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EC-ASEAN

A programme implemented by
Economic Co-operation Programme on
The European Committee for Standardisation
Standards, Quality and Conformity
Assessment

1
European Commission
EC Delegations in
ASEAN countries

EU Delegation of the European ASEAN Secretariat


Commission to Jakarta, Brunei
Darussalam and East Timor ACCSQ

Project Steering Committee


Brunei
Cambodia
CEN Brussels CEN-PCU Indonesia
Administrative
Administrative &
& Finance
Finance Asean Secretariat Lao PDR
Manager
Manager
Jakarta Malaysia
Team
Team Leader
Leader Philippines
Programme
Programme Manager
Manager Singapore
Training
Training Co-ordinator
Co-ordinator Thailand
Vietnam

Technical Assistance
Food Electricity-Electronic-Telecom Pharmacy

Finance Cosmetic Tourism

2
Regional workshop on
EU Directives and implication of
Regulatory bodies

EET Sector

Singapore 17 19 May 2004

3
Contents

17 May 2004
Part 1 :
EU Directives based on the New approach and
the global approach

Part 2 :
The Low Voltage Directive (LVD)

EC-ASEAN EET Sector 4


Singapore Workshop on EU Directives 17-19
Contents

18 May 2004

Part 3 :
The EMC Directive

Part 4 :
The R & TTE Directive

EC-ASEAN EET Sector 5


Singapore Workshop on EU Directives 17-19
Contents

19 May 2004 (morning)


Part 5 :
Working meeting with the joint committee EET
- MRA of ACCSQ

EC-ASEAN EET Sector 6


Singapore Workshop on EU Directives 17-19
Part 1

EU Directives based on the


New approach and the global
approach

By JC GOURDON EUROPACT S.A.R.L.

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Singapore Workshop on EU Directives 17-19
Contents

1. European directives based on the New


Approach and the Global Approach
1.1 Introduction
1.2 Scope of the new Approach directives
1.3 Compliance with directives
1.4 Conformity assessment procedure,
1.5 CE marking

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
Free movement of goods is a
cornerstone of the single market.

EC-ASEAN EET Sector 9


Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
The mechanisms in place are based on
prevention of new barriers to trade, mutual
recognition and technical harmonization :
In 98/34/EC(1) Directive Member States are
obliged to notify draft technical regulations
and standards to the Commission and to the
other Member States(2) and a standstill period
of 3months renewable one time is applied.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
The standstill period is 12 months for a
directive proposal. However, the standstill
period does not apply for urgent reasons.
Directive 98/34/EC also gives the Commission
the possibility of inviting, the European
standards organizations to elaborate European
standards.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
National technical regulations are subject to
the provisions of Articles 28(3) and 30(4) of the
EC Treaty establishing the European
Community, which prohibit quantitative
restrictions or measures having equivalent
effect.

EC-ASEAN EET Sector 12


Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
Case 120/78 (the Cassis de Dijon case),
provides the key elements for mutual
recognition.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
The effect of this case law is as follows:
Products legally manufactured in one country should
move freely throughout the Community, where such
products meet equivalent levels of protection to those
imposed by the Member State of exportation and where
they are marketed in the territory of the exporting
country.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction
Concept of the New Approach and the
Global Approach :
In the absence of Community measures, Member States are
free to legislate on their territory.
Barriers to trade, which result from differences between
national legislations, may only be accepted, if national
measures:
are necessary to satisfy mandatory requirements (such
as health, safety,);
serve a legitimate purpose justifying the breach of the
principle of free movement of goods; and
can be justified with regard to the legitimate purpose and
are proportionate with the aims.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
Restrictions to free movement of
products are only avoided or eliminated
through technical harmonization on
Community level.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
This harmonization was, at first, rather slow
for two reasons:
1. the legislation became highly technical, as it had the
objective of meeting the individual requirements of each
product category.
2. the adoption of technical harmonization directives
was based on unanimity in the Council.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
The creation of a single market by 31
December 1992 could not have been achieved
without a new regulatory technique that set
down only the general essential requirements,
reduced the control of public authorities prior
to a product being placed on the market, and
integrated quality assurance and other modern
conformity assessment techniques.
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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
A new regulatory technique and
strategy was laid down by the Council
Resolution of 1985 on the New
Approach to technical harmonization
and standardization.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
This decision established the following
principles:
Legislative harmonization is limited to
essential requirements that products placed
on the Community market must meet, if they
are to benefit from free movement within the
Community.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
This decision established the following
principles:
The technical specifications of products
meeting the essential requirements set out in
the directives are laid down in harmonized
standards.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
This decision established the following
principles:
Application of harmonized or other standards
remains voluntary, and the manufacturer may
always apply their technical specifications to
meet the requirements.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
This decision established the following
principles:
Products manufactured in compliance with
harmonized standards benefit from a
presumption of conformity with the
corresponding essential requirements(5).

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
A safeguard clause procedure is
necessary to allow the possibility of
contesting the conformity of a product,
or failures or shortcomings of
harmonized standards.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
The Council Resolution of 1989(6) on the
Global Approach to certification and
testing states the guiding principles for
Community policy on conformity
assessment.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
This Council Resolution specified that:
A consistent approach is developed in Community
legislation by devising modules for the various phases
of conformity assessment procedures, and by laying
down criteria for the use of these procedures, for the
designation of bodies operating these procedures,
and for the use of the CE marking.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and the


Global Approach :
This Council Resolution specified that:
The use of European standards relating to quality
assurance (EN ISO 9000 series), and to the
requirements to be fulfilled by conformity
assessment bodies operating quality assurance
(EN 45000 series) is generalised.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and the


Global Approach :
This Council Resolution specified that:
Setting up of accreditation systems and the use
of inter-comparison techniques are promoted in
Member States and at Community level.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and the


Global Approach :
This Council Resolution specified that:
Mutual recognition agreements concerning testing and
certification in the non regulatory sphere are promoted.
The differences of existing quality infrastructures (such as
calibration and metrology systems, testing laboratories,
certification and inspection bodies, and accreditation
bodies) between Member States and between industrial
sectors will be minimised by programmes.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
This Council Resolution specified that:
International trade between the Community
and third countries is promoted by means of
mutual recognition agreements, cooperation
and technical assistance programmes.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
The Global Approach was completed by
Council Decision 90/683/EEC, which
was replaced and brought up to date by
Decision 93/465/EEC.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and the


