Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) and repealing Directive 2004/40/EC - Main contents

EN

Official Journal of the European Union

L 179/1

Under the Treaty, the European Parliament and the Council may, by means of directives, adopt minimum requirements for the encouragement of improvements, in particular of the working environment, to guarantee a better level of protection of the health and safety of workers. Such directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings.

Article 31(1) of the Charter of Fundamental Rights of the European Union provides that every worker has the right to working conditions which respect his or her health, safety and dignity.

Following the entry into force of Directive 2004/40/EC of the European Parliament and of the Council of 29 April 2004 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (3), serious concerns were expressed by stakeholders, in particular those from the medical community, as to the potential impact of the implementation of that Directive on the use of medical procedures based on medical imaging. Concerns were also expressed as to the impact of the Directive on certain industrial activities.

The Commission examined attentively the arguments put forward by stakeholders and, after several consultations, decided to thoroughly reconsider some provisions of Directive 2004/40/EC on the basis of new scientific information produced by internationally recognised experts.

Directive 2004/40/EC was amended by Directive 2008/46/EC of the European Parliament and of the Council (4), with the effect of postponing, by four years, the deadline for the transposition of Directive 2004/40/EC, and subsequently by Directive 2012/11/EU of the European Parliament and of the Council (5), with the effect of postponing that deadline for transposition until 31 October 2013. This was to allow the Commission to present a new proposal, and the co-legislators to adopt a new directive, based on fresher and sounder evidence.

Directive 2004/40/EC should be repealed and more appropriate and proportionate measures to protect workers from the risks associated with electromagnetic fields should be introduced. That Directive did not address the long-term effects, including the possible carcinogenic effects, of exposure to time-varying electric, magnetic and electromagnetic fields, for which there is currently no conclusive scientific evidence establishing a causal relationship. This Directive is intended to address all known direct biophysical effects and indirect effects caused by electromagnetic fields, in order not only to ensure the health and safety of each worker on an individual basis, but also to create a minimum basis of protection for all workers in the Union, while reducing possible distortions of competition.

This Directive does not address suggested long-term effects of exposure to electromagnetic fields, since there is currently no well-established scientific evidence of a causal relationship. However, if such well-established scientific evidence emerges, the Commission should consider the most appropriate means for addressing such effects, and should, through its report on the practical implementation of this Directive, keep the European Parliament and Council informed in this regard. In doing so, the Commission should, in addition to the appropriate information that it receives from Member States, take into account the latest available research and new scientific knowledge arising from the data in this area.

Minimum requirements should be laid down, thereby giving Member States the option of maintaining or adopting more favourable provisions for the protection of workers, in particular by fixing lower values for the action levels (ALs) or the exposure limit values (ELVs) for electromagnetic fields. However, the implementation of this Directive should not serve to justify any regression in relation to the situation already prevailing in each Member State.

The system of protection against electromagnetic fields should be limited to a definition, which should be free of excessive detail, of the objectives to be attained, the principles to be observed and the fundamental values to be applied, in order to enable Member States to apply the minimum requirements in an equivalent manner.

In order to protect workers exposed to electromagnetic fields it is necessary to carry out an effective and efficient risk assessment. However, this obligation should be proportional to the situation encountered at the workplace. Therefore, it is appropriate to design a protection system that groups different risks in a simple, graduated and easily understandable way. Consequently, the reference to a number of indicators and standard situations, to be provided by practical guides, can usefully assist employers in fulfilling their obligations.

The undesired effects on the human body depend on the frequency of the electromagnetic field or radiation to which it is exposed. Therefore, exposure limitation systems need to be exposure-pattern and frequency dependent in order to adequately protect workers exposed to electromagnetic fields.

The level of exposure to electromagnetic fields can be more effectively reduced by incorporating preventive measures into the design of workstations and by giving priority, when selecting work equipment, procedures and methods, to reducing risks at source. Provisions relating to work equipment and methods thereby contribute to the protection of the workers involved. There is, however, a need to avoid duplication of assessments where work equipment meets the requirements of relevant Union law on products that establishes stricter safety levels than those provided for by this Directive. This allows for simplified assessment in a large number of cases.

