JBRBTR, 2007, 90: 65-68.

EUROPEAN DIRECTIVE ON ELECTROMAGNETIC FIELDS

Guy Frija, Secretary General of the European Society of Radiology
Jacques Bittoun, Director of the Medical Magnetic Resonance Research Group, Universit Paris Sud/CNRS; former
President of ESMRMB *
Gabriel P. Krestin, President of ESMRMB *
David Norris, Chair of the Safety Committee of ESMRMB
*ESMRMB-European Society for Magnetic Resonance in Medicine and Biology

A European Directive on electromagnetic fields was adopted in 2004

and must be transposed into
National law by April 2008 at the
latest. It followed on from recommendations published in 1999. It
defines electromagnetic field exposure limits for all workers in the EU.
If directly applied, it would seriously
compromise certain MR examinations and, in the longer term, hinder
the use of higher magnetic field
strengths, whether for treatment or
research purposes.
What is the field of application of
this Directive?
The Directive concerns staff, not
patients. It deals with only shortterm effects.
It includes all electromagnetic
fields up to 300 GHz.
The exposure limits are based on
work by ICNIRP (International
Commission on Non Ionizing
Radiation Protection) published in
1993 and updated in 1998 (to be
revised in 2009).
Why this Directive?
The Directive was adopted in
response to major concerns over
the population effects of all electromagnetic fields (from 0 Hz to
300 GHz), and especially those emitted by mobile phones and electrical
power lines, which are regularly
debated in the media.
MRI is concerned because the frequencies it uses are contained within the spectrum of frequencies dealt
with by the Directive.
What effects do electromagnetic
fields have?
Electromagnetic fields can interact with biological systems either
through the currents they induce, or
through the energy they transfer to
biological tissues. The frequency of
electromagnetic waves is a major
determinant. Schematically, low frequencies interact mainly through

0 Hz
static magnetic field

100-1000 Hz
10-400 MHz
magnetic field gradients Radiofrequencies

Spectrum of frequencies used in MRI

induced currents, while higher frequencies act mainly through the

energy they deposit in tissues.
Static (zero frequency) magnetic
fields interact either through movementrelated magnetic induction, or
through magnetic-mechanical interaction. Contrary to ionizing radiation, which exerts its biochemical
effects by breaking covalent bonds,
electromagnetic fields act via
induced currents, or by creating
and/or reorienting dipoles.

Thus, MRI interacts with the

human body in the following ways:

gradients, as they switch, induce

currents in the target tissues
radiofrequency waves can cause
tissue heating
the static magnetic field has two
types of effect: a direct effect
related to the intensity of the
field, and effects generated as
persons move through the
gradient of the field within the

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JBRBTR, 2007, 90 (1)

Frequencies

Mechanism

Static magnetic field (0 Hz)

Magnetic induction
Magnetic-mechanical interaction

Low frequencies (30 Hz 300 Hz)

Induced currents

Radiofrequences and microwaves

(0.1 MHz 10 GHz)

Energy deposited in the body

Microwaves (10 GHz 300 GHz)

Surface heating

Mechanisms of biological interactions with electromagnetic fields

simple preparation or positioning of

the patient, or even an IV injection
given during the examination. All
staff moving within the examination
room is subject to field variations
that, while difficult to measure,
nonetheless exist. Pediatric examinations are especially concerned,
because in most cases they require
sedation and close interaction with
the patient.
What actions?

examination room. These persons are subject to time varying

magnetic fields which can induce
electric fields.

What are the implications for MRI?

Cut-points
Exposure limits for personnel
exposed to magnetic fields have
been established with two different
aims, namely to avoid the risk of
peripheral nerve stimulation by
induced currents, and to prevent tissue heating. These limits were
established by ICNIRP based on
studies conducted in vitro and on
experimental animals. The intensity
of the induced currents must not
exceed 10 mA/m2, and body heating
must remain below one degree
Celsius.
In a general review of epidemiological studies on electromagnetic
field effects, no causal relationship
was found between exposure and
health disorders.
Nausea and dizziness have been
reported by subjects exposed to
highintensity MRI fields. A burning
or pins and needles sensation due
to peripheral nerve stimulation has
also been noted and shown to be
the act of switching the gradient.

