CELEX: 52011PC0773
Language: en
Date: 2011-11-21
Title: Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits

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		52011PC0773
		
			Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits /* COM/2011/0773 final - 2011/0357 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM

1.                      
context of the proposal

General context, reasons for and
objectives of this proposal 
This proposal is presented in the framework
of the implementation of the “goods package” adopted in 2008. It is part
of a package of proposals aligning ten product directives to Decision No
768/2008/EC establishing
a common framework for the marketing of products.
Union (EU) harmonisation legislation
ensuring the free movement of products has contributed considerably to the
completion and operation of the Single Market. It is based on a high level of
protection and provides economic operators with the means to demonstrate
conformity, thus ensuring free movement through trust in the products. 
Directive 2006/95/EC is an example of that
Union harmonisation legislation, ensuring the free movement of electrical
equipment. It sets out the safety objectives that electrical equipment must
comply with in order to be made available on the EU market. Manufacturers must
demonstrate that electrical equipment has been designed and manufactured in
compliance with the safety objectives and affix the CE marking. 
Experience with the implementation of Union
harmonisation legislation has shown – on a cross-sector scale - certain
weaknesses and inconsistencies in the implementation and enforcement of this
legislation, leading to
–     
the presence of non-compliant or dangerous
products on the market and consequently a certain lack of trust in CE marking
–     
competitive disadvantages for economic operators
complying with the legislation as opposed to those circumventing the rules
–     
unequal treatment in the case of non-compliant
products and distortion of competition amongst economic operators due to
different enforcement practices
–     
differing practices in the designation of
conformity assessment bodies by national authorities
Furthermore the regulatory environment has
become more and more complex, as frequently several pieces of legislation apply
simultaneously to one and the same product. Inconsistencies in these pieces of
legislation make it increasingly difficult for economic operators and
authorities to correctly interpret and apply that legislation.
To remedy these horizontal shortcomings in
Union harmonisation legislation observed across several industrial sectors, the
“New Legislative Framework” was adopted in 2008 as part of the goods
package. Its objective is to strengthen and
complete the existing rules and to improve practical aspects of their
application and enforcement. The New Legislative Framework (NLF) consists of
two complementary instruments, Regulation (EC) No 765/2008 on
accreditation and market surveillance and Decision No 768/2008/EC
establishing a common framework for the marketing of products.
The NLF Regulation has introduced rules on
accreditation (a tool for the evaluation of competence of conformity assessment
bodies) and requirements for the organisation and performance of market
surveillance and controls of products from third countries. Since 1 January
2010 these rules apply directly in all Member States.
The NLF Decision sets out a common
framework for EU product harmonisation legislation. This framework consists of
the provisions which are commonly used in EU product legislation (e.g.
definitions, obligations of economic operators, safeguard mechanisms, etc).
These common provisions have been reinforced to ensure that the directives can
be applied and enforced more effectively in practice. New elements, such as
obligations on importers, have been introduced, which are crucial for improving
the safety of products on the market. 
The provisions of the NLF Decision and
those of the NLF Regulation are complementary and closely interlinked. The NLF
Decision contains the corresponding obligations for economic operators allowing
market surveillance authorities to properly perform the tasks imposed on them
by the NLF Regulation and to ensure an effective and consistent enforcement of
EU product legislation. 
However, unlike the NLF Regulation, the
provisions of the NLF Decision are not directly applicable. To ensure that all
economic sectors subject to Union harmonisation legislation benefit from the
improvements of the NLF, the provisions of the NLF Decision need to be
integrated into the existing product legislation.
A survey after the adoption of the goods
package in 2008 showed that a majority of Union harmonisation legislation on
products was due to be revised within the following 3 years, not only to
address the problems observed throughout all sectors but also for
sector-specific reasons. Any such revision would automatically include an
alignment of the legislation concerned to the NLF Decision since Parliament, Council
and Commission have committed themselves to use its provisions as much as
possible in future legislation on products in order to further the utmost coherence
of the regulatory framework. 
For a number of other Union harmonisation
directives, including Directive 2006/95/EC no revision for sector-specific
problems had been envisaged within this timeframe. To ensure that the problems
in relation to non-compliance are nevertheless addressed in these sectors, and
for the sake of consistency of the overall regulatory environment on products,
it was decided to align these directives within a package to the provisions of
the NLF Decision.
Consistency with other policies and
objectives of the Union
This initiative is in
line with the Single Market Act[1],
which has stressed the need to restore consumer confidence in the quality of
products on the market and the importance of reinforcing market surveillance.
Furthermore it supports
the Commission’s policy on Better Regulation and simplification of the
regulatory environment.

2.                      
consultation of interested parties and impact
assessment

Consultation of interested parties
The alignment of Directive 2006/95/EC to
the NLF Decision has been discussed with national experts responsible for the
implementation of this Directive, the administrative cooperation group as well
as in bilateral meetings with industry associations.
From June to October 2010 a public
consultation was organised that comprised all the sectors involved in this
initiative. It consisted of four targeted questionnaires for economic
operators, authorities, notified bodies and users and the Commission services
received 300 replies. The results are published at: 
http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm
In addition to the general consultation a
specific SME consultation was carried out. 603 SMEs were consulted through the
Enterprise Europe Network in May/June 2010. The results are available at http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-framework/smes_statistics_en.pdf
The consultation process revealed
widespread support for the initiative. There is unanimity on the need to
improve market surveillance and the system for assessing and monitoring
Notified Bodies. Authorities fully support the exercise because it will
strengthen the existing system and improve cooperation at EU level. Industry
expects a more level playing field resulting from more effective actions
against products that do not comply with the legislation, as well as a
simplification effect from the alignment of legislation. Certain concerns were
expressed on some obligations which are, however, indispensable for increasing
the efficiency of market surveillance. These measures will not entail
significant costs for industry, and the benefits resulting from improved market
surveillance should by far outweigh the costs. 
Collection and use of expertise
The impact assessment for this
implementation package has largely built on the impact assessment carried out
for the New Legislative Framework. In addition to the expertise collected and
analysed in that context, further consultation of sector-specific experts and
interest groups, as well as horizontal experts active in the area of technical
harmonisation, conformity assessment, accreditation and market surveillance,
has taken place.
Impact assessment 
Based on the information collected, the
Commission carried out an impact assessment which examined and compared three
options.
Option 1 - No changes to the current
situation
This option proposes no changes to the
current directive and relies exclusively on certain improvements that can be
expected from the NLF Regulation.
Option 2 – Alignment to the NLF Decision
by non-legislative measures
Option 2 considers the possibility of
encouraging a voluntary alignment to the provisions set out in the NLF Decision
by, e.g., presenting them as best practices in guidance documents.
Option 3 – Alignment to NLF Decision by
legislative measures
This option consists in integrating the
provisions of the NLF Decision into the existing Directive.
Option 3 was found
to be the preferred option because
–     
it will improve the competitiveness of companies
taking their obligations seriously, as opposed to those cheating on the system;
–     
it will improve the functioning of the internal
market by ensuring equal treatment of all economic operators, notably importers
and distributors;
–     
it does not entail significant costs for
economic operators; for those who are already acting responsibly, no extra
costs or only negligible costs are expected;
–     
it is considered more effective than option 2:
due to the lack of enforceability of option 2 it is questionable that the
positive impacts would materialise under that option;
–     
options 1 and 2 do not provide answers to the
problem of inconsistencies in the regulatory framework and therefore have no
positive impact on the simplification of the regulatory environment.

3.                      
Main elements of the proposal
3.1.                
Horizontal definitions

The proposal
introduces harmonised definitions of terms which are commonly used throughout
Union harmonisation legislation and should therefore be given a consistent
meaning throughout that legislation. 

