Explanatory Memorandum to COM(2011)348 - Minimum requirements regarding the exposure of workers to physical agents (electromagnetic fields) - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2011)348 - Minimum requirements regarding the exposure of workers to physical agents (electromagnetic fields). |
|---|---|
| source | COM(2011)348  |
| date | 14-06-2011 |
· Grounds for and objectives of the proposal
The aim of this proposal is to amend 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).
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 therein 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.
Subsequently, other industrial sectors also expressed their concerns about the impact of the Directive on their activities.
In response to these concerns, the Commission has taken a number of measures. For reasons of transparency, it contacted the Member States and the European Parliament to inform them of the measures it planned to take. In this context, it asked the Member States to inform it of any difficulties associated with implementation of the Directive. It also launched a study to assess the actual impact of the Directive on medical procedures using MRI. The results of this study were made available in early 2008.
Meanwhile, in order 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;
- take into account the results of the review of the new ICNIRP recommendations, and other recent recommendations such as 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 Directive 2004/40/EC, and, finally,
- conduct an in-depth impact analysis of the Directive’s provisions and propose amendments 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,
the deadline for transposition was put back from 30 April 2008 to 30 April 2012 by Directive 2008/46/EC i of the European Parliament and of the Council of 23 April 2008 amending Directive 2004/40/EC on minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields).
The International Commission for Non-Ionising Radiation Protection (ICNIRP) has now finalised its review of the guidelines on static magnetic fields and low-frequency time-varying fields on which part of the Directive is based. New recommendations were issued in 2009 and 2010, respectively. In most cases, the reference levels and basic restrictions are set at higher levels than in the previous recommendations.
· General context
Directive 2004/40/EC is the 18th individual Directive within the meaning of Article 16 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. It relates to the short-term adverse health effects on workers exposed to electromagnetic fields during their work.
The provisions of the Directive are minimum requirements, with each Member State free to adopt stricter rules.
The Directive establishes exposure limit values for electric, magnetic and electromagnetic fields varying in time at frequencies of between 0 and 300 GHz. No worker may be exposed to values exceeding these limits, which are based on the health impact and biological considerations.
The Directive also sets action values and orientation values for time-varying and static fields. These values are directly measurable and indicate a threshold above which employers must take one or more of the actions provided for in the Directive. Compliance with these action values will ensure compliance with the relevant exposure limit values.
The limits imposed by the Directive were established on the basis of the recommendations issued by the ICNIRP in 1998, the organisation internally recognised as the authority on assessment of the health impact of this type of radiation. The ICNIRP works closely with all the relevant international organisations, such as the WHO, ILO, IRPA, ISO, CENELEC, IEC, CIE, IEEE, etc.
The Directive is based on the prevention philosophy already set out in more general terms in Framework Directive 89/391/EEC:
– protection of all workers: whatever their sector of activity, whereby workers exposed to the same risks have the same right to be protected;
– obligation on employers to determine and assess risks;
– elimination or, where this is impossible, minimisation of risks identified;
– specific information and training for and consultation of the workers concerned;
– appropriate medical surveillance.
The Directive applies to all sectors of activity without exception and has to be transposed into national legislation no later than 30 April 2012 if no further action is taken.
During the discussions preceding its adoption, the specific case of medical resonance imaging was discussed in detail by both the Council and the European Parliament. National experts from institutions such as the National Radiation Protection Board (NRPB, UK), the Institut national de recherche et de sécurité (INRS, France), the Finnish Institute of Occupational Health (FIOH, Finland) and the Bundesamt für Strahlenschutz (BfS, Germany) provided technical support for the negotiations in the Council. The Council Presidency sought, on several occasions, the opinion of the ICNIRP.
In the absence of any evidence of an undesirable impact, the joint legislators adopted the Directive, with certain amendments to the values originally proposed by the Commission, in particular not setting an exposure limit value for static magnetic fields, an essential component of MRI, because this value was being amended in the light of the latest scientific findings, which appeared as the Directive was being adopted.