Static magnetic fields (B0): as it

stands, the Directive does not
deal with static fields. However,
a person moving within a static
field with spatial variations is
submitted to magnetic field variations. With a 1.5-Tesla magnet,
the 200-mT threshold recommended for static fields is
reached about 1 meter from the
center of the magnet; this distance could double with 3-T
magnets, depending on built-in
shielding.
Gradients: MRI uses gradients
(up to 66 mT/m) to locate the signal in space. These gradients are
centered on the patient. Their
spatial extension outside the
magnet bore is not described in
the literature, but is probably
tiny. However, the recommended
reference levels (from 25 to
820 Hz: 0.025 mT) would imply
that this spatial extension, however small, could not be neglected.
Radiofrequency waves: the recommended thresholds have little
impact.

Reference values

What are the practical consequences?

Reference values have been

established by means of mathematical modeling based on extrapolation of experimental results from
threshold values. These reference
values are closely dependent on the
frequency, as shown in the following table:

Any person working with a

patient placed at the center of the
magnet or in its immediate vicinity
is at risk of exceeding the reference
values. This is particularly the case
for interventional procedures, procedures under anesthesia (that
requires close patient monitoring),

Frequencies (f)

Reference values in mT (milliteslas)

0 to 1 Hz

200

1 to 8 Hz

200 /f2 (200 to 3125)

8 to 25 Hz

25/f (3125 to 1 mT)

25 to 820 Hz

25/f (1 to 0.03 mT)

Publication of this Directive has

generated a good deal of controversy because it is based on an extrapolation of effects observed in experimental animals or in vitro to hypothetical effects on human health.
Furthermore the limits upon which it
is based are related to the possible
onset of physiological responses,
which may not necessarily be harmful. In addition, many see the exposure limits as being exceptionally
stringent considering the clinical
benignity of the phenomena in
question. Limiting exposure to the
values contained in the Directive
would also have other consequences: some MRI examinations
would have to be replaced by computed tomography, the use of
stronger fields within the European
Union would be considerably
restricted, whether for therapeutic
or research purposes, and quality
control (use of phantoms) would be
hindered. Finally, many questions
remain regarding the methods and
implementation of reliable dosimetry in clinical practice.
The
European
Society
of
Radiology (ESR), in association with
the European Society for Magnetic
Resonance in Medicine and Biology
(ESMRMB) and the European Union
of Medical Specialists (EUMS),
has approached the European
Commissioner responsible for this
Directive. The Commission has
agreed to conduct measurements at
a number of MR installations with
the purpose to establish effective
action values and calculate exposure values related to the most sensitive applications. However, results
are not expected before the end of
2007. Similarly, manufacturers have
mobilized via COCIR (European
Coordination Committee of the
Radiological, Electromedical and
Healthcare
IT
Industry). The
European Federation of Academies
of Medicine has been informed of
the difficulties likely to result from
the application of this Directive in its
current form. European task forces

EUROPEAN DIRECTIVE ON ELECTROMAGNETIC FIELDS

have been created with the aim of

ensuring that MRI is exempted from
the field of application of the
Directive, given the lack of scientific
evidence that healthcare workers
are at risk.
These actions at the European
level must be actively supported by
national radiology societies by getting in touch with national legislative bodies in order to prevent
implementation of the Directive into
national law.
Everything must be done to
modify this Directive as soon as
possible: in its present form it
severely hinders the clinical use of
MRI and also threatens research in
this field.

References
Directives
http://www.europa.eu
Council Recommendation. Official
Journal of the European Communities
30.7.1999 : L199/59-L199/70.
Directive 2004/40/EC of the European
Parliament and of the Council. Official
Journal of the European Union
24.5.2004: L184/1-L184-9.
ICNIRP (International Commission on
Non-Ionizing Radiation Protection)
http://www.icnirp.org.
Guide pour ltablissement de limites
dexposition aux champs lectriques,
magntiques et lectromagntiques.
HPA (Health Protection Agency, UK)
http://www.hpa.org.uk.

67

Review of the Scientific Evidence for

Limiting Exposure to Electromagnetic
Fields (0-300 GHZ). 2004, Vol. 15 - N3.

Epidmiologie
Epidemiology of Health Effects of
Radiofrequency Exposure. Environmental Health Perspectives 2004, 112
(17): 1741/1754.
ESMRMB (European Society for
Magnetic Resonance in Medicine and
Biology)
http://www.esmrmb.org.
A statement with respect to safety limits
concerning time varying magnetic fields
as defined by: Directive 2004/40/EC of
the European Parliament and of the
Council.

A STATEMENT WITH RESPECT TO SAFETY MIMITS CONCERNING TIME

VARYING MAGNETIC FIELDS AS DEFINED BY THE DIRECTIVE 2004/40/EC
OF THE EUROPEAN PARLIAMENT AND THE COUNCIL
Statement by Commissioner Spidla
on allegations regarding MRI
Some articles today published allegations that the directive on electromagnetic fields or so-called physical
agents directive (2004/40/EC) prevents doctors and nurses from giving proper treatment to patients. It
was also claimed that parents will
no longer be allowed to hold the
hand of their child during surgery.
This is completely false.

