8

6
2
CO-22-99-014-EN-C

Guide to the implementation

of

directives based on
the New Approach

and

EUR

the Global Approach

OFFICE FOR OFFICIAL PUBLICATIONS

OF THE EUROPEAN COMMUNITIES
L-2985 Luxembourg

European Commission

Guide to the implementation

of

directives based on
the New Approach

and

the Global Approach

European Commission

This document is available on the Internet and can be downloaded in all 11 official
EU languages from the Europa server at the following address:
[Link]
A great deal of additional information on the European Union is available on the Internet.
It can be accessed through the Europa server ([Link]
Cataloguing data can be found at the end of this publication.
Luxembourg: Office for Official Publications of the European Communities, 2000
ISBN 92-828-7500-8
European Communities, 2000
Reproduction is authorised provided the source is acknowledged.
Printed in Italy

Guide to the implementation of directives based

on the New Approach and the Global Approach

FOREWORD
The single market is one of the great achievements of our time. This economic space, where goods, services, capital
and labour can circulate freely, provides a foundation for prosperity in the European Union as we move towards the 21st
century.
The European Union has developed original and innovative instruments to remove the barriers to free circulation of
goods. Among these, the New Approach to product regulation and the Global Approach to conformity assessment take
pride of place. The common thread between these complementary approaches is that they limit public intervention to
what is essential and leave business and industry the greatest possible choice on how to meet their public obligations.
Since 1987 some 20 directives, adopted on the basis of the New Approach and the Global Approach, have progressively
come into force. The operation of any innovative system inevitably raises questions. A first Guide, intended to answer
some of these, was published in 1994. This has now been updated and rewritten, on the basis of experience.
We hope that this Guide will be helpful to those who want to do business in the single market and that it will assist those
whose job it is to manage the market place. It will be an invaluable aid to the candidate countries of central and eastern
Europe in taking over the New Approach and the Global Approach and the directives adopted following them. We dare
to hope that it will also contribute to better understanding of these methods in other countries and may even lead them
to adopt similar principles.
A Guide can, at best, only draw out the meaning, significance and practical consequences of the directives to which it
refers. It cannot replace a legal text, or change what the legislator has decided. However, it can elucidate the legal text
by bringing to bear knowledge of the usage of the European Union and the provisions of the European Community Treaty
and its derived law, including the case law of the European Court of Justice. The European Commission is uniquely well
placed to do this. It has consulted widely in preparing the Guide and all opinions have been carefully considered. The
Guide has been discussed with the Senior Officials Group on Standardisation and Conformity Assessment Policy, who
agreed to its publication. As far as possible, it reflects a broad consensus. While this does not mean that it is the last
word on anything, it certainly means that it represents an authoritative expression of opinion.
This Guide has been drawn up by the Directorate-General for Enterprise in close cooperation with other Commission services, with contributions from Member State experts and interest groups. My thanks to all who have contributed to this
enterprise.

Magnus Lemmel
Acting Director-General
Directorate-General for Enterprise
September 1999

IMPORTANT NOTICE

This Guide is intended to contribute to better understanding of directives based on the New
Approach and the Global Approach, and to their more uniform and coherent application
across different sectors and throughout the single market.
It is addressed to the Member States. It is also intended to be a manual for others who need
to be informed of the provisions designed to ensure the free circulation of CE marked products as well as a high level of protection throughout the Community (such as trade associations, consumer associations, standards bodies, manufacturers, importers, distributors,
conformity assessment bodies, trade unions).
It reflects the state of the art. Therefore, the guidance offered may be subject to modifications in the future.
Only the text of the directive is authentic in law. Accordingly, the text of the directive is applicable where there are differences between the provisions of a directive and the contents of
this Guide. In particular, these differences are due to slightly divergent provisions in the individual directives, which cannot be fully described in this Guide.
The focus of this Guide is on the New Approach and the Global Approach. However, products
covered by directives based on the principles of the New Approach and the Global Approach
may also be subject to other provisions of Community law, which are not presented in this
Guide.
The guidance offered to the Member States in this Guide also applies to Iceland, Liechtenstein and Norway as signatories of the Agreement on the European Economic Area (EEA).
References to the Community or the single market are, accordingly, to be understood as
referring to the EEA, or to the EEA market.

Contents

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

6. Notified bodies . . . . . . . . . . . . . . . . . . . . . . . .36

1.1. Concept of the New Approach and the Global Approach . .7

6.1. Principles of notification . . . . . . . . . . . . . . . . . . . . . . .36

1.2. Standard elements of New Approach directives . . . . . . . .8

6.2. Notification procedure and withdrawal of notification . . . .38

1.3. Adoption of New Approach directives . . . . . . . . . . . . . .10

6.2.1. Notification procedure . . . . . . . . . . . . . . . . . . . . . .38

1.4. Transposition of New Approach directives . . . . . . . . . . .11

6.2.2. Withdrawal of notification . . . . . . . . . . . . . . . . . . . .39

1.5. New Approach directives . . . . . . . . . . . . . . . . . . . . . .12

6.3. General responsibilities of notified bodies . . . . . . . . . . .39

6.4. Notified bodies and conformity assessment . . . . . . . . . .41

2. Scope of New Approach directives . . . . . . . . .15

6.5. Notified bodies and subcontracting . . . . . . . . . . . . . . .42

[Link] submitted to directives . . . . . . . . . . . . . . . . . .15

6.6. Coordination and cooperation . . . . . . . . . . . . . . . . . . .43

2.2. Simultaneous application of directives . . . . . . . . . . . . . .16

2.2.1. New Approach directives . . . . . . . . . . . . . . . . . . . . .16

7. CE marking . . . . . . . . . . . . . . . . . . . . . . . . . . .44

2.2.2. New Approach directives and the Directive on general

7.1. Principles of CE marking . . . . . . . . . . . . . . . . . . . . . .44

product safety . . . . . . . . . . . . . . . . . . . . . . . . . . .17

7.2. Products to be CE marked . . . . . . . . . . . . . . . . . . . . .44

2.2.3. New Approach directives and the Directive on product

7.3. Affixing of the CE marking . . . . . . . . . . . . . . . . . . . . .45

liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

7.4. CE marking and other marks . . . . . . . . . . . . . . . . . . .46

2.3. Placing on the market and putting into service . . . . . . . .18

2.3.1. Placing on the market . . . . . . . . . . . . . . . . . . . . . .18

8. Market surveillance . . . . . . . . . . . . . . . . . . . . .47

2.3.2. Putting into service . . . . . . . . . . . . . . . . . . . . . . . .19

8.1. Principles of market surveillance . . . . . . . . . . . . . . . . .47

2.4. Transitional period . . . . . . . . . . . . . . . . . . . . . . . . . . .19

8.2. Market surveillance activities . . . . . . . . . . . . . . . . . . . .48

8.2.1. Monitoring of products placed on the market . . . . . . .48

3. Responsibilities . . . . . . . . . . . . . . . . . . . . . . . .21

8.2.2. Corrective actions . . . . . . . . . . . . . . . . . . . . . . . . .50

3.1. Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

8.2.3. Complementary activities . . . . . . . . . . . . . . . . . . . .51

3.1.1. New Approach directives . . . . . . . . . . . . . . . . . . . . .21

8.3. Safeguard clause procedure . . . . . . . . . . . . . . . . . . . .52

3.1.2. The Directives on product liability and general product

8.3.1. Conditions for invoking the safeguard clause . . . . . . .52

safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

8.3.2. Notification to the Commission . . . . . . . . . . . . . . . . .53

3.2. Authorised representative . . . . . . . . . . . . . . . . . . . . . .22

8.3.3. Administering the safeguard clause . . . . . . . . . . . . . .54

3.3. Importer/person responsible for placing on the market . .23

8.4. Protection of CE marking . . . . . . . . . . . . . . . . . . . . . .54

3.4. Distributor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

8.5. Information exchange systems . . . . . . . . . . . . . . . . . .55

3.5. Assembler and installer . . . . . . . . . . . . . . . . . . . . . . .24

8.5.1. Consumer products: rapid exchange of information . . .55

3.6. User (employer) . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

8.5.2. Medical devices: vigilance system . . . . . . . . . . . . . .56

3.7. Product liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

8.5.3. Community injury data-collection and information

exchange system . . . . . . . . . . . . . . . . . . . . . . . . .56

4. Compliance with directives . . . . . . . . . . . . . . .27

8.5.4. Other information exchange systems

4.1. Essential requirements . . . . . . . . . . . . . . . . . . . . . . . .27

at Community level . . . . . . . . . . . . . . . . . . . . . . . .56

4.2. Harmonised standards . . . . . . . . . . . . . . . . . . . . . . . .27

8.6. Administrative cooperation . . . . . . . . . . . . . . . . . . . . .57

4.3. Presumption of conformity . . . . . . . . . . . . . . . . . . . . .29

8.6.1. Outline for administrative cooperation . . . . . . . . . . . .57

4.4. Withdrawal of the presumption of conformity . . . . . . . . .29

8.6.2. Infrastructures for administrative cooperation . . . . . . .58

4.5. Revision of harmonised standards . . . . . . . . . . . . . . . .30

8.7. Products imported from third countries . . . . . . . . . . . . .59

5. Conformity assessment procedure . . . . . . . . .31

5.1. The modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

9. External aspects . . . . . . . . . . . . . . . . . . . . . . .62

5.2. Application of quality system standards . . . . . . . . . . . . .33

9.1. Agreement on the European Economic Area . . . . . . . . .62

5.3. Technical documentation . . . . . . . . . . . . . . . . . . . . . .34

9.1.1. Basic elements of the Agreement . . . . . . . . . . . . . . .62

5.4. EC declaration of conformity . . . . . . . . . . . . . . . . . . . .34

9.1.2. Notification of bodies . . . . . . . . . . . . . . . . . . . . . . .62

 Guide to the implementation of directives based on the New Approach and the Global Approach

9.1.3. Safeguard clause procedure . . . . . . . . . . . . . . . . . .62

Annex 2: Additional information concerning certain Articles

9.1.4. Mutual recognition agreements and European

of the Treaty establishing the European Community

conformity assessment protocols . . . . . . . . . . . . . . .63

(the EC Treaty) . . . . . . . . . . . . . . . . . . . . . . . . . .71

9.2. Mutual recognition agreements . . . . . . . . . . . . . . . . . .63

Annex 3: Additional guidance documents . . . . . . . . . . . . . . .74

9.3. European conformity assessment protocols . . . . . . . . . .64

Annex 4: Commission contact points . . . . . . . . . . . . . . . . .77

9.4. Technical assistance . . . . . . . . . . . . . . . . . . . . . . . . .64

Annex 5: Useful web addresses . . . . . . . . . . . . . . . . . . . . .79

9.5. WTO Agreement on Technical Barriers to Trade . . . . . . .65

Annex 6: Products submitted to New Approach directives . . . .80

Annex 7: Contents of conformity assessment procedures . . . .84
Annex 8: Flow chart presentation of conformity assessment

Annexes
Annex 1: Community legislation referred to in the Guide . . . . .67

procedures as provided for by the directives . . . . . .89

Introduction
1.1.

Concept of the New Approach and the Global Approach

New barriers to trade, which result from the

Free movement of goods is a cornerstone of the single market.
adoption of diverging national technical
The mechanisms in place to achieve this aim are based on
standards and regulations, can be preventprevention of new barriers to trade, mutual recognition and
ed through a procedure laid down by Directechnical harmonisation.
tive 98/34/EC (1). Member States are
obliged to notify draft technical regulations
can only be avoided or eliminated through technical harand standards to the Commission and to the other Member
States (2). During a standstill period these may not be
monisation on Community level. This harmonisation was, at
adopted, which leaves the Commission and the other Memfirst, rather slow for two reasons. First, the legislation
ber States the possibility to react. In the absence of reacbecame highly technical, as it had the objective of meeting
tions within the initial standstill period of three months, the
the individual requirements of each product category. Secdraft technical regulations may then be adopted. Otherwise,
ond, the adoption of technical harmonisation directives was
where objections are raised, a further three months standbased on unanimity in the Council.
still is imposed. The standstill period is 12 months where
The creation of a single market by 31 December 1992
there is a proposal for a directive. However, the standstill
could not have been achieved without a new regulatory techperiod does not apply where, for urgent reasons, a Member
nique that set down only the general essential requirements,
State is obliged to introduce technical regulations in a very
reduced the control of public authorities prior to a product
short space of time in order to protect public health or safebeing placed on the market, and integrated quality assurty, animals or plants. Directive 98/34/EC also gives the
ance and other modern conformity assessment techniques.
Commission the possibility of inviting, after consultation
Moreover, the decision-making procedure needed to be
with the Member States, the European standards organisaadapted in order to facilitate the adoption of technical hartions to elaborate European standards.
monisation directives by a qualified majority in the Council.
National technical regulations are subject to the proviA new regulatory technique and strategy was laid down
sions of Articles 28 and 30 of the Treaty establishing the
by the Council Resolution of 1985 on the New Approach to
European Community (the EC Treaty), which prohibit quantitatechnical harmonisation and standardisation, which estabtive restrictions or measures having equivalent effect. Case
lished the following principles.
law of the European Court of Justice, especially case 120/78
* Legislative harmonisation is limited to essential require(the Cassis de Dijon case), provides the key elements for
ments that products placed on the Community market must
mutual recognition. The effect of this case law is as follows.
meet, if they are to benefit from free movement within the
* Products legally manufactured or marketed in one country
Community.
should in principle move freely throughout the Community,
* The technical specifications of products meeting the
where such products meet equivalent levels of protection to
essential requirements set out in the directives are laid
those imposed by the Member State of exportation and where
down in harmonised standards.
they are marketed in the territory of the exporting country.
* Application of harmonised or other standards remains
* In the absence of Community measures, Member States
voluntary, and the manufacturer may always apply other
are free to legislate on their territory.
technical specifications to meet the requirements.
* Barriers to trade, which result from differences between
* Products manufactured in compliance with harmonised
national legislations, may only be accepted, if national
standards benefit from a presumption of conformity with the
measures:
corresponding essential requirements (3).
are necessary to satisfy mandatory requirements (such

The operation of the New Approach requires that the

standards offer a guaranteed level of protection with regard
to the essential requirements established by the directives,
and that the national authorities carry out their responsibilities for the protection of safety or other interests covered
by the directive. Further, a safeguard clause procedure
is necessary to allow the possibility of contesting the
conformity of a product, or failures or shortcomings of
harmonised standards.

as health, safety, consumer protection and environmental

protection);
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.
Restrictions to free movement of products, which may
be acceptable under Articles 28 and 30 of the EC Treaty,

(1) The Directive

98/34/EC is a
codification of the
Directive 83/189/EEC
and its amendments.
The Directive 98/34/EC
has been amended by
Directive 98/48/EC.
(2) According to the
Court of Justice a
breach of the
obligation to notify
renders the technical
regulations in question
inapplicable to
individuals (case C194/94).
(3) Originally, a third
party assessment was
considered necessary
where products were
not manufactured in
compliance with
harmonised standards.
This has evolved since
the first New Approach
directives were
adopted.

 Guide to the implementation of directives based on the New Approach and the Global Approach

(4) The New Approach

has not been applied in
sectors where
Community legislation
was well advanced
prior to 1985, or where
provisions for finished
products and hazards
related to such
products cannot be
laid down. For instance,
Community legislation
on foodstuffs, chemical
products,
pharmaceutical
products, motor
vehicles and tractors
does not follow the
principles of the New
Approach.
(5) Third party approval
of product or
production quality
assurance systems and
third party product
verification can also be
provided for without
third party type or
design examination.
(6) The standard
elements are
presented in the order
usually followed in the
New Approach
directives.

Since the New Approach calls for essential requiretion. The Global Approach introduced a modular approach,
ments to be harmonised and made mandatory by direcwhich subdivided conformity assessment into a number of
tives, this approach is appropriate only where it is genuineoperations (modules). These modules differ according to
ly possible to distinguish between essential requirements
the stage of development of the product (for example
and technical specifications. Further, a wide range of proddesign, prototype, full production), the type of assessment
ucts has to be sufficiently homogenous, or a horizontal
involved (for example documentary checks, type approval,
hazard identifiable, to allow common essential requirequality assurance), and the person carrying out the assessments. The product area or hazard concerned must also be
ment (the manufacturer or a third party).
suitable for standardisation (4).
The Global Approach was completed by Council DeciIn addition to the principles of the New Approach, consion 90/683/EEC, which was replaced and brought up to
ditions for reliable conformity assessment are necessary.
date by Decision 93/465/EEC. These decisions lay down
The key elements in this respect are the building of congeneral guidelines and detailed procedures for conformity
fidence through competence and transparency, and the
assessment that are to be used in New Approach directives.
setting up of a comprehensive policy and framework for
Thus, conformity assessment is based on:
conformity assessment. The Council Resolution of 1989
manufacturers internal design and production control
on the Global Approach to certification and testing states
activities;
the following guiding principles for Community policy on
third party type examination combined with manufacturconformity assessment.
ers internal production control activities;
* A consistent approach is developed in Community legis third party type or design examination combined with
lation by devising modules for the various phases of conthird party approval of product or production quality assurformity assessment procedures, and by laying down criteria
ance systems, or third party product verification (5);
for the use of these procedures, for the designation of bod third party unit verification of design and production; or
ies operating these procedures, and for the use of the CE
third party approval of full quality assurance systems.
marking.
In addition to laying down guidelines for the use of con* The use of European standards relating to quality assurformity assessment procedures in technical harmonisation
ance (EN ISO 9000 series), and to the requirements to be
directives, Decision 93/465/EEC harmonises the rules for
fulfilled by conformity assessment bodies operating quality
the affixing and use of the CE marking.
assurance (EN 45000 series) is generalised.
* Setting up of accreditation systems and
1.2. Standard elements of New Approach
the use of inter-comparison techniques
directives
(6)
are promoted in Member States and at
Community level.
* Mutual recognition agreements con New Approach directives are based on the following
cerning testing and certification in the nonprinciples.
regulatory sphere are promoted.
* Harmonisation is limited to essential requirements.
* The differences of existing quality infra* Only products fulfilling the essential requirements may be
structures (such as calibration and metroloplaced on the market and put into service.
gy systems, testing laboratories, certifica*
Harmonised standards, the reference numbers of which
tion and inspection bodies, and accreditahave been published in the Official Journal and which have
tion bodies) between Member States and
between industrial sectors are minimised by
been transposed into national standards, are presumed to conprogrammes.
form to the corresponding essential requirements.
* International trade between the Commu* Application of harmonised standards or other technical
nity and third countries is promoted by
specifications remains voluntary, and manufacturers are free
means of mutual recognition agreements,
to choose any technical solution that provides compliance
cooperation and technical assistance prowith the essential requirements.
grammes.
*
Manufacturers may choose between different conformity
The New Approach entailed refining conassessment procedures provided for in the applicable direcformity assessment in such a way as to
allow the Community legislator to evaluate
tive.
the consequences of the utilisation of different conformity assessment mechanisms. The objective was to provide flexibility of conformity
Scope
assessment over the entire manufacturing process in order
The scope defines the range of products covered by the
for it to be adapted to the needs of each individual operadirective, or the nature of hazards the directive is intended

 Introduction

to avert. It usually covers hazards related to a product or to

Presumption of conformity

a phenomenon. Accordingly, several directives may apply to

Products that comply with national standards transposing

the same product.

harmonised standards, the reference numbers of which

Scope of New Approach directives: Chapter 2.

have been published in the Official Journal of the European

Placing on the market and putting into service

Communities, are presumed to comply with the corresponding essential requirements. Where the manufacturer

Member States are obliged to take the necessary measures

has not applied, or has only partially applied, such a stan-

to ensure that products are placed on the market and put

dard, the measures taken and their adequacy must be

into service only if they do not endanger the safety and

documented in order to comply with the essential require-

health of persons, or other public interests covered by the

ments.

directive, when properly installed, maintained and used for

Compliance with directives: Chapter 4.

the intended purposes. This entails an obligation for market

Safeguard clause

surveillance on the part of the Member States.

Member States are allowed to adopt, in compliance with

Member States are obliged to take all appropriate meas-

the Treaty (in particular Articles 28 and 30 of the EC Treaty),

ures to prohibit or restrict the placing on the market of prod-

additional national provisions to protect, in particular, work-

ucts bearing the CE marking or to withdraw them from the

ers, consumers or the environment. However, these provi-

market, if these products might compromise the safety and

sions may neither require modifications of the product nor

health of individuals or other public interests covered by the

influence the conditions for its placing on the market.

applicable directives, when the products are used for their

Placing on the market and putting into service: Section 2.3.

intended purpose. Further, Member States must inform the

Market surveillance: Chapter 8

Commission when they take such a measure. Where the

Commission considers the national measure justified, it

Essential requirements

informs all Member States who must take appropriate

Essential requirements are set out in the annexes to the

action in view of their general obligation to enforce Com-

directives, and include all that is necessary to achieve the

munity legislation.

objective of the directive. Products may be placed on the

Market surveillance: Chapter 8.

market and put into service only if they are in compliance

Safeguard clause procedure: Section 8.3.

with the essential requirements.

Conformity assessment

New Approach directives are generally designed to

cover all hazards related to the public interest that the direc-

Before placing a product on the Community market, the

tive intends to protect. Thus, compliance with Community

manufacturer must subject the product to a conformity

legislation often requires simultaneous application of sever-

assessment procedure provided for in the applicable direc-

al New Approach directives and, possibly, other Community

tive, with the view to affixing the CE marking.

legislation. Further, some elements may have been left out-

Conformity assessment procedure: Chapter 5.

side the scope of applicable Community legislation. This

allows Member States to draw up national legislation in

Notified bodies

accordance with Articles 28 and 30 of the EC Treaty.

Third party conformity assessment is carried out by notified

Compliance with directives: Chapter 4.

bodies, which have been designated by the Member States

among bodies that fulfil the requirements laid down in the

Free movement

directive and that are established on their territory.

Member States must presume that products bearing the CE

Notified bodies: Chapter 6.

marking comply with all the provisions of the applicable

directives providing for its affixing. Accordingly, Member

CE marking

States may not prohibit, restrict or impede the placing on

Products in compliance with all provisions of the applica-

the market and putting into service in their territory of prod-

ble directives providing for the CE marking must bear this

ucts bearing the CE marking, unless the provisions relating

marking. Thus, the CE marking is, in particular, an indica-

to CE marking are incorrectly applied.

tion that the products comply with the essential require-

As an exception, Member States may prohibit, restrict

ments of applicable directives and that the products have

or impede the free movement of products bearing CE mark-

been subject to a conformity assessment procedure pro-

ing in accordance with Articles 28 and 30 of the EC Treaty

vided for in the directives. Further, Member States are

because of a hazard that is not covered by the applicable

obliged to take appropriate measures to protect the CE

directives.

marking.

Placing on the market and putting into service: Section 2.3.

CE marking: Chapter 7.

CE marking: Chapter 7.

Protection of CE marking: Section 8.4.

 Guide to the implementation of directives based on the New Approach and the Global Approach

Coordination of implementation

est groups (for example notified bodies, standards organisations, manufacturers, distributors, consumer organisations and trade unions), and chaired by the Commission (7).

Where a Member State or the Commission considers that a

harmonised standard does not fully meet the essential
requirements of a directive, the matter will be brought to the
attention of the committee set up by the Directive
98/34/EC (Committee on Technical Standards and Regulations). The Commission, taking into account the Committees opinion, notifies the Member States whether or not the
standard should be withdrawn from the list published in the
Official Journal of the European Communities.
Many New Approach directives provide for a standing
committee to assist the Commission, delivering its opinion
on draft measures to implement the provisions of the relevant directive and examining matters relating to the implementation and practical application of the directive. Further,
regular meetings to discuss technical implementation
issues take place in working groups, which are composed
of representatives appointed by Member States and inter-

Withdrawal of the presumption of conformity: Section 4.4.

Administrative cooperation: Section 8.6.
Transposition and transitional provisions
Member States are required to transpose the provisions of
the directives into their national legislation. They must also
inform the Commission of the measures taken.
Member States must permit the placing on the market
of products that comply with regulations in force in their territory at the date of application of the directive in question,
until the date as set up by the directive. Under certain
restrictions, such products must also be permitted to be
put into service beyond that date.
Transposition of New Approach directives: Section 1.4.
Transitional period: Section 2.4.

After receiving a Commission proposal,

the Council requests an opinion from the Parliament and the Economic and Social Com New Approach directives are based on Article 95 of the EC
mittee before reaching its common position
Treaty, and adopted according to the co-decision procedure
on the proposal. Once the common position
provided for in Article 251 of the EC Treaty.
has been reached, it is transmitted to the Par Adopted New Approach directives are published in the L
liament, which may accept, reject or propose
amendments during this second reading. The
series of the Official Journal of the European Communities.
Commission re-examines its proposal in the
Commission proposals for New Approach directives are publight of Parliaments amendments, and relished in the C series of the Official Journal.
turns the proposal to the Council, which takes
a final decision within three months. If necessary, problems are referred to a conciliation committee of
The legal basis for adopting or modifying New Approach
Council and Parliament, in which the Commission participates
directives is Article 95 of the EC Treaty. According to Artias a moderator. The flow chart in Table 1.1 shows the adopcle 251 of the EC Treaty, the Commission initiates the legtion procedure according to Article 251 of the EC Treaty, and
islative procedure by making a proposal to the Council and
the alternatives at the different phases.
to the European Parliament. Such Commission proposals
Up to the adoption of the common position, discussion
concerning health, safety, environmental protection and
is based on the Commissions proposal. While the Commisconsumer protection should, according to Article 95 take
sion can modify its proposal at any time, for example in the
as a basis a high level of protection. Further, Article 95
light of the opinion of the Parliament, the Council can only
requires that a safeguard clause is provided for in appropridiverge from the Commissions proposal by unanimity.
ate cases.
1.3.

Adoption of New Approach directives

(7) The cooperation is

based on the Council
Resolution of 1994 on
the development of
administrative
cooperation in the
implementation and
enforcement of
Community legislation
in the internal market.

10

 Introduction

Table 1/1 Adoption of directives according to Article 251 of the EC Treaty

The Commission
makes a proposal.
The Council
after obtaining
the opinion of the
European Parliament
and the Economic
and Social Committee
adopts a common position
by a qualified majority.
The European Parliament
(within three months)

approves or does
not take a decision.

The act is
adopted by
the Council.

proposes amendments.

The Council adopts

all the amendments
and the act.

rejects.

The Council convenes

a meeting of the
conciliation committee.

The conciliation committee

approves a joint text.

If the joint text is adopted

by the European Parliament
and the Council

The Council can convene

the conciliation committee
to explain its position.

The conciliation committee

does not approve
a joint text.

The act is
not adopted.

the act is adopted.

The Council can confirm

the common position
by an absolute majority.

The European Parliament

confirms its rejection of the
common position
by an absolute majority.

The act is
not adopted.

The act is adopted, unless

the European Parliament
by an absolute majority
rejects the common
position in the last resort.

lation. Further, Member States are, as a

general rule, not allowed to maintain or
introduce more stringent measures than
New Approach directives are total harmonisation direcforeseen in the directive, as is the case for
tives: the provisions of these directives supersede all corredirectives adopted according to Article 138
sponding national provisions.
of the EC Treaty (directives aiming to
New Approach directives are addressed to the Member
improve the health and safety of workers,
States, which have an obligation to transpose them into their
especially, in the working environment) (8).
national legislation as appropriate.
Directives are, according to Article 249
National laws, regulations or administrative provisions,
of the EC Treaty, binding on the Member
States as to the result to be achieved, but
which transpose the directive, shall contain a reference to the
the choice of form and method is their own.
directive in question or shall be accompanied by such a referCase law of the European Court of Justice
ence on the occasion of their official publication.
has clarified the contents of this obligation
National laws, regulations or administrative provisions,
and the possible measures to be taken
which are adopted and published in order to transpose a
where a non-compliance can be estabdirective, must be communicated to the Commission.
lished (9).
It is up to the Member States to decide
which measures should be adopted and
New Approach directives approximate the laws of Member
published in order to comply with a directive. However,
States in order to remove barriers to trade. Since New
Member States must take appropriate implementing measApproach directives are total harmonisation directives,
ures to transpose the directive in a way that fully meets the
Member States must repeal all contradictory national legis-

1.4.

Transposition of New Approach directives

11

(8) As an exception,
additional national
provisions in areas
covered by New
Approach directives
may be acceptable in
accordance with
Articles 28 and 30 of
the EC Treaty (see
Section 1.2).
(9) Judgement of the
Court: cases C-102/79,
C-30/81, C-34/81,
C-102/79, C-29/84,
C-178/84, C-179/84,
C-188/84, C-190/84,
C-392/93, C-46/93,
C-48/93 and C-66/95.

 Guide to the implementation of directives based on the New Approach and the Global Approach

requirements of clarity and certainty in legal situations,

which directives seek for the benefit of traders established
in other Member States. This may not necessarily require
legislative action in each case as regards all the provisions
of a directive.
Failure to take measures, or the correct measures, to
transpose a directive in order to achieve the results it prescribes, within the period laid down for that purpose, constitutes a breach of Community law. According to Article
226 of the EC Treaty, the Commission may
take action against a Member State, which
1.5. New
has failed to fulfil an obligation under the
Treaty. Further, according to Article 228,
Member States are required to take necessary measures to comply with the judgement of the Court
of Justice.
Member States are obliged to make reparation for damages that result from breaching Community law. This obli-

gation exists where three conditions are fulfilled: the rule of

law infringed is intended to confer rights on individuals; the
breach is sufficiently serious; and there is a direct causal
link between the breach of the obligation resting on the
Member State and the damage sustained by the injured
party. Failure to take any of the necessary measures to
transpose a directive within the period laid down by the
directive will amount to a sufficiently serious breach (10).

Approach directives (11)

In this Guide the New Approach directives are defined as
directives that provide for the CE marking. In addition there
are certain directives that follow the principles of the New
Approach or the Global Approach, but which do not provide
for the CE marking.

Table 1/2 New Approach directives (directives providing for the CE marking)
Directive
(as referred to in this Guide)

(10) Judgement of the

Court, case C-178/94.
(11) For a complete
presentation of
directives referred
to in this section,
see Annex 1.
(12) This Directive,
drawn up in 1973
before the concept of
New Approach and
Global Approach was
established, was, to
some extent, aligned in
1993 with other New
Approach directives.
(13) This is not a
modification of the
Directive relating to
electromagnetic
compatibility, but it
has an impact on its
application.
(14) This Directive
codifies into one single
text Directive
89/392/EEC, as modified
by Directives
91/368/EEC, 93/44/EEC
and 93/68/EEC. The
date of application is
based on the original
Directives.

1.

Low voltage equipment (12)

2.

Simple pressure vessels

3.

Toys

4.

Construction products

5.

Electromagnetic compatibility

6.

Machinery (14)

7.

Personal protective equipment

Non-automatic
weighing instruments
9. Active implantable
medical devices
93/68/EEC
10. Gas appliances
8.

11.

Hot water boilers

12.

Civil explosives
Medical devices

13.

Number of Directive,
Amendment

Date of
application

End of transitional
period

73/23/EEC
93/68/EEC
87/404/EEC
90/488/EEC
93/68/EEC
88/378/EEC
93/68/EEC
89/106/EEC
93/68/EEC
89/336/EEC
92/31/EEC
93/68/EEC
(98/13/EC) (13)
98/37/EC

19/8/74
1/1/95
1/7/90
1/7/91
1/1/95
1/1/90
1/1/95
27/6/91
1/1/95
1/1/92
28/10/92
1/1/95
6/11/92
1/1/93
1/1/93
1/1/95
1/1/95
7/6/00
1/7/92
1/1/95
29/1/94
1/1/97
1/1/93
1/1/95
1/1/93
1/1/95
1/1/97
1/1/92
1/1/95
1/1/94
1/1/95
1/1/95
1/1/95
7/6/00

1/1/97
1/1/97
1/7/92

98/79/EC
89/686/EEC
93/68/EEC
93/95/EEC
96/58/EC
90/384/EEC
93/68/EEC
90/385/EEC
93/42/EEC
1/1/95
90/396/EEC
93/68/EEC
92/42/EEC
93/68/EEC
93/15/EEC
93/42/EEC
98/79/EC

12

1/1/97
1/1/97
1/1/97
31/12/95
1/1/97
31/12/94
31/12/94
31/12/96
1/1/97
30/6/95
1/1/97

31/12/02
1/1/97
31/12/94
14/6/98
31/12/95
1/1/97
31/12/97
1/1/97
31/12/02
14/6/98
30/6/01

 Introduction

Table 1/2 New Approach directives (directives providing for the CE marking) (continued)
Directive
(as referred to in this Guide)
14.

15.
16.
17.
18.
19.

20.

21.

Potentially explosive
atmospheres
Recreational craft
Lifts
Refrigeration appliances
Pressure equipment
Telecommunications
terminal equipment (15)
In vitro diagnostic
medical devices
Radio and telecommunications
terminal equipment (16)

Number of Directive,
Amendment

Date of
application

End of transitional
period

94/9/EC

1/3/96

30/6/03

94/25/EC
95/16/EC
96/57/EC
97/23/EC
98/13/EC

16/6/98
30/6/99

98/79/EC

16/6/96
1/7/97
3/9/99
29/11/99
6/11/92
1/5/92
1/1/95
7/6/00

99/5/EC

8/4/00

29/5/02

7/12/03
7/12/05
7/4/00
7/4/01

Table 1/3 Directives based on the principles of the New Approach or the Global Approach,
but which do not provide for the CE marking
Directive
(as referred to in this Guide)

Number of Directive

Date of
application

End of transitional
period

Packaging and
packaging waste (17)
2. High speed rail systems
3. Marine equipment

94/62/EC

30/6/96

31/12/99

96/48/EC
96/98/EC

8/4/99
1/1/99

1.

Table 1/4 Proposals for directives based on the principles of the New Approach
or the Global Approach
Draft Directive

Number of proposal,
Amendment

1.

Articles of precious metal

COM/93/322 final
COM/94/267 final
COM/93/646 final
COM/96/191 final
COM/98/46 final

Cableway installations designed to carry passengers

Marking of packaging
4. Noise emission
2.
3.

13

(15) This Directive

codifies into one single
text Directive
91/263/EEC, as modified
by Directive 93/68/EEC,
and the supplementary
Directive 93/97/EEC.
The date of application
is based on the original
Directives.
(16) This Directive will
replace the Directive
on telecommunications
terminal equipment.
(17) This Directive
contains neither a
conformity assessment
procedure nor a
marking regime, which
were foreseen in the
proposal for a directive
on marking of
packaging (COM/96/191
final). Thus, only
Chapter 4 of the Guide
is relevant for the
Directive on packaging
and packaging waste.

2. Scope of New Approach directives

New Approach directives apply to products

2.1. Products submitted to directives
which are intended to be placed (or put into
service) on the Community market (19). Usu New Approach directives apply to products which are
ally such products are ready for use, or
intended to be placed (or put into service) on the Community
require only adjustments that can be permarket for the first time. Consequently, the directives apply to
formed in view of their intended use. Furnew products manufactured in the Member States, and to new,
ther, the directives apply only when the
product is placed (and put into service) on
as well as used and second-hand, products imported from
the Community market for the first time.
third countries (18).
Consequently, the directives apply also to
The concept of product varies between New Approach
used and second-hand products imported
directives, and it is the responsibility of the manufacturer to
from a third country when they enter the
verify whether or not the product is within the scope of one or
Community market for the first time, but not
more directives.
to such products already on the Community
Products that have been subject to important changes may
20
market ( ). This applies even to used and
be
considered as new products that have to comply with the
second-hand products imported from a
third country that were manufactured
provisions of the applicable directives when placed on the
before the directive became applicable.
Community market and put into service. This has to be
The concept of product varies between
assessed on a case-by-case basis, unless otherwise provided
New Approach directives (21). The objects
for.
submitted to the directive are referred to,
Products, which have been repaired without changing the
for instance, as products, equipment, appaoriginal performance, purpose or type, are not subject to
ratus, devices, appliances, instruments,
conformity assessment according to the New Approach
material, assemblies, components or safedirectives.
ty components, units, fittings, accessories
or systems. It is the responsibility of the
Products specially or exclusively intended for military or
manufacturer to verify whether or not the
police purposes are explicitly excluded from the scope of
product is within the scope of a direccertain New Approach directives. For the other directives,
tive (22).
Member States may, under certain conditions, exclude from
A combination of products and parts,
their field of application according to Article 296 of the EC
which each comply with applicable direcTreaty, products intended specifically for military purposes.
tives, does not always have to comply as a
whole. However, in some cases, a combination of different products and parts
purpose or type after it has been put into service, may be
designed or put together by the same person is considered
considered as a new product. This has to be assessed on a
as one finished product which, as such, has to comply with
case-by-case basis and, in particular, in view of the objective
the directive. In particular, the manufacturer of the combiof the directive and the type of products covered by the
nation is responsible for selecting suitable products to
directive in question. Where a rebuilt or modified product is
make up the combination, for putting the combination
considered as a new product, it must comply with the protogether in such a way that it complies with the provisions
of the directives concerned, and for fulfilling all the requirevisions of the applicable directives when it is placed on the
ments of the directive in relation to the assembly, the EC
market and put into service. This has to be verified as
declaration of conformity and CE marking. The decision
deemed necessary according to the risk assessment by
whether a combination of products and parts needs to be
applying the appropriate conformity assessment procedure
considered as one finished product has to be taken by the
laid down by the directive in question. In particular, if the risk
manufacturer (22) on a case-by-case basis.
assessment leads to the conclusion that the nature of the
A product, which has been subject to important
hazard or the level of risk has increased, then the modified
changes that aim to modify its original performance,
product should normally be considered as a new product.

15

(18) Nothing in this

Guide is intended to
prevent or prohibit the
manufacture of
products to meet the
requirements of a third
country where such
products will be placed
on the market and put
into service outside the
Community.
(19) For placing on the
market and putting into
service, see Section 2.3.
(20) In this context the
Community should be
considered to mean the
present Member
States, where free
movement of used and
second-hand products
takes place according
to Articles 28 and 30 of
the EC Treaty.
(21) See Annex 6.
(22) In some situations
the responsibilities of
the manufacturer are
taken over by another
person, see Sections
3.1 3.3.

 Guide to the implementation of directives based on the New Approach and the Global Approach

(23) For products used

at the workplace the
employer must take all
measures necessary to
ensure that work
equipment is suitable
and safe. For instance,
the user of repaired
machinery must ensure
that it is no less safe
than the original. See
Section 3.6.
(24) See Directives
relating to machinery,
personal protective
equipment, civil
explosives, potentially
explosive atmospheres,
lifts, pressure
equipment, and radio
and telecommunications
terminal equipment.
(25) For instance:
the Directive
relating to low voltage
equipment is not
applicable to electrical
equipment for medical
purposes, instead
either the Directive
relating to active
implantable medical
devices or medical
devices may apply;
the Directive
relating to
electromagnetic
compatibility is not
applicable to products
covered by specific
directives that
harmonise the
protection
requirements specified
in the Directive on
electromagnetic
compatibility;
the Directive
relating to personal
protective equipment
applies in all aspects,
where the principal
intended purpose of the
personal protective
equipment is to protect
the person using it,
whether or not this
takes place in a
medical environment;
the Directive
relating to lifts is not
applicable to lifts
connected to
machinery and
intended exclusively for
access to the
workplace, instead the
Directive relating to
machinery applies; and
marine equipment,
which is also within the
scope of other

The person who carries out important changes to the prod-

from the scope of the directives. However, at the design

uct is responsible for verifying whether or not it should be

stage of the product the intended use and maintenance

considered as a new product.

must be taken into account (23).

