Efficiency and accountability in standardisation
To assess the efficiency and accountability of European standardisation under the new approach and make proposals for improvements.
Report of 13 May 1998 from the Commission to the Council and Parliament: Efficiency and Accountability in European Standardisation under the New Approach [COM(98) 291 final - Not published in the Official Journal].
This report is the Commission's response to the Council for the Internal Market's invitation, made at its meeting of November 1997, to prepare a report on the efficiency of European standardisation in co-operation with the European and national standards bodies and the appropriate European-level committees. The report describes the relationship between the new approach and standardisation and emphasises the importance of enhancing accountability and efficiency in European standardisation. It makes a number of proposals for improving efficiency.
The Commission first of all outlines the principles on which the relationship between the new approach to harmonisation and standardisation were based in 1985:
- the use of standards to meet the essential requirements laid down by the Directives;
- an approach based on large families of products (machinery, construction products, toys, packaging, etc.) or on "horizontal risks" (e.g. electromagnetic compatibility);
- the presumption of conformity for products complying with standards;
- a choice of conformity assessment procedures;
- the voluntary nature of the standardisation process;
- the independence of standards bodies.
The Commission notes that standardisation sometimes does not take place for the very reason that it is voluntary. This is especially the case in fields where the market is not sufficiently interested in European standardisation, e.g. the sectors of construction products and electric plugs and sockets.
The Commission goes on to stress that standardisation in line with Community regulations can only be justified if the system is open and transparent, if the standards are supported by all the interested parties and if they are applied in a uniform way throughout the Community. It is therefore important that the standardisation process give due regard to the principles of accountability, even if this affects the speed with which standards are drafted. The principles of accountability were laid down in 1984 in the General Guidelines for Co-operation between CEN and CENELEC and the European Commission (currently under revision) and in the Council Resolution of 18 June 1992 on the role of European standardisation in the European economy (Official Journal C 173 of 9 July 1992).
On the basis of these principles, the Commission notes that only national participation in the standardisation process can ensure accountability.
The use of Publicly Available Specifications (PAS) and similar documents in the new approach would undermine the accountability of the process. Although these specifications have certain advantages, mainly owing to the speed with which they can be adopted, they do not meet the criteria for accountability which would justify a role under the new approach.
The Commission defines an efficient standardisation system as one which should provide high-quality standards and deliver them in a timely fashion, while the standards themselves should be effectively used in the market. Several actors are involved: public authorities, companies and the two sides of industry. The efficiency of standardisation could be assessed in various ways, e.g. by evaluating the extent to which standards meet essential requirements or conducting a cost-benefit analysis, including a comparison of the impact of standardisation in Europe with other regions of the world and its effect on competitiveness. In its report the Commission opts for a pragmatic approach based on minimising the duration of the standardisation process while complying with accountability requirements.
Although considerable progress has been made in standardisation and the process has almost been completed in certain fields, there are significant delays in some sectors. The time taken to draft standards varies between 24 and 75 months.
Several measures designed to reduce these delays and, more generally, to increase the efficiency of the European standardisation system are proposed in the report. These measures concern management of the standardisation process, the role of public authorities and improving awareness and financial support for standardisation at European level. However, the Commission does not support proposals to merge European standardisation organisations or recognise new standards bodies.
While it notes that the principal responsibility for increasing the efficiency of standardisation belongs to the standards bodies themselves, the Commission suggests that management of the standardisation process could be improved by the following measures:
- setting realistic schedules for standardisation programmes and drawing up detailed reports on measures taken or planned by European standards bodies to improve efficiency;
- the use of qualified majority voting prior to the final adoption of a standard;
- the participation of interested representative parties in Europe in strategic discussions and policy development;
- use of electronic means of communication. In 1997 the Commission contributed ECU 1.6 million to the INES (CEN Internet Network for European Standardisation) project. The Commission would like to see more cooperation between CEN, CENELEC and ETSI;
- faster transposition of European standards;
- encouraging pre-normative research.
The national and European public authorities also have a role in standardisation:
- where the terms of mandates are not sufficiently clear, the Commission should clarify them at the request of the European standards bodies;
- progress in the implementation of programmes by the Commission and the national authorities should be monitored more closely. Accordingly, the Commission intends to include progress in standardisation in the Internal Market Scoreboard;
- the efficiency of Community committees and expert groups should be improved. The Commission is to draw up a report on their operation;
- in certain fields where the participation of public authorities is important in the standardisation process, the public authorities should bring their expertise to working groups. This could be the case, for example, in the fields of the environment, health and safety;
- the Commission will ensure the speedy publication in the Official Journal of references of European standards.
The report proposes several measures to improve awareness:
- the implementation of the Memorandum of Understanding between the Commission and the European standards bodies, with the participation of NORMAPME, the organisation which represents SMEs, could help raise awareness of European standards among market participants;
- progress reports on standardisation in different sectors should be published on the Internet by the European standards bodies;
- the Commission could hold a conference with all the interested parties on improving the efficiency of standardisation.
Since 1986 the Community has committed ECU 60 million to new approach standardisation work at European level. The average contribution requested for drafting standards has decreased from ECU 50 000 to ECU 30 000. The Commission organises regular review meetings with the European standards bodies to ensure that its financial support has optimal effect. Its report notes that financing policy was adjusted in 1996 and 1997 to emphasise the market-driven nature of standardisation. At the same time, the Commission calls on the European standards bodies to launch an independent evaluation of future needs with regard to the financing of European standardisation.
A table annexed to the report summarises the standardisation activities conducted under the new approach up to 13 May 1998:
|SECTORS||MANDATED||RATIFIED||UNDER APPROVAL||IN PREPARA-TION|
|90/384/EEC||Non-automatic weighing instruments||1||1||-||-|
|87/404/EEC||Simple pressure vessels||47||38||5||4|
|88/378/EEC||Safety of toys||10||6||1||3|
|89/392/EEC||Safety of machinery||894||241||370||310|
|89/686/EEC||Personal protective equipment||300||159||47||94|
|93/42/EEC||Medical devices, including||-||-||-||-|
|90/385/EEC||Active implantable medical devices||248||127||60||61|
|93/15/EEC||Explosive for civil uses||51||0||0||51|
|94/62/EC||Packaging and packaging waste||21||0||0||21|
|91/263/EEC||Telecommunications terminal equipment||30||25||-||5|
|93/97/EEC||Satellite earth station equipment||8||5||-||3|
|COM/96/643 final||In vitro diagnostic medical devices||22||0||4||18|
|COM/97/34 final||Railway equipment||104||12||28||64|
|COM/93/322 final||Precious metals||8||0||2||6|
5) FOLLOW-UP WORK
Report from the Commission to the Council and the European Parliament on actions taken following the resolutions on European standardisation adopted by the Council and the European Parliament in 1999 [COM(2001) 527 final - Not published in the Official Journal].
Council Resolution of 28 October 1999 onthe role of standardisation in Europe[Official Journal C 141 of 19.05.2000]
Council conclusions of 1 March 2002 on standardisation [Official Journal C 66 of 15.03.2002].
For further information, see:
Site of the Enterprise Directorate-General on standardisation.