Global Approach :
These decisions concerning the global
approach lay down general guidelines and
detailed procedures for conformity
assessment that are to be used in New
approach directives.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and the


Global Approach :
Thus, conformity assessment is based on:
manufacturers internal design and production
control activities;
third party type examination combined with
manufacturers' internal production control
activities;

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
Thus, conformity assessment is based
on:
third party type or design examination
combined with third party approval of product
or production quality assurance systems, or
third party product verification(7);

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and the


Global Approach :
Thus, conformity assessment is based on:
third party unit verification of design and
production; or
third party approval of full quality assurance
systems.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Concept of the New Approach and


the Global Approach :
Decision 93/465/EEC harmonises the
rules for the affixing and use of the CE
marking.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction
Standard elements of New Approach
directives(8)
New Approach directives are based on the
following principles.
Harmonisation is limited to essential
requirements.
Only products fulfilling the essential
requirements may be placed on the market and
put into service.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Standard elements of New Approach


directives
Harmonised standards, the reference numbers
of which have been published in the Official
Journal, transposed into national standards, are
presumed to conform to the corresponding
essential requirements.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Standard elements of New Approach


directives
Application of harmonised standards or other
technical specifications remains voluntary, and
manufacturers are free to choose any technical
solution that provides compliance with the
essential requirements.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Standard elements of New Approach


directives
Manufacturers may choose between different
conformity assessment procedures provided for
in the applicable directive.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Transposition of New Approach directives


New Approach directives are total
harmonisation directives:
the provisions of these directives
supersede all corresponding national
provisions.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Transposition of New Approach


directives
New Approach directives are addressed to
the Member States, which have an obligation
to transpose them into their national
legislation as appropriate.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Transposition of New Approach


directives
National laws, regulations or administrative
provisions, which transpose the directive, shall
contain a reference to the directive in question
on the occasion of their official publication.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction

Transposition of New Approach


directives
National laws, regulations or administrative
provisions, which are adopted and published
in order to transpose a directive, must be
communicated to the Commission.

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction
New Approach directives

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction
New Approach directives

EC-ASEAN EET Sector 46


Singapore Workshop on EU Directives 17-19
1.1 - Introduction
New Approach directives

EC-ASEAN EET Sector 47


Singapore Workshop on EU Directives 17-19
1.1 - Introduction

New Approach directives

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Singapore Workshop on EU Directives 17-19
1.1 - Introduction
New Approach directives

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives
Products submitted to directives :
New Approach directives apply to products
which are intended to be placed (or put into
service) on the Community market for the first
time. The directives apply to new products
manufactured in the Member States, and to new,
as well as used and second-hand, products
imported from third countries(9).

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Products submitted to directives :


The concept of product varies between New
Approach directives, and it is the responsibility
of the manufacturer to verify whether or not the
product is within the scope of one or more
directives.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)
Products submitted to directives :
Products subject to important changes may
be considered as new products, they have to
comply with the provisions of the applicable
directives when placed on the Community
market.
This has to be assessed on a case-by-case
basis, unless otherwise provided for.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Products submitted to directives :


Products, repaired without changing the
original performance, purpose or type, are
not subject to conformity assessment
according to the New Approach directives.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Products submitted to directives :


Products specially or exclusively intended for
military or police purposes are explicitly excluded
from the scope of certain New Approach
directives.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Products submitted to directives :


For the other directives, Member States may,
under certain conditions, exclude products
intended specifically for military purposes from
their field of application according to Article 296 of
the EC Treaty.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Simultaneous application of directives:


New Approach directives
Essential requirements of New Approach
directives may overlap or complement each
other, depending on the hazards covered
by these requirements related to the
product in question.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)
Simultaneous application of directives :
New Approach directives :
The placing on the market can only take
place when the product complies with the
provisions of all applicable directives, and
when the conformity assessment has been
carried out in accordance with all applicable
directives.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)
Simultaneous application of directives :
New Approach directives :
Where the same product is covered by
two or more directives, the application of
other directives can sometimes be excluded
following a risk analysis of the product by
the manufacturer.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Simultaneous application of directives :


New Approach directives and directive on general safety
of products:
The Directive on general product safety (01/95/EC) applies
to consumer products in the following cases:
the product is not covered by New Approach directives or
other Community legislation or
not all aspects of safety or categories of risk are covered
by New Approach directives or other Community legislation.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Simultaneous application of directives :


New Approach directives and the directive on
product liability :
The Directive on product liability is applicable to
all products covered by New Approach directives.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Placing on the market and putting


into service :
Placing on the market (10) is the initial action
of making a product available for the first time
on the Community market, with a view to
distribution or use in the Community. Making
available can be either for payment or free of
charge.
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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Placing on the market and putting


into service :
Putting into service takes place at the
moment of first use within the Community by
the end user.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Placing on the market and putting


into service :
A product must comply with the applicable
New Approach directives when it is placed on
the Community market for the first time and
put into service (11)

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)

Placing on the market and putting


into service :
Member States are obliged:
not to prohibit, restrict or impede the placing
on the market and putting into service of
products that comply with the applicable New
Approach directives,

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)
Placing on the market and putting
into service :
Member States are obliged:
to take any measures necessary to ensure that
products are placed on the market and put into
service only if they do not endanger the safety
and health of persons, or other interests
covered by the applicable directives, when
correctly constructed, installed, maintained, and
used in accordance with their purpose.

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)
Transitional period
Most New Approach directives provide for a
transitional period (12) .
Member States are obliged to allow on their
markets, until the end of the transitional
period, products designed and manufactured
according to their national system. Thus, the
manufacture has the choice, throughout the
transitional period, either to apply the national
system or the directive.
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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)
Transitional period
During the transitional period, products
conforming to all applicable directives may be
placed on the Community market and put into
service in any Member State. Products
manufactured in line with national regulations or
with non-mandatory technical specifications
move freely according to the principles laid
down by Articles 28 and 30 of the EC Treaty (13) .

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Singapore Workshop on EU Directives 17-19
1.2 Scope of the new approach
directives (continued)
Transitional period
At the end of the transitional period, the
directive applies to the exclusion of any
national rules covering the same products or
the same essential requirements (14).
Consequently, only products in compliance
with the applicable directive may be placed on
the Community market after the transitional
period.
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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives

Essential requirements :
Essential requirements lay down the necessary
elements for protecting the public interest.
Essential requirements are mandatory.
Only products complying with essential requirements
may be placed on the market and put into service (15).
Essential requirements must be applied as a function
of the hazards inherent to a given product.