Products which have been repaired (for example follow-

Some New Approach directives explicitly exclude prod-

ing a defect), without changing the original performance,

ucts that are specially or exclusively intended for military or

purpose or type, are not to be considered as new products

police purposes (24). For other directives Article 296 of the EC

according to New Approach directives. Thus, such products

Treaty may be taken into consideration, unless the product ac-

need not undergo conformity assessment, whether or not

cording to its definition cannot be used for military purposes

the original product was placed on the market before or

(such as toys, recreational craft and refrigeration appliances).

after the directive entered into force. This applies even if the

Article 296(1) of the EC Treaty offers Member States the pos-

product has been temporarily exported to a third county for

sibility of excluding from the application of Community legisla-

the repair operations. Such operations are often carried out

tion products intended for specifically military purposes, inso-

by replacing a defective or worn item by a spare part, which

far as the products concerned appear in the list drawn up by

either is identical, or at least similar, to the original spare

the Council according to Article 296(2), and provided such ex-

part (for example modifications may have taken place due

clusion may not have an adverse effect on the competition

to technical progress, or discontinued production of the old

conditions in the Community market concerning products that

part). Thus, maintenance operations are basically excluded

are not specifically intended for military purposes.

Simultaneous application of directives

be designed and manufactured in accordance with all applicable directives, as well

2.2.1. New Approach directives
as to undergo the conformity assessment
procedures according to all applicable
Essential requirements set up by New Approach directives
directives, unless otherwise provided for.
may overlap or complement each other, depending on the hazCertain directives make a direct referards covered by these requirements that are related to the
ence to the application of other directives
product in question.
(for example the Directive relating to lifts
The placing on the market and putting into service can only
refers to the Directives relating to machinery, and the Directive relating to telecomtake place when the product complies with the provisions of
munications terminal equipment to the
all applicable directives, and when the conformity assessDirective relating to low voltage equipment).
ment has been carried out in accordance with all applicable
Although such a reference has not been
directives.
included in a number of directives, the gen Where the same product or hazard is covered by two or more
eral principle of simultaneous application
directives, the application of other directives can sometimes
still applies where the essential requirebe excluded following an approach that includes a risk analyments of the directives are complementary
sis of the product with a view to intended use as defined by the
to each other.
Two or more directives can cover the
manufacturer.
same product or hazard. In such a case, the
New Approach directives cover a wide range of products
application of other directives is often limitand hazards, which both overlap and complement each
ed by excluding certain products from the field of applicaother. As a result several directives may have to be taken
tion of the other directives, or by giving preference to the
into consideration for one product, since the placing on the
more specific directive. This usually requires a risk analysis
market and putting into service can only take place when
of the product, or sometimes an analysis of the intended
the product complies with all applicable provisions.
purpose of the product, which then determines the applicaHazards covered by the essential requirements of the
ble directive. In specifying the hazards related to a product,
directives concern different aspects that in many cases
the manufacturer may be assisted by the risk assessment
complement each other (for example the Directives relating
performed by the standards bodies in relation to harto electromagnetic compatibility and pressure equipment
monised standards for the product in question. Taking into
cover phenomena not covered by the Directives relating to
account the dominant hazards of the product this risk analylow-voltage equipment or machinery). This calls for a joint
sis may lead to the publication of such standards under only
application of the directives. Accordingly, the product has to
one of the possibly applicable directives (25).
2.2.

16

 Scope of New Approach directives

The Directive on general product safety

2.2.2. New Approach directives and the Directive on general
(92/59/EEC) aims to ensure that consumer
product safety
products placed on the market do not pres The Directive on general product safety applies to consumer
ent a risk under conditions of use that are
products supplied in the course of commercial activity,
normal or can be reasonably foreseen. It
provided that:
requires producers to place only safe products on the market, and to inform about
* the product is not covered by New Approach directives or
risks. It also obliges Member States to surother Community legislation; or
vey products on the market, and to inform
* not all aspects of safety or categories of risk are covered by
the Commission about actions taken
New Approach directives or other Community legislation.
through either a safeguard clause procedure or the information system for serious
and immediate risks. The Directive on general product safeConsumer products outside the field of application of
ty covers new, used and reconditioned products intended
New Approach directives and other Community legislation
for consumers or likely to be used by consumers, supplied
(for example products not complying with the definition laid
in the course of commercial activity. According to this defidown by the directive in question, used and second-hand
nition, products within the scope of several New Approach
products that were originally placed on the Community mardirectives are to be considered as consumer products
ket before the directive entered into force, and repaired
(such as toys, recreational craft, refrigeration appliances,
products) come under the Directive on general product
and to certain extent electrical equipment, gas appliances,
safety, where they are supplied in the course of commercial
machinery, personal protective equipment and pressure
activity.
equipment).
New Approach directives do not contain any system for
The Directive on general product safety is applicable
rapid exchange of information between market surveillance
insofar as there are no specific provisions in rules of Comauthorities in emergency situations, with the exception of
munity law governing all the safety aspects of the products
the vigilance system included in the directives relating to difconcerned. Further, where specific rules of Community law
ferent types of medical devices. Therefore, the provisions
contain provisions governing only certain aspects of prodconcerning the procedure for rapid exchange of information
uct safety or categories of risk for the product concerned,
on dangers, and the subsequent action at Community level
these provisions are applicable to the products in question
are applicable to consumer products covered by New
with regard to the relevant safety aspects or risks. This rule
Approach directives (26).
gives priority to the application of New Approach directives
The Directive on general product safety contains
for all aspects of product safety and categories of risk they
detailed provisions on market surveillance (Articles 5 and
cover. Further, for products covered by New Approach
6). These provisions are not directly applicable in sectors
directives the objective has been to cover all foreseeable
covered by New Approach directives, but they provide a
risks, if necessary by means of simultaneous application of
model for obligations and powers that are necessary for
these directives and other relevant provisions of Communicarrying out market surveillance, in particular as regards
ty legislation.
consumer products.

The objective of New Approach directives is

2.2.3. New Approach directives and the Directive on product liability
to protect the public interest (for example
The Directive on product liability is applicable to all
health and safety of persons, consumer proproducts
covered by New Approach directives.
tection, protection of business transactions, environmental protection). Thus, they
intend to prevent, as far as possible, the placing on the marthe manufacturer, the importer and the distributor to supply
ket and putting into service of unsafe or otherwise non-comsafe products in order to avoid the costs that liability places
pliant products. The Directive on product liability
on them for defective products causing damages to individ(85/374/EEC), which is applicable to all products covered
ual or property. Consequently, New Approach directives and
by New Approach directives, provides a powerful incentive
the Directive on product liability are complementary eleto guarantee the safety of products. It is in the interest of
ments in ensuring an adequate level of protection (27).

17

directives than the

Directive on marine
equipment, is excluded
from the application of
such directives.
(26) This procedure is
described in Section
8.5.1.
(27) For product liability,
see Section 3.7.

 Guide to the implementation of directives based on the New Approach and the Global Approach

(28) Directives relating

to toys, low-voltage
equipment,
construction products,
civil explosives and
refrigeration
appliances cover only
placing on the market.
(29) Placing on the
market has only been
defined in very few
directives. According to
the Directive on toys it
covers both sale and
distribution free of
charge; according to
the Directives relating
to active implantable
medical devices,
medical devices and in
vitro diagnostic
medical devices it
means the first making
available in return for
payment or free of
charge of a device,
with a view to
distribution and/or use
on the Community
market, regardless of
whether it is new or
fully refurbished;
according to the
Directive on civil
explosives it means the
first disposal against
payment or free of
charge of explosives
covered by the
Directive, with a view
to their distribution
and/or use on the
Community market; and
according to the
Directive on lifts it
occurs when the
installer first makes the
lift available for the
end user.
(30) Thus, imports for
own use are also
considered as being
placed on the market
at the moment they
enter the Community.
The responsibility for
the compliance of the
product in such
situations is described
in Sections 3.1 3.3.
Products built
for own use are,
generally, not
considered as being
placed on the market.
However, concerning
the Directive relating to
construction products
it should be considered
that, in order to
achieve the objectives
of this Directive,

2.3.

Placing on the market and putting into service

product on the Community market (31). The

transfer may also take place directly from

Placing on the market is the initial action of making a prod-

uct 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.
Putting into service takes place at the moment of first use
within the Community by the end user. However, the need to
ensure, in the framework of market surveillance, that products
are in compliance with the provisions of the directives when
being put into service is limited.
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 (28).
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; and
* 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.

the manufacturer, or authorised representative in the Community, to the final consumer

or user.
The product is considered to be transferred either when the physical hand-over or
the transfer of ownership has taken place.
This transfer can be for payment or free of
charge, and it can be based on any type of
legal instrument. Thus, a transfer of a product is considered to have taken place, for
instance, in the circumstances of sale, loan,
hire, leasing and gift.
Placing on the market is considered not
to take place where a product is:
transferred from the manufacturer in a
third country to an authorised representative in the Community whom the manufacturer has engaged to ensure that the product complies with the directive (32);
transferred to a manufacturer for further
measures (for example assembling, packaging, processing or labelling) (33);
not (yet) granted release for free circulation by customs, or has been placed under
another customs procedure (for example
transit, warehousing or temporary importa-

2.3.1. Placing on the market (29)

tion), or is in a free zone (34);

manufactured in a Member State with a

New Approach directives are designed to ensure free movement of products that comply with the high level of protection
laid down in the applicable directives. Therefore, Member
States may not prohibit, restrict or impede the placing on the
market of such products. However, Member States are allowed to maintain or adopt, in compliance with the Treaty (in
particular Articles 28 and 30 of the EC Treaty), additional
national provisions regarding the use of particular products
which are intended for the protection of workers or other users,
or the environment. Such national provisions may neither require modifications of a product manufactured in accordance
with the provisions of the applicable directives, nor influence
the conditions for its placing on the Community market.
A product is placed on the Community market when it is
made available for the first time. This is considered to take
place when a product is transferred from the stage of manufacture with the intention of distribution or use on the Community market (30). Moreover, the concept of placing on the

view to exporting it to a third country;

displayed at trade fairs, exhibitions or demonstrations (35); or
in the stocks of the manufacturer, or the authorised representative established in the Community, where the product is not yet made available, unless otherwise provided for
in the applicable directives.
A product offered in a catalogue or by means of electronic
commerce is deemed not to have been placed on the Community market until it is actually made available for the first
time. In order to respect the rules and principles aiming to prohibit misleading advertising, a non-compliance of a product intended for the Community market should be clearly indicated.
Products must be in compliance with the applicable New
Approach directives, and other Community legislation, when
they are placed on the market. Accordingly, new products
manufactured in the Community and all products imported

market refers to each individual product, not to a type of

product, and whether it was manufactured as an individual
unit or in series.

from third countries whether new or used must meet the

The transfer of the product takes place either from the

have an obligation to ensure this in the framework of market

manufacturer, or the manufacturers authorised representa-

surveillance (36). Used products, which are on the Commu-

tive in the Community, to the importer established in the

nity market, are subject to free movement according to the

Community or to the person responsible for distributing the

principles laid down by Articles 28 and 30 of the EC Treaty.

provisions of the applicable directives when made available

for the first time on the Community market. Member States

18

 Scope of New Approach directives

2.3.2. Putting into service (37)

which are not placed on the market prior to putting into

service (for example products manufactured for own
use) (39).
Member States may not prohibit, restrict or impede the
putting into service of products that meet the provisions of
the applicable directives (40). However, Member States are
allowed to maintain and adopt, in compliance with the Treaty
(in particular Articles 28 and 30 of the EC Treaty), additional national provisions regarding the putting into service,
installation or use, of products which are intended for the
protection of workers or other users, or other products.
Such national provisions may not require modifications of a
product manufactured in accordance with the provisions of
the applicable directives.

Putting into service takes place at the moment of first use

within the Community by the end user (38). Where the product is put into service at the workplace, the employer is to
be considered as the end user.
Products must comply with the provisions of the applicable New Approach directives and other Community legislation when they are put into service. However, the need to
verify the compliance of products, and if applicable that
they are correctly installed, maintained and used for the
intended purpose, should be limited, in the framework of
market surveillance (36), to products:
which can only be used after an assembly, an installation
or other manipulation has been carried out;
whose compliance can be influenced by the distribution
conditions (for example storage, transport); or
The aim of the transitional period is to allow

2.4.

Transitional period

manufacturers and notified bodies to adjust

gradually to the conformity assessment procedures and the essential requirements set
up by the new directive, and, thus, to avert
the risk of blocking production. Further,
manufacturers, importers and distributors
need to be given time to exercise any rights
they have acquired under the rules predating the new directive, for example to sell
their stocks of products manufactured in
line with the national rules in force before
the directive. Finally, the transitional period
provides for extra time for the adoption of
harmonised standards, even though this is
not, in principle, a precondition for the
application of New Approach directives.
In line with the objectives of the transitional period, Member States are obliged to
maintain their national system as an option
until the end of the transitional period,
unless otherwise provided for (44). The obligation to maintain the pre-existing rules
applies not only to all mandatory provisions

Most New Approach directives provide for a transitional

period (41).
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.
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 (42).
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 (43). Consequently, only
products in compliance with the applicable directive may be
placed on the Community market and put into service after the
transitional period.

in force in each Member State, but also to

all national specifications applied voluntarily by manufactur-

make no changes to the system in question which would

modify product requirements or the conformity assessment
procedure or which would otherwise have an effect on
acquired rights. However, Member States are allowed to
carry out changes in cases of force majeure. For example,
technical progress or exceptional circumstances may
reveal that the system in force fails to satisfy a legitimate
requirement and that this shortcoming creates risks, which
the Member State was unable to prevent by amending the
rules in force in good time. Such amendments have to be
notified at the draft stage, as required by Directive
98/34/EC, so that the Commission and other Member

ers. Consequently, Member States with no regulations, in

the strict sense, must maintain the existing system and,
hence, refrain from legislation. Further, the national standards bodies are obliged to make available, throughout the
transitional period, copies of national standards applied
under the existing national system.
Each directive providing for a transitional period sets the
date for freezing the national system in force. Generally, this
is the date on which the directive enters into force, but
sometimes it is the date on which the directive is adopted.
During the transitional period Member States, may

19

construction products
manufactured by the
constructors themselves
on site or elsewhere
should be regarded as
placed on the market
although a transfer is
not taking place.
(31) The distribution
chain can also be the
commercial chain of
the manufacturer or
the authorised
representative.
(32) For authorised
representative, see
Section 3.2.
(33) In these situations
the person considered
as the manufacturer
has the sole and
ultimate responsibility
for the conformity of
the product to the
applicable directives,
and must be able to do
so (see Section 3.1.1).
(34) See Council
Regulation (EEC)
No 2913/92 establishing
the Community customs
code. In accordance
with this Regulation,
non-Community goods
placed under a
suspensive customs
procedure or in a free
zone are subject to
customs supervision
and do not benefit from
the free circulation in
the internal market.
Before benefiting from
the free circulation in
the internal market,
these goods must be
declared for release for
free circulation. That
entails application of
commercial policy
measures, completion
of the other formalities
laid down in respect of
the importation of
goods and the charging
of any duties legally
due.
(35) However, in such
circumstances a visible
sign must clearly
indicate that the
product in question
may not be placed on
the market or put into
service until it has
been made to comply.
(36) For market
surveillance, see
Chapter 8.
(37) Putting into service
is usually not defined in
the directives.
However, according to

 Guide to the implementation of directives based on the New Approach and the Global Approach

the Directive relating to

active implantable
medical devices,
putting into service
means making
available to the
medical profession for
implantation, and
according to the
Directives relating to
medical devices and in
vitro diagnostic
medical devices, it
means the stage at
which a device has
been made available to
the final user as being
ready for use on the
Community market for
the first time for its
intended purpose. The
Directive on marine
equipment uses the
expression of placing
on board a Community
ship instead of putting
into service.
The Directives relating
to toys, low voltage
equipment,
construction products,
civil explosives and
refrigeration appliances
do not cover putting
into service.
(38) As regards lifts and
equivalent products,
the putting into service
should be considered
to take place at the
moment when the first
use within the
Community is possible.
(39) The Directive
relating to recreational
craft excludes from the
field of application
boats built for own use,
provided that they are
not subsequently
placed on the
Community market
during a period of five
years. As an exception
concerning the
Directive relating to
construction products,
see footnote 30. As
another exception, the
Directive on pressure
equipment does not
cover the assembly of
pressure equipment on
the site and under the
responsibility of the
user.
(40) According to the
Directive relating to
hot-water boilers,
products cannot be put
into service unless they
meet, in addition to the
efficiency requirements

States may have an opportunity to submit comments on the

proposed amendment.
At the end of the transitional period, Member States are
obliged to terminate the national systems kept in force until
then, for example to repeal the relevant regulations. As a
result, the national measures implementing the new directive will be the only mandatory rules in force for the products or risks concerned in every Member State. Consequently, products may no longer be manufactured according to type approvals or other certificates issued under the
system to be repealed.
After the transitional period, products manufactured
before or during this period, in line with the system to be
repealed, may no longer be placed on the Community market. In accordance with the safety or other objectives of the
new directive, a product which is placed on the market
before the end of the transitional period should be allowed
to be put into service after that date if it was ready for use
when placed on the market. Otherwise, it may only be put

into service after that date if it fully complies with the provisions of the directive (45).
According to the general rule, CE marking is an indication that products, which are subject to several directives
providing for its affixing, conform to the provisions of all
these 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 is an indication of conformity only to the directives
applied by the manufacturer. Consequently, during a transitional period, the CE marking does not necessarily indicate
that the product conforms to all applicable directives providing for its affixing. Therefore, the documents, notices or
instructions required by the directives, and accompanying
the product, must indicate clearly the directives applied by
the manufacturer, where at least one of the applicable directives contains a transitional period when the product is manufactured. Information concerning the directives applied
must also be given in the EC declaration of conformity (46).

20

3. Responsibilities

The manufacturer is any natural or legal per3.1. Manufacturer

son who is responsible for designing and
manufacturing a product with a view to plac3.1.1. New Approach directives
ing it on the Community market under his
A manufacturer, in the meaning of New Approach, is the perown name (48). The responsibilities of the
manufacturer apply also to any natural or
son who is responsible for designing and manufacturing a
legal person who assembles, packs,
product with a view to placing it on the Community market on
processes, or labels ready-made products
his own behalf.
with a view to their being placed on the
The manufacturer has an obligation to ensure that a product
Community market under his own name.
intended to be placed on the Community market is designed
Further, the responsibility of the manufacand manufactured, and its conformity assessed, to the essenturer is placed on any person who changes
tial requirements in accordance with the provisions of the
the intended use of a product in such a way
applicable New Approach directives.
that different essential requirements will
become applicable, or substantially modi The manufacturer may use finished products, ready-made
fies or re-builds a product (thus creating a
parts or components, or may subcontract these tasks. Hownew product), with a view to placing it on the
ever, he must always retain the overall control and have the
Community market (49).
necessary competence to take the responsibility for the
The manufacturer may design and manproduct (47).
ufacture the product himself. As an alternative, he may have it designed, manufacapplies equally to situations where the manufacturer
tured, assembled, packed, processed or labelled with a
view to placing it on the Community market under his own
designs, manufactures, packs and labels the product himname, and thus presenting himself as a manufacturer.
self, as to situations where some or all of these operations
Where subcontracting takes place, the manufacturer must
are carried out by a subcontractor.
retain the overall control for the product and ensure that he
As regards conformity assessment, the manufacturers
receives all the information that is necessary to fulfil his
responsibility depends on the procedure applied (50). As a
responsibilities according to the New Approach directives.
general rule, the manufacture must take all measures necThe manufacturer who subcontracts some or all of his activessary to ensure that the manufacturing process assures
ities may in no circumstances discharge himself from his
compliance of the products, to affix the CE marking to the
responsibilities, for example to an authorised representaproduct, to establish a technical documentation and to draw
tive, a distributor, a retailer, a wholesaler, a user or a subup the EC declaration of conformity. Depending on the
contractor.
directive, the manufacturer may be required to submit the
The manufacturer has sole and ultimate responsibility
product to a third party (usually a notified body) for product
for the conformity of the product to the applicable directesting and certification, or to have the quality system certives, whether he designed and manufactured the product
tified by a notified body. In addition, several directives set
himself or is considered as a manufacturer because the
up complementary obligations (such as the requirement to
product is placed on the market under his name.
accompany the product with specified information).
He is responsible:
Directives usually require that the manufacturer is iden for designing and manufacturing the product in accortified
on the product, for example on a marking on the proddance with essential requirements laid down by the direcuct
or
the accompanying documentation (51). However,
tive(s); and
sometimes it is not possible to identify the person who, in
for carrying out conformity assessment in accordance
reality, was in charge of designing and manufacturing the
with the procedure(s) laid down by the directive(s).
product. Unless otherwise provided for, this does not
The manufacturer is obliged to understand both the
design and construction of the product to be able to take
reduce the responsibilities of the person who placed the
the responsibility for the product being in compliance with
product on the Community market (for example any natural
all provisions of the relevant New Approach directives. This
or legal person who imports a new or used product from a

21

laid down by the

Directive, the national
conditions for entry into
service. However, such
provisions may not
prevent the free
movement of boilers.
According to the
Directive on radio and
telecommunications
terminal equipment,
Member States may
restrict the putting into
service of radio
equipment for reasons
related to the effective
and appropriate use of
the radio spectrum,
avoidance of harmful
interference or matters
related to public health.
(41) The transitional
period is still running
for the Directives
relating to nonautomatic weighing
instruments (until
31/12/2002), civil
explosives (until
31/12/2002), potentially
explosive atmospheres
(until 30/6/2003),
medical devices (until
30/06/2001 as regards
putting into service),
pressure equipment
(until 29/5/2002 as
regards placing on the
market), in vitro
diagnostic medical
devices (until7/12/2003
as regards placing on
the market, and
7/12/2005 as regards
putting into service),
and radio and
telecommunications
terminal equipment
(until 7/4/00 as regards
conformity assessment
in accordance with the
existing system, and
until 7/4/2001 as
regards placing on the
market and putting into
service).
(42) However, where the
national regulations to
be replaced have
transposed existing
Community harmonised
legislation, all products
whether in
accordance with the
old or new system
are subject to free
movement during the
transitional period. For
instance, the Directive
on radio and
telecommunications
terminal equipment is
replacing the existing

 Guide to the implementation of directives based on the New Approach and the Global Approach

Community directive on
telecommunications
terminal equipment.
(43) For the exception
provided for by Articles
28 and 30 of the EC
Treaty, see Section 2.3.
(44) As an exception,
the Directive relating to
gas appliances
imposes no obligation
on the Member States,
but stipulates that they
may permit the placing
on their markets of
products complying
with the pre-existing
rules during the
transitional period. As
another exception, the
Directive on radio and
telecommunications
terminal equipment
replaces the existing
system at the
beginning of the
transitional period,
although products in
compliance with it may
be placed on the
market and put into
service during a
transitional period of
one year.
(45) Since the Directive
on civil explosives
covers only placing on
the market and since
the Directive on
pressure equipment
sets no time limit for
the putting into service,
products covered by
these Directives can be
put into service at any
time without being
subject to further
conditions according to
these Directives.
For placing on the
market and putting into
service, see Section 2.3.
(46) For the EC
declaration of
conformity, see Section
5.4; for the CE
marking, see Chapter 7.
(47) Where the
manufacturer uses
finished products,
ready-made parts or
components subject to
a New Approach
directive as such, the
responsibility for these
lies with their original
manufacturer.
(48) The manufacturer is
not defined in the New
Approach directives,
with the exception of
the Directives relating
to active implantable

third country). Accordingly, he must ensure that the product

complies with the applicable directives, and that the appropriate conformity assessment procedure has been carried
out (52).
A product may be put into service without prior placing
on the market (such as a product manufactured for own
use). In such a case the person who puts the product into
service must assume the responsibilities of the manufacturer. Accordingly, he must ensure that the product complies with the directive, and that appropriate conformity
assessment has been carried out (53).
New Approach directives do not require the manufacturer to be established in the Community. Thus, the responsibilities of a manufacturer according to the directives are
equal whether he is established outside the Community or
in a Member State.

more and different persons compared to those considered

under the New Approach directives. The definition of manufacturer (producer) and his liability according to the Directive
on product liability is described in Section 3.7.
According to the Directive on general product safety, a
producer is the manufacturer of the product when he is established in the Community. Any other person presenting
himself as the manufacturer by affixing to the product his
name, trade mark or other distinctive mark, or the person
who reconditions the product, is also the producer. A producer is also the manufacturers representative when the
manufacturer is not established in the Community or if there
is no representative established in the Community, the importer. Other professionals in the supply chain are producers insofar as their activities may affect the safety properties of a product on the market.
The Directive on general product safety requires manufacturers to place only safe products on the market. They
are obliged, within the limits of their respective activities,
to provide consumers with the relevant information to
enable them to assess the risks inherent in a product,
where such risks are not immediately obvious without adequate warnings, and to take precautions against those
risks. They are also obliged to adopt measures commensurate with the characteristics of the product in order to be
informed of possible risks, and to take appropriate action
including, if necessary, withdrawing the product from the
market (54).

3.1.2. The Directives on product liability and general

product safety
The concept of manufacturer according to New Approach is
different from that according to the Directives on product
liability and general product safety.
Legal or administrative action may take place against
any person in the supply or distribution chain who can be
considered responsible for a non-compliant product. This
may, in particular, be the case when the manufacturer is established outside the Community. According to the Directive
on product liability, the concept of manufacturer covers

The manufacturer may be based in the Com3.2. Authorised representative

munity or elsewhere. In either case, the
manufacturer may appoint an authorised
The manufacturer may appoint any natural or legal person to
representative in the Community to act on
act on his behalf as an authorised representative (55).
his behalf in carrying out certain tasks
For the purposes of New Approach directives the authorised
required in the applicable directives. Howrepresentative
must be established inside the Community.
ever, a manufacturer established outside
the Community is not obliged to have an
The authorised representative is explicitly designated by
authorised representative, although this
the manufacturer, and he may be addressed by the authorities
may present some advantages (56).
of the Member States instead of the manufacturer with regard
For the purposes of New Approach
to the latters obligations under the New Approach directive in
directives, to be able to act on behalf of the
question.
manufacturer, the authorised representative
The manufacturer remains generally responsible for actions
must be established inside the Community.
carried out by an authorised representative on his behalf.
Commercial representatives of the manufacturer (such as authorised distributors),
whether or not established inside the Community, are not to be confused with the authorised repreinstance, be appointed to ensure and declare that the prodsentative in the meaning of New Approach directives.
uct complies with the requirements, to affix the CE marking
The delegation of tasks from the manufacturer to the
and the notified bodys number to the product, to draw up
authorised representative must be explicit and should take
and sign the EC declaration of conformity, or to keep the
place in writing, in particular to define the contents of the
declaration and the technical documentation at the dispostasks and the limits of the representatives powers. Dependal of national surveillance authorities (57).
ing on the conformity assessment procedure and the direcThe tasks that may be delegated to the authorised
tive in question, the authorised representative can, for
representative according to the directives are of an

22

 Responsibilities

administrative nature. Thus, the manufacturer may neither

delegate the measures necessary to ensure that the manufacturing process assures compliance of the products nor
the setting up of a technical documentation, unless otherwise provided for. Further, an authorised representative cannot modify the product on his own initiative in order to bring
it into line with the applicable directives.
The authorised representative can, at the same time,
act as a subcontractor. Accordingly, as a subcontractor he

may, for instance, take part in the design and manufacture

of the product, on condition that the manufacturer retains
the overall control for the product to fulfil his responsibility
regarding its compliance with the provisions of the applicable directives.
The authorised representative can also at the same time
act as an importer or a person responsible for placing on
the market in the meaning of New Approach directives. His
responsibilities are extended accordingly (58).

Importer/person responsible for placing on the

market

3.3.

An importer (a person responsible for placing on the market)

in the meaning of New Approach directives is any natural
or legal person established in the Community who places a
product from a third country on the Community market.
The importer must ensure that he is able to provide the market surveillance authority with the necessary information
regarding the product, where the manufacturer is not established in the Community, and has no authorised representative
in the Community.
The natural or legal person who imports a product into the
Community may, in some situations, be considered as the person
who must assume the responsibilities placed on the manufacturer according to the applicable New Approach directives.

The importer needs neither a mandate

from the manufacturer, nor a preferential
relationship with the manufacturer like the
authorised representative. However, the
importer must ensure, in order to fulfil his
responsibilities, that a contact with the manufacturer can be established.
The importer may wish to carry out
administrative tasks on behalf of the manufacturer. In such a case, he has to be explicitly designated
by the manufacturer in order to become an authorised representative, provided that he is established in the Community.
In some situations the person referred to as an importer
shall be able to assume the responsibilities of the manufacturer. Thus, he shall ensure that the product complies with
the essential requirements and that the appropriate conformity assessment procedure has been applied (60).

The importer established in the Community who places a

product from a third country on the Community market has
a limited, but defined responsibility under the New Approach
directives. In some directives the importer is referred to as
the person responsible for placing on the market.
According to New Approach directives, the importer
(person responsible for placing on the market) must be able
to provide the surveillance authority with a copy of the EC
declaration of conformity, and make the technical docu-

3.4.

mentation available. This responsibility is

placed on the importer (person responsible
for placing on the market) only where the
manufacturer is not established in the Community, and has no authorised representative in the Community. Thus, the importer
(person responsible for placing on the market) should require formal assurance in writing from the manufacture that the documents will be made available when requested by the surveillance authority (59).

Distributor

Provisions regarding distribution are in general not included in New Approach directives.
A distributor is to be considered as any natural or legal person in the supply chain who takes subsequent commercial
actions after the product has been placed on the Community
market.
The distributor shall act with due care in order not to place
clearly non-compliant products on the Community market. He
shall also be capable of demonstrating this to the national
surveillance authority.

23

Retailers, wholesalers and other distributors in the supply chain do not need to have
a preferential relationship with the manufacturer like the authorised representative.
They may take commercial actions on
behalf of the manufacturer or on their own
behalf after the product has been made
available on the Community market.
The distributor should act with due care
and have a basic knowledge of the applicable legal requirements. He should know, for
instance, which products must bear the CE
marking, what information (for example EC
the declaration of conformity) has to

medical devices,
medical devices and in
vitro diagnostic
medical devices.
(49) For products
submitted to directives,
see Section 2.1.
(50) See Annex 7.
(51) See Directives
relating to low voltage
equipment, toys,
construction products,
machinery, nonautomatic weighing
instruments, active
implantable medical
devices, gas
appliances, medical
devices, potentially
explosive atmospheres,
recreational craft, lifts,
pressure equipment,
telecommunications
terminal equipment, in
vitro diagnostic
medical devices, and
radio and
telecommunications
terminal equipment.
Further, according to
the Directive on in vitro
diagnostic medical
devices, a
manufacturer who
places devices on the
Community market
under his own name is
obliged to register in
the Member State
where he has his place
of business.
(52) Further, according
to the Directives
relating to machinery
and lifts, obligations
regarding the
conformity assessment
procedure fall to any
person placing the
product on the market
in the Community,
where neither the
manufacturer nor the
authorised
representative
established in the
Community or the
installer of the lift fulfils
these obligations.
(53) This is not
applicable to products
covered by directives
relating to toys, low
voltage equipment, civil
explosives and
refrigeration
appliances, since these
directives only cover
placing on the market.
Further, this is not
applicable to
recreational craft built
for own use, provided

 Guide to the implementation of directives based on the New Approach and the Global Approach

that it is not
subsequently placed
on the Community
market during a period
of five years, or to craft
designed before 1950.
As an exception,
construction products
manufactured for own
use should be
considered as being
placed on the market
(see footnote 30).
(54) To a limited extent
the Directive on
general product safety
may be applicable to
products covered by
New Approach
directives (see
Section 2.2.2).
(55) The authorised
representative is
usually not defined in
the New Approach
directives, with the
exception of the
Directives on medical
devices and in vitro
diagnostic medical
devices.
(56) As an exception,
according to the
Directives on medical
devices (as regards
certain types of
devices) and in vitro
diagnostic medical
devices the
manufacturer must
designate a person
who is established in
the Community to be
responsible for the
marketing of medical
devices, if he does not
have a registered place
of business in a
Member State and he
places devices on the
Community market
under his own name.
(57) See Annex 7.
(58) See Section 3.3.
(59) Not all directives
are explicit about this
obligation. The
Decision 93/465/EEC
explicitly foresees this
obligation for
conformity assessment
procedures based on
modules A, B, C and
their variants.
(60) Where the importer
assembles, packs,
processes, or labels
ready-made products
with a view to their
being placed on the
Community market
under his own name, or
where he substantially

accompany the product, what are the language requirements for users instructions or other accompanying documents, and what is a clear indication of the product being
non-compliant. Accordingly, he may not supply products
that he knows or should have assumed, on the basis of
information in his possession and as a professional, not to
be in compliance with the legislation. Further, he should
cooperate in actions taken to avoid or minimise these risks.

tributor would take over the responsibilities of the manufac-

The distribution conditions (for example transportation

due care and ensured that the manufacturer, or his autho-

or storage) may have an impact on maintaining the compli-

rised representative in the Community, or the person who

ance with the provisions of the applicable directive. This

provided him with the product has taken the necessary

may, for instance, be the case for measuring instruments

measures required by the applicable directives. The distrib-

and medical devices. Thus, the person in charge of the dis-

utor must also be able to identify the manufacturer, his

tribution conditions shall take the necessary measures to

authorised representative in the Community, the importer or

protect the compliance of the product. This is to ensure that

the person who has provided him with the product in order

the product complies with the essential requirements at the

to assist the surveillance authority in its efforts to receive

moment of first use within the Community.

the EC declaration of conformity and the necessary parts of

turer. Therefore, he cannot, for instance, be requested to

make a copy of the EC declaration of conformity or the technical documentation available, unless he is at the same time
the authorised representative established in the Community
or the importer (person responsible for placing on the market) (62). Nevertheless, he has an obligation to demonstrate
to the national surveillance authority that he has acted with

The distribution conditions may, in the absence of Com-

the technical documentation.

munity legislation, be regulated to some extent on the

According to the Directive on general product safety the

national level in accordance with Articles 28 and 30 of the

distributor is defined as any professional in the supply chain

EC Treaty. National legislation that grants to members of a

whose activity does not affect the safety properties of a

specific profession the exclusive right to distribute certain

product. The Directive requires distributors to act with due

products is capable, insofar as it restricts sales to certain

care in order to help to ensure compliance with the general

channels, of affecting the possibilities of marketing import-

safety requirement of the Directive, in particular by not sup-

ed products. Accordingly, such legislation may constitute a

plying products that they know or should have presumed,

measure having an effect equivalent to a quantitative restric-

on the basis of the information in their possession and as

tion on imports. However, it can be justified for instance on

professionals, not to comply with this requirement. In par-

grounds of the protection of public health, if the measure is

ticular, within the limits of their activities, they must partici-

appropriate for the purpose and does not go beyond what

pate in monitoring the safety of products placed on the mar-

is necessary to achieve it (61).

ket, especially by passing on information on product risks

New Approach directives do not foresee that the dis-

and cooperating in the action taken to avoid these risks.

Some products can only be used after an

3.5. Assembler and installer
assembly, an installation or other manipulation has been carried out. This may, for
The installer and assembler of a product, which is already
instance, be the case for machinery, perplaced on the market, should take necessary measures to
sonal protective equipment, measuring inensure that it still complies with the essential requirements at
struments, gas appliances and telecommu63
the moment of first use within the Community. This applies to
nications terminal equipment ( ).
Where the directive in question covers
products where the directive in question covers putting into
putting into service (64), and where an
service, and where such manipulations may have an impact on
assembly, an installation or other manipulathe compliance of the product.
tions may have an impact on maintaining the
compliance of the product, the person
responsible for such manipulations must ensure that they
do not cause a non-compliance with the essential requireprovision of the applicable directives at the moment of first
ments. This is to ensure that the product complies with the
use within the Community.

24

 Responsibilities

Many products covered by New Approach

3.6. User (employer)
directives are used at the workplace.
According to directives based on Article
New Approach directives do not lay down obligations for
138 of the EC Treaty (65), employers have
users, apart from those related to putting into service.
obligations as regards the use of work
Community legislation concerning the health and safety of
equipment at the workplace. An employer is
the workplace has an impact on the maintenance and use of
considered to be any natural or legal person
who has an employment relationship with a
products covered by New Approach directives that are used at
worker (that is any person employed by an
the workplace.
employer), and has responsibility for the
undertaking or establishment.
According to the Directive concerning the minimum
employer is required, before choosing the personal protecsafety and health requirements for the use of work equiptive equipment, to assess that it satisfies the requirements.
ment by workers at work (89/655/EEC, modification
According to the Directive on the minimum safety and
95/63/EC), the employer must take all measures neceshealth requirements for work with display screen equipment
sary to ensure that the work equipment (for example
(90/270/EEC), employers are obliged to perform an analymachinery and apparatus) made available to the workers is
sis of workstations in order to evaluate the safety and health
suitable for the work carried out, and may be used by workconditions, particularly regarding possible risks to eyesight,
ers without impairment to their safety or health. The employphysical problems and problems of mental stress. The
er may only obtain or use work equipment that complies
Directive also lays down the minimum requirements for the
with the provisions of the applicable directives, or, if no
display screen and other equipment.
other directive is applicable or is only partially applicable,
According to the Directive on the introduction of measthe minimum requirements laid down in the annex to the
ures to encourage improvements in the safety and health of
Directive 89/655/EEC. The employer must also take the
workers at work (89/391/EEC), workers have a general
necessary measures to ensure that work equipment is kept
responsibility to take care, as far as possible, of their own
at such a level. Further, the employer has an obligation to
safety and health and that of other persons affected by their
provide information and training for workers as regards the
acts at work. In accordance with the training and the
use of work equipment.
instructions given by their employer they must, for instance,
According to the Directive concerning the minimum
make correct use of machinery, apparatus, and other
health and safety requirements for the use of personal promeans of production, and the personal protective equiptective equipment by workers at the workplace
ment.
(89/656/EEC), such equipment must comply with the releDirectives 89/391/EEC, 89/655/EEC, 89/656/EEC
vant Community provisions on design and manufacture with
and 90/270/EEC lay down minimum requirements. Thererespect to safety and health (that is the New Approach
fore, Member States are allowed to adopt or retain more
Directive relating to personal protective equipment). Further,
stringent provisions, as long as they are compatible with the
the equipment must be appropriate for the risk involved, corEC Treaty. The provisions of New Approach directives must
respond to existing conditions at the workplace, take into
be respected and, thus, additional national provisions may
account ergonomic requirements and the workers state of
neither request a modification of a product within the scope
health, fit the wearer correctly, and be compatible where
of a New Approach directive, nor influence the conditions of
more than one equipment must be used simultaneously. The
the placing on the market of such products.

The Directive on product liability covers all

3.7.