3.2.                
Obligations of economic operators and
traceability requirements

The proposal clarifies the obligations of
manufacturers and authorised representatives and introduces obligations for
importers and distributors. Importers must verify that the manufacturer has
carried out the applicable conformity assessment procedure and has drawn up a
technical documentation. They must also make sure with the manufacturer that
this technical documentation can be made available to authorities upon request.
Furthermore importers must verify that the electrical equipment is correctly
marked and accompanied by the required safety information. They must keep a
copy of the EU declaration of conformity and indicate their name and address on
the product, or where this is not possible on the packaging or the accompanying
documentation. Distributors must verify that electrical equipment bears the CE
marking, the name of the manufacturer and of the importer, if relevant, and
that it is accompanied by the required documentation and instructions.
Importers and distributors must cooperate
with market surveillance authorities and take appropriate actions when they
have supplied non-compliant electrical equipment.
Enhanced traceability obligations are introduced for all economic operators. Electrical equipment has
to bear the manufacturer’s name and address and a number allowing to identify
and link the electrical equipment to its technical documentation. When electrical
equipment is imported the importer’s name and address must also be on the
electrical equipment. Furthermore every economic operator must be able to
identify towards authorities the economic operator who has supplied him with
electrical equipment or to whom he has supplied electrical equipment.

3.3.                
Harmonised standards

Compliance with harmonised standard
provides a presumption of conformity with the essential requirements. On 1 June
2011 the Commission adopted a proposal for a Regulation on European Standardisation[2] that sets out a horizontal
legal framework for European standardisation. The proposal for the Regulation
contains inter alia provisions on standardisation requests from the Commission
to the European Standardisation Organisations, on the procedure for objections
to harmonised standards and on stakeholder participation in the standardisation
process. Consequently the provisions of Directive 2006/95/EC which cover the
same aspects have been deleted in this proposal for reasons of legal certainty.

The provision conferring presumption of
conformity to harmonised standards has been modified to clarify the extent of
the presumption of conformity when standards only partially cover the essential
requirements.

3.4.                
Conformity assessment and CE marking

Directive 2006/95/EC has selected the
appropriate conformity assessment procedure which manufacturers have to apply
in order to demonstrate that their electrical equipment comply with the safety
objectives. The proposal aligns these procedures to their updated versions set
out in the NLF Decision. It also introduces a model for the EU declaration of
conformity.
General principles of the CE marking are
set out in Article 30 of Regulation 765/2008, while the detailed provisions on
the affixing of the CE marking to electrical equipment have been inserted in this proposal.

3.5.                
Market surveillance and the safeguard clause
procedure

The proposal revises the existing safeguard
clause procedure. It introduces a phase of information exchange between Member
States, and specifies the steps to be taken by the authorities concerned, when
a non-compliant electrical equipment is found. A real safeguard clause
procedure – leading to a Decision at Commission level on whether a measure is
justified or not - is only launched when another Member State objects to a
measure taken against an electrical equipment. Where there is no disagreement
on the restrictive measure taken, all Member States must take the appropriate
action on their territory.

4.                      
legal elements of the proposal

Legal basis
The proposal is based on Article 114 of the
Treaty on the Functioning of the European Union.
Subsidiarity principle
The internal market is a competence that is
shared between the Union and the Member States. The subsidiarity principle
arises in particular with regard to the newly added provisions aiming at the
improvement of effective enforcement of Directive 2006/95/EC namely, the
importer and distributor obligations, the traceability provisions, the
provisions on the assessment, and the enhanced cooperation obligations in the
context of the revised market surveillance and safeguard procedures. 
Experience with the enforcement of the
legislation has shown that measures taken at national level have led to
divergent approaches and to a different treatment of economic operators inside
the EU, which undermines the objective of this directive. If actions are taken
at national level to address the problems, this risks creating obstacles to the
free movement of goods. Furthermore action at national level is limited to the
territorial competence of a Member State. In view of the increasing
internationalisation of trade, the number of cross-border cases is constantly
rising. Coordinated action at EU level can much better achieve the objectives
set, and will in particular render market surveillance more effective. Hence it
is more appropriate to take action at EU level.
As regards the problem of inconsistencies
throughout the directives, this is a problem which can only be solved by the EU
legislator.
Proportionality
In accordance with the principle of
proportionality, the proposed modifications do not go beyond what is necessary
to achieve the objectives set. 
The new or modified obligations do not
impose unnecessary burdens and costs on industry - especially on small and medium
sized enterprises - or administrations. Where modifications have been identified
to have negative impacts, the analysis of the impacts of the option serves to
provide the most proportionate response to the problems identified. A number of
modifications concern the improvement of clarity of the existing Directive
without introducing new requirements that entail added cost. 
Legislative technique used
The alignment to the NLF Decision requires
a number of substantive amendments to the provisions of Directive 2006/95/EC. To
ensure the readability of the amended text the technique of recasting has been
chosen in line with the Interinstitutional Agreement of 28 November 2001 on a
more structured use of the recasting technique for legal acts[3]. 
The changes made to the provisions of
Directive 2006/95/EC concern: the definitions, the obligations of economic
operators, the presumption of conformity provided by harmonised standards, the
declaration of conformity, CE marking, the safeguard clause procedure and the conformity
assessment procedures.
The proposal does not change the scope and
the safety objectives of Directive 2006/95. 

5.                      
budgetary implications

This proposal does not have any
implications for the EU budget.

6.                      
additional information

Repeal of existing legislation
The adoption of the proposal will lead to
repeal of Directive 2006/95/EC.
European Economic Area
The proposal concerns the EEA and should
therefore be extended to the European Economic Area.
ê 2006/95
(adapted)
2011/0357 (COD)
Proposal for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
on the harmonisation of the laws of Member
States relating to Öthe making
available on the market ofÕ electrical
equipment designed for use within certain voltage limits 
(Recast)

