欧盟Eurlex法规详细信息

EURLEX ID:32011L0065

OJ编号:OJ L 174, 1.7.2011, p. 88-110

中文标题:欧洲议会和理事会指令2011/65/EU ,有关对在电器和电子设备上的某些危险物质的限制使用?(1)

原文标题: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 (1)

分类:15.10.20.50_化学品、工业风险与生物技术

文件类型:二级立法 Directive|指令

生效日期:2011-07-21

废止日期:2058-12-31

法规全文:查看欧盟官方文件

L 174/88
EN
Official Journal of the European Union
1.7.2011
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
(4) Directive
2008/98/EC
of
the
European
Parliament
and
of
EUROPEAN UNION,
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
Having regard to the Treaty on the Functioning of the European
harmful substances in materials and products.
Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
(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
Having regard to the opinion of the European Economic and
delay the development of specific measures for such a
Social Committee (
programme. Human health also has to be protected and

1 ),
an overall strategy that in particular restricts the use of
cadmium and stimulates research into substitutes should
Having regard to the opinion of the Committee of Regions (
therefore be implemented. The Resolution stresses that

2 ),
the use of cadmium should be limited to cases where
suitable alternatives do not exist.
Acting in accordance with the ordinary legislative procedure ( 3 ),
(6) Regulation
(EC)
No
850/2004
of
the
European
Whereas:
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
(1) A
number
of
substantial
changes
are
to
be
made
to
persistent organic pollutants cannot be sufficiently
Directive 2002/95/EC of the European Parliament and
achieved by the Member States, owing to the trans
of the Council of 27 January 2003 on the restriction
boundary effects of those pollutants, and can therefore
of the use of certain hazardous substances in electrical
be better achieved at Union level. Pursuant to that Regu
and electronic equipment ( 4 ). In the interest of clarity,
lation, releases of persistent organic pollutants, such as
that Directive should be recast.
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,
(2) The
disparities
between
the
laws
or
administrative
where feasible.
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
(7) The
available
evidence
indicates
that
measures
on
the
thereby have a direct impact on the establishment and
collection, treatment, recycling and disposal of waste
functioning of the internal market. It therefore appears
EEE as set out in Directive 2002/96/EC of the
necessary to lay down rules in this field and to contribute
European Parliament and of the Council of 27 January
to the protection of human health and the environ
2003 on waste electrical and electronic equipment
mentally sound recovery and disposal of waste EEE.
(WEEE) ( 8 ) are necessary to reduce the waste management
problems associated with the heavy metals and flame
retardants concerned. In spite of those measures,
(3) Directive
2002/95/EC
provides
that
the
Commission
however, significant parts of waste EEE will continue to
shall review the provisions of that Directive, in particular,
be found in the current disposal routes inside or outside
in order to include in its scope equipment which falls
the Union. Even if waste EEE were collected separately
within certain categories and to study the need to adapt
and submitted to recycling processes, its content of
the list of restricted substances on the basis of scientific
mercury, cadmium, lead, chromium VI, polybrominated
progress, taking into account the precautionary principle,
biphenyls (PBB) and polybrominated diphenyl ethers
as endorsed by Council Resolution of 4 December 2000.
(PBDE) would be likely to pose risks to health or the
environment, especially when treated in less than
optimal conditions.
( 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
( 5 ) OJ L 312, 22.11.2008, p. 3.
published in the Official Journal) and decision of the Council of
( 6 ) OJ C 30, 4.2.1988, p. 1.
27 May 2011.
( 7 ) OJ L 158, 30.4.2004, p. 7.
( 4 ) OJ L 37, 13.2.2003, p. 19.
( 8 ) OJ L 37, 13.2.2003, p. 24.