Employers should make adjustments in the light of technical progress and scientific knowledge regarding the risks related to exposure to electromagnetic fields, with a view to improving the safety and health protection of workers.

Since this Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (6), it follows that Directive 89/391/EEC applies to the exposure of workers to electromagnetic fields, without prejudice to more stringent and/or specific provisions contained in this Directive.

The physical quantities, ELVs and ALs, laid down in this Directive are based on the recommendations of the International Commission on Non-Ionizing Radiation Protection (ICNIRP) and should be considered in accordance with ICNIRP concepts, save where this Directive specifies otherwise.

In order to ensure that this Directive remains up-to-date, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of purely technical amendments of the Annexes, to reflect the adoption of regulations and directives in the field of technical harmonisation and standardisation, technical progress, changes in the most relevant standards or specifications and new scientific findings concerning hazards presented by electromagnetic fields, as well as to adjust ALs. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

If amendments of a purely technical nature to the Annexes become necessary, the Commission should work in close cooperation with the Advisory Committee for Safety and Health at Work set up by Council Decision of 22 July 2003 (7).

In exceptional cases, where imperative grounds of urgency so require, such as possible imminent risks to workers’ health and safety arising from their exposure to electromagnetic fields, the possibility should be given to apply the urgency procedure to delegated acts adopted by the Commission.

In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (8), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified.

A system including ELVs and ALs, where applicable, should be seen as a means to facilitate the provision of a high level of protection against the adverse health effects and safety risks that may result from exposure to electromagnetic fields. However, such a system may conflict with specific conditions in certain activities, such as the use of the magnetic resonance technique in the medical sector. It is therefore necessary to take those particular conditions into account.

Given the specificities of the armed forces and in order to allow them to operate and interoperate effectively, including in joint international military exercises, Member States should be able to implement equivalent or more specific protection systems, such as internationally agreed standards, for example NATO standards, provided that adverse health effects and safety risks are prevented.

Employers should be required to ensure that risks arising from electromagnetic fields at work are eliminated or reduced to a minimum. It is nevertheless possible that in specific cases and in duly justified circumstances, the ELVs set out in this Directive are only temporarily exceeded. In such a case, employers should be required to take the necessary actions in order to return to compliance with the ELVs as soon as possible.

A system ensuring a high level of protection as regards the adverse health effects and safety risks that may result from exposure to electromagnetic fields should take due account of specific groups of workers at particular risk and avoid interference problems with, or effects on the functioning of, medical devices such as metallic prostheses, cardiac pacemakers and defibrillators, cochlear implants and other implants or medical devices worn on the body. Interference problems, especially with pacemakers, may occur at levels below the ALs and should therefore be the object of appropriate precautions and protective measures,

‘electromagnetic fields’ means static electric, static magnetic and time-varying electric, magnetic and electromagnetic fields with frequencies up to 300 GHz;

‘direct biophysical effects’ means effects in the human body directly caused by its presence in an electromagnetic field, including:

‘indirect effects’ means effects, caused by the presence of an object in an electromagnetic field, which may become the cause of a safety or health hazard, such as:

‘exposure limit values (ELVs)’ means values established on the basis of biophysical and biological considerations, in particular on the basis of scientifically well-established short-term and acute direct effects, i.e. thermal effects and electrical stimulation of tissues;

‘health effects ELVs’ means those ELVs above which workers might be subject to adverse health effects, such as thermal heating or stimulation of nerve and muscle tissue;

‘sensory effects ELVs’ means those ELVs above which workers might be subject to transient disturbed sensory perceptions and minor changes in brain functions;

‘action levels (ALs)’ means operational levels established for the purpose of simplifying the process of demonstrating the compliance with relevant ELVs or, where appropriate, to take relevant protection or prevention measures specified in this Directive.