(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European
Community Ö on the
Functioning of the European Union Õ , and in particular
Article 95
Ö 114 Õ 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[4],
Acting in accordance with the ordinary
legislative procedure,
Whereas:
ò new
(1)              
A
number of substantive changes are to be made to Directive 2006/95/EC of the European Parliament and
of the Council of 12 December 2006 on the harmonisation of the laws of Member
States relating to electrical equipment designed for use within certain voltage
limits[5]. In the interests of clarity, that Directive
should be recast.
(2)              
Regulation (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 and repealing Regulation (EEC) No 339/93[6] lays down rules on the accreditation
of conformity assessment bodies, provides a framework for the market
surveillance of products and for controls of products from third countries, and
lays down the general principles of the CE marking.
(3)              
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 and repealing Council Decision
93/465/EEC[7]
lays down a common framework of general principles and reference provisions
intended to apply across the legislation harmonising the conditions for the
marketing of products in order to provide a coherent basis for revision or
recasts of that legislation. Directive 2006/95/EC should therefore be adapted
to that Decision. 
ê 2006/95 recital 1 (adapted)
Council Directive 73/23/EEC of 19 February
1973 on the harmonisation of the laws of Member States relating to
electrical equipment designed for use within certain voltage limits [8] has
been substantially amended[9]. In the
interests of clarity and rationality the said Directive should be codified.
ê 2006/95 recital
2 
The provisions in
force in the Member States designed to ensure safety in the use of electrical
equipment used within certain voltage limits may differ, thus impeding trade.
ê 2006/95
recital 3
In certain Member
States in respect of certain electrical equipment, the safety legislation
takes the form of preventive and repressive measures by means of binding
provisions.
ê 2006/95
recital 4 
In other Member
States in order to achieve the same objective, the safety legislation
provides for reference to technical standards laid down by Standards Bodies.
Such a system offers the advantage of rapid adjustment to technical progress
without neglecting safety requirements.
ê 2006/95 recital
5
Certain Member
States carry out administrative operations to approve standards. Such
approval neither affects the technical content of the standards in any way nor
limits their conditions of use. Such approval cannot therefore alter the
effects, from a Community point of view, of
harmonised and published standards.
ê 2006/95
recital 6 
Within the
Community, the free movement of electrical equipment should follow when this
equipment complies with certain safety requirements recognised in all Member
States. Without prejudice to any other form of proof, the proof of
compliance with these requirements may be established by reference to
harmonised standards which incorporate these conditions. These harmonised
standards should be established by common agreement by bodies to be notified by each Member State to the
other Member States and to the Commission and should be publicised as widely as
possible. Such harmonisation should, for the purposes of trade, eliminate the
inconveniences resulting from differences between national standards
ê 2006/95 recital
7
Without prejudice
to any other form of proof, the compliance of electrical equipment with the
harmonised standards may be presumed from the affixing or issue of marks or
certificates by the competent organisations or, in the absence thereof, from
a manufacturer's declaration of compliance. In order to facilitate the removal
of barriers to trade, the Member States should recognise such marks or
certificates or such declaration as elements of proof. With this end in view, the said marks or certificates
should be publicised in particular by their publication in the Official Journal of the European Union.
ò new 
(4)              
Economic operators
should be responsible for the compliance of electrical equipment in relation to
their respective roles in the supply chain, so as to ensure a high level of
protection of public interests, such as health and safety, and the protection
of consumers and to guarantee fair competition on the Union market.
(5)              
All economic operators
intervening in the supply and distribution chain should take the appropriate
measures to ensure that they only make available on the market electrical
equipment which is in conformity with this Directive. It is necessary to
provide for a clear and proportionate distribution of obligations which
correspond to the role of each operator in the supply and distribution process.
(6)              
The manufacturer,
having detailed knowledge of the design and production process, is best placed
to carry out the complete conformity assessment procedure for electrical
equipment. Conformity assessment should therefore remain the obligation of the
manufacturer alone.
(7)              
Although conformity
assessment should be the responsibility of the manufacturer without any need to
involve an independent conformity assessment body, in order to facilitate the
completion of the conformity assessment procedure, manufacturers should be
allowed to seek assistance of an independent conformity assessment laboratory.
(8)              
It is necessary to
ensure that electrical equipment from third countries entering the Union market
comply with the requirements of this Directive, and in particular that
appropriate assessment procedures have been carried out by manufacturers with
regard to this electrical equipment. Provision should therefore be made for
importers to make sure that electrical equipment they place on the market
comply with the requirements of this Directive and that they do not place on
the market electrical equipment which does not comply with such requirements or
present a risk. Provision should also be made for importers to make sure that
conformity assessment procedures have been carried out and that product marking
and documentation drawn up by manufacturers are available for inspection by the
supervisory authorities.
(9)              
The distributor makes
electrical equipment available on the market after it has been placed on the
market by the manufacturer or the importer and should act with due care to
ensure that its handling of electrical equipment does not adversely affect the
compliance of the electrical equipment.
(10)          
When placing
electrical equipment on the market, every importer should indicate on the
electrical equipment his name and the address at which he can be contacted.
Exceptions should be provided for in cases where the size or nature of the electrical
equipment does not allow it. This includes cases where the importer would have
to open the packaging to put his name and address on the product.
(11)          
Any economic operator
that either places electrical equipment on the market under his own name or
trademark or modifies electrical equipment in such a way that compliance with
the requirements of this Directive may be affected should be considered to be
the manufacturer and should assume the obligations of the manufacturer.
(12)          
Distributors and
importers, being close to the market place, should be involved in market
surveillance tasks carried out by the competent national authorities, and
should be prepared to participate actively, providing those authorities with
all necessary information relating to the electrical equipment concerned.
(13)          
Ensuring traceability
of electrical equipment throughout the whole supply chain helps to make market
surveillance simpler and more efficient. An efficient traceability system
facilitates market surveillance authorities' task of tracing economic operators
who made non-compliant products available on the market.
(14)          
This Directive should
be limited to the expression of the safety objectives. In order to facilitate
conformity assessment with those objectives it is necessary to provide for
presumption of conformity for electrical equipment which is in conformity with
harmonised standards that are adopted in accordance with Regulation (EU) No
[../..] of the European Parliament and of the Council of […..] on European
Standardisation and amending
Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and
2009/23/EC of the European Parliament and of the Council for the purpose of expressing detailed
technical specifications of those objectives. 
(15)          
Regulation (EU) No
[../..] [on European Standardisation] provides for a procedure for objections
to harmonised standards where those standards do not entirely satisfy
requirements of this Directive.
ê 2006/95
recital 8 (adapted) 
ð new
(16)          
As a transitional measure, tThe free movement of electrical
equipment for which harmonised standards do not yet exist shouldmay be achieved by
applying the safety provisions or standards already
laid down by ð the International Electrotechnical
Commission ï other international bodies or by one of the bodies which establish harmonised
standards Öapplying
national standards Õ . 
ê 2006/95
recital 9
It is possible
that electrical equipment may be placed in free circulation even though it does
not comply with the safety requirements, and it is therefore desirable to lay
down suitable provisions to minimise this danger
ê 2006/95
recital 10 (new)
Council Decision
93/465/EEC[10] establishes the modules for the various phases of
the conformity assessment procedures which are intended to be used in the
technical harmonisation Directives.
ê 2006/95
recital 11
The choice of
procedures should not lead to a lowering of safety standards of electrical
equipment, which have already been established throughout the Community.
ò new
(17)          
In order to enable
economic operators to demonstrate and the competent authorities to ensure that electrical
equipment made available on the market is in conformity with the safety objectives
it is necessary to provide for conformity assessment procedures. Decision No
768/2008/EC establishes modules for conformity assessment procedures, which
include procedures from the least to the most stringent, in proportion to the
level of risk involved and the level of safety required. In order to ensure
inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment
procedures should be chosen from among those modules.
(18)          
Manufacturers should
draw up an EU declaration of conformity to provide detailed information on the
conformity of electrical equipment with the requirements of this Directive and
of the other relevant Union harmonisation legislation. 
(19)          
The CE marking,
indicating the conformity of electrical equipment, is the visible consequence