Product liability

movables and electricity, as well as raw

materials and components of final products. Services as such are excluded from
the scope at present. Secondly, the Directive applies only to defective products, that
is products not providing the safety that a
person is entitled to expect. The fact that
a product is not fit for the use expected is
not enough. Only if a product lacks safety,

The Directive on product liability covers any product manu-

factured or imported into the Community, which causes damage to individuals or private property. Thus, the Directive
applies also to products that fall within the scope of a New
Approach directive.
The Directive on product liability establishes a strict liability regime on manufacturers and importers in the Community.

25

modifies or changes
the intended use of the
product, he may be
considered as the
manufacturer in the
meaning of the New
Approach (see
Section 3.1.1).
The responsibilities of
the importer (person
responsible for placing
on the market) have
been explicitly
extended under the
Directives relating to
machinery and lifts,
according to which the
obligations regarding
the conformity
assessment procedure
fall to any person
placing the product on
the market in the
Community, where
neither the
manufacturer, his
authorised
representative
established in the
Community nor the
installer of the lift fulfils
these obligations.
(61) See Judgement of
the Court: case
C-271/92.
(62) See Sections 3.2
and 3.3. Further, where
the directive explicitly
requires that the
product is
accompanied by the EC
declaration of
conformity, the
distributor should
ensure that this is the
case (see Section 5.4).
(63) According to the
Directives relating to
lifts and pressure
equipment the
assembler is
considered to be the
manufacturer, and
accordingly must take
over the responsibilities
of the manufacturer.
Further, the Directive
on medical devices
contains a particular
procedure for putting
together devices
bearing the CE marking
in order to place them
on the market as a
system or procedure
pack.
(64) For putting into
service, see
Section 2.3.2.
(65) For differences
between directives
based on Articles 95
and 138, see

 Guide to the implementation of directives based on the New Approach and the Global Approach

Section 1.4.
(66) The equivalence in
national currency is
calculated at the
exchange rate of 25
July 1985.
(67) Accordingly,
harmonised standards
although they give a
presumption of
conformity do not
free from liability, but
they may reduce the
likelihood of damages.
For presumption of
conformity, see
Section 4.3.
(68) According to the
Court of Justice (case
C-300/95) this refers to
an objective state of
knowledge, related not
only to safety
standards existing in a
particular sector, but to
any high standard the
producer is presumed
to be aware of and that
was accessible to
him. Liability for
development risks
exists in only two
Member States.

does the Directive apply. The fact that a better product is

made afterwards does not render defective the older
models.
Liability, the responsibility to pay for damages, is placed
on a producer. A producer is either a manufacturer of a finished product or a component part of a finished product,
producer of any raw material, or any person who presents
himself as a manufacturer (for example by affixing a trademark). Importers placing products on the Community market from third countries are all considered to be producers
according to the Directive on product liability. If the producer cannot be identified, each supplier of the product
becomes liable, unless he informs the injured person within
a reasonable time of the identity of the producer, or of the
person who supplied him with the product. When several
persons are liable for the same damage, they are all liable
jointly and severally.
The producer must compensate for damages caused
by the defective product to individuals (death, personal
injury) and private property (goods for private use). However, the Directive does not cover any damage to property
under EUR 500 (66) for a single incident. National law may
govern non-material damages (such as pain and suffering).
The Directive does not cover the destruction of the defective product itself and, therefore, there is no obligation to
compensate for it under the Directive on product liability.
This is without prejudice to national law.
The Directive on product liability allows Member States
to set up a financial ceiling for serial accidents fixed at EUR
70 million (66) as a minimum. However, most Member
States have not used this possibility.
The producer is not automatically liable for damages
caused by the product. The injured person, whether or not
he is the buyer or user of the defective product, must claim
his rights to obtain compensation. The victim will be paid
only if he proves that he has suffered damage, the product
was defective, and this product caused the damage. If the
injured person contributes to the damage, the producers

liability may be reduced or even disallowed. However, the

victim does not need to prove that the producer was negligent, because the Directive on product liability is based on
the principle of liability without fault of the producer. Thus,
the producer will not be exonerated even if he proves he
was not negligent, if an act or omission of a third person
contributes to the damage caused, if he has applied standards, or if his product has been tested.
The producer will not have to pay, if he proves:
he did not place the product on the market (for example
the product was stolen);
the product was not defective when he placed it on the
market (thus he proves that the defect was caused subsequently);
the product was not manufactured to be sold;
the defect was caused due to compliance with mandatory regulations issued by the public authorities (which
excludes national, European and international standards) (67);
the state of scientific and technical knowledge at the time
when the product was put on the market could not as such
enable the existence of the defect to be discovered (the
development risks defence) (68); or,
where he is a subcontractor, that the defect was due
either to the design of the finished product or to defective
instructions given to him by the producer of the finished
product.
Ten years after the product is placed on the market, the
producer ceases to be liable, unless legal action is pending.
Further, the victim must file an action within three years
after the damage, the defect and the identity of the producer were known. No waivers of liability in relation to the
injured person may be agreed.
The Directive on product liability does not require Member States to repeal any other legislation on liability. In this
respect, the Directives regime is added to the existing
national rules on liability. It is up to victim to choose on what
grounds to file the action.

26

4. Compliance with directives (

69

A fundamental principle of the New

4.1. Essential requirements
Approach is to limit legislative harmonisation to the essential requirements that are
Essential requirements lay down the necessary elements for
of public interest. These requirements deal
protecting the public interest.
in particular with the protection of health
Essential requirements are mandatory. Only products
and safety of users (usually consumers and
complying
with essential requirements may be placed on the
workers) and sometimes cover other fundamental requirements (for example protecmarket and put into service (70).
tion of property or the environment).
Essential requirements must be applied as a function of the
Essential requirements are designed to
hazards inherent to a given product.
provide and ensure a high level of protection. They either arise from certain hazards
the technical solutions for doing so. This flexibility allows
associated with the product (for example physical and
manufacturers to choose the way to meet the requirements.
mechanical resistance, flammability, chemical, electrical or
It allows also that, for instance, the materials and product
biological properties, hygiene, radioactivity, accuracy), or
design may be adapted to technological progress. Accordrefer to the product or its performance (for example proviingly, New Approach directives do not necessitate regular
sions regarding materials, design, construction, manufacadaptation to technical progress, since assessment of
turing process, instructions drawn up by the manufacturer),
whether requirements have been met or not are based on
or lay down the principal protection objective (for example
the state of technical know-how at a given moment.
by means of an illustrative list). Often they are a combinaThe essential requirements are set out in annexes to the
tion of these. As a result, several directives may be applidirectives. Although no detailed manufacturing specificacable to a given product at the same time, since essential
tions are included in the essential requirements, the degree
requirements of different directives need to be applied
of detailed wording differs between directives. The wording
simultaneously in order to cover all relevant public interests.
is intended to be precise enough to create, on transposition
Essential requirements must be applied as a function of
into national legislation, legally binding obligations that can
the hazard inherent to a given product. Therefore, manube enforced, and to facilitate the setting up of mandates by
facturers need to carry out risk analysis to determine the
the Commission to the European standards organisations in
essential requirement applicable to the product. This anorder to produce harmonised standards. They are also foralysis should be documented and included in the technical
mulated as to enable the assessment of conformity with
documentation (71).
those requirements, even in the absence of harmonised
Essential requirements define the results to be attained,
standards or in case the manufacturer chooses not to apply
or the hazards to be dealt with, but do not specify or predict
them (72).

Directive 98/34/EC defines European standards as technical specifications adopted

by European standards organisations (75)
for repeated or continuous application, with
which compliance is not compulsory.
According to the internal rules of these
organisations, European standards must be
transposed at national level. This transposition means that the European standards in
question must be made available as national standards in an identical way, and that all
conflicting national standards must be withdrawn in a given period.

4.2.

Harmonised standards

Harmonised standards are European standards, which are

adopted by European standards organisations, prepared in
accordance with the General Guidelines agreed between the
Commission and the European standards organisations, and
follow a mandate issued by the Commission after consultation
with the Member States (73).
Harmonised standards in the meaning of the New Approach
are deemed to exist when the European standards organisations
formally present to the Commission the European standards
elaborated or identified in conformity with the mandate (74).

27

(69) This Chapter does

not apply to the
Directives on
refrigeration appliances
(the efficiency levels
are laid down in Annex
1 to the Directive) and
marine equipment
(such equipment has to
meet the applicable
requirements of the
international
conventions, the
relevant resolutions
and circulars of the
International Maritime
Organization (IMO),
and the relevant
international testing
standards instead of
essential
requirements).
(70) According to the
Directive relating to
construction products,
essential requirements
are mandatory only
when and where they
are regulated in
national legislation.
Further, these essential
requirements refer to
construction works:
construction products
intended for use in
construction works
may be placed on the
market only if they are
fit for the intended use
i.e. they have such
characteristics that the
works in which they
are to be incorporated
satisfy the essential
requirements.
(71) For technical
documentation, see
Section 5.3.
(72) According to the
Directive on
construction products,
essential requirements
are given concrete
form in interpretative
documents. In order to
take into account
different levels of
protection, each
essential requirement
may give rise to the
establishment of
classes in the
interpretative
documents and
the technical
specifications.
According to the
Directive on highspeed rail system each
sub-system is covered
by a Technical
Specification of
Inter-operability (TSI),

 Guide to the implementation of directives based on the New Approach and the Global Approach

which specifies the

essential requirements.
(73) For the Directive
relating to low voltage
equipment no explicit
mandate is issued.
Instead, Cenelec has a
standing mandate for
elaborating standards
in the framework of this
Directive.
(74) Although European
standards are
considered as
harmonised before
publication of the
references in the
Official Journal, it is
this publication that
gives presumption of
conformity to the
essential requirements
of the directive in
question (see
Section 4.3). However,
according to the
Directive relating to
low voltage equipment
a standard is
considered as
harmonised after it has
been drawn up by
common agreement
between the bodies
notified by the Member
States in accordance
with the procedure laid
down in the Directive,
and published under
national procedures.
(75) CEN (European
Committee for
Standardisation);
Cenelec (European
Committee for
Electrotechnical
Standardisation);
ETSI (European
Telecommunication
Standards Institute).
(76) Exceptionally,
harmonisation
documents adopted by
European standards
organisations can also
be accepted by the
Commission as
harmonised standards.
The differences
between European
standards and
harmonisation
documents essentially
relate to the degree of
obligation on the part
of the national
members.
Harmonisation
documents must be
implemented at
national level, at least
by public notification of
the title and number of

Harmonised standards are not a specific category

amongst European standards. The terminology used in New
Approach directives is a legal qualification of technical specifications existing as European standards (76), but to which
a special meaning has been given by these directives. Harmonised standards maintain their status of voluntary application in the field of New Approach directives.
The Commission formally requests the European standards organisations to present European standards by issuing a mandate. Prior to this the Commission consults the
Committee established under Directive 98/34/EC, and, in
some cases, the sectoral Committee set up under the directive in question. Reaching consensus within the Committee
under Directive 98/34/EC implies wide consultation of sectoral authorities at national level. Thus, the mandate provides a strong indication of the expectations of public
authorities (77).
The European standards organisations will formally take
a position on a mandate from the Commission in conformity with their internal regulations. Acceptance of the mandate
and the subsequent working programme of these organisations initiate the standstill period as provided for in their
internal regulations and in Directive 98/34/EC.
The elaboration and adoption of harmonised standards
is based on the General Guidelines for cooperation between
the European standards organisations and the Commission
signed on 13 November 1984. These orientations contain
series of principles and commitments concerning standardisation, such as the participation of all interested parties (for
example manufacturers, consumer associations and trade
unions), the role of public authorities, the quality of standards and a uniform application of standards throughout the
Community (78).
The European standards organisations are responsible
for identifying and elaborating harmonised standards in the
meaning of the New Approach and for presenting a list of
adopted harmonised standards to the Commission. The

technical contents of such standards are under the entire

responsibility of the European standards organisations.
Once public authorities have agreed on a mandate, the
search for technical solutions should in principle be left to
the interested parties. In certain areas, such as the environment and health and safety, the participation of public
authorities on a technical level is important in the standardisation process. However, New Approach directives
do not foresee a procedure under which public authorities
would verify or approve either at Community or national
level the contents of harmonised standards, which have
been adopted with the procedural guarantees of the standardisation process (79). The dialogue between standards
bodies and authorities and, when appropriate, their participation in the standardisation process should, nevertheless, help to ensure that the terms of the mandate are correctly understood and public concerns are properly taken
into account in the process.
The European standards organisations are not obliged
to present newly developed standards as harmonised standards. They may also identify existing standards that they
judge, after examination and possible revision, to meet the
terms of the mandate, or modify existing standards in order
to meet those terms. In the same way, they may identify
international or national standards and adopt them as European standards, and present them to the Commission as
harmonised standards.
A harmonised standard must match the essential
requirements of the relevant directive. A European standard
may contain provisions relating not only to essential requirements but also to other provisions. In such a case, these
provisions should be clearly distinguished from those covering the essential requirements. Further, a harmonised
standard does not necessarily cover all essential requirements. This would oblige the manufacturer to use other relevant technical specifications in order to meet all the essential requirements of the directive.

Table 4/1 Standardisation procedure under the New Approach

A mandate is drawn up, following consultation with the Member States.
The mandate is transmitted to European standards organisations.
3. European standards organisations accept the mandate (80).
4. European standards organisations elaborate a (joint) programme.
5. The technical committee elaborates a draft standard.
6. European standards organisations and national standards bodies organise a public enquiry.
7. The technical committee considers comments.
8. National standards bodies vote/European standards organisations ratify.
9. European standards organisations transmit references to the Commission.
10. The Commission publishes the references.
11. National standards bodies transpose the European standard.
12. National authorities publish references of national standards.
1.
2.

28

 Compliance with directives

Harmonised standards provide a presumption of conformity with the essential requirements (84), if their reference has been pub-

4.3.

Presumption of conformity

Conformity with a national standard that transposes a

lished in the Official Journal and if they have
harmonised standard, whose reference has been published,
been transposed at national level. However,
confers a presumption of conformity with the essential
it is not necessary that transposition takes
requirements of the applicable New Approach directive that
place in all Member States before the presumption of conformity becomes effective.
is covered by such a standard (81).
Since European standards have to be trans References (such as titles, identification numbers) of harposed in a uniform way, a manufacturer may
monised standards are published in the Official Journal for the
choose any of the corresponding national
directive in question. An updated list of references for each
standards.
directive can be found at the following Internet address:
The objective of publishing the refer[Link]
ence in the Official Journal is to set the eareurstd/harmstds/[Link] (82).
liest date for the presumption of conformity
Member States must publish the reference of the national
to take effect. Before the Commission publishes the reference, it may verify that the
standard that transposes a harmonised standard. It is useful to
terms of the mandate are fulfilled. When it
indicate in the publication the link with the legislation in
considers that a standard does not meet
question.
the terms of the mandate, it will either not
The application of harmonised standards, which give a prepublish the reference of this standard, or it
sumption of conformity, remains voluntary in the field of New
will limit publication of the reference to parts
Approach directives. Thus, the product may be manufactured
of this standard. In such cases, the condidirectly on the basis of the essential requirements (83).
tion for a harmonised standard to produce a
presumption of conformity is not met, or it
is only met for the part that the published references cover.
bility for conformity assessment without the intervention of
The application of harmonised standards that give a prea third party or for a larger choice of procedures (85).
83
sumption of conformity remains voluntary ( ).The manufacAccording to certain directives, national standards may
turer can choose whether or not to refer to harmonised
give a presumption of conformity as a transitional measstandards. However, if the manufacturer chooses not to folure insofar as there is no harmonised standard covering
low a harmonised standard, he has the obligation to prove
the same area (86). Member States may communicate to
that his products are in conformity with essential requirethe Commission the text of those national standards, which
ments by the use of other means of his own choice (for
they consider to meet the essential requirements. After conexample by means of any existing technical specifications).
sulting the Committee under Directive 98/34/EC and, if proIf the manufacturer applies only a part of a harmonised stanvided for, the sectoral Committee, the Commission notifies
dard or the applicable harmonised standard does not cover
the Member States whether or not the national standard
all the essential requirements, the presumption of conformshould enjoy presumption of conformity. If the opinion is
ity exists only to the extent the standard corresponds to the
positive, Member States are required to publish references
essential requirements.
of such standards. The reference is also published in the
Compliance with harmonised standards will, according
Official Journal. This procedure has not been used so far in
to certain directives, determine the applicable conformity
order to give full priority to the development of European
assessment procedure, which sometimes opens the possistandards.

New Approach directives contain a clause

4.4. Withdrawal of the presumption of conformity
according to which a harmonised standard
can be challenged (87).
The Commission withdraws the presumption of conformity,
* Where a Member State or the Commisif
it has been established that the harmonised standard does
sion considers that a harmonised standard
not
fully meet the essential requirements.
does not fully meet the essential requirements, the matter shall be brought before
the committee established under Directive
98/34/EC, and, if provided for, the sectoral committee,
* In the light of the committees opinion, the Commission
giving reasons for doing so.
shall inform the Member States who shall take necessary
* The committee shall deliver an opinion without delay.
measures.

29

the document, and by

the withdrawal of
conflicting national
standards. However, it
is acceptable to retain
or publish a national
standard dealing with a
subject covered by the
harmonisation
document, provided
that it has technically
equivalent contents. In
addition, harmonisation
documents allow for
national divergences
under special
conditions, which
could create some
application problems if
they were accepted as
harmonised standards.
Publicly available
specifications, which
are adopted by private
consortia of companies,
or other documents
from European
standards
organisations, are not
harmonised standards
in the meaning of the
New Approach.
(77) The term mandate,
although common, is
not the only term used
in this context. Rather
than focusing on the
terminology, it is
important to consider
that standardisation
activities must be
based on a formal
invitation of the
Commission, on which
Member States were
consulted.
(78) The revision of
these Guidelines is
underway. The basic
principles laid down in
the Guidelines have
been reinforced by the
Council conclusions on
efficiency and
accountability in
European
standardisation that
were adopted on 18
May 1998.
(79) Still, the
Commission may verify
that the terms of the
mandate are fulfilled
(see Section 4.3).
(80) This is without
prejudice to their right
to refuse a mandate.
(81) As regards the
Directive relating to
ow-voltage equipment,
a harmonised standard
provides a presumption
of conformity after

 Guide to the implementation of directives based on the New Approach and the Global Approach

ratification by Cenelec
and publication as a
national standard
under national
procedures. The
publication of the
references in the
Official Journal takes
place only for
information purposes.
According to the
Directives relating to
radio and
telecommunications
terminal equipment,
and packaging and
packaging waste,
conformity with a
harmonised standard,
whose reference has
been published in the
Official Journal
confers a presumption
of conformity with the
corresponding
essential requirements.
(82) For further
information, see
also [Link]
[Link]
(83) The Directive
relating to construction
products is an
exception to this
general principle. The
Directive on the highspeed rail system
requires the application
of technical
specifications for
inter-operability. The
Directive relating to
telecommunications
terminal equipment
allows harmonised
standards to be
transformed into
common technical
regulations,
compliance with which
is mandatory.
(84) In the case of the
Directive on
construction products,
the presumption of
fitness for the
intended use.
(85) See Directives
relating to simple
pressure vessel, toys,
electromagnetic
compatibility,
machinery, lifts and
recreational craft.
The lack of harmonised
standards may lead to
the application of a
specific procedure, see
the Directives relating
to construction
products (the European
technical approval may
be granted to products

* If, according to the opinion taken by the Committee, the

harmonised standard is not in full compliance with the
essential requirements, the Commission and the Member
States must withdraw the references to this standard from
the published information.
The procedure to challenge a standard and its outcome
does not affect its existence as a harmonised standard. It
may only lead to the withdrawal of its reference published
by the Commission and by the Member States. This signifies that the harmonised standard in question no longer

gives presumption of conformity with the essential requirements.

The fact that the Commission or the Member States can
challenge a harmonised standard, instead of conducting an
approval procedure prior to the publication of its reference (88), indicates that a systematic verification of the technical contents of harmonised standards is not provided for.
Only in cases where a standard, after it has been challenged, is found not to satisfy the essential requirements or
to present shortcomings, may its reference be withdrawn.

The formal decision to revise a standard is,

4.5. Revision of harmonised standards
in principle, taken by the European standards organisations. This takes place on the
The principles concerning the mandate and the adoption of
basis of their own initiative (89), or following
harmonised
standards, their availability, and the presumption
a request from the Commission directly or,
of
conformity
to the essential requirements apply also to the
indirectly, based on an initiative of a Memrevised version of harmonised standards.
ber State. The need for revision can result
from the changes of the scope of the direc During the transitional period, both the old and the revised
tive (such as an extension of the scope to
standards give presumption of conformity, provided that the
other products or a modification of the
conditions for this are met by both standards.
essential requirements), from the fact that
the Commission or a Member State chalnational level of the revised harmonised standard, and the
lenges the contents of the harmonised standard, indicating
date of withdrawal of the old standard. The transitional perithat it could no longer give presumption of conformity with
od is normally the time period between these two dates.
the essential requirements, or as a result of technological
During this transitional period both harmonised standards
development.
give presumption of conformity, provided that the condiWhen a harmonised standard is revised, the revision
tions for this are met. After this transitional period, only the
must be covered by a mandate to maintain the possibility of
revised harmonised standard gives a presumption of congiving presumption of conformity. Unless the contrary can
formity.
be deduced from the original mandate, the terms and conThe Commission may consider that, for safety or other
ditions of the original mandate apply also for the revision of
reasons, the old version of the harmonised standard must
the harmonised standard. This does not exclude the possicease giving a presumption of conformity before its date of
bility of a new mandate, in particular where the revision is
withdrawal, set by the European standards organisation in
related to shortcomings with respect to the essential
question. In such cases, the Commission fixes an earlier date
requirements.
after which the standard will no longer give a presumption of
To give presumption of conformity, the revised standard
conformity, and publishes this information in the Official Jourmust satisfy the general conditions according to the New
nal. If circumstances allow, the Commission consults the
Approach: the standard is based on a mandate, it is preMember States prior to taking a decision to reduce the period
sented by the relevant European standards organisation to
during which the standard gives a presumption of conformity.
the Commission, its reference is published by the CommisThe reference of the revised harmonised standard, the
sion in the Official Journal, and it is transposed as a nationreference of the old harmonised standard, and the date
al standard.
when the presumption of conformity of the old standard
Following its internal regulations, the relevant European
finishes are published together in the Official Journal.
standard organisation lays down the date of publication at

30

5. Conformity assessment procedure

Conformity assessment according to the

modules is either based on the intervention
of a first party (manufacturer) or a third
party (notified body) (91), and relates to the
design phase of products, to their production phase or both (see Tables 5/1 to 5/3).
Should a manufacturer subcontract design
or production, he still remains responsible
for the execution of conformity assessment
for both phases (92).
The modules give the legislator, in relation to the type of products and hazards
involved, the means to set up the appropriate procedures for manufacturers to
demonstrate product conformity against
the provisions of the directive. In setting the
range of possible modules, directives take
into consideration, according to the principle of proportionality in particular, such
issues as the type of products, the nature of
the risks involved, the economic infrastructures of the given sector (such as the exis-

5.1.

The modules (90)

Conformity assessment is subdivided into modules, which

comprise a limited number of different procedures applicable
to the widest range of products.
The modules relate to the design phase of products, their
production phase or both. The eight basic modules and their
eight possible variants can be combined with each other in a
variety of ways in order to establish complete conformity
assessment procedures.
As a general rule, a product is subject to conformity assessment according to a module during the design as well as the
production phase.
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 governing the conditions
under which the manufacturer can make a choice, if more than
one option is provided for.

tence or non-existence of third parties), the

types and importance of production to ensure a high degree
between two or more conformity assessment procedures
for the same product may, for instance, be justified, where
different certification infrastructures have developed in the
Member States as a result of different legislation. Still, the
Member States must transpose into their national legislation all the conformity assessment procedures established
under a directive and they must guarantee the free movement of all products, which have been subject to a conformity assessment procedure according to the directive in
question. The choice of modules may also be justified
where a product is subject to the provisions of more than
one directive. In such cases the objective is to provide the
manufacturer with a common procedure contained in all the
relevant directives or at least with compatible procedures.
Finally, a choice may also be justified on the basis of the
infrastructure of the branch of industry concerned, to
enable manufacturers to choose the most suitable and economic procedure.
Certain directives provide for the possibility of using
procedures based on quality assurance techniques. In these
cases the manufacturer also usually has recourse to a procedure or a combination of procedures not using such techniques, except where compliance with the requirements
demands the exclusive application of a certain procedure.

of protection as defined in Article 95(3) of the EC Treaty.

Additionally, the conformity assessment procedures under
a specific directive must provide in an equivalent way,
although the procedures are not identical, sufficient confidence as regards the conformity of products to the relevant
essential requirements. The principle of proportionality also
requires that the directives should not include unnecessary
procedures, which are too onerous relative to the objectives, in particular as laid down in the essential requirements. The factors that have been taken into account when
setting the range of possible procedures are described in
the directives.
New Approach directives establish different procedures, according to the categories of products covered, by
either leaving manufacturers no choice or by giving them
the freedom of choice within the same category of products. Alternatively, the directives can also establish, for all
the products covered by the scope, a range of procedures
from which the manufacturer shall choose. Further, each
New Approach directive determines the contents of the
applicable conformity assessment procedure, which may
differ from the models set up by the modules (93).
Providing a choice under a New Approach directive

31

for which there is

neither a harmonised
standard, a
recognised national
standard, nor a
mandate for a
harmonised standard,
and to products which
differ significantly from
harmonised or
recognised national
standards) and to
pressure equipment
(the European approval
may be granted to
materials which are not
covered by any
harmonised standard
and which are
intended for repeated
use in the manufacture
of pressure equipment).
(86) See, for instance,
Directives relating to
construction products,
electromagnetic
compatibility and gas
appliances.
(87) In addition, the
Directive relating to
radio and
telecommunications
terminal equipment
provides a possibility
for the Commission, in
the case of
shortcomings of
harmonised standards,
to publish in the
Official Journal
guidelines to the
interpretation of
harmonised standards,
or the conditions under
which compliance is
possible.
(88) Only national
standards, which may
give a presumption of
conformity according to
certain directives as a
transitional measure
before the area is
covered by a
harmonised standard,
are subject to a
verification procedure
(see Section 4.3).
(89) Under the terms of
their internal
regulations or rules of
procedure, the
European standards
organisations review
their standards
whether or not based
on a mandate at
intervals not exceeding
five years.
(90) This section does
not apply to the
Directive on
construction products,

 Guide to the implementation of directives based on the New Approach and the Global Approach

Modules based on quality assurance techniques derived from the EN ISO 9000 series of standards establish
a link between the regulated and non-regulated sectors.
This should help the manufacturers to meet simultaneously
the obligations based on directives and client needs. Further, under certain conditions it allows manufacturers to

benefit from their investment in quality systems. It contributes also to the development of the quality chain (from
the quality of products to the quality of companies themselves), and promotes awareness of the importance of
quality management strategies for improving competitiveness.

Table 5/1 Basic modules

according to which the

Commission specifies
the conformity
assessment procedure
for a product, or given
family of products,
based on methods laid
down in the annex to
this Directive.
(91) The Directive
relating to pressure
equipment has
introduced user
inspectorates, which
operate as a
second party.
(92) For manufacturers
responsibilities, see
Section 3.1.1.
(93) According to the
Directive on highspeed rail systems the
conformity assessment
procedures are defined
in the Technical
Specifications of
Inter-operability,
following the modules
provided for in the
Decision 93/465/EEC.

Internal control of production

EC type-examination

Conformity to type

Production quality assurance

Product quality assurance

Product verification

Unit verification

Full quality assurance

Covers internal design and production control. This module does not require
a notified body to take action.
Covers the design phase, and must be followed up by a module providing for
assessment in the production phase. The EC type-examination certificate is issued
by a notified body.
Covers the production phase and follows module B. Provides for conformity with the
type as described in the EC type-examination certificate issued according to
module B. This module does not require a notified body to take action.
Covers the production phase and follows module B. Derives from quality assurance
standard EN ISO 9002, with the intervention of a notified body responsible for
approving and controlling the quality system for production, final product inspection
and testing set up by the manufacturer.
Covers the production phase and follows module B. Derives from quality assurance
standard EN ISO 9003, with the intervention of a notified body responsible for
approving and controlling the quality system for final product inspection and testing
set up by the manufacturer.
Covers the production phase and follows module B. A notified body controls
conformity to the type as described in the EC type-examination certificate issued
according to module B, and issues a certificate of conformity.
Covers the design and production phases. Each individual product is examined
by a notified body, which issues a certificate of conformity.
Covers the design and production phases. Derives from quality assurance standard
EN ISO 9001, with the intervention of a notified body responsible for approving and
controlling the quality system for design, manufacture, final product inspection
and testing set up by the manufacturer.

Table 5/2 Simplified flow chart of conformity assessment procedures

DESIGN PHASE

PRODUCTION PHASE
MODULE A

MODULE C

MODULE D
MODULE B
MANUFACTURER

MODULE E

MODULE F

MODULE G

MODULE H

32

 Conformity assessment procedure

Table 5/3 Variants of basic modules

Additional elements compared to basic modules
Aa1 and Cbis1

Internal production control, and one

or more tests on one or more specific
aspect of the finished product

Aa2 and Cbis2

Internal production control, and product

checks at random intervals

Dbis

Production quality assurance

without use of module B
Product quality assurance
without use of module B
Product verification
without use of module B
Full quality assurance with
design control

Ebis
Fbis
Hbis

Intervention of a notified body either at design or

production stage regarding testing carried out by the
manufacturer or on his behalf. The products concerned
and the applicable tests are specified in the directive.
Intervention of a notified body regarding product checks
at production stage. The relevant aspects of the checks
are specified in the directive.
A technical documentation is required.
A technical documentation is required.
A technical documentation is required.
A notified body analyses the design of a product or a
product and its variants, and issues an EC design
examination certificate.

The modules based on quality assurance

5.2. Application of quality system standards
techniques (modules D, E, H and their variants) describe the elements a manufacturer
The use of quality systems for the purpose of conformity
must implement in his organisation in order
assessment
procedures in the directives is described in modto demonstrate that the product fulfils the
ules
D,
E
and
H and their variants.
essential requirements of the applicable
Compliance with standards EN ISO 9001, 9002 and 9003
directive. This means that a manufacturer is
given the possibility of using an approved
gives a presumption of conformity with the corresponding
quality system for the purpose of demonquality assurance modules as regards the provisions covered
strating compliance with regulatory requireby the standard in question, provided that the quality system
ments, thus having the capability to design
takes into consideration as necessary the specific
(if applicable), manufacture and supply prodrequirements of the products for which they are implemented.
ucts that fulfil the applicable essential
Compliance with modules D, E, H and their variants does
requirements.
not require a certified quality system according to standards
A quality system implemented on the
EN ISO 9001, 9002 or 9003, although it provides a useful means
basis of the EN ISO 9001, 9002 or
9003 (94) standard gives a presumption of
of establishing compliance. The manufacturer is free to apply
conformity with the respective modules with
other quality system models than those based on EN ISO 9000
regard to the provisions in the modules that
standards for the purpose of complying with these modules.
these standards cover, and provided that
For the purpose of complying with the applicable directives
the quality system enables the manufacturthe manufacturer shall ensure that the quality system is impleer to demonstrate that the products fulfil the
mented and applied in such a way that it ensures the full appliessential requirements of the directive in
cation of the essential requirements in question.
question. This means that the manufacturer
must specifically address regulatory needs
when implementing and applying a quality
solutions that will ensure fulfilment of the essential
system for the purpose of the New Approach directives, in
particular:
requirements;
the quality objectives, quality planning, quality manual and

the identified standards or other technical solutions must

control of documents must fully take on board the objective

be used as design input, and as verification that design out-

of delivering products that conform to the essential require-

put ensures that the essential requirements will be met;

ments;

the measures taken by the organisation to control pro-

the manufacturer must identify and document the essen-

duction must ensure that the products conform to the iden-

tial requirements that are relevant for the product and

tified safety requirements;

the harmonised standards to be used or other technical

the organisation in its measurement and control of the

33

(94) EN ISO 9001, EN

ISO 9002 and EN ISO
9003 of 1994 replaced
the 1987 versions of the
standards, i.e. EN
29001, EN 29002 and EN
29003. A revision
of the ISO 9000 series
of standards is
underway to integrate
the standards ISO 9001,
ISO 9002 and ISO 9003
into the standard ISO
9001. The structure and
contents of the revised
standard will be
different and will
include some
additional
requirements.

 Guide to the implementation of directives based on the New Approach and the Global Approach

(95) See the Directives

relating to
telecommunications
terminal equipment
and lifts.
(96) For example, the
quality systems set up
according to the
Directives relating to
active implantable
medical devices and
medical devices must
be supplemented by
standard EN 46001, or
accordingly by
standard EN 46002.
(97) For placing on the
market, see
Section 2.3.1.
(98) According to the
Directives relating to
active implantable
medical devices,
medical devices and in
vitro diagnostic
medical devices these
documents must be
kept for five years.
According to the
Directive relating to
refrigeration appliances
the time period is three
years. The Directives
relating to simple
pressure vessels, toys,
non-automatic
weighing instruments,
gas appliances and
construction products
do not define a time
period, but the general
rule should be applied
also to the technical
documentation
required according to
these Directives.
(99) For responsibilities
of the manufacturer,
the authorised
representative, the
importer and person
responsible for placing
on the market, see
Sections 3.1 3.3.
(100) See the Directives
relating to simple
pressure vessels,
machinery (for module
B), non-automatic
weighing instruments,
active implantable
medical devices, gas
appliances,
telecommunications
terminal equipment,
medical devices,
potentially explosive
atmospheres, lifts (for
modules B, C, D, G, H),
pressure equipment, in
vitro diagnostic
medical devices, and
radio and

production process and finished products must identify and

ensure in its assessment, approval and continued surveillance, that this is the case.
Very few directives refer explicitly to the quality system
standards (95). However, a general reference can be found

use methods which are identified in standards or other

appropriate methods to ensure that the essential requirements are met; and

in Decision 93/465/EEC.
Directives may lay down additional provisions for conformity assessment according to modules D, E, H, and their
variants which require that compliance with standards EN
ISO 9001, 9002 and 9003 is completed with supplementary elements. This is to take into consideration the specificity of the products for which it is implemented (96).

quality records, such as inspection reports and test data,

calibration data, qualification reports of the personnel concerned, must be suitable to ensure the fulfilment of the
applicable essential requirements.
The manufacturer has the responsibility to implement
and continuously operate the quality system in such a way
that regulatory needs are respected. The notified body must

Technical documentation

product on the Community market must

take on this responsibility (99).
The contents of the technical documen The manufacturer must draw up a technical file (technical
tation are laid down, directive by directive,
documentation).
in accordance with the products concerned.
The technical documentation is intended to provide informaAs a rule, the documentation should cover
tion on the design, manufacture and operation of the product.
the design, manufacture and operation of
the product. The details included in the documentation depend on the nature of the
product
and
on
what is considered as necessary, from the
New Approach directives oblige the manufacturer to draw
technical
point
of
view, for demonstrating the conformity of
up technical documentation containing information to
the
product
to
the
essential requirements of the relevant
demonstrate the conformity of the product to the applicable
directive
or,
if
the
harmonised
standards have been applied,
requirements. This documentation may be part of the qualito
these
instead
by
indicating
the essential requirements
ty system documentation where the directive provides for a
covered
by
the
standards.
conformity assessment procedure based on a quality sysSeveral directives require that the technical documentatem (modules D, E, H and their variants). This obligation
tion
is written in an official language of the Member State
begins when the product is placed on the market, whatever
97
where
the procedures are to be carried out, or in which the
its geographical origin is ( ).
notified
body is established, or in a language accepted by
The technical documentation must be kept for at least
100
it
(
).
In
order to carry out the conformity assessment pro10 years from the last date of manufacture of the product,
5.3.

cedures requiring third-party verification in a proper way, the

documentation should always be in a language understood
by the notified body, even if this has not been explicitly mentioned in all New Approach directives.

unless the directive expressly provides for any other duration (98). This is the responsibility of the manufacturer or the
authorised representative established within the Community. In some cases the importer or the person placing the

New Approach directives impose an obliga5.4. EC declaration of conformity

tion on the manufacturer, or the authorised
representative established within the Com The manufacturer or the authorised representative estabmunity, to draw up an EC declaration of conlished within the Community must draw up an EC declaration
formity when the product is placed on the
of conformity as part of the conformity assessment procedure
market. Depending on the procedure, the
provided for in the New Approach directives.
EC declaration of conformity must either
ensure that the product satisfies the essen The EC declaration of conformity should contain all relevant
tial requirements of the applicable direcinformation to identify the directives according to which it is
tives, or that the product is in conformity
issued, as well as the manufacturer, the authorised represenwith the type for which a type-examination
tative, the notified body if applicable, the product, and where
certificate has been issued and satisfies the
appropriate a reference to harmonised standards or other
essential requirements of the applicable
normative documents.
directives (101).
The EC declaration of conformity must
vides for any other duration (102). This is the responsibility
be kept for at least ten years from the last date of manuof the manufacturer or the authorised representative
facture of the product, unless the directive expressly pro-

34

 Conformity assessment procedure

established within the Community. In some cases the

number of the notified body when it has been involved in the

importer or the person responsible for placing on the

conformity assessment procedure, as well as the name and

market must take on this responsibility (99).

address of the person who keeps the technical documenta-

The contents of the EC declaration of conformity are

tion.

laid down, directive by directive, in accordance with the

Where several New Approach directives apply to a prod-

products concerned. The standard EN 45014 has been

uct, the manufacturer or the authorised representative can,

drawn up with the objective of providing the general criteria

basically, merge all the declarations into a single document.

for the declaration of conformity, and it can also be used as

However, this is not possible if the directive provides for a

a guidance document in view of New Approach directives.

specific form of the EC declaration of conformity (such as

According to the standard the declaration may take the

the Directive relating to personal protective equipment).

form of a document, a label or equivalent, and should con-

Consequently, the EC declaration should also provide infor-

tain sufficient information to enable all products covered by

mation on whether or not it covers only one directive. In

it to be traced back to it.

such a case the declaration should include a reference to

As a minimum the following information should be pro-

other directives in order to verify whether the manufacturer

vided:

has followed all the Community legislation, or which legisla-

the name and address of the manufacturer or the autho-

tion has been chosen during the transitional period.

rised representative issuing the declaration;

The EC declaration of conformity must be made avail-

the identification of the product (name, type or model

able to the surveillance authority immediately upon request.

number, and any relevant supplementary information, such

Moreover, Directives relating to machinery, gas appliances,

as lot, batch or serial number, sources and numbers of

potentially explosive atmospheres, recreational craft, lifts

items);

and high-speed rail systems require that products are

all relevant provisions complied with;

accompanied by the EC declaration of conformity.

the referenced standards or other normative documents

The EC declaration of conformity must be drawn up in

(such as national technical standards and specifications) in

one of the official languages of the Community. If the Com-

a precise, complete and clearly defined way;

munity directives contain no further provisions concerning

all supplementary information that may be required (for

the language of the declaration, the requirements of the

example grade, category), if applicable;

Member States to use a specific language must be

the date of issue of the declaration;

assessed according to Articles 28 and 30 of the EC Treaty

signature and title or an equivalent marking of authorised

on a case by case basis. However, for products, which are

person (103); and

required to be accompanied by the declaration of conform-

the statement that the declaration is issued under the

ity, it has to be in the official language of the country of use.

sole responsibility of the manufacturer and, if applicable,

In these situations a translation should be provided by the

the authorised representative.

manufacturer, the authorised representative or the distribu-

Other useful information to be included in the EC decla-

tor. Additionally, a copy of the declaration in the original

ration of conformity is the name, address and identification

language should be supplied.