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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives

Harmonized standards :
Harmonized standards are European
standards, which are adopted by European
standards organizations, prepared in
accordance with the General Guidelines
agreed between the Commission and the
European standards organizations, and follow
a mandate issued by the Commission after
consultation with the Member States (16).

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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives

Harmonized standards :
Harmonized standards in the meaning of the
New Approach are deemed to exist when the
European standards organizations formally
present to the Commission the European
standards elaborated or identified in
conformity with the mandate (17) .

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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives

Harmonized standards :
Standardization procedure under the New
Approach:
1. A mandate is drawn up, following
consultation with the Member States.
2. The mandate is transmitted to
European standards organizations.
3. European standards organizations
accept the mandate (18) .

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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives

Presumption of conformity :
Conformity with a national standard that
transposes a harmonized standard, whose
reference has been published, confers a
presumption of conformity with the essential
requirements of the applicable New Approach
directive that is covered by such a standard 19).

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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives
Presumption of conformity :
References (such as titles, identification
numbers) of harmonized standards are
published in the Official Journal for the
directive in question. An updated list of
references for each directive can be found at
the following Internet address:
http://europa.eu.int/comm/dg03/directs/dg3b/n
ewapproa/
eurstd/harmstds/index.html
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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives

Presumption of conformity :
Member States must publish the reference of
the national standard that transposes a
harmonized standard.

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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives

Presumption of conformity :
The application of harmonized standards,
which give a presumption of conformity,
remains voluntary in the field of New
Approach directives. Thus, the product may
be manufactured directly on the basis of the
essential requirements (19) .

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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives

Withdrawal of conformity :
The Commission withdraws the presumption
of conformity, if it has been established that
the harmonized standard does not fully meet
the essential requirements

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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives

Revision of harmonized standards :


The principles concerning the mandate and
the adoption of harmonized standards, their
availability, and the presumption of conformity
to the essential requirements apply also to the
revised version of harmonized standards.

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Singapore Workshop on EU Directives 17-19
1.3 Compliance with directives

Revision of harmonized standards :


During the transitional period, both the old
and the revised standards give presumption
of conformity, provided that the conditions for
this are met by both standards.

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment
procedure

The modules (90)

Conformity assessment is subdivided into


modules, which comprise a limited number of
different procedures applicable to the widest
range of products.

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment
procedure
The modules :
The modules relate to the design phase of
products, their production phase or both. The
eight basic modules and their possible
variants can be combined with each other in a
variety of ways in order to establish complete
conformity assessment procedures.

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment
procedure

The modules :
As a general rule, a product is subject to
conformity assessment according to a module
during the design as well as the production
phase.

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment
procedure
The modules :
Each New Approach directive describes the
range and contents of possible conformity
assessment procedures, which are considered to
give the necessary level of protection. The
directives also set out the criteria under which
the manufacturer can make a choice, if more
than one option is provided for.

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment
procedure
The modules : basic modules
A Covers internal design and production
Internal control of control. This module does not require a
production notified body.

B Covers the design phase, and must be followed


up by a module providing for assessment in the
EC type- production phase (C, D, E or F modules). The
examination EC type-examination certificate is issued by a
notified body.

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment
procedure
The modules : basic modules
C Covers the production phase and follows module
B. Provides for conformity with the type as
Conformity to described in the EC type-examination certificate
type issued according to module B. This module does
not require a notified body to take action.

D Covers the production phase and follows module


B. Derives from quality assurance standard EN
Production ISO 9002, with the intervention of a notified body
quality responsible for approving and controlling the
quality system for production, final product
assurance inspection and testing set up by the manufacturer.

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment
procedure
The modules : basic modules

E Covers the production phase and follows module


B. Derives from quality assurance standard EN
Product quality ISO 9003, with the intervention of a notified
assurance body responsible for approving and controlling
the quality system for final product inspection and
testing set up by the manufacturer.

F Covers the production phase and follows module


B. A notified body controls conformity to the type
Product as described in the EC type-examination
verification certificate issued according to module B, and
issues a certificate of conformity.

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment
procedure
The modules : basic modules
G Covers the design and production phases.
Each individual product is examined
Unit verification by a notified body, which issues a certificate
of conformity.

H Covers the design and production phases.


Derives from quality assurance standard EN
Full quality ISO 9001, with the intervention of a notified
assurance body responsible for approving and controlling
the quality system for design, manufacture,
final product inspection and testing set up by
the manufacturer.

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment procedure
The modules : Simplified flow chart

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment procedure
The modules : Additional elements

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Singapore Workshop on EU Directives 17-19
1.4 Conformity assessment
procedure

Application of quality system


standards :
The use of quality systems for the purpose of
conformity assessment procedures in the
directives is described in modules D, E and H
and their variants.

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1.4 Conformity assessment
procedure
Application of quality system
standards :
Compliance with standards EN ISO 9000
series gives a presumption of conformity with
the corresponding quality assurance modules
as regards the provisions covered by the
standard in question, provided that the quality
system takes into consideration as
necessary the specific requirements of the
products for which they are implemented.
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1.4 Conformity assessment
procedure
Application of quality system
standards :
Compliance with modules D, E, H and their
variants does not require a certified quality
system according to standards EN ISO 9000
series, although it provides a useful means of
establishing compliance. The manufacturer is
free to apply other quality system models.

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1.4 Conformity assessment
procedure

Application of quality system


standards :
For the purpose of complying with the
applicable directives the manufacturer shall
ensure that the quality system is implemented
and applied in such a way that it ensures the
full application of the essential requirements
in question.

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1.4 Conformity assessment
procedure

Technical documentation :
The manufacturer must draw up a technical
file (technical documentation).
The technical documentation is intended to
provide information on the design,
manufacture and operation of the product.

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1.4 Conformity assessment
procedure

EC declaration of conformity :
The manufacturer or the authorized
representative established within the
Community must draw up an EC declaration
of conformity as part of the conformity
assessment procedure provided for in the
New Approach directives.

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1.4 Conformity assessment
procedure
EC declaration of conformity :
The EC declaration of conformity should
contain all relevant information to identify the
directives concerned, as well as the
manufacturer, the authorized representative,
the notified body if applicable, the product,
and a reference to harmonized standards or
other normative documents.