This proposal maintains a number of important principles and provisions in the present Directive, such as:
– coverage of all sectors of activity ,
– exposure limit values and action values for electromagnetic fields in the frequency range from 100 kHz to 300 GHz,
– provisions aimed at avoiding or reducing risk,
– information and training of workers,
– consultation and participation of workers,
– sanctions,
– medical surveillance.
The most important changes introduced by the proposal, taking into account the latest scientific findings in this area, are the following:
– clearer definitions, in particular for adverse health effects (Article 2 of Directive 2004/40/EC),
– inclusion of a revised system for limit and reference values different from the current limit values and action values for the range from 0 to 100 kHz (this will affect Articles 2 and 3 of Directive 2004/40/EC plus its annex),
– introduction of indicators to facilitate measurements and calculations (Article 3(3)) and to give guidance on taking measurement uncertainties into account. Product safety legislation set by Directives 1999/5/EC and 2006/95/EC ensures that the public, including workers are not exposed to levels beyond those set by Recommendation 1999/519/EEC, provided that the products are used as intended. Since levels set for the public are lower than those set for workers and include protection against long-term effects, compliance with these Directives provides for sufficient protection under this Directive in these situations.
– introduction of some guidance to ensure simplified but more efficient risk assessments (Article 4) in order to facilitate the evaluation work and also to limit the burden on SMEs, ,
– introduction of limited but appropriate flexibility by proposing a controlled framework for limited derogations for industry,
– inclusion of a rationale for medical surveillance (Article 8),
– special attention to the specific case of medical applications using magnetic resonance and related activities, and
– provision for complementary non-binding measures such as a non-binding practical guide.
· Consistency with other European Union policies and objectives
This proposal is consistent with the objectives of other policies of the European Union, in particular those for the improvement of the regulatory framework in order to develop a clear, understandable, up-to-date and user-friendly body of secondary EU legislation, in the interests of citizens and economic operators. It will also enable the provisions of the current Directive to be updated in the light of the latest scientific findings on the impact of electromagnetic radiation on health, which were not yet available at the time of the adoption of Directive 2004/40/EC. It furthermore is intended to be consistent with related legislation that protects users of products that produce EMF in so far that it does not require that EMFs from such products have to be reassessed under this Directive but can be presumed as being below the levels set for the public in Council Recommendation 1999/519/EEC.
· Consultation of interested parties
- Consultation of the Advisory Committee for Safety and Health at Work, in accordance with the Council Decision of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work. The Committee has been invited to adopt an opinion by the end of March 2011.
- Consultation of scientific experts in this area and the International Commission for Non-Ionising Radiation Protection at bilateral meetings with the Commission.
- Consultation of the social partners in accordance with Articles 154 i and of the Treaty on the Functioning of the European Union (TFEU). The first consultation (Article 154 i TFEU) took place between 1 July and 10 September 2009. The second stage of consultation under Article 154 took place between 20 May and 5 July 2010 and was carried out independently from the impact assessment.
The results can be summarised as follows:
· In general, both trade unions and employers agree that there is a justified need for a new Directive to protect workers from the health risks caused by exposure to electromagnetic fields. However, certain employer representatives (SMEs and some national organisations) indicate their preference for non-binding instruments instead of a Directive.
· It is commonly accepted that the limit values in the current Directive are too low and based on too conservative assumptions; but while the employers are in favour of relaxing the limits, the workers’ representatives want the long-term health effects to be covered in the future Directive.
· Exempting some categories of workers from the scope of the Directive is not welcomed by employers in the industry sector (except MRI equipment manufacturers). Also, allowing derogations from exposure limits in specific branches (health care) poses some problems for the industry sector.
· The social partners confirm that no category of workers should be excluded from the benefits of any new legal instrument, provided that the new instrument gives the appropriate flexibility needed to allow activities to be continued.
· While employers are very much in favour of a flexible approach also allowing for exceptions, workers’ organisations fear that flexibility may reduce the protection of workers unless there are strict controls.