of a whole process comprising conformity assessment in a broad sense. General
principles governing the CE marking are set out in Regulation (EC) No 765/2008.
Rules governing the affixing of the CE marking should be laid down in this Directive.
(20)          
In order to ensure
legal certainty, it is necessary to clarify that rules on Union market
surveillance and control of products entering the Union market provided for in
Regulation (EC) No 765/2008 apply to electrical equipment. This Directive
should not prevent Member States from choosing the competent authorities that
carry out those tasks. 
(21)          
Directive 2006/95/EC
already provides for a safeguard procedure which applies only in the event of
disagreement between Member States over measures taken by a Member State. In
order to increase transparency and to reduce processing time, it is necessary
to improve the existing safeguard clause procedure, with a view to making it
more efficient and drawing on the expertise available in Member States.
(22)          
The existing system
should be supplemented by a procedure under which interested parties are
informed of measures intended to be taken with regard to products presenting a
risk to the health and safety of persons or to other aspects of public interest
protection. It should also allow market surveillance authorities, in
cooperation with the relevant economic operators, to act at an earlier stage in
respect of such products.
(23)          
Where the Member
States and the Commission agree as to the justification of a measure taken by a
Member State, no further involvement of the Commission should be required,
except where non-compliance can be attributed to shortcomings of a harmonised
standard.
(24)          
Member States should lay
down rules on penalties applicable to infringements of the national provisions
adopted pursuant to this Directive and ensure that they are implemented. Those
penalties should be effective, proportionate and dissuasive. 
(25)          
It
is necessary to provide for transitional arrangements that allow making
available on the market electrical equipment which has already been placed on
the market in accordance with Directive 2006/95/EC.
(26)          
Since
the objective of this Directive, namely to ensure that electrical equipment on
the market fulfil the requirements providing a high level of protection of
health and safety and other public interests while guaranteeing the functioning
of the internal market cannot be sufficiently achieved by the Member States and
can therefore, by reason of its scale and effects, 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.
(27)          
The
obligation to transpose this Directive into national law should be confined to
those provisions which represent a substantive change as compared with the
Directive 2006/95/EC. The obligation to transpose the provisions
which are unchanged arises under the earlier Directive. 
ê 2006/95
recital 12 (adapted)
(28)          
This Directive should be without prejudice to
the obligations of the Member States relating to the time-limits for
transposition into national law and application of the Directives set out in Part B of Annex V to Directive 2006/95/EC, Part B,
ê 2006/95
(adapted)
HAVE ADOPTED THIS DIRECTIVE:
Chapter 1
Ö General
provisions Õ
Article 1
Ö Scope Õ
For the purposes of tThis
Directive, Ö shall apply
to Õ ‘electrical
equipment’ means any equipment designed for
use with a voltage rating of between 50 and 1000 V for alternating current
and between 75 and 1500 V for direct current, other than the
equipment and phenomena listed in Annex II.
ò new
Article 2
[Article R1 of Decision No 768/2008/EC]
Definitions
For the
purposes of this Directive, the following definitions apply:
(1)              
"placing on the
market" means the first making available of electrical equipment on the
Union market;
(2)              
"making available
on the market" means any supply of electrical equipment for distribution,
consumption or use on the Union market in the course of a commercial activity,
whether in return for payment or free of charge;
(3)              
"manufacturer"
means any natural or legal person who manufactures electrical equipment or has
electrical equipment designed or manufactured, and markets that equipment under
his name or trademark;
(4)              
"authorised
representative" means any natural or legal person established within the
Union who has received a written mandate from a manufacturer to act on his behalf
in relation to specified tasks;
(5)              
"importer"
means any natural or legal person established within the Union who places
electrical equipment from a third country on the Union market;
(6)              
"distributor"
means any natural or legal person in the supply chain, other than the
manufacturer or the importer, who makes electrical equipment available on the
market;
(7)              
"economic
operators" means the manufacturer, the authorised representative, the
importer and the distributor;
(8)              
"technical
specification" means a document that prescribes technical requirements to
be fulfilled by an electrical equipment;
(9)              
"harmonised
standard" means harmonised standard as defined in Article 2(1)(c) of
Regulation (EU) No [../..] [on European Standardisation];
(10)          
"conformity
assessment" means the process demonstrating whether the safety objectives
relating to electrical equipment have been fulfilled;
(11)          
"recall"
means any measure aimed at achieving the return of electrical equipment that
has already been made available to the end user;
(12)          
"withdrawal"
means any measure aimed at preventing electrical equipment in the supply chain
from being made available on the market;
(13)          
"CE marking"
means a marking by which the manufacturer indicates that the electrical
equipment is in conformity with the applicable requirements set out in Union
harmonisation legislation providing for its affixing;
(14)          
"Union
harmonisation legislation" means any Union legislation harmonising the
conditions for the marketing of products.
ê 2006/95
(adapted)
ð new
Article 32
Ö Making available on the market and
safety objectives Õ
1. The Member States shall take all appropriate
measures to ensure that eElectrical equipment may be ð made available ï placed on the market only
if, having been constructed in accordance with good engineering practice in
safety matters in force in the Community Ö Union Õ, it does not
endanger the safety of persons, domestic animals or property when properly
installed and maintained and used in applications for which it was made.
ê 2006/95
2. The principal elements of the safety
objectives referred to in paragraph 1 are listed in Annex I.
ê 2006/95
(adapted)
Article 43
Ö Free movement Õ
The Member States shall take all
appropriate measures to ensure that if electrical equipment is of such a nature
as to comply with Article 2,
subject to the conditions laid down in Articles 5, 6, 7 or 8
Ö this Directive Õ, the free
movement thereof within the Community Ö Union Õ shall not be
impeded for reasons
of safety Ö the
aspects covered by this Directive Õ.
Article 54
Ö Supply of electricity Õ
In relation to electrical equipment, the
Member States shall ensure that stricter safety requirements than those laid
down in Article m2 3Ö and Annex
I Õ are not
imposed by electricity supply bodies for connection to the grid, or for the
supply of electricity to users of electrical equipment.
Chapter
2
Ö Obligations
of economic operators Õ
ê 2006/95
Article 5
The Member States
shall take all appropriate measures to ensure that, in particular,
electrical equipment which complies with the safety provisions of harmonised
standards shall be regarded by their competent administrative authorities as
complying with the provisions of Article 2, for the purposes of placing on the market and free movement as
referred to in Articles 2 and 3 respectively.
Standards shall be
regarded as harmonised once they are drawn up by common agreement between the
bodies notified by the Member States in accordance with Article 11, first
paragraph, point (a), and published under national procedures. The
standards shall be kept up to date in the light of technological progress and
the developments in good engineering practice in safety matters.
For purposes of
information the list of harmonised standards and their references shall be
published in the Official
Journal of the European Union.
ò new
Article 6
[Article R2 of Decision No 768/2008/EC]
Obligations of manufacturers
1. When
placing electrical equipment on the market, manufacturers shall ensure that it
has been designed and manufactured in accordance with Article 3 and Annex I.
2.
Manufacturers shall draw up the technical documentation referred to in Annex
III and carry out the conformity assessment procedure referred to in Annex III or
have it carried out.
Where
compliance of electrical equipment with the applicable requirements has been
demonstrated by the procedure referred to in the first subparagraph,
manufacturers shall draw up an EU declaration of conformity and affix the CE
marking.
3.
Manufacturers shall keep the technical documentation and the EU declaration of
conformity for a period of 10 years after the electrical equipment has been
placed on the market.
4.
Manufacturers shall ensure that procedures are in place for series production
to remain in conformity. Changes in product design or characteristics and
changes in the harmonised standards or in technical specifications by reference
to which conformity of electrical equipment is declared shall be adequately
taken into account.
When deemed
appropriate with regard to the risks presented by electrical equipment,
manufacturers shall, to protect the safety of consumers, carry out sample
testing of electrical equipment made available on the market, investigate, and,
if necessary, keep a register of complaints, of non-conforming electrical
equipment and electrical equipment recalls, and shall keep distributors
informed of any such monitoring.
5.
Manufacturers shall ensure that electrical equipment bear a type, batch or
serial number or other element allowing its identification, or, where the size
or nature of the electrical equipment does not allow it, that the required
information is provided on the packaging or in a document accompanying the
electrical equipment.
6.
Manufacturers shall indicate their name, registered trade name or registered
trade mark and the address at which they can be contacted on the electrical
equipment or, where that is not possible, on its packaging or in a document
accompanying the electrical equipment. The address must indicate a single point
at which the manufacturer can be contacted. 
7.
Manufacturers shall ensure that the electrical equipment is accompanied by
safety information in a language which can be easily understood by consumers
and other end-users, as determined by the Member State concerned.
8.
Manufacturers who consider or have reason to believe that electrical equipment
