Brussels, 26 October 2007
"The Commission remains committed to the protection of the health and safety of workers. However, it was never the intention of this Directive to impede the practice of MRI. Obviously, the Commission recognises MRI as a technology offering clear benefits to patients, and continues to support MRI research financially", commented Vladimír Špidla, EU Commissioner for Employment, Social Affairs and Equal Opportunities. "Postponement of the transposition will allow time to review the current Directive and amend those provisions which have been shown to be problematic by recent scientific studies. While this review is ongoing, the Commission recommends that Member States put the transposition of the current Directive on hold."
The Commission indicates in its proposal that this postponement is being carried out in order to prepare a substantive amendment to the Directive. The future amendment will aim to ensure that limits will not have an adverse effect on the practice of MRI, whilst ensuring appropriate protection of personnel. Moreover, it is intended to review the situation for all sectors where personnel are exposed to electromagnetic fields while carrying out their work.
The proposed postponement will also allow sufficient time to take into account new recommendations from relevant international bodies. The International Commission on Non-Ionising Radiation Protection (ICNIRP) is currently revising its recommendations for occupational limit values for static and low frequency electromagnetic fields (such as MRI), while the World Health Organisation is also revising its Environmental Health Criteria for electromagnetic fields. Those revisions are expected to yield results in the form of new, less stringent, recommended limit values for occupational exposure at the end of 2008.
Directive 2004/40/EC was adopted by Parliament and Council in April 2004 and was due to enter into force in April 2008. Its content was based on up-to-date scientific knowledge, as established by the International Commission on Non-Ionising Radiation Protection (ICNIRP) at the time.
In 2006, the Commission received indications from stakeholders that the implementation of the legislation might create difficulties. Commissioner Špidla immediately met the principal stakeholders and reassured them that the Commission would not hesitate to change legislation already adopted if it should be proved that it would have adverse effects on the practice of MRI. The Commission then launched a study to look into exactly what implications the Directive's exposure limits would have on MRI and identify potential problems that could arise. The study is now under way in four installations across Europe (Germany, France, Belgium and the UK). The results should be finalised by end of January 2008.
To proceed in a transparent manner, the Commission wrote to all Member States in February 2007 informing them about its willingness to address the issue and draw the necessary conclusions from ongoing studies. In addition, the Commission has also conducted a number of meetings with MRI practitioners as well as representatives of the industry to discuss potential difficulties with the Directive in terms of limits affecting MRI as well as in terms of its potential impact on other sectors. In June 2007, the UK authorities published a study indicating that the practice of MRI could indeed be affected. On the occasion of its publication, Commissioner Špidla made a public statement to Members of the European Parliament and to stakeholders to the effect that the legislation already adopted would thus have to be changed.
MRI is currently the leading technique for detecting brain tumours and many
other serious conditions. It allows doctors to help 8 million patients each year
so the European Commission, as well as the Council, is well aware of the
enormous benefits of magnetic resonance imaging and of its immense value for
public health. The EU is also a driving force behind new research in this field.
As part of its 7th Framework Programme for Research, it will in 2007 invest
roughly €6.000.000 in projects to develop hybrid imaging systems such as
MRI/PET and MRI/Ultrasound.
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