· Adaptation of the exposure limit values defined in the current Directive is acceptable to both employers’ and workers’ organisations, along with the introduction of a zoning approach to allow for light risk assessments in less problematic situations. There is also a consensus on the importance of operational guidance.
· Medical checks after situations of overexposure above the limit values are welcomed as a default approach by the trade unions. Employers’ organisations and the medical profession raise doubts as to whether this is reasonable for the low frequency range, where it might be difficult to detect effects.
· Derogations from the limit values for the medical sector to facilitate MRI treatment are viewed with scepticism by other sectors, whereas trade unions recommend a sunset clause to avoid the erosion of protective legislation.
· Gathering and use of expertise
The Commission consulted with internationally recognised scientific experts on the health impact of electromagnetic radiation. The Commission also launched the study referred to above to determine exposure levels for medical staff and their impact on the procedures used for medical MRI.
· Impact assessment
From discussions and consultations with stakeholders, the following options emerged:
Policy option A: ‘Do nothing’
In practical terms, this means that Directive 2004/40/EC has to be transposed by 30 April 2012 into legislation in all the Member States.
Policy option B: ‘New Directive with revised exposure limits’
Directive 2004/40/EC is replaced by a new Directive with revised exposure limit values that are higher than the previous ones, but are in line with scientific evidence.
Policy option C1: ‘New Directive with revised exposure limits and partial exemptions’
Directive 2004/40/EC is replaced by a new Directive with revised exposure limit values higher than the previous ones, but in line with scientific evidence (as in option B). In addition, conditional exemptions are provided for MRI, which will however remain subject to the general EMF risk management requirements and covered by the new Directive.
Policy option C2: ‘New Directive with revised exposure limits and complete exemption for MRI’
Directive 2004/40/EC is replaced by a new Directive with revised exposure limit values higher than the previous ones, but in line with scientific evidence (as in option B). Medical MRI will be exempted entirely from all the requirements of the EMF Directive.
Policy option D1: ‘Replacement of the Directive by a Recommendation’
Directive 2004/40/EC is replaced by non-binding occupational EMF exposure recommendations, based on the latest international recommendations. The form of these recommendations would be similar to the Council Recommendation on EMF exposure of the general public (1999/519/EEC).
Policy option D2: ‘Voluntary agreements between the social partners’
Directive 2004/40/EC is replaced by voluntary agreements at European or sectoral level between social partners in accordance with Article 154 TFEU.
Policy option E: ‘No EU legislation’
Directive 2004/40/EC is repealed while Directive 89/391/EEC (Framework Directive) and existing national regulatory provisions on the subject remain in force. The absence of national regulations in some Member States will allow unregulated occupational EMF exposures. For this option, it may be assumed that for example those countries which have already (partially) implemented the EMF Directive would not repeal their EMF legislation.
These options were considered as relevant by the stakeholders. Alternative options not analysed in detail include adopting a more sectoral approach, restricting legislation to the provision of safe equipment or exclusively focusing on ‘soft’ policy instruments such as information campaigns and guidance documents.
The current proposal is in line with Option C1. Option C1 is also acceptable for a large majority of stakeholders. The compliance costs are higher than for option E but lower than for option A, which will be the situation as from 1 May 2012 if Directive 2004/40/EC remains in force.
Contents
· Summary of the proposed measures
The proposal amends the relevant articles and annexes of Directive 2004/40/EC in order to achieve the objectives mentioned under point 1 above. Instead of making a long list of complex amendments to Directive 2004/40/EC, the present Directive repeals and replaces that Directive in order to achieve a clear, simple and precise text, which is transparent and readily understandable to the public and economic operators.
· Legal basis
Article 153 i of the Treaty on the Functioning of the European Union.
· Subsidiarity principle
The subsidiarity principle applies in so far as the proposal concerns a field — the protection of the health and safety of workers at work — which does not fall under the exclusive competence of the European Union.
The objectives of the proposal cannot be achieved sufficiently by the Member States, as the provisions of directives cannot be amended or repealed at national level.