which they have placed on the market is not in conformity with this Directive
shall immediately take the necessary corrective measures to bring that
electrical equipment into conformity, to withdraw it or recall it, if
appropriate. Furthermore, where the electrical equipment presents a risk,
manufacturers shall immediately inform the competent national authorities of
the Member States in which they made the electrical equipment available to that
effect, giving details, in particular, of the non-compliance and of any
corrective measures taken.
9. Manufacturers
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of the electrical equipment, in a language which can be easily
understood by that authority. They shall cooperate with that authority, at its
request, on any action taken to eliminate the risks posed by electrical
equipment which they have placed on the market. 
Article 7
[Article R3 of Decision No 768/2008/EC]
Authorised representatives
1. A manufacturer
may, by a written mandate, appoint an authorised representative.
The obligations
laid down in Article 6(1) and the drawing up of technical documentation shall
not form part of the authorised representative's mandate.
2. An authorised
representative shall perform the tasks specified in the mandate received from
the manufacturer. The mandate shall allow the authorised representative to do
at least the following:
(a)              
keep the EU
declaration of conformity and the technical documentation at the disposal of
national surveillance authorities for a period of 10 years after the electrical
equipment has been placed on the market;
(b)              
further to a reasoned
request from a competent national authority, provide that authority with all
the information and documentation necessary to demonstrate the conformity of
electrical equipment;
(c)              
cooperate with the
competent national authorities, at their request, on any action taken to
eliminate the risks posed by electrical equipment covered by the authorised
representative's mandate.
Article 8
[Article R4 of Decision No 768/2008/EC]
Obligations of importers
1. Importers
shall place only compliant electrical equipment on the market.
2. Before
placing electrical equipment on the market importers shall ensure that the
appropriate conformity assessment procedure has been carried out by the
manufacturer. They shall ensure that the manufacturer has drawn up the
technical documentation, that the electrical equipment bears the CE marking and
is accompanied by the required documents, and that the manufacturer has
complied with the requirements set out in Article 6(5) and (6).
Where an
importer considers or has reason to believe that electrical equipment is not in
conformity with Article 3 and Annex I, he shall not place the electrical
equipment on the market until it has been brought into conformity. Furthermore,
where the electrical equipment presents a risk, the importer shall inform the
manufacturer and the market surveillance authorities to that effect.
3. Importers
shall indicate their name, registered trade name or registered trade mark and
the address at which they can be contacted on the electrical equipment or,
where that is not possible, on its packaging or in a document accompanying the
electrical equipment. 
4. Importers
shall ensure that the electrical equipment is accompanied by safety information
in a language which can be easily understood by consumers and other end-users,
as determined by the Member State concerned.
5. Importers
shall ensure that, while electrical equipment is under their responsibility,
storage or transport conditions do not jeopardize its compliance with the
safety objectives set out in Article 3 and Annex I.
6. When
deemed appropriate with regard to the risks presented by electrical equipment,
importers shall, to protect the safety of consumers, carry out sample testing
of electrical equipment made available on the market, investigate and, if
necessary, keep a register of complaints, of non-conforming electrical
equipment and electrical equipment recalls, and shall keep distributors
informed of such monitoring.
7. Importers
who consider or have reason to believe that electrical equipment which they
have placed on the market is not in conformity with this Directive shall
immediately take the corrective measures necessary to bring that electrical
equipment into conformity, to withdraw it or recall it, if appropriate.
Furthermore, where the electrical equipment presents a risk, importers shall
immediately inform the competent national authorities of the Member States in
which they made the electrical equipment available to that effect, giving
details, in particular, of the non-compliance and of any corrective measures
taken.
8. Importers
shall, for a period of 10 years after the electrical equipment has been placed
on the market, keep a copy of the EU declaration of conformity at the disposal
of the market surveillance authorities and ensure that the technical
documentation can be made available to those authorities, upon request.
9. Importers
shall, further to a reasoned request from a competent national authority, provide
it with all the information and documentation necessary to demonstrate the
conformity of electrical equipment in a language which can be easily understood
by that authority. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by electrical equipment which
they have placed on the market.
Article 9[Article
R5 of Decision No 768/2008/EC]
Obligations of distributors
1. When
making electrical equipment available on the market distributors shall act with
due care in relation to the requirements of this Directive.
2. Before
making electrical equipment available on the market distributors shall verify
that the electrical equipment bears the CE marking, that it is accompanied by
the safety information in a language which can be easily understood by
consumers and other end-users in the Member State in which the electrical
equipment is to be made available on the market, and that the manufacturer and
the importer have complied with the requirements set out in Article 6(5) and
6(6) and Article 8 (3). 
Where a
distributor considers or has reason to believe that electrical equipment is not
in conformity with the requirements set out in Article 3 and Annex I, he shall
not make the electrical equipment available on the market until it has been
brought into conformity. Furthermore, where the electrical equipment presents a
risk, the distributor shall inform the manufacturer or the importer to that
effect as well as the market surveillance authorities.
3.
Distributors shall ensure that, while electrical equipment is under their
responsibility, storage or transport conditions do not jeopardise its
compliance with the requirements set out in Article 3 and Annex I.
4.
Distributors who consider or have reason to believe that electrical equipment
which they have made available on the market is not in conformity with this
Directive shall make sure that the corrective measures necessary to bring that
equipment into conformity, to withdraw it or recall it, if appropriate, are taken.
Furthermore, where the electrical equipment presents a risk, distributors shall
immediately inform the competent national authorities of the Member States in
which they made the electrical equipment available to that effect, giving
details, in particular, of the non-compliance and of any corrective measures
taken.
5.
Distributors shall, further to a reasoned request from a competent national
authority, provide it with all the information and documentation necessary to
demonstrate the conformity of electrical equipment. They shall cooperate with
that authority, at its request, on any action taken to eliminate the risks
posed by electrical equipment which they have made available on the market.
Article 10 [Article R6 of Decision No 768/2008/EC]
Cases in which obligations of manufacturers apply to
importers and distributors
An importer
or distributor shall be considered a manufacturer for the purposes of this
Directive and he shall be subject to the obligations of the manufacturer under
Article 6, where he places electrical equipment on the market under his name or
trademark or modifies electrical equipment already placed on the market in such
a way that compliance with the requirements of this Directive may be affected.
Article 11
[Article R7 of Decision No 768/2008/EC]
Identification of economic operators
Economic
operators shall, on request, identify the following to the market surveillance
authorities:
(a)        any
economic operator who has supplied them with electrical equipment;
(b)        any
economic operator to whom they have supplied electrical equipment.
Economic
operators shall be able to present the information referred to in the first
paragraph for a period of 10 years after they have been supplied with the
electrical equipment and for a period of 10 years after they have supplied the
electrical equipment.
Chapter 3
Conformity of
the electrical equipment
Article 12
[Article R8 of Decision No 768/2008/EC]
Presumption of conformity with harmonised standards
Electrical
equipment which is in conformity with harmonised standards or parts thereof the
references of which have been published in the Official Journal of the
European Union shall be presumed to be in conformity with the safety objectives
covered by those standards or parts thereof, set out in Article 3 and Annex I. 
[Where a
harmonised standard satisfies the requirements which it covers and which are
set out in Article 3 and Annex I, the Commission shall publish the references
of those standards in the Official Journal of the European Union.]
ê 2006/95
(adapted)
ð new
Article 136
Ö Presumption of conformity with international standards Õ
1. Where harmonised standards as defined Ö referred
to Õ in
Article 125
have not yet been drawn up and
published, the Member States shall take all appropriate measures to ensure
that, for the purposes of placing
ð making available ï on the market or free movement as referred to in Articles 23 and 34 respectively, their competent
administrative authorities shall also regard as complying with the provisions of
Article 32
Ö and Annex
I Õ electrical
equipment which complies with the safety provisions of the International Commission on the Rules for
the Approval of Electrical Equipment (CEE)
or of the
International Electrotechnical Commission (IEC) in respect of
which the publication procedure laid down in paragraphs 2 and 3 of this
Article has been applied
2. The safety provisions referred to in
paragraph 1 shall be notified to the Member States by the Commission as from the entry into
force of this Directive, and thereafter as and when they are published.
The Commission, after consulting the Member States, shall state the provisions
and in particular the variants which it recommends to be published.
3. The Member States shall inform the
Commission within a period of three months of such Ö any Õ objections as they
may have to the provisions thus notified Ö in
