DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 8 June 2011
on the restriction of the use of certain hazardous substances in electrical and electronic equipment
(recast)
(Text with EEA relevance)
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 114 thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the European Economic and
Social Committee ( 1 ),
Having regard to the opinion of the Committee of Regions ( 2 ),
Acting in accordance with the ordinary legislative procedure ( 3 ),
Whereas:
(1) A number of substantial changes are to be made to
Directive 2002/95/EC of the European Parliament and
of the Council of 27 January 2003 on the restriction
of the use of certain hazardous substances in electrical
and electronic equipment ( 4 ). In the interest of clarity,
that Directive should be recast.
(2) The disparities between the laws or administrative
measures adopted by the Member States regarding the
restriction of the use of hazardous substances in electrical
and electronic equipment (EEE) could create barriers to
trade and distort competition in the Union and may
thereby have a direct impact on the establishment and
functioning of the internal market. It therefore appears
necessary to lay down rules in this field and to contribute
to the protection of human health and the environ
mentally sound recovery and disposal of waste EEE.
(3) Directive 2002/95/EC provides that the Commission
shall review the provisions of that Directive, in particular,
in order to include in its scope equipment which falls
within certain categories and to study the need to adapt
the list of restricted substances on the basis of scientific
progress, taking into account the precautionary principle,
as endorsed by Council Resolution of 4 December 2000.
(4) Directive 2008/98/EC of the European Parliament and of
the Council of 19 November 2008 on waste ( 5 ) gives first
priority to prevention in waste legislation. Prevention is
defined, inter alia, as measures that reduce the content of
harmful substances in materials and products.
(5) Council Resolution of 25 January 1988 on a Community
action programme to combat environmental pollution by
cadmium ( 6 ) invited the Commission to pursue without
delay the development of specific measures for such a
programme. Human health also has to be protected and
an overall strategy that in particular restricts the use of
cadmium and stimulates research into substitutes should
therefore be implemented. The Resolution stresses that
the use of cadmium should be limited to cases where
suitable alternatives do not exist.
(6) Regulation (EC) No 850/2004 of the European
Parliament and of the Council of 29 April 2004 on
persistent organic pollutants ( 7 ) recalls that the objective
of protecting the environment and human health from
persistent organic pollutants cannot be sufficiently
achieved by the Member States, owing to the trans
boundary effects of those pollutants, and can therefore
be better achieved at Union level. Pursuant to that Regu
lation, releases of persistent organic pollutants, such as
dioxins and furans, which are unintentional by-products
of industrial processes, should be identified and reduced
as soon as possible with the ultimate aim of elimination,
where feasible.
(7) The available evidence indicates that measures on the
collection, treatment, recycling and disposal of waste
EEE as set out in Directive 2002/96/EC of the
European Parliament and of the Council of 27 January
2003 on waste electrical and electronic equipment
(WEEE) ( 8 ) are necessary to reduce the waste management
problems associated with the heavy metals and flame
retardants concerned. In spite of those measures,
however, significant parts of waste EEE will continue to
be found in the current disposal routes inside or outside
the Union. Even if waste EEE were collected separately
and submitted to recycling processes, its content of
mercury, cadmium, lead, chromium VI, polybrominated
biphenyls (PBB) and polybrominated diphenyl ethers
(PBDE) would be likely to pose risks to health or the
environment, especially when treated in less than
optimal conditions.
EN L 174/88 Official Journal of the European Union 1.7.2011
( 1 ) OJ C 306, 16.12.2009, p. 36.
( 2 ) OJ C 141, 29.5.2010, p. 55.
( 3 ) Position of the European Parliament of 24 November 2010 (not yet
published in the Official Journal) and decision of the Council of
27 May 2011.
( 4 ) OJ L 37, 13.2.2003, p. 19.
( 5 ) OJ L 312, 22.11.2008, p. 3.
( 6 ) OJ C 30, 4.2.1988, p. 1.
( 7 ) OJ L 158, 30.4.2004, p. 7.
( 8 ) OJ L 37, 13.2.2003, p. 24.