The attainment of the objectives of the proposal can be achieved only by Union action, as this proposal amends an act of EU law which is currently in force, which cannot be done by the Member States themselves.
The principle of subsidiarity is respected in as much as the proposal amends existing Union legislation.
· Proportionality principle
The proposal complies with the proportionality principle for the following reason.
It aims to guarantee the protection of workers exposed to EMF while simplifying the burden on employers compared with the situation under Directive 2004/40/EC.
· Choice of instruments
Proposed instrument: directive.
No other instruments would have been suitable. The aim is to amend a directive and the only way to do this is to adopt another directive.
The proposal has no implications for the Union budget except for the meetings of the proposed committees. The appropriations will be taken from the existing budget lines as is usually done for the functioning of the Advisory Committee for Safety and Health at Work (PROGRESS administrative line) and for the invitation of experts (general line).
· Simplification
The proposal contributes to the simplification of the legislative framework by introducing appropriate proportionality and flexibility.
· Repeal of existing legislation
The adoption of the proposal will entail the repeal of Directive 2004/40/EC.
· European Economic Area
This draft instrument is concerned with a subject covered by the EEA Agreement and must therefore be extended to cover the European Economic Area.
· Detailed explanation of the proposal by chapter or by article
This proposal amends a number of articles and annexes of Directive 2004/40/EC.
Article 1 of the proposal is almost unchanged compared to Directive 2004/40/EC and addresses the aim and scope of the proposal. A new sentence in paragraph 2 explicitly mentions the existence of direct and indirect effects due to exposure to EMF. Both types of effects are covered by the Directive.
Article 2 defines ‘electromagnetic fields’, ‘exposure limit values’ and ‘action values’, as was the case in Directive 2004/40/EC. The new article also defines the ‘orientation values’ introduced in the proposal and ‘adverse health effects’ and adverse safety effects for the sake of clarification.
This article refers to the exposure limit values and action values as in Directive 2004/40/EC. However, paragraph 1 briefly sets out the roles of the new orientation and action values in order to achieve the proportionality required by stakeholders. This applies to the frequency range from 0 Hz to 100 kHz. From 100 kHz to 300GHz, the levels remain the same as in Directive 2004/40/EC, as no new recommendations have been published since 1998.
Paragraph 3 is similar to the corresponding paragraph of Directive 2004/40/EC but has been adapted to limit extensive measurements to cases where they are really necessary. This will in practice simplify the carrying out of the risk assessment for a large majority of workplaces.
Paragraph 4 is new and provides an exemption from the exposure limits for the medical MRI sector and related activities, which will continue to be subject to all other obligations.
Paragraph 5 is new and provides the right for the military to use a protection system adapted to its specific working situations (e.g. radars). This request was made by NATO, which uses a protection system based on recommendations proposed by IEEE. This system can be considered equivalent to the system set out in this proposal.
Paragraph 6 is new and provides for temporary derogations under controlled conditions where the exposure limits are likely to be exceeded.
Article 4 concerns the ‘determination of exposure and assessment of risks’ as in Directive 2004/40/EC.
Paragraphs 1 to 3 and 6 remain unchanged. Paragraph 4 has been slightly modified to meet the aim for more flexibility and proportionality.
Paragraph 5 remains unchanged except for point (c), where groups at particular risk are defined more precisely. Also, the limit in (d)(ii) concerning static magnetic fields for the projectile risk from ferromagnetic objects has been raised from 3 to 30 mT, in line with the current updated evidence.
Article 5 ‘Provisions aimed at avoiding or reducing risks’ is substantially unchanged. Only small changes have been made in order to ensure consistency.
Article 6 on ‘Worker information and training’ has been changed only slightly to ensure consistency.
The same applies to Article 7 on ‘Consultation and participation of workers’.
Article 8 on ‘Health surveillance’ has been amended to introduce a distinction between exposure in the low frequency range (0 Hz to 100 kHz) and exposure in the high frequency range. The change takes into account the fact, confirmed by medical experts, that effects induced by low frequency fields cannot be observed once the worker has left the area of undesired exposure. Any health damage resulting from such exposure therefore cannot be determined by a medical examination.