EN
1.7.2011 Official
Journal
of
the
European
Union L
174/89
(8) Taking
into
account
technical
and
economic
feasibility, (13) Directive
2009/125/EC
of
the
European
Parliament
and
including for small and medium sized enterprises (SMEs),
of the Council of 21 October 2009 establishing a
the most effective way of ensuring a significant reduction
framework for the setting of ecodesign requirements
of risks to health and the environment relating to those
for energy-related products ( 2 ) enables specific ecodesign
substances, in order to achieve the chosen level of
requirements to be set for energy-related products which
protection in the Union, is the substitution of those
may also be covered by this Directive. Directive
substances in EEE by safe or safer materials. Restricting
2009/125/EC and the implementing measures adopted
the use of those hazardous substances is likely to
pursuant to it are without prejudice to Union waste
enhance the possibilities and economic profitability of
management legislation.
recycling of waste EEE and decrease the negative
impact on the health of workers in recycling plants.
(14) This
Directive
should
apply
without
prejudice
to
Union
legislation on safety and health requirements and specific
(9) The
substances
covered
by
this
Directive
are
scientifically
Union waste management legislation, in particular
well researched and evaluated and have been subject to
Directive 2006/66/EC of the European Parliament and
different measures both at Union and at national level.
of the Council of 6 September 2006 on batteries and
accumulators and waste batteries and accumulators ( 3 )
and Regulation (EC) No 850/2004.
(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
(15) The
technical
development
of
EEE
without
heavy
metals,
measures are necessary to achieve the chosen level of
PBDE and PBB should be taken into account.
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
(16) As
soon
as
scientific
evidence
is
available,
and
taking
into
kept under review and, if necessary, adjusted to take
account the precautionary principle, the restriction of
account of available technical and scientific information.
other hazardous substances, including any substances of
The annexes to this Directive should be reviewed peri
very small size or with a very small internal or surface
odically to take into account, inter alia, Annexes XIV and
structure (nanomaterials) which may be hazardous due to
XVII to Regulation (EC) No 1907/2006 of the European
properties relating to their size or structure, and their
Parliament and of the Council of 18 December 2006
substitution by more environmentally friendly alter
concerning the Registration, Evaluation, Authorisation
natives which ensure at least the same level of protection
and Restriction of Chemicals (REACH) and establishing
of consumers should be examined. To this end, the
a European Chemicals Agency ( 1 ). In particular, the risks
review and amendment of the list of restricted substances
to human health and the environment arising from the
in Annex II should be coherent, maximise synergies with,
use of Hexabromocyclododecane (HBCDD), Bis (2-
and reflect the complementary nature of the work carried
ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate
out under other Union legislation, and in particular
(BBP) and Dibutyl phthalate (DBP) should be considered
under Regulation (EC) No 1907/2006 while ensuring
as a priority. With a view to further restrictions of
the mutually independent operation of this Directive
substances, the Commission should re-investigate the
and that Regulation. Consultation with the relevant stake
substances that were subject to previous assessments, in
holders should be carried out and specific account should
accordance with the new criteria set out in this Directive
be taken of the potential impact on SMEs.
as part of the first review.
(17) The
development
of
renewable
forms
of
energy
is
one
of
(11) This
Directive supplements the general Union waste
the Union’s key objectives, and the contribution made by
management legislation, such as Directive 2008/98/EC
renewable energy sources to environmental and climate
and Regulation (EC) No 1907/2006.
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
(12) A
number
of
definitions
should
be
included
in
this
coherence between those objectives and other Union
Directive in order to specify its scope. In addition, the
environmental legislation. Consequently, this Directive
definition of ‘electrical and electronic equipment’ should
should not prevent the development of renewable
be complemented by a definition of ‘dependent’, to cover
energy technologies that have no negative impact on
the multipurpose character of certain products, where the
health and the environment and that are sustainable
intended functions of EEE are to be determined on the
and economically viable.
basis of objective characteristics, such as the design of the
product and its marketing.
( 2 ) OJ L 285, 31.10.2009, p. 10.
( 3 ) OJ L 266, 26.9.2006, p. 1.
( 1 ) OJ L 396, 30.12.2006, p. 1.
( 4 ) OJ L 140, 5.6.2009, p. 16.

L 174/90
EN
Official Journal of the European Union
1.7.2011
(18) Exemptions
from
the
substitution
requirement
should
be
(23) The
market
surveillance
mechanisms
laid
down
by
Regu
permitted if substitution is not possible from the
lation (EC) No 765/2008 of the European Parliament and
scientific and technical point of view, taking specific
of the Council of 9 July 2008 setting out the
account of the situation of SMEs or if the negative envi
requirements for accreditation and market surveillance
ronmental, health and consumer safety impacts caused
relating to the marketing of products ( 4 ) provide the
by substitution are likely to outweigh the environmental,
safeguard mechanisms to check compliance with this
health and consumer safety benefits of the substitution or
Directive.
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.
(24) In
order
to
ensure
uniform
conditions
for
the
implemen
Life-cycle thinking on the overall impacts of exemptions
tation of this Directive, particularly with regard to the
should apply, where relevant. Substitution of the
guidelines and format of applications for exemptions,
hazardous substances in EEE should also be carried out
implementing powers should be conferred on the
in such a way as to be compatible with the health and
Commission. Those powers should be exercised in
safety of users of EEE. The placing on the market of
accordance with Regulation (EU) No 182/2011 of the
medical devices requires a conformity assessment
European Parliament and of the Council of 16 February
procedure, according to Council Directive 93/42/EEC of
2011 laying down the rules and general principles
14 June 1993 concerning medical devices
(
concerning mechanisms for control by Member States

