, inclusiveness, transparency, and consensus.

The Regulation’s existing provisions fulfill its objectives and remain future-proof to deliver standards supporting a green, digital, and resilient single market. We therefore believe the Regulation’s principles and content do not require any change. 

However, EU efforts should be focused on resolving issues related to the current implementation of the European standardisation system, particularly the timely citation of harmonised standards supporting EU policies. 

Since 2016, the European Commission’s procedures for developing and citing harmonised standards have introduced unjustified pressures and critical bottlenecks. These issues have severely affected the system’s efficiency. The current implementation process needs to be improved without destabilising the solid legal framework established by the Standardisation Regulation. 

Key areas of concern include: 

• Implementation challenges: The procedures initiated by the Commission following the James Elliott court case and the guidelines outlined in the Vademecum have created significant delays and obstacles in the citation of harmonised standards.2 These procedures have undermined the leading role of the European standardisation system.

• Bottlenecks in citation: The Commission’s prescriptive approach has resulted in stringent timelines and detailed work programmes that put undue pressure on experts, limiting their ability to develop high-quality standards. This approach has also led to frequent challenges and refusals of consensual support for deliverables that meet the standardisation request requirements.

• Divergence from international standards: The Commission’s approach has required European-specific modifications to international standards. This divergence increases development time, costs, and technical barriers to trade, putting European industry at a competitive disadvantage.

• Consequences for economic operators: The current lists of harmonised standards are often obsolete, incomplete, or delayed, causing confusion and uncertainty among manufacturers, importers, SMEs, customs officers, and market surveillance authorities. This loss of certainty has degraded the implementation of EU policy objectives and weakened the CE marking.

To address these challenges, trust between the ESOs and the Commission must be restored. Clearer roles and responsibilities need to be reinforced. The assessment process should focus on compliance with the standardisation request without subjective criteria that contradict the consensus-making process. Additionally, improving the timeline for preparing and citing harmonised standards is essential. 

Whilst the principles and content of the Standardisation Regulation are sound and do not require change, the implementation process needs significant improvement. By addressing these implementation issues, the European standardisation system can continue to support a robust single market and maintain Europe’s global leadership in standardisation.