PURPOSE : to postpone until 30 April 2012 the deadline for the transposition of Directive 2004/40/EC.
PROPOSED ACT : Directive of the European Parliament and of the Council
CONTENT : Directive 2004/40/EC has to be transposed into national legislation no later than 30 April 2008. This proposal aims to amend Article 13(1) of Directive 2004/40/EC in order to postpone the date of transposition until 30 April 2012.
In 2006, the medical community informed the Commission of its concerns regarding the implementation of this Directive, claiming that the exposure limit values laid down in the Directive would limit to a disproportionate extent the use and development of magnetic resonance imaging (MRI), considered today to be a vital tool for the diagnosis and treatment of several diseases. Other industrial sectors also subsequently expressed their concerns about the impact of the Directive on their activities.
The Commission discusses two recent studies that confirm the possibility that the limit values established in the Directive may interfere with medical procedures using MRI. Moreover, the International Commission for Non-ionising Radiation Protection (ICNIRP) is currently reviewing the guidelines on static magnetic fields and low-frequency time-varying fields on which the Directive is based. In both cases, new recommendations will probably provide for less strict limit values for low-frequency fields than those laid down in the Directive. These changes are likely to be backed up by the new scientific studies conducted since the adoption of the Directive. The new recommendations of the ICNIRP are expected in November 2007 and autumn 2008 respectively. The World Health Organisation (WHO) is also currently revising its environmental health criteria for electromagnetic fields in order to reflect the latest scientific studies available.
In view of these, the current deadline of 30 April 2008 should be postponed for four years:
-to allow a full analysis of the studies, including that launched by the Commission, regarding the potential negative impact of the exposure limit values set by the
Directive on the medical use of MRI;
-pending the results of the review of the ICNIRP recommendations, to take into account the WHO's environmental health criteria for electromagnetic fields based on the latest scientific studies concerning the impact of electromagnetic fields on human health published since the adoption of the directive; and
-to conduct an in-depth impact analysis of the Directive's provisions and propose amendments to it in order to guarantee both a high level of health and safety protection for workers and the continuation and development of medical and industrial activities using electromagnetic fields.