1 ) and
Directive 98/79/EC of the European Parliament and of
of the Commission’s exercise of implementing powers ( 5 ).
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
(25) For the purposes of achieving the objectives of this
Member States. If such a notified body certifies that the
Directive the Commission should be empowered to
safety of the potential substitute for the intended use in
adopt delegated acts in accordance with Article 290 of
medical devices or in vitro diagnostic medical devices is
the Treaty on the Functioning of the European Union in
not demonstrated, the use of that potential substitute will
respect of amendments to Annex II, detailed rules for
be deemed to have clear negative socioeconomic, health
complying with maximum concentration values, and
and consumer safety impacts. It should be possible, from
the adaptation of Annexes III and IV to technical and
the date of entry into force of this Directive, to apply for
scientific progress. It is of particular importance that the
exemptions for equipment, even before the actual
Commission carry out appropriate consultations during
inclusion of that equipment in the scope of this
its preparatory work, including at expert level.
Directive.
(26) The
obligation
to
transpose
this
Directive
into
national
(19) Exemptions from the restriction for certain specific
law should be confined to those provisions which
materials or components should be limited in their
represent a substantive change as compared with the
scope and duration, in order to achieve a gradual
earlier Directive. The obligation to transpose the
phase-out of hazardous substances in EEE, given that
provisions which are unchanged arises under the earlier
the use of those substances in such applications should
Directive.
become avoidable.
(20) As
product
reuse,
refurbishment
and
extension
of
lifetime
(27) This
Directive
should
be
without
prejudice
to
the
obli
are beneficial, spare parts need to be available.
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.
(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
(28) When
reviewing
this
Directive,
a
thorough
analysis
of
its
European Parliament and of the Council of 9 July 2008
coherence with Regulation (EC) No 1907/2006 should
on a common framework for the marketing of
be carried out by the Commission.
products ( 3 ). Harmonising conformity assessment
procedures should give manufacturers legal certainty as
to what they have to provide as proof of compliance to
(29) In
accordance
with
paragraph
34
of
the
Interinstitutional
the authorities throughout the Union.
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
(22) The conformity marking applicable for products at
far as possible, illustrate the correlation between this
Union level, CE marking, should also apply to EEE that
Directive and their transposition measures, and to make
is subject to this Directive.
those tables public.
( 1 ) OJ L 169, 12.7.1993, p. 1.
( 4 ) OJ L 218, 13.8.2008, p. 30.
( 2 ) OJ L 331, 7.12.1998, p. 1.
( 5 ) OJ L 55, 28.2.2011, p. 13.
( 3 ) OJ L 218, 13.8.2008, p. 82.
( 6 ) OJ C 321, 31.12.2003, p. 1.

EN
1.7.2011 Official
Journal
of
the
European
Union L
174/91
(30) Since
the
objective
of
this
Directive,
namely
to
establish
(f) means of transport for persons or goods, excluding electric
restrictions on the use of hazardous substances in EEE,
two-wheel vehicles which are not type-approved;
cannot be sufficiently achieved by the Member States and
can therefore, by reason of the scale of the problem and
(g) non-road mobile machinery made available exclusively for
its implications in respect of other Union legislation on
professional use;
recovery and disposal of waste and areas of common
interest, such as human health protection, be better
(h) active implantable medical devices;
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.
(i) photovoltaic panels intended to be used in a system that is
In accordance with the principle of proportionality, as set
designed, assembled and installed by professionals for
out in that Article, this Directive does not go beyond
permanent use at a defined location to produce energy
what is necessary in order to achieve that objective,
from solar light for public, commercial, industrial and resi
dential applications;
HAVE ADOPTED THIS DIRECTIVE:
(j) equipment specifically designed solely for the purposes of
research and development only made available on a
Article 1
business-to-business basis.
Subject matter
Article 3
This Directive lays down rules on the restriction of the use of
hazardous substances in electrical and electronic equipment
Definitions
(EEE) with a view to contributing to the protection of human
For the purposes of this Directive, the following definitions shall
health and the environment, including the environmentally
apply:
sound recovery and disposal of waste EEE.
(1) ‘electrical and electronic equipment’ or ‘EEE’ means
Article 2
equipment which is dependent on electric currents or elec
tromagnetic fields in order to work properly and
Scope
equipment for the generation, transfer and measurement
1. This
Directive
shall,
subject
to
paragraph
2,
apply
to
EEE
of such currents and fields and designed for use with a
falling within the categories set out in Annex I.
voltage rating not exceeding 1 000 volts for alternating
current and 1 500 volts for direct current;
2. Without prejudice to Article 4(3) and 4(4), Member States
shall provide that EEE that was outside the scope of Directive
(2) for the purposes of point 1, ‘dependent ‘ means, with
2002/95/EC, but which would not comply with this Directive,
regard to EEE, needing electric currents or electromagnetic
may nevertheless continue to be made available on the market
fields to fulfil at least one intended function;
until 22 July 2019.
(3) ‘large-scale stationary industrial tools’ means a large-scale
assembly of machines, equipment, and/or components,
3. This
Directive
shall
apply
without
prejudice
to
the
functioning together for a specific application,
requirements of Union legislation on safety and health, and
permanently installed and de-installed by professionals at
on chemicals, in particular Regulation (EC) No 1907/2006, as
a given place, and used and maintained by professionals in
well as the requirements of specific Union waste management
an industrial manufacturing facility or research and devel
legislation.
opment facility;
4. This
Directive
does
not
apply
to:
(4) ‘large-scale fixed installation’ means a large-scale combi
nation of several types of apparatus and, where applicable,
(a) equipment which is necessary for the protection of the
other devices, which are assembled and installed by profes
essential interests of the security of Member States,
sionals, intended to be used permanently in a pre-defined
including arms, munitions and war material intended for
and dedicated location, and de-installed by professionals;
specifically military purposes;
(5) ‘cables’ means all cables with a rated voltage of less than
(b) equipment designed to be sent into space;
250 volts that serve as a connection or an extension to
connect EEE to the electrical outlet or to connect two or
more EEE to each other;
(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,
(6) ‘manufacturer’ means any natural or legal person who
which can fulfil its function only if it is part of that
manufactures an EEE or who has an EEE designed or
equipment, and which can be replaced only by the same
manufactured and markets it under his name or
specifically designed equipment;
trademark;
(7) ‘authorised representative’ means any natural or legal
(d) large-scale stationary industrial tools;
person established within the Union who has received a
written mandate from a manufacturer to act on his behalf
(e) large-scale fixed installations;
in relation to specified tasks;