(8) Taking into account technical and economic feasibility,
including for small and medium sized enterprises (SMEs),
the most effective way of ensuring a significant reduction
of risks to health and the environment relating to those
substances, in order to achieve the chosen level of
protection in the Union, is the substitution of those
substances in EEE by safe or safer materials. Restricting
the use of those hazardous substances is likely to
enhance the possibilities and economic profitability of
recycling of waste EEE and decrease the negative
impact on the health of workers in recycling plants.
(9) The substances covered by this Directive are scientifically
well researched and evaluated and have been subject to
different measures both at Union and at national level.
(10) The measures provided for in this Directive should take
into account existing international guidelines and recom
mendations and should be based on an assessment of
available scientific and technical information. The
measures are necessary to achieve the chosen level of
protection of human health and the environment, with
due respect for the precautionary principle, and having
regard to the risks which the absence of measures would
be likely to create in the Union. The measures should be
kept under review and, if necessary, adjusted to take
account of available technical and scientific information.
The annexes to this Directive should be reviewed peri
odically to take into account, inter alia, Annexes XIV and
XVII to Regulation (EC) No 1907/2006 of the European
Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH) and establishing
a European Chemicals Agency ( 1 ). In particular, the risks
to human health and the environment arising from the
use of Hexabromocyclododecane (HBCDD), Bis (2-
ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate
(BBP) and Dibutyl phthalate (DBP) should be considered
as a priority. With a view to further restrictions of
substances, the Commission should re-investigate the
substances that were subject to previous assessments, in
accordance with the new criteria set out in this Directive
as part of the first review.
(11) This Directive supplements the general Union waste
management legislation, such as Directive 2008/98/EC
and Regulation (EC) No 1907/2006.
(12) A number of definitions should be included in this
Directive in order to specify its scope. In addition, the
definition of ‘electrical and electronic equipment’ should
be complemented by a definition of ‘dependent’, to cover
the multipurpose character of certain products, where the
intended functions of EEE are to be determined on the
basis of objective characteristics, such as the design of the
product and its marketing.
(13) Directive 2009/125/EC of the European Parliament and
of the Council of 21 October 2009 establishing a
framework for the setting of ecodesign requirements
for energy-related products ( 2 ) enables specific ecodesign
requirements to be set for energy-related products which
may also be covered by this Directive. Directive
2009/125/EC and the implementing measures adopted
pursuant to it are without prejudice to Union waste
management legislation.
(14) This Directive should apply without prejudice to Union
legislation on safety and health requirements and specific
Union waste management legislation, in particular
Directive 2006/66/EC of the European Parliament and
of the Council of 6 September 2006 on batteries and
accumulators and waste batteries and accumulators ( 3 )
and Regulation (EC) No 850/2004.
(15) The technical development of EEE without heavy metals,
PBDE and PBB should be taken into account.
(16) As soon as scientific evidence is available, and taking into
account the precautionary principle, the restriction of
other hazardous substances, including any substances of
very small size or with a very small internal or surface
structure (nanomaterials) which may be hazardous due to
properties relating to their size or structure, and their
substitution by more environmentally friendly alter
natives which ensure at least the same level of protection
of consumers should be examined. To this end, the
review and amendment of the list of restricted substances
in Annex II should be coherent, maximise synergies with,
and reflect the complementary nature of the work carried
out under other Union legislation, and in particular
under Regulation (EC) No 1907/2006 while ensuring
the mutually independent operation of this Directive
and that Regulation. Consultation with the relevant stake
holders should be carried out and specific account should
be taken of the potential impact on SMEs.
(17) The development of renewable forms of energy is one of
the Union’s key objectives, and the contribution made by
renewable energy sources to environmental and climate
objectives is crucial. Directive 2009/28/EC of the
European Parliament and of the Council of 23 April
2009 on the promotion of the use of energy from
renewable sources ( 4 ) recalls that there should be
coherence between those objectives and other Union
environmental legislation. Consequently, this Directive
should not prevent the development of renewable
energy technologies that have no negative impact on
health and the environment and that are sustainable
and economically viable.
