# EUR-Lex - 52012PC0015 - EN

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# 52012PC0015

**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) /* COM/2012/015 final - 2012/0003 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

1.1.
Grounds for and objectives of the proposal

The aim of this proposal is to postpone
until 30 April 2014 the deadline for the transposition of Directive 2004/40/EC[1] 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).

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[2]
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 Commission examined the situation thoroughly,
analysing the latest scientific studies, including the one launched by the
Commission, 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[3], the Commission adopted, on 14
June 2011, proposal COM (2011) 348 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. Adoption had been delayed mainly by the fact that the new
international recommendations for exposure of workers and the public to
electromagnetic fields had only been published in December 2010, rather than in
2009, as had been expected.

In addition, proposal COM(2011) 348 aims to
update and improve a significant number of other provisions of Directive
2004/40/EC; it also introduces some new elements to make it easier for
employers, especially small businesses, to implement the measures.

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

·
the technical complexity of the subject-matter,
requiring long discussions with national experts,

·
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, we shall need a
new Directive postponing for a second time the deadline for transposition of Directive
2004/40/EC. We have to prevent a very uncertain legal situation from arising
after 30 April 2012, which is when all the Member States would have to
transpose the current Directive 2004/40/EC by, if no further action were taken.

This legal uncertainty would have two
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.

We consider it appropriate to postpone the
transposition deadline for two years to allow sufficient time for the European
Parliament and the Council to discuss and reach a compromise on the basis of
the Commission proposal COM (2011) 348 for a new Directive, which would update
and improve the provisions of Directive 2004/40/EC while repealing and
replacing the earlier Directive.

1.2.
Directive 2004/40/EC

Directive 2004/40/EC is the 18th 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. 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 [4].
No worker may be exposed to values exceeding these limits, which are based on
health impact and biological considerations.

The Directive also sets action 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 measures
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 assessing 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 and IEEE.

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 European Parliament and the Council adopted the
Directive, with certain amendments to the values originally proposed by the
Commission. These included 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 became available
at the time of  the adoption of the Directive.

1.3.
Proposal COM (2011) 348 for a new Directive

The above proposal aims to update and
improve the provisions of Directive 2004/40/EC while repealing and replacing it.
It maintains a number of important principles and provisions in Directive
2004/40/EC.

The most important changes introduced by
the proposal, taking into account the latest scientific findings in this area,
are:

–
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 differing 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 will provide for sufficient
protection in these situations;

–
introduction of some guidance to ensure
simplified but more efficient risk assessments (Article 4), in order to
facilitate evaluation work and limit the burden on SMEs;

–
introduction of limited but appropriate
flexibility by proposing a controlled framework for limited derogations for
industry from action and limit values. The proposal includes two specific
derogations, one for medical magnetic resonance applications (MR), and another
for the armed forces. A third derogation is for occasional situations, subject to
strict control and authorisation by Member States, followed by evaluation.
Member States must report to the Commission on any authorisations granted.
These three derogations, which are the result of intense consultations with all
stakeholders and are well defined in their scope, guarantee a high level of
health and safety protection while ensuring that medical and industrial
activities are not unduly hampered;

–
inclusion of a rationale for medical
surveillance (Article 8);

–
special attention to the specific case of
medical applications using magnetic resonance and related activities;

–
provision for complementary non-binding measures
such as a non-binding practical guide.

2.
CONSULTATION OF INTERESTED PARTIES AND IMPACT
ASSESSMENT
2.1.
Consultation of interested parties

Consultation of the Advisory Committee
on Safety and Health at Work

The representatives of the social partners
and the government representatives of the 27 Member States in the Advisory
Committee on Safety and Health at Work, meeting in plenary on 1 December 2011, came
out in favour of postponing the deadline for the transposition of Directive
2004/40/EC into the national legal order of Member States in order to avoid a situation
of legal uncertainty after 30 April 2012, and to allow sufficient time for the
European Parliament and the Council to reach a compromise on Commission
proposal COM(2011) 348.