accordance with paragraph 2 Õ, stating the
safety grounds on account of which the provisions should not be recognised.
For purposes of information those Ö the Õ safety
provisions against which no objection has been raised shall be published in the
Official Journal of the European Union.
Article 147
Ö Presumption of conformity with
national standards Õ
Where harmonised standards within the meaning of
Ö referred
to in Õ Article 5
12 or safety provisions published in accordance with Ö referred
to in Õ Article 613 are not yet in existence, the Member
States shall take all appropriate measures to ensure that, for the purpose of placing ð making available ï on the market or free movement as referred to in Articles 23 and 34 respectively, their competent
administrative authorities shall also regard as complying with the provisions of
Article 23Ö and Annex
I Õ electrical
equipment manufactured in accordance with the safety provisions of the
standards in force in the Member State of manufacture, if it ensures a safety
level equivalent to that required in their own territory.
ê 2006/95
Article 8
1. Before being
placed on the market, the electrical equipment must have affixed to it the
CE marking provided for in Article 10 attesting to its conformity to
the provisions of this Directive, including the conformity assessment
procedure described in Annex IV.
2. In the event of
a challenge, the manufacturer or importer may submit a report, drawn up by a
body, which is notified in accordance with Article 11, first paragraph,
point (b), on the conformity of the electrical equipment with the
provisions of Article 2.
3. Where
electrical equipment is subject to other Directives concerning other aspects
which also provide for the affixing of the CE marking, the latter shall
indicate that the equipment in question is also presumed to conform to the
provisions of those other Directives.
However, where one
or more of these Directives allow the manufacturer, during a transitional
period, to choose which arrangements to apply, the CE marking shall indicate
conformity to the provisions only of those Directives applied by the
manufacturer. In this case, particulars of the Directives applied, as published
in the Official
Journal of the European Union, must be given in the documents, notices or
instructions required by the Directives and accompanying the electrical
equipment.
Article 9
1. If, for safety
reasons, a Member State prohibits the placing on the market of any electrical
equipment or impedes its free movement, it shall immediately inform the other
Member States concerned and the Commission, indicating the grounds for
its decision and stating in particular:
              (a)
whether its non-conformity with Article 2 is attributable to a shortcoming
in the harmonised standards referred to in Article 5, the provisions
referred to in Article 6 or the standards referred to in
Article 7;
              (b)
whether its non-conformity with Article 2 is attributable to faulty
application of such standards or publications or to failure to comply with good
engineering practice as referred to in that Article.
2. If other Member
States raise objections to the decision referred to in paragraph 1, the
Commission shall immediately consult the Member States concerned.
3. If an agreement
has not been reached within three months from the date of communication of the
information as laid down in paragraph 1, the Commission shall obtain
the opinion of one of the bodies notified in accordance with Article 11,
first paragraph, point (b), having its registered office outside the
territory of the Member States concerned and which has not been involved in the procedure provided for in
Article 8. The opinion shall state the extent to which the provisions of
Article 2 have not been complied with.
4. The Commission
shall communicate the opinion of the body referred to in paragraph 3 to
all Member States which may, within a period of one month, make their
observations known to the Commission. The Commission shall at the same time
note any observations by the parties concerned on that opinion.
5. Having taken
note of these observations the Commission shall, if necessary, formulate the
appropriate recommendations or opinions.
Article 10
1. The CE
conformity marking referred to in Annex III shall be affixed by the
manufacturer or his authorised representative established within the Community
to the electrical equipment or, failing that, to the packaging, the
introduction sheet or the guarantee certificate so as to be visible, easily
legible and indelible.
2. The affixing on
electrical equipment of any markings liable to deceive third parties as to the
meaning and form of the CE marking shall be prohibited. However, any other
marking may be affixed to the electrical equipment, its packaging, the
instruction sheet or the guarantee certificate provided that the visibility and
legibility of the CE marking is not thereby
reduced.
3. Without
prejudice to Article 9:
              (a)
where a Member State establishes that the CE marking has been affixed unduly,
the manufacturer or his authorised representative established within the
Community shall be obliged to make the electrical equipment comply as
regards the provisions concerning the CE marking and to end the infringement
under conditions imposed by the Member State;
              (b)
where non-compliance continues, the Member State shall take all appropriate
measures to restrict or prohibit the placing on the market of the electrical
equipment in question or to ensure that it is withdrawn from the market in
accordance with Article 9.
Article 11
Each Member State
shall inform the other Member States and the Commission of the following:
              (a)
the bodies referred to in Article 5, second paragraph;
              (b)
the bodies which may make a report in accordance with Article 8(2) or give
an opinion in accordance with Article 9;
              (c)
the publication reference referred to in the second paragraph of Article 5.
Any amendment to
the above shall be notified by each Member State to the other
Member States and to the Commission.
Article 12
This Directive
shall not apply to electrical equipment intended for export to third countries.
ò new
Article 15
[Article R10 of Decision No 768/2008/EC]
EU declaration of conformity
1. The EU
declaration of conformity shall state that the fulfilment of the safety
objectives set out in Article 3 and Annex I has been demonstrated.
2. The EU
declaration of conformity shall have the model structure set out in Annex IV of
this Directive, shall contain the elements specified in the Module A as set out
in Annex III of this Directive and shall be continuously updated. It shall be
translated into the language or languages required by the Member State in which
market the electrical equipment is placed or made available. 
3. Where the
electrical equipment is subject to more than one Union act requiring an EU
declaration of conformity, a single EU declaration of conformity shall be drawn up in
respect of all such Union acts. That declaration shall contain
the identification of the acts concerned including the publication references.
4. By
drawing up the EU declaration of conformity, the manufacturer shall assume
responsibility for the compliance of the electrical equipment. 
Article 16
[Article R11 of Decision No 768/2008/EC]
General principles of the CE marking
The CE
marking shall be subject to the general principles set out in Article 30 of
Regulation (EC) No 765/2008.
Article 17
[Article R12 of Decision No 768/2008/EC]
Rules and conditions for affixing the CE marking
1. The CE
marking shall be affixed visibly, legibly and indelibly to the electrical
equipment or to its data plate. Where that is not possible or not warranted on
account of the nature of the electrical equipment, it shall be affixed to the
packaging and to any accompanying documents.
2. The CE
marking shall be affixed before the electrical equipment is placed on the
market. 
Chapter 4 
Union market
surveillance, control of products entering the Union market and safeguard
procedures
Article 18
Union market surveillance and control of
products entering the Union market
Article 15(3) and
Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to electrical equipment.
Article 19 [Article
R31 of Decision No 768/2008/EC]
Procedure for dealing with electrical equipment presenting a risk at
national level
1. Where the
market surveillance authorities of one Member State have taken action pursuant
to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient
reason to believe that electrical equipment covered by this Directive presents
a risk to the safety of persons, domestic animals or property, they shall carry
out an evaluation in relation to the electrical equipment concerned covering
all the requirements laid down in this Directive. The relevant economic
operators shall cooperate as necessary with the market surveillance
authorities.
Where, in
the course of that evaluation, the market surveillance authorities find that
the electrical equipment does not comply with the requirements laid down in
this Directive, they shall without delay require the relevant economic operator
to take all appropriate corrective action to bring the electrical equipment into
compliance with those requirements, to withdraw the electrical equipment from
the market, or to recall it within a reasonable period, commensurate with the
nature of the risk, as they may prescribe.
Article 21
of Regulation (EC) No 765/2008 shall apply to the measures referred to in the
second subparagraph.
2. Where the
market surveillance authorities consider that non-compliance is not restricted
to their national territory, they shall inform the Commission and the other
Member States of the results of the evaluation and of the actions which they
have required the economic operator to take.
3. The
economic operator shall ensure that all appropriate corrective action is taken
in respect of electrical equipment concerned that it has made available on the
market throughout the Union.
4. Where the
relevant economic operator does not take adequate corrective action within the
period referred to in the second subparagraph of paragraph 1, the market
surveillance authorities shall take all appropriate provisional measures to
prohibit or restrict the electrical equipment's being made available on their
national market, to withdraw the electrical equipment from that market or to
recall it.
The market
surveillance authorities shall inform the Commission and the other Member
States, without delay, of the measures taken.
5. The
information referred to in paragraph 4 shall include all available details, in
particular the data necessary for the identification of the non-compliant
electrical equipment, the origin of the electrical equipment, the nature of the
non-compliance alleged and the risk involved, the nature and duration of the
national measures taken and the arguments put forward by the relevant economic