L 174/92
EN
Official Journal of the European Union
1.7.2011
(8) ‘distributor’ means any natural or legal person in the
(21) ‘medical device’ means a medical device within the
supply chain, other than the manufacturer or the
meaning of point (a) of Article 1(2) of Directive
importer, who makes an EEE available on the market;
93/42/EEC and which is also EEE;
(9) ‘importer’ means any natural or legal person established
(22) ‘in vitro diagnostic medical device’ means an in vitro diag
within the Union, who places an EEE from a third country
nostic medical device within the meaning of point (b) of
on the Union market;
Article 1(2) of Directive 98/79/EC;
(10) ‘economic operators’ means the manufacturer, the auth
orised representative, the importer and the distributor;
(23) ‘active implantable medical device’ means any active
implantable medical device within the meaning of point
(c) of Article 1(2) of Council Directive 90/385/EEC of
(11) ‘making available on the market’ means any supply of an
20 June 1990 on the approximation of the laws of the
EEE for distribution, consumption or use on the Union
Member States relating to active implantable medical
market in the course of a commercial activity, whether
devices ( 2 );
in return for payment or free of charge;
(12) ‘placing on the market’ means making available an EEE on
(24) ‘industrial monitoring and control instruments’ means
the Union market for the first time;
monitoring and control instruments designed for
exclusively industrial or professional use;
(13) ‘harmonised standard’ means a standard adopted by one of
the European standardisation bodies listed in Annex I to
(25) ‘availability of a substitute’ means the ability of a substitute
Directive 98/34/EC of the European Parliament and of the
to be manufactured and delivered within a reasonable
Council of 22 June 1998 laying down a procedure for the
period of time as compared with the time required for
provision of information in the field of technical standards
manufacturing and delivering the substances listed in
and regulations and of rules on Information Society
Annex II;
services ( 1 ) on the basis of a request made by the
Commission in accordance with Article 6 of Directive
(26) ‘reliability of a substitute’ means the probability that an
98/34/EC;
EEE using a substitute will perform a required function
without failure under stated conditions for a stated
(14) ‘technical specification’ means a document that prescribes
period of time;
technical requirements to be fulfilled by a product, process
or service;
(27) ‘spare part’ means a separate part of an EEE that can
replace a part of an EEE. The EEE cannot function as
(15) ‘CE marking’ means a marking by which the manufacturer
intended without that part of the EEE. The functionality
indicates that the product is in conformity with the
of EEE is restored or is upgraded when the part is replaced
applicable requirements set out in Union harmonisation
by a spare part;
legislation providing for its affixing;
(16) ‘conformity assessment’ means the process demonstrating
(28) ‘non-road mobile machinery made available exclusively for
whether the requirements of this Directive relating to an
professional use’ means machinery, with an on-board
EEE, are met;
power source, the operation of which requires either
mobility or continuous or semi-continuous movement
(17) ‘market surveillance’ means the activities carried out and
between a succession of fixed working locations while
measures taken by public authorities to ensure that EEE
working, and is made available exclusively for professional
complies with the requirements set out in this Directive
use.
and does not endanger health, safety or other issues of
public interest protection;
Article 4
Prevention
(18) ‘recall’ means any measure aimed at achieving the return of
a product that has already been made available to the end
1. Member
States
shall
ensure
that
EEE
placed
on
the
market,
user;
including cables and spare parts for its repair, its reuse, updating
of its functionalities or upgrading of its capacity, does not
(19) ‘withdrawal’ means any measure aimed at preventing a
contain the substances listed in Annex II.
product in the supply chain from being made available
on the market;
2. For the purposes of this Directive, no more than the
maximum concentration value by weight in homogeneous
(20) ‘homogeneous material’ means one material of uniform
materials as specified in Annex II shall be tolerated. The
composition throughout or a material, consisting of a
Commission shall adopt, by means of delegated acts in
combination of materials, that cannot be disjointed or
accordance with Article 20 and subject to the conditions laid
separated into different materials by mechanical actions
down in Articles 21 and 22, detailed rules for complying with
such as unscrewing, cutting, crushing, grinding and
these maximum concentration values taking into account, inter
abrasive processes;
alia, surface coatings.
( 1 ) OJ L 204, 21.7.1998, p. 37.
( 2 ) OJ L 189, 20.7.1990, p. 17.