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1.5 CE marking

Principles of CE marking:
The CE marking symbolizes the
conformity of the product with the
applicable Community requirements
imposed on the manufacturer.

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1.5 CE marking

Principles of CE marking:
The CE marking affixed to products is a
declaration by the person responsible that :
the product conforms to all applicable
Community provisions,
the appropriate conformity assessment
procedures have been completed.

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1.5 CE marking

Products to be CE marked :
The CE marking is mandatory and must be
affixed before any product subject to it is
placed on the market, save where specific
directives require otherwise.

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1.5 CE marking

Products to be CE marked :
Where products are subject to several
directives, which all provide for the affixing of
the CE marking, the marking indicates that the
products are presumed to conform to the
provisions of all these directives.

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1.5 CE marking

Products to be CE marked :
A product may not be CE marked, unless it is
covered by a directive providing for its
affixing.

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1.5 CE marking

Affixing of the CE marking :


The CE marking must be affixed by the
manufacturer, or by the authorized
representative established within the European
Community.

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1.5 CE marking
Affixing of the CE marking :
The CE marking must take the form below. If the CE
marking is reduced or enlarged the proportions must
be respected.

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1.5 CE marking

Affixing of the CE marking :


The CE marking must be affixed visibly, legibly and
indelibly to the product or to its data plate. However,
where this is not possible or not warranted on account
of the nature of the product, it must be affixed to the
packaging, if any, and to the accompanying
documents, where the directive concerned provides for
such documents.

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1.5 CE marking

Affixing of the CE marking :


Where a notified body is involved in the production
control phase according to the applicable directives,
its identification number must follow the CE marking.
The manufacturer or the authorized representative
established in the Community affixes the
identification number, under the responsibility of the
notified body.

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1.5 CE marking

CE marking and other marks :


CE marking is the only marking which
symbolizes conformity to all the obligations
incumbent on manufacturers for the product
as required by the applicable directives
providing for its affixing.

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1.5 CE marking

CE marking and other marks :


Member States shall refrain from introducing
any reference to another conformity marking
into their national regulations, which would
signify conformity with objectives that relate to
the CE marking.

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1.5 CE marking

CE marking and other marks :


A product may bear additional markings and
marks, provided that they:
fulfill a different function from that of the
CE marking,
are not liable to cause confusion with it, and
do not reduce its legibility and visibility.

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1.5 CE marking

CE marking and other marks :


CE marking + CCA marks

CCA

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Singapore Workshop on EU Directives 17-19
1.5 CE marking

CE marking and other marks :


CE marking + European marks

HAR LCIE

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Singapore Workshop on EU Directives 17-19
Part 2

The Low Voltage directive


73/23/EEC (LVD)

By JC GOURDON EUROPACT S.A.R.L.

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Contents

2. The Low voltage directive (LVD)


2.1 Introduction
2.2 Scope of the LVD
2.3 Safety requirements for placing on EU
market electrical equipment covered by LVD
2.4 Conformity assessment procedures,
2.5 Relationship between the LVD and other
community directives

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2.1 Introduction

Pursuant to the Agreement on the European


Economic Area (EEA), the provisions of this
European directive are extended to the EFTA
countries: Iceland, Liechtenstein and Norway.
All references in this presentation to the
Community or the Community market must be
understood to mean the EEA and its market.

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2.1 Introduction

Directive 73/23/EEC (LVD) was


adopted by the Council on 19
February 1973 with the aim of
harmonising the laws of the Member
States relating to electrical equipment
designed for use within certain
voltage limits.
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2.1 Introduction

In 1993 LVD was amended by Directive


93/68/EEC, the so-called "CE marking Directive",
solely in respect of the procedures for conformity
assessment and conformity marking.
The objective of this amendment was to align the
provisions concerning conformity assessment and
the CE marking of electrical equipment on those
introduced for the "new approach" directives.

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2.1 Introduction

The provisions introduced by the


CE marking directive (Directive
93/68/EEC) became mandatory with
effect from 1 January 1997.

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2.1 Introduction
The "Low Voltage" Directive is a "total"
harmonisation directive which has
superseded existing national regulations in
the field covered:
electrical equipment may only be put on the market if
it is in conformity with the requirements of the
Directive
Member States may not impede free circulation or the
marketing of conforming equipment.

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2.2 Scope of the Low Voltage Directive

Which products are covered?


Broadly, the Directive covers electrical equipment (20)
(consumer and capital goods) designed to operate
with a voltage rating of between 50 and 1000 V AC
and between 75 and 1500 V DC(21) such:
electrical appliances (22) ,
lighting equipment including ballasts,
switch gear and control gear,
electric wiring,
appliance couplers and cord sets,
electrical installation equipment (23) ,etc

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2.2 Scope of the Low Voltage Directive

Which products are covered?


covered?
The Commission confirms, as already
expressed in the Communication of 15
December 1982, that cable management
systems are covered by the "Low Voltage"
Directive.

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2.2 Scope of the Low Voltage Directive

Which products are covered?


covered?
Voltage ratings refer to the voltage of the
electrical input or output, not to voltages
appearing inside the equipment :
the Commission has taken the position that the
term "designed for use with a voltage range"
shall be understood as rated input voltage or
output voltage inside this voltage range.
Internally there may be higher voltages.

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2.2 Scope of the Low Voltage Directive

Which products are covered?


covered?
Voltage ratings refer to the voltage of the
electrical input or output, not to voltages
appearing inside the equipment :
Battery operated equipment outside the voltage
rating is outside the scope of the LVD.
Nevertheless, the accompanying battery-charger
or power supply unit within the voltage ranges of
the Directive, are in the scope of the LVD.

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2.2 Scope of the Low Voltage Directive

Which products are covered?


covered?
Voltage ratings refer to the voltage of the
electrical input or output, not to voltages
appearing inside the equipment :
This applies for example in the case of battery-
operated equipment with supply voltage rating
under 75 V DC, for their accompanying power
supply unit rating between 110 and 240 V AC (e.g.
Notebooks).

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2.2 Scope of the Low Voltage Directive

Which products are excluded?


the following, covered by other Community
directives, are excluded from the scope of the "Low
Voltage" Directive:
Electrical equipment for use in a potentially explosive
atmosphere
Electrical equipment for radiology and medical
purposes
Electrical parts for lifts
Electricity meters,

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2.2 Scope of the Low Voltage Directive

Which products are excluded?


excluded?
The following are not covered by any
Community directive and therefore must not
be CE marked.
marked.
Plugs and socket outlets for domestic use (24) ,
Electric fence controllers ,
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.