Consultation of the EU social partners

Given the nature of the proposal, which
affects only the date of transposition of the Directive without amending the
provisions themselves, and after consultation with the Commission's Legal
Service and Secretariat-General, it was decided that there was no need in this
case to consult the social partners formally at European level, pursuant to
Article 154 of the  Treaty on the Functioning of the European Union.
Nevertheless, the EU cross-industry social partners were informed of the
proposal by a letter from Commissioner Andor and invited to send their comments.

2.2.
Transmission of this proposal to the national parliaments

Draft legislative acts, including proposals
from the Commission, sent to the European Parliament and to the Council must be
forwarded to national parliaments in accordance with the Protocol (No 1) on the
role of national Parliaments in the European Union, annexed to the Treaties.

According to Article 4 of the Protocol, an
eight-week period must elapse between a draft legislative act being made
available to national parliaments and the date when it is placed on a
provisional agenda for the Council for its adoption or for adoption of a
position under a legislative procedure.

However, exceptions are possible under
Article 4 in cases of urgency, the reasons for which must be stated in the act
or position of the Council. The adoption of this proposal by the European
Parliament and the Council has to be considered as a case of absolute
urgency for the reasons explained above, and which can be summarised as
follows.

Commission proposal COM(2011) 348, which is
currently being discussed by the European Parliament and the Council, is
intended to update and improve the provisions of Directive 2004/40/EC, while
repealing and replacing it, before 30 April 2012. Consequently, the great
majority of Member States did not transpose Directive 2004/40/EC, waiting for
the adoption of the new updated Directive based on the above proposal.

Nevertheless, given the complexity of the
subject-matter and the deeply diverging views in the Council, there appears to
be no chance of the European Parliament and the Council finalising the adoption
process before the 30 April 2012 deadline.

This proposal, whose sole aim is to
postpone the deadline for transposition of Directive 2004/40/EC for two years,
has therefore to be adopted as a matter of urgency within the very short period
remaining. If the proposal is not adopted by the 30 April 2012 deadline, there
may be negative legal consequences in the internal legal orders of any Member
States that have not yet transposed the Directive (see above section 1.1).

2.3.
Impact assessment

Given the urgency of the proposal and its
limited impact, the proposal is not accompanied by a separate 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.
Certain industrial activities might also be adversely affected.

In any Member States which did not
transpose the Directive by the deadline, a very uncertain legal situation
would arise. Under the principle of vertical direct effect of EU directives,
established by the Court of Justice, their citizens could bring actions against
them in national courts for failure to implement the Directive. Furthermore,
the Commission would in principle have to launch infringement procedures
against those Member States for non-communication of transposition measures.

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 Commission proposal COM(2011) 348. Reflecting new scientific findings,
this would guarantee a high level of protection for workers and the continuity
of economic activities.

The proposed amendment affects only the
obligation on Member States to transpose the Directive by 30 April 2012,
extending it to 30 April 2014. It does not alter the substance of the Directive
in question and does not therefore impose any additional obligations on businesses.

3.
LEGAL ELEMENTS OF THE PROPOSAL
3.1.
Summary of the proposed measures

The proposal amends Article 13(1) of
Directive 2004/40/EC by postponing the date of transposition to 30 April 2014.

3.2.
Legal basis

Article 153(2) of the Treaty on the
Functioning of the European Union.

3.3.
Subsidiarity principle

The subsidiarity principle applies as the
proposal concerns a field — the protection of the health and safety of workers
at work — which does not fall within 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 objectives of the proposal can be
achieved only by EU action, as this proposal amends an act of EU law which is
in force, and this is something which cannot be done by the Member States
themselves.

The principle of subsidiarity is complied
with in that the proposal amends existing EU legislation.

3.4.
Proportionality principle

The proposal complies with the
proportionality principle for the following reason.

It does not alter the substance of the
current EU legislation: it is restricted to postponing the date for the
transposition of Directive 2004/40/EC until 30 April 2014, in order to avoid a
situation of legal uncertainty after the current deadline has expired and to
allow sufficient time for the European Parliament and the Council to discuss
and to reach a compromise on Commission proposal COM(2011) 348, which seeks to
update and improve the provisions of Directive 2004/40/EC while repealing and
replacing it.