EN
1.7.2011 Official
Journal
of
the
European
Union L
174/93
3. Paragraph
1
shall
apply
to
medical
devices
and
monitoring
Decisions on the inclusion of materials and components of
and control instruments which are placed on the market from
EEE in the lists in Annexes III and IV and on the duration of
22 July 2014, to in vitro diagnostic medical devices which are
any exemptions shall take into account the availability of
placed on the market from 22 July 2016 and to industrial
substitutes and the socioeconomic impact of substitution.
monitoring and control instruments which are placed on the
Decisions on the duration of any exemptions shall take
market from 22 July 2017.
into account any potential adverse impacts on innovation.
Life-cycle thinking on the overall impacts of the exemption
4. Paragraph
1
shall
not
apply
to
cables
or
spare
parts
for
shall apply, where relevant;
the repair, the reuse, the updating of functionalities or
upgrading of capacity of the following:
(b) deletion of materials and components of EEE from the lists
(a) EEE placed on the market before 1 July 2006;
in Annexes III and IV where the conditions set out in point
(a) are no longer fulfilled.
(b) medical devices placed on the market before 22 July 2014;
2. Measures
adopted
in
accordance
with
point
(a)
of
(c) in vitro diagnostic medical devices placed on the market
paragraph 1 shall, for categories 1 to 7, 10 and 11 of Annex
before 22 July 2016;
I, have a validity period of up to 5 years and, for categories 8
(d) monitoring and control instruments placed on the market
and 9 of Annex I, a validity period of up to 7 years. The validity
before 22 July 2014;
periods are to be decided on a case-by-case basis and may be
renewed.
(e) industrial monitoring and control instruments placed on the
market before 22 July 2017;
For the exemptions listed in Annex III as at 21 July 2011, the
maximum validity period, which may be renewed, shall, for
(f) EEE which benefited from an exemption and which was
categories 1 to 7 and 10 of Annex I, be 5 years from
placed on the market before that exemption expired as far
21 July 2011 and, for categories 8 and 9 of Annex I, 7 years
as that specific exemption is concerned.
from the relevant dates laid down in Article 4(3), unless a
shorter period is specified.
5. Paragraph
1
shall
not
apply
to
reused
spare
parts,
recovered from EEE placed on the market before 1 July 2006
and used in equipment placed on the market before 1 July
For the exemptions listed in Annex IV as at 21 July 2011, the
2016, provided that reuse takes place in auditable closed-loop
maximum validity period, which may be renewed, shall be 7
business-to-business return systems, and that the reuse of parts
years from the relevant dates laid down in Article 4(3), unless a
is notified to the consumer.
shorter period is specified.
6. Paragraph
1
shall
not
apply
to
the
applications
listed
in
Annexes III and IV.
3. An
application
for
granting,
renewing
or
revoking
an
exemption shall be made to the Commission in accordance
Article 5
with Annex V.
Adaptation of the Annexes to scientific and technical
progress
4. The
Commission
shall:
1. For
the
purposes
of
adapting
Annexes
III
and
IV
to
scientific and technical progress, and in order to achieve the
(a) acknowledge receipt of an application in writing within 15
objectives set out in Article 1, the Commission shall adopt by
days of its receipt. The acknowledgement shall state the date
means of individual delegated acts in accordance with Article 20
of receipt of the application;
and subject to the conditions laid down in Articles 21 and 22,
the following measures:
(b) inform the Member States of the application without delay
and make the application and any supplementary
(a) inclusion of materials and components of EEE for specific
information supplied by the applicant available to them;
applications in the lists in Annexes III and IV, provided that
such inclusion does not weaken the environmental and
health protection afforded by Regulation (EC) No
(c) make a summary of the application available to the public;
1907/2006 and where any of the following conditions is
fulfilled:
(d) evaluate the application and its justification.
— their elimination or substitution via design changes or
materials and components which do not require any of
5. An
application
for
renewal
of
an
exemption
shall
be
made
the materials or substances listed in Annex II is scien
no later than 18 months before the exemption expires.
tifically or technically impracticable,
— the reliability of substitutes is not ensured,
The Commission shall decide on an application for renewal of
an exemption no later than 6 months before the expiry date of
— the total negative environmental, health and consumer
the existing exemption unless specific circumstances justify
safety impacts caused by substitution are likely to
other deadlines. The existing exemption shall remain valid
outweigh the total environmental, health and
until a decision on the renewal application is taken by the
consumer safety benefits thereof.
Commission.