The AL terminology used in Annex II is as follows:

low ALs for electric fields (Annex II, Table B1), where justified by the practice or process, provided that either the sensory effects ELVs (Annex II, Table A3) are not exceeded; or

low ALs for magnetic fields (Annex II, Table B2) where justified by the practice or process, including in the head and torso, during the shift, provided that either the sensory effects ELVs (Annex II, Table A3) are not exceeded; or

the sensory effects ELVs (Annex II, Table A1) during the shift, where justified by the practice or process, provided that:

the sensory effects ELVs (Annex II, Table A3 and Annex III, Table A2) during the shift, where justified by the practice or process, provided that:

the health effects ELVs, the sensory effects ELVs and the ALs referred to in Article 3 and Annexes II and III to this Directive;

the frequency, the level, duration and type of exposure, including the distribution over the worker’s body and over the volume of the workplace;

any direct biophysical effects;

any effects on the health and safety of workers at particular risk, in particular workers who wear active or passive implanted medical devices, such as cardiac pacemakers, workers with medical devices worn on the body, such as insulin pumps, and pregnant workers;

any indirect effects;

the existence of replacement equipment designed to reduce the level of exposure to electromagnetic fields;

appropriate information obtained from the health surveillance referred to in Article 8;

information provided by the manufacturer of equipment;

other relevant health and safety related information;

multiple sources of exposure;

simultaneous exposure to multiple frequency fields.

other working methods that entail less exposure to electromagnetic fields;

the choice of equipment emitting less intense electromagnetic fields, taking account of the work to be done;

technical measures to reduce the emission of electromagnetic fields, including, where necessary, the use of interlocks, shielding or similar health protection mechanisms;

appropriate delimitation and access measures, such as signals, labels, floor markings, barriers, in order to limit or control access;

in the case of exposure to electric fields, measures and procedures to manage spark discharges and contact currents through technical means and through the training of workers;

appropriate maintenance programmes for work equipment, workplaces and workstation systems;

the design and layout of workplaces and workstations;

limitations of the duration and intensity of the exposure; and

the availability of adequate personal protection equipment.

sensory perceptions and effects in the functioning of the central nervous system in the head evoked by time varying magnetic fields; and

static magnetic field effects, such as vertigo and nausea.

measures taken in application of this Directive;

the values and concepts of the ELVs and ALs, the associated possible risks and the preventive measures taken;

the possible indirect effects of exposure;

the results of the assessment, measurement or calculations of the levels of exposure to electromagnetic fields, carried out in accordance with Article 4 of this Directive;

how to detect adverse health effects of exposure and how to report them;

the possibility of transient symptoms and sensations related to effects in the central or peripheral nervous system;

the circumstances in which workers are entitled to health surveillance;

safe working practices to minimise risks resulting from exposure;

workers at particular risk, as referred to in Article 4(5)(d) and Article 5(3) and (4) of this Directive.

exposure may exceed the ELVs if the exposure is related to the installation, testing, use, development, maintenance of or research related to magnetic resonance imaging (MRI) equipment for patients in the health sector, provided that all the following conditions are met:

Member States may allow for an equivalent or more specific protection system to be implemented for personnel working in operational military installations or involved in military activities, including in joint international military exercises, provided that adverse health effects and safety risks are prevented;

Member States may allow, in duly justified circumstances and only for as long as they remain duly justified, for the ELVs to be temporarily exceeded in specific sectors or for specific activities outside the scope of points (a) and (b). For the purposes of this point, ‘duly justified circumstances’ shall mean circumstances in which the following conditions are met:

take into account the adoption of regulations and directives in the field of technical harmonisation and standardisation with regard to the design, building, manufacture or construction of work equipment or workplaces;

take into account technical progress, changes in the most relevant standards or specifications, and new scientific findings concerning electromagnetic fields;

make adjustments to the ALs where there is new scientific evidence, provided that employers continue to be bound by the existing ELVs set out in Annexes II and III.

the determination of exposure, taking into account appropriate European or international standards, including:

guidance on demonstrating compliance in special types of non-uniform exposure in specific situations, based on well-established dosimetry;

the description of the ‘weighted peak method’ for the low frequency fields and of the ‘multifrequency fields summation’ for high frequency fields;

the conduct of the risk assessment and, wherever possible, the provision of simplified techniques, taking into account in particular the needs of SMEs;

measures aimed at avoiding or reducing risks, including specific prevention measures depending on the level of exposure and the workplace characteristics;

the establishment of documented working procedures, as well as specific information and training measures for workers exposed to electromagnetic fields during MRI-related activities falling under Article 10(1)(a);

the evaluation of exposures in the frequency range from 100 kHz to 10 MHz, where both thermal and non-thermal effects are to be considered;

the guidance on medical examinations and health surveillance to be provided by the employer in accordance with Article 8(2).

