DIRECTIVE 2013/.../EU
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
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
As it was described in our early publication, the proposed Directive 2004/40/ЕС by the European Parliament and the Union has been repealed and replaced by new Directive 2008/46/ЕС, with a deadline for implementation – 30 April 2012. This didn’t happen in the history, and the problems with the implementation of magnetic resonance imaging systems (MRI) remained unsettled. Workers engaged with such technology, also with other specific medical and technological devices were found to be not protected. This is in discrepancy with the Directive 89/391/ЕС requiring equal treatment of workers regardless of their place or type of work..
All this forced the European Commission to work hard for proposing a new draft of a Directive to the member states in 2011. This proposal was discussed in details for a long time by different groups of experts from all member states, in Brussels in the buildings Justus Lipsuis and Lex. Several consecutive presidencies of the EU – Poland, Danmark, Cyprus, Ireland, organized monthly meetings for the experts of the member states, to finalize the Directive.
At this moment, especially in June2013, the Directive 2013/…/EC of the European Parliament… was voted and accepted for impelementation.
In the “General Provisions” the following subject matter and scope is described:
1. This Directive, which is the 20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, lays down minimum requirements for the protection of workers from risks to their health and safety arising, or likely to arise, from exposure to electromagnetic fields during their work.
2. This Directive covers all known direct biophysical effects and indirect effects caused by electromagnetic fields.
3. The exposure limit values (ELVs) laid down in this Directive cover only scientifically well-established links between short-term direct biophysical effects and exposure to electromagnetic fields.
4. This Directive does not cover suggested long-term effects.
The Commission shall keep under review the latest scientific developments. If well-established scientific evidence on suggested long-term effects becomes available, the Commission shall consider a suitable policy response, including, if appropriate, the submission of a legislative proposal to address such effects. The Commission shall, through its report referred to in Article 15, keep the European Parliament and the Council informed in this regard.
It is very important, that this Directive implements requirements for protection of workers exposed to electromagnetic fields not only for thermal effects, such as tissue heating through energy absorption from electromagnetic fields in the tissue, and for first time for non-thermal effects, such as the stimulation of muscles, nerves or sensory organs. These effects might have a detrimental effect on the mental and physical health of exposed workers. Moreover, the stimulation of sensory organs may lead to transient symptoms, such as vertigo or phosphenes. These effects might create temporary annoyance or affect cognition or other brain or muscle functions, and may thereby affect the ability of a worker to work safely (i.e. safety risks). This is very big achievement of the experts who succeeded to use new research studies in the field of human exposure to electromagnetic fields.
In addition, the exposure limits for limb currents in the Directive are the same as in ICNIRP Guidelines.
A brand new idea is the implementation of different 'exposure limit values (ELVs)'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.
For applying measures for protection of workers, low and high ALs are implemented in the Directive. for magnetic fields, "Low ALs" means levels which relate to the sensory effects ELVs and "high ALs" to the health effects ELVs.
The ELVs are simplified nevertheless that they are developed on the basis of the International Commission of Non-Ionizing Radiation Protection (ICNIRP) Guidelines. The simplification of ELVs refer to the values that should be measured for exposure assessment, also for the values inside the body. They are mainly in units V/m (electric field strength) or µT (magnetic flux density). The power density is used only for thermal effects for frequency above 6 GHz. Of course, power density can be used for evaluation of all radiofrequency fields as equivalent plane wave unit for the far zone.
The exposure limits are as in ICNIRP basic restrictions (ELVs) – induction currents, limb currents, Specific absorption rate (SAR, W/kg) or specific absorption (SA, J/kg), and reference levels (ALs) using the same definition that they are parameters for measurement in working places: E, V/m; B, T; S, W/m2.
One of the main texts in the new Directive from political view is Article 10 concerning derogations. This Article gives the opportunity of derogation of specific activities that need specific protection of the workers. For example, in Article 10, for the MRI working conditions is written the following:
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:
(i) the risk assessment carried out in accordance with Article 4 has demonstrated that the ELVs are exceeded;
(ii) given the state of the art, all technical and/or organisational measures have been applied;
(iii) the circumstances duly justify exceeding the ELVs;
(iv) the characteristics of the workplace, work equipment, or work practices have been taken into account; and
(v) the employer demonstrates that workers are still protected against adverse health effects and against safety risks, including by ensuring that the instructions for safe use provided by the manufacturer in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices[1] are followed.
Similar derogation is accepted for the exposure conditions for personnel working in operational military installations or involved in military activities, including in joint international military exercises, or in specific sectors or for specific activities. Of course, all derogations are accepted only in cases that the employer demonstrates that workers are still protected against adverse health effects and safety risks, including using comparable, more specific and internationally recognised standards and guidelines.
In the Directive, the Article 14 requires in order to facilitate the implementation of the Directive the Commission to make available non-binding practical guides at the latest six months before 1 July 2016. This Practical Guide should help the employers for explanation, simplify the exposure and risk assessment, and to take eligible protective measure.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2016. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
For us remains the serious work to prepare our industry, employers, working conditions for applying the Directive in the country, and to provide the control bodies for demonstrating a compliance with the requirements. Mainly, those activities should be in the prerogatives of the Ministry of Labour and Social Policy, Ministry of Health, the Main Labour Inspection. Last but not least, the Bulgarian Accreditation Body should have the competence for accreditation of laboratories for measurement on the base of the new requirements.
It is clear that the whole process will be coordinated by the Bulgarian National Programme Committee (BNPC), respectively by the Foundation “Faraday” – Research Centre of Non-Ionizing Radiation.