35

telecommunications
terminal equipment.
(101) As an exception,
the Directive relating to
toys does not require
an EC declaration of
conformity.
(102) According to the
Directives relating to
active implantable
medical devices,
medical devices and
in vitro diagnostic
medical devices the EC
declaration must be
kept for five years.
According to the
Directive relating to
refrigeration appliances
the time period is three
years. The Directives
relating to simple
pressure vessels,
machinery, nonautomatic weighing
instruments, gas
appliances and
construction products
do not define a time
period, but the general
rule should be applied
also to the EC
declaration required
according to these
Directives.
(103) It is not necessary
for the signatory to be
domiciled in the
Community. A
manufacturer
established outside the
Community is entitled
to carry out all the
certification
procedures at his
premises and,
therefore, to sign the
declaration of
conformity, unless
otherwise provided for
in the directive(s).

6. Notified bodies

(104) Under certain New

Approach directives
this body is not called a
notified body, but for
example an inspection
body (Directives
relating to simple
pressure vessels and
construction products),
a testing laboratory
and a certification body
(Directive relating to
construction products),
or an approved body
(Directive relating to
toys). Competent
bodies under the
Directive on
electromagnetic
compatibility have a
similar purpose to that
of the notified bodies
and, thus, the same
principles that apply to
notified bodies are
applicable to these
bodies. Further, most
of the principles
described in this
Chapter also apply to
recognised third-party
organisations referred
to in Article 13 (except
Section 6.4) and to the
user inspectorates
referred to in Article 14
(only Sections 6.1 and
6.2) of the Directive on
pressure equipment.
(105) For the purpose of
the Directive on marine
equipment, notified
bodies shall fulfil the
requirements of the
relevant standards of
the EN 45000 series.
(106) European
Accreditation (EA) has
set up a system of
mutual recognition.

Principles of notification

competence of the notified bodies vis--vis

the other Member States and the Community institutions. Therefore, they must verify
Notified bodies carry out the tasks pertaining to the conthe competence of the bodies seeking notiformity assessment procedures referred to in the applicable
fication. This shall be based on the criteria
New Approach directives when a third party is required.
laid down in the applicable directive in con Member States are responsible for their notification. They
junction with essential requirements and the
conformity assessment procedure in quesmay choose the bodies they notify from the bodies under their
tion. In general, the competence criteria set
jurisdiction which comply with the requirements of the direcout in the directives cover:
tives and the principles laid down in Decision 93/465/EEC.
availability of personnel and equipment;
The assessment of the body seeking notification determines
independence and impartiality in relation
if it is technically competent and capable of carrying out the
to those directly or indirectly concerned
conformity assessment procedures in question, and if it can
with the product (such as the designer, the
demonstrate the necessary level of independence, impartiality
manufacturer, the manufacturers authoand integrity. Further, the competence of the notified body
rised representative, the supplier, the
assembler, the installer, the user);
should be subject to surveillance, which is carried out at
technical competence of personnel that
regular intervals and follows the practice established by the
is relevant to the products and conformity
accreditation organisations.
assessment procedure in question;
The EN 45000 series of standards and accreditation are
maintenance of professional secrecy and
important instruments to help in establishing conformity with
integrity; and
the requirements of the applicable directive.
subscription to civil liability insurance,
unless that liability is covered by the state
under national law.
The assessment of the body seeking notification will
Notified bodies (104) take responsibilities in areas of public
determine if the body fulfils the requirements. Accreditation
interest and, therefore, should remain answerable to the
according to the EN 45000 series of standards is a support
competent national authorities. To be eligible a body must
to the technical part of notification and, although it is not a
be a legal entity established on the territory of the Member
requirement, it remains an important and privileged instruState and, thus, come under its jurisdiction. Otherwise
ment for evaluating the competence, impartiality and
Member States remain free to decide whether or not to notiintegrity of the bodies to be notified (105). Further, accredify a body which complies with the requirements laid down in
tation should be considered by national notifying authorities
the directives and Decision 93/465/EEC.
as the most favoured technical basis for the assessment in
Since notification falls within the discretion of Member
order to reduce differences in the criteria applied for notifiStates, they are not obliged under Community law to notify
cation. It falls within the discretion of the notifying Member
all the bodies demonstrating technical competence. FurState to decide whether or not assessment carried out by a
ther, Member States are not obliged to notify bodies in
competent accreditation body established in another Memrespect of each procedure to be applied according to a speber State is taken into consideration (106).
cific directive. Even so, they cannot prohibit the placing on
The EN 45000 series cover different types of conformthe market of products which have been subject to one of
ity assessment bodies (certification bodies, testing laborathe conformity assessment procedures set up by a directive
tories, inspection bodies and accreditation bodies). It is
and which a body notified by another Member State has
irrelevant whether the body calls itself a laboratory, a certicertified. This is due to the fact that Member States have
fication body or an inspection body as long as it carries out
an obligation to transpose each conformity assessment
the tasks in the conformity assessment procedure and has
procedure established in the directive into their national
technical ability to do so in an independent and impartial
legislation.
way.
Member States take the final responsibility for the
6.1.

36

 Notified bodies

Table 6/1 The EN 45000 series of standards relevant for notified bodies
Certification bodies

Testing laboratories

Inspection bodies

Criteria for accreditation bodies

EN 45010

EN 45010

Accreditation and
assessment criteria
Operational criteria

EN 45010

EN 45002
EN 45003
EN 45002
EN 45003
EN 45001

EN 45011
EN 45012
EN 45013

EN 45010
EN 45004

ensure the reliability and capability of the operations of the

conformity assessment bodies. For the assessment of
competence of bodies seeking notification the essential
standards are EN 45001, 45004, EN 45011 and EN
45012 (107).

The EN 45000 standards consist, in general terms, of a

part dealing with the organisation and management of the
body, and a part dealing with the technical requirements
relating to the operation of the body. The standards must be
seen as an integral whole, since both parts are needed to

Table 6/2 Relevant standards of the EN 45000 series for each module
Module

EN 45000 standard(s) applicable

Aa1, Aa2

EN 45001 (+ ability to evaluate and decide on conformity), or

EN 45004 (EN 45001 to be observed for testing required), or
EN 45011 (EN 45001 to be observed for testing required)
EN 45004 (EN 45001 to be observed for testing required), or
EN 45011 (EN 45001 to be observed for testing required)
EN 45001 (+ ability to evaluate and decide on conformity), or
EN 45004 (EN 45001 to be observed for testing required), or
EN 45011 (EN 45001 to be observed for testing required)
EN 45012 (+ product related knowledge)
EN 45012 (+ product related knowledge)
EN 45001 (+ ability to evaluate and decide on conformity), or
EN 45004 (EN 45001 to be observed for testing required), or
EN 45011 (EN 45001 to be observed for testing required)
EN 45004 (EN 45001 to be observed for testing required), or
EN 45011 ((EN 45001 to be observed for testing required)
EN 45012 (+ product related knowledge)
EN 45012 + EN 45004 or
EN 45011

B
Cbis1, Cbis2

D, Dbis
E, Ebis
F, Fbis

G
H
Hbis

The determination of the technological knowledge and

experience of the body seeking notification, and its capability to carry out assessment and verification with regard to
specific technical specifications or general objectives or
performance requirements in accordance with the directive
in question is essential.
Conformity to the relevant standard of the EN 45000
series on the part of the notified body constitutes an element of presumption of conformity to the requirements of
the directive, but is not always in itself sufficient without
demonstration of technical capability within the scope of the
directives. If the assessment of competence according to
the relevant standard of the EN 45000 series is to give a
presumption of conformity, the criteria in the specific EN

45000 standards must relate to the specific tasks to be

performed according to the directive. Consequently, elements such as knowledge of the products and conformity
assessment procedures in question, technology involved,
and voluntary nature of standards must be considered. The
request for product related knowledge is, in particular,
important for conformity assessment procedures that
involve a quality system (modules D, E, H and their variants),
because the quality system must ensure that the product in
question meets the requirements of the applicable directive.
Where a notified body operates conformity assessment
according to different modules, it may lead to the need to
apply several of the EN 45000 standards. This is evident
since the modules, like the standards, relate to different

37

(107) The standard EN

45001 sets out the
general requirements a
laboratory must meet if
it is to be recognised to
carry out testing or
calibration. To be
eligible as a notified
body the laboratory
must be a third party.
The standard EN 45004
specifies the general
criteria for the
competence of bodies
performing inspection.
Inspection involves
examination of a
product design,
product, service,
process or plant and
determination of its
conformity with
specific requirements
or, on the basis of
professional judgement,
general requirements.
To be eligible as a
notified body the
inspection body must
be a third party
(type A). The standard
EN 45011 specifies the
general requirements
that a third party
operating a product
certification system
must meet. Product
certification entails
assurance that a
product conforms to
specified requirements
such as standards,
regulations,
specifications or other
normative documents.
Inspection and product
certification have a
similarity and there is
some overlapping in
the definitions.
Generally, inspection
involves direct
determination of
conformity with the
specifications or
general requirements
of unique, often
complex or critical,
products or small
series of products,
whereas product
certification primarily
involves indirect
determination of the
conformity of products
manufactured in long
series. The standard
EN 45012 specifies the
general requirements
that a third party
operating quality
system certification
must meet.

 Guide to the implementation of directives based on the New Approach and the Global Approach

technical activities. However, for such bodies a complete

assessment or re-assessment according to each applicable
standard is not necessary as regards the management
requirements, since the main objective is always to ensure
consistency and reliability. Thus, the overall management
requirements could be considered as a common element
among the EN 45000 standards, even if these requirements are formulated differently. For the technical competence (such as equipment, training and qualification of personnel) assessment on the basis of each relevant standard
should be carried out.
In order to build and maintain confidence between the
Member States concerning the assessment of notified bodies, it is essential not only to apply the same assessment criteria. It is also important that the bodies performing the assessment of notified bodies have the capability to do so, can
demonstrate an equivalent competence and operate according to the same criteria. Such requirements are laid
down in EN 45003 and EN 45010. Most of the national accreditation bodies of the Member States fulfil and operate
according to the requirements of these standards, and have
put into place peer evaluation schemes in order to attain
Quality system
certification involves
the assessment,
determination of
conformity against
quality system
standard and within a
certain scope of
activity and
surveillance of the
suppliers quality
system.
(108) This section does
not apply to the body
mentioned in Article 8
(2) of the Directive
relating to low voltage
equipment or to the
competent body
referred to in Article 10
of the Directive relating
to electromagnetic
compatibility.
(109) The notification
will comprise the
names and addresses
of the establishments
(operational units)
concerned, with details
of the product range
covered and
qualification criteria
used by the individual
notifications as well as
a clear indication of the
conformity assessment
procedures for which
the bodies are notified.
Should notification be
limited in time by the
notifying authorities,
the duration of the
notification will also be
indicated.

mutual recognition of the accreditation results. The peer

evaluation schemes should ensure that the national accreditation bodies are operating on the same basis and according to the same requirements and, thus, provide confidence
that the bodies they accredit or assess operate according
to the same rules, criteria and level of competence.
Member States are responsible for ensuring that notified bodies maintain their competence at all times and are
capable of carrying out the work for which they are notified.
It is up to the Member States to choose the means and
methods for this. However, the practice concerning surveillance and re-assessment developed by the accreditation
bodies should be followed. Member States may also decide
to notify a body for a limited period of time, and to renew
the notification subsequently.
The Commission does not check or have checked the
technical competence of notified bodies. However, Member
States having notified bodies unable to prove their conformity with the EN 45000 series may be requested to provide the Commission and other Member States with the
appropriate supporting documents on the basis of which
notification was carried out.

single number irrespective of the number of

directives for which it is notified. Allocation
of the number is a purely administrative act
designed to ensure the consistent manage Notification is an act to inform the Commission and the other
ment of the lists of notified bodies, and it
Member States that a body, which fulfils the requirements, has
does not confer rights or commit the Commission in any way.
been designated to carry out conformity assessment accordMember States should designate their
ing to a directive.
bodies within three months of the number
The Commission publishes a list of notified bodies in the
being allocated. Once this deadline has
Official Journal of the European Communities for information
expired the Commission can take back the
purposes. The list is constantly updated and can be obtained
number allocated to the body.
directly from the Commission services.
Official notification of a body takes
Withdrawal of notification takes place when the notified
place when all the information required (109)
body ceases to fulfil the requirements or its obligations. Withand the identification number allocated
beforehand to each body is sent normaldrawal is the responsibility of the notifying Member State. It
ly by the national administration responsible
can also be the end result of an infringement procedure.
for the implementation and management of
the directive in question via the Perma6.2.1. Notification procedure
nent Representation to the Commission (Secretariat-General) and to the other Member States (via their Permanent
Member States are free to notify a body at any time
Representations). The notification takes effect after it has
after the directive has been adopted. To put the transitional
been sent to the Commission and the other Member States.
periods provided for in the directives to effective use so that
The Commission ensures that a consolidated list of noticertificates may be granted as from the date of first applified bodies is regularly kept up to date. The Commission
cation, Member States should consider the possibility of
has this list published for information purposes in the Offiensuring a mechanism by which to notify bodies before forcial Journal of the European Communities (C series).
mal transposition. In such a case notified bodies are not,
Amendments or reductions of the scope, modifications of
however, entitled to issue certificates before the directive is
the validity of the notification and reduction or cancellation
in force.
of the notification will likewise be published in the same
Notification requires that the Commission has allocated
form. The Member States should also publish at the
an identification number to the body. Each body receives a

Notification procedure and withdrawal of

notification (108)

6.2.

38

 Notified bodies

national level the information concerning all notified bodies

its obligations, the Member State has to withdraw or, if

(those they notify as well as those notified by other Member

appropriate, suspend the notification after immediately con-

States).

tacting the body in question. The Member State must also

have this information published, and inform the Commission

6.2.2. Withdrawal of notification

and the other Member States following a procedure similar

The Commission and the Member States have the respon-

to that of the notification. The body in question should have

sibility to act when doubt arises about the competence of a

the possibility to appeal against such a decision. Whether

notified body, either at the moment of notification or there-

this appeal postpones the de-notification or not depends on

after. Should the Commission consider, on its own initiative

the national legislation.

or after complaint, that a notified body does not comply with

The national authority in question is solely entitled to

the requirements or fulfil its responsibilities, it will inform the

withdraw notification. The Commission can only withdraw a

national notifying authority and ask for appropriate docu-

notified body from the consolidated list when the notifying

mented evidence concerning the basis for the notification or

authority of a Member State itself withdraws its notification

the maintenance of the competence of the body. Should a

or when, at the end of an infringement procedure under Arti-

Member State not provide such information, the Commis-

cle 226 or 227 of the EC Treaty, the Court declares a Mem-

sion may bring this to the attention of the other Member

ber State to be in infringement of a given directive and, con-

States for discussion or initiate the procedure under Article

sequently, declares a notification to be invalid.

The withdrawal of a notification does not affect certifi-

226 of the EC Treaty against the notifying Member State.

Apart from presenting a complaint to the Commission,

cates issued by the notified body until such time as demon-

Member States may have recourse to the procedure laid

stration can be made that the certificates should be with-

down in Article 227 of the EC Treaty, if they dispute that a

drawn. Where a Member State withdraws its notification, it

body notified by another Member State fulfils the require-

shall take appropriate steps to ensure that another notified

ments or its obligations properly.

body processes files of the body concerned in order to

When a notified body ceases to fulfil the requirements or

ensure continuity.

Notified bodies must keep their national

6.3. General responsibilities of notified bodies
notifying authorities informed of their activities (for example concerning the conduct of
Notified bodies shall provide relevant information to their
conformity assessments, availability of
notifying authority, the market surveillance authorities and
resources, subcontracting, situations of
other notified bodies.
conflicts of interest), either directly or via an
Notified bodies shall operate in a competent, non-discrimiauthorised body (for example the accreditation body). They must also be prepared to
natory, transparent, neutral, independent and impartial
provide to their notifying authorities all informanner.
mation concerning the proper implementa Notified bodies shall employ the necessary personnel,
tion of the conditions under which they were
which has sufficient and relevant knowledge and experience
notified, either at the request of their notifyto carry out conformity assessment in accordance with the
ing authorities or of the Commission.
directive in question.
Notified bodies have generally an obli
Notified bodies shall make adequate arrangements to
gation to inform the other notified bodies
ensure
confidentiality of the information obtained in the
and the national surveillance authority about
all certificates suspended or withdrawn and,
course of conformity assessment.
on request, about certificates issued or
Notified bodies shall be adequately insured to cover their
refused. They shall also provide the surveilprofessional activities, unless liability is assured under the
lance authority and, according to some
national legislation of the notifying Member State.
directives also the competent authorities of
Notified bodies shall participate in coordination activiother Member States, with relevant inforties (110). They shall also take part directly or be represented in
mation for the purpose of market surveilEuropean standardisation, or otherwise ensure that they know
lance (111). Further, notified bodies shall
the situation of relevant standards.
provide the Commission services responsible for administering a safeguard clause
necessary information related to the product or the conindependent of their clients and other interested parties.
formity assessment upon request.
The legal status of bodies seeking notification, whether they
Notified bodies are and must remain third parties
are private or State-owned, is irrelevant as long as their

39

(110) For coordination of

notified bodies, see
Section 6.6.
(111) However, notified
bodies are not
responsible for
providing the EC
declaration of
conformity or the
technical
documentation. See
Sections 3.1 3.3, 5.3
and 5.4.

 Guide to the implementation of directives based on the New Approach and the Global Approach

independence, impartiality and integrity are ensured, and

they are identifiable as a legal entity to bear rights and
obligations.
In order to guarantee impartiality, the notified body
and its staff has to be free from any commercial, financial
and other pressure that might influence their judgement.
The body also has to implement procedures to ensure
that its work cannot be influenced from outside. The
structure of the body shall safeguard impartiality, especially if the body has other activities than those as a notified body. Further, the body shall have policies and procedures that distinguish between the tasks carried out as
a notified body and any other activity in which the body is
engaged, making this distinction clear to their customers.
Accordingly, marketing material should not give any
impression that assessment or other activities carried
out by the body are linked with tasks described in the
applicable directives.
Notified bodies should not offer or provide additional
services, unless they have an added value for the product (112). They should also ensure that their activities outside the scope of the New Approach directives do not compromise or diminish confidence in their competence, objectivity, impartiality or operational integrity as notified bodies.
To safeguard objectivity, impartiality and operational integrity the body and its staff (whether directly employed or subcontracted) responsible for the activities carried out as a
notified body may, for instance, neither be the manufacturer, the authorised representative, a supplier or their commercial competitor, nor offer or provide (or have offered or
provided) consultancy or advice to any of these parties as
regards the design, construction, marketing or maintenance of the products in question. However, this does not
preclude the possibility of exchanging technical information
and guidance between the manufacturer, the authorised
representative, suppliers and the notified body.
To safeguard impartiality it is important to make a clear
distinction between conformity assessment and market surveillance. Therefore, it is to be considered as a general

rule as inappropriate for notified bodies to be responsible

for market surveillance (113).
Notified bodies shall have documented procedures for
the identification, review and resolution of all cases where
conflict of interest is suspected or proven. The notified body
should also require all staff acting on its behalf to declare
any potential conflict of interest.
Notified bodies shall have under their control the necessary personnel, who have sufficient knowledge and experience relating to the products and conformity assessment procedure in question, and who are subject to appropriate training. In particular, knowledge and experience should relate to
relevant regulatory requirements and enforcement policies,
European and international standardisation activities, relevant
technologies, production methods and verification procedures, and normal conditions of use of the product in question. The body shall be in a position to manage, control and
be responsible for the performance of all its resources and
maintain comprehensive records concerning the suitability of
all the staff it uses in particular areas, whether they are
employees, employed on contract or provided by external
bodies.
Notified bodies shall make adequate arrangements to
ensure confidentiality of the information obtained in the
course of conformity assessment. These arrangements
must ensure that no results or other information is disclosed to any other party than the competent authority in
question, and to the manufacturer or the authorised representative.
Notified bodies shall be adequately insured to cover their
professional activity according to New Approach directives,
unless liability is assured under the national legislation of the
notifying Member State. The scope and overall financial value
of liability insurance must correspond to the level of activity
of the notified body. The manufacturer in particular retains,
however, the overall responsibility for the conformity of the
product with all the requirements of the applicable directives,
even if some stages of the conformity assessment are carried out under the responsibility of a notified body (114).

(112) For the added

value in relation to
the CE marking, see
Section 7.4. However,
notified bodies may
offer any type of
certification and
markings where the
products are intended
for the markets of third
countries, for example
in the context of
Mutual Recognition
Agreements (see
Section 9.2).
(113) See Section 8.1.
(114) For product
liability, see Section 3.7.

40

 Notified bodies

Notified bodies are designated to assess

6.4. Notified bodies and conformity assessment
the conformity with the essential requirements, and to ensure consistent technical
The primary task of a notified body is to provide services
application of these requirements according
for conformity assessment on the conditions set out in the
to the relevant procedures in the directives
directives. This is a service to the manufacturers in an area
concerned. The notified bodies must have
of public interest.
appropriate facilities that enable them to
carry out technical and administrative tasks
Notified bodies are free to offer their conformity assessment
related to conformity assessment. They
services, within their scope of notification, to any economic
must also apply appropriate procedures of
operator established either inside or outside the Community.
quality control in relation to such services
They may carry out these activities also on the territory of
provided.
other Member States or of third countries.
The conformity assessment proce Manufacturers are free to choose any notified body that has
dures have been divided into a set of sepbeen designated to carry out the conformity assessment proarate modules, which cannot be further
cedure in question according to the applicable directive.
subdivided without putting into question the
coherence of the system and the responsibilities which should lie with the manufacauthorised representative regarding the directive in questurer and, where applicable, the notified bodies. This
tion, apply the conformity assessment procedure without
means that a notified body must be capable of taking the
unnecessary burdens for the economic operators, and
responsibility and have the competence to carry out the
refrain from proposing additional certification or marking
conformity assessment according to a complete module
that has no added value (116).

or for several complete modules. Consequently, the body

cannot be notified for part of a module. For instance, as
regards the module Hbis a body may not be notified to
deal with the design phase only. Further, a body notified
for modules D, E, H or their variants must be capable of
taking the responsibility not only for the aspects of the
quality systems involved but also for product-related
requirements. In either case the notified body may subcontract some of the operations (115).
A notified body wishing to offer services according to
several conformity assessment procedures must fulfil the
relevant requirements for the respective tasks, and this has
to be assessed according to the requirements for each
different procedure in question. However, since the scope
of most New Approach directives can be relatively wide
and heterogeneous, a notified body need not be qualified
to cover all products falling within its scope, just a
defined range of products within its scope.
Notified bodies shall have appropriate structures and
procedures to ensure that the conduct of conformity
assessment and the issuing of certificates are subject to a
review process. Relevant procedures must, in particular,
cover obligations and responsibilities in relation to suspension and withdrawal of certificates, requests addressed to
the manufacturer to take corrective measures, and reporting to the competent authority.
Apart from carrying out certain responsibilities in the
field of public interest, notified bodies must regard themselves as rendering services to industry. Thus, they should
provide relevant information to the manufacturer and the

To avoid unnecessary burdens for economic operators, the technical documentation provided to notified bodies has to be limited to that which is required solely for the
purpose of assessing conformity to the directives. Further,
a quality system approved by a notified body or an accredited certification body should be taken into account
when the same or any other notified body is carrying out
conformity assessment according to modules D, E, H, or
their variants, either for the same or another product category. In such cases, however, the notified body should
check that the certificate covers the applicable provisions
of the directive. It should also consider whether or not it
is necessary to require appropriate supplementary audits
specifically relating to the (new) product category, although there is often no need to fully duplicate the quality
system approval as such.
Although the notified body must be established on the
territory of the notifying Member States, it may have activities or personnel outside the Member State, or even outside
the Community. Certificates are, however, always issued by
and in the name of the notified body. Since the notified body
always has to carry out its assessment functions within the
jurisdiction of the designating Member State, it shall inform
the notifying authority, which must be capable of ensuring
the monitoring of the total body as it has to take the responsibility for its operations. If monitoring is not considered
possible, the notifying authority should withdraw or limit the
scope of the notification as deemed necessary.

41

(115) For the modules,

see Section 5.1; for
subcontracting, see
Section 6.5; and for
notified bodies tasks
according to the
conformity assessment
procedures, see
Annex 7.
(116) For the added
value in relation with
the CE marking, see
Section 7.4.

 Guide to the implementation of directives based on the New Approach and the Global Approach

Notified bodies and subcontracting

with the requirements laid down in the relevant

directive.
Information on subcontracting activities
A notified body can have part of its work carried out by
and on the competence of the subcontracanother body on the basis of established and regularly monitors shall be available for the notifying
tored competence.
authority so that it can take necessary
The body subcontracted by the notified body must be techniaction, and for communication without
delay to the Commission and the other
cally competent, and display independence and objectivity
Member States on request. Compliance
according to the same criteria and under the same conditions
with the EN 45000 series of standards
as the notified body. However, notification is not necessary.
entails a presumption of conformity with
The Member State that has notified the body, which subconmost of the requirements, as is the case
tracts part of its work, must be capable of ensuring effective
with the notified body itself.
monitoring of the competence of the body subcontracted by
A notified body can subcontract strictly
the notified body.
limited technical tasks (such as tests and
A further condition for subcontracting is that the conformity
examinations), as long as these can be defined as substantial and coherent parts of
assessment procedure can be subdivided into technical operthe technical operation. The notified body
ations and assessment operations, and that the methodology
cannot under any circumstances subconused to carry out the technical operations is sufficiently
tract all of its activities, as that would make
precise. The body subcontracted by the notified body must,
the notification meaningless. Notified bodnevertheless, carry out substantial and coherent parts of
ies may for example subcontract tests while
these technical operations.
continuing to assess their results and, in
Subcontracting must be based on a contract, which makes it
particular, to validate the test report in order
possible to ensure the transparency of and have confidence in
to evaluate whether the requirements of the
directive are met. Similarly, subcontracting
the notified bodys operations.
is possible in the field of certification of qual A subcontracting notified body remains responsible for all
ity systems by using external persons as
the activities covered by the notification. Subcontracting does
auditors, provided that the notified body carnot entail the delegation of powers or responsibilities. Certifiries out the evaluation of the audit results.
cates are always issued in the name and under the responsiThe subcontracted work must be carried
bility of the notified body.
out according to pre-established technical
The conditions for subcontracting apply to any subcontracspecifications setting out a detailed procetor whether or not established within the Community.
dure based on objective criteria to guarantee total transparency. Where the body subThe bodies acting as subcontractors for the notified bodies
contracted by the notified body is involved in the assessment
need not be notified as such. Nevertheless, the notified
of conformity to standards, these must be used if they lay
body must inform the Member State concerned of its intendown the procedures. If this body is involved in the assesstion to subcontract certain work. Consequently, the Memment of conformity to essential requirements, the procedure
ber State may decide that it cannot take the overall responfollowed by the notified body itself or a procedure deemed by
sibility as a notifying authority for such an arrangement, and
the notified body to be equivalent to that must be used.
withdraw or limit the scope of the notification. The notified
The notified body shall in all cases have a direct privatebody shall keep a register of all its subcontracting activities,
law contractual link with its subcontractors to ensure the fuland update it systematically.
filling of its general responsibilities (117). Serial subcontractThe notified body shall ensure that its subcontractors have
ing is prohibited in order to avoid undermining the coherthe necessary competence and that they maintain this compeence of the system and confidence in it.
tence, for example by carrying out regular evaluations and by
The notified body remains entirely responsible for the
keeping itself regularly informed of the details regarding the
work carried out for it by the subcontractor. It can have its
performance of their tasks. The notified body must also be
notification withdrawn for any reason connected with its
able to provide proof of the compliance of its subcontractors
subcontractor.
6.5.

(117) See Section 6.3.

42

 Notified bodies

The coordination of Member States is car6.6. Coordination and cooperation

ried out through the sectoral working
groups of governmental experts estab A coherent application of the conformity assessment procelished under the directives (118). The coopdures
requires close cooperation between the notified bodies,
eration of notified bodies takes place under
the Member States and the European Commission.
the authority of the relevant working groups.
The Commission supports the Member States in their efforts
Cooperation of notified bodies is established for each New Approach directive, by
to establish coherence between the notifying authorities
usually making use of existing structures.
regarding, in particular, the assessment of the competence of
Each group has a technical secretariat and
the bodies to be notified, the application of notification procea president. The cooperation is limited to
dures and the surveillance of notified bodies.
technical problems relating to conformity
The Commission, in coordination with Member States, also
assessment in order to ensure a uniform
ensures
that cooperation is organised between the notified
application of the technical provisions of the
bodies.
New Approach directives.
In recognition of the fact that notified
bodies fulfil tasks delegated to them by public authorities
sentatives of notified bodies (119). To achieve a higher degree
they must take part in coordination activities organised by
of efficiency in their work the groups can set up subgroups
the Commission. If a body refuses to cooperate, the notifiwith a restricted number of participants to discuss specific
cation may be withdrawn. However, the notified bodies are
technical questions. The Commission is represented in the
not obliged to participate in meetings at European level, if
groups. Governmental experts and representatives of the authey keep themselves informed of, and apply as general
thorities directly responsible for the effective implementation
guidance, the administrative decisions and documents proof the directives can participate as observers in the groups.
duced by their group. The relevant working documents,
The European standards organisations (CEN, Cenelec and
meeting reports, recommendations and guidelines elaboETSI) will be represented in the groups when such issues
rated by the sectoral and intersectoral groups of notified
arise. The groups will also invite relevant European federabodies or their subgroups will be circulated to all notified
tions or representatives of other interested parties as obbodies forming part of those groups, whether they have
servers. Where the groups of notified bodies have to treat
taken part in the meetings or not.
subjects of a confidential nature, the participation in meetThe groups of notified bodies are composed of repreings will be restricted as deemed necessary.

(118) See Section 1.2.

(119) Should the number
of notified bodies per
directive become
excessive, the
Commission can
request the Member
States to put in place a
proper mechanism for
their representation.

43

7. CE marking
7.1.

(120)

Principles of CE marking
The directives providing for the affixing
of the CE marking mostly follow the principles of the New Approach and the Global
Approach, but this is in itself irrelevant for
the application of the CE marking. In fact,
CE marking can be introduced in Community legislation as legal conformity marking if:
the method of total harmonisation is
used, which means that diverging national
regulations that cover the same public
interests as the directive are prohibited;
and
the directive contains conformity assessment procedures according to Decision 93/465/EEC (122).
As a general rule, all New Approach directives provide
for the affixing of the CE marking. In duly justified cases
a total harmonisation directive that follows Decision
93/465/EEC may provide for a different marking instead of
the CE marking (123).
Since all products covered by New Approach directives
bear CE marking, this marking is not intended to serve commercial purposes. Neither is the CE marking a mark of origin, as it does not indicate that the product was manufactured in the Community.

The CE marking symbolises the conformity of the product

with the applicable Community requirements imposed on the
manufacturer.
The CE marking affixed to products is a declaration by the
person responsible that:
* the product conforms to all applicable Community provisions, and
* the appropriate conformity assessment procedures have
been completed.

(120) This Chapter does

not apply to the
Directive on the highspeed rail system.
(121) For market
surveillance, see
Chapter 8.
(122) Conformity
assessment according
to the Directive relating
to construction
products does not
follow Decision
93/465/EEC. However,
this Directive provides
for the CE marking.
(123) The Directive on
marine equipment does
not provide for a CE
marking, but instead for
a special conformity
mark to which the
guidelines of this
chapter generally
apply.
(124) For products
submitted to directives,
see Section 2.1.
(125) In addition, the
Directive on pressure
equipment entitles
Member States to
authorise, on their
territory, the placing
on the market and the
putting into service by
users, of pressure
equipment or
assemblies not bearing
the CE marking, but
that have been subject
to a conformity
assessment carried out
by a user inspectorate
instead of a notified
body.

CE marking symbolises conformity to all the obligations

incumbent on manufacturers for the product by virtue of the
Community directives providing for its affixing. When
affixed to products it is a declaration by the natural or legal
person having affixed or been responsible for the affixing of
CE marking that the product conforms to all applicable provisions, and that it has been subject to the appropriate conformity assessment procedures. Hence, Member States
are not allowed to restrict the placing on the market and putting into service of CE marked products, unless such measures can be justified on the basis of evidence of the noncompliance of the product (121).

7.2.

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 and put into service, save where specific directives require otherwise.
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.
A product may not be CE marked, unless it is covered by a
directive providing for its affixing.

to substantially modified products that

are subject to directives as new products.
Directives may exclude the application
of the CE marking on certain products, even
if the directive otherwise applies to the
product. As a general rule, such products
are subject to free circulation (125), if:

they are accompanied by a declaration of

conformity (as is the case for safety components referred to in the Directive on machinery and partly completed boats referred to
in the Directive on recreational craft);
they are accompanied by a declaration of
compliance (as is the case for products playing a minor part with respect to the health and safety listed in
accordance with the Directive on construction products);
they are accompanied by a statement (as is the case for
custom-made medical devices and devices intended for
clinical investigations referred to in the Directives on active
implantable medical devices and medical devices, and
devices intended for performance evaluation referred to in
the Directive on in vitro diagnostic medical devices);

The obligation to affix the CE marking extends to all products within the scope of directives providing for its affixing,
and which are intended for the Community market (124).
Thus, the CE marking must be affixed:
to all new products, whether manufactured in the Member States or in third countries;
to used and second-hand products imported from third
countries; and

44

 CE marking

they are accompanied by a certificate of conformity (as

is the case for components referred to in the Directive relating to potentially explosives atmospheres which are intended to be incorporated into equipment or protective systems, and fittings referred to in the Directive relating to gas
appliances);
the product bears the manufacturers name and an indication of maximum capacity (as is the case for instruments
not subject to conformity assessment according to the Directive relating to non-automatic weighing instruments); or
the product is manufactured in accordance with sound

The manufacturer, whether established

inside or outside the Community, is the person ultimately responsible for the conformity of the product with the provisions of the
directive and for the affixing of the CE marking. The manufacturer may appoint an
authorised representative established in the
Community to act on his behalf. The person
responsible for placing the product on the
market may, exceptionally, be deemed to
have assumed the responsibilities of the
manufacturer (127).

7.3.

engineering practice (as is the case for certain vessels

referred to in the Directives relating to simple pressure vessels and pressure equipment).
During the transitional period of a directive the manufacturer usually has the choice to either meet the requirements of the directive or the relevant national regulations.
The option chosen and, hence, the extent of the conformity
expression enshrined in the CE marking shall be clarified by
the manufacturer in the EC declaration of conformity, and in
the documents, notices or instructions accompanying the
product (126).

Affixing of the CE marking

The CE marking must be affixed by the manufacturer, or by

the authorised representative established within the Community.
The CE marking must take the form below. If the CE marking
is reduced or enlarged the proportions must be respected.

The CE marking may not, in principle, be

affixed until the conformity assessment procedure has been completed to ensure that
The CE marking must be affixed visibly, legibly and indelibly
the product complies with all the provisions
of the relevant directives. This will usually be
to the product or to its data plate. However, where this is not
at the end of the production phase. This
possible or not warranted on account of the nature of the prodposes no problem if, for example, the CE
uct, it must be affixed to the packaging, if any, and to the
marking is on a data plate that is not affixed
accompanying documents, where the directive concerned
to the product until after the final inspection.
provides for such documents.
However, if the CE marking forms an insepa Where a notified body is involved in the production control
rable part of the product, or of a component,
phase according to the applicable directives, its identification
for example by stamping or casting, the
number must follow the CE marking. The manufacturer or the
marking can be affixed at any other stage of
the production phase, provided that the conauthorised representative established in the Community affixformity of the product is verified as appropries the identification number, under the responsibility of the
ate throughout the production phase.
notified body.
The CE marking shall, as a rule, be
affixed to the product or to its data plate. In
ments. The CE marking on the product may neither be omitaddition, it can be affixed, for instance, to the packaging or
ted nor be moved to the packaging or accompanying docuto the accompanying documents. However, it may excepments on purely aesthetic grounds (128).
tionally be moved from the product or its data plate if this
The CE marking symbolises conformity to essential public
rule cannot be followed. This would be justified where affixinterests covered by the directives in question. Therefore, it is
ing it to the product was impossible (for example on certain
to be considered as essential information to Member States
types of explosives), or not possible under reasonable techauthorities as well as other relevant parties (for example disnical or economic conditions, or where the minimum dimentributors, consumers and other users). Accordingly, the resions could not be respected, or it could not be ensured
quirement for visibility means that the CE marking must be
that the CE marking was visibly, legibly and indelibly affixed.
easily accessible for all parties. It could, for instance, be afIn such cases, the CE marking has to be affixed to the packfixed on the back or underside of a product. A minimum height
aging, if it exists, and to the accompanying document,
of 5 mm is required to ensure that it is legible (129). It shall also
where the directive concerned provides for such docu-

45

(126) For the transitional

period, see Section 2.4.
(127) See Sections 3.1
3.3.
(128) The provisions
regarding the affixing
of the CE marking vary
between directives; in
some sectors they are
more stringent (see for
instance Directives
relating to simple
pressure vessels,
machinery, nonautomatic weighing
instruments, active
implantable medical
devices, gas
appliances, medical
devices,
telecommunications
terminal equipment,
hot-water boilers,
recreational craft (as
regards boats), lifts,
potentially explosive
atmospheres,
refrigeration
appliances, pressure
equipment, in vitro
diagnostic medical
devices, and radio and
telecommunications
terminal equipment),
and in other sectors
more flexible (see for
instance Directives
relating to low voltage
equipment, toys,
construction products
and electromagnetic
compatibility).
(129) According to the
Directives relating to
machinery, personal
protective equipment,
active implantable
medical devices,
medical devices,
potentially explosives
atmospheres, lifts (as
regards safety
components), in vitro
diagnostic medical
devices, and radio and
telecommunications
terminal equipment the
minimum dimension of
the CE marking may be
waived for small
devices. The same
applies to the
conformity mark
provided for in the
Directive on marine
equipment.