Electric field strength (E) is a vector quantity that corresponds to the force exerted on a charged particle regardless of its motion in space. It is expressed in volt per metre (Vm–1). A distinction has to be made between the environmental electric field and the electric field present in the body (in situ) as a result of exposure to the environmental electric field.

Limb current (IL) is the current in the limbs of a person exposed to electromagnetic fields in the frequency range from 10 MHz to 110 MHz as a result of contact with an object in an electromagnetic field or the flow of capacitive currents induced in the exposed body. It is expressed in ampere (A).

Contact current (IC) is a current that appears when a person comes into contact with an object in an electromagnetic field. It is expressed in ampere (A). A steady state contact current occurs when a person is in continuous contact with an object in an electromagnetic field. In the process of making such contact, a spark discharge may occur with associated transient currents.

Electric charge (Q) is an appropriate quantity used for spark discharge and is expressed in coulomb (C).

Magnetic field strength (H) is a vector quantity that, together with the magnetic flux density, specifies a magnetic field at any point in space. It is expressed in ampere per metre (Am–1).

Magnetic flux density (B) is a vector quantity resulting in a force that acts on moving charges, expressed in tesla (T). In free space and in biological materials, magnetic flux density and magnetic field strength can be interchanged using the magnetic field strength of H = 1 Am–1 equivalence to magnetic flux density of T (approximately 1,25 microtesla).

Power density (S) is an appropriate quantity used for very high frequencies, where the depth of penetration in the body is low. It is the radiant power incident perpendicular to a surface, divided by the area of the surface. It is expressed in watt per square metre (Wm–2).

Specific energy absorption (SA) is an energy absorbed per unit mass of biological tissue, expressed in joule per kilogram (Jkg–1). In this Directive, it is used for establishing limits for effects from pulsed microwave radiation.

Specific energy absorption rate (SAR), averaged over the whole body or over parts of the body, is the rate at which energy is absorbed per unit mass of body tissue and is expressed in watt per kilogram (Wkg–1). Whole-body SAR is a widely accepted quantity for relating adverse thermal effects to radio frequency (RF) exposure. Besides the whole-body average SAR, local SAR values are necessary to evaluate and limit excessive energy deposition in small parts of the body resulting from special exposure conditions. Examples of such conditions include: an individual exposed to RF in the low MHz range (e.g. from dielectric heaters) and individuals exposed in the near field of an antenna.

f is the frequency expressed in hertz (Hz).

The health effects ELVs for internal electric field are spatial peak values in the entire body of the exposed subject.

The ELVs are peak values in time which are equal to the Root-Mean-Square (RMS) values multiplied by √2 for sinusoidal fields. In the case of non-sinusoidal fields, exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method (filtering in time domain), explained in the practical guides referred to in Article 14 but other scientifically proven and validated exposure evaluation procedures can be applied, provided that they lead to approximately equivalent and comparable results.

f is the frequency expressed in hertz (Hz).

The sensory effects ELVs for internal electric field are spatial peak values in the head of the exposed subject.

The ELVs are peak values in time which are equal to the Root-Mean-Square (RMS) values multiplied by √2 for sinusoidal fields. In the case of non-sinusoidal fields, the exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method (filtering in time domain), explained in the practical guides referred to in Article 14, but other scientifically proven and validated exposure evaluation procedures can be applied, provided that they lead to approximately equivalent and comparable results.

Low ALs(E) and high ALs(E) for electric field strength E of time varying electric fields as specified in Table B1;

Low ALs(B) and high ALs(B) for magnetic flux density B of time varying magnetic fields as specified in Table B2;

ALs(IC) for contact current as specified in Table B3;

ALs(B0) for magnetic flux density of static magnetic fields as specified in Table B4.

f is the frequency expressed in hertz (Hz).

The low ALs (E) and high ALs (E) are the Root-Mean-Square (RMS) values of the electric field strength which are equal to the peak values divided by √2 for sinusoidal fields. In the case of non-sinusoidal fields, the exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method (filtering in time domain), explained in the practical guides referred to in Article 14, but other scientifically proven and validated exposure evaluation procedures can be applied, provided that they lead to approximately equivalent and comparable results.