L 174/94
EN
Official Journal of the European Union
1.7.2011
6. In
the
event
that
the
application
for
renewal
of
an During that review, the Commission shall consult interested
exemption is rejected or that an exemption is revoked, the
parties, including economic operators, recyclers, treatment
exemption shall expire at the earliest 12 months, and at the
operators, environmental organisations and employee and
latest 18 months, after the date of the decision.
consumer associations.
7. Before
Annexes
are
amended,
the
Commission
shall,
inter 2. The proposals to review and amend the list of restricted
alia, consult economic operators, recyclers, treatment operators,
substances, or a group of similar substances, in Annex II shall
environmental organisations and employee and consumer
contain at least the following information:
associations and make the comments received publicly available.
(a) precise and clear wording of the proposed restriction;
8. The
Commission
shall
adopt
a
harmonised
format
for
applications referred to in paragraph 3 of this Article as well
(b) references and scientific evidence for the restriction;
as comprehensive guidelines for such applications, taking into
account the situation of SMEs. Those implementing acts shall be
(c) information on the use of the substance or the group of
adopted in accordance with the examination procedure referred
similar substances in EEE;
to in Article 19(2).
(d) information on detrimental effects and exposure in
Article 6
particular during waste EEE management operations;
Review and amendment of list of restricted substances in
Annex II
(e) information on possible substitutes and other alternatives,
their availability and reliability;
1. With
a
view
to
achieving
the
objectives
set
out
in
Article 1 and taking account of the precautionary principle, a
review, based on a thorough assessment, and amendment of the
(f) justification for considering a Union-wide restriction as the
list of restricted substances in Annex II shall be considered by
most appropriate measure;
the Commission before 22 July 2014, and periodically
thereafter on its own initiative or following the submission of
(g) socioeconomic assessment.
a proposal by a Member State containing the information
referred to in paragraph 2.
3. The
measures
referred
to
in
this
Article
shall
be
adopted
by the Commission by means of delegated acts in accordance
The review and amendment of the list of restricted substances
with Article 20 and subject to the conditions laid down in
in Annex II shall be coherent with other legislation related to
Articles 21 and 22.
chemicals, in particular Regulation (EC) No 1907/2006, and
shall take into account, inter alia, Annexes XIV and XVII to
Article 7
that Regulation. The review shall use publicly available
knowledge obtained from the application of such legislation.
Obligations of manufacturers
Member States shall ensure that:
In order to review and amend Annex II, the Commission shall
take special account of whether a substance, including
(a) when placing EEE on the market, manufacturers ensure that
substances of very small size or with a very small internal or
it has been designed and manufactured in accordance with
surface structure, or a group of similar substances:
the requirements set out in Article 4;
(a) could have a negative impact during EEE waste management
(b) manufacturers draw up the required technical documen
operations, including on the possibilities for preparing for
tation and carry out the internal production control
the reuse of waste EEE or for recycling of materials from
procedure in line with module A of Annex II to Decision
waste EEE;
No 768/2008/EC or have it carried out;
(c) where compliance of EEE with the applicable requirements
(b) could give rise, given its uses, to uncontrolled or diffuse
has been demonstrated by the procedure referred to in point
release into the environment of the substance, or could
(b), manufacturers draw up an EU declaration of conformity
give rise to hazardous residues, or transformation or degra
and affix the CE marking on the finished product. Where
dation products through the preparation for reuse, recycling
other applicable Union legislation requires the application of
or other treatment of materials from waste EEE under
a conformity assessment procedure which is at least as
current operational conditions;
stringent, compliance with the requirements of
Article 4(1) of this Directive may be demonstrated within
the context of that procedure. A single technical documen
(c) could lead to unacceptable exposure of workers involved in
tation may be drawn up;
the waste EEE collection or treatment processes;
(d) manufacturers keep the technical documentation and the EU
(d) could be replaced by substitutes or alternative technologies
declaration of conformity for 10 years after the EEE has
which have less negative impacts.
been placed on the market;

