In 2011 (see KANBrief 3/11), the European Commission had presented the draft of a regulation by which the standardization system was to be adapted better to the challenges of our time. Following intensive negotiations and certain changes to the original proposal, the European Parliament and the Council passed the negotiated compromise in September and October 2012 respectively. The regulation will apply from 1 January 2013.
Involvement of the stakeholders
The regulation does not call the essential foundations and proven structures of European standardization into question. For example, despite the greater support given to stakeholders at European level, it is stressed that their participation must continue to be promoted in particular at national level. Nor does the regulation accord voting rights at European level to organizations such as NORMAPME, ANEC, ECOS or ETUI, which represent the interests of SMEs, consumers, the environment and trade unions in Europe. The principle of national delegation is not therefore at risk.
The involvement of market surveillance bodies in standardization work will remain a requirement, but will not receive financial support. The involvement of the authorities in the formulation of mandates will however be strengthened.
It is still difficult at this stage to estimate the ramifications of the European Commission's Joint Research Centre also being given a more important role in standardization activity. This was the very Directorate-General which had repeatedly issued standards organizations with mandates which failed to observe the underlying statutory requirements. Examples include CWAs for civil protection (The products concerned fall in some cases within the scope of the PPE Directive and in others within areas governed at national level) and the mandate issued to a CEN workshop to publish up-to-date research results on emerging risks directly in the form of CWAs. In KAN's view however, documents resembling standards are not suitable for such subjects.
Standards and documents resembling standards
Despite this, standards generally retain their priority over consortial documents (Documents developed by private fora and consortia and which do not have the status of standards). Qualitative properties have been added to the definition of standards; these elevate them above other documents resembling standards. Even in the area subject to the directives governing public procurement for information and communications technology, international consortial documents are not elevated to the status of standards, but are merely identified for a specific purpose, and retain the status of specifications. They too must now satisfy strict supplementary criteria, such as consistency with the body of standards. The mutual relationship between consortia and European standards organizations is however to become closer. The role of consortial documents that had already been emerging, namely of final formulations suitable for submission as draft standards in an accelerated procedure, is therefore likely to become even more significant.
Quality of the standards
The procedure for formal objections has been harmonized for almost all New Approach Directives. Besides the Member States, the European Parliament may now also submit formal objections. Conversely, the Commission is no longer able to do so. A further change is that the Commission must indicate on its website (and not just in the Official Journal) all standards on which a ruling has been made following a formal objection, irrespective of the outcome.
In the future, the European Commission is to evaluate, in conjunction with the European standards organizations, whether the harmonized standards satisfy the mandates. How this is to be achieved is still unclear. The role to be assumed by the Consultants in this context and whether this is even compatible with the philosophy of the New Approach, i.e. with the clear separation of official legislation and private standardization, is completely open. It is also unclear what responsibility the Commission must then accept for the standards that are deemed acceptable.
In the future, funding of standardization activity will be linked to conditions such as timely completion of the work. This is a cause for concern, since standards committees are already under considerable time pressure. It is to be feared that this will result in standards increasingly containing premature results, a development that could also have worrying consequences for safety.