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2.2 Scope of the Low Voltage Directive

Are "components" included in the scope?


In general, the scope of the Directive
includes both :
electrical equipment intended for incorporation
into other equipment and
equipment intended to be used directly without
being incorporated.

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2.2 Scope of the Low Voltage Directive

Are "components" included in the


scope?
However, some basic components designed
and manufactured for being used as to be
incorporated into other electrical equipment,
are such that their safety, to a very large
extent, depends on how they are integrated
into the final product and the overall
characteristics of the final product.

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2.2 Scope of the Low Voltage Directive

Are "components" included in the


scope?
These basic components , the safety of which
can only, to a very large extent, be assessed
taking into account how they are
incorporated, are not covered as such by the
Directive and must not be CE marked.

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2.2 Scope of the Low Voltage Directive

Are "components" included in the


scope?
They include electronic and certain other
components such as:
active components such as integrated circuits,
transistors, diodes, rectifiers, triacs, GTOs,
IGTBs, opto-semi-conductors
passive components such as capacitors,
inductance, resistors, filters

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2.2 Scope of the Low Voltage Directive

Are "components" included in the


scope?
And also:
electromechanical components such as
connectors, devices for mechanical protection
which are part of equipment
relays with terminals for printed circuit
boards, micro switches.

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2.2 Scope of the Low Voltage Directive

Are "components" included in the


scope?
However, other electrical components
incorporated into electrical equipment, but for
which a safety assessment is feasible (25) , like
- for example - some types of transformers
and electrical motors, are covered as such by
the Directive and must be CE marked.

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2.2 Scope of the Low Voltage Directive

Are "components" included in the scope?


Moreover, items like :
Lamps, starters, fuses, switches for household
use, elements of electrical installations, etc
which, even if they are often used in conjunction with
other electrical equipment and have to be properly
installed, are themselves to be considered electrical
equipment in the sense of the Directive and must be
CE marked.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
The Directive also covers health aspects of
noise and vibrations, and ergonomic aspects
as far as ergonomic requirements are
necessary to protect against hazards in the
sense of the Directive.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the Directive?


Article 2 resume the essential requirements :
Article 2 of LVD 73/23/EEC:
1. The Member States shall take all appropriate measures to
ensure that electrical equipment may be placed on the
market only if, having been constructed in accordance with
good engineering practice in safety matters in force in the
Community, 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.
2. The principal elements of the safety objectives referred
to in paragraph 1 are listed in Annex I.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
The eleven "safety objectives of Annex I precise the
essential requirements article 2 :
1.General
1. conditions
1. The 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.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the Directive?


The eleven "safety objectives of Annex I precise the
essential requirements article 2 :
2. The manufacturers or brand name or trade
mark should be clearly printed on the electrical
equipment or, where that is not possible, on the
packaging.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
The eleven "safety objectives of Annex I precise the
essential requirements article 2 :
3. The electrical equipment, together with its
component parts should be made in such a way
as to ensure that it can be safely and properly
assembled and connected.

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Singapore Workshop on EU Directives 17-19
2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
The eleven "safety objectives of Annex I precise the
essential requirements article 2 :
4. The electrical equipment should 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.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
Theeleven "safety objectives of Annex I precise the
essential requirements article 2 :
2.Protection against hazards arising from the electrical equipment
Technical measure should be prescribed in
accordance with point 1, in order to ensure:
5. that persons and domestic animals are
adequately protected against danger of physical
injury or other harm which might be caused by
electrical contact direct or indirect;

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Singapore Workshop on EU Directives 17-19
2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the Directive?


Theeleven "safety objectives of Annex I precise the
essential requirements article 2 :
2.Protection against hazards arising from the electrical equipment
Technical measure should be prescribed in
accordance with point 1, in order to ensure:
6. that temperatures, arcs or radiation which
would cause a danger, are not produced;

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Singapore Workshop on EU Directives 17-19
2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
Theeleven "safety objectives of Annex I precise the
essential requirements article 2 :
2.Protection against hazards arising from the electrical equipment
Technical measure should be prescribed in
accordance with point 1, in order to ensure:
7. that persons, domestic animals and property
are adequately protected against non-electrical
dangers caused by the electrical equipment which
are revealed by experience;

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the Directive?


Theeleven "safety objectives of Annex I precise the
essential requirements article 2 :
2.Protection against hazards arising from the electrical equipment
Technical measure should be prescribed in
accordance with point 1, in order to ensure:
8. that the insulation must be suitable for
foreseeable conditions.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
Theeleven "safety objectives of Annex I precise the
essential requirements article 2 :
3. Protection against hazards due to external influences
Technical measure should be laid down in
accordance with point 1, in order to ensure:
9. that the electrical equipment meets the
expected mechanical requirements in such a way
that persons, domestic animals and property are
not endangered;
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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the Directive?


Theeleven "safety objectives of Annex I precise the
essential requirements article 2 :
3. Protection against hazards due to external influences
Technical measure should be laid down in
accordance with point 1, in order to ensure:
10. 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;
EC-ASEAN EET Sector 143
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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
Theeleven "safety objectives of Annex I precise the
essential requirements article 2 :
3. Protection against hazards due to external influences
Technical measure should be laid down in
accordance with point 1, in order to ensure:
11. that the electrical equipment shall not
endanger persons, domestic animals and property
in foreseeable conditions of overload.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
It should be noted that electromagnetic
compatibility (emission and immunity) aspects
are excluded from the scope of this Directive
and are separately regulated under Directive
89/336/EEC

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
Radiation aspects referred to in Annex I to the
Directive are limited to those directly relevant
for health and safety of persons and domestic
animals and do not cover electromagnetic
disturbances in the sense of the EMC Directive.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
The Commission interpret that all
electromagnetic aspects relating to safety
including functional safety are covered by the
LVD. This covers also the effect of
electromagnetic fields, emitted by electrical
apparatus.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
The Commission interpret that all
electromagnetic aspects relating to safety
including functional safety are covered by the
LVD. This covers also the effect of
electromagnetic fields, emitted by electrical
apparatus.