EN 1.7.2011 Official Journal of the European Union L 174/89
( 1 ) OJ L 396, 30.12.2006, p. 1.
( 2 ) OJ L 285, 31.10.2009, p. 10.
( 3 ) OJ L 266, 26.9.2006, p. 1.
( 4 ) OJ L 140, 5.6.2009, p. 16.
(18) Exemptions from the substitution requirement should be
permitted if substitution is not possible from the
scientific and technical point of view, taking specific
account of the situation of SMEs or if the negative envi
ronmental, health and consumer safety impacts caused
by substitution are likely to outweigh the environmental,
health and consumer safety benefits of the substitution or
the reliability of substitutes is not ensured. The decision
on exemptions and on the duration of possible
exemptions should take into account the availability of
substitutes and the socioeconomic impact of substitution.
Life-cycle thinking on the overall impacts of exemptions
should apply, where relevant. Substitution of the
hazardous substances in EEE should also be carried out
in such a way as to be compatible with the health and
safety of users of EEE. The placing on the market of
medical devices requires a conformity assessment
procedure, according to Council Directive 93/42/EEC of
14 June 1993 concerning medical devices ( 1 ) and
Directive 98/79/EC of the European Parliament and of
the Council of 27 October 1998 on in vitro diagnostic
medical devices ( 2 ), which could require the involvement
of a notified body designated by competent authorities of
Member States. If such a notified body certifies that the
safety of the potential substitute for the intended use in
medical devices or in vitro diagnostic medical devices is
not demonstrated, the use of that potential substitute will
be deemed to have clear negative socioeconomic, health
and consumer safety impacts. It should be possible, from
the date of entry into force of this Directive, to apply for
exemptions for equipment, even before the actual
inclusion of that equipment in the scope of this
Directive.
(19) Exemptions from the restriction for certain specific
materials or components should be limited in their
scope and duration, in order to achieve a gradual
phase-out of hazardous substances in EEE, given that
the use of those substances in such applications should
become avoidable.
(20) As product reuse, refurbishment and extension of lifetime
are beneficial, spare parts need to be available.
(21) Procedures for assessing the conformity of EEE subject to
this Directive should be consistent with relevant Union
legislation, in particular Decision No 768/2008/EC of the
European Parliament and of the Council of 9 July 2008
on a common framework for the marketing of
products ( 3 ). Harmonising conformity assessment
procedures should give manufacturers legal certainty as
to what they have to provide as proof of compliance to
the authorities throughout the Union.
(22) The conformity marking applicable for products at
Union level, CE marking, should also apply to EEE that
is subject to this Directive.
(23) The market surveillance mechanisms laid down by Regu
lation (EC) No 765/2008 of the European Parliament and
of the Council of 9 July 2008 setting out the
requirements for accreditation and market surveillance
relating to the marketing of products ( 4 ) provide the
safeguard mechanisms to check compliance with this
Directive.
(24) In order to ensure uniform conditions for the implemen
tation of this Directive, particularly with regard to the
guidelines and format of applications for exemptions,
implementing powers should be conferred on the
Commission. Those powers should be exercised in
accordance with Regulation (EU) No 182/2011 of the
European Parliament and of the Council of 16 February
2011 laying down the rules and general principles
concerning mechanisms for control by Member States
of the Commission’s exercise of implementing powers ( 5 ).
(25) For the purposes of achieving the objectives of this
Directive the Commission should be empowered to
adopt delegated acts in accordance with Article 290 of
the Treaty on the Functioning of the European Union in
respect of amendments to Annex II, detailed rules for
complying with maximum concentration values, and
the adaptation of Annexes III and IV to technical and
scientific progress. It is of particular importance that the
Commission carry out appropriate consultations during
its preparatory work, including at expert level.
(26) The obligation to transpose this Directive into national
law should be confined to those provisions which
represent a substantive change as compared with the
earlier Directive. The obligation to transpose the
provisions which are unchanged arises under the earlier
Directive.