ESMRMB comment. The EU directive will prevent nurses and doctors

(but not parents) sitting next to MRI
scanners during scanning thus making pediatric MR imaging less
patient friendly.
1. The directive is designed to protect workers against excessive
exposure
to
MRI
(Magnetic
Resonance Imaging) and electromagnetic fields which scietific
experts agree is dangerous for
health.

ESMRMB comment. MRI devices

result only in an exposure to magnetic fields (rather than combined
electric and magnetic fields). There
are no known long term effects of
exposure to magnetic fields. This is
not to argue that there should be no
limits on exposure, rather that exposure limits should be based on current scientific knowledge. As our

ability to generate strong static

and time-varying magnetic fields
increases, so does our understanding of the effects of these fields.
Exposure limits are set according to
the degree of exposure and the
associated risk. Blanket statements
such as that MRI is dangerous for
health are thus not compatible with
the principles according to which
limits are set, and certainly are not
representative of any body of scientific opinion.
2. The directive limits exposure to
MRI and other radiation for workers.
It was drafted by the Commission
based on the results and recommendations issued by ICNIRP
(International Commission for Non
Ionizing Radiation Protection), an
independent world wide recognized
organisation using the expertise of
technicians, scientists and doctors
working in the field.

ESMRMB comment. ICNIRP is

indeed the international body
responsible for setting limits.
ICNIRP itself has recognised that its
current limits for occupational exposure to all electromagnetic fields are
in need of review, a process that is
currently taking place.
3. The European Parliament and all
Member States including the UK
Government agreed in April 2004
that it is essential to have the same

standards for the health and safety

of workers regarding electromagnetic fields since the risk is the same
for nurses and doctors throughout
Europe. The directive was adopted
unanimously and has to be implemented by April 2008.

ESMRMB comment. This is a laudable aim and ICNIRP should be

encouraged to finalize their revision
before April 2008.
Commissioner for Employment,
Social Affairs and Equal Opportunities Vladimir Spidla commented:
The risk of MRI is a real one for
everybody who is exposed to it
regularily, NOT to parents or their
children undergoing treatment. I am
concerned that those who are
protesting are underestimating the
radiation of MRI at the expense of
the health of their employees. I am
glad that this directive will give a
solid protection to doctors and nurses exposed to MRI.

ESMRMB comment. Risk assessment and research into safety

aspects of electro-magnetic fields
is taken very seriously by the
European and international MR
community. Progress in the understanding of the bioeffects of magnetic fields is regularly discussed
and reported at numerous scientific
meetings as well as at dedicated
workshops. There are three types of

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magnetic field associated with an

MRI examination. The static field:
this can cause transient effects such
as vertigo, but despite considerable
effort, no long term effects have
been identified. Switched magnetic
fields: current safety limits for
these are designed to avoid painful
muscle stimulation in patients, but
there is no evidence that prolonged
sub-threshold exposure is harmful.
Finally the patient is exposed to
radiofrequency fields: current safety
limits for patient exposure prevent
tissue heating, personnel are hardly
ever exposed to these fields and
they are hence not relevant to the
current debate.
The commissioner should also bear
in mind that those protesting are not
unscrupulous employers intent on

JBRBTR, 2007, 90 (1)

exploiting their workforce come

what may, but responsible scientists
who regularly expose themselves to
these fields and hence have a maximal interest in working in a safe and
well regulated environment.
In conclusion, the ESMRMB would
like to point out that inflammatory
and incorrect statements such as
contained in the commissioners
statement do not contribute constructively to the resolution of the
current debate about safety regulations for MRI. Statements such as
this can make it more difficult to
recruit health workers to work with
MRI and erroneously lead the public
to believe that MRI is in some way
dangerous. A major factor in the
extremely rapid development of MR
has been the fact, that it is (to all cur-

rent knowledge and with all due precaution) harmless and thus can in
many instances replace examinations with ionizing radiation. The
fact that despite considerable effort
no long term harmful effects of MRI
could be identified, which of itself
makes legislation difficult, should
not be misrepresented to create a
perception of insecurity or danger.
The result can be that more patients
are examined with ionising radiation which has definitely known
harmful side-effects.
Katharina von Schnurbein
Spokesman
Official information of the European
Commission is available at any time
at http://europa.eu.int/rapid/