The system of CEN/CENELEC Consultants has been suspended since the beginning of this year. The European standards organizations and the European Commission have as yet been unable to reach agreement on renewal of the framework agreement governing co-operation between them, which includes arrangements concerning the Consultants. An important pillar of the quality assurance of harmonized European standards is thus lacking.
Harmonized European standards are developed in response to mandates issued by the European Commission and are intended to support the essential safety requirements set out in EU Single Market directives. In order for the standards to satisfy this purpose, independent advisers – the CEN/CENELEC Consultants
(CEN/CENELEC Guide 15: Tasks and responsibilities of the New Approach consultants (pdf); see also KANBrief 3/10) – support the Technical Committees (TCs) in the task of developing the standards (Transposing Article 10 (5) of the EU Standards Regulation 1025/2012). This includes providing interpretations of the directives, and identifying deficits in the proposed provisions for the standards. The Consultants review, comment upon and evaluate each draft standard developed in response to a mandate. They pay particular attention to satisfaction of the requirement that Annex Z cross-reference the sections of the standard to the respective essential safety requirements of the corresponding directive addressed by them. The Consultants are to be available to both the TCs and the European Commission to answer questions concerning the development of the standards.
The European Commission publishes the titles and references of harmonized standards in the Official Journal (OJ) of the EU only once the standards have passed assessment by the Consultants. This listing in the OJ is a prerequisite for the presumption of conformity. The presumption of conformity means that when a product satisfies the provisions of a harmonized standard, it is also presumed to satisfy the requirements of the directive covered by the standard.
Experience shows the work of the Consultants to be an important element in assuring the quality of the standards, and that the Consultants thus make an essential contribution to functioning of the New Approach.
Standards in limbo: what next?
The Consultants have a contract with CEN/ CENELEC but are funded by the European Commission. The arrangements governing their work are part of a bilateral framework agreement governing the co-operation between the standards organizations and the Commission. This agreement must be renewed each year. Implementation of EU Standards Regulation 2012/1025, which has been in force since 2013 and which for example links funding of the standards organizations more closely to the observance of specified development times, has necessitated amendments to the agreement. As yet however the two parties have not been able to agree on new terms. CEN does not anticipate agreement being reached on the Consultants' contracts before September of this year at the earliest.
As early as the end of January, CEN/CENELEC had instructed the Technical Committees to cease involving the Consultants in the work of standards development, since with the framework agreement suspended, funding for them was not assured. To all intents and purposes, this means that the work of the Consultants has been put on hold. Since the development of standards nevertheless continues, CEN/CENELEC will report standards to the European Commission that have not undergone the review by the Consultants conducted routinely in the past.
It remains unclear how the Commission will now proceed. In the long term, it is considering fundamental changes to the system of Consultants. This includes the idea of placing the Consultants directly under the responsibility of the Commission rather than merely assuring their funding at CEN/CENELEC, as has been the case to date.
A swift solution is needed
A solution for the short term is required. Either no new lists of harmonized standards will be published in the coming months; or review will be conducted by some other means; or the references to the standards will be published in the form delivered by CEN/CENELEC, without further review.
Any of these short-term alternatives would represent a significant deviation from the practice observed to date, probably to the detriment of quality and therefore also of safety. In their common declaration on standardization policy in the field of occupational safety and health (pdf), KAN and the French OSH institutions EUROGIP and INRS have stressed that the proven independent reviews conducted by the Consultants are absolutely essential in order for standards of high quality to continue to be published and listed in the future. In order to prevent the system from grinding to a halt, those responsible should reach an agreement as quickly as possible.
Dr Michael Thierbach