KANBrief 3/10
In order to ensure that harmonized European standards adequately support the essential safety requirements of EU directives, CEN/CENELEC and the European Commission make use of a system of independent consultants. These consultants are contracted to CEN/CENELEC. Through their review of the standards – approximately 570 in the area of machinery alone – they make an important contribution to quality assurance of the standardization system.
CEN/CENELEC Consultants advise the Technical Committees (TCs) and the European Commission on all issues relating to support of the essential requirements of directives. In addition, they submit written assessments on standards at the draft stage at the request of the CEN/ CENELEC Management Centre (CCMC), the TCs or Working Groups (WGs).
The assessments are presented to the standards organizations in the form of the template provided for comments. For final draft standards, the assessment is also marked “Positive” or “Negative”. At this point at the latest, the Consultant states whether the draft of the standard is suitable for satisfying the requirements of the relevant EU directive.
The comments may be technical, general or editorial in nature. Technical comments must relate to the essential health and safety requirements of the EU directive in question, such as omission of a requirement for fixed servicing access points on machines. Comments of a general nature relate for example to a defective or missing Annex ZA or ZZ. Omission of an Annex Z is sufficient to prompt a negative assessment.
The veto is a myth
The mechanisms concerning the tasks and responsibilities of the CEN/CENELEC Consultants (CEN/CENELEC Guide 15: Tasks and responsibilities of the New Approach consultants (pdf)) do not make provision for a formal veto. Further progress of a final draft standard is however halted if the Consultant deems it defective. In this case, the document is referred back to the TC for revision. Only once the Consultant has presented a positive assessment is the draft of the standard approved for final voting. In the very rare cases in which the Consultant and TC are unable to reach agreement, the CEN/ CENELEC Technical Board is called upon to launch further steps.
Timely contact
The TCs should contact the responsible Consultant (the CEN/CENELEC Management Centre provides information on which Consultant is responsible in a particular case: CEN.consultants@cencenelec.eu) as early as possible during the work item, since particular requirements in EU directives are easily overlooked, and retrospective amendment of the standard easily leads to frustration, particularly when a consensus has already been reached on the TC. It is advisable to present the draft of the standard to the Consultant at least at the CD, prEN/DIS and FprEN/FDIS stages (see table).
International standards
In international standardization projects under the Dresden or Vienna Agreements in particular, it is important that the TC also include the comments made by the Consultant in the compilation of the comments made by Committee members. Only in this way can it be ensured that the members of the Committee outside Europe are also informed of the Consultant’s objections. Separate negotiation of the Consultant’s comments at European level alone generally leads to “common modifications”, i.e. to a European standard that deviates from the international standard. This is counter-productive.
Involvement of all stakeholders
Sadly, the operators of machinery and equipment and representatives of government bodies are increasingly being seen to withdraw from active participation in standardization. This makes the work of Consultants more difficult, since they are then often alone in presenting the OSH requirements of the EU directives. Where the comments phase has already passed by the time complaints are made regarding deficits in standards, they lead to formal objections, which may set a work item back several years. Both the Technical Committees and all experts are therefore called upon to assume their responsibilities within standardization at an early stage (refer also to the EUROSHNET Cracow Memorandum, Standardization for safe products).