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2.2 Scope of the Low Voltage Directive

Which safety aspects are covered by the


Directive?
Finally, it should also be noted again that for
certain electrical equipment, the provisions of
other directives also apply :
For example EMC Directive may apply to electrical
equipment for Radio-electrical interference
phenomena which are out of scope of LVD .

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
The mandatory requirements are those of
Article 2 and annex 1 of the Directive.

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
Member States must ensure the freedom to
place on the market and the free movement of
electrical equipment, which is in conformity with
the requirements of the Directive.

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
the mandatory safety provisions which
products must comply with in order to be
allowed onto the EU market and benefit from
freedom of movement in the Community are the
eleven "objectives" mentioned in Annex 1 to the
directive.
EC-ASEAN EET Sector 152
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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
Consequently, any national standards or
national specifications related to the safety of
electrical equipment do not have a mandatory
status and may not be a condition for its placing
on the market.

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
Article 7 of the Directive provides for mutual
recognition of national standards in case of absence of
standards within the meaning of Articles 5 and 6.
However, such national standards might, in certain
cases, not cover all the "safety objectives" of the
Directive. Therefore, manufacturers using those
standards should carefully check compliance with all the
safety requirements of the Directive.

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
The phrase at the end of Article 7 ("if it ensures
a safety level equivalent to that required in their
own territory") does not, per se, authorise
Member States to require compliance with
safety levels other than those resulting from the
"safety objectives".

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
Nevertheless, compliance with the safety
objectives of the Directive may imply in some
cases compliance with different requirements
from one Member State to another to take
account of different objective situations, e.g.
requirements resulting from supply systems
which vary from one region of the Community to
another.
EC-ASEAN EET Sector 156
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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
National laws or regulations requiring
compliance with particular technical
specifications (where they exist) may not be
considered to be mandatory. They may only
eventually have the status of specifications
giving presumption of conformity.

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
Manufacturers can no longer be obliged to
comply with national specifications in the case
of equipment otherwise satisfying the "safety
objectives" of the Directive. Where the
standards referred to in Articles 5 or 6 do not
yet exist, manufacturers are entitled to comply
with any appropriate specifications in order to
comply with the "safety objectives".
EC-ASEAN EET Sector 158
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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
The non mandatory nature of specifications in
national rules is from the point of view of EC
law confirmed by the rulings of the Court of
Justice, according to which national authorities
and courts must not apply national provisions
which conflict with Community provisions(26).

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
The existence of national laws or regulations cannot
prevent the drawing up of harmonised standards in
accordance with Article 5.
Nor can such provisions be imposed in addition to, or
instead of, the technical specifications contained in the
harmonised standards, as they have ceased to be
binding.

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

Which are the mandatory safety


requirements applicable in the EU?
Within the field covered by the Directive there
is therefore no longer any point in referring to
such provisions under "A - deviations" in
"harmonisation documents" (HD) or "European
standards" (EN)(27).

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

How to ensure conformity to those


requirements?
Products are presumed to conform to the
safety objectives of the "Low Voltage" Directive
where the equipment has been manufactured in
accordance with technical standards in the
order laid down as follow.

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

How to ensure conformity to those


requirements?
Order of application of technical standards :
1. European standards (EN or HD), referred to
as harmonised standards in the Directive (28), drawn
up in accordance with Article 5 by the bodies
notified by the Member States (in fact, these are
standards made by CENELEC);

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

How to ensure conformity to those


requirements?
Order of application of technical standards :
2. Where standards as defined in Article 5 have
not yet been drawn up and published, international
rules issued by the two international bodies, the
International Commission on the rules for the
approval of electrical equipment (CEE)(29) or the
International Electrotechnical Commission (IEC)
(Article 6(1)), and published in accordance with
the procedure laid down in Article 6(2) and (3)(30);

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

How to ensure conformity to those


requirements?
Order of application of technical standards :
3. where standards as defined in Article 5 or
international standards as defined in Article 6 do
not yet exist, the national standards of the
Member State of manufacturer (Article 7).

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

How to ensure conformity to those


requirements?
The standards referred to in Articles 5, 6 and
7, the application of which remains voluntary,
provide a presumption of conformity for
equipment manufactured in accordance with
those standards.

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

How to ensure conformity to those


requirements?
The presumption of conformity provided by
harmonised standards arises at the moment of
national publication of standards, according to
article 5; the listing in the Official Journal of the
EC is only for information.

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2.3 Safety requirements for placing on the EU
market electrical equipments covered by LVD.

How to ensure conformity to those requirements?


Alternatively, the manufacturer may construct the
product in conformity with the essential requirements
(safety objectives) of the directive, without applying
harmonised, international or national standards. In such
a case the product will not benefit from presumption of
conformity conferred by the use of such standards and
the manufacturer must include in the technical
documentation (see chapter V) a description of the
solutions adopted to satisfy the safety aspects of the
Directive.

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2.4 Conformity assessment procedures

What are the conformity assessment


procedure to be applied?
Article 8 and Annex IV of the Directive
describe the procedure by which the
manufacturer or his authorised
representative established in the Community
ensures and declares conformity of the
electrical equipment with the provisions of the
Directive.
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2.4 Conformity assessment procedures

What are the conformity assessment


procedure to be applied?
The three main elements for ensuring and
declared assessment :
1.Technical documentation : Before a product is
placed on the market the manufacturer puts
together the technical documentation which
makes it possible to assess whether the electrical
equipment complies with the requirements of the
Directive (31)

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2.4 Conformity assessment procedures

What are the conformity assessment


procedure to be applied?
The three main elements for ensuring and
declared assessment :
2. Declaration of conformity : The
manufacturer or his authorised representative
established in the Community are also required,
and are the only ones authorised to do so, to draw
up in writing a declaration of conformity (see
below) before placing the product on the market

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2.4 Conformity assessment procedures

What are the conformity assessment


procedure to be applied?
The three main elements for ensuring and
declared assessment :
3. CE marking : Before it is placed on the
market the electrical equipment must have the
"CE" marking affixed. Only the manufacturer or
his authorised representative established in the
Community are authorised to affix the "CE"
marking (see below).

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2.4 Conformity assessment procedures

What are the conformity assessment


procedure to be applied?
The responsibilities of the importer :he will
not in general, have detailed knowledge of
which directives have been considered by the
manufacturer or which standards have been
applied.

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2.4 Conformity assessment procedures

What are the conformity assessment


procedure to be applied?
As a consequence, the importer cannot:
affix CE marking;
draw up the EC declaration of conformity;
compile the Technical File.
Where neither the manufacturer nor his authorised
representative are established within the Community, the
importer is responsible for ensuring that the requirements
of Annex IV section 2 and 3 are complied with.