 Guide to the implementation of directives based on the New Approach and the Global Approach

for the tests on specific aspects of the product (modules

Aa1 and Cbis1 where the notified body intervened during
the production phase);
for product checks (modules Aa2 and Cbis2);
for the examinations and tests carried out to assess the
conformity of the product during the production control
phase (modules F, Fbis and G); or
for the assessment of production, product quality assurance or full quality assurance (modules D, E, H and their
variants).
The CE marking and the identification number of the
notified body do not necessarily have to be affixed within the
Community. They may be affixed in a third country, for
example if the product is manufactured there and the notified body carried out conformity assessment in accordance
with the directive in that country. The CE marking and the
identification number can also be affixed separately, as long
as they remain combined.

be indelible so that it cannot be removed under normal circumstances without leaving noticeable traces (for example
some product standards use a rub test with water and petroleum spirits). However, this does not mean that the CE marking must form an integral part of the product.
A notified body may be involved in the design phase, the
production phase, or both, depending on the conformity
assessment procedures applied (130). The CE marking shall
only be followed by the identification number of the notified
body if it is involved in the production phase. Thus, the identification number of a notified body involved in conformity
assessment according to module B does not follow the CE
marking. Sometimes several notified bodies are involved in
the production phase, which is possible where more than
one directive is applicable. In these situations several identification numbers follow the CE marking.
Thus, the CE marking may appear on products either:
without an identification number, which means that a notified body did not intervene in the production phase (module
A, modules Aa1 and Cbis1 where the notified body only
intervened during the design phase, and the combination of
modules B and C); or
with an identification number, which means that the notified body assumes the responsibility:

CE marking and other marks

Owners of trademarks similar to the CE

marking, that were acquired before the introduction of the CE marking, will be protected
CE marking is the only marking which symbolises conformagainst expropriation since such marks will,
ity to all the obligations incumbent on manufacturers for the
as a rule, not be liable to deceive market surproduct as required by the applicable directives providing for
veillance authorities, distributors, users, conits affixing. Member States shall refrain from introducing any
sumers or other third parties.
In view of the objectives of technical
reference to another conformity marking into their national
harmonisation,
markings and marks addiregulations, which would signify conformity with objectives
tional
to
the
CE
marking need to fulfil a difthat relate to the CE marking.
ferent function from that of the CE mark A product may bear additional markings and marks, proing. Thus, they should provide an added
vided that they:
value in signifying conformity with objec* fulfil a different function from that of the CE marking,
tives that are different from those to which
* are not liable to cause confusion with it, and
the CE marking relates (for example envi* do not reduce its legibility and visibility.
ronmental aspects not covered by applicable directives).
The CE marking replaces all mandatory conformity markThe affixing of legal marking (such as a protected tradeings having the same meaning, which existed before harmark of a manufacturer), or of acceptable certification and
monisation took place. Such national conformity markings
other marks additional to the CE marking, is allowed to the
are incompatible with CE marking and would constitute an
extent that such markings or marks do not create confusion
infringement of the applicable New Approach directives.
with the CE marking, and that they do not reduce the legiWhen transposing the directives, Member States shall incorbility and visibility of the CE marking. This confusion may
porate the CE marking in their national regulations and
either refer to the meaning or form of the CE marking (132).
administrative procedures. They shall also refrain from
Whether or not a marking or mark is confusing should be
introducing any other conformity marking into their national
decided from the point of view of all relevant parties likely
legislation that has the same meaning as the CE marking.
to come into contact with it.
7.4.

(130) See Section 5.1

and Annex 7.
(131) For instance, the
symbol to indicate that
telecommunications
terminal equipment is
suitable for connection
to the public
telecommunications
network, the energy
performance label
required for hot-water
boilers, the explosion
protection symbol
required for equipment
and protective systems
intended for use in
potentially explosive
atmospheres, or the
equipment class
identifier required for
radio equipment. Some
directives also require
that the last digits of
the year in which the
CE marking was affixed
is indicated.
(132) The wording used
in various New
Approach directives
varies slightly, but any
other interpretation
would prevent
achieving the purpose
of the applicable
provisions.

The CE marking consists exclusively of the letters CE

followed by the identification numbers of any notified body
involved in the production phase. Pictograms or other
marks indicating, for instance, the category of use are,
according to some New Approach directives, complementary to the CE marking but do not form part of it (131).

46

8. Market surveillance

Enforcement of Community legislation is an

8.1. Principles of market surveillance
obligation on Member States: Article 10 of
the EC Treaty requires Member States to
Market surveillance is an essential tool for the enforcement
take all appropriate measures to ensure fulof New Approach directives.
filment of their obligation arising out of the
The purpose of market surveillance is to ensure that the proTreaty. Market surveillance is an essential
visions
of applicable directives are complied with across the
tool for enforcing New Approach directives,
in particular by taking measures to check
Community. Citizens are entitled to an equivalent level of prothat products meet requirements of the
tection throughout the single market, regardless of the origin
applicable directives, that action is taken to
of the product. Further, market surveillance is important for the
bring non-compliant products into compliinterest of economic operators, because it helps to eliminate
ance, and that sanctions are applied when
unfair competition.
necessary.
Member States must nominate or establish authorities to be
A high level of protection is envisaged in
responsible
for market surveillance. These authorities need to
the New Approach directives. This requires
have
the
necessary
resources and powers for their surveilMember States to take all necessary measures to ensure that products may be placed
lance activities, ensure technical competence and profeson the market and put into service only if
sional integrity of their personnel, and act in an independent
they do not endanger the safety and health
and non-discriminatory way respecting the principle of proof persons, or other interests covered by
portionality.
the applicable New Approach directives,
Notified bodies should, basically, be excluded from the
when correctly constructed, installed and
responsibility of market surveillance activities. This is to
maintained, and used in accordance with
avoid conflicts of interest.
their purpose. This implies an obligation for
Member States to organise and carry out
market surveillance, in a way that is effective and sufficontaining provisions on all safety aspects, such as New Apciently extensive to discover non-compliant products. This
proach directives. However, it can be used as a reference
is to protect not only the interests of consumers, workers
for market surveillance carried out in the field of New Apand other users, but also the interests of economic operaproach directives, especially regarding consumer products.
tors from unfair competition.
Market surveillance is the responsibility of public authorThe obligation for market surveillance is complementaities (135). This is, in particular, to guarantee the impartiality
ry to the provisions of the New Approach directives that
of market surveillance operations. Each Member State can
require Member States to allow free movement of products
decide upon the market surveillance infrastructure, for
that are in compliance with the requirements. This obligation
example there is no limitation on the allocation of responsialso corresponds to the right of Member States to chalbilities between authorities on a functional or geographical
lenge, under the safeguard clause, the free movement of
basis as long as surveillance is efficient and covers the
substantially non-compliant products (133).
whole territory (136). As a result, the legal and administrative
The Directive relating to toys lays down provisions for
market surveillance infrastructures differ from one Member
the market surveillance authority, and obliges the Member
State to another. This requires, in particular, that efficient
States to send to a report the Commission every three
administrative cooperation between competent national
years (134). Other New Approach directives do not contain
authorities is in place so that an equivalent level of protecspecial provisions on how market surveillance should be ortion can be ensured throughout the Community, in spite of
ganised and carried out in Member States. The Directive on
the competence for market surveillance being limited to
general product safety has a more detailed description of
each Member States territory.
the obligation of Member States to organise market surveilMarket surveillance authorities should have the neceslance and to adopt appropriate surveillance tools. This Disary resources and powers to conduct their surveillance acrective is not applicable to products that are covered by spetivities. This is to monitor products placed on the market
cific rules of Community law based on total harmonisation
and, in cases of non-compliance, to take appropriate action

47

(133) For application of

the safeguard clause
procedure, see
Section 8.3.
(134) See Article 12 of
the Directive relating to
toys, according to
which Member States
are required to ensure
that sample checks are
carried out on toys to
verify their conformity
with the directive. The
surveillance authority
must be entitled to
obtain access to places
of manufacture or
storage, to receive
information, and to
select a sample and
take it away for
examination and
testing.
(135) The Directive on
general product safety
requires Member
States to establish or
nominate market
surveillance authorities.
(136) According to
Article 249 of the EC
Treaty the choice of
form and method of
implementing the
directives lies with the
Member States (see
also Section 1.4).

 Guide to the implementation of directives based on the New Approach and the Global Approach

to enforce conformity. As regards personnel resources, the

authority needs to have, or have access to, a sufficient
number of suitably qualified and experienced staff, with the
necessary professional integrity. To guarantee the quality of
the test data, the testing facility used by the authority should
comply with the relevant criteria of the EN 45001 standard.
The authority should also be independent, and carry out its
operations in an impartial and non-discriminatory way. Further, the authority should carry out market surveillance respecting the principle of proportionality, for example action
must be in accordance with the degree of risk or noncompliance and the impact on the free circulation of
products may not be more than is necessary for achieving
the objectives of market surveillance.
The surveillance authority may subcontract technical
tasks (such as testing or inspection) to another body, provided that it retains the responsibility for its decisions, and provided there is no conflict of interest between the other bodys
conformity assessment activities and its surveillance tasks.
In doing so the authority should exercise great care to ensure
that the impartiality of the advice it receives is beyond reproach. The responsibility for any decision to be taken on the
basis of such advice shall reside in the surveillance authority.

Market surveillance activities

moment when placed on the market and, if

relevant, when put into service (138). Basically, market surveillance cannot take place
Market surveillance involves two main stages:
during the design and production stages,
* national surveillance authorities shall monitor that prodthat is before the manufacturer has taken
ucts placed on the market comply with the provisions of the
formal responsibility for the conformity of
applicable national legislation transposing the New Approach
the products, usually by affixing the CE
marking. However, this does not exclude
directives;
collaboration between the surveillance
* subsequently, when necessary, they shall take action to
authority and the manufacturers and suppliestablish conformity.
ers (139).
Although market surveillance operations cannot take place
For market surveillance to be efficient,
during the design and product stages, efficient enforcement
resources should be concentrated where
usually requires that surveillance authorities act in collaborarisks are likely to be higher or non-complition with manufacturers and suppliers in order to prevent the
ance more frequent, or where a particular
placing on the market of non-compliant products.
interest can be identified. Statistics and risk
assessment procedures can be used for
8.2.1. Monitoring of products placed on the market
this purpose. To be able to monitor products placed on the market, surveillance
The objective of monitoring products placed on the market is
authorities shall have the power, competo verify that they comply with applicable directives at the motence and resources:
ment when placed on the market and, if relevant, when put into
to regularly visit commercial, industrial
service.
and storage premises;
The EC declaration of conformity and the technical docu to regularly visit, if appropriate, work
mentation provide the surveillance authority with necessary
places and other premises where products
information about the product.
are put into service (140);
to organise random and spot checks;
to take samples of products, and to subject them to
Market surveillance authorities must monitor products
examination and testing; and
placed on the market. The aim is to find out whether or not
to require all necessary information (141).
a product complies with the applicable provisions at the
8.2.

(137) Directives relating

to active implantable
medical devices,
potentially explosive
atmospheres, medical
devices and in vitro
diagnostic medical
devices have
provisions on
confidentiality.
(138) For placing on the
market and putting into
service, see
Section 2.3.
(139) See also
Section 8.2.3.
(140) This is usually not
necessary for
consumer products
that are made available
in shops or otherwise
on the market. It is
more important for
products (for example
machinery and
pressure equipment)
that are directly, after
being manufactured,
installed and put into
service at the premises
of the client.
(141) For the
responsibility to provide
information, see
Sections 3.1. 3.4
and 6.3.

As a general rule, it is inappropriate for notified bodies

to be responsible for market surveillance. In order to avoid
a conflict of interest it is necessary to make a clear distinction between conformity assessment (which takes place
before the product is placed on the market) and market surveillance (which takes place after the product has been
placed on the market). As an exception, where a notified
body and a market surveillance authority come under the
same superior authority in a Member State, the lines of
responsibility should be so organised that there is no
conflict of interest between these activities.
New Approach directives include certain provisions that
require Member States to inform the Commission or the
other Member States, but they usually say nothing on the
confidentiality or transparency of information obtained
during market surveillance operations (137). Consequently,
rules on confidentiality are based on the national legal
systems, and therefore vary between Member States.
However, information on activities underway that concern
individual economic operators should generally be considered as confidential. An exception to this may be justified
where the health and safety of consumers is subject to serious and immediate danger.

48

 Market surveillance

Although market surveillance cannot, basically, take

place during the design and production stages, the surveillance authority may make a check on the production premises after a non-compliance has been discovered to verify
whether or not a constant error can be established (142).
Other exceptions to the principle that market surveillance
can only take place after the manufacturer has taken formal
responsibility for the products are trade fairs, exhibitions
and demonstrations. Most New Approach directives allow
the showing of non-compliant products under such circumstances, provided that a visible sign clearly indicates that
the products may not be marketed or put into service until
they have been made to comply, and that adequate measures are taken during demonstrations, where appropriate,
to ensure the protection of persons. Market surveillance
authorities must monitor that this obligation is respected.
Market surveillance should cover all applicable provisions of the directives in question. To a certain extent formal checks are sufficient, for example regarding the CE
marking and its affixing, the availability of the EC declaration
of conformity, the information accompanying the product
and the correct choice of conformity assessment procedures. More profound checks are necessary to verify the
material conformity of the product, for example regarding
the correct application of the conformity assessment procedure, the compliance with the essential requirements,
and the contents of the EC declaration of conformity. In
practice, individual market surveillance operations can
focus on certain aspects of the requirements.
Besides market surveillance operations, that have as
their explicit object the verification of products placed on
the market, other public mechanisms exist that, although
not directly designed for that aim, can nevertheless have as
a consequence the uncovering of non-compliance (143).
Labour inspectorates that check safety at the workplace,
for example, can discover that the design or construction of
a machine, or personal protective equipment bearing the
CE marking, is not in conformity with the applicable requirement (144). Consequently, they may take measures that
affect the placing on the market of a product and, thus,
carry out market surveillance, or they may contact the market surveillance authority that may take the necessary
measures. Information on the compliance of a product at
the moment when it was placed on the market can also be
obtained during in-use inspections, or by analysing the factors that caused an accident. Complaints from consumers
or other users about the product, or from manufacturers or
distributors about unfair competition can also provide information for market surveillance purposes.
Monitoring of products placed on the market may be
divided between several authorities on the national level, for
example functionally or geographically. Where the same
products are subject to control by more than one authority
(for example customs and a sectoral authority, or local
authorities), coordination between services within a
Member State is necessary.

Voluntary initiatives, such as product certification or

application of a quality system, cannot be put on the same
footing as surveillance activities carried out by an authority.
Still, they can contribute to the elimination of risks. However, market surveillance authorities must be impartial, in
the light of Article 28 of the EC Treaty, regarding all voluntary marks, labels and arrangements, and they may only be
taken into consideration, in a transparent and non-discriminatory way, for the risk assessment. Accordingly, products
may not be excluded from market surveillance operations
even if they have been subject to voluntary certification or
other voluntary initiatives.
New Approach directives provide for two different tools
that enable surveillance authorities to receive information
on the product: the EC declaration of conformity and the
technical documentation. These must be made available by
the manufacturer, the authorised representative established
within the Community, or under certain circumstances by
the importer or person responsible for placing on the market. Other natural or legal persons, such as notified bodies,
distributors, retailers, suppliers or subcontractors, cannot
be obliged to make these available. However, they can
assist the surveillance authority in obtaining them. Further,
the surveillance authority may request the notified body to
provide information on the conduct of conformity assessment for the product in question (145).
The EC declaration of conformity must be made available for the market surveillance authority immediately upon
request. Therefore, it should be kept inside the Community.
It can be made available for surveillance purposes in each
of the Member States, for instance, by means of administrative cooperation. A failure to present the declaration
when requested by a national surveillance authority may
constitute sufficient grounds for doubting the presumption
of conformity with the requirements of the directive (146).
The technical documentation must be made available to
the surveillance authority within a period of time commensurate with its importance and the risk in question, but the
authority cannot request it systematically. In general, it can
be requested only during random checks made for market
surveillance purposes, or when there are grounds for a concern that a product does not offer the level of protection
required in all respects. Initially the surveillance authority
may be provided with only a summary of the technical documentation (the essential technical data), if it has been
drawn up, with reasonable time allowed for transmission.
More detailed information (for example certificates and
decisions from the notified body) can, nevertheless, be
requested in cases of serious doubt about the conformity of
the product to the Community regulations. The full technical
documentation should be requested only where clearly necessary, and not, for example, when only a detail has to be
checked. This request has to be evaluated in accordance
with the principle of proportionality and, thus, taking into

49

(142) An explicit
provision has been
included in the
Directive relating to
toys (Article 12).
However, such a
provision is difficult to
apply where the
manufacturing process
takes place outside the
Community.
(143) According to the
Directive on highspeed rail systems,
each Member State
authorises the putting
into service of the
structural subsystems
in their territory. This is
a systematic
mechanism to monitor
the compliance of
subsystems and their
inter-operability
constituents.
(144) Member States are
obliged, according to
the Directive on the
introduction of
measures to encourage
improvements in the
safety and health of
workers at work
(89/391/EEC), to ensure
adequate controls and
supervision.
(145) For responsibilities,
see Chapter 3; for EC
declaration of
conformity, see Section
5.4; for technical
documentation, see
Section 5.3; for notified
bodies general
responsibilities, see
Section 6.3.
(146) This does not
apply to products
covered by directives
that do not provide for
the EC declaration of
conformity, such as the
Directive relating to
toys.

 Guide to the implementation of directives based on the New Approach and the Global Approach

account the need to ensure the health and safety of persons

or other public interests foreseen in the directives, as well
as to protect the economic operators from unnecessary
burden. Further, failure to present the documentation in
response to a duly substantiated request by a national surveillance authority, within an acceptable delay, may constitute sufficient grounds for doubting the presumption of conformity with the requirements of the directive (147).
A national authority may request a translation of the
technical documentation and the EC declaration of conformity into its official language. However, it should avoid
doing so if they, especially the detailed technical information of the documentation, are available in a language that
can be understood by the national authority in question. If
the authority considers a translation necessary, it must
clearly define the part of the documentation to be translated and allow reasonable time for this to take place. No further conditions may be imposed on the translation, such as
a requirement of a translator accredited or recognised by
the public authorities. The request for a translation must be
assessed on the basis of Article 28 of the EC Treaty on a

case by case basis, taking into consideration the proportionality of the demands.
It must be possible to make the technical documentation available in the Community. However, it need not be
kept inside the Community, unless otherwise provided for in
the applicable directives (148). The requirement for making
it available does not mean that the person who bears this
responsibility must be in possession of it, as long as he is
capable of stating where it can be found and of presenting
it on request from the national authority. The name and
address of the person in possession of the documentation
need not be expressly mentioned on the product or on its
packaging, unless otherwise specified. Further, the technical documentation can be kept in any format (for example
as a hard copy or CD-ROM), which allows it to be made
available within a period of time commensurate with its
importance and the risk in question.
Member States must ensure that everyone receiving
information about the contents of the technical documentation during market surveillance is bound to secrecy according to principles laid down in the national legislation.

8.2.2. Corrective actions

(147) As essential
technical data is to be
considered, in
particular: the name
and address of the
manufacturer; the list
of harmonised
standards followed or
other solutions adopted
to satisfy the essential
requirements; a
description of the
product; the operating
instructions, if any; and
the overall plan of the
product, if any.
Examples of detailed
technical information
are test reports, quality
manual information,
quality control plans
and other plans,
descriptions of the
products and
processes and
standards applied.
(148) According to
Annex IV of the
Directive relating to
low voltage equipment
the technical
documentation must be
kept on Community
territory.

could also be the situations where other

conformity markings provided for in the
Before any action is taken, the party concerned must be notidirective are incorrectly affixed, or where
fied and unless the matter is urgent given the possibility
the EC declaration of conformity cannot be
of being consulted.
provided for immediately or it does not
The corrective action depends on the level of nonaccompany the product when this is mandacompliance, which has to be established on a case by case
tory, or the requirement to accompany
other information provided for in the direcbasis, and it has to be in accordance with the principle of
tive(s) is complied with insufficiently, or,
proportionality:
where applicable, the identification number
* first, the manufacturer, or the authorised representative,
of the notified body has not been affixed to
should be obliged to make the product comply with the provithe CE marking.
sions and to remedy the infringement;
Non-conformity to essential require* ultimately, where other measures have failed or they are not
ments must usually be considered as a subconsidered as sufficient, all appropriate measures shall be
stantial non-compliance, because this may,
taken to restrict or prohibit the placing on the market and putfor instance, present a potential or actual
risk to the health and safety of citizens.
ting into service of the product in question, and to ensure that
However, non-conformity to a harmonised
it is withdrawn from the market.
standard is not, as such, sufficient evidence
of non-conformity to essential requireCompetent national authorities must take action to enforce
ments, but indicates that further investigations may be necconformity, when they discover that a product is not in comessary.
pliance with the provisions of the applicable directives.
Depending on the circumstances, it may be considered
The corrective action depends on the degree of noneither as a non-substantial or substantial non-compliance, if
compliance and, thus, must be in accordance with the prina product is not CE marked when it should be according to
ciple of proportionality. However, the difference between
the applicable directives, or a product is CE marked when it
non-substantial and substantial non-compliance is not
should not be. It needs to be taken into account that the
always clear, and must be decided on a case by case basis.
application of a directive, and accordingly the requirement
The incorrect affixing of the CE marking as regards, for
to affix the CE marking, can sometimes prove to be difficult.
instance, the design, size, visibility, indelibility or legibility,
On the other hand, if a product covered by a New Approach
can usually be considered as a non-substantial non-complidirective is not CE marked, it is an indication that the prodance. Examples of typically non-substantial non-compliance
uct does not comply with the essential requirements or the

50

 Market surveillance

safety of persons), the manufacturer, or the authorised repconformity assessment procedure has not been applied
resentative established in the Community, should have an
and, consequently, the product may, for instance, endanger
opportunity to be consulted in advance, before the compethe health and safety of persons. Such non-compliance
tent authority takes action to restrict the free circulation of
should be considered as substantial.
products. In practice, it should be considered as sufficient
Enforcement of conformity can be achieved by obliging
when the manufacturer or the authorised representative has
the manufacturer, the authorised representative, or other
been provided with an opportunity to react. However, it
responsible persons, to take required measures (149). Corshould not delay the proceeding, if the manufacturer or the
rective action can also take place if the necessary measauthorised representative remains passive (151).
ures are taken (for example the product is modified or withThe decision to restrict the free movement of a CE
drawn from the market), either as a result of consultations
marked product in case of substantial non-compliance usucarried out by the surveillance authority or as a result of forally invokes the safeguard clause procedure. This procemal or informal warnings. In all cases the surveillance
dure is aimed to enable the Commission to keep an
authority must establish accompanying measures to ensure
overview of such measures and to consider whether or not
that conformity is enforced.
they are justified. In addition, the exchange of information
Action taken against non-substantial non-compliance
between national surveillance authorities on corrective
can be on two levels.
actions taken, whether or not based on substantial non* First, the surveillance authority should oblige the manucompliance, should take place, where this is considered
facturer, or the authorised representative, to make the prodappropriate and necessary, and where the need for confiuct intended to be placed on the market and, if necessary,
dentiality as well as transparency can be respected (152).
the product already on the market, comply with the proviA manufacturer, the authorised representative, or other
sions and to remedy the infringement.
person may consider himself to have suffered a loss as a
* Secondly, if no result can be achieved, the competent
result of an inappropriate national measure that restricted
authority shall, ultimately, take a further step to restrict or
the free movement of a product. In such a case he could be
prohibit the placing on the market of the product and, if necentitled to claim damages under the jurisdiction of the State
essary, to ensure that it is also withdrawn from the market.
which initiated the procedure and in accordance with the
In case of substantial non-compliance the competent
laws of that State. For instance, an opinion taken by the
authority has to take appropriate measures, following the
Commission, at the end of a safeguard clause procedure,
principle of proportionality, to enforce conformity.
* The authority shall, ultimately, restrict or prohibit the
where the national measure is considered as non-justified,
placing on the market and the putting into service of the
may raise the question whether or not a liability case for
product and ensure that it is withdrawn from the market, if
incorrect implementation of Community law could take
no other measures are sufficient to maintain the high level
place.
of protection envisaged in the directives. This usually
invokes the safeguard clause.
8.2.3. Complementary activities
Action to prohibit or restrict the placing
Efficient enforcement of directives usually requires that, in
on the market may first be temporary to
allow the surveillance authority to obtain
addition to market surveillance operations described in
sufficient evidence about the danger or
Sections 8.2.1 and 8.2.2, surveillance authorities should:
other substantial non-compliance of the
* act in collaboration with manufacturers and suppliers;
product.
* take appropriate action against the person who has affixed
Any decision taken by national authorithe CE marking to a non-compliant product, and against those
ties to restrict or prohibit the placing on the
who are responsible for the non-compliance of the product;
market, or the putting into service, or to
and
withdraw products from the market must
state the exact grounds on which it is
* have the possibility to warn persons who might be at risk,
based. The party concerned in particular,
to destroy dangerous products and ban their export, to prohibthe manufacturer, or the authorised repreit the use of such products, and to require the withdrawal of
sentative established in the Community
certificates.
shall be notified. They shall also be
informed about remedies available under
the national law in force in the Member State in question,
Surveillance authorities should not limit their activities to
and of the time limits to which such remedies are subjectmonitoring products placed on the market, and to taking
ed (150).
the necessary corrective actions. Informal contacts and
Unless the matter is urgent (for example the product
other collaboration between the authority and the manupresents a serious and immediate danger to the health and
facturers and suppliers may help in preventing the placing

51

(149) For responsibilities,

see Chapter 3.
(150) See Directives
relating to simple
pressure vessels, toys,
machinery, personal
protective equipment,
non-automatic
weighing instruments,
active implantable
medical devices, gas
appliances, potentially
explosive atmospheres,
medical devices,
recreational craft, lifts,
refrigeration
appliances, pressure
equipment, and in vitro
diagnostic medical
devices.
(151) An explicit
provision to consult has
been included in the
Directives relating to
medical devices and in
vitro diagnostic
medical devices.
(152) For application of
the safeguard clause
procedure, see Section
8.3; for administrative
cooperation, see
Section 8.6.

 Guide to the implementation of directives based on the New Approach and the Global Approach

(153) The Directives

relating to low voltage
equipment, hot-water
boilers, and
refrigeration appliances
do not explicitly require
this. However, it should
be considered that this
obligation applies to all
New Approach
directives.
(154) This obligation is
based on Article 10 of
the EC Treaty; see case
68/88 from the Court of
Justice. The Directive
on civil explosives
requires Member
States to determine
penalties to be applied
for infringement of the
provisions adopted in
implementation of the
Directive, and which
must be sufficient to
promote compliance
with these provisions.
(155) See Article 6 of the
Directive on general
product safety.
(156) Article 7 of the
Directive on general
product safety contains
a safeguard clause
similar to that included
in the New Approach
directives. The general
principles that apply to
the safeguard clause
under the New
Approach directives
are, therefore, also
applicable to the
safeguard clause under
the Directive on
general product safety.
Directives relating to
hot-water boilers and
refrigeration appliances
do not provide for a
safeguard clause.
However, the Directive
relating refrigeration
appliances contains
provisions for the
exchange of
information.

on the market of non-compliant products. For instance,

tures as those subject to market surveillance actions, in
the authority can provide general advice and guidance to
order to ensure a high level of protection.
the economic operators on the application of the direcNew Approach directives may require the competent
tives. Further, the authority should also consider the posauthority to take special action regarding non-compliant
sibilities of raising the awareness of consumers and other
products. For instance, the directive relating to telecommuusers, for example on issues relevant to their health and
nications terminal equipment requires Member States to
safety.
disconnect equipment from the public telecommunication
New Approach directives require that action is taken
network if it is not used for the intended purpose.
against persons who affix the CE marking to non-compliant products (153). Action should, as well,
8.3. Safeguard clause procedure
be taken against the manufacturer (or
other person) responsible for placing a
non-compliant product on the market.
New Approach directives include a form of safeguard
These actions can, for instance, consist of
clause, which obliges Member States to restrict or forbid the
warnings or legal proceedings. Actions
placing on the market and the putting into service of dangerous
must also be considered against the noti or, according to some directives, otherwise non-compliant
fied body, if it was involved in the conproducts, or to have them withdrawn from the market (156).
formity assessment procedure that had, as
As a general rule, this safeguard clause procedure is
a result, non-compliant products. In such
restricted to products which are:
cases, the competence of the notified
body may need to be assessed as well.
* covered by New Approach directives;
Since New Approach directives do not
* CE marked; and
specify any penalty, Member States remain
* ascertained by the Member State to present a substantial
free to choose the sanctions to be used
hazard, even if the products are correctly constructed,
when infringements take place. These
installed and maintained, and used according to their intendpenalties must be analogous to those applied purpose.
cable to infringements of national law of a
This safeguard clause procedure shall be applied to nationsimilar nature and importance. In addition,
al measures which:
these penalties must be effective, proportionate and dissuasive (154).
* restrict or forbid the placing on the market of a product, or
Usually some products from the same
have a product withdrawn from the market;
product series will have already been sold
* relate to all products belonging to the same batch or series;
or even put into use after the non-compliand
ance has been discovered. In these cases,
* have binding legal effects.
it is important to ensure that persons who
The Member State must notify the Commission immediately
might be exposed to a risk from a product
after
taking action that invokes the safeguard clause. The necare informed. This should basically be conessary information and evidence to justify the action must
sidered as a responsibility of the manufacturer or the distributor, in particular as
accompany the notification.
regards consumer products (155). The warn If the Commission considers the national action to be justiing can take the form of a general publicafied, it informs the other Member States. They are required to
tion or, if the number of persons at risk is
take the necessary measures on their territory.
limited, it can be directed to individuals. The
authority should also consider whether or
8.3.1. Conditions for invoking the safeguard clause
not it would be necessary to restrict the use of products
that have proven to be dangerous.
The safeguard clause is designed to allow the Commission
When a competent authority decides to restrict or proto analyse the justification of national measures restricting
hibit the placing on the market and the putting into service
the free movement of CE marked products (products preof a product, or to withdraw it from the market, it should
sumed to comply with requirements). Secondly, it provides
also consider in accordance with the principle of propora means to inform all national surveillance authorities about
tionality whether or not it would be necessary to destroy
dangerous products, and, accordingly, to have the necesthe product, or ban its export to other Member States, and
sary restrictions extended to all Member States so as to
to require the withdrawal of certificates. Sometimes it is
ensure an equivalent level of protection throughout the Comalso important to verify whether or not decisions need to be
munity.
taken for other products which have the same technical feaThe safeguard clause shall be applied to products that

52

 Market surveillance

fall within the scope of a New Approach directive and bear

by the manufacturer on the labelling, in the instructions, in

the CE marking provided by such a directive. Consequently,

the users manual or in promotion materials are to be taken

the safeguard clause cannot be applied to products that are

into consideration (160).

The reason for invoking the safeguard clause may

not CE marked in accordance with the directive providing

for the safeguard procedure in question (157).

result, for instance, from differences or failures in the appli-

For the safeguard clause to be applicable, the non-con-

cation of essential requirements, incorrect application of

formity has to be established regarding a systematic failure

harmonised standards or shortcomings in them. The sur-

in the design of a whole series of products manufactured,

veillance authority can add or specify other motives (for

however limited the series. For an isolated error, limited to

example failure to comply with good engineering practice)

the territory of the Member State that has discovered the

when invoking the safeguard clause, provided that they are

non-compliance, there is no need to invoke the safeguard

directly linked with these three reasons.

Where non-compliance with harmonised standards that

clause, since there is no need to take action on Community

give a presumption of conformity is established, the manu-

level.
The application of the safeguard clause requires that the

facturer, or the authorised representative in the Community,

competent national authority decides to restrict or forbid

must be requested to provide evidence about compliance

the placing on the market and, possibly, the putting into

with essential requirements. The decision of the competent

service of the product, or has it withdrawn from the market.

authority to take corrective action must always be based on

The contents of the decision should relate to all products

an established non-compliance with the essential require-

belonging to the same batch or series. It must also have

ments invoking the application of the safeguard clause.

binding legal effect: it is followed by sanctions, if not

respected, and can be subject to an appeals procedure.

8.3.2. Notification to the Commission

Court decisions, which restrict the free movement of CE

As soon as a competent national authority restricts or for-

marked product within the scope of the relevant directive(s),

bids the free movement of a product in such way that the

do not invoke the safeguard clause. However, where admin-

safeguard clause is invoked, the Member State must imme-

istrative proceedings initiated by the surveillance authority

diately notify the Commission indicating the reasons and

must be, according to the national law, confirmed by a

justification for the decision (161). At this stage, the Com-

court, such court decisions are not excluded from the safe-

mission does not distribute the information it has received.

guard clause procedure.

The safeguard clause does not include an obligation to

Conformity can be enforced if the national authority re-

inform the other Member States (162). In several sectors

quests the manufacturer or the authorised representative to

Member States tend to send a copy of their notification to

take the necessary measures, or if the product is modified

other Member States (163). Member States that have

or voluntarily withdrawn from the market. Unless a formal

received such a notification from another Member State

decision is taken in these cases, to prohibit or restrict the

should decide if action is necessary, and take into account

placing on the market of the product or to have it withdrawn

that such action must be justified.

from the market, the safeguard clause procedure is not in-

To reduce the time taken to process the file by the Com-

voked. Thus, a direct exchange of information between mar-

mission, the notification should include:

ket surveillance authorities may be necessary (158).

a reference to the directive(s), and in particular to the

The findings that justify the national measure are estab-

essential requirements, against which the non-compliance

lished either by the market surveillance authority on its own

has been established;

initiative, or based on information received from a third

name and address of the manufacturer, the authorised

party (such as consumers, competitors, consumer organi-

representative, and in addition if necessary the name

sations, labour inspectorates). Further, the national meas-

and address of the importer or other person responsible for

ure must be based on evidence (for example tests or exam-

placing the product on the Community market;

inations) that constitutes sufficient proof of errors in the

a copy of the declaration of conformity;

product design or the manufacture to indicate a foreseeable

the name and number of the notified body that intervened

potential or actual danger or other substantial non-compli-

in the conformity assessment procedure, if applicable;

ance, even when the products are correctly constructed,

information on the procedure which was used by the

installed, maintained and used in accordance with their

authority to verify the compliance of the product; and

intended purpose or in a reasonably foreseeable way. There

a comprehensive assessment and evidence to justify the

is a grey zone between correct and incorrect maintenance

measure (for example harmonised standards or other tech-

and use, and it can be considered that, to a certain extent,

nical specifications used by the authority, the test reports

products should be safe, even if maintained and used with

and identification of the testing laboratory).

their intended purpose in an incorrect way that can reason-

Where the manufacturer, the authorised representative,

ably be expected (159). In evaluating this, the data supplied

or other responsible person, agrees to modify the product

53

(157) However,
according to the
Directive relating to
machinery safety
components and
according to the
Directive relating to
medical devices,
custom-made medical
devices may be subject
to the safeguard clause
procedure, although
they may not be CE
marked. The same
applies to
inter-operability
constituents according
to the Directive relating
to high-speed rail
system. As regards the
Directive on marine
equipment the
safeguard clause is
applicable to products
that bear the mark of
conformity provided for
in the Directive.
The Directives relating
to low voltage
equipment,
construction products,
active implantable
medical devices, and
radio and
telecommunications
terminal equipment do
not lay down as a
precondition for
invoking the safeguard
clause that the CE
marking is affixed to
the product. However,
it should generally be
considered that also
under these Directives
the safeguard clause is
only applied to
products which are
considered to comply
with all applicable
provisions (including
the provisions
regarding CE marking).
The reason for this is
that the safeguard
clause allows a
Member State to
challenge a product,
which is, basically,
subject to free
movement. For
corrective action in
cases where a noncompliance has been
established regarding
products that either are
or are not CE marked,
see Section 8.2.
(158) For administrative
cooperation, see
Section 8.6.1.
(159) The Directive on
toys requires that toys

 Guide to the implementation of directives based on the New Approach and the Global Approach

must be safe when

used as intended or in
a foreseeable way,
bearing in mind the
normal behaviour of
children.
(160) The manufacturer
is explicitly required to
supply data according
to the Directives
relating to low voltage
equipment, simple
pressure vessels, toys
(only for certain toys),
machinery, personal
protective equipment,
active implantable
medical devices, gas
appliances, medical
devices, potentially
explosive atmospheres,
recreational craft, lifts,
pressure equipment, in
vitro diagnostic
medical devices, and
radio and
telecommunications
terminal equipment.
(161) The official
notification usually
takes place via the
Permanent
Representation with a
copy sent to the
Commission
department responsible
for managing the
directive in question.
(162) As an exemption,
Member States have to
inform the other
Member States as well
as the Commission
when invoking the
safeguard clause
according to the
Directive relating to
low voltage equipment.
(163) The copy is
usually sent via the
Permanent
Representation.
(164) A safeguard clause
that is notified
according to the
Directive relating to
low voltage equipment
is examined only if
other Member States
raise objection as
regards the measures
taken.
(165) In addition, the
Directives on medical
devices and in vitro
medical devices
foresee a possibility to
take measures at
Community level.
(166) For withdrawal of
the presumption of
conformity, see
Section 4.4.

in such a way that it complies with the applicable provisions,

the Member State should withdraw the safeguard clause
notification.

will consider initiating the procedure provided for by Article

226 of the EC Treaty (165).
Conversely, should the Commission see no justification
for the national action that invoked the safeguard clause, it
will ask the Member State to withdraw its action and take
immediate appropriate steps to re-establish the free movement of the products in question on its territory. This opinion is addressed to the Member State that invoked the safeguard clause, to the manufacturer and, if appropriate, to the
authorised representative or other person who is responsible for placing the product on the Community market. Also,
in this case, the Commission will consider initiating the
infringement procedure provided for by Article 226 of the
EC Treaty, on the basis of the Member State not complying
with the principle of free movement of goods. This procedure may cause the Commission to take the matter to the
Court of Justice. In such cases, legal proceedings may be
taken at national level by the manufacturer, or other person
who considers himself to have suffered damage, in order to
obtain compensation for the damage that resulted from a
national measure not in compliance with Community law.
If the safeguard clause is invoked because of a shortcoming in a harmonised standard that gives a presumption
of conformity, the Commission, after consulting the interested parties, will submit the case to the Committee set up
by Directive 98/34/EC and, if provided for, the sectoral
committees (166).
Whether the action taken by the Member State is considered justified or not, in either case, the Commission
keeps the Member States informed of the progress and the
results of the procedure.

8.3.3. Administering the safeguard clause

The Commission is responsible for administering the safeguard clause at Community level, and for ensuring that it
applies to the whole of the Community. To this end, the
Commission consults the interested parties to verify
whether or not the action that invoked the safeguard clause
can be justified. Precautions are necessary during the consultations to protect the confidentiality of the information (164).
The action to be taken is decided case by case. After
the Commission departments responsible for managing the
directive have been informed, they will, as a general rule,
first contact the Member State and the national surveillance
authority which invoked the procedure, and the manufacturers concerned or their authorised representative. The Commission may also contact the other Member States most
directly concerned by the case in question (usually the
Member States where the manufacturer or notified body is
established), and the notified bodies (or other third parties)
involved in the conformity assessment procedure.
If the Commission considers it necessary, it may in
collaboration with the Member State(s) concerned seek
the opinion of other adequately qualified, impartial bodies or
experts capable of providing further information directly relevant to the subject (such as other surveillance authorities,
other notified bodies, scientific committees of the Commission, standards organisations, conformity assessment bodies, organisations representing industry,
distributors or consumers, trade unions,
8.4. Protection of CE marking
research institutes or scientific experts).
Although these consultations can be rela Market surveillance authorities must check that the affixing
tively wide, the urgency of the problem is
and use of the CE marking is correct, and that the principles
taken into account and the procedure is
regarding additional markings and marks are respected.
kept as short as possible.

