Annexes to COM(2018)764 - Harmonised standards: Enhancing transparency and legal certainty for a fully functioning Single Market

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dossier COM(2018)764 - Harmonised standards: Enhancing transparency and legal certainty for a fully functioning Single Market.
document COM(2018)764 EN
date November 22, 2018
agreement on a joint Action Plan to address the issue of harmonised standards which are not cited in the Official Journal following a negative assessment by the Commission. This issue was raised by the REFIT Platform16 and by several stakeholders, as it impacts the sound functioning of the European standardisation system. To respond to this concern, the Commission has prioritised the rapid decrease of the backlog of such harmonised standards, in cooperation with the European Standardisation Organisations. Dealing with the remaining backlog remains a priority for the Commission.

First Action: The Commission will use its best endeavours to eliminate the remaining backlog as rapidly as possible.

To ensure the timeliness and the efficiency of the citation of compliant harmonised standards in the Official Journal, it is useful to identify emerging issues as early as possible in the development process. The Commission has set up a framework of consultants for such purposes. The consultants provide Commission services with technical assistance in assessing draft harmonised standards, thereby contributing to strengthening further the Commission control of the consistency of harmonised standards with the relevant legislation.

To enhance coordination within the public-private standardisation partnership, the Commission and the European Standardisation Organisations have held regular structural

12SWD(2015)205 final of 27.10.2015, http://ec.europa.eu/growth/single-market/european-standards/vademecum_en

13 http://www.cc.cec/Ares/ext/documentInfoDetails.do?documentId=080166e5ae43cdde

14 COM(2015) 550 final

15 COM(2016) 358 final

dialogues. These dialogues have focused on technical and policy aspects of European standardisation, including on matters related to the quality of harmonised standards and the impact they have on businesses, markets and consumers.

To promote a stronger involvement of co-legislators in the process of priority-setting for European standardisation, the Commission organised in June 2018 an inter-institutional dialogue. The dialogue included high-level representatives of European Union institutions, standardisation organisations, businesses (including small and medium-sized enterprises) and other relevant stakeholders, such as consumers, workers and environmental organisations. It focused on priority issues relevant to the process of developing harmonised standards and future priorities in this area, such as the digitisation and the booming collaborative economy.

The inter-institutional dialogue and the discussions with the key actors in the European standardisation system have highlighted the need to further enhance legal certainty to ensure that the Union legislative framework for standardisation is interpreted uniformly, in particular in light of the Standardisation Regulation, the case law of the Court of Justice of the European Union and the guidance documents.

3. Further actions to enhance transparency, reinforce legal certainty and

speed of adoption

While significant progress has been made, the Commission recognises that the efforts to improve the functioning of the European standardisation system need to be sustained. To this end, the Commission will take a set of dedicated, immediate actions to further enhance the transparency and efficiency of the European standardisation process. This will reinforce the legal certainty for stakeholders and users and clarify the roles and responsibilities of the different actors.

The Commission

reviewing its internal decision making processes with a view to

streamlining the procedures for publishing the references to harmonised standards in the Official Journal17. This review is based on best practices within the framework of the Commission’s internal rules of procedure and will ensure a co-ordinated, timely and thorough preparation of the necessary decisions.

Second Action: The Commission is reviewing its internal decision making processes with a view to streamlining the procedures for publishing the references to harmonised standards in the Official Journal.

In order to further clarify the roles and responsibilities of the different actors during all stages of the harmonised standards development, the Commission will prepare a guidance document.

This guidance, complementing existing documents18 will in particular explain the substantive and procedural aspects of the new format of the standardisation request which the Commission is developing with the aim of ensuring greater transparency and predictability in the development of the standards. It will also clarify the role of the Commission and its expert consultants. Finally, it will provide additional guidance to improve the consistency and speed of the assessment procedure of harmonised standards across the all relevant sectors.

Third Action: The Commission will elaborate over the next months in consultation with stakeholders, a guidance document on practical aspects of implementing the Standardisation

17 As of 1 December 2018, these Decisions will be taken by accelerated written procedure by the Commission.

is

Regulation, paying particular attention to the division of roles and responsibilities in the development process of harmonised standards as well as to efficiency and speed.

In order to ensure better upstream coordination in the process of assessing harmonised standards, which the European Standardisation Organisations are in the process of developing, the Commission will continue to rely on the scientific input of the Joint Research Centre and, at the same time, will reinforce its liaison with the technical committees in charge of developing standards through the recently introduced system of expert consultants. The goal will be to maximise the speed, quality and accuracy of the assessments to improve the quality of the process and to ensure that the references to harmonised standards are published as quickly as possible in the Official Journal. Measures will include:

- reinforcing links between the relevant Commission services in charge of harmonised legislation and the technical committees in charge of developing harmonised standards;

- expanding the pool of expert consultants and their skills-sets to ensure the expertise required for high-quality assessments and the resilience of the system;

- refining the structure of the work procedures and task allocation to expert consultants;

- focussing on continuous quality review of the consultants' input; including training programmes for expert consultants;

- enhancing the horizontal coherence of the assessments by applying streamlined guidance across all sectors;

- appropriate management of possible conflicts of interest.

Fourth Action: The Commission will reinforce, on an on-going basis, the system of consultants to support swift and robust assessments of harmonised standards and timely citation in the Official Journal of the European Union.

Conclusion

The European standardisation system has been instrumental for the development of the Single Market. The presumption of conformity with the relevant Union legislation provides important legal certainty to all standard users and small and medium-sized companies in particular. The Standardisation Regulation, which came into force in 2013, introduced a new division of roles and responsibilities of the actors in the system based on a public private partnership. It also established a strong framework for inclusiveness requirements, allowing interests of small and medium-sized enterprises, consumers and workers, as well as environmental interests to be taken into consideration in the standardisation process. The joint objective of all partners in the European standardisation system is to ensure that the Standardisation Regulation and other relevant Union laws are implemented as effectively as possible.

The Commission is entrusted with the responsibility for the assessment of European harmonised standards. The Commission also needs to ensure that these standards are compatible with the requirements of the relevant harmonised Union legislation. The case law of the Court of Justice of the European Union has confirmed the importance of this responsibility and highlighted its legal implications.

While the current system is functional, the Commission recognises that further improvement

further progress with regard to inclusiveness, legal certainty, predictability and the rapid delivery of the benefits of harmonised standards for the Single Market. Innovation and the protection of citizens and the environment are also key objectives in this context. The Commission will continue to work with all relevant partners to ensure the continued success of European standardisation as a cornerstone of a fully functioning Single Market.