operator. In particular, the market surveillance authorities shall indicate
whether the non-compliance is due to either of the following:
(a) failure
of the electrical equipment to meet requirements relating to the safety of
persons, domestic animals or property ;
(b)
shortcomings in the harmonised standards referred to in Article 12 conferring a
presumption of conformity.
6. Member
States other than the Member State initiating the procedure shall without delay
inform the Commission and the other Member States of any measures adopted and
of any additional information at their disposal relating to the non-compliance
of the electrical equipment concerned, and, in the event of disagreement with
the notified national measure, of their objections.
7. Where,
within two months of receipt of the information referred to in paragraph 4, no
objection has been raised by either a Member State or the Commission in respect
of a provisional measure taken by a Member State, that measure shall be deemed
justified.
8. Member
States shall ensure that appropriate restrictive measures are taken in respect
of the electrical equipment concerned without delay.
Article 20 [Article
R32 of Decision No 768/2008/EC]
Union safeguard procedure
1. Where, on
completion of the procedure set out in Article 19(3) and (4), objections are
raised against a measure taken by a Member State, or where the Commission
considers a national measure to be contrary to Union legislation, the
Commission shall without delay enter into consultation with the Member States
and the relevant economic operator or operators and shall evaluate the national
measure. On the basis of the results of that evaluation, the Commission shall
decide whether the national measure is justified or not.
The
Commission shall address its decision to all Member States and shall
immediately communicate it to them and the relevant economic operator or
operators.
2. If the
national measure is considered justified, all Member States shall take the
measures necessary to ensure that the non-compliant electrical equipment is
withdrawn from their market, and shall inform the Commission accordingly. If
the national measure is considered unjustified, the Member State concerned
shall withdraw the measure.
3. Where the
national measure is considered justified and the non-compliance of the
electrical equipment is attributed to shortcomings in the harmonised standards
referred to in Article 19(5)(b) of this Directive, the Commission shall apply
the procedure provided for in Article 8 of Regulation (EU) No [../..] [on
European Standardisation]. 
Article 21 [Article
R33 of Decision No 768/2008/EC]
Compliant electrical equipment which present a risk to safety
1. Where,
having performed an evaluation under Article 19(1), a Member State finds that
although electrical equipment is in compliance with this Directive, it presents
a risk to the safety of persons, it shall require the relevant economic
operator to take all appropriate measures to ensure that the electrical
equipment concerned, when placed on the market, no longer presents that risk,
to withdraw the electrical equipment from the market or to recall it within a
reasonable period, commensurate with the nature of the risk, as it may
prescribe.
2. The
economic operator shall ensure that corrective action is taken in respect of
electrical equipment concerned that he has made available on the market
throughout the Union.
3. The
Member State shall immediately inform the Commission and the other Member
States of the corrective action taken. That information shall include all
available details, in particular the data necessary for the identification of
the electrical equipment concerned, the origin and the supply chain of the
electrical equipment, the nature of the risk involved and the nature and
duration of the national measures taken.
4. The
Commission shall without delay enter into consultation with the Member States
and the relevant economic operator or operators and shall evaluate the
corrective measures taken. On the basis of the results of that evaluation, the
Commission shall decide whether the measure is justified or not, and where
necessary, propose appropriate measures.
5. The
Commission shall address its decision to all Member States and shall
immediately communicate it to them and the relevant economic operator or
operators.
Article 22 [Article
R34 of Decision No 768/2008/EC]
Formal non-compliance
1. Without
prejudice to Article 19, where a Member State makes one of the following
findings, it shall require the relevant economic operator to put an end to the
non-compliance concerned:
(a) the CE
marking has been affixed in violation of Article 30 of Regulation (EC) No
765/2008 or of Article 17 of this Directive;
(b) the CE
marking has not been affixed;
(c) the EU
declaration of conformity has not been drawn up;
(d) the EU
declaration of conformity has not been drawn up correctly;
(e)
technical documentation is either not available or not complete.
2. Where the
non-compliance referred to in paragraph 1 persists, the Member State concerned
shall take all appropriate measures to restrict or prohibit the electrical
equipment being made available on the market or ensure that it is recalled or
withdrawn from the market.
Chapter 5
Transitional
and final provisions
Article 23
Penalties
Member
States shall lay down rules on penalties for economic operators, applicable to
infringements of the national provisions adopted pursuant to this Directive and
shall take all measures necessary to ensure that they are enforced. 
The
penalties provided for shall be effective, proportionate and dissuasive. 
Member
States shall notify those provisions to the Commission by [insert date – the
date set out in the second subparagraph of Article 25(1)] at the latest and
shall notify it without delay of any subsequent amendment affecting them.
Article 24
Transitional provisions
Member States
shall not impede the making available on the market of electrical equipment
covered by Directive 2006/95/EC which is in conformity with that Directive and
which was placed on the market before [date set out in the second subparagraph
of Article 25(1)].
ê 
Article 25
Transposition
1. Member
States shall adopt and publish, by [insert date - 2 years after adoption] at
the latest, the laws, regulations and administrative provisions necessary to
comply with Articles 2, 3(1), 6, 7, 8, 9, 10, 11 ,12, 13(1), 14, 15, 16, 17,
18, 19, 20, 21, 22, 23 and 24 and Annexes III and IV . They shall forthwith
communicate to the Commission the text of those provisions and a correlation
table between those provisions and this Directive.
They shall
apply those provisions from [day after the date set out in the first
subparagraph].
When Member
States adopt those provisions, they shall contain a reference to this Directive
or be accompanied by such a reference on the occasion of their official
publication. They shall also include a statement that references in existing
laws, regulations and administrative provisions to the directive repealed by
this Directive shall be construed as references to this Directive. Member
States shall determine how such reference is to be made and how that statement
is to be formulated. 
ê 2006/95
(adapted)
Article 13
2. The
Member States shall communicate to the Commission the texts of the main
provisions of national laws which they adopt in the field covered by this
Directive.
Article 1426
Ö Repeal Õ
Directive 73/23/EEC2006/95/EC is hereby repealed Ö with effect from [the date set out in the second
subparagraph of Article 25(1) of this Directive], Õ without prejudice to the obligations of
the Member States relating to the time-limits for transposition into national
law and application of the Directives set out in Annex V,
Part B of Annex V to Directive
2006/95/EC.
References made to the repealed Directive
shall be construed as Ö references Õ being made
to this Directive and should Ö shall Õ be read in accordance with the
correlation table in Annex VAnnex VI.
Article 2715
Ö Entry into force Õ
ê 2006/95
This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.
ê 
Articles 1,
3(2), 4, 5, 13(2) and 13(3) and Annexes I, II and V shall apply from [the date
set out in the second subparagraph of Article 25(1)]. 
ê 2006/95
(adapted)
Article 2816
Ö Addressees Õ
ê 2006/95 
This Directive
is addressed to the Member States.
Done at […],
For the European Parliament                       For
the Council
The
President                                                 The President
ê 2006/95 (adapted)
ANNEX I
Principal Elements of the Safety
Objectives for Electrical Equipment Designed For Use within Certain Voltage
Limits
1. General conditions
(a) Tthe essential characteristics, the
recognition and observance of which will ensure that electrical equipment will
be used safely and in applications for which it was made, shall be marked on
the equipment, or, if this is not possible, on an accompanying notice.;
(b) The brand name or the trade mark should be
clearly printed on the electrical equipment or, where that is not possible, on
the packaging.
(c)(b) Tthe
electrical equipment, together with its component parts, shallshould be made in
such a way as to ensure that it can be safely and properly assembled and
connected.;
(d)(c) Tthe
electrical equipment shallshould
be so designed and manufactured as to ensure that protection against the
hazards set out in points 2 and 3 of this Annex is assured, providing that the
equipment is used in applications for which it was made and is adequately
maintained.
2. Protection against hazards arising from
the electrical equipment
Measures of a technical nature shallshould be prescribed
in accordance with point 1, in order to ensure:
              (a) that persons and domestic
animals are adequately protected against the danger of physical injury or other
harm which might be caused by direct or indirect contact;
              (b) that temperatures, arcs or
radiation which would cause a danger, are not produced;
              (c) that persons, domestic
animals and property are adequately protected against non-electrical dangers
caused by the electrical equipment which are revealed by experience;
              (d) that the insulation must be
suitable for foreseeable conditions.
3. Protection against hazards which may be
caused by external influences on the electrical equipment
Technical measures are to be laid down in
accordance with point 1, in order to ensure:
              (a) that the electrical
equipment meets the expected mechanical requirements in such a way that
persons, domestic animals and property are not endangered;
              (b) that the electrical
equipment shall be resistant to non-mechanical influences in expected
environmental conditions, in such a way that persons, domestic animals and
property are not endangered;
              (c) that the electrical
equipment shall not endanger persons, domestic animals and property in
foreseeable conditions of overload.
ANNEX II
Equipment and Phenomena outside the
Scope of this Directive
Electrical equipment for use in an