Where necessary, the authority has to take appropriate

At the end of the consultation procecorrective action to protect the CE marking.
dure, the Commission takes an opinion on
the justification of the national measure that
A Member State must notify to the Commission and to the
restricted or prohibited the free movement
other Member States when it decides to restrict free moveof products.
ment due to incorrect affixing of the CE marking, or when it
Where the Commission considers in its
takes action against those who are responsible for a nonopinion that the action is justified, it informs
compliant product bearing the CE marking.
the Member State concerned and the other
Member States immediately. The Commission may also decide to publish this opinion. Consequently,
Member States must provide in their national legislation for
Member States have an obligation to take appropriate
appropriate measures both to prevent the abuse and misaction, with a view to the opinion of the Commission, to
use of CE marking, and to redress the situation if such
ensure a similar level of protection throughout the Commuabuse or misuse takes place.
nity. This requirement is based on the general obligation of
The affixing of the CE marking to a product that is not
Member States for market surveillance and for enforcement
covered by any of the directives providing for its affixing is
of Community legislation. If a Member State refuses to folconsidered to be deceiving because consumers or users,
low the position taken by the Commission, the Commission
for instance, are likely to get the impression that the

54

 Market surveillance

product in question satisfies certain Community safety

provisions. Competent authorities must, therefore, have at
their disposal legal instruments that enable them to act
where the deceptive use of the CE marking is evident.
Action must be taken to enforce conformity, and against
those responsible for a non-compliant product bearing the
CE marking.
The affixing of marking and marks in addition to the CE
marking is subject to certain restrictions (167). The surveillance authority shall take the necessary measures to ensure
that these principles are respected and, where necessary,
take appropriate action.
The action to be taken by market surveillance authori-

8.5.1. Consumer products: rapid

exchange of information

8.5.

ties shall be decided on a case by case basis according to

the principle of proportionality (168).
A Member State must inform the Commission and the
other Member States of its decision to restrict free movement due to incorrect affixing of the CE marking, and of its
action against the person who has affixed the CE marking
to a non-compliant product (169). It is then up to the other
Member States to decide whether or not similar action is
necessary. No detailed evidence to justify the action is necessary, and no consultations regarding the national measures, as envisaged for the safeguard clause, take place.
However, the Commission can take action under Article 226
of the EC Treaty should it consider it necessary.

Information exchange systems

The Directive on general product safety pro A rapid information exchange system has been set up by the
vides a legal basis for an information
Directive on general product safety to handle emergency situexchange system for emergency situations.
ations caused by consumer products that present a serious
This system for the rapid exchange of inforand immediate danger.
mation on dangers arising from the use of
A vigilance system applies for medical devices. This system
consumer products (RAPEX) (170) is a genrequires
that a national surveillance authority notifies to the
eral and horizontal early warning and moniCommission
and to the other Member States serious performtoring system. It is designed for handling
urgent situations caused by new, used or
ance defects, inadequate marking or instructions that can
repaired products that present a serious
result in, or have resulted in, the death of patients or users, or
and immediate risk to the health and safety
a serious deterioration in their health.
of consumers. Its essential aim is to provide
Information on injuries, particularly those resulting
information in order to allow authorities of
from home and leisure accidents, for example, caused by or
all Member States to take immediate and
involving products, is available in the Community injury dataappropriate action when a serious risk ariscollection and information-exchange system.
ing from a product has been detected.
RAPEX applies to all products intended
for consumers, or likely to be used by consumers, which,
vent, restrict or impose specific conditions on the possible
used under normal or reasonably foreseeable conditions,
marketing or use of consumer products presenting a seripresent, for any reason, an immediate and serious risk to
ous and immediate risk. A further condition for invoking
the health and safety of consumers. It covers both foodRAPEX is that the effects of the risk can go beyond the terstuffs and industrial (non-food) products. It is also applicritory of the Member State concerned. Member States are
able to consumer products covered by the New Approach
not required, as is the case under the safeguard clause prodirectives and it is, in particular, important for toys and low
cedure according to the New Approach directives, to provoltage products. This is because the New Approach direcvide evidence to justify the national measure. The Commistives do not provide for such a procedure (171).
sion verifies that the information complies with the proviRAPEX works according to the detailed procedures laid
sions of the Directive on general product safety, and will
down in the annex to the Directive on general product safepass it to the other Member States.
ty. As soon as a serious and immediate risk is detected, the
Where RAPEX has been applied, the Commission, after
national authority must consult, insofar as possible and
consulting the Member States and at the request of at least
appropriate, the producer or distributor of the product conone of them, may adopt a decision requiring Member States
cerned. The authority should try to obtain the maximum of
to take temporary measures. This is to ensure the proinformation on the products and the nature of the danger,
tection of health and safety of consumers and the proper
without compromising the need for rapidity.
functioning of the single market.
A Member State shall inform the Commission when it
The safeguard clause procedures under the New
adopts, or decides to adopt, emergency measures to preApproach directives apply independently from RAPEX.

55

(167) See Section 7.4.

(168) For actions to be
taken see Section 8.2.2.
(169) According to the
New Approach
directives, the
provision on CE
marking usually
contains an obligation
to inform the
Commission and other
Member States by
referring to the
provision on the
safeguard clause
procedure. However,
regarding measures
taken due to unduly
affixed CE marking, the
safeguard clause
procedure should not
be applied as such but
only to the extent
relating to information
exchange.
(170) The system is also
known under the
names of REIS and
SERI.
(171) As an exception, a
vigilance system has
been established for
medical devices; see
Section 8.5.2.

 Guide to the implementation of directives based on the New Approach and the Global Approach

Accordingly, RAPEX does not necessarily have to come into

measure vis--vis non-compliant CE marked products, if the

play before the safeguard clause procedure is applied. How-

conditions for invoking the safeguard clause apply and,

ever, the safeguard clause procedure has to be applied, in

accordingly, notify this measure following the safeguard

addition to RAPEX, when the Member State takes a decision

clause procedure. However, the vigilance system does not

to permanently prohibit or restrict the free movement of CE

necessarily have to come into play before the safeguard

marked products on the basis of a danger or other serious

clause procedure is applied.

risk presented by the product.

8.5.3. Community injury data-collection and
8.5.2. Medical devices: vigilance system

information exchange system

Risks posed by medical devices have necessitated a com-

The Community action programme on injury prevention with-

prehensive monitoring system whereby all serious product

in the framework for action in the field of public health aims

incidents will be reported (172). The medical devices vigi-

to contribute to public health activities which seek to reduce

lance system applies to all incidents which might lead to, or

the incidence of injuries, particularly injuries caused by

might have led to, the death of a patient or a user, or to a

home and leisure accidents (173). For this purpose the pro-

serious deterioration in their state of health, and which

gramme promotes:

result from:

the epidemiological monitoring of injuries by means of a

any malfunction or deterioration in the characteristics or

Community system for the collection of data and the

performance of a device;

exchange of information on injuries based on strengthening

any inadequacy in the labelling or the instructions for use;

and improving on the achievements of the European home

or

and leisure accident surveilance system (Ehlass); and

any technical or medical reason in relation to the charac-

information exchanges on the use of those data to con-

teristics or performance of a device, and which leads the

tribute to the definition of priorities and better prevention

manufacturer to systematically recall all devices of the

strategies.
The data is collected from hospitals and other appropri-

same type.
The manufacturer is responsible for activating the vigi-

ate establishments and services within the Member States,

lance system and must, accordingly, inform the surveillance

and by means of surveys. The collection and transmission

authority about incidents that invoke it. After the notifica-

of data to the information system is carried out under the

tion, the manufacturer is obliged to make investigations,

responsibility of the Member States, which have an obliga-

send a report to the surveillance authority and consider, in

tion to ensure the reliability of sources.

The setting up of an on-line telematic tool for sharing

collaboration with the authority, what action should be

and transferring data is underway. This will facilitate direct

taken.

exchanges of information between national administrations,

The manufacturers notification is followed by an

Commission and international organisations.

assessment carried out by the surveillance authority, if possible together with the manufacturer. After the assessment,

The programme is also open to participation by the

the authority must immediately inform the Commission, and

associated countries of central and eastern Europe, and by

the other Member States, of the incidents for which relevant

Cyprus and Malta.

measures have been taken or are contemplated. The Com8.5.4.

mission may then take any steps to coordinate, facilitate

and support measures taken by the national surveillance

(172) See Directives

relating to active
implantable medical
devices, medical
devices and in vitro
diagnostic medical
devices.
(173) European
Parliament and Council
Decision 372/99/EC.

Other information exchange systems at

Community level

authorities when dealing with the same type of incidents, or,

The safeguard clause procedure, under the New Approach

if necessary, take measures at Community level (for exam-

directives, provides a means to exchange information,

ple envisaging the re-classification of the device).

although its primary objective is to verify whether or not the

A databank containing, among other information, data

national measure can be justified and, if this is the case, to

obtained in accordance with the vigilance system will be set

resolve the problem at Community level. In addition, the

up and made accessible to the competent authorities.

New Approach directives oblige Member States to inform

The vigilance system is different from the safeguard

the Commission, and the other Member States, when free

clause procedure, since it requires notification even if the

circulation is restricted due to incorrect affixing of the CE

manufacturer takes the necessary measures on a voluntary

marking, or action has been taken against those who are

basis. Nevertheless, when applying the vigilance system the

responsible for a non-compliant product bearing the CE

surveillance authority is also obliged to adopt a restrictive

marking.

56

 Market surveillance

Administrative cooperation

8.6.1. Outline for administrative

cooperation

8.6.

The proper application of Community law

depends upon smooth administrative cooperation to ensure uniform and efficient
enforcement of Community legislation in all
Member States. The obligation to cooperate is in accordance with Article 10 of the
EC Treaty, which states that Member States
must take all appropriate measures to fulfil
their obligations (174).

Administrative cooperation is an obligation of Member

States. National surveillance authorities and the Commission
must provide mutual assistance to ensure proper and uniform
application of New Approach directives.
Member States need to communicate to the Commission and
the other Member States a list of surveillance authorities,
which they have designated as contact points to coordinate
administrative cooperation.
National surveillance authorities should make information
available spontaneously or on request, according to mutually
agreed principles and mechanisms.
National surveillance authorities should consider if coordination of national operations provides a means to increase the
efficiency of market surveillance at Community level.
The information exchanged in the framework of administrative cooperation has to be covered by the requirements of
professional secrecy.
Administrative cooperation regarding the enforcement of
New Approach directives is organised in the standing committees established under the directives, and in the horizontal
group of Senior Officials for Standardisation and Conformity
Assessment Policy.

Although technical harmonisation has

created a single market, where products
move over national borders, market surveillance is carried out on a national basis.
Administrative

cooperation

mechanisms

between national surveillance authorities,

therefore, need to be developed to increase
the efficiency of surveillance, to minimise
the effect of different surveillance practices
and to reduce the overlapping of national
surveillance

operations.

Cooperation

between market surveillance authorities can

also spread good surveillance practice and
techniques across the Community, as
national authorities can compare their methods with those of other authorities, for

example in the framework of comparisons

and joint surveys or study visits. In addition,
cooperation can be useful for exchanging views and solving

communicate to the Commission any information they con-

practical problems.

sider relevant, spontaneously or in response to a reasoned

Administrative cooperation calls for mutual trust and

request from the Commission. The Commission may then

transparency between national surveillance authorities.

communicate this information to the other national authori-

Member States and the Commission need to be informed

ties when considered necessary.

about the way enforcement of New Approach directives, in

Information exchange has been set up in Community leg-

particular market surveillance of products covered by the

islation to a limited extent, mainly where a risk of a serious

New Approach, is organised throughout the single market.

danger is present (175). For instance, the safeguard clause of

This includes information about national authorities in charge

the New Approach directives is, basically, only applicable to

of market surveillance for the different product sectors, and

CE marked products, and all non-consumer products as well

about national market surveillance mechanisms to clarify

as minor non-compliance are excluded from the application

how monitoring of products placed on the market takes

of the rapid information exchange system according to the

place and what corrective actions and other activities the

Directive on general product safety. In some circumstances,

surveillance authority is entitled to use. Transparency is also

the existing information exchange systems are not quick

necessary regarding the national rules on confidentiality.

For the achievement of effective market surveillance in
the Community, it is important that national surveillance
authorities assist each other. On request, a national authority should make information available and provide other
assistance. Without prior request, a national authority may
consider sending to the other national authorities all relevant information concerning operations that constitute, or
are likely to constitute, breaches of New Approach directives, which may have an impact on the territory of other
Member States. In addition, the national authorities should

enough as regards the potential or actual risk. For example,

the safeguard clause requires consultation and an opinion
taken by the Commission that justifies the national measure
before the information is forwarded to other Member States.
In cases where the mechanisms provided for are insufficient,
the need to exchange information should be considered,
with a view to assuring confidentiality. To keep exchange of
information manageable, it should be limited to findings
where the non-compliance is considered as substantial or
where it is otherwise considered as essential to keep surveillance authorities in different Member States informed.

57

(174) An explicit
obligation for
administrative
cooperation is laid
down in the Directives
relating to pressure
equipment and in vitro
diagnostic medical
devices: Member
States are required to
take appropriate
measures in order to
encourage/ensure that
the authorities
responsible for
implementing the
Directive cooperate
with each other, and
provide each other
(and the Commission)
with information in
order to assist the
functioning of the
Directive.
(175) See Sections
8.3 8.5.

 Guide to the implementation of directives based on the New Approach and the Global Approach

Cooperation and mutual assistance are, in particular,

dent for every sector, which would coordinate internally as

necessary to ensure that action can be taken against all

appropriate;

those who are responsible for a non-compliant product

agreement about the types of cases for which the com-

being placed on the market. In such cases the authority of

munication of surveillance information would serve a useful

the Member State, where the manufacturer, the authorised

purpose;

representative, or other responsible person is established,

developing a common approach to issues such as the

classification of risks and hazards and their coding;

176

needs to be contacted (

). This is to obtain information

from these economic operators, for example to require the

identification of the details which should be communicat-

EC declaration of conformity or some specified details from

ed in each case, including the request for further informa-

the technical documentation, or to request information con-

tion;

cerning the distribution chain. The Member State under

accepting the obligation to respond to enquiries within a

whose jurisdiction the notified body operates needs to be

given time scale (178);

contacted as well. When a national authority acts due to

transmitting information (requests and responses), as

information it has received from another national body, it

simply as possible, by e-mail, or through a telematic system

should report back to this authority on the outcome of the

operated by the Commission or an external body, and by

action.

using standard multi-language forms;

taking advantage of up-to-date data recording techniques

Moreover, market surveillance would be more efficient,

so that enquiries can be easily undertaken; and

on the Community level, if the national surveillance authori-

treating the information received in complete confidence.

ties could agree on how to allocate their resources in such

a way that a maximum number of different product types

8.6.2. Infrastructures for administrative cooperation

could be covered in each sector. To avoid duplication of

Committees and working groups

product tests, or other investigations for market surveil-

Cooperation between national administrations takes place

lance purposes, national authorities should build up a mech-

in working groups set up under the New Approach direc-

anism to exchange a summary report of these tests. Nation-

tives. Discussions mainly focus on interpretation issues, but

al surveillance authorities should also consider whether or

questions related to market surveillance and administrative

not there is special need to carry out technical analyses or

cooperation are also dealt with.

laboratory tests when another surveillance authority has

Administrative cooperation between national authorities

already done so, and the results are available to those

carrying out market surveillance is taking place in the fol-

authorities or may at their request be placed at their dis-

lowing sectors: low voltage equipment, electromagnetic

177

posal (

). It might also be useful to exchange results of

compatibility (EMC administrative cooperation), machinery

periodic inspections on equipment in service, to the extent

(Machex) (179), medical devices (in particular regarding the

that they provide information on the compliance of products

vigilance system), telecommunications terminal equipment,

when they were placed on the market.

recreational craft, and consumer products (Prosafe, the

Information exchanged between national surveillance

(176) For responsibilities,
see Sections 3.1 3.4.
(177) See Judgement of
the Court, cases 272/80
and 25/88.
(178) An information
request does not
infringe the right of a
national authority to
take whatever
measures are needed
to ensure compliance
with New Approach
directives within its
jurisdiction.
(179) See Commission
Decision 95/319/EC
setting up a Committee
of Senior Labour
Inspectors.
(180) See Commission
Decision 93/72/EEC on
the setting-up of an
Advisory Committee for
coordination in the
internal market field.

product safety forum of Europe).

authorities has to be covered by professional secrecy,

The group of Senior Officials for Standardisation and

according to principles of the national legal system in ques-

Conformity Assessment Policy is a horizontal committee

tion, and it has to enjoy the protection extended to similar

where, for instance, general questions related to the imple-

information under national law. Where a Member States has

mentation and enforcement of New Approach directives,

rules permitting free access by persons to information held

such as horizontal aspects of market surveillance, are

by surveillance authorities, this fact must be revealed at the

discussed.

time of the request to another surveillance authority, or dur-

The emergencies committees, set up under the Direc-

ing the exchange of information if no such request occurs.

tive on general product safety, regularly discusses adminis-

If the sending authority indicates that the information

trative cooperation issues of general interest.

involves matters of professional or commercial secrecy, the

The Internal Market Advisory Committee (IMAC) (180)

receiving authority should ensure that this can be provided

advises the Commission on all aspects concerned with the

for. Otherwise the sending authority is entitled to withhold

functioning of the single market. The committee facilitates

the information.

exchange of information between the Commission and the

Coordination and exchange of information between

Member States. The committee does not intervene if other

national surveillance authorities need to be agreed by the

appropriate mechanisms are in place, but it can deal with

parties involved and taking into account the needs of the

situations that do not come within the scope of existing

sector concerned. The following principles could be taken

mechanisms.

into consideration, where appropriate:

Data on national enforcement structures

appointing a national communication point or correspon-

Member States have been required to notify to the Com-

58

 Market surveillance

mission their respective ministries for certain priority areas

low voltage electrical equipment, electromagnetic compati-

of single market legislation (181). The main aim behind this

bility; equipment and protective systems intended for use in

provision is to enable governments to cooperate with each

potentially explosive atmospheres; medical devices; gas

other to enforce legislation, mainly through exchange of

appliances; pressure vessels; chemicals; civil explosives;

information, such as data about dangerous products,

machinery; motor vehicles; recreational craft; and different

inspections and tests carried out in another Member State,

quality control instruments.

approvals, licensing and audits. This resolution also

requires the Member States to notify contact points for
enterprises and for citizens, which will be
available to help to solve problems related

8.7.

Products imported from third countries

to the exercise of rights granted to them

under single market rules.
The Commission also maintains a database of contact points within Member
States administrations for the purpose of
facilitating contact with the administrations
of other Member States. This database is a
directory of all officials, in the Member
States and the Commission, who have
responsibility for the different single market
legislative measures. It is planned to make
the database available on-line on the Europa
web site. Thereby it will become directly
accessible to the officials concerned. However, it does not give direct information on
the national authorities responsible for carrying out market surveillance in the field of
New Approach directives.
A complementary framework document
describing national enforcement structures
and procedures has been produced. The
main purpose of the document is to assist
Member States and the Commission in
understanding

the

national

means

of

enforcement.
Karolus programme
The Karolus programme (182) provides for
the exchange between Member States officials who are engaged in the enforcement
of Community legislation to complete the
single market. The programme has been
opened to the participation of central and

A manufacturer established in a third country is responsible,

in the same way as a manufacturer established in a Member
State, for designing and manufacturing a product in accordance with all applicable New Approach directives and for
carrying out the required conformity assessment procedure,
where the product is intended to be placed or put into service
on the Community market (183).
The manufacturer may appoint an authorised representative
established in the Community to act on his behalf (184).
Where the manufacturer is not established in the Community
and has no authorised representative in the Community, the
importer or person responsible for placing the product on the
Community market may become responsible to some
extent (185).
Customs authorities shall, in the case of products imported
from third countries, suspend the release of goods:
* if they find products that display certain characteristics
which would give rise to a serious concern as to the existence
of a serious and immediate risk to health and safety; or
* if they find products that are not accompanied by a document or marked in accordance with applicable rules on
product safety.
As regards products covered by New Approach directives,
the attention of customs authorities must be drawn, in particular, to the CE marking of toys.
Customs authorities and market surveillance authorities
must keep each other informed, and take appropriate action
based on the information received.

eastern European countries, the EEA EFTA

States and Cyprus.

Regulation (EEC) No 339/93 on checks for conformity with

The objectives of the programme are to develop a con-

the rules on product safety in the case of products import-

vergent approach to enforcing Community legislation relat-

ed from third countries requires the customs authorities to

ing to the single market, to raise awareness of the European

be closely involved in the market surveillance operations

dimension, to build mutual confidence between Member

and information systems provided for under Community and

States administrations, and to permit cross-fertilisation of

national rules, in cases relating to products from third

ideas.

countries.

The Commission decides, on an annual basis, the prior-

Customs authorities are, in particular, requested to sus-

ity areas for the Karolus programme. These have included

pend the release of goods that display certain characteris-

conformity testing and market supervision, and in particular

tics which would give rise to a serious concern as to the

the following sectors: toys; personal protective equipment;

existence of a serious and immediate risk to health and

59

(181) See Council

Resolution of 8 July
1996 on cooperation
between
administrations for the
enforcement of
legislation on the
internal market.
(182) See Council
Decision 92/481/EEC for
the period 199397,
which was
extended by Council
Decision 889/98/EC
until the end of 1999.
(183) See Section 3.1.
(184) See Section 3.2.
(185) See Section 3.3.

 Guide to the implementation of directives based on the New Approach and the Global Approach

safety under normal and foreseeable conditions of use. The

conditions and formalities regarding release for free circu-

same applies where customs authorities find that a docu-

lation have been met.

ment required to accompany the products is missing, or

By virtue of several community acts including Regu-

that products do not bear conformity marking or labelling

lation (EEC) No 339/93 and the Directive on general prod-

required under Community or national rules on product

uct safety the surveillance authorities have an obligation

safety.

to notify the customs authorities of their findings, which concern products imported from third countries. The following

Regulation (EEC) No 339/93 applies to products

(186) See Decision

93/583/EEC establishing
the list of products
provided for in Article 8
of Council Regulation
(EEC) No 339/93. Other
products included in
this list are medicinal
products for human
use, veterinary
medicinal products and
foodstuffs. For placing
on the market and
putting into service,
see Section 2.3.
(187) If the products are
declared for
customs-approved
treatment or use other
than release for free
circulation, and
provided the market
surveillance authorities
have no objections, the
same wording must be
added, under the same
conditions, to the
documents relating to
that treatment or use.
(188) For the application
of the Directive on
general product safety
to products covered by
New Approach
directives, see Section
2.2.2; for the rapid
exchange of
information on dangers
arising from the use of
consumer products,
see Section 8.5.1.

imported from third countries, whether or not covered by

three situations may be possible.

New Approach directives. As regards products covered by

(1) Products imported from third countries intended for con-

New Approach directives, customs authorities must be par-

sumers or likely to be used by them present a serious and

ticularly vigilant in checking that toys are CE marked, where

immediate risk to health and safety according to the Direc-

these can be considered as finished products that are pre-

tive on general product safety.

sented in a manner (packaging, marking, labelling) indicat-

* In this case the system for the rapid exchange of infor-

ing that they are to be placed on the market without further

mation on dangers arising from the use of consumer prod-

processing (186).

ucts according to the Directive on general product safety

Customs authorities must notify their decisions to sus-

applies to consumer products covered by New Approach

pend release of a product to the market surveillance author-

directives or other Community legislation. As a conse-

ities, which in turn must be in a position to take appropriate

quence, market surveillance authorities in all Member

action. Four hypotheses must be distinguished as from the

States are informed, and they may in turn inform the nation-

moment of the notification.

al customs authorities about products imported from third

(1) The products in question present a serious and immedi-

countries, which display characteristics giving rise to a

ate risk to health or safety.

serious doubt as to the existence of a serious and immedi-

* In this case the market surveillance authorities must take

ate risk to health and safety. This information is of particu-

measures to prohibit the placing on the market in accor-

lar importance for customs authorities where it involves

dance with the applicable Community or national rules, and

measures banning or withdrawing from the market products

request the customs authorities to mark the commercial

imported from third countries, based on a Commission deci-

invoice accompanying the product, and any other relevant

sion taken in accordance with Article 9 of the Directive on

accompanying document, with the words Dangerous prod-

general product safety (188).

uct release for free circulation not authorised Regula-

(2) Products imported from third countries are not accom-

tion (EEC) No 339/93 in one of the 11 official Community

panied by documents, or bear no conformity marking or

languages (187).

labelling as provided for by Community or national rules on

(2) The products in question do not comply with Communi-

product safety.

ty or national rules on product safety.

* In this case the market surveillance authorities must

* In this case the market surveillance authorities must take

inform the customs authorities in order to draw their atten-

appropriate measures, if necessary prohibiting the placing

tion to the existence of such products falling under the

on the market under the rules in question. In cases where

scope of Regulation (EEC) No 339/93.

placing on the market is prohibited, they must ask the cus-

(3) Products imported from third countries, which present a

toms authorities to mark the commercial invoice accompa-

risk to health or safety that is not serious and immediate,

nying the products, and any other relevant accompanying

and are subject to measures prohibiting or restricting their

document, with Product not in conformity release for

placing on the market, or imposing their withdrawal from

free circulation not authorised Regulation (EEC)

the market.

No 339/93 in one of the eleven official Community lan-

* In this case the Member State taking these measures

guages (187).

must notify them to the Commission according to the safe-

(3) The products in question do not present a serious and

guard clause procedure under the New Approach direc-

immediate risk and cannot be considered as not conform-

tives, provided that the conditions for triggering such a

ing to the rules applicable to product safety.

clause are met. Where the product is intended for con-

* In this case the products must be released for free cir-

sumers or likely to be used by consumers, the safeguard

culation, provided that all the other conditions and formali-

clause under the Directive on general product safety

ties regarding release for free circulation are met.

applies, unless the product is covered by Community legis-

(4) The customs authorities have not been notified of any

lation providing for a safeguard clause (such as the New

action taken by the market surveillance authorities.

Approach directives). In such cases, it is necessary to

* In this case the products in question must be released

inform customs authorities.

for free circulation, at the latest within three working days

For the purposes of applying Regulation (EEC)

from the suspension of release, provided that all the other

No 339/93, the provisions of Council Regulation (EC)

60

 Market surveillance

No 515/97 on mutual assistance between the administrative authorities of the Member States and cooperation
between the latter and the Commission to ensure correct
application of the law on customs and agricultural matters
are applicable as appropriate. This is the case, in particular,
where the endorsement Dangerous product release

for free circulation not authorised Regulation (EEC)

No 339/93 or Product not in conformity release for free
circulation not authorised Regulation (EEC) No 339/93
are added to the commercial invoice and to any other relevant document accompanying products imported from third
countries.

61

9. External aspects

9.1.

Agreement on the European Economic Area

experts of these States in the same way as

it seeks advice from experts of the Member

The Agreement on the European Economic Area is established between the European Community and Iceland, Liechtenstein and Norway. The Agreement extends the single market to these three EFTA States.

States. As regards the committees assisting the Commission in its work, close cooperation has been established. The EEA
Council meets biannually, and the EEA Joint
Parliamentary Committee and the EEA Consultative Committee regularly.

9.1.1. Basic elements of the Agreement

9.1.2. Notification of bodies

The Agreement on the European Economic Area, in force

Procedures for notification of conformity assessment bod-

since 1 January 1994, covers all New Approach directives,

ies from the EEA EFTA States have been established based

and other Community legislation and acquis relevant to the

on provisions of the EEA Agreement. The request for allo-

free circulation of products. Hence, it extends the single

cation of an identification number is first presented to the

market to the so-called EEA EFTA States: Iceland, Liechten-

EFTA Secretariat, applying the same notification form as in

stein and Norway.

the Community. The Secretariat verifies its formal correct-

The objective of the EEA Agreement is to establish a

ness and transmits the application to the Commission with

dynamic and homogeneous European Economic Area,

a request for an identification number (or for an extension

based on common rules and equal conditions of competi-

of the use of the identification number to new

tion. The Agreement is amended on a continuous basis

directives/tasks). The Commission allocates the number

through decisions of the EEA Joint Committee following

and communicates it via the Secretariat to the notifying

changes in relevant Community legislation. To arrive at and

country. After this the EEA EFTA State makes a formal noti-

maintain a uniform interpretation and application of the

fication to the other EEA EFTA States, the EFTA Surveillance

Agreement an EFTA Court and an EFTA Surveillance Author-

Authority and the Secretariat. The Surveillance Authority

ity have been established.

examines the notification and informs the Commission,

Rights conferred and obligations imposed upon the

which keeps an updated list of notified bodies from the

Member States, or their public entities, undertakings, or

Member States and the EEA EFTA States, and publishes it

individuals in relation to each other, are, according to the

in the Official Journal.

EEA Agreement, understood to be conferred or imposed in

When a notified body ceases to fulfil the requirements or

the same way also upon the EEA EFTA States. This ensures

its obligations, the EEA EFTA State has the responsibility to

that the EEA EFTA States, and their economic operators,

withdraw the notification. The Member State must also pub-

are subject to the same rights and obligations as their coun-

lish this information, and inform the other EEA EFTA States,

terparts in the Community. For instance, the New Approach

the EFTA Surveillance Authority and the Secretariat. The

directives are applied in exactly the same way in the EEA

Surveillance Authority informs the Commission about the

EFTA States as in the Member States although the admin-

withdrawal, which will then update the list of notified bodies.

istrative procedures concerning notification bodies and the

safeguard clause are modified. Therefore, all guidance

9.1.3. Safeguard clause procedure

applicable to the Member States according to this Guide

The EFTA Surveillance Authority is responsible for the exam-

applies also to the EEA EFTA States.

ination of the safeguard clause notifications from the EEA

For the purpose of the EEA Agreement references to the

EFTA States. The Authority consults all parties concerned

Community or the common market in the EU/EEA acts are

and exchanges information with the Commission on the pro-

understood to be references to the territories of the Con-

ceedings of the case. The Authority transmits its decision to

tracting Parties. Accordingly, a product is not only placed

the EEA EFTA States and the Commission for further

on the Community market, but on the EEA market.

actions. If an EEA EFTA State does not follow the decision,

The EEA Agreement ensures a close cooperation

the Surveillance Authority can initiate an infringement

between the Commission and the administration of the EEA

procedure.
In cases where a Member State triggers a safeguard

EFTA States. The Commission seeks informal advice from

62

 External aspects

clause, consultations between the Commission and the Surveillance Authority are envisaged. The Commission communicates its decision to the EFTA Surveillance Authority,
which sends it to the EEA EFTA States for further actions. If
an EEA EFTA State does not follow the decision, the Surveillance Authority can initiate an infringement procedure.

the third countries concerned will conclude with the EEA

EFTA States parallel agreements and protocols equivalent
to those to be concluded with the Community, and which
will, possibly, have the same date for entry into force (189).
The system of parallel agreements and protocols formally grants the third country concerned the same market
access throughout the European Economic Area for products covered by the mutual recognition agreements or European conformity assessment protocols. As to the practical
implementation of these agreements and protocols, common sessions of the Joint Committee meetings with the
third country concerned will be arranged.

9.1.4. Mutual recognition agreements and European

conformity assessment protocols
The mandate from the Council to the Commission to negotiate mutual recognition agreements and European conformity assessment protocols indicated the objective that

The Community in its relations with third

9.2. Mutual recognition agreements
countries endeavours to promote international trade in regulated products, in partic Mutual recognition agreements are established between
ular by concluding mutual recognition
the
Community and the government of third countries, which
agreements (MRAs) on the basis of Article
are on a comparable level of technical development and have
133 of the EC Treaty.
a compatible approach concerning conformity assessment.
MRAs are designed so that each party
shall accept the reports, certificates and
These agreements are based on the mutual acceptance of
marks that are in accordance with its own
certificates, marks of conformity and test reports issued by the
legislation. These are drawn up and issued
conformity assessment bodies of either party in conformity
by bodies that the other party has designatwith the legislation of the other party.
ed under the MRA for assessing conformity
in the field(s) covered by the MRA. This can
be achieved, because MRAs include all the conformity
designating these bodies and, if applicable, transitional
assessment requirements of the parties necessary to
periods. More sectorial annexes can be added successively.
obtain full market access (190), and the products are evaluMRAs are not based on the necessity to mutually accept
ated in the country of production against the regulatory
other partys standards or technical regulations, or to conrequirements of the other party.
sider the legislation of the two parties as equivalent. HowMRAs cover the entire territory of the parties in order to
ever, MRAs can pave the way towards a harmonised system
guarantee, in particular in States with a federal structure,
of standardisation and certifications of the parties. Neverthe full free movement of products certified to be in contheless, the two legislations are, as a rule, deemed to
formity. As a general rule, MRAs are limited to products that
ensure a comparable level regarding the protection of
have their origin on the territory of either party (191).
health, safety, environment or other public interests. MoreMRAs apply to one or more categories of products or
over, MRAs increase the transparency of the regulatory syssectors falling within the regulated field (they are covered
tems, since the different systems are shown to other counby New Approach or other Community technical harmonitries and they have to demonstrate coherence.
sation directives in force) and, in certain cases, by nonAs a result of the different conditions established and
harmonised national law. In principle MRAs should cover all
the interest of third countries and the Community, the Comthe industrial products for which the regulations of at least
mission was authorised in 1992 to negotiate with the folone of the parties require third party conformity assesslowing countries: United States, Japan, Canada, Australia,
ment.
New Zealand, Hong Kong, Israel, Singapore, Philippines,
MRAs comprise a framework agreement and sectorial
South Korea and Switzerland.
annexes. The framework agreement lays down the essential
At the time of writing (May 1999), the Commission has
principles of a traditional agreement. Sectorial annexes
finalised negotiations with Australia, New Zealand, the
specify, in particular, the scope and coverage, regulatory reUnited States, Canada, Switzerland and Israel (192), and is
quirements, the list of designated conformity assessment
negotiating with Japan. The concluded MRAs all contain
bodies, the procedures and authorities responsible for
commitments to further negotiations.

63

(189) See Section 9.2 for

mutual recognition
agreements and
Section 9.3 for
European conformity
assessment protocols.
(190) This is the
principal difference
with subcontracting
that provides only for
some of the
procedures, such as
tests.
(191) According to some
MRAs the rule of origin
may not be applicable
(such as MRAs with
the USA and Canada).
(192) The MRA with
Israel covers only good
laboratory practice.

 Guide to the implementation of directives based on the New Approach and the Global Approach

European conformity assessment protocols

tries, to support the progressive extension

of the single market to these countries, and
to promote health and safety. The deter The European conformity assessment protocols are intendmining factor for an ECAP is the capacity of
ed to be established between the European Community and the
the applicant countries to specifically implegovernments of the applicant countries of central and eastern
ment the parts of the Community acquis
Europe (Hungary, Poland, the Czech Republic, Slovenia, Estothat are adopted in the protocol. Since
ECAPs are based on alignment to Communia, Romania, Bulgaria, Slovakia, Latvia and Lithuania).
nity rules, products assessed according to
The objective of the European conformity assessment protoCommunity legislation in a Member State or
cols is to support the progressive alignment of the applicant
an applicant country can be placed on the
countries with the Community acquis and the facilitation of
Community market and on the market of the
trade and market access.
applicant country.
In order to ensure the development in
terms of reciprocal openness of markets until the accession
The central and eastern European countries, which have
of the applicant countries, the ECAPs are based on the consigned an association agreement with the Community comditions necessary for the adoption and implementation of
mitting them to align their legislation with the Community
the Community acquis as follows:
acquis, and which at the same time are applying for mem progressive alignment of framework laws;
bership of the European Union, have a special status. This
progressive alignment of sectorial laws with the New
has provided the opportunity of designing a specific model
Approach directives and other directives;
of mutual recognition agreements for those countries.
development of technical infrastructures in order to
These are called European Conformity Assessment Protoensure that the technical competence of the bodies involved
cols (ECAP or PECA).
in the conformity assessment procedures is at the level
The ECAPs should cover the products submitted to
required by the European Union;
Community legislation, and should include all procedures
setting up the necessary structures for the correct
required to verify the conformity of products to this legislaenforcement of the acquis; and
tion. They comprise a framework protocol and sectorial
taking into account the need of the applicant countries to
annexes. The framework protocol adopts the essential prindefine the procedures and means for correctly carrying out
ciples concerning mutual recognition of products, based on
market surveillance.
the principle of the adoption of the acquis. Sectorial annexAs part of the pre-accession strategy, the Commission
es are added successively.
supports the applicant countries through technical assisThe ECAPs should be seen as a support for the aligntance programmes in aligning their legislation with Commument process, and as an instrument of the pre-accession
nity legislation. This aid is frequently completed by bilateral
strategy. At the same time they are a means to facilitate
assistance from Member States.
trade between the Member States and the applicant coun9.3.

Technical assistance

and vice versa. Successful implementation

should benefit both parties in this way. The
main aims of technical assistance, there Technical assistance is the basis for creating a homogefore, are to increase trade relationships and
neous, transparent and credible technical environment in
investment opportunities, improve the qualwhich the public authorities, economic operators and users
ity of goods on the domestic market, help
can have confidence.
the recipient countries develop their own
infrastructure and to reinforce the human
Technical assistance aims to achieve the availability of high
capacity of the countries in the technical
quality products on the market.
areas.
Technical assistance programmes take place in the
Technical assistance is a transfer of knowledge and legislafields of institutional cooperation, standardisation,
tion policies, such as the New Approach and the Global
metrology, certification, accreditation, quality manageApproach, but also a transfer of European best practice. It
ment and quality assurance. These programmes are inenables European experience to be shared with partners
tended for countries that are not on a comparable level
from non-member countries in all areas, with the objective of
with the Member States in these fields. Since some partlifting barriers to trade as a result of increased compatibility
ner countries have reached a stage of economic and inor harmonisation on the international level, and increasing
dustrial development where basic infrastructures are in
investment from the Member States to recipient countries

9.4.

64

 External aspects

place, assistance may be targeted towards areas such

as improving the regulatory regime for specific sectors,
or refining the infrastructure necessary for ECAPs or
MRAs to be concluded.
Technical assistance programmes can be regionally or
nationally oriented. There have been a number of national
programmes, which are usually very wide in scope, covering all aspects of technical assistance. Nevertheless, there
is no single model for technical assistance as every country
is at a different stage of development and seeks the fulfil-

ment of different objectives. The Commission too has different priorities in each case, for example where technical
assistance is used as part of the accession strategy. The
PRAQ programmes (the Regional Programmes on Quality
Assurance and other related fields) are examples of regional assistance. At the beginning they provided the European
Union with information about the central and eastern Europe
countries, but they have subsequently been used as a
preliminary step towards the possible acceptance of these
countries into the European Union.

The TBT Agreement lays down obligations,

9.5. WTO Agreement on Technical Barriers to Trade
which apply to technical regulations and
conformity assessment procedures issued
The WTO Agreement on Technical Barriers to Trade (the TBT
either on a national or a regional basis. A
Agreement) is a market access instrument, using a variety of
Code of Good Practice for the preparation,
measures that help to prevent and eliminate technical barriers
adoption and application of standards has
to trade caused by technical regulations, voluntary standards
been annexed to the TBT Agreement. WTO
Members are invited to ensure that stanand conformity assessment procedures.
dards bodies accept and comply with it.
WTO Members are also encouraged, within
the limits of their resources, to actively parpublished and notified via the WTO Secretariat to the other
ticipate in the work of international standardisation bodies,
members, who can make comments and, if necessary,
and to negotiate mutual recognition agreements on conrequest discussions. Following these discussions, if a
formity assessment.
technical barrier to trade persists, the disagreement may
Draft technical legislation deviating from international
lead to a consultation procedure and, eventually, to a
standards and having a significant effect on trade must be
dispute settlement.