3.5.
Choice of instruments

Proposed instrument(s): directive.

No other instrument would have been
suitable. As this is an amended directive, the only way forward is to adopt another
directive.

4.
BUDGETARY IMPLICATION

–
          The proposal has no implication for
the EU budget.

5.
ADDITIONAL INFORMATION

·
Simplification

The proposal does not simplify the
legislative framework. It is aimed solely at postponing the date for
transposition of Directive 2004/40/EC to 30 April 2014.

·
Repeal of existing legislation

The adoption of the proposal will not
entail the repeal of existing legislation.

·
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 postpones the date of
transposition of Directive 2004/40/EC to 30 April 2014. These extra two years for
transposing the provisions of the Directive into national law are justified by
the concerns expressed — and in some cases confirmed — that the exposure limit
values laid down in the Directive might have a disproportionate impact on the
continuity of medical procedures which use magnetic resonance imaging. The
postponement will give sufficient time for the Directive, and particularly the
exposure limit values, to be updated and improved, by means of a new Directive
based on Commission proposal COM(2011) 348, which is currently being discussed
in the Council and the EP and which aims to guarantee a high level of
protection for workers and the continuity of medical procedures and other
economic activities. 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.

Article 1 of the proposal amends Article
13(1) ‘Transposition’ of Directive 2004/40/EC accordingly.

2012/0003 (COD)

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 EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning
of the European Union, and in particular Article 153(2) thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee[5],

Having regard to the opinion of the
Committee of the Regions[6],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)
After 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)[7],
serious concerns were expressed by stakeholders, in particular in the medical
community, about the potential impact of 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.

(2)
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.

(3)
The deadline for transposition of Directive
2004/40/EC was therefore postponed until 30 April 2012 by Directive 2008/46/EC
of 23 April 2008[8],
in order to allow the adoption of a new directive based on the most recent
evidence.

(4)
On 14 June 2011 the Commission adopted a
proposal for a new Directive to replace Directive 2004/40/EC. The new Directive
should 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, the majority of Member States have not yet transposed
Directive 2004/40/EC, pending the adoption of the new Directive.

(5)
However, given the technical complexity of the
subject-matter it is unlikely that the new Directive will be adopted before the
deadline for transposition of Directive 2004/40/EC.

(6)
Consequently, that deadline should be extended.

(7)
In view of the above and given the very short
period of time left before the time limit of 30 April 2012, it must be ensured
that this Directive is adopted by the European Parliament and the Council as a
matter of urgency and that it enters into force without delay.

(8)
Consequently, as regards the transmission to
national Parliaments in accordance with Protocol (No 1) on the role of national
Parliaments in the European Union, the exception for urgent cases provided for
in Article 4 of this Protocol has been applied in this case with regard to the
eight-week period to elapse between a draft legislative act being made
available to national Parliaments and the date when it is placed on a
provisional agenda for the Council for its adoption or for adoption of a
position under a legislative procedure.

HAVE ADOPTED THIS DIRECTIVE:

Article 1

In Article 13(1) of Directive 2004/40/EC
the date "30 April 2012" is replaced
by "30 April 2014."

Article 2

This Directive shall enter into force on
the day of its publication in the Official Journal of the European Union.

Article 3

This
Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament                       For
the Council

The President                                                 The
President

[1]               OJ L 184, 24.5.2004, p. 23.

[2]               OJ L 114, 26.4.2008, p. 88.

[3]               In particular the recommendations from the
International Commission for Non Ionising Radiation Protection (ICNIRP) for
static magnetic fields (April 2009) and for electric and magnetic fields in the
1Hz to 100 kHz range (December 2010).

[4]               300 GHz: frequency of 300
billion hertz or cycles per second. The hertz (abbreviation Hz) is the
international unit of frequency.

[5]               OJ C [...], [...], p. [...].

[6]               OJ C [...], [...], p. [...].

[7]               OJ L 184, 24.5.2004, p. 1.

[8]               OJ L 114, 26.4.2008, p. 88-89.