explosive atmosphere
Electrical equipment for radiology and
medical purposes
Electrical parts for goods and passenger
lifts
Electricity meters
Plugs and socket outlets for domestic use
Electric fence controllers
Radio-electrical interference
Specialised electrical equipment, for use
on ships, aircraft or railways, which complies with the safety provisions drawn
up by international bodies in which the Member States participate.
ê 2006/95 
ANNEX III
Ce Conformity Marking And
EC Declaration of Conformity
A.
CE conformity marking
The CE conformity
marking shall consist of the initials ‘CE’ taking the following form:
–                        
If the CE marking
is reduced or enlarged the proportions given in the above graduated drawing
must be respected.
–                        
The various
components of the CE marking must have substantially the same vertical
dimension, which may not be less than 5 mm.
B.
EC declaration of conformity
The EC declaration
of conformity must contain the following elements:
–                        
name and address
of the manufacturer or his authorised representative established within the
Community,
–                        
a description
of the electrical equipment,
–                        
reference to the
harmonised standards,
–                        
where appropriate,
references to the specifications with which conformity is declared,
–                        
identification of
the signatory who has been empowered to enter into commitments on behalf of
the manufacturer or his authorised representative established within the
Community,
–                        
the last two
digits of the year in which the CE marking was affixed.
ò new
ANNEX III [Annex
II, Module A, of Decision No 768/2008/EC]
Module A
Internal production control
1. Internal
production control is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2, 3 and 4, and
ensures and declares on his sole responsibility that the electrical equipment
concerned satisfy the requirements of this Directive.
2. Technical
documentation
The manufacturer
shall establish the technical documentation. The documentation shall make it
possible to assess the electrical equipment's conformity to the relevant
requirements, and shall include an adequate analysis and assessment of the
risk(s). The technical documentation shall specify the applicable requirements
and cover, as far as relevant for the assessment, the design, manufacture and
operation of the electrical equipment. The technical documentation shall,
wherever applicable, contain at least the following elements:
– a general
description of the electrical equipment ,
– conceptual
design and manufacturing drawings and schemes of components, subassemblies,
circuits, etc.,
- descriptions
and explanations necessary for the understanding of those drawings and schemes
and the operation of the electrical equipment ,
– a list of the
harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the
European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the safety objectives of this Directive where those
harmonised standards have not been applied. In the event of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied,
– results of
design calculations made, examinations carried out, etc., and
– test reports.
3. Manufacturing
The manufacturer shall take all measures
necessary so that the manufacturing process and its monitoring ensure
compliance of the electrical equipment with the technical documentation
referred to in point 2 and with the requirements of this Directive.
4. CE marking and EU declaration of conformity
4.1. The manufacturer shall affix the CE
marking to each individual electrical equipment that satisfies the applicable
requirements of this Directive.
4.2. The manufacturer shall draw up a
written EU declaration of conformity for a product model and keep it together
with the technical documentation at the disposal of the national authorities
for ten years after the electrical equipment has been placed on the market. The
EU declaration of conformity shall identify the electrical equipment for which
it has been drawn up.
A copy of the EU declaration of conformity
shall be made available to the relevant authorities upon request.
5. Authorised representative
The manufacturer's obligations set out in
point 4 may be fulfilled by his authorised representative, on his behalf and
under his responsibility, provided that they are specified in the mandate.
ê 2006/95 
ANNEX IV
INTERNAL PRODUCTION CONTROL
1. Internal
production control is the procedure whereby the manufacturer or his authorised
representative established within the Community, who carries out the
obligations laid down in point 2, ensures and declares that the electrical
equipment satisfies the requirements of this Directive that apply to it. The
manufacturer or his authorised representative
established within the Community must affix the CE marking to each product and
draw up a written declaration of conformity.
2. The
manufacturer must establish the technical documentation described in point 3
and he or his authorised representative established within the Community
must keep it on Community territory at the disposal of the relevant national
authorities for inspection purposes for a period ending at least 10 years after
the last product has been manufactured.
Where neither the
manufacturer nor his authorised representative is established within the
Community, this obligation is the responsibility of the person who places the
electrical equipment on the Community market.
3. Technical
documentation must enable the conformity of the electrical equipment to the
requirements of this Directive to be assessed. It must, as far as relevant for
such assessment, cover the design, manufacture and operation of the electrical
equipment. It must include:
–          a
general description of the electrical equipment,
–          conceptual
design and manufacturing drawings and schemes of components, sub-assemblies,
circuits, etc.,
–          descriptions
and explanations necessary for the understanding of said drawings and schemes
and the operation of the electrical equipment,
–          a
list of the standards applied in full or in
part, and descriptions of the solutions adopted to satisfy the safety aspects
of this Directive where standards have not been applied,
–          results
of design calculations made, examinations carried out, etc.,
–          test
reports.
4. The
manufacturer or his authorised representative must keep a copy of the
declaration of conformity with the technical documentation.
5. The
manufacturer must take all measures necessary in order that the manufacturing
process shall ensure compliance of the manufactured products with the
technical documentation referred to in point 2 and with the requirements of
this Directive that apply to them.
ò new
ANNEX IV [Annex
III of Decision No 768/2008/EC]
EU DECLARATION OF CONFORMITY
1.           No xxxxxx (unique identification of the
electric equipment):
2.           Name and address of the manufacturer or
his authorised representative: 
3.           This EU declaration of conformity is
issued under the sole responsibility of the manufacturer: 
4.           Object of the declaration
(identification of electrical equipment allowing traceability. It shall
include a colour image of sufficient clarity to enable the identification of
the electric equipment).
5.           The object of the declaration described
above is in conformity with the relevant Union harmonisation legislation………: 
6.           References to the relevant harmonised
standards used, or references to the specifications in relation to which
conformity is declared:
7.           Additional information:
Signed for and on
behalf of:………………………….
(place and date
of issue)
(name,
function)(signature)
ê 2006/95
(adapted)
ANNEX V
Part A
Repealed Directive with its amendment
 Council Directive 73/23/EEC Council Directive 93/68/EEC Article 1 point 12 and Article 13 only || (OJ L 77, 26.3.1973, p. 29) (OJ L 220, 30.8.1993, p. 1) 
Part B
List of time-limits for transposition into
national law and application
(referred to in Article 14)
 Directive || Time-limit for transposition || Date of application 
 73/23/EEC 93/68/EEC || 21 August 1974[11] 1 July 1994 || - 1 January 1995[12] 
ê 2006/95
(adapted)
ANNEX VI
Correlation
Table
 Directive 73/23/EEC Ö 2006/95/EC Õ || This Directive || 
 Articles 1 — 7 Article 8(1) Article 8(2) Article 8(3)(a) Article 8(3)(b) Article 9(1), first indent Article 9(1), second indent Article 9(2) to (5) Article 10 Article 11, first indent Article 11, second indent Article 11, third indent Article 12 Article 13(1) Article 13(2) — — Article 14 Annexes I to IV — — || Articles 1 — 7 Article 8(1) Article 8(2) Article 8(3), first subparagraph Article 8(3), second subparagraph Article 9(1) (a) Article 9(1) (b) Article 9(2) to (5) Article 10 Article 11(a) Article 11(b) Article 11(c) Article 12 — Article 13 Article 14 Article 15 Article 16 Annexes I to IV Annex V Annex VI || 
 Ö Article 1 Article 2 Article 3  Article 4 Article 5 Article 6 Article 7 Article 8 (1) Article 8 (2) Article 8 (3) Article 9 Article 10 Article 11 Article 12 Article 13 Article 14 Article 15 Annex I Annex II Annex III Annex IV Annex VÕ || Ö Article 1 Article 3 Article 4 Article 5  Article 12 Article 13 Article 14 Article 16 - - Articles 18 to 20 Articles 16 and 17 - - Article 25 (2) Article 26 Article 27 Annex I Annex II Articles 15 and 16 and Annex IV Annex III -Õ 
[1]               Communication from the Commission to the European
Parliament, the Council, the Economic and Social Committee and the Committee of
the Regions, COM(2011) 206 final.
[2]               COM(2011) 315 final, Proposal for a Regulation of the
European Parliament and of the Council on European Standardisation and amending
Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and
2009/23/EC of the European Parliament and of the Council.
[3]               OJ C 77, 28.3.2002, p. 1.
[4]               OJ C […], […], p. […].
[5]               OJ
L 374, 27.12.2006, p. 10.
[6]               OJ L 218, 13.8.2008, p. 30.
[7]               OJ L 218, 13.8.2008, p. 82.
[8]               (3)OJ L 77, 26.3.1973,
p. 29.Directive as amended by Directive
93/68/EEC (OJ L 220, 30.08.1993, p. 1).
[9]               (4)See Annex V, Part A.
[10]             (1)Council Decision 93/465/EEC of 22 July 1993
concerning the modules for the various phases of the conformity assessment
procedures and the rules for the affixing and use of the CE conformity marking,
which are intended to be used in the
technical harmonisation directives (OJ L 220, 30.08.1993, p. 23).
[11]             (1)In the case of Denmark the time-limit was extended to five years,
i.e. 21 February 1978. See Article 13(1) of
Directive 73/23/EEC.
[12]             (2)Until 1 January 1997 Member States had to allow the placing on the market and the bringing into service of
products which complied with the marking arrangements in force before
1 January 1995. See Article 14(2) of Directive 93/68/EEC.