ALs represent maximum calculated or measured values at the workers’ body position. This results in a conservative exposure assessment and automatic compliance with ELVs in all non-uniform exposure conditions. In order to simplify the assessment of compliance with ELVs, carried out in accordance with Article 4, in specific non-uniform conditions, criteria for the spatial averaging of measured fields based on established dosimetry will be laid down in the practical guides referred to in Article 14. In the case of a very localised source within a distance of a few centimetres from the body, the induced electric field shall be determined dosimetrically, case by case.

f is the frequency expressed in hertz (Hz).

The low ALs and the high ALs are the Root-Mean-Square (RMS) values which are equal to the peak values divided by √2 for sinusoidal fields. In the case of non-sinusoidal fields the exposure evaluation carried out in accordance with Article 4 shall be based on the weighted peak method (filtering in time domain), explained in practical guides referred to in Article 14, but other scientifically proven and validated exposure evaluation procedures can be applied, provided that they lead to approximately equivalent and comparable results.

ALs for exposure to magnetic fields represent maximum values at the workers’ body position. This results in a conservative exposure assessment and automatic compliance with ELVs in all non-uniform exposure conditions. In order to simplify the assessment of compliance with ELVs, carried out in accordance with Article 4, in specific non-uniform conditions, criteria for the spatial averaging of measured fields based on established dosimetry will be laid down in the practical guides referred to in Article 14. In the case of a very localised source within a distance of a few centimetres from the body, the induced electric field shall be determined dosimetrically, case by case.

f is the frequency expressed in kilohertz (kHz).

Localised SAR averaging mass is any 10 g of contiguous tissue; the maximum SAR so obtained should be the value used for estimating exposure. This 10 g of tissue is intended to be a mass of contiguous tissue with roughly homogeneous electrical properties. In specifying a contiguous mass of tissue, it is recognised that this concept may be used in computational dosimetry but may present difficulties for direct physical measurements. A simple geometry, such as cubic or spheric tissue mass, can be used.

Localised SA averaging mass is 10 g of tissue.

The power density shall be averaged over any 20 cm2 of exposed area. Spatial maximum power densities averaged over 1 cm2 should not exceed 20 times the value of 50 Wm–2. Power densities from 6 to 10 GHz are to be averaged over any six-minute period. Above 10 GHz, the power density shall be averaged over any 68/f1,05-minute period (where f is the frequency in GHz) to compensate for progressively shorter penetration depth, as the frequency increases.

ALs(E) for electric field strength E of time varying electric field, as specified in Table B1;

ALs(B) for magnetic flux density B of time varying magnetic field, as specified in Table B1;

ALs(S) for power density of electromagnetic waves, as specified in Table B1;

ALs(IC) for contact current, as specified in Table B2;

ALs(IL) for limb current, as specified in Table B2;

f is the frequency expressed in hertz (Hz).

[ALs(E)]2 and [ALs(B)]2 are to be averaged over a six-minute period. For RF pulses, the peak power density averaged over the pulse width shall not exceed 1 000 times the respective ALs(S) value. For multi-frequency fields, the analysis shall be based on summation, as explained in the practical guides referred to in Article 14.

ALs(E) and ALs(B) represent maximum calculated or measured values at the workers’ body position. This results in a conservative exposure assessment and automatic compliance with ELVs in all non-uniform exposure conditions. In order to simplify the assessment of compliance with ELVs, carried out in accordance with Article 4, in specific non-uniform conditions, criteria for the spatial averaging of measured fields based on established dosimetry will be laid down in the practical guides referred to in Article 14. In the case of a very localised source within a distance of a few centimetres from the body, compliance with ELVs shall be determined dosimetrically, case by case.

The power density shall be averaged over any 20 cm2 of exposed area. Spatial maximum power densities averaged over 1 cm2 should not exceed 20 times the value of 50 Wm–2. Power densities from 6 to 10 GHz are to be averaged over any six-minute period. Above 10 GHz, the power density shall be averaged over any 68/f1,05-minute period (where f is the frequency in GHz) to compensate for progressively shorter penetration depth as the frequency increases.

[ALs(IL)]2 is to be averaged over a six-minute period.