EN
1.7.2011 Official
Journal
of
the
European
Union L
174/95
(e) manufacturers ensure that procedures are in place for series
— keep the EU declaration of conformity and the technical
production to remain in conformity. Changes in product
documentation at the disposal of national surveillance
design or characteristics and changes in the harmonised
authorities for 10 years following the placing on the
standards or in technical specifications by reference to
market of the EEE,
which conformity of EEE is declared shall be adequately
taken into account;
— further to a reasoned request from a competent national
authority, provide that authority with all the information
(f) manufacturers keep a register of non-conforming EEE and
and documentation necessary to demonstrate the
product recalls, and keep distributors informed thereof;
conformity of an EEE with this Directive,
(g) manufacturers ensure that their EEE bears a type, batch or
serial number or other element allowing its identification,
— cooperate with the competent national authorities, at
or, where the size or nature of the EEE does not allow it,
their request, on any action taken to ensure compliance
that the required information is provided on the packaging
with this Directive of EEE covered by their mandate.
or in a document accompanying the EEE;
Article 9
(h) manufacturers indicate their name, registered trade name or
Obligations of importers
registered trade mark and the address at which they can be
contacted on the EEE or, where that is not possible, on its
Member States shall ensure that:
packaging or in a document accompanying the EEE. The
address must indicate a single point at which the manu
facturer can be contacted. Where other applicable Union
(a) importers place only EEE that complies with this Directive
legislation contains provisions for the affixing of the manu
on the Union market;
facturer’s name and address which are at least as stringent,
those provisions shall apply;
(b) importers, before placing an EEE on the market, ensure that
the appropriate conformity assessment procedure has been
(i) manufacturers who consider or have reason to believe that
carried out by the manufacturer, and that they further
EEE which they have placed on the market is not in
ensure that the manufacturer has drawn up the technical
conformity with this Directive immediately take the
documentation, that the EEE bears the CE marking and is
necessary corrective measures to bring that EEE into
accompanied by the required documents, and that the
conformity, to withdraw it or recall it, if appropriate, and
manufacturer has complied with the requirements set out
immediately inform the competent national authorities of
in points (f) and (g) of Article 7;
the Member States in which they made the EEE available to
that effect, giving details, in particular, of the non-
compliance and of any corrective measures taken;
(c) where an importer considers or has reason to believe that
an EEE is not in conformity with Article 4, that importer
does not place the EEE on the market until it has been
(j) manufacturers, further to a reasoned request from a
brought into conformity, and that that importer informs
competent national authority, provide it with all the
the manufacturer and the market surveillance authorities
information and documentation necessary to demonstrate
to that effect;
the conformity of the EEE with this Directive, in a
language which can be easily understood by that authority,
and that they cooperate with that authority, at its request,
on any action taken to ensure compliance with this
(d) importers indicate their name, registered trade name or
Directive of EEE which they have placed on the market.
registered trade mark and the address at which they can
be contacted on the EEE or, where that is not possible,
on its packaging or in a document accompanying the
Article 8
EEE. Where other applicable Union legislation contains
provisions for the affixing of the importer’s name and
Obligations of authorised representatives
address which are at least as stringent, those provisions
Member States shall ensure that:
shall apply;
(a) manufacturers have the possibility to appoint an authorised
(e) importers, in order to ensure compliance with this Directive,
representative by written mandate. The obligations laid
keep a register of non-compliant EEE and EEE recalls, and
down in point (a) of Article 7 and the drawing up of
keep distributors informed thereof;
technical documentation shall not form part of the auth
orised representative’s mandate;
(f) importers who consider or have reason to believe that an
EEE which they have placed on the market is not in
(b) an authorised representative performs the tasks specified in
conformity with this Directive immediately take the
the mandate received from the manufacturer. The mandate
corrective measures necessary to bring that EEE into
shall allow the authorised representative to do at least the
conformity, to withdraw it or recall it, as appropriate, and
following:
immediately inform the competent national authorities of

L 174/96
EN
Official Journal of the European Union
1.7.2011
the Member States in which they made the EEE available to
Article 11
that effect, giving details, in particular, of the non-
compliance and of any corrective measures taken;
Cases in which obligations of manufacturers apply to
importers and distributors
Member States shall ensure that an importer or distributor is
(g) importers keep, for 10 years following the placing on the
considered a manufacturer for the purposes of this Directive
market of the EEE, a copy of the EU declaration of
and that he is subject to the obligations of the manufacturer
conformity at the disposal of the market surveillance
under Article 7, where he places EEE on the market under his
authorities and ensure that the technical documentation
name or trademark or modifies EEE already placed on the
can be made available to those authorities, upon request;
market in such a way that compliance with the applicable
requirements may be affected.
(h) importers, further to a reasoned request from a competent
Article 12
national authority, provide it with all the information and
documentation necessary to demonstrate the conformity of
Identification of economic operators
an EEE with this Directive in a language which can be easily
understood by that authority, and that they cooperate with
Member States shall ensure that economic operators, on request,
that authority, at its request, on any action taken to ensure
identify the following to the market surveillance authorities, for
compliance with this Directive of EEE which they have
10 years following the placing on the market of the EEE:
placed on the market.
(a) any economic operator who has supplied them with an EEE;
Article 10
(b) any economic operator to whom they have supplied an EEE.
Obligations of distributors
Article 13
Member States shall ensure that:
EU declaration of conformity
1. The
EU
declaration
of
conformity
shall
state
that
it
has
(a) when making an EEE available on the market, distributors
been demonstrated that the requirements specified in Article 4
act with due care in relation to the requirements applicable
have been met.
in particular by verifying that the EEE bears the CE marking,
that it is accompanied by the required documents in a
language which can be easily understood by consumers
2. The
EU
declaration
of
conformity
shall
have
the
model
and other end-users in the Member State in which the
structure and shall contain the elements specified in Annex VI
EEE is to be made available on the market, and that the
and shall be updated. It shall be translated into the language or
manufacturer and the importer have complied with the
languages required by the Member State on the market of which
requirements set out in points (g) and (h) of Article 7 and
the product is placed or made available.
in point (d) of Article 9;
Where other applicable Union legislation requires the appli
cation of a conformity assessment procedure which is at least
(b) where a distributor considers or has reason to believe that
as stringent, compliance with the requirements of Article 4(1) of
an EEE is not in conformity with Article 4, that distributor
this Directive may be demonstrated within the context of that
does not make the EEE available on the market until it has
procedure. A single technical documentation may be drawn up.
been brought into conformity, and that that distributor
informs the manufacturer or the importer as well as the
3. By
drawing
up
the
EU
declaration
of
conformity,
the
market surveillance authorities to that effect;
manufacturer shall assume responsibility for the compliance
of the EEE with this Directive.
(c) distributors who consider or have reason to believe that an
Article 14
EEE which they have made available on the market is not in
conformity with this Directive make sure that the corrective
General principles of the CE marking
measures necessary to bring that EEE into conformity, to
The CE marking shall be subject to the general principles set out
withdraw it or recall it, as appropriate, are taken and that
in Article 30 of Regulation (EC) No 765/2008.
they immediately inform the competent national authorities
of the Member States in which they made the EEE available
to that effect, giving details, in particular, of the non-
Article 15
compliance and of any corrective measures taken;
Rules and conditions for affixing the CE marking
1. The
CE
marking
shall
be
affixed
visibly,
legibly
and
(d) distributors, further to a reasoned request from a competent
indelibly to the finished EEE or to its data plate. Where that
national authority, provide it with all the information and
is not possible or not warranted on account of the nature of the
documentation necessary to demonstrate the conformity of
EEE, it shall be affixed to the packaging and to the accom
EEE with this Directive, and that they cooperate with that
panying documents.
authority, at its request, on any action taken to ensure the
compliance with this Directive of the EEE which they have
2. The
CE
marking
shall
be
affixed
before
the
EEE
is
placed
made available on the market.
on the market.