65

 Annex 1

Annex 1
Community legislation referred to in the Guide
I

Number of Directive
amendment

Reference in the OJEC

amendment
(corrigendum)

Council Directive of 19 February 1973 on the harmonisation of the laws of Member States relating to
electrical equipment designed for use within
certain voltage limits
Council Directive of 25 June 1987 on the harmonisation
of the laws of the Member States relating to simple
pressure vessels

73/23/EEC
93/68/EEC

OJ L 77 of 26/03/73
OJ L 220 of 30/08/93
(OJ L 181 of 04/07/73)

87/404/EEC
90/488/EEC
93/68/EEC

3.

Council Directive of 3 May 1988 on the approximation of

the laws of the Member States concerning the safety of
toys

88/378/EEC
93/68/EEC

4.

Council Directive of 21 December 1988 on the approximation of laws, regulations and administrative provisions
of the Member States relating to construction products

89/106/EEC
93/68/EEC

OJ L 220 of 08/08/87
OJ L 270 of 02/10/90
OJ L 220 of 30/08/93
(OJ L 31 of 02/02/90)
OJ L 187 of 16/07/88
OJ L 220 of 30/08/93
(OJ L 281 of 14/10/88)
(OJ L 347 of 16/12/88)
(OJ L 37 of 09/02/91)
OJ L 40 of 11/02/89
OJ L 220 of 30/08/93

5.

Council Directive 89/336/EEC of 3 May 1989 on the

approximation of the laws of the Member States relating
to electromagnetic compatibility

89/336/EEC
92/31/EEC
93/68/EEC
(98/13/EC)

OJ L 139 of 23/05//89
OJ L 126 of 12/05/92
OJ L 220 of 30/08/93
(OJ L 74 of 12/03/98)
(OJ L 144 of 27/05/89)

6.

Directive of the European Parliament and of the Council

of 22 June 1998 on the approximation of the laws of the
Member States relating to machinery

98/37/EC
98/79/EC

OJ L 207 of 23/07/98
OJ L 331 of 07/12/98
(OJ L 16 of 21/01/99)

7.

Council Directive of 21 December 1989 on the approximation of the laws of the Member States relating to
personal protective equipment

8.

Council Directive of 20 June 1990 on the harmonisation

of the laws of the Member States relating to nonautomatic weighing instruments

89/686/EEC
93/68/EEC
93/95/EEC
96/58/EC
90/384/EEC
93/68/EEC

OJ L 399 of 30/12/89
OJ L 220 of 30/08/93
OJ L 276 of 09/11/93
OJ L 236 of 18/09/96
OJ L 189 of 20/07/90
OJ L 220 of 30/08/93
(OJ L 258 of 22/09/90)

9.

Council Directive of 20 June 1990 on the approximation

of the laws of the Member States relating to active
implantable medical devices

90/385/EEC
93/42/EEC
93/68/EEC

OJ L 189 of 20/07/90
OJ L 169 of 12/07/93
OJ L 220 of 30/08/93
(OJ L 7 of 11/01/94)
(OJ L 323 of 26/11/97)

10.

Council Directive 90/396/EEC of 29 June 1990 on the

approximation of the laws of the Member States relating
to appliances burning gaseous fuels

90/396/EEC
93/68/EEC

OJ L 196 of 26/07/90
OJ L 220 of 30/08/93

11.

Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with
liquid or gaseous fuels

92/42/EEC
93/68/EEC

12.

Council Directive of 5 April 1993 on the harmonisation

of the provisions relating to the placing on the market
and supervision of explosives for civil uses

93/15/EEC

OJ L 167 of 22/06/92
OJ L 220 of 30/08/93
(OJ L 195 of 14/07/92)
(OJ L 268 of 29/10/93)
OJ L 121 of 15/05/93
(OJ L 79 of 07/04/95)

13.

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

93/42/EEC
98/79/EC

14.

Directive 94/9/EC of the European Parliament and the

Council of 23 March 1994 on the approximation of the
laws of the Member States concerning equipment and
protective systems intended for use in potentially explosive atmospheres

94/9/EC

1.

2.

New Approach directives

(i.e. directives providing for the CE marking)

67

OJ L 169 of 12/07/93
OJ L 331 of 07/12/98
(OJ L 323 of 26/11/97)
(OJ L 61 of 10/03/99)
OJ L 100 of 19/04/94
(OJ L 257 of 10/10/96)

 Guide to the implementation of directives based on the New Approach and the Global Approach

Number of Directive
amendment

Reference in the OJEC

amendment
(corrigendum)

Directive 94/25/EC of the European Parliament and of

the Council of 16 June 1994 on the approximation of
the laws, regulations and administrative provisions of the
Member States relating to recreational craft
European Parliament and Council Directive 95/16/EC of
29 June 1995 on the approximation of the laws of the
Member States relating to lifts

94/25/EC

OJ L 164 of 30/06/94
(OJ L 127 of 10/06/95)
(OJ L 17 of 21/01/97)

95/16/EC

OJ L 213 of 07/09/95

Directive 96/57/EC of the European Parliament and of

the Council of 3 September 1996 on energy efficiency
requirements for household electric refrigerators,
freezers and combinations thereof
Directive 97/23/EC of the European Parliament and of
the Council of 29 May 1997 on the approximation of
the laws of the Member States concerning pressure
equipment
Directive 98/13/EC of the European Parliament and of
the Council of 12 February 1998 relating to telecommunications terminal equipment and satellite earth station
equipment, including the mutual recognition of their
conformity

96/57/EC

OJ L 236 of 18/09/96

97/23/EC

OJ L 181 of 09/07/97
(OJ L 265 of 27/09/97)

98/13/EC

OJ L 74 of 12/03/98

20.

Directive 98/79/EC of the European Parliament and of

the Council of 27 October 1998 on in vitro diagnostic
medical devices

98/79/EC

OJ L 331 of 07/12/98
(OJ L 22 of 29/01/99)
(OJ L 74 of 19/03/99)

21.

Directive 99/5/EC of the European Parliament and of

the Council relating to radio equipment and telecommunications terminal equipment and the mutual recognition
of their conformity

99/5/EC

OJ L 91 of 07/04/99

Number of Directive
amendment

Reference in the OJEC

amendment
(corrigendum)

15.

16.

17.

18.

19.

II

New Approach directives

(i.e. directives providing for the CE marking)

Directives based on the principles of the New

Approach or the Global Approach, but which do
not provide for the CE marking

1.

European Parliament and Council Directive 94/62/EC of

20 December 1994 on packaging and packaging waste

94/62/EC

OJ L 365 of 31/12/1994

2.

Council Directive 96/48/EC of 23 July 1996 on the

inter-operability of the trans-European high-speed rail
system

96/48/EC

OJ L 235 of 17/09/1996
(OJ L 262 of 16/10/1996)

3.

Council Directive 96/98/EC of 20 December 1996 on

marine equipment

96/98/EC

OJ L 46 of 17/02/1997
(OJ L 246 of 10/09/1997)
(OJ L 241 of 29/08/1998)

Number of Directive
amendment

Reference in the OJEC

amendment

III

Proposals for directives based on the principles

of the New Approach or the Global Approach

1.

Proposal for a Council Directive on articles of precious

metal

COM/93/322 final
COM/94/267 final

OJ C 318 of 25/11/93
OJ C 209 of 29/07/94

2.

Proposal for a European Parliament and Council

Directive relating to cableway installations designed to
carry passengers

COM/93/646 final

OJ C 070 of 08/03/94

3.

Proposal for a European Parliament and Council

Directive on marking of packaging and on the establishment of a conformity assessment procedure for
packaging
Proposal for a European Parliament and Council
Directive on the approximation of the laws of the
Member States relating to the noise emission by
equipment used outdoors

COM/96/191 final

OJ C 382 of 18/12/96

COM/98/46 final

OJ C 125 of 22/04/1998

4.

68

 Annex 1

IV

Number of
document
amendment

Reference in the OJEC

amendment
(corrigendum)

Council Directive 85/374/EEC of 25 July 1985 on the

approximation of the laws, regulations and administrative provisions of the Member States concerning liability
for defective products
Council Directive 89/391/EEC of 12 June 1989 on the
introduction of measures to encourage improvements in
the safety and health of workers at work

85/374/EEC

OJ L 210 of 07/08/85
(OJ L 307 of 12/11/88)

89/391/EEC

OJ L 183 of 29/06/89
(OJ L 275 of 05/10/90)
(OJ L 347 of 28/11/89)

3.

Council Directive 89/655/EEC of 30 November 1989

concerning the minimum safety and health requirements
for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16
(1) of Directive 89/391/EEC)

89/655/EEC
95/63/EC

OJ L 393 of 30/12/89
OJ L 335 of 30/12/95
(OJ L 59 of 06/03/91)
(OJ L 335 of 30/12/95)
(OJ L 79 of 29/03/96)

4.

Council Directive 89/656/EEC of 30 November 1989

on the minimum health and safety requirements for the
use by workers of personal protective equipment at the
workplace (third individual Directive within the meaning
of Article 16 (1) of Directive 89/391/EEC)

89/656/EEC

OJ L 393 of 30/12/89
(OJ L 59 of 06/03/1991)

5.

Council Directive 90/270/EEC of 29 May 1990 on the

minimum safety and health requirements for work with
display screen equipment (fifth individual Directive within
the meaning of Article 16 (1) of Directive 89/391/EEC)
Council Directive 92/59/EEC of 29 June 1992 on
general product safety

90/270/EEC

OJ L 156 of 21/06/90
(OJ L 171 of 04/07/90)

92/59/EEC

OJ L 228 of 11/08/92

7.

Council Decision of 22 September 1992 on the adoption of an action plan for the exchange between Member
State administrations of national officials who are
engaged in the implementation of Community legislation
required to achieve the internal market

92/481/EEC

OJ L 286 of 01/10/92

8.

Council Regulation (EEC) No 2913/92 of 12 October

1992 establishing the Community Customs Code

2913/92

OJ L 302 of 19/10/92

9.

Commission Decision of 23 December 1992 on the

setting-up of an Advisory Committee for coordination in
the internal market field

93/72/EEC

OJ L 26 of 03/02/93

10.

Council Decision 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

93/465/EEC

OJ L 220 of 30/08/93
(OJ L 282 of 17/11/93)

11.

Council Regulation (EEC) No 339/93 of 8 February

1993 on checks for conformity with the rules on product safety in the case of products imported from third
countries
Commission Decision of 28 July 1993 establishing the
list of products provided for in Article 8 of Council
Regulation (EEC) No 339/93

339/93

OJ L 40 of 17/02/93
(OJ L 92 of 16/04/93)
(OJ L 134 of 03/06/93)
(OJ L 159 of 01/07/93)
OJ L 279 of 12/11/93

13.

Commission Decision of 12 July 1995 setting up a

Committee of Senior Labour Inspectors

95/319/EC

OJ L 188 of 09/08/95
(OJ L 283 of 25/11/95)

14.

Council Regulation (EC) No 515/97 of 13 March 1997

on mutual assistance between the administrative authorities of the Member States and cooperation between the
latter and the Commission to ensure the correct application of the law on customs and agricultural matters

515/97

OJ L 82 of 22/03/97

15.

Decision No 889/98/EC of the European Parliament and

of the Council of 7 April 1998 amending Council
Decision 92/481/EEC on the adoption of an action plan
for the exchange between Member State administrations of national officials who are engaged in the implementation of Community legislation required to achieve
the internal market (Karolus programme)

889/98/EC

OJ L 126 of 28/04/98

1.

2.

6.

12.

Other Community directives, regulations and

decisions referred to in the Guide

69

93/583/EEC

 Guide to the implementation of directives based on the New Approach and the Global Approach

IV

16.

17.

Other Community directives, regulations and

decisions referred to in the Guide
Directive 98/34/EC of the European Parliament and of
the Council of 22 June 1998 laying down a procedure
for the provision of information in the field of technical
standards and regulations
Decision No 372/1999/EC of the European Parliament
and of the Council of 8 February 1999 adopting a programme of Community action on injury prevention in the
framework of action in the field of public health (1999 to
2003)

70

Number of
document
amendment

Reference in the OJEC

amendment
(corrigendum)

98/34/EC
98/48/EC

OJ L 204 of 21/07/98
OJ L 217 of 05/08/98

372/1999/EC

OJ L 46 of 20/02/99

 Annex 2

Annex 2
Additional information concerning certain Articles of the Treaty establishing the
European Community (the EC Treaty)
A. The previous numbers of Articles of the EC Treaty referred to in the Guide
Article of the EC Treaty
10
28
30
95
133
137, 138
226
227
228
249
251

Previous number of the article

5
30
36
100a
113
118a
169
170
171
189
189b

B. The text of certain Articles of the EC Treaty

Art. 10

Member States shall take all appropriate measures, whether general or particular, to ensure
fulfilment of the obligations arising out of this Treaty or resulting from action taken by the
institutions of the Community. They shall facilitate the achievement of the Communitys tasks.
They shall abstain from any measure which could jeopardise the attainment of the objectives
of this Treaty.

Art. 28

Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States.

Art. 30

The provisions of Articles 28 and 29 shall not preclude prohibitions or restrictions on

imports, exports or goods in transit justified on grounds of public morality, public policy or
public security; the protection of health and life of humans, animals or plants; the protection
of national treasures possessing artistic, historic or archaeological value; or the protection
of industrial and commercial property. Such prohibitions or restrictions shall not, however,
constitute a means of arbitrary discrimination or a disguised restriction on trade between
Member States.

Art. 95

1. By way of derogation from Article 94 and save where otherwise provided in this Treaty,
the following provisions shall apply for the achievement of the objectives set out in
Article 14. The Council shall, acting in accordance with the procedure referred to in
Article 251 and after consulting the Economic and Social Committee, adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.
2. Paragraph 1 shall not apply to fiscal provisions, to those relating to the free movement
of persons nor to those relating to the rights and interests of employed persons.
3. The Commission, in its proposals envisaged in paragraph 1 concerning health, safety,
environmental protection and consumer protection, will take as a base a high level of
protection, taking account in particular of any new development based on scientific
facts. Within their respective powers, the European Parliament and the Council will also
seek to achieve this objective.
4. If, after the adoption by the Council or by the Commission of a harmonisation measure,
a Member State deems it necessary to maintain national provisions on grounds of major
needs referred to in Article 30, or relating to the protection of the environment or the
working environment, it shall notify the Commission of these provisions as well as the
grounds for maintaining them.
5. Moreover, without prejudice to paragraph 4, if, after the adoption by the Council or by
the Commission of a harmonisation measure, a Member State deems it necessary to
introduce national provisions based on new scientific evidence relating to the protection
of the environment or the working environment on grounds of a problem specific to that
Member State arising after the adoption of the harmonisation measure, it shall notify the
Commission of the envisaged provisions as well as the grounds for introducing them.
6. The Commission shall, within six months of the notifications as referred to in paragraphs
4 and 5, approve or reject the national provisions involved after having verified whether

71

 Guide to the implementation of directives based on the New Approach and the Global Approach

Art. 226

or not they are a means of arbitrary discrimination or a disguised restriction on trade

between Member States and whether or not they shall constitute an obstacle to the
functioning of the internal market.
In the absence of a decision by the Commission within this period the national provisions
referred to in paragraphs 4 and 5 shall be deemed to have been approved.
When justified by the complexity of the matter and in the absence of danger for human
health, the Commission may notify the Member State concerned that the period referred
to in this paragraph may be extended for a further period of up to six months.
7. When, pursuant to paragraph 6, a Member State is authorised to maintain or introduce
national provisions derogating from a harmonisation measure, the Commission shall
immediately examine whether to propose an adaptation to that measure.
8. When a Member State raises a specific problem on public health in a field which has
been the subject of prior harmonisation measures, it shall bring it to the attention of the
Commission which shall immediately examine whether to propose appropriate measures
to the Council.
9. By way of derogation from the procedure laid down in Articles 226 and 227, the
Commission and any Member State may bring the matter directly before the Court of
Justice if it considers that another Member State is making improper use of the powers
provided for in this Article.
10. The harmonisation measures referred to above shall, in appropriate cases, include a
safeguard clause authorising the Member States to take, for one or more of the noneconomic reasons referred to in Article 30, provisional measures subject to a
Community control procedure.
If the Commission considers that a Member State has failed to fulfil an obligation under this
Treaty, it shall deliver a reasoned opinion on the matter after giving the State concerned the
opportunity to submit its observations.
If the State concerned does not comply with the opinion within the period laid down by the
Commission, the latter may bring the matter before the Court of Justice.

Art. 227

A Member State which considers that another Member State has failed to fulfil an obligation
under this Treaty may bring the matter before the Court of Justice.
Before a Member State brings an action against another Member State for an alleged
infringement of an obligation under this Treaty, it shall bring the matter before the
Commission.
The Commission shall deliver a reasoned opinion after each of the States concerned has
been given the opportunity to submit its own case and its observations on the other partys
case both orally and in writing.
If the Commission has not delivered an opinion within three months of the date on which the
matter was brought before it, the absence of such opinion shall not prevent the matter from
being brought before the Court of Justice.

Art. 228

1. If the Court of Justice finds that a Member State has failed to fulfil an obligation under
this Treaty, the State shall be required to take the necessary measures to comply with
the judgment of the Court of Justice.
2. If the Commission considers that the Member State concerned has not taken such
measures it shall, after giving that State the opportunity to submit its observations, issue
a reasoned opinion specifying the points on which the Member State concerned has not
complied with the judgment of the Court of Justice.
If the Member State concerned fails to take the necessary measures to comply with the
Courts judgment within the time-limit laid down by the Commission, the latter may bring the
case before the Court of Justice. In so doing it shall specify the amount of the lump sum or
penalty payment to be paid by the Member State concerned which it considers appropriate
in the circumstances.
If the Court of Justice finds that the Member State concerned has not complied with its judgment it may impose a lump sum or penalty payment on it.
This procedure shall be without prejudice to Article 227.

Art. 249

In order to carry out their tasks and in accordance with the provisions of this Treaty, the
European Parliament acting jointly with the Council, the Council and the Commission shall
make regulations and issue directives, take decisions, make recommendations or deliver
opinions.
A regulation shall have general application. It shall be binding in its entirety and directly
applicable in all Member States.
A directive shall be binding, as to the result to be achieved, upon each Member State to
which it is addressed, but shall leave to the national authorities the choice of form and
methods.
A decision shall be binding in its entirety upon those to whom it is addressed.
Recommendations and opinions shall have no binding force.

72

 Annex 2

Art. 251

1. Where reference is made in this Treaty to this Article for the adoption of an act, the
following procedure shall apply.
2. The Commission shall submit a proposal to the European Parliament and the Council.
The Council, acting by a qualified majority after obtaining the opinion of the European
Parliament,
if it approves all the amendments contained in the European Parliaments opinion,
may adopt the proposed act thus amended;
if the European Parliament does not propose any amendments, may adopt the
proposed act;
shall otherwise adopt a common position and communicate it to the European
Parliament. The Council shall inform the European Parliament fully of the reasons
which led it to adopt its common position. The Commission shall inform the
European Parliament fully of its position.
If, within three months of such communication, the European Parliament:
(a) approves the common position or has not taken a decision, the act in question shall
be deemed to have been adopted in accordance with that common position;
(b) rejects, by an absolute majority of its component members, the common position,
the proposed act shall be deemed not to have been adopted;
(c) proposes amendments to the common position by an absolute majority of its component members, the amended text shall be forwarded to the Council and to the
Commission, which shall deliver an opinion on those amendments.
3. If, within three months of the matter being referred to it, the Council, acting by a qualified majority, approves all the amendments of the European Parliament, the act in question shall be deemed to have been adopted in the form of the common position thus
amended; however, the Council shall act unanimously on the amendments on which the
Commission has delivered a negative opinion. If the Council does not approve all the
amendments, the President of the Council, in agreement with the President of the
European Parliament, shall within six weeks convene a meeting of the Conciliation
Committee.
4. The Conciliation Committee, which shall be composed of the members of the Council or
their representatives and an equal number of representatives of the European
Parliament, shall have the task of reaching agreement on a joint text, by a qualified
majority of the members of the Council or their representatives and by a majority of the
representatives of the European Parliament. The Commission shall take part in the
Conciliation Committees proceedings and shall take all the necessary initiatives with a
view to reconciling the positions of the European Parliament and the Council. In fulfilling
this task, the Conciliation Committee shall address the common position on the basis of
the amendments proposed by the European Parliament.
5. If, within six weeks of its being convened, the Conciliation Committee approves a joint
text, the European Parliament, acting by an absolute majority of the votes cast, and the
Council, acting by a qualified majority, shall each have a period of six weeks from that
approval in which to adopt the act in question in accordance with the joint text. If either
of the two institutions fails to approve the proposed act within that period, it shall be
deemed not to have been adopted.
6. Where the Conciliation Committee does not approve a joint text, the proposed act shall
be deemed not to have been adopted.
7. The periods of three months and six weeks referred to in this Article shall be extended
by a maximum of one month and two weeks respectively at the initiative of the European
Parliament or the Council.

73

 Guide to the implementation of directives based on the New Approach and the Global Approach

Annex 3
Additional guidance documents
I
1.

Documents related to
New Approach directive
Guidelines on the application of Council
Directive 73/23/EEC (electrical equipment
designed for use within certain voltage limits)

Number

Date
12/97

Language
ES, DA, DE, EL, EN,
FR, IT, NL, PT, FI, SV

2.

Communication of the Commission with regard to

the interpretative documents of Council Directive
89/106/EEC (construction products)

OJ C 62 of 28/2/94

3.

The designation of approved bodies in the field of

the construction products Directive

Guidance paper A

11/95

EN

4.

The definition of factory production control in

technical specifications for construction products

Guidance paper B

5/95

EN

5.

The treatment of kits and systems under the construction products Directive

Guidance paper C

2/97

EN

6.

CE marking under the construction products

Directive

Guidance paper D

12/98

EN

7.

Electromagnetic compatibility EMC;

Guide to the application of Directive 89/336/EEC

ISBN 92-828-0762-2

12/97

DE, EN, FR

8.

Useful facts in relation to Directive 89/392/EEC

(machinery)

ISBN 92-827-9200-5

97

EN

9.

Community legislation on machinery;

comments on Directive 98/37/EC

99

ES, DE, EN, FR, IT

10.

Personal protective equipment (PPE);

useful facts in relation to Directive 89/686/EEC

ISBN 92-827-9199-8

97

EN

11.

Guidelines relating to the demarcation between

Directive 90/385/EEC on active implantable
medical devices, Directive 93/42/EEC on medical
devices, and Directive 65/65/EEC relating to
medicinal products and related directives

Meddev. 2.1/3
Rev. 5.1

3/98

EN

12.

Guidelines on a medical devices vigilance system

Meddev 2.12/1
Rev. 3

3/98

EN

13.

Guidelines on the application of Council Directive

94/9/EC concerning equipment and protective
systems intended for use in potentially explosive
atmospheres
Recreational craft Directive (94/25/EC) and
comments to the Directive combined

99

EN

6/98

EN

Handbook on implementation of Conformity Assessment Procedures relating to Directive 91/263/EEC

(telecommunications terminal equipment)

11/95

EN

14.
15.

74

ES, DA, DE, EL, EN,

FR, IT, NL, PT

 Annex 3

II
1.

Draft Documents related to Language

New Approach directives
Draft guidance paper on the treatment of dangerous
substances under the construction products Directive

EN

2.

Draft guidance paper on levels and classes in the

construction products Directive

EN

3.

Draft guidance paper on transitional arrangements

under the construction products Directive

EN

4.

Draft guidance paper related to pressure equipment

EN

III

Documents related to the New Approach or the

Global Approach in general

Number of
document

Reference in the OJEC

1.

Council Resolution of 7 May 1985 on a New Approach

to technical harmonisation and standardisation

OJ C 136 of 04/06/85

2.

Council Resolution of 21 December 1989 on a Global

Approach to Conformity Assessment

OJ C 10 of 16/01/90

3.

Commission Communication to the Council of 15 June

1989 on a Global Approach to certification and testing
quality measures for industrial products

4.

Opinion of the Economic and Social Committee on the

Communication from the Commission to the Council on
the proposal for a Council Decision concerning the
modules for various phases of the conformity assessment procedures which are intended to be used in the
technical harmonisation directives
Opinion of the Economic and Social Committee on the
Communication from the Commission to the Council on
a Global Approach to Certification and Testing

OJ C 112 of 07/05/90

Council Resolution of 16 June 1994 on the development

of administrative cooperation in the implementation and
enforcement of Community legislation in the internal
market
Council Resolution of 8 July 1996 on cooperation
between administrations for the enforcement of legislation on the internal market

OJ C 179 of 01/07/94

5.

6.

7.

8.

Report from the Commission to the Council and the

European Parliament of 13 May 1998 on the efficiency
and accountability in European standardisation under the
New Approach

IV

Certif documents related to the

New Approach or the Global Approach
Methods of coordinating the procedures governing the notification and management of notified
bodies

1.

COM(89) 209 final

OJ C 267 of 19/10/89

OJ C 112 of 07/05/90

OJ C 224 of 01/08/1996

COM(98) 291 final

Number
Certif. 93/1
Rev.3

Date

Language
DE, EN, FR

2.

Framework for coordination and cooperation

between notified bodies, Member States and the
European Commission under the Community
harmonisation directives based on the New
Approach and the Global Approach

Certif. 94/6
Rev. 6

20/02/98

EN, FR

3.

Specifications concerning the assessment and

supervision of systems applying to conformity
assessment bodies with a view to their designation under the mutual recognition agreements
between the European Union (EU) and certain nonmember countries

Certif. 96/1

26/06/96

DE, EN, FR

4.

Procedure for designation of conformity assessment bodies (CAB) under mutual recognition
agreements (MRAs) with non-member countries

Certif. 96/3
Rev. 4

6/10/98

EN, FR

75

 Guide to the implementation of directives based on the New Approach and the Global Approach

IV

Certif documents related to the

New Approach or the Global Approach
Various factors to be taken into account in order
to clarify the meaning of CE marking

Number
Certif. 96/4

Date
5/11/96

Language
DE, EN, FR

6.

Code of conduct for the functioning of the system

of notified bodies

Certif. 97/1
Rev. 3

17/7/98

DE, EN, FR

7.

Accreditation and the Communitys policy in the

field of conformity assessment

Certif. 97/4
Rev. 2

15/12/97

DE, EN, FR

8.

The EN 45000 series of standards and the

conformity assessment procedures of the Global
Approach

Certif. 97/5
Rev. 1

24/3/98

DE, EN, FR

9.

Conformity marking and market surveillance

Certif. 98/2

30/1/98

DE, EN, FR

10.

The EN 45000 standards, accreditation and

notification of notified bodies

Certif. 98/4

25/3/98

DE, EN, FR

11.

State of play on accreditation and the EN 45000

standard

Certif. 98/5

11/5/98

EN

12.

List of presidents and technical secretariats for

notified body groups

Certif. 98/6

1/9/98

FR

13.

Implementation of mutual recognition agreements

on conformity assessment (MRA) and protocols
on European conformity assessment (PECA)

Certif. 98/7

24/7/98

DE, EN, FR

14.

Protocols of European conformity assessment

(PECA)

Certif. 98/8

10/8/98

DE, EN, FR

Other relevant documents

1.

Common standards for enterprises

Number
ISBN 92-8268110-6

94

Language
ES, DA, DE, EL, EN,
FR, IT, NL

2.

A commentary on Directive 83/189/EEC;

a guide to the procedure for the provision of
information in the field of technical standards
and regulations

98

DE, EN, FR

5.

ISBN 92-8282785-2

76

Date

 Annex 4

Annex 4
Commission contact points
I

New Approach directives

DG

Contact
Unit

Fax number (32-2) 29- ...

1.

Low voltage equipment (73/23/EEC, amendment

93/68/EEC)

Enterpr.

G3

66273

2.

Simple pressure vessels (87/404/EEC, amendments

90/488/EEC and 93/68/EEC)

Enterpr.

G4

66273

3.

Toys (88/378/EEC, amendment 93/68/EEC)

Enterpr.

E5

66273

4.

Construction products (89/106/EEC, amendment

93/68/EEC)

Enterpr.

G5

61065

5.

Electromagnetic compatibility (89/336/EEC, amendments 92/31/EEC and 93/68/EEC)

Enterpr.

G3

66273

6.

Machinery (98/37/EC, amendment 98/79/EC)

Enterpr.

G3

66273

7.

Personal protective equipment (89/686/EEC, amendments 93/68/EEC, 93/95/EEC and 96/58/EC)

Enterpr.

G3

66273

8.

Non-automatic weighing instruments (90/384/EEC,

amendment 93/68/EEC)

Enterpr.

G4

66273

9.

Active implantable medical devices (90/385/EEC,

amendments 93/42/EEC and 93/68/EEC)

Enterpr.

G4

66273

10.

Gas appliances (90/396/EEC, amendment

93/68/EEC)

Enterpr.

G4

66273

11.

Hot water boilers (92/42/EEC, amendment

93/68/EEC)

Energy

C2

64254

12.

Civil explosives (93/15/EEC)

Enterpr.

E3

50281

13.

Medical devices (93/42/EEC, amendment 98/79/EC)

Enterpr.

G4

66273

14.

Potentially explosive atmospheres (94/9/EC)

Enterpr.

G3

66273

15.

Recreational craft (94/25/EC)

Enterpr.

E6

67014

16.

Lifts (95/16/EC)

Enterpr.

G3

66273

17.

Refrigeration appliances (96/57/EC)

Energy

C1

66283

18.

Pressure equipment (97/23/EC)

Enterpr.

G4

66273

19.

Telecommunications terminal equipment (98/13/EC)

Enterpr.

G3

94157

20.

In vitro diagnostic medical devices (98/79/EC)

Enterpr.

G4

66273

21.

Radio and telecommunications terminal equipment

(99/5/EC)

Enterpr.

G3

94157

II

1.

Directives based on the principles of the New

Approach or the Global Approach, but which do
not provide for the CE marking
Packaging and packaging waste (94/62/EC)

2.

High-speed rail systems (96/48/EC)

Enterpr.

E6

56851

3.

Marine equipment (96/98/EC)

Transp.

D3

69066

Contact
Unit
Environ.
E3

DG

77

Fax number (32-2) 29- ...

91068

 Guide to the implementation of directives based on the New Approach and the Global Approach

III

Proposals for directives based on the principles

of the New Approach or the Global Approach
Articles of precious metal (COM/93/322 final, amendment COM/94/267 final)

Contact
Unit
Enterpr.
G4

2.

Cableway installations designed to carry passengers

(COM/93/646 final)

Enterpr.

E6

56851

3.

Marking of packaging (COM/96/191 final)

Enterpr.

EI

91925

4.

Noise emissions (COM/98/46 final)

Environ.

D3

69554

IV

Other Community legislation referred to in the

Guide
Directive on product liability (85/374/EEC)

Contact
Unit
Internal
D1

1.

1.

DG

DG

Fax number (32-2) 29- ....

66273

Fax number (32-2) 29- ....

93088

market

2.

Directive on general product safety (92/59/EEC)

Health &
consumer
protection

A4

91858

3.

Decision 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 (93/465/EEC)
Regulation concerning checks on products imported
from third countries (EEC No 339/93)

Enterpr.

G1

53877

Internal
market

D2

54351

5.

Commission Decision referring to Regulation (EEC)

No 339/93

Internal
market

D2

54351

6.

Council Directives concerning the minimum safety and

health requirements at workplace (89/391/EEC,
89/655/EEC and amendement 95/63/EC,
89/656/EEC and 90/270/EEC)
Directive on the procedure for the provision of information in the field of technical standards and regulations
(98/34/EC, amendment 98/48/EC)
As regards the part on standards
As regards the part on regulations

Employment
& social
affairs

D6

34259

Enterpr.
Enterpr.

G2
F2

91675
60851

4.

7.

V
1.

Horizontal issues related to New Approach

directives
Conformity assessment procedures, notified bodies
(also updated lists of notified bodies), CE marking,
market surveillance

Contact
Unit
Enterpr.
G1

2.

Standardisation

Enterpr.

DG

78

G2

Fax number (32-2) 29- ....

53877

91675

 Annex 5

Annex 5
Useful web addresses
DG III Documents and publications:
[Link]
References to harmonised standards in the context of New Approach directives:
[Link]
(also access via [Link]
New Approach standardisation in the European internal market
how to access European standards and standards activities on the web:
[Link]
One stop Internet shop for business
[Link]
Directive 98/13/EC
[Link]
Directive 99/5/EC
[Link]

79

 Guide to the implementation of directives based on the New Approach and the Global Approach

Annex 6
Products submitted to New Approach directives
Each directive defines the products that are within its scope. This annex is not an exhaustive list of all products covered by
the directive in question, and does not take into account that several directives exclude certain products from the field of
application although they comply with the product definition used in the directive.

I
1.

New Approach
directive
Low voltage equipment

Products that are as a general rule covered by the directive in question

Electrical equipment

designed for use with a voltage rating of between

50 and 1000 volts for alternating current and
between 75 and 1500 volts for direct current

2.

Simple pressure vessels

Welded vessels

3.

Toys

Products or material

manufactured in series, subjected to an internal

gauge pressure greater than 0.5 bar, intended to
contain air or nitrogen, and not intended to be
fired
designed or clearly intended for use in play by
children of less than 14 years of age

4.

Construction products

Products

which are produced for incorporation in a permanent manner in construction works (i.e. building
and civil engineering works)

5.

Electromagnetic
compatibility

Apparatus

6.

Machinery

Machinery

i.e. all electrical and electronic appliances

together with equipment and installations containing electrical and/or electronic components
which are liable to cause electromagnetic disturbance or the performance of which is liable to be
affected by such disturbance
i.e. an assembly of linked parts or components at
least one of which moves, with the appropriate
actuators, control and power circuits, etc.; joined
together for a specific application, in particular
for the processing, treatment, moving or packaging of a material;
i.e. an assembly of machines which, in order to
achieve the same end, are arranged and controlled to function as an integral whole;
i.e. interchangeable equipment modifying the
function of a machine, and the purpose of which
is to be assembled with a machine or a series of
different machines or with a tractor by the operator himself in so far as this equipment is not a
spare part or a tool
placed on the market separately to fulfil a safety
function when in use and the failure or malfunctioning of which endangers the safety or health of
exposed persons, provided that the component
is not an interchangeable equipment

Safety components

7.

Personal protective
equipment

Devices or appliances

designed to be worn or held by an individual for

protection against one or more health and safety
hazards

Units of several devices or

appliances

which have been integrally combined by the manufacture for the protection of an individual against
one or more potentially simultaneous risks

Protective devices or
appliances

combined, separably or inseparably, with personal non-protective equipment worn or held by

an individual for the execution of a specific activity

Interchangeable
components

essential to the satisfactory functioning of the

personal protective equipment, and used
exclusively for such equipment

80

 Annex 6

I
8.

New Approach
directive
Non-automatic weighing
instruments

Products that are as a general rule covered by the directive in question

Measuring instruments

serving to determine the mass of a body by using

the action of gravity on that body, or to determine other mass related magnitudes, quantities,
parameters or characteristics; and which require
the intervention of an operator during weighing
which are intended by the manufacturer to be
used for human beings for certain defined purposes (e.g. diagnosis, prevention, monitoring,
treatment of disease); which rely for their functioning on an external source of power; which are
intended to be totally or partially introduced, surgically or medically, into the human body or by
medical intervention into a natural orifice; and
which are intended to remain after the procedure
i.e. appliances burning gaseous fuels used for
cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding
105 C; or forced draught burners and heating
bodies to be equipped with such burners
i.e. safety devices, controlling devices or regulating devices and sub-assemblies, other than
forced draught burners and heating bodies to be
equipped with such burners, if they are separately marketed for trade use and designed to be
incorporated into an appliance burning gaseous
fuel or assembled to constitute such an appliance
with a rated output of no less than 4 kW and no
more than 400 kW; which are fired with liquid or
gaseous fuels and which are designed to transmit
to water the heat released from burning
i.e. the boiler-body designed to have a burner
fitted, or the burner designed to be fitted to a
boiler-body

9.

Active implantable medical

devices

Instruments, apparatus,
appliances, material or
other article, whether used
alone or in combination
(including any accessories
or software necessary for
its proper application)

10.

Gas appliances

Appliances

Fittings

11.

Hot-water boilers

Combined boiler-body units

Appliances

12.

Civil explosives

Materials and articles

13.

Medical devices

Instrument, apparatus,
appliances, materials or
other article, whether used
alone or in combination
(including the software
necessary for its proper
application)
Accessories

14.

Potentially explosive
atmospheres

Equipment

81

considered to be explosives in the United Nations

recommendations on the transport of dangerous
goods and falling within Class 1 of those recommendations
which are intended by the manufacturer to be
used for human beings for certain defined purposes (e.g. diagnosis, prevention, monitoring,
treatment of disease); and which does not
achieve its principal intended action in or on the
human body by pharmacological, immunological
or metabolic means
i.e. an article which, whilst not being a medical
device, is intended specifically by its manufacturer to be used together with a device to enable
it to be used in accordance with the use of the
device intended by the manufacturer of the
device
i.e. machines, apparatus, fixed or mobile
devices, control components (i.e. items essential
to the safe functioning of equipment and protective system, without autonomous function) and
instrumentation thereof; and detection or prevention systems intended for use in potentially explosive atmospheres (i.e. atmospheres that could
become explosive due to local and operational
conditions), and intended, separately or jointly,
for the generation, transfer, storage, measurement, control and conversion of energy for the
processing of material, and capable of causing
an explosion through their own potential sources
of ignition

 Guide to the implementation of directives based on the New Approach and the Global Approach

New Approach
directive

Products that are as a general rule covered by the directive in question

Protective systems

Safety devices, controlling

devices and regulating
devices
15.

16.

Recreational craft

Lifts

Boats

i.e. design units intended for use in potentially

explosive atmospheres; intended to halt incipient
explosions immediately and/or to limit the effective range of explosion flames and explosion
pressures; and separately placed on the market
for use as autonomous systems
intended for use outside potentially explosive
atmospheres, but required for or contributing to
the safe functioning of equipment and protective
systems with respect to the risks of explosion
from 2.5m to 24m hull length, measured according to the appropriate harmonised standards; and
intended for sports and leisure purposes

Partly completed boats

i.e. boats consisting of a hull and/or components

Components

referred to in Annex II of the Directive when

separate and when installed

Appliances

permanently serving specific levels in buildings

and constructions; having a car moving along
guides that are rigid and inclined at an angle of
more than 15 degrees to the horizontal; and
intended for the transport of persons and/or
goods, the car being in each case accessible
used in lifts and referred to in Annex IV of the
Directive

Safety components
17.

Refrigeration appliances

Electric mains-operated
refrigerators
Frozen food storage cabinets
Food freezers
Combinations of these

18.