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2.4 Conformity assessment procedures

What are the conformity assessment


procedure to be applied?
Where no standards have been applied, the
manufacturer has to provide within the technical
documentation a description of the solutions adopted to
satisfy the safety requirements of the Directive.
In addition to the three basic conformity assessment
measures, mentioned above , Article8(2) provides, in the
event that conformity is challenged, for the possible
submission to the market surveillance authority of a test
report drawn up by a notified body

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Singapore Workshop on EU Directives 17-19
2.4 Conformity assessment procedures

What are the conformity assessment


procedure to be applied?
The manufacturer or his authorised representative
established in the Community may wish in certain cases
to ask in advance for a report to be drawn up by a
notified body in accordance with the procedure provided
for in Article 11 and to keep it together with the technical
documentation. The availability of such a report would
make matters easier and speedier in the event of a
challenge by the authorities.

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Singapore Workshop on EU Directives 17-19
2.4 Conformity assessment procedures

What must be included in the technical


documentation?
Details of the design, manufacture and
operation :
a general description of the electrical equipment,
design and manufacture drawings plus diagrams of
components, sub- assemblies, circuits, etc.,
descriptions and explanations needed to
understand the above mentioned drawings and
diagrams plus the operation of the electrical
equipment,
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2.4 Conformity assessment procedures

What must be included in the technical


documentation?
Details of the design, manufacture and operation :
a list of the standards used, in full or in part, and a
description of the solutions employed to meet the safety
aspects of this directive when standards have not been
applied,
the results of design calculations and of checks carried
out, etc.,
test reports (in fact, the test reports which may be
available, either established by the manufacturer or a third
party).
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2.4 Conformity assessment procedures

Who must keep the technical


documentation and where?
The manufacturer or his authorised
representative established in the Community for
at least ten years from the last date of
manufacture of the product.

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2.4 Conformity assessment procedures

Who must keep the technical


documentation and where?
The technical documentation may be kept on
electronic support,
Where the manufacturer is not established and
he has no authorised representative in the
Community, this obligation is incumbent upon
the importer or the person responsible for
placing the product on the Community market.
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2.4 Conformity assessment procedures

Who must keep the technical


documentation and where?
This technical documentation must be kept
within the Community .

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2.4 Conformity assessment procedures

Where must the CE marking be affixed?


The "CE" conformity marking is placed by the
manufacturer, or his authorised
representative established in the
Community, on the electrical equipment or,
failing that, on the packaging, the instructions
for use or the guarantee.

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2.4 Conformity assessment procedures

What are the meaning of, and


requirements for the CE marking?
The CE marking declares conformity of the
electrical equipment with the essential
requirements and conformity assessment
procedures of LVD and all the other directives
applicable to it.

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2.4 Conformity assessment procedures

What are the meaning of, and


requirements for the CE marking?
The "CE" conformity marking must be affixed
visibly, legibly and indelibly.
The affixing of markings which are likely to
deceive third parties as to the meaning and
form of the "CE" marking is prohibited.

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Singapore Workshop on EU Directives 17-19
2.4 Conformity assessment procedures

Who must keep the declaration of


conformity and where?
The manufacturer, or his authorised representative
established in the Community, or, when they not
established in the Community, the importer or person
responsible for placing the product on the market,
They must keep a copy of the declaration of conformity
at the disposal of the national authorities for inspection
purposes, in the same way as the technical
documentation.

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Singapore Workshop on EU Directives 17-19
2.4 Conformity assessment procedures

Who must keep the declaration of


conformity and where?
the national market surveillance authorities
may, if appropriate, require a copy of the
declaration of conformity.

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Singapore Workshop on EU Directives 17-19
2.4 Conformity assessment procedures

What must be included in the declaration of


conformity (see Annex III.B)?
name and address of the manufacturer or his
authorised representative established within the
Community,
a description of the electrical equipment,

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Singapore Workshop on EU Directives 17-19
2.4 Conformity assessment procedures

What must be included in the declaration of


conformity (see Annex III.B)?
reference to the harmonised standards used
or, where appropriate, reference to the
specifications on which conformity is declared,

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Singapore Workshop on EU Directives 17-19
2.4 Conformity assessment procedures

What must be included in the declaration of


conformity (see Annex III.B)?
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,

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Singapore Workshop on EU Directives 17-19
2.4 Conformity assessment procedures

What must be included in the declaration of


conformity (see Annex III.B)?
the last two digits of the year in which the CE
marking was affixed (for the first time).

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2.4 Conformity assessment procedures

In which language must be drawn up the


declaration of conformity?
The declaration of conformity must be drawn
up at least in one of the official languages of the
Community.

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2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to


electrical equipment which is also a "machine"
(within the meaning of the Machinery
Directive(32))?
Certain electrical equipment are also
"machinery" within the meaning of Directive
98/37/EC as amended.

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2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to .


(Within the meaning of the "Machinery Directive) ?
Certain electrical equipment which are also
machinery, are excluded altogether from the
scope of the "Machinery" Directive, by virtue of
Article 1(5) of that Directive(33).

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Singapore Workshop on EU Directives 17-19
2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to .


(Within the meaning of the "Machinery Directive) ?
Article 1(5) of the "Machinery" Directive states
that:
Where, for machinery, the risks are mainly of
electrical origin, such machinery shall be
covered exclusively by LVD.

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2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to .


(Within the meaning of the "Machinery Directive) ?
In order to determine whether the exclusion from the
scope of the "Machinery" Directive under Article 1(5)
applies to a specific product which may be considered to
be "machinery" and an electrical equipment in the sense
of LVD, the manufacturer has to perform a risk
assessment of that product.

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2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to .


(Within the meaning of the "Machinery Directive) ?
The European Standard EN 1050 (Safety of
Machinery - Principles for risk assessment)
provides for principles which may be applied for
performing such risk assessment.

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2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to .


(Within the meaning of the "Machinery Directive) ?
When the results of the risk assessment by the
manufacturer show that the risks are mainly of
electrical origin, the machinery equipment will be
covered exclusively by LVD, which anyhow
deals with all the safety aspects, including
mechanical safety

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Singapore Workshop on EU Directives 17-19
2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to . (Within


the meaning of the "Machinery Directive) ?
In determining whether the risks related to particular
products are mainly of electrical origin, manufacturers
may be assisted by risk assessment performed by the
relevant standardisation bodies in relation to
harmonised standards, when it has led to publication of
such standards under only the "Low Voltage"
Directive(34) or only the "Machinery" Directive based on
consideration of the dominant risks.