EN
1.7.2011 Official
Journal
of
the
European
Union L
174/97
3. Member
States
shall
build
upon
existing
mechanisms
to
Article 20
ensure the correct application of the regime governing the CE
marking and take appropriate action in the event of improper
Exercise of the delegation
use of the CE marking. Member States shall also provide for
1. The powers to adopt the delegated acts referred to in
penalties for infringements, which may include criminal
Article 4(2), Article 5(1) and Article 6 shall be conferred on
sanctions for serious infringements. Those penalties shall be
the Commission for a period of 5 years from 21 July 2011. The
proportionate to the seriousness of the offence and constitute
Commission shall draw up a report in respect of delegated
an effective deterrent against improper use.
powers at the latest 6 months before the end of the 5 year
period. The delegation of power shall be automatically extended
Article 16
for periods of an identical duration, unless the European
Parliament or the Council revokes it in accordance with
Presumption of conformity
Article 21.
1. In the absence of evidence to the contrary, Member States
shall presume EEE bearing the CE marking to comply with this
2. As
soon
as
it
adopts
a
delegated
act,
the
Commission
shall
Directive.
notify it simultaneously to the European Parliament and to the
Council.
2. Materials,
components
and
EEE
on
which
tests
and
measurements demonstrating compliance with the requirements
3. The
powers
to
adopt
delegated
acts
are
conferred
on
the
of Article 4 have been performed, or which have been assessed,
Commission subject to the conditions laid down in Articles 21
in accordance with harmonised standards, the references of
and 22.
which have been published in the Official Journal of the
European Union, shall be presumed to comply with the
requirements of this Directive.
Article 21
Revocation of the delegation
Article 17
1. The
delegation
of
power
referred
to
in
Article
4(2),
Formal objection to a harmonised standard
Article 5(1) and Article 6 may be revoked at any time by the
European Parliament or by the Council.
1. Where
a
Member
State
or
the
Commission
considers
that
a harmonised standard does not entirely satisfy the requirements
which it covers and which are set out in Article 4, the
2. The
institution
which
has
commenced
an
internal
Commission or the Member State concerned shall bring the
procedure for deciding whether to revoke the delegation of
matter before the Committee set up pursuant to Article 5 of
powers shall endeavour to inform the other institution and
Directive 98/34/EC, giving its arguments. The Committee shall,
the Commission within a reasonable time before the final
after consulting the relevant European standardisation bodies,
decision is taken, indicating the delegated powers which could
deliver its opinion without delay.
be subject to revocation and possible reasons for a revocation.
2. In the light of the Committee’s opinion, the Commission
3. The
decision
of
revocation
shall
put
an
end
to
the
dele
shall decide to publish, not to publish, to publish with
gation of the powers specified in that decision. It shall take
restriction, to maintain, to maintain with restriction or to
effect immediately or at a later date specified therein. It shall
withdraw the references to the harmonised standard
not affe

附件:

P020171219094611435178.pdf

触碰右侧展开