Pressure equipment

Vessels*

i.e. housings designed and built to contain fluids

under pressure including their direct attachments
up to the coupling point connecting it to other
equipment
i.e. piping components intended for the transport
of fluids, when connected together for integration
into a pressure system

Piping*

Safety accessories*

i.e. devices designed to protect pressure equipment against the allowable limits being exceeded

Pressure accessories*

i.e. devices with an operational function and

having pressure-bearing housings

Assemblies*

i.e. several pieces of pressure equipment

assembled by a manufacturer to constitute an
integrated and functional whole*
intended to be connected to the public telecommunications network in order to transmit,
process or receive data capable of being used
either for transmission only, or for transmission
and reception, or for reception only, of radiocommunications signals by means of satellites
or other space-based systems
which are intended by the manufacturer to be
used for human beings for certain defined purposes (e.g. diagnosis, prevention, monitoring,
treatment or alleviation of disease); and which do
not achieve their principal intended action in or on
the human body by pharmacological, immunological or metabolic means; and which are reagent, a
reagent product, calibrator, control material, kit,
instrument, apparatus, equipment, or system,
whether used alone or in combination, intended
by the manufacturer to be used in vitro for the examination of specimens derived from the human
body for the purpose of providing information

19.

Telecommunications
terminal equipment

Equipment

20.

In vitro diagnostic medical

devices

Instruments, apparatus,
appliances, materials or
other articles, whether
used alone or in combination (including the software
necessary for its proper
application)

* provided that the

maximum allowable
pressure is greater
than 0.5 bar

82

 Annex 6

21.

II

New Approach
directive

Radio and telecommunications terminal equipment

Directive based on
the principles of
the New Approach
or the Global Approach

Products that are as a general rule covered by the directive in question

Accessories

i.e. an article intended specifically by its manufacturer to be used together with others for in vitro
diagnostic examination

Telecommunications
terminal equipment

i.e. a product enabling communication or a relevant component thereof which is intended to be

connected directly or indirectly by any means
whatsoever to interfaces of public telecommunications networks

Radio equipment

i.e. a product, or relevant component thereof,

capable of communication by means of the emission and/or reception of radio waves utilising the
spectrum allocated to terrestrial/space radio
communications

Products that are as a general rule covered by the directive in question

1.

Packaging and packaging

waste

Products

2.

High-speed rail system

Subsystems

made of any materials of any nature to be used

for the containment, protection, handling, delivery
and presentation of goods, from raw materials of
processed goods, from the producer to the user
or the consumer, as well as wastes from these
products
the trans-European high-speed rail-system is subdivided into eight subsystems;
the structural subsystems: infrastructures,
energy, control and command and signalling,
rolling stock;
the functional subsystems: maintenance, environment, operation, users
i.e. any elementary component, group of components, subassembly or complete assembly of
equipment incorporated or intended to be incorporated into a subsystem, upon which the interoperability of the trans-European high-speed rail
system depends either directly or indirectly
listed in the annexes to the directives, which must
either be placed on board a ship for use in order
to comply with international instruments or is
voluntarily placed on board for use, and for which
the approval of the flag State administration is
required according to international conventions,
resolutions, circulars, and testing standards

Inter-operability
constituents

3.

Marine equipment

Equipment

83

 Guide to the implementation of directives based on the New Approach and the Global Approach

Annex 7
Contents of conformity assessment procedures
Council Decision 93/465/EEC lays down the modules for conformity assessment, which are further defined in each directive. This annex is intended to give an overview of the tasks that are to be carried out under the responsibility of the manufacturer and the notified body, and the tasks that the manufacturer can delegate to the authorised representative. However,
there are differences between the conformity assessment procedures adopted by the directives, which are not taken into
account in this general presentation. Furthermore, the tasks to be carried out by the importer or the person responsible for
placing on the market are described in Section 3.3. of the Guide.

Module

Manufacturer

establishes a technical documentation as regards the

design, manufacture and
operation of the product
takes all measures necessary to ensure that the manufacturing process assures
compliance of the products
with the technical documentation and with the applicable
requirements (i.e. operates a
quality system)
In addition to the responsibilities as in module A:
carries out, or has carried
out on his behalf, one or
more tests for each product
manufactured
chooses a notified body on
whose responsibility the tests
are carried out

Aa1

Manufacturer or the
authorised representative
ensures and declares that
the products concerned
satisfy the requirements
affixes the CE marking to
each product
draws up a declaration of
conformity
keeps a copy of the declaration of conformity and the
technical documentation at
the disposal of the surveillance authorities
In addition to the responsibilities as in module A:
affixes the notified bodys
identification number to
follow the CE marking, if the
notified body intervened
during the production stage

Aa2

As in module A:
applies for product checks at
random intervals

In addition to the responsibilities as in module A:

affixes the notified bodys
identification number to
follow the CE marking

establishes a technical
documentation as regards
the design, manufacture and
operation of the product

applies for the EC typeexamination

places at the disposal of the
notified body one (or more)
specimen(s), which is (are)
representative of the production envisaged
informs the notified body of
all modifications to the
approved product
keeps the technical documentation, including a copy
of the EC type-examination
certificate, at the disposal of
the surveillance authorities

84

Notified body

supervises the tests carried

out by the manufacturer
supervises the affixing of its
identification number, where
it was involved in conformity
assessment during the production stage
keeps a record of relevant
information
communicates to the other
notified bodies relevant information (on request)
carries out or has carried out
product checks at random intervals, and for this purpose
takes samples of final products
supervises the affixing of its
identification number
keeps a record of relevant
information
communicates to the other
notified bodies relevant information (on request)
ascertains, by performing or
having performed examinations and tests, that the specimen(s) meet(s) the applicable
provisions and is manufactured in accordance with the
technical documentation
issues an EC type-examination certificate
keeps a copy of the certificate and a record of other
relevant technical information
communicates to the other
notified bodies the relevant
information concerning the
EC type-examination certificates (on request)

 Annex 7

Module

Manufacturer

Manufacturer or the
authorised representative
ensures and declares that
the products concerned are
in conformity with the EC
type-examination certificate
and satisfy the applicable
requirements
affixes the CE marking to
each product
draws up a declaration of
conformity
keeps relevant technical
information and a copy of the
declaration of conformity at
the disposal of the surveillance authorities

Notified body

takes all measures necessary to ensure that the manufacturing process assures
compliance of the products
with the type as described in
the EC type-examination certificate and with the applicable requirements (i.e. operates a quality system, which
includes establishing the
necessary documentation)

Cbis1
Cbis2

As in modules C and Aa1

As in modules C and Aa1

As in module Aa1

As in modules C and Aa2

As in modules C and Aa2

As in module Aa2

operates an approved quality

system for production, final
product inspection and
testing, which includes the
drawing up of a technical
documentation (i.e. relevant
information for the product
category envisaged, documentation concerning the
quality system and its updating, technical documentation
of the approved type, a copy
of the EC type-examination
certificate, and the decisions
and reports from the notified
body)
applies for the assessment
of the quality system for the
products concerned
ensures and declares that
the products concerned are
in accordance with the EC
type-examination certificate
and satisfy the applicable
requirements
undertakes to fulfil the obligations arising out of the
approved quality system and
upholds it so that it remains
adequate and efficient
supports the action carried
out by the notified body for
surveillance purpose
keeps at the disposal of the
surveillance authority the
documentation concerning
the quality system, details of
any updating of the quality
system, the decisions and
reports of the notified body

affixes the CE marking to

each product
affixes the notified bodys
identification number to
follow the CE marking
draws up a declaration of
conformity
informs the notified body of
any intended updating of the
quality system
keeps a copy of the declaration of conformity at the
disposal of the surveillance
authorities

assesses the quality system

to determine whether it satisfies the applicable requirements, and accordingly takes
a decision
supervises the affixing of its
identification number
carries out surveillance of the
manufacturer by means of
periodic and unexpected
visits
keeps a record of relevant
technical information
communicates to the other
notified bodies the relevant
information concerning the
quality system approvals
issued and withdrawn (on
request)

85

 Guide to the implementation of directives based on the New Approach and the Global Approach

Module

Manufacturer

Dbis

establishes a technical documentation as regards the design, manufacture and operation of the product
operates an approved quality
system for production, final
product inspection and
testing, which includes the
drawing up of a technical
documentation (i.e. relevant
information for the product
category envisaged, documentation concerning the
quality system and its updating, and the decisions and
reports from the notified body)
applies for the assessment of
the quality system for the
products concerned
ensures and declares that
the products concerned
satisfy the requirements
undertakes to fulfil the
obligations arising out of the
approved quality system and
upholds it so that it remains
adequate and efficient
supports the action carried
out by the notified body for
surveillance purpose
keeps at the disposal of the
surveillance authority the documentation concerning the
quality system, details of any
updating of the quality system, the decisions and reports of the notified body
As in module D, but operates
an approved quality system for
final product inspection and
testing
As in module Dbis, but operates
an approved quality system for
final product inspection and
testing
takes all measures necessary to ensure that the manufacturing process assures
conformity of the products
with the type as described in
the EC type-examination
certificate and with the applicable requirements (i.e.
operates a quality system,
which includes establishing
the necessary documentation)

Ebis

Where the statistical verification

is used:
presents the products in the
form of homogeneous lots
and takes all measures
necessary in order that the
manufacturing process
ensures the homogeneity of
each lot produced

Manufacturer or the
authorised representative
As in module D

Notified body

As in module D

As in module D

As in module D

As in module D

applies for certification of

conformity
checks and attests that the
products are in conformity
with the type as described in
the EC type-examination
certificate and satisfy the
applicable requirements
affixes the CE marking to
each product
affixes the notified bodys
identification number to
follow the CE marking
draws up a declaration of
conformity
keeps relevant technical
information (e.g. the notified
bodys certificate of conformity) and a copy of the declaration of conformity at the
disposal of the surveillance
authorities

carries out the appropriate

examinations and tests in
order to check the conformity of the product with the
applicable requirements
either by examination and
testing of every product, or
by examination and testing of
products on a statistical
basis
supervises the affixing of its
identification number
draws up a certificate of
conformity relating to the
tests carried out
if a lot is rejected, takes
appropriate measures to
prevent the putting on the
market of that lot
keeps a record of relevant
technical information
communicates to the other
notified bodies relevant
information (on request)

86

As in module D

 Annex 7

Module

Manufacturer

Fbis

establishes a technical documentation as regards the

design, manufacture and
operation of the product
takes all measures necessary to ensure that the manufacturing process assures
conformity of the products
with the applicable requirements (i.e. operates a quality
system)

Where the statistical verification

is used:
presents the products in the
form of homogeneous lots
and takes all measures
necessary in order that the
manufacturing process
assures the homogeneity of
each lot produced
establishes a technical
documentation as regards
the design, manufacture and
operation of the product
ensures and declares that
the product concerned
conforms to the applicable
requirements

operates an approved quality

system for design, manufacture, final product inspection
and testing, which includes
the drawing up of a technical
documentation (i.e. relevant
information for the design,
the product category envisaged, documentation concerning the quality system
and its updating, and the
decisions and reports from a
notified body)
applies for the assessment
of the quality system for the
products concerned
ensures and declares that the
products concerned satisfy
the applicable requirements
undertakes to fulfil the obligations arising out of the
approved quality system and
upholds it so that it remains
adequate and efficient
supports the action carried
out by the notified body for
surveillance purpose
keeps at the disposal of the
surveillance authority the
documentation concerning
the quality system, details of
any updating of the quality
system, the decisions and
reports of the notified body

Manufacturer or the
authorised representative
applies for certification of
conformity
checks and attests that the
products satisfy the applicable requirements
affixes the CE marking to
each product
affixes the notified bodys
identification number to
follow the CE marking
draws up a declaration of
conformity
keeps a copy of the declaration of conformity, the technical documentation and the
notified bodys certificate of
conformity at the disposal of
the surveillance authorities

Notified body

applies for certification of

conformity
affixes the CE marking to
each product
affixes the notified bodys
identification number to
follow the CE marking
draws up a declaration of
conformity
keeps a copy of the declaration of conformity and the
technical documentation at
the disposal of the surveillance authorities

examines the individual

product, and carries out the
appropriate tests to ensure
its conformity with the
relevant requirements
supervises the affixing of its
identification number
keeps a record of relevant
information
draws up a certificate of
conformity concerning the
tests carried out
communicates to the other
notified bodies relevant
information (on request)

As in module D

As in module D

87

As in module F

 Guide to the implementation of directives based on the New Approach and the Global Approach

Module

Manufacturer

Hbis

In addition to responsibilities as
in module H:
applies for examination of the
design
informs the notified body of
any modification to the
approved design

Manufacturer or the
authorised representative
As in module D

88

Notified body
In addition to responsibilities as
in module D:
examines the application
issues an EC design examination certificate, if the design
meets the applicable provisions
keeps a record of the EC
design examination certificates and the EC design
approvals
communicates to the other
notified bodies relevant information concerning the EC
design examination certificates and the EC design
approvals (on request)

 Annex 8

Annex 8
Flow chart presentation of conformity assessment procedures as provided for by the
directives

I
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
II
21.

New Approach directives

Low voltage equipment (73/23/EEC, amendment 93/68/EEC)
Simple pressure vessels (87/404/EEC, amendments 90/488/EEC and 93/68/EEC)
Toys (88/378/EEC, amendment 93/68/EEC)
Electromagnetic compatibility (89/336/EEC, amendments 92/31/EEC and 93/68/EEC)
Machinery (98/37/EC, amendment 98/79/EC)
Personal protective equipment (89/686/EEC, amendments 93/68/EEC, 93/95/EEC and 96/58/EC)
Non-automatic weighing instruments (90/384/EEC, amendment 93/68/EEC)
Active implantable medical devices (90/385/EEC, amendments 93/42/EEC and 93/68/EEC)
Gas appliances (90/396/EEC, amendment 93/68/EEC)
Hot water boilers (92/42/EEC, amendment 93/68/EEC)
Civil explosives (93/15/EEC)
Medical devices (93/42/EEC, amendment 98/79/EC)
Potentially explosive atmospheres (94/9/EC)
Recreational craft (94/25/EC)
Lifts (95/16/EC)
Refrigeration appliances (96/57/EC)
Pressure equipment (97/23/EC)
Telecommunications terminal equipment (98/13/EC)
In vitro diagnostic medical devices (98/79/EC)
Radio and telecommunications terminal equipment (99/5/EC)
Directive based on the principles of the Global Approach, but which does not provide for the CE marking
Marine equipment (96/98/EC)

89

90
Module A

EC declaration of conformity
(Internal Production Control - Annex III. B).
Manufacturer ensures and declares
compliance of manufactured products with
technical documentation and with Directive
requirements.

NB: In the event of a challenge the manufacturer may submit a report by a notified body on the conformity of the equipment with the safety objectives (Article 8.2).

MANUFACTURER

Technical File (Annex IV.3)

Manufacturer establishes the
technical documentation covering
the design, manufacture and
operation of the electrical equipment

1. Flow chart for the conformity assessment procedures provided for in

Directive 73/23/EEC on electrical equipment designed for use within certain voltage limits

Guide to the implementation of directives based on the New Approach and the Global Approach

(*)

91

PS. V <
50 bar.L

Function
of value PS. V
(Art. 3.2
& 8.1)

No or
partial

Manufacture in
accordance with
sound engineering
practice (Art. 3.2)

MODULE B (*)

EC type
examination
(Art.10)

MODULE A+ (*)
Value
of PS. V

PS. V <
3000 bar.L

PS. V >
3000 bar.L

Manufacturers
choice

No CE
marking

MODULE Cbis2+

EC conformity declaration,
by manufacturers,
plus EC surveillance by NB
if PS. V>200 bar.L (Art. 12).

MODULE F (*)

EC Verification (Art. 11)

NB verifies and certifies SPV
conformity. Manufacturers
declare the conformity.

These procedures were approved before the adoption of Council Decision 90/683/EEC (as amended by Decision 93/465/EEC) on conformity assessment procedures (modules).
Their provisions may therefore not be identical to those of the modules.

MANUFACTURER

PS. V >
50 bar.L

Compliance with
standards

Yes

Manufacturers
choice

Certification of
file adequacy
by NB

2. Flow chart for the conformity assessment procedures provided for in

Directive 87/404/EEC on simple pressure vessels

Annex 8

(*)

92
Non-compliance,
in whole or in part

Compliance
with
standards

MODULE B (*)

EC type-examination
(Art. 10)

MODULE C (*)

Manufacturer confirms
conformity of production with
type and keeps technical file or
technical reports inspection (Art. 8.2)

These procedures were approved before the adoption of Council Decision 90/683/EEC (as amended by Decision 93/465/EEC) on conformity assessment procedures (modules).
Their provisions may therefore not be identical to those of the modules.

MANUFACTURER

Yes

MODULE A (*)

Manufacturer keeps technical file

or technical report, ensuring
conformity of production
to standard (Art. 8)

3. Flow chart for the conformity assessment procedures provided for in

Directive 88/378/EEC on the safety of toys

Guide to the implementation of directives based on the New Approach and the Global Approach

(*)

93

Radio
transmitters

Type
of product
Technical construction
file (Art. 10.2)
by manufacturer

MODULE B (*)

EC type-examination
(Art 10.5)

Non-application or
partial application of
harmonised standards

MODULE A (*)

Technical report or
certificate by a
competent body (Art. 10.2)

EC declaration of conformity
by manufacturer

MODULE C (*)

EC declaration of
conformity with type
approved

Self certification (Art. 10.1)

These procedures were approved before the adoption of Council Decision 90/683/EEC (as amended by Decision 93/465/EEC) on conformity assessment procedures (modules).
Their provisions may therefore not be identical to those of the modules.

MANUFACTURER

Other than
radio transmitters

Application
of harmonised
standards

Full
application

4. Flow chart for the conformity assessment procedures provided for in

Directive 89/336/EEC on electromagnetic compatibility

Annex 8

(*)

94

Referred to
in Annex IV
and complying
with standards

(Annex IV)

(Annex IV)

Type
of machines and
safety components

Referred to in Annex IV,

without meeting or only
partly meeting the
standards, or if no such
standards exist

MODULE B (*)

EC type-examination
(Annex VI)

Technical file (Annex VI)

submitted to NB for
certification of adequacy
for the file

Technical file (Annex VI)

sent to notified body

MODULE B (*)

EC type examination
(Annex VI)

MODULE A

(1)

bear CE marking. All machines

and safety components
must be accompanied by
the EC declaration of
conformity.

(1) Safety components do not

Conformity declaration to type

covered by the EC type examination

MODULE A

EC conformity declaration
with essential requirements

These procedures were approved before the adoption of Council Decision 90/683/EEC (as amended by Decision 93/465/EEC) on conformity assessment procedures (modules).
Their provisions may therefore not be identical to those of the modules.

MANUFACTURER

Type
of machines and
safety components

Not referred
to in Annex IV

Technical construction
file (Annex V)

5. Flow chart for the conformity assessment procedures provided for in

Directive 98/37/EC on machinery

Guide to the implementation of directives based on the New Approach and the Global Approach

(*)

95

Technical file
(Annex III)

MODULE B (*)

EC type-examination
(Art. 10)

Other
equipment

Type of
product

Complex design
PPE (Art. 8.4a)

Type of
product

Other
equipment

Manufacturers
choice

MODULE C (*)

MODULE D (*)

EC declaration of conformity
(EC production quality system
(Art 11B))
NB assesses and monitors
the manufacturers quality
system.

MODULE C bis2 (*)

EC declaration of conformity
(EC final product quality
system (Art. 11A))
NB carries out product checks

EC declaration of conformity
to type (Art. 12)

MODULE A (*)

These procedures were approved before the adoption of Council Decision 90/683/EEC (as amended by Decision 93/465/EEC) on conformity assessment procedures (modules).
Their provisions may therefore not be identical to those of the modules.

MANUFACTURER

Simple design
PPE (Art. 8.3)

EC declaration of conformity
to essential requirements (Art. 12)

6. Flow chart for the conformity assessment procedures provided for in

Directive 89/686/EEC on personal protection equipment (PPE)

Annex 8

(*)

96

Art. 1.2b

Use of
product

Manufacturers
choice

Manufacturers
choice

Manufacturers
choice

The product must bear:

the manufacturers mark or name
the maximum capacity
(Annex IV.2)

MODULE G (*)

EC unit verification (Annex II.4)

NB verifies and certifies that instrument
meets the directive requirements.

MODULE B (*)

EC type-examination
(Annex II.1)

MODULE F (*)

EC verification (Annex II.3)

NB verifies and certifies that
products conform to type

MODULE D (*)

EC conformity declaration
with type (product quality
assurance - Annex II.2)
NB assesses and monitors the
manufacturers quality system

No CE
marking

These procedures were approved before the adoption of Council Decision 90/683/EEC (as amended by Decision 93/465/EEC) on conformity assessment procedures (modules).
Their provisions may therefore not be identical to those of the modules.

MANUFACTURER

Art. 1.2a

Instruments
Art. 8.1a
2nd para

7. Flow chart for the conformity assessment procedures provided for in

Directive 90/384/EEC on non-automatic weighing instruments

Guide to the implementation of directives based on the New Approach and the Global Approach

(*)

97

All other
devices

Type
of product
Art. 9

Manufacturers
choice

MODULE B (*)

EC type-examination
(Annex 3)

MODULE Hbis (*)

Manufacturers
choice

EC declaration of conformity
(complete quality assurance
system + product design file (Annex 2))
NB issues an EC design examination
certificate (Annex 2, para. 4)
NB assesses and monitors the
manufacturers quality system

MODULE F (*)

EC verification (Annex 4)
NB verifies and certifies that
products conform to the type

MODULE D (*)

EC declaration of conformity
to type (production quality
assurance (Annex 5))
NB assesses and monitors the
manufacturers quality system

No CE
marking

These procedures were approved before the adoption of Council Decision 90/683/EEC (as amended by Decision 93/465/EEC) on conformity assessment procedures (modules).
Their provisions may therefore not be identical to those of the modules.

MANUFACTURER

Custom made
devices and devices for
clinical investigations

Manufacturers declaration
(Annex 6)
+ technical file

8. Flow chart for the conformity assessment procedures provided for in

Directive 90/385/EEC on active implantable medical devices

Annex 8

(*)

98

Other
equipment

Type of
production

MODULE B (*)

EC type examination
(Annex II.1)

MODULE G (*)

Manufacturers
choice

MODULE F (*)

EC verification (Annex II.5)

NB verifies and certifies that products
conform with the type

MODULE E (*)

EC conformity declaration with the type

(production quality assurance, Annex II.4)
NB assesses and monitors the manufacturers quality system

MODULE D (*)

EC conformity declaration with the type

(production quality assurance, Annex II.3)
NB assesses and monitors the manufacturers quality system

MODULE C (*)

EC conformity declaration with

the type (Annex II.2)
NB carries out spot checks on devices

CE marking, but they are

accompanied by a certificate.

(1) Fittings dont bear

(1)

These procedures were approved before the adoption of Council Decision 90/683/EEC (as amended by Decision 93/465/EEC) on conformity assessment procedures (modules).
Their provisions may therefore not be identical to those of the modules.

MANUFACTURER

Simple design
PPE (Art. 8.3)

EC unit verification (Annex II.6)

NB verifies and certifies that the appliance
meets the directive requirements
Technical design file (Annex IV) is made
available to the NB

9. Flow chart for the conformity assessment procedures provided for in

Directive 90/396/EEC on appliances burning gaseous fuels

Guide to the implementation of directives based on the New Approach and the Global Approach

99

Liquid-fired boilers,
series production

Type of
production

MODULE B

EC type-examination
(Annex III)

Manufacturers
choice

Note: the Directive provides in Article 6 for a label system awarding the boilers energy performances.

MANUFACTURER

Gas-fired
boilers

Gas-fired boilers are submitted to conformity

assessment procedures provided for in
Directive 90/396/EEC, appliances burning
gaseous fuels (Art. 7(2))

MODULE E

EC conformity declaration with type

(product quality assurance, Annex IV)
NB assesses and monitors
manufacturers quality system

MODULE D

EC conformity declaration with type

(production quality assurance, Annex IV)
NB assesses and monitors
manufacturers quality system

MODULE Cbis2

EC conformity declaration with type (Annex IV).

NB carries out spot checks on appliances

10. Flow chart for the conformity assessment procedures provided for in
Directive 92/42/EEC on efficiency requirements for new hot water boilers fired with liquid or gaseous fuel

Annex 8

MANUFACTURER

Manufacturers
choice

100
MODULE B

EC type examination
(Annex II.1)

MODULE G

Manufacturers
choice

EC unit verification (Annex II.6)

NB verifies and certifies that the appliance
meets the directive requirements
Technical file (Annex IV) is made
available to the NB

MODULE F

Product verification (Annex II. 5)

NB verifies and certifies that products
conform with the type

MODULE E

Production quality assurance

(Annex II.4)
NB assesses and monitors the manufacturers quality system

MODULE D

Production quality assurance

(Annex II.3)
NB assesses and monitors the manufacturers quality system

MODULE Cbis2

Conformity to type (Annex II.2)

NB carries out products checks
at random intervals.

11. Flow chart for the conformity assessment procedures provided for in
Directive 93/15/EEC on explosives for civil uses

Guide to the implementation of directives based on the New Approach and the Global Approach

101

(a) obtention of sterile devices,

(b) metrological aspects.

(*) Third party assessment relates to

MANUFACTURER

to Chart 2

Type of
product

Product
class II

Product
class II B

Product
class I

Product
class II B

Manufacturers
choice

MODULE A

EC declaration of
conformity
(Annex VII)
+ technical file

Manufacturers
choice

Yes

MODULE B

EC type-examination
(Annex III)

Manufacturers
choice

MODULE H

Manufacturers
choice

Full quality assurance system (Annex II)

NB assesses and monitors the
manufacturers quality system
EC design verification by NB
(Annex II.4) not applicable

MODULE A

EC declaration of
conformity
(Annex VII)
+ technical file

Products
in Annex
VII.5

No

(*)

(*)

(*)

MODULE E

Product quality assurance (Annex VI)

NB assesses and monitors the
manufacturers quality system

MODULE D

Production quality assurance (Annex V)

NB assesses and monitors the
manufacturers quality system

MODULE F

EC verification (Annex IV)

NB verifies and certifies that
products conform with the type

MODULE E

Production quality assurance (Annex VI)

NB assesses and monitors the manufacturers quality
system. Manufacturer declares that products conform
with the technical file

MODULE D

Production quality assurance (Annex V)

NB assesses and monitors the manufacturers quality
system. Manufacturer declares that products conform
with the technical file

MODULE F

EC verification (Annex IV)

NB verifies and certifies that
products conform with the technical file

12.1. Flow chart for the conformity assessment procedures provided for in
Directive 93/42/EEC on medical devices

Annex 8

Manufacturers
choice

102

Medical devices, bearing

the CE marking,
marketed as systems
or procedure packs (Art. 12)

Manufacturers
choice

Sterile
devices

Manufacturers
choice

Statement concerning devices

for special purposes (Annex VIII)
The manufacturer declares that
products conform with essential
requirements

MODULE B

EC type-examination
(Annex III)

Manufacturer declaration
according to Art. 12.2

Devices for clinical

investigations and
custom-made devices

Product
class III

from Chart 1

MODULE E

Product quality assurance (Annex VI)

NB assesses and monitors the
manufacturers quality system

MODULE D

Production quality assurance (Annex V)

NB assesses and monitors the
manufacturers quality system

MODULE F

EC verification (Annex IV)

NB verifies and certifies that
products conform with the type

MODULE E

Full quality assurance system (Annex II)

NB assesses and monitors the manufacturers quality
system. NB verifies and certifies the design
conformity

MODULE D

Production Quality Assurance (Annex V)

NB assesses and monitors the manufacturers quality
system. Manufacturer declares that products conform
with the type

MODULE F

EC verification (Annex IV)

NB verifies and certifies that
products conform with the technical file

12.2. Flow chart for the conformity assessment procedures provided for in
Directive 93/42/EEC on medical devices (cont.)

No
complementary
CE marking

No CE
marking

Guide to the implementation of directives based on the New Approach and the Global Approach

103

Manufacturers
choice
(*) (**)

Products
Art. 8.1 (c)

MODULE G

Unit verification (Annex IX)

NB verifies and certifies that products
meet the directive requirements

Products
Art. 8.1 (b)(ii)

Products
Art. 8. 1(b)

Products
Art. 8.1 (b)(i)

Manufacturers
choice

MODULE A

Internal control of production (Annex VIII)

Manufacturer declares conformity to the
directive and keeps the technical file

MODULE A+

Internal control of production (Annex VII)

Manufacturer declares
conformity to the directive and
communicates the technical
file to NB

MODULE E

Production quality assurance (Annex VII)

NB assesses and monitors the
manufacturers quality system

MODULE Cbis1

Conformity to type (Annex VI)

Manufacturer declares that products
conform with the type

MODULE F

Product verification (Annex V)

NB verifies and certifies that products
conform with the type

MODULE D

MODULE B
Manufacturers
choice

Production quality assurance (Annex IV)

NB assesses and monitors the
manufacturers quality system

EC type examination
(Annex III)

(*) All referred procedures shall be applied in respect of components, with the exception of the affixing of the CE marking (Art. 8.3).
(**) Manufacturer may follow the internal control of production (Annex VIII) procedure with regard to the safety aspects referred to in point 1.2.7 of Annex II to the Directive.

for components

(1) No CE marking

MANUFACTURER

Type
of
product

Products
Art. 8.1 (a)
and Art. 8.2

13. Flow chart for the conformity assessment procedures provided for in
Directive 94/9/EC on equipment and protective systems intended for use in potential explosive atmospheres

(1 )

Annex 8

104

Type of
product

Boat design
category D
2.5 m < hull < 24 m

boats are not CE

marketed. All products
must be accompanied
by the EC declaration
of conformity.

(1) Partly completed

MANUFACTURER
Boat design
category C

12 m < hull < 24 m

Components
in Annex II

Boat design
categories A and B

Hull
length

hull < 12 m

Hull
length

2.5 m < hull < 12 m

2.5 m < hull < 12 m

Manufacturers
choice

MODULE B

EC type-examination
(Annex VII)

MODULE Aa

Internal production control

plus test (Annex VI)

Comply
with
standards
YES

NO

Manufacturers
choice

14. Flow chart for the conformity assessment procedures provided for in
Directive 94/25/EC on recreational craft

MODULE A

Internal production control

(Annex V)

MODULE H

Internal production control

plus tests (Annex VI)

MODULE H

Full quality assurance (Annex XII)

NB assesses and monitors the
manufacturers quality system

MODULE G

Unit verification (Annex XI)

NB verifies and certifies that
the products meet the directive
requirements

MODULE F

Product verification (Annex X)

NB verifies and certifies that
products conform with the type

MODULE D

Production quality assurance

(Annex IX)
NB assesses and monitors the
manufacturers quality system

MODULE C

Conformity to type (Annex VIII)

Manufacturer declares that
products conform with the type

(1 )

Guide to the implementation of directives based on the New Approach and the Global Approach

105

Safety
components
on lift

Manufacturers
choice

INSTALLER (for lifts)

MANUFACTURER
(for safety components)

Safety
components

Lifts

Installers
choice

MODULE B

Manufacturers
choice

Lift designed in accordance with

a lift for which a full quality
assurance system (Annex XIII)
was implemented, supplemented
by a design examination in case
it does not wholly comply with
the harmonised standards

Lift designed in accordance with

a model lift having undergone
EC type-examination
(Annex V)

EC type-examination
(Annex V)

Design
approach

Lift designed in accordance with

a lift having undergone
EC type-examination (Annex V)

MODULE D

Production quality assurance (Annex XIV)

NB assesses and monitors the installers
quality system
Installer draws up a declaration of conformity

Product quality assurance (Annex XII)

NB assesses and monitors the installers
quality system
Installer draws up a declaration of conformity
MODULE E

MODULE H

Full quality assurance (Annex IX).

NB assesses and monitors manufacturers quality system
Manufacturer draws up a declaration of conformity

MODULE E

Product quality assurance (Annex VIII)

NB assesses and monitors manufacturers quality system
Manufacturer draws up a declaration of conformity

MODULE Cbis2

Conformity to type with random checking (Annex XI)

NB carries out product checks at random intervals
Manufacturer draws up a declaration of conformity

MODULE Hbis

Full quality assurance (Annex X)

NB assesses and monitors the installers quality system
Installer draws up a declaration of conformity
NB inspects the design where it is not entirely in accordance with
harmonised standards

MODULE G

Unit verification (Annex X)

NB verifies and certifies that lifts meet the Directive requirements
Installer draws up a declaration of conformity

Installers
choice

Final inspection (Annex VI)

NB verifies and certifies that lifts meet
Directive requirements
Installer draws up a declaration of conformity

15. Flow chart for the conformity assessment procedures provided for in
Directive 95/16/EC on lifts

Annex 8

MANUFACTURER

Electric mains-operated refrigerators,

frozen food storage cabinets,
food freezers, combination of these

106
MODULE A

Internal control of production (Annex II)

16. Flow chart for the conformity assessment procedures provided for in
Directive 96/57/EC on refrigeration appliances

Guide to the implementation of directives based on the New Approach and the Global Approach

107

Steam or
superheated
water
6

n-d

gaseous
d

liquid

n-d

Yes

No

CE marking

(1) If classified on the basis of PS and V. See Annex II, point 3.

(2) If classified on the basis of PS and DN. See Annex II, point 3.
(3) d means dangerous fluid. See Article 9.2.1.
(4) n-d means non-dangerous fluid. See Article 9.2.2.
(5) Within an assembly, CE marking need not be affixed to each individual item of pressure equipment.

A; A1; D1; E1; B1+D; B1+F; B+E; B+C1; H; B+D; B+F; G; H1

A1; D1; E1; B1+D; B1+F; B+E; B+C1; H; B+D; B+F; G; H1
B1+D; B1+F; B+E; B+C1; H; B+D; B+F; G; H1
B+D; B+F; G; H1

n-d

I
II
III
IV

liquid

See Article 3.3

Piping
Pressure accessories (2)

SEP
(Sound engineering
practice)

n-d ( 4)

Fired or
otherwise
heated
equipment

Applicable procedures
(For categories I to IV, the manufacturer must apply one of the modules
or one of the module combinations set out in the relevant category)

d (3)

gaseous

Vessels
Pressure accessories (1)

Category

Annex II:
Tables
specific categories as a
function of PS, V or DN

Fluid to be contained
(Art. 9)

Type of equipment

For specific equipment:

Category of equipment to be protected

In general:
Category IV

Safety accessories
(Annex II, point 2)

17. Directive 97/23/EC concerning pressure equipment

CE marking (5)

(c) Protection of assembly:

highest category of equipment to be
protected.

(b) Integration of items:

according to the highest category of
equipment not considering safety
accessories;

(a) Each item making up the

assembly:
according to its category;

Assemblies
Global procedure
(Art. 10.2)

Annex 8

108

Manufacturers
choice

MODULE H

EC conformity declaration
(full quality assurance)
(Annex IV)
NB assesses and monitors the
manufacturers quality system

Manufacturers
choice

MODULE D

EC conformity declaration with type

(production quality assurance)
(Annex II)
NB assesses and monitors
manufacturers quality system

NB: For specific equipment elements the manufacturer of satellite earth station equipment may use the internal production control procedure (Module A, Annex IX) as an alternative
to the above conformity assessment procedures.

MANUFACTURER

MODULE B

EC type-examination.
NB examines documentation
and tests products

MODULE Cbis2

EC conformity declaration with type

(Annex II)
NB carries out product checks

18. Flow chart for the conformity assessment procedures provided for in
Directive 98/13/EC relating to telecommunications terminal equipment and satellite earth station equipment

Guide to the implementation of directives based on the New Approach and the Global Approach

MANUFACTURER

Device covered
by Annex II

Yes

109

to Chart 2

Referred to in
list B of
Annex II

Referred to in
List A of
Annex II

Intended for
performance
evaluation

Manufacturers
choice

Manufacturers
choice

MODULE B

EC type-examination
(Annex V)

MODULE H

EC declaration of
conformity/full quality
assurance (Annex IV,
except points 4 and 6)

MODULE B

EC type-examination
(Annex V)

MODULE Hbis +

EC declaration of conformity/
full quality assurance + design
examination + verification of
manufactured products
(Annex IV)

Procedure
according to
Annex VIII

Manufacturers
choice

MODULE D +

MODULE D

from Chart 2

Statement
drawn up by
the manufacturer

EC declaration of
conformity/production
quality assurance
(Annex IV,
except point 5)

MODULE F

EC verification
(Annex V)

EC declaration of conformity/
production quality assurance/
verification of manufactured
products (Annex IV)

19.1. Flow chart for the conformity assessment procedures provided for in
Directive 98/79/EC on in vitro diagnostic medical devices

Annex 8

No

110

Intended for
performance
evaluation

Intended for
self testing

from Chart 1

No

Yes

Manufacturers
choice

Procedure according to
Annex VIII

MODULE A

EC declaration of conformity
(Annex III, except point 6)

MODULE A +

EC declaration of conformity +
examination of design
(Annex III)

19.2. Flow chart for the conformity assessment procedures provided for in
Directive 98/79/EC on in vitro diagnostic medical devices (cont.)

Statement drawn up by
the manufacturer

to Chart 1

Guide to the implementation of directives based on the New Approach and the Global Approach

111

Other than receiving parts of radio

equipment

Application of
harmonised standards

Manufacturers
choice

Yes

No

Manufacturers
choice

Manufacturers
choice

MODULE Aa

Internal control of production and

specific apparatus tests
(Annex III)

MODULE H

Full quality assurance

(Annex II)

MODULE Aa +

Internal control of production,

specific apparatus tests and
examination of the technical
construction file (Annex IV)

MODULE A

Internal control of production

(Annex II)

At the choice of the manufacturer, compliance with the essential requirements may be demonstrated, as an alternative, using the procedures of the Directives relating to low voltage equipment
and electromagnetic compatibility respectively, where the apparatus is within the scope of these Directives (see Tables 1 and 4)

MANUFACTURER

Telecommunications terminal equipment

which does not make use of the spectrum
allocated to terrestrial/space radio
communication, receiving parts of radio
equipment

20. Flow chart for the conformity assessment procedures provided for in
Directive 99/5/EC on radio and telecommunications terminal equipment

Annex 8

MANUFACTURER

112
Yes

Produced individually or
in small quantities and
not in series or in mass

No

Manufacturers
choice

Manufacturers
choice

MODULE G

Unit verification
(Annex B)

MODULE Hbis

Full quality assurance

and design examination
(Annex B)

MODULE B

EC type-examination
(Annex B)

MODULE F

Product verification
(Annex B)

MODULE E

Product quality
assurance (Annex B)

MODULE D

Production quality
assurance (Annex B)

MODULE C

Conformity to type
(Annex B)

Manufacturers
choice

21. Flow chart for the conformity assessment procedures provided for in
Directive 96/98/EC on marine equipment

Guide to the implementation of directives based on the New Approach and the Global Approach

European Commission
Guide to the implementation of directives based on the New Approach and the Global Approach
Luxembourg: Office for Official Publications of the European Communities
2000 112 pp. 21 x 29.7 cm
ISBN 92-828-7500-8

8
6
2
CO-22-99-014-EN-C

Guide to the implementation

of

directives based on
the New Approach

and

EUR

the Global Approach

OFFICE FOR OFFICIAL PUBLICATIONS

OF THE EUROPEAN COMMUNITIES
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European Commission