(27) This Directive should be without prejudice to the obli
gations of the Member States relating to the time-limits
for transposition into national law and application of the
Directive set out in Annex VII, Part B.
(28) When reviewing this Directive, a thorough analysis of its
coherence with Regulation (EC) No 1907/2006 should
be carried out by the Commission.
(29) In accordance with paragraph 34 of the Interinstitutional
Agreement on better law-making ( 6 ), Member States are
encouraged to draw up, for themselves and in the
interests of the Union, their own tables, which will, as
far as possible, illustrate the correlation between this
Directive and their transposition measures, and to make
those tables public.
EN L 174/90 Official Journal of the European Union 1.7.2011
( 1 ) OJ L 169, 12.7.1993, p. 1.
( 2 ) OJ L 331, 7.12.1998, p. 1.
( 3 ) OJ L 218, 13.8.2008, p. 82.
( 4 ) OJ L 218, 13.8.2008, p. 30.
( 5 ) OJ L 55, 28.2.2011, p. 13.
( 6 ) OJ C 321, 31.12.2003, p. 1.
(30) Since the objective of this Directive, namely to establish
restrictions on the use of hazardous substances in EEE,
cannot be sufficiently achieved by the Member States and
can therefore, by reason of the scale of the problem and
its implications in respect of other Union legislation on
recovery and disposal of waste and areas of common
interest, such as human health protection, be better
achieved at Union level, the Union may adopt
measures, in accordance with the principle of subsidiarity
as set out in Article 5 of the Treaty on European Union.
In accordance with the principle of proportionality, as set
out in that Article, this Directive does not go beyond
what is necessary in order to achieve that objective,
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Subject matter
This Directive lays down rules on the restriction of the use of
hazardous substances in electrical and electronic equipment
(EEE) with a view to contributing to the protection of human
health and the environment, including the environmentally
sound recovery and disposal of waste EEE.
Article 2
Scope
1. This Directive shall, subject to paragraph 2, apply to EEE
falling within the categories set out in Annex I.
2. Without prejudice to Article 4(3) and 4(4), Member States
shall provide that EEE that was outside the scope of Directive
2002/95/EC, but which would not comply with this Directive,
may nevertheless continue to be made available on the market
until 22 July 2019.
3. This Directive shall apply without prejudice to the
requirements of Union legislation on safety and health, and
on chemicals, in particular Regulation (EC) No 1907/2006, as
well as the requirements of specific Union waste management
legislation.
4. This Directive does not apply to:
(a) equipment which is necessary for the protection of the
essential interests of the security of Member States,
including arms, munitions and war material intended for
specifically military purposes;
(b) equipment designed to be sent into space;
(c) equipment which is specifically designed, and is to be
installed, as part of another type of equipment that is
excluded or does not fall within the scope of this Directive,
which can fulfil its function only if it is part of that
equipment, and which can be replaced only by the same
specifically designed equipment;
(d) large-scale stationary industrial tools;
(e) large-scale fixed installations;
(f) means of transport for persons or goods, excluding electric
two-wheel vehicles which are not type-approved;
(g) non-road mobile machinery made available exclusively for
professional use;
(h) active implantable medical devices;
(i) photovoltaic panels intended to be used in a system that is
designed, assembled and installed by professionals for
permanent use at a defined location to produce energy
from solar light for public, commercial, industrial and resi
dential applications;
(j) equipment specifically designed solely for the purposes of
research and development only made available on a
business-to-business basis.
Article 3
Definitions
For the purposes of this Directive, the following definitions shall
apply:
(1) ‘electrical and electronic equipment’ or ‘EEE’ means
equipment which is dependent on electric currents or elec
tromagnetic fields in order to work properly and
equipment for the generation, transfer and measurement
of such currents and fields and designed for use with a
voltage rating not exceeding 1 000 volts for alternating
current and 1 500 volts for direct current;
(2) for the purposes of point 1, ‘dependent ‘ means, with
regard to EEE, needing electric currents or electromagnetic
fields to fulfil at least one intended function;
(3) ‘large-scale stationary industrial tools’ means a large-scale
assembly of machines, equipment, and/or