SP(2012)323

PURPOSE: to amend Directive 2004/40/EC regarding the exposure of workers to the risks arising from electromagnetic fields in order to extend the deadline for transposition.

LEGISLATIVE ACT : Directive 2012/11/EU of the European Parliament and of the Council 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) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)

CONTENT: the purpose of this Directive is to postpone the deadline for the transposition of Directive 2004/40/EC until 31 October 2013.

Following the entry into force of Directive 2004/40/EC, stakeholders expressed serious concerns about the impact that implementing that Directive could have on the use of medical procedures based on medical imaging, as well as its impact on certain industrial activities. The Commission examined the arguments put forward by stakeholders and decided to reconsider some provisions of Directive 2004/40/EC, on the basis of new scientific evidence.

The deadline for transposition of Directive 2004/40/EC was postponed, by Directive 2008/46/EC , until 30 April 2012, in order to allow a new Directive based on the most recent evidence to be adopted by that date.

On 14 June 2011, the Commission adopted a proposal for a new Directive to replace Directive 2004/40/EC. The aim of the new Directive is to ensure both a high level of health and safety protection for workers and the continuation and development of medical and other industrial activities using electromagnetic fields. Consequently, anticipating the adoption of the new Directive by 30 April 2012, the majority of Member States have not transposed Directive 2004/40/EC. However, given the technical complexity of the subject matter, it is unlikely that the new Directive will be adopted by 30 April 2012.

Consequently, the deadline of 30 April 2012 had to be extended.

ENTRY INTO FORCE: 24/04/2012.

Directive 2012/11
OJ L 110 24.04.2012, p. 0001

00007/2012/LEX

Results of vote in Parliament

The European Parliament adopted by 610 votes to 37, with 14 abstentions, a legislative resolution on the proposal for a directive of the European Parliament and of the Council 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) (eighteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).

Parliament adopted its position at first reading under the ordinary legislative procedure. The only amendment adopted in plenary is the result of a compromise negotiated between the European Parliament and the Council and aims to amend the delay of transposition of Directive 2004/40/EC .

The Commission suggested the date to the brought forward to 30 April 2014 (instead of 30 April 2012) so as to take into account a number of technical difficulties relating to the implementation of the directive for the medical imaging industry. Following the vote in plenary, the date for the delay of transposition of Directive 2004/40/EC is set at 31 October 2013 .

T7-0107/2012

COM(2012)0015

COM(2012)0015

The Committee on Employment and Social Affairs adopted the report drafted by Elisabeth MORIN-CHARTIER (EPP, FR) on the proposal for a directive of the European Parliament and of the Council 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) (eighteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).

The committee recommends that the European Parliament’s position at first reading adopted under the ordinary legislative procedure should amend the Commission proposal so that the delay of transposition of Directive 2004/40/EC on minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (the Commission suggested the date to the brought forward to 30 April 2014 so as to take into account a number of technical difficulties relating to the implementation of the directive for the medical imaging industry) be replaced by the date of 31 October 2013 .

A7-0042/2012

CES0481/2012

PE483.526

PE480.822

PURPOSE: to amend Directive 2004/40/EC regarding the exposure of workers to the risks arising from electromagnetic fields.

PROPOSED ACT: Directive of the European Parliament and of the Council.

BACKGROUND: in 2006, the medical community informed the Commission of its concerns about implementing this Directive, claiming that the exposure limit values laid down therein would place disproportionate limitations on the use and development of medical magnetic resonance applications (MR), considered today to be a vital tool for the diagnosis and treatment of a number of diseases. Other industrial sectors subsequently expressed their concerns about the impact of the Directive on their activities.

In response to these concerns, the Commission took a number of steps:

to enable the Commission to conduct an in-depth impact analysis and propose amendments, the deadline for transposition of the Directive was put back from 30 April 2008 to 30 April 2012 by Directive 2008/46/EC ; the Commission examined the situation thoroughly, analysing the latest scientific studies on the negative impact the exposure limit values set by the Directive might have on the medical use of imaging technologies using magnetic resonance (MR) ; after a significant number of consultations of stakeholders and having due regard to the latest scientific recommendations, the Commission adopted, on 14 June 2011, the proposal for a new Directive to amend and replace Directive 2004/40/EC, with a view to guaranteeing a high level of health and safety protection for workers while at the same time enabling medical and other industrial activities using electromagnetic fields to continue and develop; once the Commission proposal had been adopted, the European Parliament and the Council immediately started work with a view to amending Directive 2004/40/EC before 30 April 2012. However, because of i) the technical complexity of the subject-matter, requiring long discussions with national experts; ii) the highly divergent views on some key provisions of the proposal, the European Parliament and the Council will be unlikely to finalise the adoption process before 30 April 2012.

Under these circumstances, a new Directive is required to postpone for a second time the deadline for transposition of Directive 2004/40/EC in order to prevent an uncertain legal situation from arising after 30 April 2012

IMPACT ASSESSMENT: given the urgency of the proposal and its limited impact, this proposal is not accompanied by a specific impact assessment.

Doing nothing at this stage would oblige the great majority of Member States which have not yet transposed Directive 2004/40/EC into national law to do so and to enforce it within a very short period of time, i.e. by the current deadline of 30 April 2012, with potentially serious consequences for the continuity of healthcare services using MRI.

Moreover, the legal uncertainty that might arise due to the non-transposition of the Directive could have the following consequences:

the Commission would in principle have to launch infringement proceedings for non-communication of transposition measures against any Member States which have not transposed the Directive yet; Directive 2004/40/EC would start to have direct vertical effect in the national legal order of all Member States, and citizens could take their governments to court for their failure to implement the Directive.

Postponing the date of transposition will not unduly impede the use of MRI or other industrial activities. At the same time, postponement would give sufficient time for the Directive, in particular the exposure limit values, to be updated and improved, by means of a new Directive based on the Commission proposal.

LEGAL BASIS: Article 153 (2) of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: the purpose of this proposal is simply to postpone the deadline for the transposition of Directive 2004/40/EC until 30 April 2014 .

These extra two years will give sufficient time for the Directive, and particularly the exposure limit values, to be updated and improved, by means of a new Directive proposed by the Commission which is currently being discussed in the Council and the EP. The two-year postponement will also avoid any negative legal consequences in the legal orders of Member States which have not yet transposed the Directive.

BUDGETARY IMPACT: the proposal will have no impact on the EU’s budget.

COM(2012)0015
EUR-Lex