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Singapore Workshop on EU Directives 17-19
2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to . (Within


the meaning of the "Machinery Directive) ?
One example is the hand-held and transportable
electrically driven tools. It has been agreed by the LVD
Working Party that standards covering this type of
equipment shall be published only under the
"Machinery" Directive in the Official Journal, and hence
it has been agreed to apply the conformity assessment
procedures of the "Machinery" Directive rather than
those of the LVD.

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2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to .


(Within the meaning of the "Machinery Directive) ?
Apart from machinery covered by Article 1(5),
all machinery having an electrical supply and
designed to operate between 50 and 1000 V in
AC or 75 and 1500 V in DC is covered by both
the "Machinery" Directive and the "Low Voltage"
Directive, applying in a complementary way.

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Singapore Workshop on EU Directives 17-19
2.5 Relationship between the LVD and other
community directives?
What are the requirements applicable to . (Within
the meaning of the "Machinery Directive) ?
In fact, paragraph 1.5.1 of Annex I of the "Machinery"
Directive says:
"1.5.1 Where machinery has an electricity supply it
must be designed, constructed and equipped so that all
hazards of an electrical nature are or can be prevented.
The specific rules in force relating to electrical
equipment designed for use within certain voltage limits
must apply to machinery which is subject to those
limits." (35)

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Singapore Workshop on EU Directives 17-19
2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to .


(Within the meaning of the "Machinery Directive) ?
Obviously, the considerations made in
paragraph 9 above for electrical components
apply as appropriate to the electrical components
of a machinery.

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2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to .


(Within the meaning of the "Machinery Directive) ?
To ensure consistency of application, CEN &
CENELEC, under a mandate of the Commission
have been requested to ensure that all
harmonised electrical equipment standards
comply with all the relevant Essential Safety
Requirements of both the "Low Voltage"
Directive and the "Machinery" Directive.

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2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable to electrical


equipment which is intended for being permanently
incorporated in construction works?
Some types of electrical equipment covered by the "Low
Voltage" Directive are manufactured for being permanently
incorporated in construction works.
Such equipment must meet the essential requirements as
provided for by directive 89/106/EEC(36), and comply with the
conformity assessment procedures set out in its Article 13.

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2.5 Relationship between the LVD and other
community directives?
What are the requirements applicable
incorporated in construction works?
As a result, application to such electrical equipment of
the provisions of the "Construction Products" Directive
presupposes the existence of both harmonised
standards within the meaning of the "Construction
Products" Directive and decisions concerning the
conformity assessment procedures, again within
the meaning of that Directive.

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Singapore Workshop on EU Directives 17-19
2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable


incorporated in construction works?
Should these essential conditions not be met,
the provisions of Directive 89/106/EEC cannot
in practice be applied to the relevant electrical
equipment.

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2.5 Relationship between the LVD and other
community directives?

What are the requirements applicable


incorporated in construction works?
However, the "Low Voltage" Directive sets a wide
range of safety objectives, overlapping with essential
requirements in Annex I to Directive 89/106/EEC. In
order to best ensure the objectives of both directives,
existing harmonised standards (as published under the
"Low Voltage" Directive) are being examined to ensure
that they are also consistent with the relevant essential
requirements of the "Construction Products" Directive.

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Singapore Workshop on EU Directives 17-19
2.5 Relationship between the LVD and other
community directives?

What is the relation with the "Radio


equipment and telecommunications terminal
equipment" directives(37)?
Equipment, or relevant components of equipment,
falling under the R&TTE D are covered by the
provisions of that Directive regarding the essential
requirements. However, the R&TTE D does not have its
own detailed requirements, and refers to the safety
objectives of the LVD, but with no voltage limit applying.

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Singapore Workshop on EU Directives 17-19
2.5 Relationship between the LVD and other
community directives?

What is the relation with the "Radio


terminal equipment" directives?
directives?
Harmonised standards listed in the OJEC
under the LVD and identified as also applicable
under the R&TTED give a presumption of
conformity under that latter Directive, even for
voltages outside the LVD limits. Safety
standards for voltages outside the LVD range
are mandated and referenced under the
R&TTED only.
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2.5 Relationship between the LVD and other
community directives?

What is the relation with the "Radio


terminal equipment" directives?
directives?
Manufacturers can choose to use the
conformity assessment procedures of the LVD
for equipment falling within the LVD voltage
range.

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Singapore Workshop on EU Directives 17-19
2.5 Relationship between the LVD and other
community directives?

What is the relation with the "Radio


terminal equipment" directives?
directives?
Products that are subject to more than one
Directive must meet the requirements of all
applicable Directives. Where the R&TTE
element of a product is integrated into the
product, the product marking must include the
appropriate R&TTE marking, including R&TTE
equipment class identifiers and notified body
numbers, if applicable.
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2.5 Relationship between the LVD and other
community directives?

What is the relation with the "Gas


Appliances" Directive ? (38)

Appliances covered by the "Gas Appliances"


Directive often include electrical components
(controlling devices or regulating devices and
subassemblies(39)) which fall also under the "Low
Voltage" Directive. Article 1 of the "Gas
Appliances" Directive specifies that it also
applies to safety devices.

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Singapore Workshop on EU Directives 17-19
2.5 Relationship between the LVD and other
community directives?

What is the relation with the "Gas


Appliances" Directive ?
The "Gas Appliance" Directive and the "Low
Voltage" Directive apply in a complementary
way to electrical components (designed to be
used in the voltage ranges of that Directive)
incorporated into gas appliances.

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2.5 Relationship between the LVD and other
community directives?

What is the relation with the "Gas Appliances"


Directive ?
Conformity assessment within the framework of the
"Gas Appliance" Directive shall be conducted in
accordance with the procedure laid down in that
Directive, but must take into account the results of the
conformity assessment procedures of LVD applied to
electrical components of gas appliances.

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2.5 Relationship between the LVD and other
community directives?

What is the relation with the "Gas


Appliances" Directive ?
The safety aspects of the way in which the
electrical components are incorporated into the
gas appliances and ensure their proper
functioning will be subject to direct examination
by notifies bodies.

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