Article 9 on ‘Sanctions’ remains identical to the same article in Directive 2004/40/EC. This article was introduced by the EP during the discussions preceding the adoption of Directive 2004/40/EC.
Article 10 ‘Technical amendments’. Compared with the same article in Directive 2004/40/EC, significant changes have been introduced. The first paragraph, containing a reference to the legislative procedure laid down in Article 153 i with regard to the adoption of modifications of the exposure limit values, has been deleted since the proposal itself is based on Article 153 i of the Treaty and it is not necessary to refer to it again in the enacting terms. The European Parliament and the Council do not empower the Commission to modify the exposure limit values. Any such modifications would therefore not be introduced by the Commission delegated acts but by amendments of the Directive according to the procedure laid down in Article 153 i TFEU. However, the actual directly measurable reference levels, i.e. the orientation and action values, are considered as amendments of a strictly technical nature in the proposal and are therefore referred to under a new point c) added in the first subparagraph of Article 10. This will facilitate appropriate and timely changes if scientific knowledge and refined modelling methods justify simplifications or adaptations in this area. In the light of the new ‘comitology’ rules introduced by the Lisbon Treaty, the purely technical amendments to Annexes referred to in Article 10 are measures of general scope that are designed to amend non-essential elements of the Directive. They thus come under ‘delegated acts’ within the meaning of Article 290 TFEU, and the procedure laid down in that Article (on delegating powers) should be used to adopt those technical amendments. Consequently, the power for the Commission to make use of this procedure is included in this Article 10, along with the possibility to use an urgency procedure referred to in the second subparagraph of this Article.
Article 11 The old ‘comitology’ procedure referred to in Directive 2004/40/EC has been replaced by new rules on delegating powers introduced by the Lisbon Treaty. Consequently, this article sets out the formal procedure under Article 290 TFEU concerning the exercise of the power conferred on the Commission to adopt delegated acts designed to amend the Directive by making purely technical amendments to its Annexes.
The former Article 12 of Directive 2004/40/EC, ‘Reports’ has been removed because it was repealed by Article 3(20) of Directive 2007/30/EC. The provisions for implementation reports for all the individual Directives within the meaning of Article 16 of Directive 89/391/EEC are now in Article 17a of Directive 89/391/EEC.
Article 12 ‘Urgency procedure’ lays down rules on the exercise of the urgency procedure under the power conferred on the Commission to adopt delegated acts. The possibility to use the urgency procedure is accepted in the field of the protection of health and safety according to the interinstitutional Common Understanding on delegated acts. This possibility was already provided by the old EMF directive 2004/40. It will only be used 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.
Article 13 is new and refers to the need to establish a practical guide in order to facilitate implementation of the Directive. This practice is already followed in other directives, in particular in the latest Directive 2006/25/EC on physical agents (artificial optical radiation).
Articles 14, 15, 16 and 17 are provisions concerning reporting, transposition, the repeal of Directive 2004/40/EC and entry into force.
Annex I introduces a number of physical quantities not included in the main text (Article 2). This option is considered preferable for better coherence of the text of the proposal.
Annex II is an important part of the proposal because it sets out all the elements required to ensure more flexibility and proportionality in the frequency range from 0 Hz to 100 kHz. It introduces in practice the ‘zoning’ system supported by most stakeholders together with measures to facilitate risk assessment procedures whenever possible.
Annex III covers the higher end of the frequency spectrum. As there have been no new international recommendations over recent years in this area, the changes are limited to a different presentation and some elements to facilitate the work of employers.
Annex IV is specific to medical magnetic resonance (MR). It is designed to ensure the smooth and harmonised application of appropriate qualitative protection measures in a controlled environment.
Annex V includes a list of legislative acts amending Directive 2004/40/EC (referred to in Article 15) and a correlation table between the provisions of Directive 2004/40/EC, as amended, and this proposal.